This rule is necessary to correct omissions, typographical errors, and erroneous citations and references that appear in title 10, chapter I of the Code of Federal Regulations. As to amendatory instruction number 19, this error is purely typographical and has existed since 1984 when 10 CFR part 51 was republished in the Federal Register on March 12, 1984 (49 FR 9352), with the error being corrected in this rulemaking. In republishing the S-3 rule in 1984, the Commission stated that “no changes have been made in the substantive provisions of the S-3 rule” (49 FR 9364).

Because these amendments involve minor corrections to existing regulations, the NRC has determined that notice and comment under the Administrative Procedure Act, 5 U.S.C. 553(b)(A) and (B), is unnecessary and that good cause exists to dispense with such notice and comment. For these reasons, good cause also exists to dispense with the usual 30-day delay in the effective date. Therefore, the amendments are effective upon their publication in the Federal Register .

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 contains no information collection requirements and, therefore, is not subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

A regulatory analysis has not been prepared for this final rule because the final rule makes corrections to the regulations.

The NRC has determined that these amendments do not involve any provision which would impose backfits as defined in 10 CFR chapter I; therefore, a backfit analysis need not be prepared.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) by superseding AD 95-18-14, Amendment 39-9361 (60 FR 46216, September 6, 1995); AD 99-24-15, Amendment 39-11440 (64 FR 66554, November 29, 1999); and AD 2000-16-12, Amendment 39-11868 (65 FR 50623, August 21, 2000); which are applicable to GE CF6-45, -50, -80A, -80C2, and -80E1 turbofan engines, was published in the Federal Register on June 12, 2002, (67 FR 40239). That action proposed to combine the requirements of AD 99-24-15 and AD 2000-16-12 with the following additional changes to:

• Adopt the accelerated initial inspection requirements of AD 2000-16-12 to spools acquiring 7,000 cycles-since-new (CSN) or more in service after July 28, 2001,

• Relax initial compliance requirement for the CF6-45, -50, and CF6-80A 13-inch billet spools to make them consistent with 9 and 10-inch billet spools,

• Add repetitive inspection requirements to the existing one-time inspection requirement for the CF6-80C and -80E series engine spool web and hub-to-web transition areas,

• Replace engine shop visit inspection threshold limits for certain spools with cyclic limits,

• Add a time limit for slot bottom inspection for 13-inch billet spools for CF6-45, -50, -80A engines and for 9-inch and 10-inch billet spools for CF6-45, -50, -80A, and -80C engines,

• Add a time limit for the initial inspection and add repeat inspection intervals for stage 3-5 slot bottom inspection for certain spools,

• Add a time limit for one-time inspection of 8-inch billet 2-piece spools, and

• Provide for an alternative modular inspection for the slot bottoms.

The action was prompted by a report of an uncontained failure of an HPCR 3-9 spool.

The inspections must be done in accordance with the following GE alert service bulletins (ASB's):

• ASB GE CF6-50 S/B 72-A1108, Revision 5, dated October 2, 2002.

• ASB GE CF6-50 S/B 72-A1131, Revision 4, dated October 2, 2002.

• ASB GE CF6-50 S/B 72-A1157, Revision 4, dated October 2, 2002.

• ASB GE CF6-80A S/B 72-A0678, Revision 5, dated October 2, 2002.

• ASB GE CF6-80A S/B 72-A0691, Revision 5, dated October 2, 2002.

• ASB GE CF6-80A S/B 72-A0719, Revision 5, dated October 2, 2002.

• ASB GE CF6-80C2 S/B 72-A0812, Revision 4, dated October 2, 2002.

• ASB GE CF6-80C2 S/B 72-A0848, Revision 8, dated October 2, 2002.

• ASB GE CF6-80C2 S/B 72-A0934, Revision 4, dated October 2, 2002.

• ASB GE CF6-80E1 S/B 72-A0135, Revision 3, dated October 2, 2002.

• ASB GE CF6-80E1 S/B 72-A0126, Revision 5, dated October 2, 2002.

• ASB GE CF6-80E1 S/B 72-A0137, Revision 4, dated October 2, 2002.

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

Several commenters state that inspection of the web per Alert Service Bulletin 72-A0848, after January 27, 2003, at 3,500 CSN is a decrease from inspection requirements prior to that date. The commenters feel that this requirement will force operators to remove engines off wing to do the inspection in order to comply with this proposed AD.

The FAA agrees. Based on information received from several commenters, this requirement will have an adverse economic and operational impact on several operators. We have reviewed a risk analysis that includes an extension of the web inspection requirement by six months, relative to the date proposed in the NPRM, and find that the new risk is still acceptable under the guidelines appropriate for this type of failure. As a result, the requirement has been extended by six months.

One commenter requests that a FAX number be added to the reporting requirements. Due to time differences around the world, the time allotted for reporting may not be sufficient for other means of communication

The FAA agrees. We have added a facsimile number to the reporting requirements.

One commenter requests certain word changes, such as replacing “by” with “at”, replacing “within” with “before”, etc., and adding certain paragraph headings. These changes are requested to make the AD requirements consistent and more understandable.

The FAA partially agrees. We consider the consistency of wording and the readability of the requirements of the AD to be of highest concern. However, we also feel that many of the suggested changes are stylistic and do not affect the technical accuracy or readability of the AD. We have made some of the requested changes to ensure consistency among the requirements and to improve the readability of the requirements of the AD.

Several commenters request that the title for paragraph (d) be corrected from “CF6-508-inch” to “CF6-50 8-inch.” The same commenters also request that the FAA correct service bulletin identifications in paragraphs (f), (g), and (j).

The FAA agrees. The title for paragraph (d) and the service bulletin numbers in paragraphs (f), (g), and (j) have been corrected.

Several commenters request that the definition of an engine shop visit be changed to exclude compressor top and bottom case removals for variable stator vane bushing replacements. The commenters feel the inclusion was made to add another condition to the conditions already identified as not constituting engine shop visits (ESV's).

The FAA agrees. We have changed the ESV definition paragraph to exclude the induction of an engine into the shop for the purpose of replacing the variable stator vane bushing.

One commenter feels that further explanation on the meaning of paragraph (c)(7) is needed.

The FAA agrees. Addition of a heading “Spool Reinstallation Limit” in this paragraph helps in clarifying the intent of this paragraph. Furthermore, as the paragraph states, an engine with a spool that has 10,500 CSN or more may not be installed ( i.e. returned to service). The paragraph does not require the removal of an installed engine that has a spool with 10,500 CSN or more.

One commenter requests clarification of paragraph (a)(3)(ii). The commenter feels that paragraph (a)(3)(ii) is necessary to do paragraphs (a)(3)(i) and (a)(3)(iii). The commenter feels that paragraphs (a)(3)(i) and (a)(3)(iii) are redundant to (a)(3)(ii) and can be deleted to simplify the requirements.

The FAA does not agree with deleting paragraphs (a)(3)(i) and (a)(3)(iii). A spool that is exposed as a piece part (paragraph (a)(3)(i)) is also exposed as a rotor (paragraph (a)(3)(ii)). Likewise, a spool that requires a hub inspection in accordance with ASB CF6-50 S/B 72-A1108 hub inspection (paragraph (a)(3)(iii)) must be exposed at least to a rotor level {(a)(3)(ii)} in order to do a module level inspection. In this sense, (a)(3)(i) and (a)(3)(iii) are redundant to (a)(3)(ii). However, each condition represents a common but distinct and different level of planned engine maintenance, therefore it was advisable to address each condition specifically for clarity.

One commenter requests that the FAA verify that paragraph (a)(4)(iii) and Table 5 are correct. The commenter feels that Table 5 of the AD causes a jump in the inspection interval. The commenter provides a correction to Table 5 of the AD to correct a perceived error in that Table.

The FAA has not been able to confirm the commenter's findings. The cyclic intervals for the Table 5 requirements are A; 3,500 cycles, B; 3,000 cycles, C; 3,000 cycles, D; 2,500 cycles, E; 2,500 cycles, F; 2,000 cycles, and G; 2,000 cycles. These intervals are as intended.

One commenter states that one of the requirements of this proposed rule may be misread as extending the inspection deadline of AD 2000-16-12 to beyond July 28, 2001. The commenter also suggests that if all the high-risk spools have been inspected, the proposed rule should be expedited, since one year has passed since the deadline of AD 2000-16-12.

The FAA agrees with the commenter on the need to expedite issuance of this AD. While the statement in the Discussion Section of the preamble of the proposal may be misinterpreted, the preamble is not regulatory and in fact, even the structure of the preamble changes when an NPRM is converted into a final rule. However, we have made changes to the statement in the Supplementary Information section to clarify the intent of this final rule. The intent of the proposed rule is to apply the same requirement on the population of the spools that would acquire 7,000 CSN after July 28, 2001. In regard to the comment inquiring if all spools have been inspected, we are not aware of any spool with 7,000 CSN or more that has not been inspected as required by AD 2000-16-12.

One commenter suggests that AD 95-18-14 that addresses FPI of the 3-9 spool should be included, since Standard Practices are only a suggestion and not a law. The commenter makes this comment out of concern that under this proposed rule the benefit of an additional inspection is eliminated.

The FAA does not agree. The requirements promulgated by AD 95-18-14 ensure that a spool is properly wetted internally prior to the FPI. Although FPI of the 3-9 spool is desired for the areas not affected by this AD, FPI is not the best technique for the inspection program established by this AD. While FPI is effective only for detection of surface cracks, the combination of ultrasonic and eddy current inspections required by this AD provide both surface and subsurface inspections that are of equal or greater sensitivity than FPI. The FPI required by AD 95-18-14 was an emergency measure instituted in 1995 after discovery of cracking in the disk web area, an area not then covered by ultrasonic and eddy current inspections. These inspection methods were subsequently developed and incorporated into the inspection plan. Additionally, AD 95-18-14 did not prescribe inspection intervals, only inspection techniques, therefore, the benefit of AD 95-18-14 was not considered in the risk analysis associated with the current AD's.

One commenter expresses a concern that additional spool P/N's, which have been generated due to unrelated repairs on spools that are subject to the inspection requirements of this AD, are not being captured by the AD. The commenter feels that these P/N's should be added to the AD. The commenter raises this issue to ensure that spools with P/N's that were not included in the proposed rule are not excluded from this inspection program.

The FAA agrees. The new P/N's will be incorporated in this AD. However, their incorporation does not increase the originally affected spool population size.

One commenter, the manufacturer, advises the FAA that the applicable service bulletins may be revised for nontechnical reasons. The commenter feels that the latest revisions of the service bulletins need to be incorporated into the AD.

The FAA agrees. The revision numbers and dates have been incorporated into this final rule.

One commenter requests that paragraph (j)(2) be changed to ensure that the hub and web receive an initial inspection if either of the two areas were not previously inspected. The same commenter suggests that paragraph (j)(2) be split into two paragraphs to properly specify the inspection deadlines for the hub and for the web, now that the originally proposed deadlines have been changed to accommodate the economic and operational burden associated with the web inspection.

The FAA agrees. We have changed paragraph (j)(2) of this AD. Because of the new schedule requirements, two paragraphs, each with its own schedule, are appropriate and the change has been made.

One commenter observes that the “replace before further flight” requirements for the CF6-50 spools include the reject limits of service bulletin CF6-50 S/B 72-A1131, while the preceding paragraph does not include this service bulletin. The commenter raised this comment out of concern that the inspection requirement per service bulletin CF6-50 S/B 72-A1131 was not identified in the preceding step.

The FAA partially agrees. In the current text, an inference may be made that spools must be inspected to all three referenced bulletins at each repeat inspection. The spool disposition requirements apply to results of all prescribed inspections specified in all the steps of the pertinent paragraph in the AD and not just to the preceding step. Therefore, for further clarification a heading “Spool Disposition” has been inserted.

One commenter requests that the heading Spool Reinstallation Limit be added before the applicable paragraphs. The commenter feels that the addition will clarify the intent of the paragraphs.

The FAA agrees. We have added the heading to the applicable paragraphs.

One commenter expresses concern that the requirements of ASB CF6-80C2 72-A0934, Revision 3, can not be done because the equipment and training necessary to carry out this inspection are not available at this time. The commenter makes this comment out of concern that the prescribed inspections could not be done, per the proposed rule timetables, since there was no scheduled delivery of the necessary equipment and associated training.

The FAA agrees. However, this issue has been addressed by the engine manufacturer. Both equipment and training will be available in time to enable the commenter to comply with the requirements of this AD, therefore, no changes have been made.

One commenter states that the introduction of an engine into the shop solely for the 3-9 spool inspection should not be considered a shop visit. The request is made so that the stage 3-5 dovetail slot bottom inspection for the CF6-80C2 13-inch billet spools would not be forced if the spools could otherwise comply using the module level inspection. The hub and web inspections can be done at module level merely by removing the fan module from the core. The slot bottom inspection requires additional disassembly to remove the compressor top case. The request is made to avoid this additional disassembly.

The FAA disagrees. Material testing and stress analysis indicate that the dovetail slot bottoms have a dwell-fatigue limitation. Accordingly, the rule requires initial slot bottom inspection at the earliest exposure (piece-part exposure or rotor exposure, which is realized upon top case removal) but not later than the next required inspection of the hub and/or web for dwell fatigue cracking. As the cracking mode is the same for all areas, the FAA can not apply lesser criteria to the slot bottoms.

One commenter requests that the repeat inspection of the CF6-80C 13-inch billet spool stage 3-5 dovetail slot bottoms be required at piece-part exposure only. Accomplishment of this inspection at a module level would require, at a minimum, the removal of the compressor top case.

The FAA disagrees for reasons stated in the answer to the previous comment.

One commenter states that there is no reference date for the initial inspection required in paragraph (a)(3) from which the operator is to determine items (i), (ii), and (iii) under this paragraph. The commenter uses the example that item (i) requires an inspection at the first piece-part exposure (PPE) after 1,000 CSN. The spool may have had several PPE's after 1,000 CSN in its life but never had the requirement to inspect at those visits. The commenter requests clarification of the reference date in this paragraph to ensure the proper time set.

The FAA disagrees. The proposal does not contain new requirements. It consolidates requirements of existing airworthiness directives, which include paragraph (a)(3). In the past, if an opportunity to have a PPE arose as the commenter states, the requirement of AD 99-24-15 would have been applicable. Additionally, the cyclic requirements of steps (i) and (ii) are associated with the cyclic life of the spool and not an independent cyclic interval. The third step (iii) also does not need the association with the effective date of this AD. Incorporation of the change the commenter proposes would conflict with requirements of the existing AD relative to the dovetail inspection. The proposed change would also affect additional paragraphs of the rule, not identified by the commenter, where similar arguments can be made.

One commenter, the manufacturer, informs the FAA that a potential for confusion exists regarding the requirements for the one-time hub inspection of 8-inch billet spools. The existing wording in certain ASB's could be interpreted such that a modular level inspection of the hub could be performed, when in fact, piece-part inspection using Procedure A is required to achieve the intended level of safety. The manufacturer has revised the appropriate ASB's to add this clarification and suggests additional wording be added to this rule to ensure the correct procedure is used.

The FAA agrees. We have clarified the hub inspection requirements for affected spools in paragraphs (d)(1), (h)(1), (k)(1), and (m)(1).

The same commenter states that the part number and serial number relationships for the CF6-50 16-inch and 13-inch billet spools relative to Table 2 were incorrect in the information that it sent to the FAA and need to be corrected in paragraphs (a) and (b), respectively.

The FAA agrees. We have made the appropriate changes to 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 changes described previously. The FAA has determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD.

There are approximately 3,147 engines of the affected design in the worldwide fleet. The FAA estimates that 1,289 engines installed on airplanes of U.S. registry would be affected by this proposed AD. The FAA also estimates that it would take approximately 238 work hours per engine to perform the proposed actions. The average labor rate is $60 per work hour. Required parts would cost approximately $35,000 per engine. In addition, because of the previous AD actions, the FAA estimates that only 72 percent (928 engines) of the engines installed on airplanes of U.S. registry would be affected. Based on these figures, the total cost of the proposed AD on U.S. operators is estimated to be $45,731,840.

This final rule does not have federalism implications, as defined in Executive Order 13132, because it would 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. Accordingly, the FAA has not consulted with state authorities prior to publication of this final rule.

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 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. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained by contacting the Rules Docket at the location provided under the caption ADDRESSES .

A final rule correction AD, FR Doc. 02-31173 applicable to General Electric Company CF34-8C1 turbofan engines was published in the Federal Register on December 11, 2002 (67 FR 76111). The following correction is needed:

On page 76111, in the third column, in the third line of the Summary, remove the AD number “(AD) 2002-23-09” and add in its place “(AD) 2002-23-02”.

Executive Order 13202 was signed on February 17, 2001, and amended on April 6, 2001 (E.O. 13208). The order provides that agencies may not require or prohibit offerors, contractors, or subcontractors from entering into or adhering to agreements with one or more labor organizations. It also permits agency heads to exempt a project from the requirements of the E.O. under special circumstances, but the exemption may not be related to a possible or an actual labor dispute. The amended E.O. also allows for exemption of a project governed by a project labor agreement in place as of February 17, 2001, which had a construction contract awarded as of February 17, 2001.

The E.O. applies to any construction project using Federal funds regardless of whether the award is expected to result in a contract, grant, or cooperative agreement. The Federal Acquisition Regulation (FAR) has already been revised to implement the E.O. relative to contracts. NASA is revising its Grant and Cooperative Agreement Handbook to implement the E.O. using language substantially the same as found in FAR section 36.202(d)), to ensure that E.O. 13202 requirements are consistently followed when funding construction projects under grants and cooperative agreements.

This is not a significant regulatory action and, therefore, was not subject to review under Section 6(b) of Executive Order 12866, Regulatory Planning and Review, dated September 30, 1993. This final rule is not a major rule under 5 U.S.C. 804.

NASA certifies that this final rule will not have a significant economic impact on a substantial number of small business entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) because most NASA construction projects are accomplished by contracts subject to the FAR and very few through grants or cooperative agreements.

The Paperwork Reduction Act does not apply because this final rule does not impose any recordkeeping or information collection requirements that require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq.

FDA regulations require persons submitting a new drug application (NDA) to provide bioavailability information (21 CFR 314.50(c)(2)(vi) and (d)(3)), and persons submitting an abbreviated new drug application (ANDA) to provide information pertaining to bioavailability and bioequivalence (§ 314.94(a)(7) (21 CFR 314.94(a)(7)).

FDA regulations in part 320 (21 CFR part 320) establish definitions and requirements for bioavailability and bioequivalence studies. FDA finalized the bioavailability and bioequivalence regulations on January 7, 1977 (42 FR 1624), and amended these regulations on April 28, 1992 (57 FR 17950). The 1992 amendments were designed to reflect statutory changes resulting from the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417).

In the Federal Register of November 19, 1998 (63 FR 64222), FDA proposed to revise its regulations on bioavailability and bioequivalence and the content and format of an ANDA to reflect current FDA policy and to correct certain typographical and inadvertent errors (the proposed rule). The publication of this final rule completes this rulemaking.

FDA is finalizing the proposed rule with the following revisions made in response to comments received on the proposal.

As proposed, the final rule changes the term “enteric coated” to “delayed release” and the term “controlled release” to “extended release” in § 320.22(c). To conform to this change, the final rule also amends §§ 320.1, 320.22(d)(2)(iv), 320.25(f), 320.27(a)(3)(iv), 320.27(b)(2), 320.28, and 320.31 by changing “controlled release” to “extended release.” To conform to the new terminology, the final rule also amends § 320.25(f) by changing “noncontrolled release” to “nonextended release.”

The following new first sentence has been added to redesignated § 320.25(a)(2): “An in vivo bioavailability study is generally done in a normal adult population under standardized conditions.” This sentence is a necessary lead-in for the existing text that refers to situations in which bioavailability studies may be conducted in patients.

The proposed rule would have revised § 320.26(b)(2)(i) to require a customary drug elimination period of five times, rather than at least three times, the half-life of the active drug ingredient or therapeutic moiety, or its active metabolite(s). In response to a comment pointing out that a drug elimination period of five half-lives may be impractically long for a drug with a long half-life, the agency has decided not to revise § 320.26(b)(2)(i).

The proposed rule would have revised § 320.27(d)(1) and (d)(2) to state that blood or urine samples should be taken on 3 or more consecutive days to establish that steady-state conditions have been achieved. Some comments stated that obtaining samples on consecutive days may be impractical and, for drugs with long half-lives, may be less sensitive to the establishment of steady state than data obtained over a longer period of time. The final rule requires that “appropriate dosage administration and sampling should be carried out to document steady state.” Specific advice about dosage administration and sampling may be obtained from the appropriate review division for the drug product.

The agency received seven comments from pharmaceutical companies, pharmaceutical company trade associations, and a law firm.

Section 314.94(a)(9) establishes information requirements for the chemistry, manufacturing, and controls section of an abbreviated application. Section 314.94(a)(9)(ii) through (v) provides that an abbreviated application may have different inactive ingredients than the reference listed drug as long as the applicant identifies and characterizes the inactive ingredients in the proposed drug product and provides information demonstrating that the inactive ingredients do not affect the safety of the drug product. The agency proposed to amend this section to recognize the possibility that the use of different inactive ingredients can also affect a product's efficacy.

(Comment 1) We received several comments about the addition of the word “efficacy.” One comment said this change is unnecessary because demonstrating bioequivalence provides proof of efficacy. One comment interpreted the change as suggesting that FDA is departing from its position that bioequivalence shows that the generic product is as effective as its reference listed drug. This comment asked what additional proof of effectiveness FDA would require. One comment agreed with the proposed change and asked that it apply to pending ANDA's. This comment also stated that animal tests should not be used to demonstrate that different inactive ingredients do not affect safety or efficacy because the act prohibits the use of animal or clinical studies to establish that the drug is safe or effective. Another comment expressed concern that the need to show that a different inactive ingredient does not affect safety or efficacy makes it more difficult to get approval for a generic topical drug product because clinical trials must be conducted.

As stated in the proposed rule, by adding the word “efficacy,” the agency acknowledges the possibility that the use of different inactive ingredients can also affect a product's efficacy. FDA is not departing from its position that a generic product that demonstrates bioequivalence to the reference listed drug has shown that it is as effective as that reference listed drug.

The agency disagrees with the comment stating the animal tests should not be used in the process of assessing the safety or efficacy of inactive ingredients that differ from those in the reference listed drug. In the preamble to the proposed ANDA regulations, the agency suggested that data from animal studies might be used as limited confirmatory testing to support an ANDA suitability petition or an ANDA resulting from such a petition (54 FR 28872 at 28880, July 10, 1989). The preamble cited as an example the use of limited confirmatory testing to show that an approved change in an active ingredient did not have acute effects on the safety of the product. In similar fashion, animal studies may be useful and appropriate to assist FDA in evaluating the safety or the effect on efficacy of a changed inactive ingredient.

Section 314.127 (21 CFR 314.127) lists the reasons why FDA will refuse to approve an ANDA. The agency proposed to revise § 314.127(a)(8) to clarify that, consistent with current FDA policy, the applicant must show that different inactive ingredients would not affect a product's efficacy.

(Comment 2) One comment stated that the proposed change is consistent with FDA's current policy when applied to parenteral and ophthalmic dosage forms, but otherwise is inconsistent with current policy. Another comment said this change is unnecessary because demonstrating bioequivalence provides proof of efficacy.

As stated in the proposed rule, and in the response to the previous comment, the addition of the word “efficacy” simply clarifies the current FDA approach rather than effecting a substantive change.

Proposed § 320.1(c) revised the definition of “pharmaceutical equivalents” with regard to drug products that contain a reservoir that facilitates delivery or where residual volume may vary.

(Comment 3) One comment approved of the change. The final rule is unchanged from the proposed rule.

Section 320.21(c)(1) provides that any person submitting a supplemental application to FDA must provide evidence or information regarding the product's bioavailability or bioequivalence if the supplemental application proposes “[a] change in the manufacturing process, including a change in product formulation or dosage strength, beyond the variations provided for in the approved application.” The agency proposed to amend this provision to include a change in the manufacturing site because such a change may affect the bioavailability or bioequivalence of the drug product because of equipment, personnel, or environmental changes.

(Comment 4) Several comments asserted that this proposed change is inconsistent with FDA's guidance “Immediate Release Solid Oral Dosage Forms—Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation” (November 1995) (SUPAC-IR guidance), which does not specify a demonstration of bioequivalence for level 1-3 changes. The comments recommended that any change to the regulation be consistent with the SUPAC-IR guidance.

FDA believes that this change is consistent with the SUPAC-IR guidance. The SUPAC-IR guidance describes the levels of changes, recommended tests, and filing documentation that ensure continuing product quality and performance characteristics of an immediate release dosage form for specific postapproval changes. Depending on the level of change and the solubility and permeability characteristics of the active drug substance, the SUPAC-IR guidance recommends different levels of in vitro dissolution tests and/or in vivo bioequivalence studies. The addition of a change in the manufacturing site to § 320.21(c)(1) does not mean that the agency would require an in vivo demonstration of bioequivalence in the circumstances provided for in the SUPAC-IR guidance. For manufacturing site changes, dissolution testing alone is generally sufficient to ensure unchanged product quality and performance for an immediate release solid oral dosage form. FDA expects to continue to follow the SUPAC-IR guidance in implementing § 320.21(c)(1) as revised.

The agency proposed to amend § 320.22(c) to change “enteric coated” to “delayed release” and “controlled release” to “extended release.”

(Comment 5) One comment stated that these terms should also be replaced in § 320.22(d)(2)(iv).

FDA agrees with this comment. The final rule amends § 320.22(d)(2)(iv) by changing “enteric coated” to “delayed release” and “controlled release” to “extended release.” The final rule also amends §§ 320.1, 320.25(f), 320.27(a)(3)(iv), 320.27(b)(2), 320.28, and 320.31 by changing “controlled release” to “extended release.” To conform to these changes, the final rule also amends § 320.25(f) by changing “noncontrolled release” to “nonextended release.”

Section 320.24 describes the types of evidence needed to establish bioavailability or bioequivalence. Instead of stating that bioavailability is demonstrated or established, the agency proposed to use the word “measured.”

(Comment 6) One comment objected to this across-the-board change, asserting that it is not possible to get a quantitative measure of bioavailability from an acute pharmacological effect, a well-controlled clinical trial, or an in vitro test. The comment suggested that the words “demonstrated” or “established” be used in discussing these types of evidence.

FDA disagrees with this comment. Bioavailability is an observational measure that always results in a quantitative figure. Therefore, the final rule will remain as it was proposed.

The agency proposed to remove § 320.25(a)(2) and redesignate § 320.25(a)(3) as § 320.25(a)(2). Current § 320.25(a)(2) provides in part that “[a]n in vivo bioavailability study shall not be conducted in humans if an appropriate animal model exists and correlation of results in animals and humans has been demonstrated.”

(Comment 7) One comment proposed the following new first sentence for redesignated § 320.25(a)(2): “An in vivo bioavailability study shall ordinarily be done in normal adults under standardized conditions.” The comment stated that this sentence is a necessary lead-in for the existing text that refers to situations in which bioavailability studies may be conducted in patients.

FDA agrees with this comment and has included similar language in the final rule.

Proposed § 320.26(b)(2)(i) stated that the customary drug elimination period should be five times the half-life of the active drug ingredient or therapeutic moiety, or its active metabolite(s).

(Comment 8) FDA received several comments on this section. One comment approved of the change from the three half-lives in the current regulation, while another comment recommended four half-lives. One comment disagreed with using half-life multiples to establish the duration of sampling because the terminal half-life is a function of the study design and the sensitivity of the assay and, in many cases, represents the elimination of small amounts of drug from deep compartments. In those cases, a five half-life requirement may greatly overestimate the time needed to measure the area under the curve (AUC) extrapolated to infinity. The comment recommended that the rule state: “The duration of blood sampling should be adequate to insure that the measured AUC represents at least 90% of AUC (infinity)” (AUC∞). Another comment, noting that many drugs exhibit multiexponential serum concentration-time profiles, asked FDA to substitute “97% of the AUC∞” for “five times the half-life.”

The agency recognizes that for a drug with a long half-life, a drug elimination period of five half-lives may be impractically long. FDA has concluded that a drug elimination period of three half-lives, which characterizes approximately 88 percent of the AUC∞, is sufficent. Therefore, the final rule leaves § 320.26(b)(2)(i) unchanged.

(Comment 9) One comment suggested that § 320.26(b)(2) should use an alternative phrase such as “washout period” or “time between dosings” rather than the term “drug elimination period” because that term could be confused with the concept of drug elimination. FDA disagrees with this comment. The term “drug elimination period” has been used in § 320.26(b)(2) since the bioequivalence regulations were finalized in 1992, and the agency has not found that it causes confusion. Drug elimination is the metabolic process that eliminates the drug from the body. The drug elimination period is the time allowed for subjects to clear the first drug from the body before giving the second drug. The term “drug elimination period” is retained in the final rule.

Proposed § 320.27(d)(1) and (d)(2) would have required sampling on 3 or more consecutive days to establish that steady-state conditions have been achieved whenever comparison of the test product and the reference material is to be based on blood concentration-time curves at steady state or urinary excretion-time curves at steady state.

(Comment 10) Several comments suggested deleting the word “consecutive” from § 320.27(d)(1). One comment stated that drugs with long half-lives accumulate slowly and the use of data from consecutive days for such drugs is less sensitive to the establishment of steady state than data obtained over a longer period of time. Another comment said that the 3-consecutive-day requirement is often not practical, particularly for urinary collection, and proposed dosing drugs for five to six half-lives or 1 week, whichever is longer, and then sampling blood or urine over one dosing interval.

One comment agreed that it is appropriate to obtain samples on 3 or more consecutive days. This comment stated that sometimes predose blood concentrations may be below the limit of quantitation; then it would not be possible to confirm attainment of steady state. The comment recommended that the predose collection time should be at a time when the blood drug concentrations are in the reliable range of quantitation of the assay and will be identical on all 3 days for all subjects.

Another comment stated that the proposed change to § 320.27(d)(1) reflects current practice, but that the requirement for consecutive-day data in § 320.27(d)(2) is unnecessarily restrictive. This comment proposed eliminating the word “consecutive” and instead saying “to define adequately the predose blood concentration on 3 or more days (or doses) to establish that steady-state conditions are achieved.”

The agency has carefully considered these comments and has decided not to require that sampling be done on 3 or more consecutive days. Therefore, FDA has revised § 320.27(d)(1) and (d)(2) to state that “* * * appropriate dosage administration and sampling should be carried out to document attainment of steady state.”

The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 et seq .), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Public Law 94-295), the Safe Medical Devices Act of 1990 (the SMDA) (Public Law 101-629), and the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115), established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the act (21 U.S.C. 360c) establishes three categories (classes) of devices, depending on the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).

The 1976 amendments broadened the definition of “device” in section 201(h) of the act (21 U.S.C. 321(h)) to include certain articles that were once regulated as drugs. Under the 1976 amendments, Congress classified into class III all transitional devices, i.e., those devices previously regulated as new drugs, including the absorbable PDS suture. Section 520(l)(2) of the act (21 U.S.C. 360j(l)(2)) provides that the manufacturer or importer of a device classified in class III under the transitional provisions may file a petition for reclassification of the device into class I or class II. Procedures for filing and review of classification petitions are set forth in § 860.136 (21 CFR 860.136).

Under section 520(l)(2) of the act and § 860.136, on August 25, 1999, FDA filed a petition submitted by Ethicon, Inc., requesting reclassification of the absorbable PDS suture from class III to class II. Class II devices are those devices for which the general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but for which there is sufficient information to establish special controls to provide such assurance, including performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines, recommendations, and any other appropriate actions the agency deems necessary (section 513(a)(1)(B) of the act). FDA consulted with members of the General and Plastic Surgery Devices Panel (the Panel members) regarding reclassification of the absorbable PDS suture. The Panel members recommended that FDA reclassify the absorbable PDS suture for soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery, from class III to class II. The Panel members also recommended consensus standards and device-specific labeling as the special controls that could reasonably assure the safety and effectiveness of the device.

FDA considered the Panel members' recommendations that the generic type of device, the absorbable PDS suture for soft tissue approximation, be reclassified from class III to class II. After reviewing the data in the petition and after considering the Panel members' recommendations and the comments, FDA, based on the information set forth, issued an order to the petitioner on September 4, 2001, reclassifying the absorbable PDS suture, and substantially equivalent devices of this generic type, from class III to class II. Accordingly, as required under § 860.136(b)(6), FDA is announcing the reclassification of the generic absorbable PDS suture from class III (premarket approval) into class II (special controls). The special control capable of providing reasonable assurance of safety and effectiveness for this device is a guidance document entitled “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA,” which FDA is making available elsewhere in this issue of the Federal Register . The guidance document describes a means by which surgical suture devices may comply with the requirement of special controls for class II devices. Any firm submitting a premarket notification (510(k)) for a new PDS suture will need to address the issues covered in the special control guidance. However, the firm needs only to show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness. The special control guidance document reframes the risks identified in the PDS reclassification order to better show how the mitigating measures recommended by the guidance are associated with each risk. The clinical sequelae of the risks identified in the order and of the risks identified in the guidance are identical. FDA notes that the class II special control guidance document incorporates consensus standards and device-specific labeling. FDA is codifying the reclassification of the device by adding § 878.4840.

For the convenience of the readers, FDA is adding 21 CFR 878.1(e) to inform the readers where they may find guidance documents referenced in 21 CFR part 878.

Guidance documents are available from the Division of Small Manufacturers, International, and Consumer Assistance (DSMICA) (HFZ-220), Food and Drug Administration, Center for Devices and Radiological Health, 1350 Piccard Dr., Rockville, MD 20850. To receive the guidance document via your fax machine, telephone the CDRH Facts-On-Demand (FOD) system at 800-899-0381 or 301-827-0111 from a touch tone telephone. Press 1 to enter the system and enter the document number (1387) followed by the pound sign (#). Follow the remaining voice prompts to complete your request.

Persons interested in obtaining a copy of the guidance may also do so using the Internet. The Center for Devices and Radiological Health (CDRH) maintains a home page on the Internet at http://www.fda.gov/cdrh for easy access to information that may be downloaded to a personal computer. Updated on a regular basis, the CDRH Internet site includes device safety alerts; Federal Register reprints; information on premarket submissions, including lists of approved applications and manufacturers' addresses; small manufacturers' assistance; information on video conferencing and electronic submissions; Mammography Matters; and other medical device-oriented information. A search capability for all guidance documents may be found at http://www.fda.gov/cdrh/guidance.html .

The agency has determined under 21 CFR 25.34(b) that this reclassification 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 examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this final rule is consistent with the regulatory philosophy and principles identified in the Executive order. In addition, 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.

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Reclassification of the device from class III to class II relieves all manufacturers of the device of the cost of complying with the premarket approval requirements in section 515 of the act (21 U.S.C. 360e). There was only one manufacturer of this device at the time FDA reclassified it. Subsequently, FDA has found another manufacturer's device to be substantially equivalent to the reclassified device. The special controls guidance document does not impose any new burdens on these or future manufacturers. It merely assures that, in the future, devices of this generic type will be at least as safe and effective as the presently marketed devices. These devices are already subject to premarket notification and labeling requirements. The guidance document merely advises manufacturers on appropriate means of complying with these requirements. Furthermore, this rule may permit small potential competitors to enter the marketplace by lowering their costs. The agency, therefore, certifies that this rule will not have a significant economic impact on a substantial number of small entities. In addition, this rule will not impose costs of $100 million or more on either the private sector or State, local, and tribal governments in the aggregate, and therefore a summary statement or analysis under section 202(a) of the Unfunded Mandates Reform Act of 1995 is not 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 has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

This final rule contains no collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520) is not required. The information collections addressed in the special control guidance document identified by this rule have been approved by OMB in accordance with the PRA under the regulations governing premarket notification submissions (21 CFR part 807, subpart E, OMB control number 0910-0120).

The authority to issue this document is vested in the Secretary of the Interior by 5 U.S.C. 301 and 25 U.S.C. 2 and 9. The Secretary has redelegated this authority to the Assistant Secretary—Indian Affairs under part 209, Chapter 8.1, of the Departmental Manual.

On March 26, 2002, at 67 FR 13732, the BIA published a proposed rule to remove 25 CFR part 21, Arrangement with States, Territories, or Other Agencies for Relief of Distress and Social Welfare of Indians. We received no comments in response to the proposed rule.

This part is no longer necessary because this program now falls under the regulations in 25 CFR part 900 and 25 CFR 273, which carry out the Indian Self-Determination and Education Assistance Act (Pub. L. 93-638, 88 Stat. 2203, 25 U.S.C. 450 et seq. , as amended). Therefore, we are removing this part to clarify that tribal governments have total responsibility for managing social service programs.

This rule has never been used by the Office of Tribal Services, and used only once by the Office of Indian Education Programs. The Office of Indian Education staff has ensured that their programs will not be negatively impacted by the removal of this rule.

This rule was reviewed by the Office of Management and Budget, and determined not to be a significant regulatory action under Executive Order 12866. This rule has not had an effect of $100 million or more on the economy, nor had it adversely or materially affected the economy, productivity, competition, jobs, the environment, public health or safety, of State, local, or tribal governments or communities. The removal of this rule will also not create any serious inconsistency or otherwise interfere with an action taken or planned by another agency. The removal of this rule removes the apparent inconsistency with the Self-Determination and Education Assistance Act, as amended. This rule does not alter the budgetary effects or entitlements, grants, user fees, or loan programs or rights or obligations of their recipients. Part 21 deals with the negotiation, execution and planning of social service contracts yet, it has never been funded or used by the social services programs. This rule does not raise novel legal or policy issues because it has been replaced by a law more responsive to the needs of the tribes.

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. ). This rule involves the negotiation, execution and planning of social service contracts, between the Federal Government and State or local governments, and does not have an effect upon the regulation of small business, organizations or grant jurisdiction over small governments. State and local governments will not be negatively impacted with the elimination of this rule because it has never been funded. They also are free to apply for grants under the Johnson-O'Malley Act providing no tribe or tribal entities are interested in applying.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule provides guidance for social services contracting and has no effect on the costs or prices in local communities. This rule does not have significant adverse effect on competition, employment, investments, productivity, innovation, or the ability of the U.S.-based enterprises to compete with foreign-based enterprises. This rule does not affect local enterprises and has never been used for operation of social service programs under this part.

This rule imposes no unfunded mandates on any State, local, or tribal government or private entities and is in compliance with the provisions of the Unfunded Mandates Act of 1995. This rule, if funded and used, would provide the funds needed in the contract to perform the services.

The Department has determined that this rule does not have significant “takings” implications, or pertain to “taking” of private property interests, nor does it affect private property.

This rule involves the negotiation, execution and planning of social service contracts, and does not deal with private property, or trusts. This rule does not affect property rights protected by the Constitution and does not pose a risk of compensable taking.

The Department has determined that this rule does not have significant Federalism effects because it pertains solely to Federal-tribal relations and will not interfere with the roles, rights and responsibilities of states.

In accordance with Executive Order 12988, the Office of the Solicitor has determined that this rule does not unduly burden the judicial system and meets the requirements of section 3(a) and 3(b)(2) of the Order.

This rule has been examined under the Paper Reduction Act of 1995. Information collection was necessary for 25 CFR part 21 to identify how contract funds were to be used, and to measure contractors' performance and plans for future performance. Since its inception, part 21 has never been used by the social service program, and thus the information collections approved for contract funding or performances were allowed to expire, unused.

The Department has determined that this rule does not constitute a major Federal action significantly affecting the quality of human environment and that no detailed statement is required under the National Environmental Policy Act of 1969.

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

The final regulations that are the subject of these corrections are under sections 1502 and 6402(j) of the Internal Revenue Code.

As published, the final regulations contain errors that may prove to be misleading and are in need of clarification.

The collection of information contained in these final regulations has been reviewed and approved by the Office of Management and Budget in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) under control number 1545-1678. Responses to this collection of information are mandatory.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by the Office of Management and Budget.

The estimated reporting burden for the reporting in these regulations is reflected on the burden for Form 1098-T.

Estimated total annual reporting burden for 2001 for Form 1098-T: 3,056,411 hours.

Estimated number of responses for 2001 for Form 1098-T as of November 22, 2002: 20,376,075.

Estimated average annual burden hours per response for 2001 for Form 1098-T: 9 minutes.

Comments concerning the accuracy of this burden and suggestions for reducing this burden should be sent to the Internal Revenue Service, Attn: IRS Reports Clearance Officer, W:CAR:MP:FP:S, Washington, DC 20224, and to the Office of Management and Budget, Attn: Desk Officer for the Department of the Treasury, Office of Information and Regulatory Affairs, Washington, DC 20503.

Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.

This document contains amendments to the Income Tax Regulations (26 CFR part 1) relating to the information reporting requirements for qualified tuition and related expenses under section 6050S of the Internal Revenue Code (Code) and amendments to the Procedure and Administration Regulations (26 CFR part 301) relating to magnetic media reporting. The Taxpayer Relief Act of 1997 (Public Law 105-34 (111 Stat. 788) (TRA ’97)) added section 6050S of the Code. Section 6050S was amended by the Internal Revenue Service Restructuring and Reform Act of 1998 (Public Law 105-206 (112 Stat. 685) (RRA ’98)), and Public Law 107-131 (115 Stat. 2410). In general, section 6050S requires any eligible educational institution (institution) to file information returns and to furnish written information statements to assist taxpayers and the Internal Revenue Service (IRS) in determining the amount of qualified tuition and related expenses (qualified expenses) for which an education tax credit is allowable under section 25A (as well as other tax benefits for higher education expenses). See H.R. Conf. Rept. No. 599, 105th Cong., 2d Sess., pp. 319-320 (1998).

As provided by Public Law 107-131, for calendar years beginning after December 31, 2002, institutions may elect to report either the aggregate amount of payments received, or the aggregate amount billed, for qualified expenses during the calendar year with respect to individuals enrolled for any academic period. Institutions must report separately adjustments ( i.e. , refunds of payments or reductions in charges) made during the calendar year to payments received, or amounts billed, for qualified expenses that were reported in a prior calendar year. In addition, institutions must report the aggregate amount of scholarships or grants received for an individual’s costs of attendance that the institution administered and processed during the calendar year. Institutions must report separately adjustments ( i.e. , refunds or reductions) made during the calendar year to scholarships that were reported in a prior calendar year.

In addition, section 6050S requires any person engaged in a trade or business of making payments to any individual under an insurance agreement as reimbursements or refunds of qualified expenses (an insurer) to file information returns and to furnish written information statements.

A notice of proposed rulemaking under section 6050S (REG-105316-98) was published in the Federal Register (65 FR 37728) on June 16, 2000 (the 2000 proposed regulations). The 2000 proposed regulations relating to the information reporting requirements for institutions and insurers were withdrawn and a new notice of proposed rulemaking (REG-161424-01) was published in the Federal Register (67 FR 20923) on April 29, 2002 (the 2002 proposed regulations). No request for a public hearing was received on the 2002 proposed regulations. The IRS received written and electronic comments responding to the 2002 notice of proposed rulemaking. After consideration of all the comments, the 2002 proposed regulations are adopted as amended by this Treasury decision. The revisions are discussed below.

One commentator to the 2002 proposed regulations requested that institutions be allowed to report financial data based on an academic year, and not based on a calendar year. Section 6050S requires institutions to report on a calendar year in order to assist taxpayers in calculating the education tax credit that is allowable for qualified expenses paid during a calendar year. Therefore, the final regulations do not adopt this recommendation.

The 2002 proposed regulations provide an exception to reporting for any student who is enrolled during the calendar year only in courses for which no academic credit is offered. Several commentators to the 2002 proposed regulations requested that if a student is enrolled both in courses for which academic credit is offered ( e.g. , courses in a postsecondary degree program) and courses for which no academic credit is offered ( e.g. , courses in a continuing education program), institutions should be required to report only the courses for which academic credit is offered. The commentators suggested that the exception to reporting should be based on the category of courses, not the category of students. The commentators explained that institutions maintain separate databases for credit courses and noncredit courses and that it would create a substantial hardship if institutions were required to report for both credit courses and noncredit courses. In response to these comments, and because under section 25A and the regulations thereunder a student enrolled in a postsecondary degree program is not eligible to claim a Hope Scholarship Credit (and may not be eligible to claim a Lifetime Learning Credit) for noncredit courses, the final regulations adopt this recommendation. Accordingly, the final regulations provide that institutions are not required to report with respect to courses for which no academic credit is offered by the institution, even if the student is enrolled in a degree program.

One commentator to the 2002 proposed regulations requested that the regulations provide an exception to reporting for qualified expenses of $100 or less. The limited exceptions to required reporting are based on the fact that certain categories of students may not be eligible to claim the education tax credit and that certain payments may not be taken into account in calculating the amounts paid for qualified expenses for which an education tax credit is allowable. An exception to reporting for small amounts of qualified expenses has no relationship to whether an education tax credit is allowable for amounts paid for qualified expenses. Therefore, the final regulations do not adopt this recommendation.

The 2002 proposed regulations provide an exception to reporting for any student whose qualified expenses are paid by the student's employer through a formal billing arrangement under which the employer's employees attend the institution, the institution bills only the employer, and the institution does not maintain a separate account for any employee/student. Several commentators to the 2002 proposed regulations requested that this exception be expanded to include formal billing arrangements between institutions and other third party payors, such as the Veterans' Administration, U.S. Armed Forces, and other governmental and private organizations.

Under section 25A and the regulations thereunder, a taxpayer cannot claim the education tax credit for educational expenses paid with amounts that are excludable from gross income. Educational expenses paid through a formal billing arrangement between an institution and a governmental entity, such as the Veterans' Administration, often are excludable from the gross income of the individual student. Therefore, the final regulations expand the exception to cover formal billing arrangements between an institution and a governmental entity under which the institution bills only the governmental entity and does not maintain a separate account with respect to any individual student. In addition, the final regulations authorize the Commissioner to designate additional types of formal billing arrangements for which no reporting will be required. It is anticipated that any additional formal billing arrangements designated by the Commissioner will be limited to situations in which the individual students generally would not be eligible to claim an education tax credit with respect to the payments made by the institutional third party payor.

The U.S. Department of Education has previously determined that reporting under section 6050S does not violate the Family Educational Rights and Privacy Act (FERPA) (20 U.S.C. 1232g). Several commentators to the 2002 proposed regulations requested clarification as to whether an institution that chooses to report on all students under section 6050S, even if the regulations provide an exception to required reporting, would violate FERPA. After the 2002 proposed regulations were issued, the Treasury Department asked the Department of Education to consider whether its earlier determination would extend to an institution that chooses to report on students otherwise covered by an exception to required reporting. The Department of Education has recently determined that an institution will not violate FERPA if it chooses to report information on all students in accordance with section 6050S, even if the regulations provide an exception to required reporting.

Several commentators to the 2002 proposed regulations requested that the final regulations eliminate the requirement that institutions indicate that amounts reported as billed in one calendar year relate to qualified expenses for an academic period that begins during the first three months of the next calendar year. The commentators explained that most institutions bill late in one calendar year for the qualified expenses that relate to an academic period that begins in the first three months of the next calendar year. The commentators questioned the usefulness of this information.

Under section 25A and the regulations thereunder, the education tax credit is allowable only for amounts actually paid during the calendar year for an academic period that begins during the same calendar year or during the first three months of the next calendar year. Therefore, there may be situations where an institution reports amounts billed for qualified expenses in one calendar year that relate to an academic period that begins during the first three months of the next calendar year, and the taxpayer pays the qualified expenses in the next calendar year. In this situation, the taxpayer and the IRS should be advised that the amounts reported as billed during a calendar year may not be amounts for which the taxpayer may claim the education tax credit for that year. Therefore, the final regulations do not adopt this recommendation.

One commentator requested clarification as to whether the 2002 proposed regulations purposely did not require separate reporting for increases to charges for qualified expenses and grants reported by the institution for a prior calendar year. The amendments to section 6050S by Public Law 107-131 require institutions to report the aggregate amount of charges for qualified expenses and the aggregate amount of grants administered and processed during the calendar year. These aggregate amounts would include any increases in charges for qualified expenses that relate to a prior year and any increases in grants that relate to a prior year. Therefore, no separate reporting is required for increases to charges for qualified expenses and grants that relate to a prior year.

The 2002 proposed regulations require institutions and insurers to include on the information statement furnished to the student the name, address, and phone number of the office or department within the institution or insurer that is the information contact. Several commentators requested that the regulations be revised to allow third party service providers that file information returns on behalf of the institutions or the insurers, as well as a third party call centers, to be designated as the information contact. Consistent with section 6050S(d)(1), the final regulations require institutions and insurers to include the name, address, and phone number of the information contact of the person required to file the information return. This provision does not preclude any institution or insurer that is required to file an information return from including, in addition to its own name, address, and phone number, the name, address, and phone number of a third party service provider.

Several commentators to the 2002 proposed regulations requested that institutions not be required to file information returns and to furnish information statements for students who refuse to provide their TINs. Information returns and information statements with missing TINs are useful to both the IRS and the taxpayer in verifying the amount of any allowable education tax credit (as well as other tax benefits for higher education expenses). Therefore, the final regulations do not adopt this recommendation.

The final regulations amend the regulations under section 6011(e) to require institutions and insurers who are required to file 250 or more Forms 1098-T, “Tuition Statement,” to file on magnetic media.

It has been determined that this Treasury decision is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required. It has also been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations. A final regulatory flexibility analysis has been prepared for the collection of information in this Treasury decision. This analysis is set forth in this preamble under the heading “Final Regulatory Flexibility Analysis.” Pursuant to section 7805(f) of the Code, the proposed regulations preceding these regulations were submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business.

The collection of information contained in § 1.6050S-1 is needed to assist the IRS and taxpayers in determining the amount of any education tax credit allowable under section 25A (as well as other tax benefits for higher education expenses). The objectives of these final regulations are to provide uniform, practicable, and administrable rules under section 6050S. The types of small entities to which the regulations may apply are small eligible educational institutions (such as colleges and universities) and certain insurers who reimburse educational expenses.

There are no known Federal rules that duplicate, overlap, or conflict with these regulations. The regulations are considered to have the least economic impact on small entities of all alternatives considered.

Moreover, the regulations requiring filing Forms 1098-T on magnetic media impose no additional reporting or record keeping and only prescribe the method of filing information returns that are already required to be filed. Further, these regulations are consistent with the statutory requirement that an institution or insurer is not required to file Forms 1098-T on magnetic media unless required to file at least 250 or more returns during the year. Finally, the economic impact caused by requiring Forms 1098-T on magnetic media should be minimal because most institutions' or insurers' operations are computerized. Even if their operations are not computerized, the incremental cost of magnetic media reporting should be minimal in most cases because of the availability of computer service bureaus. In addition, the existing regulations under section 6011(e) provide that the IRS may waive the magnetic media filing requirements on a showing of hardship. The waiver authority will be exercised so as not to unduly burden institutions and insurers lacking both the necessary data processing facilities and access at a reasonable cost to computer service bureaus.

The principal author of the regulations is Tonya Christianson, Office of Associate Chief Counsel (Procedure and Administration), Administrative Provisions and Judicial Practice Division. However, other personnel from the IRS and the Treasury Department participated in the development of the regulations.

The Agency has received comments from the regulated community and States requesting clarification of certain aspects of the September 30, 1999 Rule (64 FR 52828) as revised by three subsequent rules: the July 3, 2001 Direct Final Rule (66 FR 35087), the February 13, 2002 Interim Standards Rule (67 FR 6792), and the February 14, 2002 Final Amendments Rule (67 FR 6968). Today's technical corrections respond to these comments.

In the July 3, 2001 Direct Final Rule, we revised the 1999 rule to encourage early compliance with the regulations. See 66 FR at 35098. We indicated that, in developing the 1999 rule, we did not consider situations where sources would conduct performance testing prior to the compliance date. Sources may choose to test prior to the compliance date for reasons including: (1) To begin complying with the regulations prior to the compliance date; (2) to coordinate RCRA and CAA testing; or (3) to ensure compliance with the requirement to commence the test not later than six months after the compliance date. In the Direct Final Rule, we eliminated two impediments to early compliance: (1) The requirement to stop burning hazardous waste for sources that fail the initial comprehensive performance test if the test is conducted prior to the compliance date; and (2) the requirement for the Documentation of Compliance for sources that submit the Notification of Compliance (NOC) prior to the compliance date.

We intended to eliminate a third impediment for sources that conduct the comprehensive performance test prior to the compliance date (since the purpose of the amendments was to remove impediments to early compliance): The requirement to submit the NOC within 90 days of completion of the performance test. The deadline for submitting the NOC is intended to require sources to document compliance with the emission standards as quickly as possible after the compliance date. The deadline is not necessary for sources that intend to comply early. We inadvertently included that amendment in a proposed Final Amendments Rule, also published on July 3, 2001 (66 FR 35126), rather than the Direct Final Rule. See proposed revisions to § 63.1207(j)(1)(i) and (j)(5), 66 FR at 35153. We also inadvertently did not provide preamble language discussing that regulatory change in the proposed amendments.

We are not amending the rule exactly as we proposed, however. We conclude that we need to revise the proposed regulatory language even though we did not receive adverse comment. Although we intended the waiver of the requirement (to submit the NOC within 90 days of completing the initial comprehensive performance test) to apply only to sources that comply early, the proposed regulatory language inadvertently did not restrict eligibility to early compliers. Accordingly, we have revised the amendment to require that a source that conducts the performance test prior to the compliance date, and that takes advantage of the waiver of the requirement to submit the NOC within 90 days of completing the test, must nonetheless submit the NOC by the compliance date or 90 days after completing the test, whichever is later. This provision ensures that sources using the waiver will begin complying with the emission standards using operating parameter limits documented by a performance test well before the regulatory deadline. 1

We have apprised key stakeholders of our intent to correct the standard to include this amendment, and did not receive adverse comment. Accordingly, we are amending § 63.1207(j) by revising (j)(1)(i) and adding (j)(5), consistent with this preamble discussion.

In the Interim Standards Rule, we explained that we were revising the hydrochloric acid/chlorine gas standard for new lightweight aggregate kilns to be 600 ppmv. See 67 FR at 6797. We failed, however, to make the corresponding change to the regulation. Therefore, in today's action, we are revising the regulation at § 63.1205(b)(6) to include the correct standard of 600 ppmv for hydrochloric acid/chlorine gas.

In the Interim Standards Rule, we deleted the limit on minimum total power to an ionizing wet scrubber required under § 63.1209(m)(1)(i)(D). The limit was intended to ensure compliance with the particulate matter standard. We determined, however, that a limit on total power may not ensure that the removal efficiency will be maintained for a multistage ionizing wet scrubber. We explained that until we evaluate other compliance alternatives and promulgate new requirements, sources and permit officials should use the alternative monitoring provisions of § 63.1209(g) to identify appropriate compliance assurance controls for ionizing wet scrubbers on a site-specific basis. See 67 FR at 6802. Although we deleted the limit for compliance with the particulate matter standard, we inadvertently did not make a conforming change to delete § 63.1209(o)(3)(vi), which also requires a limit on minimum total power to an ionizing wet scrubber to ensure compliance with the total chlorine emission standard. 2 To conform with our stated intent to delete the limit on minimum total power to an ionizing wet scrubber, we are today deleting § 63.1209(o)(3)(vi).

In the Interim Standards Rule, we deleted the requirement to establish a limit on the useful life of a carbon bed or bed segment and associated requirements to conduct testing subsequent to the comprehensive performance test to verify performance of the carbon bed. In lieu of those requirements, the revised rule requires you to monitor performance of the bed according to manufacturer's specifications to ensure the bed has not reached the end of its useful life. See 67 FR at 6803 and § 63.1209(k)(7)(i).

Although we deleted the requirement to confirm the useful life of a carbon bed by testing subsequent to the comprehensive performance test, we inadvertently did not make a conforming change to § 63.1207(f)(1)(xxi)(A). That provision requires you to include in the comprehensive performance test plan a schedule for conducting testing to verify bed performance. Accordingly, we are making that conforming change today by deleting § 63.1207(f)(1)(xxi)(A).

In the proposed Final Amendments Rule (66 FR at 35132, July 3, 2001), we proposed to make changes to §§ 63.1201(a), 63.1206(c)(5), and 63.1209(p) requiring sources to use a pressure monitor and recording frequency that is adequate to detect combustion system leak events. We also clarified that the intent of the combustion system leak requirement is to prevent fugitive emissions that originate from the combustion of hazardous waste, not fugitive emissions that originate from nonhazardous process streams. We also proposed regulatory language for these changes (see pages 35152 and 35154).

In the Final Amendment Rule, we reiterated that we were finalizing these changes. See 67 FR at 6973. We failed, however, to make the necessary regulatory changes to §§ 63.1201(a), 63.1206(c)(5), and 63.1209(p). We are, therefore, correcting these sections of the regulation by including the regulatory language that was set out in the proposed rule.

Section 63.1206(a)(1) requires existing sources to comply with the Subpart EEE emission standards no later than September 30, 2003, unless the Administrator or State grants an extension of time under §§ 63.6(i) or 63.1213. The § 63.1213 compliance extension may be granted for a period of up to one year and is designed to allow for the installation of pollution prevention or waste minimization measures that significantly reduce the amount and/or toxicity of hazardous wastes in the feedstream to the combustor. Section 63.6(i)(4) in the Part 63 General Provisions provides for a similar extension should a source need additional time for the installation of controls without which the source would not be able to comply with the emission standards.

Both §§ 63.1213 and 63.6(i)(4) initially required you to submit your extension request in writing no later than 12 months before the compliance date. On April 5, 2002, we amended § 63.6(i)(4)(i)(B) to allow sources to submit their extension requests no later than 120 days (four months) prior to the compliance date. See 67 FR 16582. If the need for an extension arises later than 120 days prior to the compliance date, the amendment further allows sources to request an extension, but only if the need is due to circumstances beyond the reasonable control of the source that came to light after the extension deadline but before the actual compliance date. The amendment further provided that nonfrivolous extension requests would temporarily stay the applicability of the emission standards in question until the Administrator or State grants or denies the request.

The extension provisions of §§ 63.1213 and 63.6(i)(4) are similar in intent; both allow sources to request extensions to the compliance date for the installation of controls. As discussed in the preamble to the March 23, 2001 proposed amendments to the General Provisions (66 FR 16328), we believe that most sources will complete any necessary control installations well before the compliance date; however, we recognize that situations may arise prohibiting this. Sources acting in good faith may not be able to complete the installation, testing and implementation of additional controls due to circumstances or events not of their own making. Work stoppages at a control equipment supplier's factory, shortages of skilled design and construction engineers, and shortages of available technology are some of the examples of circumstances or events that may be beyond the influence of an individual source and that could impact that source's ability to properly install control equipment and measures. Sources that believed they would be able to meet the compliance date without an extension might be unduly penalized should any of these types of events occur within the 12 months prior to the compliance date. We do not believe that it is in the best interest of environmental protection to penalize sources that are actively improving upon their waste minimization and pollution prevention controls because of circumstances and events that are beyond their control occurring prior to the compliance date. Thus, we are making a conforming change to the § 63.1213 compliance date extension requirements to reflect the changes already put in place under § 63.6(i)(4) of the General Provisions.

We are also making a conforming change to the § 63.1213 applicability language to take into consideration the recently promulgated Subpart EEE Interim Standards Rule and our extension of the compliance date. Section 63.1213 requires that a source reasonably document if it cannot install the necessary control measures and comply with the emission standards and operating requirements within three years of the emission standards effective date. This ending phrase corresponded to the September 30, 1999 effective date of the original standards ( i.e. , the date of publication) and to the September 30, 2002 original compliance date. On December 6, 2001, we extended the compliance date of those 1999 standards by one year, to September 30, 2003. We also promulgated negotiated Interim Standards on February 13, 2002 to temporarily replace the original 1999 standards. The Interim Standards were effective on the date of their promulgation. See 66 FR 63313 and 67 FR 6792. We did not, however, make a conforming change to § 63.1213(a) to address these changes. Therefore, in today's action, we are revising § 63.1213(a) to state that when a source submits a request for an extension, it must document that it cannot install the necessary control measures and comply with the standards and operating requirements by the compliance date.

In the proposed Final Amendments Rule, published on July 3, 2001, we proposed to clarify the applicability and introductory language in 40 CFR 270.19(e), 270.22, 270.62, and 270.66 regarding the reference to the Notification of Compliance (NOC). See 66 FR 35126. These sections currently state that once a source demonstrates compliance with the Subpart EEE standards by conducting a comprehensive performance test and submitting a NOC, the requirements of each section no longer apply (except with respect to certain startup, shutdown, and malfunction requirements). We proposed to specify that in order for the part 270 requirements to no longer apply, the NOC must actually document compliance with the Subpart EEE standards and requirements. While we did receive public comments on other proposed changes to the RCRA permitting requirements in the July 3, 2001 action (which we are not finalizing in today's action), we did not receive any comments on our proposal to specify in part 270 that the NOC must document compliance.

Under §§ 63.1207(j) and 63.1210, sources are required to postmark and submit to the Administrator a Notification of Compliance (NOC). This notification must document compliance or noncompliance with the Subpart EEE standards and requirements. As the regulatory language of part 270 currently states, the RCRA permitting requirements no longer apply only after the source demonstrates compliance. This can only be accomplished by conducting the comprehensive performance test and submitting a NOC that documents compliance. Obviously, the submittal of a NOC that does not document compliance should not constitute an opportunity to be relieved of the RCRA combustion permitting requirements. We should also note that the applicability language in 40 CFR 264.340(b), 265.340(b), and 266.100(b) specify that those sections no longer apply only after the source demonstrates compliance by conducting a comprehensive performance test and submitting a NOC that documents compliance. Therefore, in today's action we are finalizing the correction we proposed in the July 3, 2001 notice to add documenting compliance to the part 270 applicability language.

Section 63.1209(k)(4) of the rule requires you to establish a limit on the maximum waste feedrate to ensure compliance with the dioxin/furan emission standard. Commenters have brought to our attention that preamble discussion explaining the rationale for this requirement refers to a limit on the maximum hazardous waste feedrate. (64 FR at 52937, September 30, 1999) As the preamble states, we intended the limit to apply to the hazardous waste feedrate, not the feedrate of hazardous and nonhazardous waste combined. Accordingly, we are correcting § 63.1209(k)(4) to conform with the preamble discussion.

Section 63.1209(m)(3) requires owners and operators of hazardous waste incinerators to establish a maximum ash feedrate limit as the average of the test run averages. The preamble discussion states that you must establish a maximum 12-hour rolling average feedrate limit based on operations during the comprehensive performance test. (64 FR at 52955, September 30, 1999.) However, we failed to specify the averaging period for this limit in the regulation. We are correcting § 63.1209(m)(3) to conform with the preamble language by adding a requirement to establish the maximum ash feedrate limit based on a 12-hour rolling average.

Section 63.1209(c)(2)(v) requires you to obtain a representative sample of each feedstream to be analyzed using sampling methods described in Appendix I, Part 26, or an equivalent method. This is an incorrect cite. The correct cite is Appendix IX, Part 266. Also, please note that Appendix IX simply refers you to sampling and analysis methods published in “Test Methods for Evaluating Solid Waste, Physical/Chemical Methods,” EPA Publication SW-846. Thus, the sampling method for any feedstream must be either that specified in SW-846, or an equivalent method.

Section 553 of the Administrative Procedure Act, 5 U.S.C. 553(b)(B), provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the agency may issue a rule without providing notice and an opportunity for public comment. 3 EPA has determined that there is good cause for making today's rule final without prior proposal and opportunity for comment because it merely corrects errors in the September 30, 1999 Rule (64 FR 52828), as revised by three subsequent rules: the July 3, 2001 Direct Final Rule (66 FR 35087), the February 13, 2002 Interim Standards Rule (67 FR 6792), and the February 14, 2002 Final Amendments Rule (67 FR 6968). These final rules were subject to notice and comment, and the clarified regulatory language reflects the Agency's views already set out during the rulemaking and in past Agency statements (notably the applicable preambles). EPA also provided opportunity for further comment on most of these provisions by means of telephone calls and other communications with key stakeholders before issuing these amendments. Thus, EPA finds that further notice and opportunity for public participation in this action are unnecessary, and hence that good cause exists to issue the rule without further notice and further opportunities for comment.

Today's action does not create any new regulatory requirements; rather, it corrects errors in the September 30, 1999 Rule (64 FR 52828), as revised by three subsequent rules: The July 3, 2001 Direct Final Rule (66 FR 35087), the February 13, 2002 Interim Standards Rule (67 FR 6792), and the February 14, 2002 Final Amendments Rule (67 FR 6968). For this reason, we find that good cause exists under 5 U.S.C. 553(d)(3) to waive the requirement that regulations be published at least 30 days before they become effective.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and is therefore not subject to review by the Office of Management and Budget. Because the Agency has made a “good cause” finding (see section III above) that this action is not subject to notice-and-comment requirements under the Administrative Procedure Act or any other statute, it is not subject to the regulatory flexibility provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), or to sections 202 and 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). In addition, this action does not significantly or uniquely affect small governments or impose a significant intergovernmental mandate, as described in sections 203 and 204 of UMRA. This rule also does not significantly or uniquely affect the communities of tribal governments, as specified by Executive Order 13084 (63 FR 27655, May 10, 1998). This rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This rule also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant.

This interpretive clarification and technical correction action does not involve technical standards; thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. The rule also does not involve special consideration of environmental justice related issues as required by Executive Order 12898 (59 FR 7629, February 16, 1994). In issuing this rule, we have taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct, as required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996). EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the executive order. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). Our compliance with these statutes and Executive Orders for the underlying rules are discussed in the July 3, 2001, the February 13, 2002, and February 14, 2002 Federal Register notices.

The Congressional Review Act, (5 U.S.C. 801 et seq. ), as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States.

Section 808 allows the issuing agency to make a good cause finding that notice and public procedure is impracticable, unnecessary or contrary to the public interest. This determination must be supported by a brief statement. 5 U.S.C. 808(2). As stated previously, EPA has made such a good cause finding, including the reasons therefore, and established an effective date of December 19, 2002. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

The U.S. Exchange Visitor Program, administered by the Department of State, seeks to promote peaceful relations and mutual understanding with other countries through educational and cultural exchange programs. Under one facet of this program, foreign national physicians may come to the United States to participate in graduate medical education programs under J-1 visas.

Upon completion of the graduate medical education program and expiration of the visa and prior to pursuing permanent residency, the Exchange Visitor physician must return to his or her country of nationality or last country of legal permanent residence for a minimum of two years to share the benefit of the knowledge and experience gained in the United States. Under limited and exceptional circumstances, an Exchange Visitor may obtain a waiver of the requirement to return home. An avenue through which a waiver may be obtained is by a request made, on the Exchange Visitor's behalf, by an interested United States Government Agency (IGA). Numerous Federal agencies have sought waivers as IGAs.

The vast majority of IGA requests for waivers involve international medical graduates who entered the United States to pursue graduate medical education or training. Historically, HHS has restricted its activity as an IGA to requesting waivers for researchers whose research could have national or international significance. In contrast, the Department of Agriculture and the Appalachian Regional Commission have been the most active IGAs seeking waivers for physicians to provide services in Health Professional Shortage Areas (HPSAs) or Medically Underserved Areas and Populations (MUA/Ps). On April 16, 2002, the Department of Agriculture announced it would process its pending waiver requests and then cease participation as an IGA.

Pursuant to section 332 of the Public Health Service Act, HHS designates areas, facilities or population groups as HPSAs if they meet the criteria specified in 42 CFR part 5. HPSA designations are separated into three categories: those for shortages of primary medical care, dental, and mental health professionals. HHS publishes lists of the designated areas annually in the Federal Register , and publishes updates to the list on the HHS web site periodically. Pursuant to Sec. 330(b)(3)-(6), HHS also designates areas and population groups as MUA/Ps based on established criteria that indicate a shortage of personal health services.

HHS is committed to increasing access to care for the nation's most medically underserved individuals. In accordance with this mission, HHS has decided to request waivers for physicians to provide primary care services in HPSAs and MUA/Ps and for psychiatrists to provide care in Mental Health HPSAs. In determining whether to request a waiver for an Exchange Visitor to deliver primary health care services, HHS will consider information from and coordinate with State Departments of Public Health (or the equivalent), other IGAs that request waivers, HHS programs such as the National Health Service Corps, and other relevant government agencies. This change in HHS's role requires amendment of the HHS regulations governing J-1 visa waiver requests.

The Secretary recognizes that the determination of need for health care services in specific geographic areas is affected by services provided by physicians holding nonimmigrant visas, as well as physicians assigned to these areas under HHS programs, such as the National Health Service Corps. On a related issue, during the first quarter of calendar year 2003, the Secretary intends to propose revisions to the regulations governing the designation of HPSAs and MUA/Ps.

HHS continues to endorse the philosophy that Exchange Visitors are committed to return to their country of nationality or last legal permanent residence home for at least two years after completing their program. Consistent with this philosophy, the regulations provide that the HHS Exchange Visitor Waiver Review Board may determine the appropriate numbers and geographic areas for waivers for the delivery of health care service. These determinations would be made based on data relating to the health care needs of the relevant areas.

The HHS eligibility criteria established under this rule are solely for the purpose of requesting HHS to act as an IGA and are consistent with the Department of State regulations governing such waiver requests. HHS eligibility requirement criteria for waiver requests are in addition to and independent of the existing waiver and visa criteria established by the Immigration and Naturalization Service (INS), the Department of State, and the Department of Labor. HHS stresses that its waiver regulations do not relieve alien physicians from their responsibility to comply with visa requirements on a timely basis to maintain lawful status. Nor should these HHS regulations be confused with criteria applicable to the waiver program implemented by state departments of health (the Conrad program).

Alien physicians are strongly encouraged to begin the waiver process as early as they possibly can while still in the residency training program. Early filing of the waiver request by the alien physician, coupled with timely processing of the request by the relevant government agencies, will facilitate the timely completion of the waiver process before the authorized J-1 admission expires, and the physician's subsequent application for change of nonimmigrant status from J-1 to H-1B.

HHS also notes that during the 12-month period following completion of the residency training program, an alien physician who has departed from the United States is still eligible to apply for an IGA waiver. He or she may pursue the waiver from abroad. If the waiver is granted, the alien physician may then procure an H-1B visa and seek admission to the United States to begin working in the location specified in the employment contract and approved by HHS.

The HHS criteria for waiver requests incorporate the requirements currently imposed by the Department of State regulations that govern waiver requests from IGAs based on the need for the delivery of health care services. In brief, the criteria for a waiver recommendation by HHS acting as an IGA are as follows:

1. Eligibility to apply for HHS waiver requests is limited to primary care physicians, and general psychiatrists who have completed their primary care or psychiatric residency training programs no more than 12 months before the date of commencement of employment under the contract described in the paragraph below. This 12-month eligibility limitation is to ensure that the physicians' primary care training is current and they are not engaged in subspecialty training. This HHS eligibility requirement relates only to eligibility for an HHS waiver recommendation and does not relieve physicians of the responsibility to maintain their lawful status. Primary care physicians are defined as: physicians practicing general internal medicine, pediatrics, family practice or obstetrics/gynecology and who are willing to work in a primary care HPSA or MUA/P; and general psychiatrists willing to work in a Mental Health HPSA.

2. The petitioning health care facility must establish that it has recruited actively and in good faith for U.S. physicians in the recent past, but has been unable to recruit a qualified United States physician.

3. The head of a petitioning health care facility must execute a statement to confirm that the facility is located in a specific, designated HPSA or MUA/P, and that it provides medical care to Medicaid and Medicare eligible patients and the uninsured indigent.

4. The Exchange Visitor must execute a statement that he or she does not have pending, and will not submit, other IGA waiver requests while HHS processes the waiver request.

5. The employment contract must require the Exchange Visitor to practice a specific primary care discipline for a minimum of three years, 40 hours per week in a specified HPSA or MUA/P. It may not include a non-compete clause that limits the Exchange Visitor's ability to continue to practice in any HHS-designated primary care or mental health HPSA or MUA/P after the period of obligation. The contract must be terminable only for cause and not terminable by mutual agreement until completion of the three-year commitment, except that the contract may be assigned to another eligible employer, subject to approval by HHS and consistent with all applicable INS and Department of Labor requirements.

6. Both the employer and the alien physician must submit information to HHS as the Secretary may reasonably require.

7. Both the employer and the alien physician must comply with all applicable Department of State, Department of Labor, INS, and HHS statutes, regulations and policies.

HHS notes that if an alien physician acquires H-1B nonimmigrant status following approval by the INS of a request for waiver, then he or she becomes subject not only to the terms and conditions of the waiver, but also the terms and conditions of the H-1B nonimmigrant status. Failure to comply with those conditions will make that physician subject to removal from the United States by the INS.

This rule also amends the HHS regulations by replacing references to the United States Information Agency (USIA) with the Department of State, following the consolidation of USIA and the Department of State as mandated by the Foreign Affairs Agencies Consolidation Act of 1998.

The amendments to 45 CFR Part 50 are as follows:

(1) Revise § 50.1 to replace the reference to “the United States Information Agency” with “the Department of State” to reflect the reorganization of the two agencies.

(2) In § 50.2 revise paragraph (b) to delete the “s” in “Exchanges Visitor Program”; revise paragraph (c) to replace the reference to “Office of International Affairs” with the “Office of Global Health Affairs”; remove the parenthetical examples in sentence three and add a new sentence at the end to authorize the Exchange Visitor Waiver Review Board to establish a workgroup to review requests for waivers for the delivery of health care services; and redesignate and move former paragraph (d) to new § 50.6(a) entitled “Procedures for submission of application to HHS.”

(3) In § 50.3 redesignate and move former paragraphs (a)(1) through (3) to new § 50.4 entitled “Waivers for research,” and revise former § 50.3 to include policy for waivers for the delivery of health care services.

(4) Revise § 50.4 to redesignate, remove former paragraph (b) as unnecessary and move former paragraph (a) to make it paragraph (b) of new § 50.6. Retitle § 50.4 as “Waivers for research” and insert former paragraphs § 50.3 (a)(1) through (3) as new paragraphs (a) through (c). Revise new paragraph (a) to remove the sentence which reads “The Board will not request a waiver when the application demonstrates that the exchange visitor is needed merely to provide services for a limited geographical area and/or to alleviate a local community or institutional manpower shortage, however serious.”

(5) Add a new § 50.5 entitled “Waivers for the delivery of health care service” to provide criteria for requests for waivers based on a need for the provision of health care service.

(6) Add new § 50.6 entitled “Procedures for Submission of application to HHS” and insert former paragraph § 50.2(d) as paragraph (a), and former paragraphs § 50.4(a) and (b) as paragraphs (b) and (c).

(7) Redesignate former § 50.5 as new § 50.7.

(8) Remove former § 50.6 as unnecessary.

(9) Add new § 50.8 entitled “Compliance” to note the enforcement authority of INS and the responsibility of the alien physician for compliance with the terms and conditions of both the applicable visa status and of the waiver.

Notice and public comment and delayed effective date have been waived for these amendments because it has been found for good cause in accordance with 5 U.S.C. 553 that notice and comment are “impracticable, unnecessary or contrary to the public interest.”

Since the mid-1990's, the Department of Agriculture placed more than 3,098 physicians in underserved areas in 48 states through its J-1 visa waiver program. While the Department of Agriculture will no longer be doing so, there remains a critical need for physicians in many parts of the United States that HHS is prepared to help meet by expanding its role in the J-1 visa waiver program and improving coordination of the placement of physicians in these areas. Any delay in implementation of these regulations would harm the medical needs of these vulnerable populations. Health care entities which will apply for exchange-visitor waivers have been unable to recruit adequate numbers of physicians to provide health services within their geographic areas. While the health care needs of underserved areas have decreased through the success of programs such as the National Health Service Corps and waivers requested by state public health departments, chronic shortages of physicians continue in certain geographic areas. Without Exchange Visitor physicians to help fill this gap, the health care needs of the populations in these areas remain unmet.

Accordingly, the Secretary has determined, in accordance with 5 U.S.C. 553 and HHS policy, that it would be unnecessary and contrary to the public interest to follow proposed rulemaking procedures in the issuance of these regulations or to delay their effective date. However, comments will be accepted at the above listed address for a period of 45 days following the publication of these regulations.

Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when rulemaking is necessary, to select regulatory approaches that provide the greatest net benefits (including potential economic, environmental, public health, safety distributive and equity effects). In addition, under the Regulatory Flexibility Act (RFA of 1980), if a rule has a significant economic effect on a substantial number of small entities, the Secretary must specifically consider the economic effect of a rule on small entities and analyze regulatory options that could lessen the impact of the rule.

Executive Order 12866 requires that all regulations reflect consideration of alternatives of costs, of benefits, of incentives, of equity, and of available information. Regulations must meet certain standards, such as avoiding an unnecessary burden. Regulations which are “significant” because of cost, adverse effects on the economy, inconsistency with other agency actions, effects on the budget, or novel legal or policy issues, require special analysis.

The Department has determined that the resources required to implement the requirement in these regulations are minimal. Therefore, according to the RFA and the Small Business Regulatory Enforcement Act of 1996, which amended the RFA, the Secretary certifies this action will not impose a significant burden on a substantial number of small entities. The Secretary has also determined that this action does not meet criteria for a major rule as defined by Executive Order 12866 and would have no major effect on the economy of Federal expenditures.

We have determined that the rule is not a “major rule” within the meaning of the statute providing for Congressional Review of Agency Rulemaking, 5 U.S.C. 801. Similarly, the rule will not have effects on State, local and tribal governments and on the private sector such as to require consultation under the Unfunded Mandates Reform Act of 1995.

Further, Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a rule that imposes substantial direct compliance costs on State and local governments, preempts State law, or otherwise has Federalism implications. We have reviewed the action herein under the threshold criteria of Executive Order 13132, Federalism, and have determined that this action would not have substantial direct effects on the rights, roles and responsibilities of States.

This rule at 45 CFR Part 50 contains collection of information requirements subject to Office of Management and Budget (OMB) Review under the Paperwork Reduction Act (PRA) of 1995. These collection of information requirements are necessary to carry out the provisions of the Exchange Visitor program. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the PRA requires that we solicit comment on the following issues:

• Whether the information collection is necessary and useful to carry out the proper functions of the agency;

• The accuracy of the agency's estimate of the information collection burden;

• The quality, utility, and clarity of the information to be collected; and

• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.

Section 50.4 of the rule contains information collection requirements currently approved under OMB Control Number 0990-0001.

Sections 50.5(e)(4) and (5) of the rule contain disclosure requirements.

Section 50.5(e)(4) requires facilities or practices sponsoring an Exchange Visitor waiver request for the delivery of health care to post a notice of the charges for services. On an annual basis it is estimated that it will take 300 practices one hour each to prepare and post such notices. The total annual burden associated with this requirement is 300 hours.

Section 50.5(e)(5) of the rules contains the requirements for the submission of evidence that the applicant made unsuccessful efforts to recruit a U.S. physician. The burden associated with these requirements is the time and effort necessary for an applicant to submit the documentation. On an annual basis it is estimated that it will take 300 applicants two hours each to and submit this documentation. The total annual burden associated with this requirement is 600 hours.

The Department will submit a copy of this Rule to the Office of Management and Budget (OMB) for its review of the information collection requirements described above. These requirements are not effective until OMB has approved them.

If you comment on any of these information collection requirements, please mail copies directly to the following:

Cynthia Agens Bauer, OS Reports Clearance Officer, Room 503H, Humphrey Building, 200 Independence Avenue SW., Washington DC, 20201; and

Office of Information and Regulatory Affairs, Office of Management and Budget, Room 10235, New Executive Office Building, Washington, DC 20503, ATTN: Allison Eydt, HHS Desk Officer.

The Public Health Service is committed to achieving the health promotion and disease prevention objectives of Healthy People 2010. This is an HHS-led effort to set priorities for national attention. The activities covered by these amendments are related to the priority area (Access to Quality Health Services) in Healthy People 2010, which is available online at http://www.health.gov/healthypeople.

This program is not subject to the Public Health Systems Reporting Requirements.