The Nuclear Regulatory Commission amended its maintenance rule, 10 CFR 50.65, “Requirements for monitoring the effectiveness of maintenance at nuclear power plants,” on July 19, 1999 (64 FR 38551). This amendment requires nuclear power plant licensees to assess and manage the increase in risk that may result from proposed maintenance activities. The implementation date of this amendment was made dependent upon guidance being issued to nuclear power plant licensees on assessing and managing increases in risk associated with maintenance activities.

Rather than issue Revision 3 to Regulatory Guide 1.160, “Monitoring the Effectiveness of Maintenance at Nuclear Power Plants,” the NRC staff decided to issue Regulatory Guide 1.182, “Assessing and Managing Risk Before Maintenance Activities at Nuclear Power Plants,” as guidance to nuclear power plant licensees on assessing and managing risk before maintenance activities are conducted at the nuclear power plant. Regulatory Guide 1.182 is being issued as a companion guide to Regulatory Guide 1.160, which provides guidance on the structure of the licensees' maintenance effectiveness monitoring programs.

Regulatory Guide 1.160 endorses a document prepared by the Nuclear Energy Institute (formerly NUMARC), NUMARC 93-01, “Industry Guideline for Monitoring the Effectiveness of Maintenance at Nuclear Power Plants.” Regulatory Guide 1.182 endorses a revised Section 11, “Assessment of Risk Resulting from Performance of Maintenance Activities,” of NUMARC 93-01. Regulatory Guide 1.182 was published for public comment (64 FR 70098, December 15, 1999) as DG-1082, “Assessing and Managing Risk Before Maintenance Activities at Nuclear Power Plants.” There were no public comments on the draft guide, and NEI addressed the comments on Section 11 of NUMARC 93-01 with minor revisions, and the NRC staff concurs in these revisions.

Therefore, the effective date of the July 19, 1999, amendment to 10 CFR 50.65 is November 28, 2000.

A holder of an operating license (i.e., the licensee) for a light-water power reactor is required by regulations issued by the NRC to submit a safety analysis report that contains an evaluation of emergency core cooling system (ECCS) performance under loss-of-coolant accident (LOCA) conditions. 10 CFR 50.46, “Acceptance criteria for emergency core cooling systems for light-water nuclear power reactors,” requires that ECCS performance under LOCA conditions be evaluated and that the estimated performance satisfy certain criteria. Licensees may conduct an analysis that “realistically describes the behavior of the reactor system during a LOCA” (often termed a “best-estimate analysis”), or they may develop a model that conforms with the requirements of Appendix K to 10 CFR part 50. Most ECCS evaluations are based on Appendix K requirements. Before this revision, the opening sentence of Appendix K specified that a power level of 102 percent be assumed when conducting ECCS analyses. Licensees have proposed using instrumentation that would reduce the uncertainties associated with measurement of reactor power when compared with existing methods of power measurement. This development could justify a reduced margin between the licensed power level and the power level assumed for ECCS evaluations. This final rule amends this provision in Appendix K and allows licensees the option of using a value lower than 102 percent of licensed power in their ECCS analyses where justified.

Several licensees have expressed interest in using updated feedwater flow measurement technology discussed later in “Calorimetric Uncertainty and Feedwater Flow Measurement” as a basis for seeking exemptions from the Appendix K power level requirement and to implement power uprates. One licensee, TXU Electric Company, obtained an exemption from the Appendix K requirement for Comanche Peak Units 1 and 2 as well as an increase in licensed power based, in part, on more accurate feedwater flow measurement capability. The prospect of additional exemption requests from other licensees provides the impetus for the final rule.

The objective of this rulemaking is to reduce an unnecessarily burdensome regulatory requirement. Appendix K was originally issued to ensure an adequate performance margin of the ECCS in the event a design-basis LOCA were to occur. The margin is provided by conservative features and requirements of the evaluation models and by the ECCS performance criteria. The original regulation did not require that the power measurement uncertainty be demonstrated, but rather mandated a 2-percent margin. The final rule allows licensees to justify a smaller margin for power measurement uncertainty. Because there will continue to be substantial conservatism in other Appendix K requirements, sufficient margin to ECCS performance in the event of a LOCA will be preserved, which is the underlying purpose of Appendix K. The final rule does not significantly affect plant risk, as discussed in the section entitled, “ECCS Evaluation Conservatism.”

Another objective is to avoid unnecessary exemption requests. A licensee has obtained an exemption from the 2-percent margin requirement in 10 CFR part 50, Appendix K. The final rule eliminates the need for licensees to obtain exemptions.

The final rule gives licensees the option of applying a reduced margin between the licensed power level and the assumed power level for ECCS evaluation, or maintaining the current margin of 2-percent power. As discussed in the section entitled “ECCS Evaluation Conservatism,” the NRC has concluded that the 2 percent power margin requirement in the original rule appeared to be based solely on considerations associated with power measurement extant at the time of the original ECCS rulemaking. The original rule unnecessarily restricted operation for licensees that can show that the uncertainties associated with power measurement instrumentation errors are less than 2 percent.

This amendment gives licensees the opportunity to use a reduced margin if they determine that there is a sufficient benefit. Licensees may apply the margin to gain benefits from operation at higher power, or the margin could be used to relax ECCS-related technical specifications ( e.g., pump flows). Another potential benefit could be in modifying fuel management strategies ( e.g., possibly by altering core power peaking factors). However, the final rule, by itself, does not allow increases in licensed power levels. Because licensed power level for a plant is a technical specification limit, proposals to raise the licensed power level must be reviewed and approved under the license amendment process. The license amendment request should include a justification of the reduced power measurement uncertainty and the basis for the modified ECCS analysis, including the justification for reduced power measurement uncertainty, should then be included in documentation supporting the ECCS analysis (see Section-by-Section Analysis).

As licensees apply the final rule and the NRC gains experience reviewing related license amendment requests, the NRC will consider the need for specific guidance to help licensees appropriately account for power measurement uncertainty in safety analyses. In the absence of specific guidance, the NRC expects that power uprate amendment requests based on this amendment to the regulations will address the suitability of non-LOCA analyses for operation at proposed higher power levels. Licensees can refer to available instrumentation guidance such as the Instrument Society of America Standard ISA 67.04, 1982, “Safety-Related Instrumentation Used in Nuclear Power Plants,” and NRC Regulatory Guide 1.105, Revision 2, “Instrument Setpoints for Safety-Related Systems.”

Appendix K defines conservative analysis assumptions for ECCS performance evaluations during design-basis LOCAs. Large safety margins are provided by conservatively selecting the ECCS performance criteria as well as conservatively establishing ECCS calculational requirements. The major analytical parameters and assumptions that contribute to the conservatisms in Appendix K are set forth in sections A through D of the rule: (A) “Sources of Heat During the LOCA” (the 102-percent power provision is a key factor); (B) “Swelling and Rupture of the Cladding and Fuel Rod Thermal Parameters;” (C) “Blowdown Phenomena;” and (D) “Post-Blowdown Phenomena: Heat Removal by ECCS.” In each of these areas, several assumptions are typically used to ensure substantial conservatism in the analysis results. For instance: under “Sources of Heat During the LOCA,” decay heat is modeled on the basis of an American Nuclear Society standard with an added 20-percent penalty, and the power distribution shape and peaking factors expected during the operating cycle are chosen to yield the most conservative results. In “Blowdown Phenomena,” the rule requires use of the Moody model and the discharge coefficient that yields the highest peak cladding temperature. “Post-Blowdown Phenomena; Heat Removal by the ECCS,” requires that the analysis assume the most damaging single failure of ECCS equipment.

One of several conservative requirements in section A of the original Appendix K was to assume that the reactor was operating at 102 percent power when the LOCA occurred “to allow for such uncertainties as instrumentation error * * *.” (Appendix K, section I.A., first sentence, emphasis added). The phrase, “such as,” suggested that the two percent power margin was intended to address uncertainties related to heat source considerations beyond instrument measurement uncertainties. However, the basis for the required assumption of 102 percent power (2 percent power margin) does not appear to be contained in the rulemaking record for the ECCS rules, 10 CFR 50.46 and Appendix K. These rules were adopted in 1974 (39 FR 1001; January 4, 1974), and were preceded by a formal rulemaking hearing which ultimately resulted in a Commission decision on the proposed rulemaking, CLI-73-39, 6 AEC 1085 (December 28, 1973). Neither the statement of considerations (SOC) for the final rule nor the Commission decision appear to provide specific basis for the required assumption of 102 percent power.

The SOC for the January 4, 1974, final rule discusses the 102 percent power assumption in general terms, and does not mention instrumentation uncertainty:

The Commission's decision in the ECCS rulemaking hearing also does not explain whether the 102 percent assumed power level was intended to address uncertainties other than instrumentation uncertainties. Section I of the Commission decision was the basis for the SOC discussion on the 102 percent assumed power level (see 6 AEC at 1093-94). Section III. A. of the Commission's decision, “Required and Acceptable Features of the Evaluation Model,” does not offer a detailed technical basis for the power level chosen, but instead uses the language ultimately adopted in the original Appendix K rule:

NRC review of the ECCS rulemaking hearing record did not disclose presentations relating to quantification of power measurement uncertainties, or the magnitude of other uncertainties that the 102 percent assumed power level may have been intended to address. The Commission decision (CLI-73-39, 6 AEC 1085, December 28, 1973) cited three documents in the rulemaking hearing record.

The first, cited in the Commission decision as Exhibit 1113, was “Supplemental Testimony of the AEC Regulatory Staff on the Interim Acceptance Criteria for Emergency Core Cooling Systems for Light-Water Cooled Power Reactors” (filed October 26, 1972). In section 10 of the document, stored energy in the fuel was considered, specifically the expected power distributions in fuel rods. The 102-percent power analysis requirement is not discussed.

The second item, cited in the Commission decision as Exhibit 1137 was “Redirect and Rebuttal Testimony of Dr. Donald H. Roy on Behalf of Babcock & Wilcox,” (October 26, 1972) in which the characteristic of the decay heat release following reactor shutdown was discussed. In this document, the 102-percent assumption is associated with the predicted decay heat generation rate. The over-power condition is associated with a “design-basis maneuvering operation,” but the basis for the value of power chosen for the analysis ( i.e., 102 percent) is not disclosed.

Finally, in the “Concluding Statement of Position of the Regulatory Staff—Public Rulemaking Hearing on: Acceptance Criteria for Emergency Core Cooling Systems for Light-Water Cooled Nuclear Power Reactors,” April 16, 1973 (the Concluding Statement), the power level assumption is included as part of the proposed rule itself. The proposed rule language clearly states that the power level assumption is to “allow for instrumentation error.” The term “such as” does not appear here. It is unclear when or why the proposed language in this regard was changed to its current form. The power level assumption is mentioned again in the Concluding Statement indirectly in association with power level changes before the LOCA and the effect on decay heat generation. But it is discussed most directly with regard to initial stored energy in the fuel. In the discussion on stored energy, the 102-percent assumption is attributed to “uncertainties inherent in the measurement of the operating power level of the core” (page 144 of the Concluding Statement). Reasons for choosing 102-percent as the value are not discussed.

When Appendix K was first issued, as is the case today, the thermal power generated by a nuclear power plant was determined by steam plant calorimetry, which is the process of performing a heat balance around the nuclear steam supply system (called a calorimetric). The heat balance depends upon measurement of several plant parameters, including flow rates and fluid temperatures. The differential pressure across a venturi installed in the feedwater flow path is a key element in the calorimetric measurement. Licensees have proposed using instrumentation other than a venturi- based system to obtain feedwater flow rate for calorimetrics. The lower uncertainty associated with the new instrumentation is information that was apparently not available during the original Appendix K rulemaking.

In view of the regulatory history for Appendix K, the Commission now believes that the 2-percent margin embodied in the requirement for a 102-percent assumed power level in Appendix K was based solely on uncertainties associated with the measurement of reactor power level.

The Commission believes that other requirements of Appendix K modeling contain substantial conservatisms of much greater magnitude than the 2 percent margin embodied in the requirement for a 102 percent assumed power level. This point was discussed in “Conservatisms in Appendix K ECCS Evaluation Model,” above.

The Commission is also aware of new information gained since the 1974 rulemaking which shows that the Appendix K model contains additional conservatisms not recognized in 1974. Evidence from experiments designed to simulate LOCA phenomena suggest that these conservatisms added hundreds of degrees Fahrenheit to the prediction of peak fuel cladding temperature than would actually occur during a LOCA. The significant conservatism was necessary when the rule was written because of a lack of experimental evidence at that time with respect to the relative effects of analysis input parameters, including pre-accident power level. Since that time, there has been substantial additional research on LOCA. NUREG-1230, “Compendium of ECCS Research for Realistic LOCA Analysis,” December 1988, contains the technical basis for improved understanding of LOCA progression and ECCS evaluation gained after the ECCS rule was issued. The NUREG includes a discussion of the basis for uncertainties in detailed fuel bundle power calculations as part of the consideration of overall calculational uncertainty inherent in best-estimate evaluations. Chapters 7 and 8 of the NUREG include consideration of the changes in licensed power level that could result from application of best-estimate evaluation methods. The discussion includes an estimated sensitivity of predicted peak clad temperature (PCT) associated with changes in pre-accident power level. From that estimate, the NRC expects peak cladding temperature changes of approximately 15 °F to result from 1-percent changes in plant power level that could result from the final rule.

In view of: (i) Substantial conservatisms known in 1974 that were embodied in the Appendix K requirements for ECCS evaluations; (ii) new information developed since the 1974 rulemaking which shows additional conservatism in the Appendix K modeling requirements beyond that understood by the Commission when it adopted the 1974 rule; and (iii) the relative insensitivity of the calculated clad temperatures to assumed power level, the Commission concludes that it is acceptable to allow a reduction in the currently-required 102 percent power level assumption if justified by the actual power level measurement instrumentation uncertainty. Accordingly, the Commission is amending the Appendix K requirement for an assumed 102 percent power level. This amendment allows a licensee to use an assumed power level of less than 102 percent (but not less than 100 percent), if the licensee has determined that the uncertainties in the measurement of core power level justifies the reduced margin.

The NRC staff has approved an exemption to the 102-percent power level requirement for Comanche Peak Units 1 and 2. The basis for the action is application of upgraded feedwater flow measurement technology at the plant. As indicated, the prospect of additional licensees requesting similar action has prompted the final rule. Other methods, systems, or analyses could be used as the basis for demonstrating reduced power measurement uncertainty.

In most nuclear power plants, operators obtain a continuous indication of core thermal power from nuclear instruments that provide a measurement of neutron flux. The nuclear instruments must be periodically calibrated to counteract the effects of changes in flux pattern, fuel burnup, and instrument drift. Steam plant calorimetry, which is the process of performing a heat balance around the nuclear steam supply system (called a calorimetric), is used to determine core thermal power and is the basis for the calibration. The differential pressure across a venturi installed in the feedwater flow path is a key element in the calorimetric measurement. Some plants use this calorimetric value directly to indicate thermal power; the nuclear instruments are used as anticipatory indicators for transients and for reactivity adjustments made with the control rods.

The system in use at Comanche Peak Units 1 and 2 is the Leading Edge Flowmeter (LEFM), manufactured by Caldon, Inc. The LEFM system is an ultrasonic flow meter that measures the transit times of pulses traveling along parallel acoustic paths through the flowing fluid. LEFM technology has been employed in non-nuclear applications, such as petroleum, chemical, and hydroelectric plants for several years. This operating experience will provide reliability data, supplementing data from nuclear applications. Additional information on the Comanche Peak Appendix K exemption and on the Caldon, Inc. LEFM system appears in safety evaluations issued by the NRC staff on March 8, 1999, and May 6, 1999.

The NRC issued a safety evaluation on March 20, 2000, on the ABB Combustion Engineering ultrasonic flow-measuring system known as Crossflow. The Crossflow system is expected to be part of a licensee amendment request for power uprate in the near future.

In the proposed rulemaking (64 FR 53270; October 1, 1999), the NRC sought comments from the public on four issues related to the revision of Appendix K. The NRC received comments from four utility companies, the Nuclear Energy Institute (NEI), and Caldon, Inc., manufacturer of the LEFM system. All of the commenters supported the proposed rule. NEI and Caldon offered comments on the four issues that the Commission included in the proposed rule. NEI and the New York Power Authority commented on several other issues as well.

The issues that accompanied the proposed rule were:

1. The current rule states that the required 2-percent analysis margin is to account for “ such uncertainties as instrumentation error * * *.” (emphasis added). This suggests that the 2-percent margin was intended to account for other sources of uncertainty in addition to instrumentation error. However, explicit documentation of the basis for the value of the margin does not appear to be contained in the rulemaking record for the original 1974 ECCS rulemaking. The Commission was interested in whether there were other sources of uncertainty, relevant to sources of heat following a LOCA, that should be considered when licensees seek to reduce the margin in the Appendix K requirement for assumed power.

As discussed in the section entitled, “Conservatisms in Appendix K ECCS Evaluation Model,” the Commission considered the rulemaking historical record for Appendix K and concluded that instrument uncertainty was likely the only source of uncertainty that was to be accounted for by the 2-percent margin. NEI and Caldon have not identified other sources of uncertainty, relevant to sources of heat following a LOCA, that are connected with the power level assumption.

2. Were there rulemaking alternatives to the proposed rule that were not considered in the regulatory analysis?

The Commission considered rulemaking alternatives in the accompanying regulatory analysis. The alternatives were: (i) No rule change; (ii) removal of the 102 percent requirement while requiring justification of a power level margin; (iii) the approach taken in the amended rule to maintain the 102 percent requirement and offer the option to reduce the margin; (iv) elimination of the power level margin; and (v) broad revision of Appendix K addressing all analysis requirements. Additional alternatives were not identified in the comments received for the proposed rule.

3. What criteria should be used for determining whether a proposed reduction in the 2 percent power margin has been justified, based upon a determination of instrumentation error? For example, should a demonstrated instrumentation error of 1 percent in power level be presumptive of an acceptable reduction in assumed power margin of 1 percent?

The comments from NEI on this point emphasized that any criteria developed to evaluate proposed reductions in ECCS analysis power margin should be based only on the instrumentation error associated with power measurement. NEI said that the conservatism inherent in the ECCS analysis requirements embodied in Appendix K provide sufficient margin to maintain safety so that instrumentation uncertainty should be the only basis for the power level assumption. The comments also stated that the overall impact on safety should be considered and that degradation in safety should not be allowed.

The Commission agrees that the main criteria determining the suitability of proposed power level margin reductions should be the details associated with uncertainties in power level measurement. The Commission also agrees that the overall impact on plant safety should be considered, preferably in a risk-informed manner. However, the commenter contended that a lower probability of exceeding the analyzed power level translates to an overall improved level of safety at a facility. The Commission does not necessarily equate a lower probability of exceeding an analysis limit with improved safety for facilities that obtain approvals to increase reactor thermal power or make other changes based on the amendment. For example, when plants obtain power uprates in conjunction with the relaxation in the amended rule, other factors come into play that may reduce the overall margin of safety, albeit probably only slightly for the small power increases anticipated with the amendment. Such changes in safety margin, if small and controlled, can be acceptable in light of other substantial conservatisms or associated risk-related information.

Caldon offered detailed comments on this issue. Their comments went beyond general instrumentation uncertainty considerations by proposing a list of criteria that appeared to be based on application of the LEFM to power measurement at a plant. Although the Commission considers the criteria provided by Caldon to be helpful, the Commission is not yet prepared to formalize any criteria for evaluating reductions in the power level margin for ECCS analysis. The safety evaluations associated with the Appendix K exemption and power uprate for Comanche Peak granted to TXU Electric Company set forth basic review criteria, including many of those proposed by Caldon. In those reviews, the NRC staff referred to available instrumentation guidance such as the Instrument Society of America Standard ISA 67.04, 1982, “Safety-Related Instrumentation Used in Nuclear Power Plants,” and NRC Regulatory Guide 1.105, Revision 2, “Instrument Setpoints for Safety-Related Systems.”

The NRC staff intends to gain further experience with licensee proposals that pursue the relaxation offered by the amendment before deciding whether a regulatory guide providing detailed acceptance criteria needs to be developed. Licensee proposals may involve use of advanced flow measurement systems or other approaches to determine the level of power measurement uncertainty and to reduce it. However, the Commission does not believe that generic acceptance criteria should be too closely based on any particular measurement technology or analysis method.

4. How should the rule address cases in which licensees determine that power measurement instrument error is greater than 2 percent?

Both NEI and Caldon offered comments on this issue. Caldon maintained that current regulatory processes provide a sufficient basis for dealing with such situations. NEI recommended that licensees should conduct Appendix K ECCS evaluations at rated thermal power level plus the value of power measurement uncertainties, regardless of the magnitude of the uncertainty. The comments clearly stated that this position also applies for uncertainties determined to be greater than 2 percent. NEI considered the need for licensees to ensure that safety analyses are valid for their facility. According to NEI, if the required margin for power level measurement were found to be insufficient to account for actual uncertainty levels, then licensees must take appropriate action, including lowering the operating power level. NEI offered alternatives for licensees to accommodate uncertainties above 2 percent, including demonstration that the PCT margin for a facility could accommodate greater-than-expected uncertainty. Also, NEI indicated that other conservatisms in Appendix K methodologies could be applied to “offset” the excessive power measurement uncertainty.

The Commission agrees that licensees who find that the power measurement uncertainty for their facilities is greater than expected should take action to ensure that their plant is operated within the assumptions used in safety analyses. This follows from the requirement in 10 CFR 50 Appendix B, section III, “Design Control.” The Appendix B requirement states that design control measures will be applied to items such as accident analyses, and that design changes shall be subject to design control measures. Therefore, licensees must take action if the power measurement uncertainty is greater than typically expected or as determined in a plant-specific analysis. The expected magnitude of uncertainty at a facility could be the 2-percent margin that is preserved in the final rule, or it could be based on a plant-specific analysis supporting a smaller value. As already considered, the basis for the value in the rule is not clearly illuminated in the rulemaking history of Appendix K. However, the Commission believes that the Appendix K value represents a typical value for power measurement uncertainty, unless demonstrated otherwise for a particular facility.

The Commission does not believe that it is necessary to allow application of safety margins based on other conservative factors in an Appendix K ECCS evaluation to offset excessive uncertainties discovered in power measurement for a plant. By proposing to use safety margin “offsets” to justify higher-than-expected power measurement uncertainties, NEI is proposing an alternative to Appendix K ECCS evaluation methods already permitted by § 50.46. The Commission considers the available analysis alternatives offered by § 50.46 ( i.e., those based on Appendix K and the so-called best estimate methods) to offer sufficient flexibility to licensees without introducing large complexities to the review and approval process that could be anticipated if Appendix K were to be applied in a “piecemeal” fashion.

The Commission originally instituted the ECCS evaluation requirements with the understanding that substantial conservatisms existed. Later, the relative contributions of various conservative factors were estimated on a largely generic basis to demonstrate the feasibility of best-estimate evaluations. However, when the revisions to § 50.46 were considered in 1988, the Commission deliberately maintained two distinct options: (i) Licensees could use the method defined by Appendix K; or (ii) they could develop a best-estimate approach. The alternatives discussed in the NEI comment can be accommodated by a licensee using the best-estimate option offered by § 50.46, rather than applying Appendix K in a “piecemeal” fashion.

On the basis of the “best-estimate” alternative to Appendix K requirements available in § 50.46, the Commission takes the position that Appendix K requirements should not be applied in a “piecemeal” fashion, as discussed in the NEI comment. Rather than searching for customized adjustments to Appendix K requirements, licensees should develop a “best-estimate” method, as permitted in § 50.46. The Commission position does not present licensees with an onerous burden. Licensees discovering that actual power measurement uncertainty at their plant is greater than the uncertainty assumed in safety analysis can take corrective action to address the problem while continuing plant operation. For example, plant power level may be reduced while the problem is addressed. Therefore, in the final rule the Commission has not adopted the NEI approach of applying offsetting uncertainties.

The comments received from NEI addressed four additional areas:

1. Uncertainties from additional heat sources. NEI commented that utilities would be able to use the amended rule to reduce the decay heat input used in Appendix K evaluations. NEI proposed that licensees could use the power measurement uncertainty to, “ensure that the expected decay heat bounds the full rated plant power plus the uncertainty value.”

The NEI comment expands the scope of the proposed revision to Appendix K, bringing into consideration decay heat uncertainty, which is a separate analysis requirement in the rule. The Commission agrees that the decay heat level used in the Appendix K analysis could be reduced commensurate with a lower assumed power level. However, the reduced power level assumption must be justified by an acceptable analysis of the power measurement uncertainty. Also, the decay heat level used in the analysis must continue to meet the requirement in Appendix K(I)(A)(4), “Fission Product Decay.” Discussion of the uncertainty involved with decay heat value required by Appendix K(I)(A)(4) is beyond the scope of this rulemaking. Licensees who wish to address the uncertainty of the decay heat level in their ECCS analysis should develop a “best-estimate” method which addresses uncertainties of all of the ECCS analysis parameters.

2. Consistency among NRC documents. NEI pointed out that other Commission documents besides Appendix K contain the 1.02 power level multiplier. In the regulatory analysis accompanying the rule, the Standard Review Plan sections and Regulatory Guide 1.49 are listed as part of the current regulatory framework considered during the rulemaking.

The NRC staff agrees with the comment that changes to guidance documents may be necessary and will make the necessary revisions to these documents to maintain consistency with the amended rule.

3. Requirement for upgrade to feedwater flow measurement. NEI commented that the proposed rule appeared to be based upon application of upgraded feedwater flow technology. NEI recommended that the rule or associated guidance make clear that availability of the relaxation offered by the final rule is not restricted to licensees applying upgraded flow measurement technology.

The preamble for the proposed rule does indeed discuss application of improved flow measurement technology. This discussion is appropriate because this new technology is the impetus for the exemption granted to one licensee and is a key justification for the Commission action in amending the current rule. In the section, “Calorimetric Uncertainty and Feedwater Flow Measurement,” the Commission pointed out that methods other than application of improved flow measurement technology could be used as the basis for demonstrating reduced power measurement uncertainty. Also, in its discussion of the Caldon comments on issue number 3, the Commission acknowledged that licensee proposals may involve use of advanced flow measurement systems or other approaches. To prevent misinterpretation of the rule, the Section-by-Section analysis has been modified to reiterate that other methods not considered in the rulemaking could be used to justify a reduced power measurement uncertainty allowance. Although various approaches to reduce the uncertainty involved with PCT calculation may be used, the only uncertainty considered under this amendment is that associated with power level measurement.

4. Reportability under 10 CFR 50.46(a)(3). NEI cited the Section-by-Section analysis of the proposed rule, where the Commission stated that, “estimated changes in ECCS performance due to final analysis inputs are reported under section 50.46 (a)(3), at least annually.” NEI recommended clarification of the statement to reflect an interpretation of § 50.46 so as to relate only to evaluation model parameters, but not to plant design parameters. NEI contended that plant parameters change from cycle to cycle and that changes in PCT caused by plant specific input parameter changes to design information fall outside the scope of reportability under 10 CFR 50.46(a)(3).

Although the Commission accepts that the results of ECCS evaluations could change as a result of cycle specific variations in model inputs, the Commission does not agree with NEI on this point. In their comment, NEI drew a distinction between design inputs and model inputs to ECCS evaluations. The amended rule does not change the reporting requirements of 10 CFR 50.46 for changes to ECCS evaluations. The regulations are clear on the definition of an ECCS evaluation model and when reports are required. 10 CFR 50.46 (c)(2) defines ECCS evaluation models and provides a list of the elements including, “one or more computer programs and all other information necessary for application of the calculational framework to a specific LOCA, such as * * * values of parameters, and all other information necessary to specify the calculational procedure.” In other words, the ECCS evaluation model is comprised of the computer code or codes, the input parameters (including plant-specific design parameters), and the calculational results. The Commission should be informed as described in 10 CFR 50.46(a)(3) when even a relatively small change to the calculational framework is made, especially when the PCT result is affected. As discussed in the statement of considerations to the September 16, 1988, final rule (53 FR 35996), the Commission needs to be cognizant of such changes to be able to confirm licensee or vendor assessments of the significance of the changes and to ensure that approved models continue to be used.

10 CFR 50.46 (a)(ii) contains an unambiguous requirement that changes to the ECCS evaluation must be reported at least annually: “For each change to or error discovered in an acceptable evaluation model or in the application of such a model that affects the temperature calculation, the applicant or licensee shall report the nature of the change or error and its estimated effect on the limiting ECCS analysis to the Commission at least annually as specified in § 50.4.” Therefore, on the basis of the definition of an evaluation model in § 50.46, the Commission does not accept the distinction made by NEI between “model parameters” and “design parameters.” Based on the requirements of § 50.46, changes to the ECCS evaluation model under the amended Appendix K rule which affect the temperature calculation must be reported at least annually.

The comments from one licensee, the New York Power Authority (NYPA), considered two areas not already discussed:

1. Other potential benefits. NYPA commented that licensees could seek benefits other than increasing licensed power under the amended rule. The commenter offered two examples of such benefits—revised containment analyses conducted at power levels below 102 percent power and relaxation of operating restrictions on ultimate heat sink temperatures.

The Commission agrees that licensees could request the relaxation offered by the amended rule while not pursuing a power level increase. In the Background section the Commission recognized that other benefits are available to licensees and that power level increase is just one option. The examples offered by the NYPA comments may be suitable to a licensee, depending on plant characteristics and plant-specific safety analyses.

2. Changes to technical specifications. NYPA interpreted statements in the proposed rule to suggest that licensees pursuing the relaxation offered in the amendment would need to change their plant technical specifications to include a limiting condition for operation for new feedwater flow instrumentation. Further, the comments suggested that clarification was needed to address when license amendments were required for changes associated with the rule.

In the Section-by-Section Analysis, the Commission discusses technical specification modifications that might be necessary when a power measurement uncertainty reduction is used in safety analyses. Typically, when an ECCS methodology is changed, a revision is made to the technical specification list of references associated with plant safety analysis methods. Technical specifications for nuclear power plants do not contain explicit requirements for feedwater flow instrumentation. The Commission does not believe that technical specification requirements for feedwater flow instruments are necessary for licensees to use the relaxation offered by the amended rule. Clarification regarding this point has been added to the Section-by-Section Analysis.

This section is amended by removing words from the first sentence in the section to specifically associate the power level requirement with instrumentation error, and by adding a sentence immediately following the first sentence in the section. The new sentence indicates that licensees may assume a power level lower than 102 percent, but not less than 100 percent, if the proposed lower alternative value can be shown to account for core thermal power measurement instrumentation uncertainty. Licensee proposals may involve use of advanced flow measurement systems or other approaches to determine the level of power measurement uncertainty and to support reduction of the power level assumption. Only the uncertainty associated with power level measurement is considered in this amendment.

Appendix K, part II (1)(a) requires that the values of analysis parameters or their basis be sufficiently documented to allow NRC review. The requirement applies to all analysis input parameters, including those related to other plant instrumentation, such as temperature and pressure. Changes to other inputs are documented in the same manner as the power measurement uncertainty would be documented under the final rule. NRC review and approval is not needed to change a parameter in an approved ECCS evaluation model unless the change is associated with technical specification or license condition modfications, or a final safety analysis report change not covered by § 50.59, “Changes, tests and experiments.” Estimated changes in ECCS performance due to revised analysis inputs are reported under § 50.46 (a)(3), at least annually. As discussed in the Statement of Considerations for a final rule amending Appendix K (53 FR 36001; September 16, 1988), the annual reports keep NRC apprised of changes. This should ensure that the NRC staff can evaluate a licensee's assessment of the significance of changes and maintain cognizance of modifications made to NRC-approved evaluation models. The licensee must include revised parameters and other changes in the ECCS evaluation model as required by § 50.46 (a)(3) when a single change or an accumulation of changes is expected to affect peak cladding temperature by 50°F or more. The basis for the revised analysis parameter (i.e., the assumed power level) should be included in documentation of the evaluation model, as required by Appendix K, Part II (1)(a).

Licensees could take advantage of the amended rule without a change to technical specifications or to the plant license by simply updating the ECCS analysis and following the reporting requirements of § 50.46. However, in most cases the NRC expects that the analysis supporting the power measurement uncertainty, as well as the description of the relevant instrumentation and associated plant-specific parameters involved in the uncertainty analysis, would be submitted for NRC review and approval before being used. These requests are expected because most licensees have adopted Generic Letter 88-16, “Removal of Cycle-Specific Parameter Limits from Technical Specifications.” The generic letter provided guidance for licensees to transfer cycle-specific parameters from their technical specifications to a Core Operating Limits Report (COLR). Licensees following the generic letter guidance added an administrative requirement to their technical specifications that specifically identifies NRC-reviewed and approved methods used to determine core operating limits ( e.g., topical reports). Because a number of core operating limits are based on LOCA analysis results, ECCS evaluation methods are included in the technical specification list. Therefore, most licensees opting to use the relaxation in the final rule will need to amend technical specifications to include a reference to an NRC-approved topical report that includes the uncertainty analysis justifying reduced power measurement uncertainty. However, a technical specification requirement specifically related to feedwater flow measurement system operability is not needed.

An additional technical specification consideration for licensees pursuing changes based on the final rule could involve nuclear instrument (NI) requirements. Existing plant technical specifications include surveillance requirements to calibrate the power range NIs based on the calorimetric measuring reactor thermal power. The NIs provide the indication of reactor power used as an input for safety systems. Licensees obtaining the relaxation offered in the final rule are expected to change some operating parameter of the plant, whether it be power level, required ECCS flow, etc. By incorporating the justification of reduced uncertainty in power measurement in the basis for their ECCS analysis, licensees would be placing a condition on an input to the calorimetric. The NI calibration required by the plant licensee would then be based on a calorimetric assuming the reduced power measurement uncertainty. If, for some reason, during the course of plant operation the reduced uncertainty did not apply ( e.g., the new feedwater flow meter was no longer operating), the calorimetric would no longer be a valid source of calibration for the NIs. Licensees would need to take action to maintain compliance with their technical specification, for example, by using an alternate input to the calorimetric. The power measurement uncertainties associated with the alternate input would then apply and the plant would need to adjust its operating condition (possibly lower its operating power level) to satisfy the final rule and to maintain the validity of applicable safety analyses. A change to technical specifications for NIs is not required in this situation.

Copies of GL-88-16, and CLI-73-39, and “Supplemental Testimony of the AEC Regulatory Staff on the Interim Acceptance Criteria for Emergency Core Cooling Systems for Light-Water Cooled Power Reactors,” and “Redirect and Rebuttal Testimony of Dr. Donald H. Roy on Behalf of Babcock & Wilcox,” and “Concluding Statement of Position of the Regulatory Staff—Public Rulemaking Hearing on: Acceptance Criteria for Emergency Core Cooling Systems for Light-Water Cooled Nuclear Power Reactors,” and NRC safety evaluations are available for inspection and copying for a fee at the NRC Public Document Room, 2120 L Street, NW. (Lower Level), Washington, DC. GL-88-16 is also available via the Internet at http://www.nrc.gov/NRC/GENACT/GC/index.html#GL.

NUREG-1230 is available from the Superintendent of Documents, U.S. Government Printing Office, Post Office Box 37082, Washington, DC 20013-7082 or from the National Technical Information Service, Springfield, VA 22161.

The National Technology Transfer Act of 1995, Pub. L. 104-113, requires that Federal agencies use technical standards that are developed or adopted by voluntary consensus standards bodies unless the use of such a standard is inconsistent with applicable law or otherwise impractical. In this final rule, the NRC provides holders of operating licenses for nuclear power plants the option of reducing the assumed reactor power level used in ECCS evaluations. This action constitutes a modification to an existing government-unique standard, 10 CFR part 50, Appendix K issued by the NRC on January 4, 1974. The NRC is not aware of any voluntary consensus standard that could be adopted instead of the government-unique standard. The NRC considered using a voluntary consensus standard. However, an appropriate standard was not identified.

The NRC has determined under the National Environmental Policy Act of 1969, as amended, and the NRC's regulations in subpart A of 10 CFR part 51, that this regulation is not a major Federal action significantly affecting the quality of the human environment and, therefore, an environmental impact statement is not required.

The action is likely to result in relatively small changes to ECCS analyses or to the licensed power of nuclear reactor facilities. The NRC staff expects that no significant environmental impact will result from the final rule, because licensee actions based on the rule should not significantly increase the probability or consequences of accidents; no changes will be made in the types of any effluents that may be released off site; and there should be no significant increase in occupational or public radiation exposure. Therefore, there are no significant radiological environmental impacts associated with the action. The action does not involve non-radiological plant effluents and has no other environmental impact. Therefore, there are no significant non-radiological environmental impacts associated with the final rule.

The determination of the environmental assessment is that there will be no significant offsite impact on the public from this action. Also, the NRC has committed itself to complying in all its actions with Executive Order (E.O.) 12898, “Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations,” dated February 11, 1994. The NRC has determined that there are no disproportionately high and adverse impacts on minority and low-income populations. The NRC uses the following working definition of environmental justice: Environmental justice means the fair treatment and meaningful involvement of all people, regardless of race, ethnicity, culture, income, or educational level with respect to the development, implementation and enforcement of environmental laws, regulations, and policies. In the letter and spirit of E.O. 12898, the NRC requested public comments on environmental justice considerations or other questions related to this rule, but none were received.

This final rule increases the burden on licensees opting to use a reduced power level assumption for ECCS analysis (i.e., below 102 percent) to include the change in their annual report required under 10 CFR 50.46 (a)(3)(ii). The public burden to modify the annual report is estimated to average one-half hour per response. The estimated public burden for record keeping, analysis, and other effort associated with this information collection will be included in the Office of Management and Budget FY2000 Information Collection Budget. Existing requirements were approved by the Office of Management and Budget, approval number 3150-0011.

If a means used to impose an information collection does not display a currently valid OMB control number, the NRC may not conduct or sponsor, and a person is not required to respond to, the information collection.

The Commission has prepared a regulatory analysis on this regulation. Copies of the regulatory analysis may be obtained as indicated in the ADDRESSES section.

As required by the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b), the Commission certifies that this final rule does not have a significant economic impact on a substantial number of small entities. This final rule would affect only the licensing and operation of nuclear power plants. The companies that own these plants do not fall within the definition of “small entities” found in the Regulatory Flexibility Act or within the size standards established by the NRC in 10 CFR 2.810.

The NRC has determined that the backfit rule in 10 CFR 50.109 does not apply to this final rule and that a backfit analysis is not required for this amendment because the change does not involve any provisions that impose backfits as defined in 10 CFR 50.109(a)(1). The final rule establishes an alternative approach for ECCS performance evaluations that may be voluntarily adopted by licensees. Licensees may continue to comply with existing requirements in Appendix K. The final rule does not impose a new requirement on current licensees and therefore, does not constitute a backfit as defined in 10 CFR 50.109(a)(1).

In accordance with the Small Business Regulatory Enforcement Fairness Act of 1996, the NRC has determined that this action is a major rule and has verified this determination with the Office of Information and Regulatory Affairs of‘OMB.

In accordance with NCUA's regulatory review process, at year end 1998, NCUA staff identified part 745 as one of its regulations in need of updating, clarification and simplification. On April 15, 1999, the NCUA Board issued an interim final rule adopting changes to its share insurance rules regarding joint accounts and revocable trust accounts. 64 FR 19685 (April 22, 1999). The FDIC adopted similar changes to its deposit insurance rules on March 23, 1999. 64 FR 15653 (April 1, 1999). When issuing the interim rule, NCUA was aware that additional changes to part 745 were necessary and would be forthcoming, but believed it was important to implement the interim rule at that time to maintain parity between NCUA's and FDIC's insurance programs. Subsequently, NCUA conducted a more comprehensive review of part 745. NCUA issued a proposed rule on November 18, 1999 that suggested additional amendments as discussed below. 64 FR 66812 (November 30, 1999).

The interim and proposed rules solicited comments from the public. Those comments have been given careful consideration and are reflected in the final amendments to the interim and proposed rules discussed below.

The interim rule amended the share insurance rules pertaining to revocable trust accounts and joint accounts. Revocable trust accounts are accounts that evidence an intention on the part of the owner to pass funds onto one or more beneficiaries upon the owner's death. They include payable-on-death accounts, and tentative or “Totten” trust accounts. Prior to the interim rule, these accounts were insured separately from other accounts of the owner only if the beneficiary was the owner's spouse, child or grandchild. If there were multiple beneficiaries, and each beneficiary was either a spouse, child or grandchild of the owner, then the account would have been insured up to $100,000 for each beneficiary. For example, if an account was held by a husband “in trust for” his wife and three children, then the account would have been insured for up to $400,000. That coverage was separate from any insurance the husband, wife or children may have had on their own accounts. For these accounts, insurance was provided on a per beneficiary basis for the spouse, child or grandchild. If, however, prior to the interim rule, a credit union member named a parent or sibling as a beneficiary, a common practice particularly for single individuals, then the account would have been added to the individual account of the owner and insured up to $100,000. There was no separate coverage for those beneficiaries even though there was a close familial relationship.

The interim rule added parents and siblings to the list of family members who qualify as beneficiaries for separate coverage. The interim rule also clarified that the degree of kinship for named beneficiaries includes relationships through blood, adoption or by virtue of remarriage.

Prior to the interim rule, NCUA's joint account regulation did not expressly refer to a two-step process in determining insurance coverage for those accounts, as did the FDIC's rule. Insurance coverage was determined, however, by applying two regulatory subsections where an individual had several joint accounts, some with different joint owners. First, under § 745.8(d), joint accounts with the same combination of owners were added together and insured up to $100,000. Even though there was more than one account, if the owners were the same, the accounts were treated as one. Then, under § 745.8(e), a person's interest in all joint accounts he or she owned with different combinations of owners was added together and insured up to $100,000. Thus, NCUA followed the same type of two-step process used by the FDIC.

The application of this process resulted in certain inequities. If a person had ownership interests in several different joint accounts, each with a different combination of joint owners, his or her interest in each of those accounts would have been added together and insured to $100,000. The same would have been done for each of the other joint owners as well. If instead, that person had had one or more joint accounts with the same combination of joint owners, the maximum insurance available to all of those joint owners combined would have been limited to $100,000. Thus, in one instance, each joint owner's interest could have been insured up to $100,000, while in the other, total coverage on the account was limited to $100,000, notwithstanding the amount of each of the joint owner's interest.

The interim rule simplified coverage on joint accounts. It is no longer necessary to add together all joint accounts owned by the same combination of individuals. Under the interim rule, each person's interest in all qualifying joint accounts will be added together and insured to a maximum of $100,000. The interim rule also eliminated the signature requirement for share certificates and accounts maintained by certain fiduciaries for joint owners as long as the credit union's records reflect that there are joint owners.

The proposed rule suggested amendments to the share insurance rules regarding living trusts, joint revocable trusts, IRA accounts, public unit accounts, guardian accounts, the application of local law to share insurance determinations and the substance and format of the Appendix to part 745.

A living trust is a formal trust that an owner creates and retains control over during his or her lifetime. NCUA proposed to treat a revocable trust account that is held in connection with a living trust in the same manner it treats all other revocable trust accounts, if the living trust otherwise meets all requirements pertaining to revocable trust accounts. Living trusts that include conditions that could prevent a beneficiary from acquiring a vested and non-contingent interest in the account funds upon the owner's death, however, would not qualify for this coverage.

Joint revocable trust accounts are revocable trust accounts, as described in § 745.4 of NCUA's regulations, established by more than one owner and held for the benefit of others. NCUA proposed to provide separate insurance coverage for qualifying accounts of this kind.

NCUA also proposed to clarify the degree of control that state or local law has on share insurance determinations to maintain uniform national rules and consistent insurance determinations. When the proposed rule was issued, § 745.2(a) provided that, to the extent local law enters into a share insurance determination, the law of the jurisdiction in which the insured credit union's principal office is located will govern. The proposal indicated that this meant the law of the jurisdiction in which the insured credit union's principal office is located will control over the law of other jurisdictions where the insured credit union may have branch offices or service facilities. It further clarified that this provision in no way effects the supremacy of federal law.

NCUA proposed to include Roth IRAs and Education IRAs among member accounts eligible for share insurance. Federal tax laws first made these accounts available to consumers on January 1, 1998. The proposal also stated that although both are colloquially known as IRA accounts, only Roth IRAs would be treated as traditional IRAs, for share insurance purposes, under § 745.9-2 of NCUA's regulations. Education IRAs would be treated as irrevocable trust accounts, for share insurance purposes, under § 745.9-1 of NCUA's regulations.

NCUA proposed to liberalize its share insurance coverage for some kinds of public unit accounts. At the time the proposal was issued, public funds were generally separately insured up to $100,000 if invested by an official custodian of funds of: (1) The United States; (2) any state of the United States or any county, municipality, or political subdivision thereof; (3) the District of Columbia; (4) specified territories or possessions of the United States; and (5) tribal funds of any Indian tribe. NCUA proposed to distinguish share draft accounts from share certificate and regular share accounts in this context. The result would be to provide separate insurance coverage up to $100,000 for share draft accounts, and up to an additional $100,000 for share certificate and regular share accounts combined. This more liberal coverage would only be available where an official custodian establishes public unit accounts in an authorized, federally-insured credit union that is located within the jurisdiction from which the custodian's authority is derived. Accounts established outside of that jurisdiction would be limited to the current $100,000 limit without regard to whether the funds are held in share draft accounts or share certificate and regular share accounts.

Funds held in the name of a guardian, custodian or conservator for the benefit of a ward or minor are insured up to $100,000 in the aggregate, separately from any other accounts of the guardian, custodian, conservator, ward or minor. FDIC, however, treats these accounts as agency or nominee accounts and does not provide separate insurance coverage. Rather, FDIC adds the guardian account together with the individual accounts of the beneficiary of the guardian account and insures that aggregate up to $100,000. NCUA proposed to treat these accounts in a manner consistent with FDIC's treatment. This would have resulted in a reduction in insurance coverage.

The Appendix to part 745 provides examples that illustrate the application of share insurance coverage. The Appendix is not expected to answer every share insurance question that could conceivably be asked. Rather, its function is to address and clarify the most common insurance coverage issues in a simple and manageable format. NCUA proposed to enhance the usefulness of the Appendix by incorporating additional information and examples and putting it into an easy to read question-and-answer format.

NCUA received twelve comment letters regarding the interim rule. Four from credit union trade associations, three from federal credit unions, two from banking trade associations, one from a state chartered credit union, one from an association of state credit union supervisors and one from a law firm. All of the commenters generally supported the interim rule. The commenters also raised other points.

Eight commenters offered their opinions whether examples illustrating insurance coverage should be moved to the body of the regulations or kept in their present location in the Appendix to the regulations. There was an even split of opinion among the commenters. The examples will remain in the Appendix where they are easily accessible and cannot be confused as part of the regulatory language.

Three commenters expressed concern over NCUA's use of the term “revocable trust account.” They noted that there are many different terms used to describe this kind of account and that this might cause confusion among some credit unions. NCUA believes the language used in § 745.4 of NCUA's rules will minimize any confusion in this context. Additionally, “revocable trust account” is the term used in the FDIC's deposit insurance rules and its use in NCUA's rules should avoid confusion for the public when comparing coverage.

Several general comments pertaining to livings trusts and joint revocable trusts were also received in connection with the interim rule. Those comments have been considered in conjunction with the comments to the proposed rule as discussed below.

NCUA received seventeen comment letters regarding the proposed rule. Eight from credit union trade associations, seven from federal credit unions, one from an association of state credit union supervisors and one from a banking trade association. All of the commenters generally supported the proposed rule. The commenters also raised other points.

Three commenters expressed concern over the proposal to exclude from revocable trust insurance coverage any living trust that includes conditions that could prevent a beneficiary from acquiring a vested and non-contingent interest in the account funds upon the owner's death. Specifically, they noted that credit unions might have difficulty determining whether a living trust contains such a defeating contingency. NCUA does not intend for credit unions to make this kind of determination. The burden is on the member to create a living trust that qualifies for insurance coverage. Credit unions may choose to advise members to have their living trusts reviewed by private counsel for legal and regulatory sufficiency prior to account opening.

Two commenters asked NCUA to clarify how a one-owner living trust account or other revocable trust account would be insured if there were qualifying and non-qualifying beneficiaries. Assuming the living trust is treated as any other revocable trust account and eligible for coverage, shares in the account attributable to the qualifying beneficiaries would be insured up to $100,000 for each qualifying beneficiary. Shares in the account attributable to the non-qualifying beneficiaries would be added to any individual accounts of the owner and insured up to $100,000.

Two commenters questioned whether the Education IRA should be insured as an irrevocable trust because, under some circumstances, the beneficiary of an Education IRA could be changed to a member of the designated beneficiary's family. The structure and exclusive purpose of Education IRAs, and the restrictions imposed on them by the Internal Revenue Service, demonstrate that these trusts are irrevocable in nature. We do not believe a limited ability to change beneficiaries diminishes the irrevocable nature of these trusts or warrants treating them as anything other than irrevocable. The FDIC also insures Education IRAs as irrevocable trusts.

Nine commenters strongly opposed the proposal to eliminate separate insurance coverage for guardian accounts. They contended that separate insurance for guardian accounts poses no threat to the National Credit Union Share Insurance Fund and that eliminating separate coverage would create more confusion and problems for credit union members than achieve good. They also noted that, while parity between NCUA's and FDIC's insurance is generally desirable, the two programs need not be identical especially to the detriment of credit union members. We find these arguments persuasive. Accordingly, NCUA has determined not to take action to eliminate the existing separate coverage for custodial accounts at this time.

The Regulatory Flexibility Act requires NCUA to prepare an analysis to describe any significant economic impact any final regulation may have on a substantial number of small entities. For purposes of this analysis, credit unions under $1 million in assets will be considered small entities. As of June 30, 1999, there were 1,690 such entities with a total of $807.3 million in assets, with an average asset size of $0.5 million. These small entities make up 15.6 percent of all credit unions, but only 0.2 percent of all credit union assets.

The NCUA Board has determined and certifies that this final rule will not have a significant economic impact on a substantial number of small entities. The reason for this determination is that the final rule clarifies and simplifies the share insurance regulations. It does not impose any additional costs or significant regulatory requirements on small entities. Accordingly, the NCUA has determined that a Regulatory Flexibility Analysis is not required.

NCUA has determined that the final amendments do not increase paperwork requirements under the Paperwork Reduction Act of 1995 and regulations of the Office of Management and Budget.

Executive Order 13132 encourages independent regulatory agencies to consider the impact of their regulatory actions on state and local interests. In adherence to fundamental federalism principles, NCUA, an independent regulatory agency as defined in 44 U.S.C. 3502(5), voluntarily complies with the executive order. This rule will apply to all federally-insured credit unions, but it will not have 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. NCUA has determined that this rule does not constitute a policy that has federalism implications for purposes of the executive order.

NCUA has determined that this rule will not affect family well-being within the meaning of Section 654 of the Treasury and General Government Appropriations Act, 1999, Pub. L. 105-277, 112 Stat. 2681 (1998).

The Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121) provides generally for congressional review of agency rules. A reporting requirement is triggered in instances where NCUA issues a final rule as defined by Section 551 of the Administrative Procedure Act. 5 U.S.C. 551. The Office of Management and Budget has determined that this rule is not a major rule for purposes of the Small Business Regulatory Enforcement Fairness Act of 1996.

The Direction Ge ne rale de l'Aviation Civile (DGAC), which is the airworthiness authority for France, recently notified the FAA that an unsafe condition may exist on all Dassault Model Mystere-Falcon 900, Falcon 900EX, Fan Jet Falcon, Mystere-Falcon 50, Mystere-Falcon 20, and Mystere-Falcon 200 series airplanes. The DGAC advises that two Mystere-Falcon 900 series airplanes have experienced severe pitch oscillations during descent.

The exact cause of the pitch oscillation is unknown at this time, and is still under investigation. However, in one case, it was considered that failure of the pitch feel system may have contributed to the severity of the pitch oscillations. Since this system is similar in design to that of Dassault Model Falcon 2000, Falcon 900EX, Fan Jet Falcon, Mystere-Falcon 50, Mystere-Falcon 20, and Mystere-Falcon 200 series airplanes, these airplanes may be subject to the same unsafe condition revealed on the Mystere-Falcon 900 series airplanes.

Dassault Aviation has issued the following Airplane Flight Manual (AFM) Temporary Revisions and Temporary Changes:

• Temporary Revision 19, DTM589/590/591/592, Temporary Revision 19 DTM592, and Temporary Revision 11, DTM918, each dated October 27, 1999 (for Model Fan Jet Falcon series airplanes.)

• Temporary Change 20, DTM30528, dated October 27, 1999 (for Model Mystere-Falcon 20 series airplanes.)

• Temporary Change 29, DTM308A, dated October 27, 1999 (for Model Mystere-Falcon 200 series airplanes.)

• Temporary Change 50, DTM813, dated October 27, 1999 (for Model Mystere-Falcon 50 series airplanes.)

• Temporary Change 49, FM813EX, dated October 27, 1999 (for Model Mystere-Falcon 50EX series airplanes.)

• Temporary Change 80, DTM20103, and Temporary Change 4, FM900C, each dated October 27, 1999 (for Model Mystere-Falcon 900 series airplanes.)

• Temporary Change 46, DTM561, dated October 27, 1999 (for Model Falcon 900EX.)

Procedures described in the Temporary Revisions and Temporary Changes provide instructions to reduce the airspeed to 260 knots indicated airspeed or 0.76 mach indicated if the pitch feel system light ( i.e. , PITCH, AQ PITCH, AQ ROLL, PITCH FEEL, or Q UNIT) is illuminated. The DGAC classified these temporary revisions and temporary changes as mandatory and issued French airworthiness directives 1999-464-029(B), dated November 17, 1999, as revised by Erratum, dated December 15, 1999 (for Model Mystere-Falcon 50, Mystere-Falcon 900, and Falcon 900EX series airplanes); and 1999-467-026(B), dated November 17, 1999, as revised by Erratum, dated December 15, 1999 (for Model Fan Jet Falcon, Mystere-Falcon 20, and Mystere-Falcon 200 series airplanes); in order to assure the continued airworthiness of these airplanes in France.

These airplane models are manufactured in France and are type certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. Pursuant to this bilateral airworthiness agreement, the DGAC has kept the FAA informed of the situation described above. The FAA has examined the findings of the DGAC, reviewed all available information, and determined that AD action is necessary for products of this type design that are certificated for operation in the United States.

This is considered to be interim action until final action is identified, at which time the FAA may consider further rulemaking.

Since an unsafe condition has been identified that is likely to exist or develop on other airplanes of the same type design registered in the United States, this AD is being issued to provide the flight crew with speed limitations in the event of failure indications of the pitch feel system. These limitations are intended to mitigate severe pitch oscillations of the airplane. The actions are required to be accomplished in accordance with the AFM Temporary Revisions and Temporary Changes described previously, except as discussed below.

Operators should note that the applicability of this AD includes all Model Falcon 2000 series airplanes, whereas this airplane model is not included in the previously identified French airworthiness directives. Since Model Falcon 2000 series airplanes are similar in design to those airplanes identified in the French airworthiness directives, the FAA has determined that Model Falcon 2000 series airplanes may be subject to the same unsafe condition and, therefore, must be included in the applicability of this AD.

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

Although this action is in the form of a final rule that involves requirements affecting flight safety and, thus, was not preceded by notice and an opportunity for public comment, comments are invited on this rule. Interested persons are invited to comment on this rule by submitting such written data, views, or arguments as they may desire. Communications shall identify the Rules Docket number and be submitted in triplicate to the address specified under the caption ADDRESSES. All communications received on or before the closing date for comments will be considered, and this rule may be amended in light of the comments received. Factual information that supports the commenter's ideas and suggestions is extremely helpful in evaluating the effectiveness of the AD action and determining whether additional rulemaking action would be needed.

Submit comments using the following format:

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

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

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

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

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2000-NM-109-AD.” The postcard will be date stamped and returned to the commenter.

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

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

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to all Boeing Model 767 series airplanes was published in the Federal Register on November 15, 1999 (64 FR 61798). That action proposed to require repetitive inspections to detect discrepancies of the wiring and surrounding Teflon sleeves of the fuel tank boost pumps and override/jettison pumps; replacement of the sleeves with new sleeves, for certain airplanes; and repair or replacement of the wiring and sleeves with new parts, as necessary.

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

Two commenters support the proposed rule.

One commenter requests that the FAA revise the proposed rule to clarify that airplanes inspected prior to the effective date of this AD in accordance with Boeing Service Bulletin 767-28A0053, Revision 1, dated April 1, 1999, do not have to be inspected again until 60,000 flight hours or 30,000 flight cycles after the last inspection, whichever occurs first. The commenter states that there is no mechanism in the notice of proposed rulemaking (NPRM) to provide credit for inspections accomplished previously.

The FAA concurs with the intent of the commenter's request. Airplanes that have been inspected prior to the effective date of this AD in accordance with the referenced service bulletin should be inspected next according to the repetitive interval (60,000 flight hours or 30,000 flight cycles after the most recent inspection, whichever occurs first) specified in this AD. However, credit for applicable actions accomplished prior to the effective date of an AD is always provided by means of the statement in the body of the AD, “Compliance: Required as indicated, unless accomplished previously.” Therefore, no change to the final rule is necessary in this regard.

One commenter requests that the FAA revise paragraph (e) of the proposed rule to eliminate the requirement to include, in any report of positive inspection findings, “a statement indicating whether any wire has ever been removed and inspected during maintenance, along with the date (if known) of any such inspection.” The commenter states that it would be “virtually impossible” to meet this requirement, and only a review of maintenance records would show if a wire was inspected. Further, the commenter states that, because operators are only required to retain maintenance records for one year, a review of maintenance records would only show whether such an inspection was completed within the past year.

The FAA concurs with the commenter's request to revise the reporting requirement of this AD. As the commenter states, a review of maintenance records would be the most effective method for determining if wiring of the fuel tank boost pumps had previously been removed and inspected. The FAA also acknowledges that an operator may not have maintenance records extending back for more than one year for its airplanes. Therefore, the subject statement in paragraph (e) of this AD has been revised to specify that the report of positive inspection findings should include, “a statement indicating, if known , whether any wire has ever been removed and inspected during maintenance, along with the date (if known) of any such inspection.” However, the FAA expects that any available maintenance records will be thoroughly reviewed to determine if boost pump wiring has been removed and inspected previously.

One commenter requests that the proposed rule be revised to correct a typographical error. The commenter points out that “NOTE 1” of the NPRM refers to paragraph (e), but should refer to paragraph (f). The FAA concurs with the commenter's request, and “NOTE 1” of this final rule has been revised accordingly.

One commenter requests that the proposed rule be revised to exclude Model 767 series airplanes on which wiring and Teflon sleeving were replaced in accordance with the requirements of AD 98-10-10, amendment 39-10522 (63 FR 26063, July 13, 1998), provided that lacing ties were not installed on the outside of the sleeving (except at sleeve ends). The commenter points out that AD 98-10-10 requires a one-time visual inspection to confirm installation of Teflon sleeves over the electrical wires to the fuel tank boost pumps installed inside conduits in the main and center wing tanks of certain Boeing Model 767 series airplanes. The commenter states that it accomplished the inspection required by that AD on its entire fleet of Model 767 series airplanes and installed new wiring and Teflon sleeving through the conduits to the boost pumps in all locations. The commenter notes that it detected no damage during examination of the removed wiring.

The FAA partially concurs with the commenter's request. The FAA concurs with the commenter's summary of the requirements of AD 98-10-10 with respect to Model 767 series airplanes. However, this AD requires actions that differ from those required by AD 98-10-10. While AD 98-10-10 confirms the installation of the Teflon sleeves and requires additional inspections to detect chafing of wiring on airplanes on which Teflon sleeves are found to be missing, this AD requires inspection of the Teflon sleeves over the fuel pump wires to detect and correct damage or installation discrepancies. Therefore, the FAA finds that it would be inappropriate to reference AD 98-10-10 in establishing compliance with this AD. However, as provided in paragraph (f) of this AD, the commenter may request approval of actions accomplished in accordance with the requirements of AD 98-10-10 as an alternative method of compliance for the actions required by this AD. No change to the final rule is necessary in this regard.

One commenter requests that the FAA revise the proposed rule to extend the initial compliance threshold for the inspection of Model 767 series airplanes having line numbers 721 and subsequent. The commenter states that the intent of Boeing Service Bulletin 767-28A0053, Revision 1 (which was referenced in the proposed rule as the appropriate source of service information for the proposed actions), has been incorporated during production on airplanes having line numbers 721 and subsequent, and any discrepancies (e.g., splices, cuts, splits, holes, worn areas, and lacing ties installed on the outside) of the Teflon sleeves surrounding the wiring of the fuel boost pumps and override/jettison pumps have been corrected.

The FAA concurs with the intent of the commenter's request. However, the manufacturer has been unable to verify that all of the actions recommended in Boeing Service Bulletin 767-28A0053, Revision 1, were accomplished during production on Model 767 series airplanes having line numbers 721 and higher. The FAA finds that it would be inappropriate to delay the issuance of this AD for identification of the line numbers on which the intent of the service bulletin was accomplished during production. However, as provided in paragraph (f) of this AD, once the correct line numbers have been identified, the commenter may request approval of actions accomplished during production as an alternative method of compliance for the actions required by this AD. No change to the final rule is necessary in this regard.

One commenter, the manufacturer, requests that the proposed rule be revised to remove the word “significant” from the following sentence in the “Discussion” section of the NPRM: “The inspections revealed significant chafing through the Teflon sleeves that enclose wire bundles inside the conduits located in the fuel tanks.” The commenter states that it has reviewed inspection results received from operators of Boeing Model 767 series airplanes, and the results show that no chafing through both layers of the Teflon sleeves or of the wiring inside the Teflon sleeves has been found.

The FAA does not concur with the commenter's request to not refer to the degree of chafing as “significant.” As stated previously, the FAA has issued AD 98-10-10, which requires a one-time visual inspection to confirm installation of Teflon sleeves over the electrical wires to the boost pumps installed inside conduits in the main and center wing tanks of certain Boeing Model 767 series airplanes. A review of the data from inspections accomplished in accordance with that AD revealed three instances of chafing through both layers of Teflon sleeves. Therefore, the FAA does consider chafing through the Teflon sleeves to be significant. However, the section of the proposal to which the commenter refers is not restated in this final rule; thus, no change to the final rule is necessary in this regard.

One commenter requests that the FAA revise paragraph (a) of the proposed rule to specify a compliance time of 36 months after the effective date of this AD for airplanes inspected previously in accordance with Boeing Service Bulletin 767-28A0053 “Preliminary.” The commenter states that the FAA should not require airplanes on which the proposed actions were accomplished in accordance with the preliminary service bulletin to be inspected again within 18 months after the effective date of this AD. The commenter asserts that Teflon sleeves inspected previously will not be worn within 18 months.

The FAA concludes that the “preliminary” service bulletin to which the commenter refers is the validation copy of Boeing Alert Service Bulletin 767-28A0053, dated May 21, 1998. The FAA does not concur with the commenter's request to provide credit for inspections accomplished in accordance with the validation copy of the service bulletin. The FAA finds that the validation copy did not provide instructions for inspecting or replacing the Teflon sleeves. Also, because the validation copy of the service bulletin was effective for only a small number of airplanes, the FAA finds that it would be inappropriate to complicate this AD by including specific instructions for airplanes inspected in accordance with that issue of the service bulletin. However, as provided in paragraph (f) of this AD, the commenter may request approval of inspections accomplished in accordance with the validation copy of the service bulletin as an alternative method of compliance with this AD. No change to the final rule is necessary in this regard.

One commenter requests that the FAA revise the proposed rule to state that airplanes on which the center fuel tank is deactivated are not subject to the inspections specified in the proposed AD. The commenter states that it operates several Boeing Model 767 series airplanes on which the center fuel tank has been deactivated in accordance with certain Boeing service bulletins. The commenter states that the airplanes are configured with the override/jettison pumps' motor winding circuits opened at the P36 and P37 panels, and, with no power available to these wires, the possibility of arcing is eliminated. The commenter also requests that, if the FAA does not revise the proposed rule to exempt airplanes with the center fuel tank deactivated, paragraph (d) of the proposed rule be revised to state that, if the center fuel tank is deactivated, the test of the override fuel pumps must be accomplished prior to reactivation of the center fuel tank (rather than prior to further flight).

The FAA does not concur with the commenter's request to revise this AD to accommodate airplanes on which the center fuel tank is deactivated. The FAA acknowledges that it may not be necessary for operators to perform initial or repetitive inspections of the override/jettison fuel pump wiring on airplanes with deactivated center fuel tanks. However, as stated in NOTE 1 of the proposed rule (as well as the final rule), for airplanes that have been modified, altered, or repaired so that the performance of the requirements of the proposed rule is affected, the operator must request approval for an alternative method of compliance in accordance with paragraph (f) of this AD. No change to the final rule is necessary in this regard.

In the NPRM, the FAA referred to Boeing Service Bulletin 767-28A0053, Revision 1, as an “alert” service bulletin. However, while the original issue of the service bulletin was considered an “alert” service bulletin, Revision 1 is not. Therefore, this final rule has been revised to remove the word “alert” from the service bulletin references throughout the AD.

After careful review of the available data, including the comments noted above, the FAA has determined that air safety and the public interest require the adoption of the rule with the changes 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 716 airplanes of the affected design in the worldwide fleet. The FAA estimates that 253 airplanes of U.S. registry will be affected by this AD. It will take approximately 5 work hours per airplane (for airplanes with jettison pumps) or 3 work hours per airplane (for airplanes without jettison pumps) to accomplish the required inspection/replacement, at an average labor rate of $60 per work hour. Parts, if required, will cost $336 for the sleeve replacement required by this AD. Based on these figures, the cost impact of this AD on U.S. operators is estimated to be $636 or $516 per airplane, if required to accomplish the replacement action; and $300 or $180 per airplane, per inspection cycle.

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

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

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

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) by superseding AD 97-05-01, amendment 39-9945 (62 FR 8613, February 26, 1997), which is applicable to certain Boeing Model 747-200, -300, and -400 series airplanes, was published in the Federal Register on December 21, 1999 (64 FR 71336). The action proposed to require that the repetitive high frequency eddy current (HFEC) inspections to detect cracking of the front spar web of the center section of the wing required by the existing AD be accomplished at a reduced threshold. The action also proposed to require that the HFEC inspection be accomplished on repaired areas.

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

One commenter supports the proposed rule.

One commenter requests that the FAA revise paragraph (b) of the proposed rule to allow the HFEC inspection described in that paragraph to be accomplished in accordance with Boeing Alert Service Bulletin 747-57A2298, Revision 1, dated September 12, 1996. [The proposed rule references Boeing Service Bulletin 747-57A2298, Revision 2, dated October 2, 1997, and Revision 3, dated January 7, 1999, as appropriate sources of service information for accomplishment of the actions required by paragraph (b).] The commenter states that the inspection method to detect cracking of the forward side of the front spar web in Revision 1 of the alert service bulletin is identical to the method described in Revisions 2 and 3. The commenter also states that operators who have accomplished the HFEC inspection in accordance with paragraph (a)(1) of AD 97-05-01 [which is restated as paragraph (a)(1) of this AD] should be given credit for performing the inspection. To this end, the commenter requests that the compliance time of paragraph (b) of this AD be revised from “Prior to accumulation of 12,000 total landings, or within 12 months after the effective date of this AD, whichever occurs later,” to incorporate an option for the inspection to be accomplished “within 1,400 landings after the previous HFEC inspection.”

The FAA partially concurs with the commenter's request. Although the inspection method is identical in Revisions 1, 2, and 3 of the service bulletin, as explained in the preamble of the proposed rule, Revisions 2 and 3 of the service bulletin describe an inspection of the aft side of the front spar web for areas where a repair is located on the forward side. For this reason, paragraph (b) of the proposed rule requires inspection in accordance with Revision 2 or 3 of the service bulletin. However, because the inspection is the same for airplanes without repairs in the area of the inspection, the FAA finds that inspections accomplished prior to the effective date of this AD in accordance with Revision 1 of the alert service bulletin are acceptable for compliance with the initial inspection required by paragraph (b) of this AD, provided that the airplane does not have a repair installed in the inspection area. A new “Note 2” has been added to this final rule accordingly. However, the FAA has determined that the accomplishment instructions in Revisions 2 and 3 of the service bulletin are clearer than those in Revision 1 of the alert service bulletin; therefore, inspections in accordance with paragraph (b) of this AD accomplished after the effective date of this AD are required to be accomplished in accordance with Revision 2 or 3 of the service bulletin.

With regard to the commenter's request to revise the compliance time for the actions required by paragraph (b) of this AD, the FAA finds that no change to the final rule is required beyond the inclusion of the new “Note 2,” as described above. Credit is always given for actions accomplished prior to the effective date of an AD by means of the phrase, “Compliance: Required as indicated, unless accomplished previously.”

One commenter requests that the FAA revise the estimated number of work hours stated in the cost impact section of the preamble of the proposed rule from 8 work hours to 48 work hours per airplane. The commenter points out that the manufacturer estimates 48 work hours per airplane in Boeing Alert Service Bulletin 747-57A2298, Revision 3, dated January 7, 1999. The commenter states that, based on its experience, the proposed actions take approximately 48 work hours.

The FAA does not concur with the commenter's request. The estimate of 48 work hours given in the service bulletin includes time for gaining access and closing up. The cost analysis in AD rulemaking actions, however, typically does not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions. Because incidental costs may vary significantly from operator to operator, they are almost impossible to calculate. The number of work hours necessary to accomplish the required actions, specified as 8 in the cost impact information in the proposal and restated below, represents the time necessary to perform only the actions actually required by this AD (that is, the inspection). No change to the final rule is necessary in this regard.

One commenter, the airplane manufacturer, states that one operator was confused by the statement in paragraph (b) of the proposed rule that, “Accomplishment of the HFEC inspection constitutes terminating action for the repetitive inspection requirements of paragraph (a) of this AD.” The operator was confused because paragraph (a) of the proposed rule specifies repetitive inspections at intervals not to exceed 1,400 landings. The operator found these statements contradictory.

The commenter makes no specific request for a change to the proposed rule. The FAA infers that the operator to whom the commenter refers does not understand the meaning of “terminating action.” Paragraph (a) of this AD states that the inspection in that paragraph is to be performed “at the time specified in paragraph (a)(1) or (a)(2) of this AD, * * * until accomplishment of the requirements of paragraph (b) of this AD.” As stated previously, paragraph (b) of this AD states that “Accomplishment of the HFEC inspection constitutes terminating action for the repetitive inspection requirements of paragraph (a) of this AD.” Once the initial inspection in accordance with paragraph (b) of this Ad has been accomplished, the repetitive inspections in paragraph (a) of this Ad are no longer necessary and need not be accomplished. The repetitive inspections specified in paragraph (b) of this AD must be accomplished at intervals not to exceed 1,400 landings (as stated in that paragraph). The FAA finds that no further clarification is necessary, and no change to the final rule is necessary in this regard.

One commenter requests that the FAA revise AD 94-15-18, amendment 39-8989 (59 FR 41233, August 11, 1994), to exclude Supplemental Structural Inspection Document (SSID) Items W-3A and W-3B on SSID-candidate airplanes that are included in the effectivity listing of Boeing Service Bulletin 747-57A2298. The commenter states that the SSID inspections allow detailed visual and surveillance inspections of the front spar web at “D”-check intervals using sampling methods. This AD requires HFEC inspections of the front spar web at intervals not to exceed 1,400 landings for all airplanes included in the applicability of this AD.

The FAA does not concur with the commenter's request. The commenter's request is not relevant to this proposed rule. In the future, should the FAA consider further rulemaking to revise AD 94-15-18, the issue raised by the commenter would be appropriate to address. No change to the final rule is necessary in this regard.

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

There are approximately 485 Model 747-200, -300, and -400 series airplanes of the affected design in the worldwide fleet. The FAA estimates that 105 airplanes of U.S. registry will be affected by this AD.

The inspections that are currently required by AD 97-05-01 and retained in this AD, take approximately 8 work hours per airplane to accomplish, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of the currently required actions on U.S. operators is estimated to be $50,400, or $480 per airplane, per inspection cycle.

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

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

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

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) by superseding AD 98-08-23, amendment 39-10472 (63 FR 18817, April 16, 1998), which is applicable to certain Boeing Model 747 and 767 series airplanes, was published in the Federal Register on December 15, 1999 (64 FR 69964). The action proposed to continue the requirements of AD 98-08-23 and add identical requirements applicable to airplanes on which standard fuel nozzles are not installed.

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

Two commenters request that Table 1 of the proposed rule be revised to include a certain General Electric (GE) fuel flow nozzle. Table 1 of the proposed rule lists GE fuel nozzles that are acceptable for installation. The commenters state that the GE fuel flow nozzle having part number 9331M72P22 is a previously certified standard ( i.e., non-dribble) fuel nozzle configuration that should be included on this list. The FAA concurs with the commenters' request and has revised Table 1 of this final rule accordingly.

One commenter requests that, in order to preclude the need for future rulemaking, the FAA revise the proposed rule to list the part numbers for the dribble flow fuel nozzles (DFFN), rather than the acceptable part numbers, in Table 1 of this AD or to reference the GE service bulletin. The commenter notes that the proposed rule references acceptable GE fuel nozzle part numbers instead of DFFN part numbers to avoid the need for future AD revisions as new DFFN part numbers are approved. However, the commenter points out that, as GE improves its products, the list of acceptable part numbers may expand beyond those listed in Table 1 of the proposed rule. The commenter also indicates that the wording of the proposed rule is confusing because the existing AD referenced DFFN part numbers directly.

The FAA does not concur with the commenter's request. The FAA concurs with the commenter's statement that listing standard fuel nozzle part numbers in Table 1 of the proposed rule is intended to avoid future AD revisions as new DFFN part numbers are approved. However, if the FAA was to continue to list DFFN part numbers in the proposed AD, the only way to require a restriction on wide cut fuels for Model 747 and 767 series airplanes equipped with DFFN's certified in the future would be to supersede this AD. The FAA finds it inappropriate to impose the additional administrative burden of a supersedure of this AD on operators (as well as on the FAA itself). Also, the FAA notes that standard fuel nozzle part numbers certified in the future (and, therefore, not listed in Table 1 of the proposed rule) can be approved as an alternative method of compliance to this AD, in accordance with paragraph (g)(1) of this AD. No change to the final rule is necessary in this regard.

One commenter requests that the applicable service bulletins be revised to include in the effectivity listing only airplanes that are currently operating with DFFN's. The commenter notes that Boeing Alert Service Bulletin 747-11A2052, Revision 1, dated August 5, 1999, includes additional airplanes in the effectivity listing. The commenter states that these airplanes were added to the effectivity listing to ensure that all affected airplanes are modified in accordance with the alert service bulletin. The commenter also states that the proposed rule does not consider airplanes having documentation that specifies compliant delivery configurations. The commenter notes that some operators that have airplanes already in full compliance with this AD will have to apply to the FAA for relief, which will cost additional time and effort for both the FAA and affected operators. The commenter states that its airplanes are not subject to the requirements of the existing AD, but under the proposed rule, it will have to show compliance for airplanes that are not affected.

The FAA acknowledges that Boeing Alert Service Bulletin 747-11A2052, Revision 1, adds airplanes to the effectivity listing of that service bulletin. However, the FAA does not concur with the commenter that airplanes added to the effectivity listing of Revision 1 of the alert service bulletin are not subject to the existing AD. AD 98-08-23 is applicable to all Boeing Model 747 and 767 series airplanes powered by GE Model CF6-80C2 series engines. The airplanes added to the effectivity listing of Revision 1 of the service bulletin were added to make the service bulletin consistent with the applicability of AD 98-08-23. The applicability of the proposed rule is the same as that of the existing AD. The FAA finds that no change to the service bulletin is necessary.

The FAA also does not concur with the commenter that the proposed rule does not provide for airplanes with documentation that specifies compliant delivery configurations. If an operator has documentation provided by the manufacturer upon delivery of a new airplane that positively shows that the airplane is equipped with fuel nozzles having part numbers listed in Table 1 of this AD, no further action is necessary, provided that all of the other airplanes in the operator's fleet are equipped with standard (non-DFFN) nozzles.

The FAA also does not concur with the commenter that its airplanes are not subject to the existing AD because the operator's fleet includes only airplanes equipped with standard fuel flow nozzles. As explained previously, AD 98-08-23 applies to all Boeing Model 747 and 767 series airplanes powered by GE CF6-80C2 series engines. Therefore, the Model 747 and 767 series airplanes powered by General Electric CF6-80C2 series engines in the commenter's fleet are subject to the requirements of AD 98-08-23. The fact that the operator has no airplane equipped with DFFN's having the affected part numbers means that the operator is not required to restrict the use of wide cut fuels. However, if the operator introduces an airplane with DFFN's into its fleet, it would be required to comply with the Airplane Flight Manual (AFM) revision and placarding requirements described in AD 98-08-23 and retained in this AD. No change to the final rule is necessary in this regard.

One commenter requests that the FAA revise paragraph (c)(1) of the proposed rule to be consistent with the wording used in the applicable Boeing AFM. The commenter states that the Boeing AFM's do not add the sentence identified in paragraphs (a)(1)(ii) and (c)(2) of the proposed rule to paragraph 2 of the Engine Fuel System section of the AFM. Instead, the sentence is included in paragraph 1 of the Engine Fuel System section of the AFM. Therefore, the commenter proposes moving the sentence in paragraphs (a)(1)(ii) and (c)(2) to the end of the paragraphs provided in paragraphs (a)(1)(i) and (c)(1) of the proposed rule.

The FAA does not concur with the commenter's request. The proposed rule carries over the requirements of AD 98-08-23, including the changes to the text of the AFM. Because the commenter's proposal does not substantively change the intent of the proposed AFM revision, the FAA considers such a change to the proposed rule to be unnecessary and potentially confusing. The operator may choose to obtain approval for its proposed wording by requesting an alternative method of compliance in accordance with paragraph (g)(1) of this AD. No change to the final rule is necessary in this regard.

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

There are approximately 430 Model 747 and 767 series airplanes of the affected design in the worldwide fleet. The FAA estimates that 115 airplanes of U.S. registry will be affected by this AD.

The AFM revision that is currently required by AD 98-08-23, and retained in this AD, takes approximately 1 work hour per airplane to accomplish, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of this current requirement on U.S. operators is estimated to be $6,900, or $60 per airplane.

The placard replacement that is currently required by AD 98-08-23, and retained in this AD, takes approximately 1 work hour per airplane to accomplish, at an average labor rate of $60 per work hour. Required parts cost approximately $12 per airplane. Based on these figures, the cost impact of this current requirement on U.S. operators is estimated to be $8,280, or $72 per airplane.

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

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

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

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to certain Airbus Model A319, A320, and A321 series airplanes was published in the Federal Register on February 15, 2000 (65 FR 7465). That action proposed to require repetitive inspections of the sliding tube subassembly on the main landing gear (MLG) to detect cracks, and replacement of a cracked subassembly with a new subassembly. That action also proposed to eventually require a more extensive, one-time inspection of the same area and corrective actions, if necessary; which would terminate the repetitive inspections.

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

Two commenters request that the applicability of the proposed AD be revised to exclude airplanes on which certain conditions regarding the MLG sliding tubes are met. Specifically, the commenters request that airplanes be excluded if it can be determined that (1) the MLG sliding tubes have never been removed; (2) a magnetic particle non-destructive test (NDT2) inspection has never been accomplished on the installed MLG sliding tubes; or, (3) an NDT2 inspection has been accomplished on the installed MLG sliding tubes only after removal of attaching hardware and bushings. One commenter states that, contrary to the assertion in the proposed AD that these conditions cannot be easily determined, each operator is required to track such information for its airplanes. The commenter notes that, since an MLG sliding tube is a safe life-limited item, operators are required to maintain complete records of maintenance and overhaul. And, since the NDT2 inspection can be performed only in a shop environment, there should be no concern that such an inspection could have occurred “on-wing,” without generation of proper maintenance records.

The FAA acknowledges that operators are required to maintain status records for each safe life-limited part with regard to the life limits of that part, i.e., hours or cycles of operation. However, not all operators maintain complete maintenance records for the life of the part, and such records would be necessary in order to make a definitive determination of the conditions defined above. The FAA has no objection to revising the applicability of the AD to exclude those airplanes on which one of these conditions can be definitively shown. The FAA has revised the applicability accordingly, and has added a “NOTE” to the final rule to specify that complete maintenance records are considered necessary in order to determine whether one of the above conditions has been met.

One commenter, an operator, states that its airplanes have never been subjected to an NDT2 inspection (as referenced in Airbus Service Bulletin A320-32-1189, dated December 23, 1998), and hence are exempt from the repetitive inspections required by the proposed AD.

The FAA considers that reiteration of the requirements of the specified applicability of the proposed AD is necessary. The commenter is referring to a determination that an NDT2 inspection has never been accomplished [as described in condition (2) above] on its airplanes. All operators should be aware that the applicability of this AD (or any other AD) takes precedence over the effectivity listed in the referenced service bulletin. The exemption declared by the commenter, based on the information in the service bulletin, was NOT included in the applicability of the proposed AD, for reasons described in the “Differences” section of the preamble of the proposed AD. Therefore, the commenter was indeed subject to the requirements of the AD with the applicability as proposed. However, since the applicability of the final rule has been revised, as discussed above, the commenter may now reevaluate its determination of affected airplanes based on the applicability specified in the final rule.

One commenter states that the applicability of the proposed AD is confusing, and suggests that it be revised to include airplanes “only if the initial issue of Messier-Dowty SB 200-32-250 has been accomplished.” (The original Messier-Dowty service bulletin called for an NDT2 inspection without specifying removal of the jacking dome bushings. If the jacking dome bushings were not removed, high temperature damage could have occurred to the MLG bore and bushings.) The commenter states that Airbus Service Bulletin A320-32-1189, dated December 23, 1998, was issued to alert operators of potential cracking that can occur if the NDT2 inspection procedures in the original Messier-Dowty service bulletin were used.

The FAA does not concur with limiting the applicability as suggested, due to potential difficulties in determining the complete inspection history of installed MLG sliding tubes, as described previously. However, the FAA has determined that an inadvertent error in the proposed applicability may have created confusion. The applicability of the proposed AD includes airplanes “. . . except those on which Airbus Service Bulletin A320-32-1189, dated December 23, 1998, has not been accomplished.” Since the actions described in Airbus Service Bulletin A320-32-1189 are actually required by this AD, the FAA's intent in the proposed applicability was to exclude airplanes on which all actions described in Service Bulletin A320-32-1189 have been accomplished. Therefore, the FAA has determined that the applicability should have read “. . . except those on which Airbus Service Bulletin A320-32-1189, dated December 23, 1998, has been accomplished.” The final rule has been revised accordingly.

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

The FAA estimates that 179 airplanes of U.S. registry will be affected by this AD.

It will take approximately 1 work hour per airplane to accomplish the required “Part A” (repetitive) inspection, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of the “Part A” (repetitive) inspection on U.S. operators is estimated to be $10,740, or $60 per airplane, per inspection cycle.

It will take approximately 6 work hours per airplane to accomplish the required “Part B” (one-time) inspection, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of the “Part B” (one-time) inspection on U.S. operators is estimated to be $64,440, or $360 per airplane.

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

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

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

What events have caused this AD? The FAA has received four reports of failure of the Aeroquip V-band exhaust clamp (Aeroquip part number 00624-55677-340M or Lycoming alternate part number 40D21162-340M) on Commander Aircraft Company Model 114TC airplanes. The V-band exhaust clamp attaches the exhaust stack to the turbocharger.

What are the consequences if the condition is not corrected? The exhaust stack detaching from the turbocharger could result in the release of high temperature gases inside the engine compartment with a consequent airplane cabin fire.

Is there service information that applies to this subject? Commander Aircraft Company has issued Service Bulletin No. SB-114-33A, dated May 9, 2000.

What are the provisions of this service bulletin? The service bulletin includes procedures for replacing the Aeroquip V-band exhaust clamp (Aeroquip part number 00624-55677-340M or Lycoming alternate part number 40D21162-340M) with a part of improved design (Aeroquip part number NH1009399-10).

What has FAA decided? After examining the circumstances and reviewing all available information related to the incidents described above, including the relevant service information, FAA has determined that:

What does this AD require? This AD requires you to accomplish the actions in Commander Aircraft Company Service Bulletin No. SB-114-33A, dated May 9, 2000.

Will I have the opportunity to comment prior to the issuance of the rule? Because the unsafe condition described in this document could result in the release of high temperature gases inside the engine compartment, FAA finds that notice and opportunity for public prior comment are impracticable. Therefore, good cause exists for making this amendment effective in less than 30 days.

Although this action is in the form of a final rule and was not preceded by notice and opportunity for public comment, FAA invites comments on this rule. You may submit whatever written data, views, or arguments you choose. You need to include the rule's docket number and submit your comments in triplicate to the address specified under the caption ADDRESSES. The FAA will consider all comments received on or before the closing date. We may amend this rule in light of comments received. Factual information that supports your ideas and suggestions is extremely helpful in evaluating the effectiveness of the AD action and determining whether we need to take additional rulemaking action.

The FAA is re-examining the writing style we currently use in regulatory documents, in response to the Presidential memorandum of June 1, 1998. That memorandum requires federal agencies to communicate more clearly with the public. We are interested in your comments on whether the style of this document is clearer, and any other suggestions you might have to improve the clarity of FAA communications that affect you. You can get more information about the Presidential memorandum and the plain language initiative at http://www.plainlanguage.gov.

The FAA specifically invites comments on the overall regulatory, economic, environmental, and energy aspects of the rule that might suggest a need to modify the rule. You may examine all comments we receive before and after the closing date of the rule in the Rules Docket. We will file a report in the Rules Docket that summarizes each FAA contact with the public that concerns the substantive parts of this AD.

If you want us to acknowledge the receipt of your comments, you must include a self-addressed, stamped postcard. On the postcard, write “Comments to Docket No. 99-CE-81-AD.” We will date stamp and mail the postcard back to you.

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

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

The Bureau of Export Administration's (BXA) Office of Antiboycott Compliance is responsible for the enforcement of the antiboycott provisions of the Export Administration Act (the Act), as amended. The Act encourages, and in some cases requires, U.S. persons to refuse to participate in foreign boycotts that the United States does not sanction. U.S. persons are also required to report receipt of boycott-related requests. The antiboycott provisions of the Act are implemented in part 760 of the Export Administration Regulations (EAR). Examples accompany the text of the regulations to aid in their interpretation.

The antiboycott provisions of the EAR became effective on January 18, 1978 and provided for a six-month grace period ending June 21, 1978, when enforcement of certain of the sections of the regulations commenced. The purpose of the delayed effective date, which was provided by Section 4A(a)(2)(B) of the Export Administration Act of 1977, as amended, was to allow the regulated public time to adjust their practices to the new regulations.

This rule removes all references to the 1978 grace period, including deletions of language in the text of the regulations and the interpretative examples that no longer apply. In some cases, new text has been added to preserve the substantive meaning of the regulation or example. The rule also removes the phrase “effective date of this part” and replaces it with the January 18, 1978 date of publication of the original rule. In addition, this rule corrects paragraph references, particularly in the interpretative Supplements. It also provides clarifying language in instances where the original text was unclear, as well as making typographical corrections, as appropriate.

This rule also addresses issues raised by a proposed rule published by the Department on September 26, 1989 (54 FR 39415). The proposed rule contained revisions and clarifications to the antiboycott provisions of the EAR that, at the time, the Department found “[were] still debated or confusing.”

Since 1989, the Department has had an additional ten years of experience in implementing the antiboycott provisions of the EAR and has concluded that some of the changes proposed in 1989 rule remain useful. These have been incorporated into the final rule. In some cases, proposed changes are incorporated with additional revisions or clarifying language as appropriate. Other proposed changes addressed issues which the Department no longer considers “debated or confusing” and have not been adopted in the final rule.

The 1989 Proposed Rule addressed the following issues:

(1) The intent provision to the reporting requirement;

(2) The jurisdictional requirements relating to the implementation of letters of credit;

(3) The furnishing information prohibitions about the nationality of directors and blacklisted persons;

(4) The shipping requirement exception to refusals to use blacklisted vessels; and

(5) The import and shipping document exception to information about the nationality of carriers and residence of manufacturers or suppliers.

At the end of the 30-day comment period, three comments were received. Two additional comments were received after the comment period closed. All five comments were taken into account in developing this final rule. Having reviewed the comments received on this proposed rule, BXA is now issuing this rule in final form.

Readers should note that part 769 was redesignated as part 760 on March 25, 1996. All comments were received prior to that date refer to part 769. Accordingly, in the following discussion, all references by commenters to part 769 have been changed to part 760 and its corresponding sections.

One commenter contended that the two proposed changes to the intent provisions fail to clarify the applicable standards of intent. The Department's proposal removed example (ix) and the accompanying Note following example (x) to § 760.1(e). The commenter believed that elimination of this example would expand the scope of the prohibitions, because the example is an illustration of situations where the prohibitions of § 760.2(d) may not apply because either there is no intent to violate the regulations, or the information supplied is of a type generally used for a legitimate business purpose.

Example (ix) would permit U.S. company A to furnish information “demonstrat[ing] that A does at least as much business in [boycotting country] Y and other countries engaged in a boycott of [boycotted country X] as it does in X.” By furnishing this information relating to country X, A would be violating § 760.2(d)(1) which prohibits a U.S. person from furnishing information concerning “his . . . past, present or proposed business relationships . . . with or in a boycotted country. . . .” By stating that A could furnish this information, the example can lead to unnecessary confusion concerning the meaning of the intent requirement. The commenter's suggestion was not adopted, and example (ix) and the accompanying Note following example (x) were deleted.

The commenter also contended that the Department's proposed revision to § 760.1(e)(3), which would remove the intent as an element of the reporting requirement, implied that a failure to comply with the reporting requirements would be a strict liability offense.

The intent requirement is set forth in section 8(a) of the Export Administration Act (Act). The obligation to report, however, arises from section 8(b)(2). In addition, § 760.1(e)(3) of the regulations was adopted when part 760 included only the prohibitions in § 760.2. When the reporting requirements in § 760.5 were later revised to reflect the requirements of the 1977 amendments to the Export Administration Act, the language of § 760.1(e)(3) was apparently overlooked and not changed. The proposed rule would revise the general statement in paragraph (e)(3) to make it clear that intent is an element only of a violation of the prohibitions set forth in § 760.2 of the regulations.

Furthermore, § 760.5(a)(2) provides that requests are reportable if the U.S. person “knows or has reason to know” that the purpose of the request is to further a boycott or restrictive trade practice. Thus, it is clear that failure to report is not a strict liability violation, and the proposed rule is adopted by incorporating the change proposed to be made in § 760.1(e)(3).

One commenter opposed the proposed revision of § 760.1(d)(20), which replaced the language “by this part” with the phrase “by the prohibition of § 760.2(f).” The commenter contended that the effect of this revision would be to subject the implementation of letters of credit to the other prohibitions contained in part 760, not only to the prohibition of § 760.2(f), which specifically addresses the implementation of letters of credit. The final rule makes no change to § 760.1(d)(20) because the Department has concluded that the issue is no longer debated or confusing.

One commenter suggested that an additional example be included in the regulations concerning a contract with a form of a letter of credit that contains a number of preprinted provisions. These provisions would include a stipulation that documents covering goods of Israeli origin are not acceptable. However, the letter of credit would simultaneously contain a provision imposing the requirement that the documents must certify that the goods are 100 percent of U.S. origin. This additional example was not adopted because the Department believes it is not of general interest.

The proposed rule would have changed example (vii) to § 760.2(c), relating to Furnishing Information about Race, Religion, Sex or National Origin. The proposed revision stated that furnishing permissible information about the nationalities of directors or corporate officers would not violate § 760.2(c) but “would violate § 760.2(d)—the prohibition on furnishing information about business relationships.” Two commenters pointed out that the proposed revision to example (vii) is in conflict with other provisions of the regulations and with the Act's legislative history.

One of the two commenters further contended that furnishing information on the nationality of officers, directors, or employees should be presumed to be normal commercial information sought for legitimate business purposes, unless there are reasons or facts available to the exporter indicating otherwise. Information sought about an employment relationship should not be considered to be information about a business relationship as that term is commonly understood.

The final rule makes no change to example (vii) because the Department has concluded after ten years of additional experience that furnishing information concerning nationalities of officers, directors, or employees has not been confused with violations of § 760.2(d), furnishing information about business relationships.

The proposed rule added example (vi) to § 760.3(b) relating to Examples of Compliance with the Shipping Requirements of a Boycotting Country. The Department received no comments on example (vi), and the final rule adopts this example.

The proposed rule revised subparagraphs (ii), (iv), and (v) of the text of § 760.3(c)(1) by adding a reference to the “nationality” of the carrier, and a reference to the “residence” of the supplier of the shipment and the provider of other services, with respect to compliance with import and shipping document requirements. No comments were received on these revisions. The final rule adopts the proposed revision to subparagraph (ii), and adds the word “address” to subparagraphs (iv) and (v). The Department believes that “address” is a more commonly used term than “residence” in import and shipping documents.

One commenter suggested that § 760.3(c)(2) be revised to provide that not only the names, but the nationalities, “of carriers or routes of shipments” may be stated “in negative terms in conjunction with shipments to a boycotting country. . . .” The final rule adopts this suggestion. The Department has long taken the position that furnishing information about the nationality of a carrier may be supplied in negative terms. This information relates to requirements protecting against war risks or confiscation.

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

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

2. Notwithstanding any other provision of law, no person is required to respond to nor be subject to a penalty for failure to comply with a collection of information, subject to the requirements of the Paperwork Reduction Act, unless that collection of information displays a current valid OMB Control Number. This rule involves collection of information subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq. ). This collection has been approved by the Office of Management and Budget under control number 0694-0012. There are neither additions nor subtractions to this collection due to this rule.

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

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

The Act provides, in title II, for the payment of disability benefits to persons insured under the Act. Title II also provides, under certain circumstances, for the payment of child's insurance benefits based on disability and widow's and widower's insurance benefits for disabled widows, widowers, and surviving divorced spouses of insured persons. In addition, the Act provides, in title XVI, for SSI payments to persons who are aged, blind, or disabled and who have limited income and resources.

For adults under both the title II and title XVI programs (including persons claiming child's insurance benefits based on disability under title II), “disability” means the inability to engage in any substantial gainful activity. For an individual under age 18 claiming SSI benefits based on disability, “disability” means that an impairment(s) causes “marked and severe functional limitations.” (Our regulations at § 416.902 explain that, “[m]arked and severe functional limitations, when used as a phrase, * * * is a level of severity that meets or medically or functionally equals the severity of a listing in the Listing of Impairments in appendix 1 of subpart P of part 404 * * *.”) Under both title II and title XVI, disability must be the result of a medically determinable physical or mental impairment or combination of impairments that can be expected to result in death or that has lasted or can be expected to last for a continuous period of at least 12 months.

The Act also provides that an individual shall not be considered to be under a disability unless he or she furnishes such medical and other evidence of the existence of such impairment(s) as the Commissioner may require.

Sections 404.1513 and 416.913 provide that we need reports about an individual's impairments from acceptable medical sources; they also provide a list of “acceptable medical sources.” Acceptable medical sources are individuals who have the training and expertise to provide us with the signs and laboratory findings based on medically acceptable clinical and laboratory diagnostic techniques that establish the existence of a medically determinable physical or mental impairment.

We are amending §§ 404.1513 and 416.913 by revising the list of acceptable medical sources and making other changes to these and other sections of our regulations as explained below.

For clarity, we refer to the new rules, as revised in this regulatory publication, as “final” rules and to the rules that are being changed by these final rules as the “prior” rules. However, these final rules do not go into effect until 30 days after the date of this publication. Therefore, the “prior” rules will still be in effect for another 30 days.

We are revising the heading to read, “ Medical and other evidence of your impairment(s) ” to more accurately identify the subject of these sections. Even though these prior sections were called “ Medical evidence of your impairment, ” they have always described how we use evidence from both acceptable medical sources and other sources, such as (but not limited to) nurse-practitioners, chiropractors, school teachers, and social workers. Sections 223(d)(3) and 1614(a)(3)(D) of the Act require that an individual have a medically determinable physical or mental impairment that results from anatomical, physiological, or psychological abnormalities which are demonstrable by medically acceptable clinical and laboratory diagnostic techniques. To establish the existence of a medically determinable impairment, we require evidence from acceptable medical sources. However, as indicated in both the prior §§ 404.1513(e) and 416.913(e) and the final §§ 404.1513(d) and 416.913(d), we also may use evidence from other sources to help us understand how an adult's impairment(s) affects the ability to work and how a child's impairment(s) affects the ability to function.

We are revising the heading of §§ 404.1513(a) and 416.913(a) to “ Sources who can provide evidence to establish an impairment ” and the provisions of these paragraphs as well. These revisions make it clear that we need evidence from acceptable medical sources to establish the existence of a medically determinable impairment. We then continue to list the sources that we consider acceptable medical sources in final paragraphs (a)(1) through (a)(5). In addition, as described below, we are making some revisions to this list of acceptable medical sources. We are also adding a cross-reference to § 404.1508 in § 404.1513(a) and a cross-reference to § 416.908 in § 416.913(a). The regulations to which we are cross-referring, both entitled “ What is needed to show an impairment, ” describe the type of medical evidence we require to establish the existence of a medically determinable impairment.

We are revising prior paragraph (a)(1) (“Licensed physicians”) by combining it with prior paragraph (a)(2) (“Licensed osteopaths”) because osteopaths are physicians. Their medical degree is usually Doctor of Osteopathy (D.O.), rather than Doctor of Medicine (M.D.). Thus, a licensed physician may be either a medical or an osteopathic physician. Because of this consolidation of two paragraphs, we are renumbering prior paragraphs (a)(3) and (a)(4) as final paragraphs (a)(2) and (a)(3).

We have also added language to final paragraph (a)(2) (prior paragraph (a)(3), “Licensed or certified psychologists”) to provide that licensed or certified school psychologists, or licensed or certified individuals with other titles who perform the same function as a school psychologist in a school setting, are acceptable medical sources for establishing the existence of mental retardation, learning disabilities, and borderline intellectual functioning. The final provision reflects our longstanding operating instructions. It also includes an additional change, which did not appear in the proposed rules, that we have made in response to public comments.

Before including school psychologists as acceptable medical sources in our operating instructions for purposes of establishing the existence of mental retardation and learning disabilities, we conducted a State-by-State analysis of the educational qualifications and other requirements for their licensure or certification, and we had discussions with representatives of the National Association of School Psychologists on the issue of what school psychologists are uniformly qualified to do nationwide. Although the term “licensed or certified psychologists” encompasses school psychologists, we found that there was a lack of national uniformity among the States as to what school psychologists are allowed to do beyond assessing cognitive functioning, such as in the areas of mental retardation and learning disabilities. We determined, however, that licensed or certified school psychologists (or licensed or certified individuals with other titles who perform the same functions as school psychologists in school settings) are able to provide us with a complete medical report of manifestations related to these kinds of disorders. Therefore, we concluded that all individuals who are licensed or certified by their States as school psychologists (or approved in Michigan, which is equivalent to licensure or certification in other States) are medical sources who can establish the existence of mental retardation and learning disabilities. We discuss an additional change below in the Public Comments section, where we summarize and respond to the public comments we received following our publication of these regulatory provisions in the Federal Register as proposed rules on October 9, 1998 (63 FR 54417). The additional change is that we have concluded that these individuals are also acceptable medical sources for the purpose of establishing the existence of borderline intellectual functioning.

We are adding a new paragraph (a)(4) to include licensed podiatrists as acceptable medical sources for impairments of the foot, or foot and ankle, depending on the delineation in the State licensure. We have included these sources in our operating instructions for many years as acceptable medical sources for purposes of establishing the existence of a medically determinable impairment of the foot, or foot and ankle, because they are licensed to practice medicine and perform surgery on a specific part of the body. They can do everything that a physician is licensed to do with respect to the foot, or foot and ankle, and have equal standing to physicians in this respect. Final paragraph (a)(4) provides that whether evidence from a given podiatrist can be used to establish the existence of a medically determinable impairment of the foot only, or the foot and ankle, will depend on the scope of practice of podiatry in a State; i.e., whether the State in which the podiatrist practices permits the practice of podiatry on the foot only, or on the foot and ankle. Medical reports from podiatrists can provide us with all the evidence we require to establish the existence of a medically determinable impairment of the foot, or foot and ankle.

We are deleting prior paragraph (a)(5), which provided that persons authorized to send us a copy or summary of the medical records of a hospital or other institution were acceptable medical sources. Regardless of who is authorized to send us a medical report, the evidence itself must be provided by an acceptable medical source identified in final paragraphs (a)(1) through (a)(5). Similarly, we are deleting prior paragraph (a)(6) (that appears only in § 416.913), which provided that reports of an interdisciplinary team were acceptable medical sources as long as they contained the evaluation and signature of an acceptable medical source. It does not matter whether the evaluation by an acceptable medical source identified in final paragraphs (a)(1) through (a)(5) is included in an interdisciplinary team report or is contained in a separate report. Because acceptable medical sources are individuals, it is redundant and somewhat misleading to provide that an interdisciplinary team report containing the evaluation and signature of an acceptable medical source is such a source.

We are adding a new paragraph (a)(5) to include qualified speech-language pathologists as acceptable medical sources who can establish the existence of a speech or language impairment. For several years, we have included these individuals in our operating instructions as medical sources who can provide evidence to establish the existence of a medically determinable speech or language impairment in SSI childhood disability cases in which the child is found disabled. The final regulation now provides that these individuals are acceptable medical sources for speech and language impairments regardless of whether the determination or decision is favorable to the individual, and is applicable to both adults and children and to disability claims under both titles of the Act.

Before including qualified speech-language pathologists in our operating instructions, we conducted a State-by-State analysis of the educational qualifications and other requirements for licensure or certification of speech-language pathologists, and we had discussions with representatives of the American Speech-Language-Hearing Association. We determined that the evaluation report of a qualified speech-language pathologist can provide us with the detailed evidence we need about a person's communicative ability that enables us to determine the existence of a medically determinable speech or language impairment.

Final paragraph (a)(5) provides that “qualified” speech-language pathologists are individuals who are licensed by the State professional licensing agency, or fully certified by their State's education agency, or who hold a Certificate of Clinical Competence from the American Speech-Language-Hearing Association. We have cited State licensure as the first credential for speech-language pathologists to be consistent with the paragraphs for physicians and other acceptable medical sources in this section, all of which require that the individual be “licensed.” We have cited the State education agency certification as an alternative credential because some States do not have licensing agencies for speech-language pathologists; thus, the only State credential that speech-language pathologists have in such States is State education agency certification. To maintain either State licensure or State education agency certification, an individual must meet certain criteria ( e.g., must obtain 20 continuing education units in the field over a 2-year period). We have also cited a Certificate of Clinical Competence from the American Speech-Language-Hearing Association as another acceptable credential because it indicates that a speech-language pathologist has met the stringent criteria for education, training, examination, and clinical practice set forth by the American Speech-Language-Hearing Association.

Finally, we have made minor editorial revisions to the provisions in §§ 404.1513(a)(1) through (a)(5) and 416.913(a)(1) through (a)(5). The revisions, mostly to correct punctuation, are not substantive and are not intended to change the meaning of the provisions.

We are redesignating prior §§ 404.1513(d) and 416.913(d), “ Completeness, ” as §§ 404.1513(e) and 416.913(e). We are redesignating prior paragraph (e) of those sections, “ Information from other sources, ” as paragraph (d). Our intent in switching the positions of these two paragraphs is to make it clearer that, when we decide whether the evidence in a case is complete enough for a determination, we consider all the evidence in the case record, including the medical evidence from acceptable medical sources identified in paragraph (a), information from the individual, and any evidence that may have been provided by other sources, such as those identified in final paragraph (d).

We are also revising the language in final §§ 404.1513(d) and 416.913(d) (prior paragraph (e)) by making technical changes for clarity and for consistency between these provisions in parts 404 and 416, which contained some differences in our prior rules. We are also reorganizing and renumbering the subparagraphs in final paragraph (d). In addition, we are deleting the words “ Information from ” in the heading.

We are revising the first sentence of § 404.1513(d) to read: “In addition to evidence from the acceptable medical sources listed in paragraph (a) of this section, we may also use evidence from other sources to show the severity of your impairment(s) and how it affects your ability to work.” We are also revising the first sentence of § 416.913(d) to read: “In addition to evidence from the acceptable medical sources listed in paragraph (a) of this section, we may also use evidence from other sources to show the severity of your impairment(s) and how it affects your ability to work or, if you are a child, your functioning.” In both of these sentences, we are adding a reference to the severity of the individual's impairment(s) because we may use evidence from other sources to show impairment severity, as well as how it affects the ability to work or, in § 416.913(d), a child's functioning. In final § 416.913(d), we are changing the language “or, if you are a child, your ability to function independently, appropriately, and effectively in an age-appropriate manner” to “or, if you are a child, your functioning,” in response to section 211 of Public Law 104-193 which, on August 22, 1996, added a new paragraph 1614(a)(3)(C) to the Act that changed the definition of disability for individuals under age 18 claiming SSI benefits.

We are adding the phrase “but are not limited to” to the second sentence of final § 404.1513(d) to clarify that the list of other sources is not an exclusive list and to make it consistent with the language in prior § 416.913(e) (final § 416.913(d)). We also have deleted the words “may” and “and” from the second sentence of final § 416.913(d), and inserted the word “but” after the phrase “Other sources include” to make it consistent with the second sentence of final § 404.1513(d).

In making these changes in the two sections, we are consolidating the provisions from prior §§ 416.913(e)(3) and (e)(4) in final paragraph (d)(1) and modifying the example of therapists that was in the proposed rules so that it is not restricted to just physical therapists. The examples in the proposed rules should not have been limited to physical therapists because there are other types of therapists, such as occupational therapists, as identified in prior § 416.913(e)(4), recreational therapists, and kinesiotherapists. We are deleting “speech and language therapists” from the examples that were in prior § 416.913(e)(4) because, as discussed earlier in this preamble, we are amending the regulations to include these individuals as acceptable medical sources. (However, in final § 404.1513(a)(5) and 416.913(a)(5), we use the term “speech-language pathologists” because it is a more accurate title for these health care professionals.)

We are clarifying in final §§ 404.1513(d)(1) and 416.913(d)(1), the list of individuals, such as nurse-practitioners and audiologists, who provide some medical services by adding the phrase, “Medical sources not listed in paragraph (a) of this section.” We are including in §§ 404.1513(d)(1) and 416.913(d)(1) some of the examples of other medical sources that previously were contained only in prior § 404.1513(e)(3) or only in prior § 416.913(e)(3) and (e)(4). The prior provisions did not provide all the same examples, and the final rules are now consistent in parts 404 and 416.

Final §§ 404.1513(d)(2) and 416.913(d)(2) reflect provisions that were only in prior § 416.913(e)(5).

We are adding the word “personnel” in final §§ 404.1513(d)(3) and 416.913(d)(3). The prior sections (§§ 404.1513(e)(1) and 416.913(e)(1)) referred to public and private social welfare “agencies.” However, when we refer to “sources” in these rules, we mean people, not entities. This change also makes the provision similar to other provisions within these sections.

We begin final §§ 404.1513(d)(4) and 416.913(d)(4) with the phrase, “Other non-medical sources,” instead of “Observations by,” to make the construction of final paragraph (d)(4) parallel to that of final paragraphs (d)(1) through (d)(3). We are also adding the language “(for example, spouses, parents and other caregivers, siblings, other relatives, friends, neighbors, and clergy)” to final § 404.1513(d)(4) to make it consistent with the language in prior § 416.913(e)(2) (final § 416.913(d)(4)).

As is discussed below in the Public Comments section, we revised the proposed first sentence of final §§ 404.1513(e) and 416.913(e) (prior paragraph (d)) to read: “The evidence in your case record, including the medical evidence from acceptable medical sources (containing the clinical and laboratory findings) and other medical sources not listed in paragraph (a), information you give us about your medical condition(s) and how it affects you, and other evidence from other sources, must be complete and detailed enough to allow us to make a determination or decision about whether you are disabled or blind.” In the Notice of Proposed Rulemaking (NPRM), we proposed to simplify the sentence by deleting any reference to the medical evidence and referring only to “the evidence” in a claim. A commenter believed that it would be better to retain reference to the medical evidence and simply to refer to the types of evidence we obtain. As in the proposed rules, the change in the final rules will clarify that we do not look only at medical evidence from the acceptable medical sources identified in paragraph (a), but also at information provided by the individual and any evidence that might have been provided by other sources, as described in final paragraph (d), when we make a determination whether the individual is disabled or blind.

We have revised final paragraph (e)(1) by deleting the term “limiting effects” and substituting in its place the word “severity,” which more accurately conveys the statutory requirement that an individual must have a severe impairment to be found disabled. We are revising the language in final paragraph (e)(2) to more accurately refer to whether the duration requirement, as described in §§ 404.1509 and 416.909, is met.

We are revising final paragraph (e)(3) by qualifying the language about residual functional capacity because the combined evidence must be complete and detailed enough to allow us to determine the individual's residual functional capacity only when the evaluation steps described in §§ 404.1520(e) or (f)(1) and 416.920(e) or (f)(1) apply. We are also adding the phrase “or, if you are a child, your functioning” to § 416.913(e)(3) because ability to function is the relevant issue that we must determine for a child, not residual functional capacity.

We have removed the last sentence in paragraph (e) because it addressed only the role in disability determinations of psychological consultants, and did not address the parallel situations of speech-language pathologists and other consultants. We now provide more comprehensive rules in revised paragraphs (c) and (f) of §§ 404.1616 and 416.1016. We explain that non-physician medical consultants and psychological consultants can only evaluate impairments within their area of expertise.

We are changing the cross-reference in paragraph (b)(4) from paragraph (e) to paragraph (d) to reflect the reversal and redesignation of these two paragraphs already explained above.

We are revising the second sentence in paragraph (c) of §§ 404.1526 and 416.926 to indicate that a medical consultant must be an acceptable medical source identified in §§ 404.1513(a)(1) or (a)(3) through (a)(5) and 416.913(a)(1) or (a)(3) through (a)(5). We believe the acceptable medical sources identified in these sections, in addition to physicians, are fully qualified to serve as medical consultants within their areas of expertise.

As we discuss below in the Public Comments section, we received comments indicating that our intent was unclear. Accordingly, we are also revising the last sentence of paragraph (c), the parenthetical cross-references to §§ 404.1616 and 416.1016. The additional language we have included in final §§ 404.1616 and 416.1016 clarifies that medical consultants who are not physicians are limited to evaluating impairments within their specialties; for example, a speech-language pathologist functioning as a medical consultant would be able to provide an opinion about medical equivalence only with respect to a speech or language impairment.

We are removing the last sentence in paragraph (d). In the NPRM, we inadvertently failed to propose deleting this last sentence, which is the exact same provision contained in the last sentence we are removing in paragraph (e) of §§ 404.1503 and 416.903. Therefore, for the same reasons discussed earlier for the deletion in §§ 404.1503 and 416.903, we are deleting this last sentence as well from §§ 404.1615(d) and 416.1015(d).

In the NPRM, we proposed to revise the first sentence in §§ 404.1616 and 416.1016 to indicate that a medical consultant must be an acceptable medical source identified in §§ 404.1513(a)(1) or (a)(3) through (a)(5) and 416.913(a)(1) or (a)(3) through (a)(5). As we discuss below in the Public Comments section, we received a number of comments that indicated to us that our intent was unclear or that recommended additional rules defining the authority of medical consultants who are not physicians. Accordingly, we have extensively revised §§ 404.1616 and 416.1016.

The final rules now contain six paragraphs, designated (a) through (f). Paragraph (a), “ What is a medical consultant ?” explains that a “medical consultant” is a person who is a member of a team that makes disability determinations in a State agency, as explained in §§ 404.1615 and 416.1015, or who is a member of a team that makes disability determinations for us when we make disability determinations ourselves.

Paragraph (b), “ What qualifications must a medical consultant have ?” provides that a medical consultant must be an acceptable medical source identified in §§ 404.1513(a)(1) and (a)(3) through (a)(5) and 416.913(a)(1) and (a)(3) through (a)(5) and names all of the acceptable medical sources, in addition to cross-referencing these provisions as we had done in the NPRM. We believe that this is a clearer way to explain who is included. The paragraph also provides that the medical consultant must meet any appropriate qualifications for his or her specialty as explained in § § 404.1513(a) or 416.913(a).

Final paragraph (c) is called, “ Are there any limitations on what medical consultants who are not physicians can evaluate ?” In this paragraph, we clarify in response to comments what was always our intent: that even though any individual who is an acceptable medical source may be a medical consultant, medical consultants who are not physicians are limited to evaluations to the same extent that they would be limited in providing evidence of a medically determinable impairment. We provide an example explaining the limitations of a State agency medical consultant who, as a team member that makes disability determinations, is a speech-language pathologist.

Paragraph (d) is called, “ What is a psychological consultant ?” It explains that a psychological consultant may function in the same capacity as any of the individuals in paragraph (a) except that they are limited to the evaluation of mental impairments.

Paragraph (e) incorporates the second and third sentences of the opening paragraph of prior §§ 404.1616 and 416.1016, and paragraphs (a), (b), and (c) of those sections. We have incorporated the provisions verbatim. The only differences are in the letter and number designations of the paragraph and subparagraphs and the new heading we added to final paragraph (e) for consistency with the headings of the previous paragraphs. The prior provisions did not use headings.

Paragraph (f) is called, “ Are there any limitations on what a psychological consultant can evaluate ?” It parallels paragraph (c) of this section, discussed above.

We published these regulatory provisions in the Federal Register as an NPRM on October 9, 1998 (63 FR 54417). The comment period closed on December 8, 1998. We received comments in response to this notice from 12 individuals and organizations, including government agencies whose interests and responsibilities require them to have some expertise in the evaluation of medical evidence used in making disability determinations under titles II and XVI of the Act. We also received comments from a private, non-profit organization for the disabled, an individual attorney, health care professional organizations, and an employee union.

Most of the commenters stated that they supported the proposed rules. However, a number of commenters offered suggestions for revisions and additions, as explained below. Three commenters supported the rules without making any recommendations. One commenter opposed all of the rules. Because some of the comments were similar, we condensed, summarized, or paraphrased them. We have, however, tried to summarize the commenters' views accurately and to respond to all of the significant issues raised by the commenters that are within the scope of these rules.

Comment: Two commenters recommended that we revise paragraph (a)(2) of §§ 404.1513 and 416.913 to include borderline intellectual functioning in the list of impairments that can be established by evidence from licensed or certified school psychologists.

Response: We adopted the comments. As one of the commenters noted, borderline intellectual functioning is a medically determinable mental impairment that results from psychological abnormalities demonstrable by medically acceptable clinical and laboratory diagnostic techniques. It is usually assigned to individuals who have an intelligence quotient (IQ) score in the 71-84 range and for whom the diagnosis of mental retardation has been excluded. School psychologists are qualified to assess cognitive abilities at all levels, and we agree that they can establish the existence of borderline intellectual functioning.

Comment: One commenter recommended that we expand proposed paragraph (a)(5) of §§ 404.1513 and 416.913 to permit qualified speech-language pathologists to establish speech, language, “or related ( e.g., swallowing)” impairments. The commenter also recommended that we expand the qualification criterion in the proposed rules concerning meeting State education agency standards to say: “* * * provided such standards are consistent with the highest requirements for State-approved or State-recognized certification, licensing, registration, or other comparable requirements for speech-language pathologists.” The commenter believed that this would make clear that the word “qualified” refers to individuals who have met the requirements in the State, and would ensure that only those individuals with sufficient training and clinical expertise are allowed to provide evidence used in making a disability determination.

Response: We are not adopting the recommendation to consider speech-language pathologists as acceptable medical sources for “related ( e.g., swallowing)” impairments. Because of the complex anatomical and physiological construct involved in the swallowing mechanism, specific knowledge and training that encompass the medical areas of neurology, otolaryngology, and gastroenterology are required for the proper interpretation of laboratory and imaging studies necessary in arriving at the diagnosis, prognosis, and treatment regimen pertaining to the variety of disorders associated with swallowing. Therefore, we will continue to require evidence from a licensed physician to establish the existence of a medically determinable swallowing impairment.

We are also not adopting the second comment about State education agency standards being consistent with the highest State requirements because it would not be feasible for us to constantly monitor such standards and requirements in each State.

For reasons already noted above in the summary of the changes in these final rules, we have cited State licensure as the first credential in the rule.

Comment: One commenter recommended that we not delete paragraph (a)(6) of § 416.913, the paragraph that addresses interdisciplinary assessments in which there is a signature from an acceptable medical source. The commenter believed that this paragraph helps to avoid confusion about the acceptability of evidence that is signed by both a medical and a nonmedical source. The commenter also recommended that we add the same provision to § 404.1513.

Response: We did not adopt the comment because the construction of paragraph (a)(6) is confusing and not parallel to the construction of the other paragraphs in paragraph (a). Paragraph (a) concerns who is an acceptable medical source, not what is “acceptable medical evidence.” Moreover, an acceptable medical source must be a person, not “[a] report” as stated in paragraph (a)(6). The fact that an interdisciplinary team report is co-signed by both a medical and nonmedical source does not mean that the report cannot be considered “acceptable medical evidence,” i.e., evidence from an acceptable medical source. Provided that the medical source is an acceptable medical source identified in final paragraphs (a)(1) through (a)(5) of § § 404.1513 and 416.913, it does not matter whether an evaluation signed by an acceptable medical source is included in an interdisciplinary team report or is contained in a separate report.

Comment: Three commenters recommended that we include other medical professionals in our list of acceptable medical sources. One commenter recommended that we include optometrists for the determination of other aspects of eye diseases, in addition to the measurement of visual acuity and visual fields. Another commenter recommended that we recognize audiologists as acceptable medical sources for purposes of establishing hearing or related ( e.g., balance) impairments only. This source recommended criteria for establishing that an audiologist is “qualified” for our program. The third commenter recommended that we include pediatric nurse-practitioners for establishing the existence of medically determinable impairments in children.

Response: We did not adopt the comments. Sections 223(d)(3) and 1614(a)(3)(D) of the Act require that an individual have a medically determinable physical or mental impairment that results from anatomical, physiological, or psychological abnormalities which are demonstrable by medically acceptable clinical and laboratory diagnostic techniques. In keeping with these statutory provisions, we generally consider licensed physicians and licensed or certified psychologists, who are the most qualified health care professionals, as “acceptable medical sources” who can establish the existence of a medically determinable impairment. We have also provided in these final rules that podiatrists and speech-language pathologists may be acceptable medical sources, not only because of their unique qualifications, but because we have determined that there is sufficient standardization of their qualifications across the States for us to provide rules for their general use in claims. We have not determined this for other specialties. Therefore, we believe it would be inappropriate to include these additional specialties at this time.

However, we want to make clear that we consider information from the sources named in the comments to be important evidence when we determine the severity of an individual's impairment. The rules on who is an acceptable medical source address a single, narrow issue in our disability evaluations: who can provide evidence to establish whether an individual has a medically determinable impairment as required by the Act. Once an individual has crossed this threshold, we can and do consider all evidence that helps us to determine the severity of the impairment and its effects on the individual. For this critical aspect of the disability determination process, we will continue to use information from the sources named in the comments.

Comment: One commenter disagreed with our inclusion of licensed or certified psychologists, school psychologists and speech-language pathologists as “acceptable medical sources” in our regulations. The commenter said that we should clarify that these sources are acceptable sources of evidence but that they are not “medical” sources. The commenter believed that “medical” sources should refer only to physicians and that Congress did not intend for us to include any of the other sources.

Response: We did not adopt the comment. Sections 223(d)(3) and 1614(a)(3)(D) of the Act define a medically determinable impairment as one that results from “anatomical, physiological, or psychological abnormalities which are demonstrable by medically acceptable clinical and laboratory diagnostic techniques.” As we noted in the preamble to the proposed rules, we have included licensed or certified school psychologists (or licensed or certified individuals with other titles who perform the same function as a school psychologist in a school setting) and speech-language pathologists as “acceptable medical sources” because we have determined that they can provide us with medical evidence to establish the existence of a medically determinable impairment within their areas of specialty using “medically acceptable clinical and laboratory diagnostic techniques,” as defined in section 223(d)(3) of the Act. We have included licensed or certified psychologists in our regulations defining acceptable medical sources for many years, and, in fact, section 221(h) of the Act refers to these sources as qualified to complete the medical portion of our case review where there is evidence which indicates the existence of a mental impairment.

Comment: Five of the commenters commented about the provisions in § § 404.1526(c), 404.1616, 416.926(c) and 416.1016 of the proposed rules that would define the term “medical consultant” to include any acceptable medical source in § § 404.1513(a)(1) or (a)(3) to (a)(5) and 416.913(a)(1) or (a)(3) to (a)(5). One commenter simply noted that this would permit licensed optometrists, licensed podiatrists, and qualified speech-language pathologists to function as “medical consultants,” but the commenter did not note approval or disapproval or make any recommendations. Two commenters indicated that such sources would have limited usefulness as medical consultants in the State agencies that make disability determinations for us because their expertise is so narrow. One of these commenters recommended that we should include provisions defining the authority of these individuals in § § 404.1526(c) and 416.926(c), our regulations on “ Who is a designated medical or psychological consultant ” for purposes of determining medical equivalence, and in § § 404.1616 and 416.1016, our regulations defining the standards for who can be a medical or psychological consultant.

Two commenters opposed expanding the definition of medical consultant to include optometrists, podiatrists, and speech-language pathologists as medical consultants. One commenter believed that there was no rational justification in the proposed regulations for the “dramatic” change, and was concerned that the change would jeopardize the integrity of the disability programs, especially if it is implemented in conjunction with some of the Disability Redesign proposals. This commenter, while opposing the use of the sources as medical consultants, otherwise generally agreed with our proposal to consider these sources to be acceptable medical sources for purposes of providing medical evidence we need to establish the existence of a medically determinable impairment.

The last commenter, who opposed using these sources even as “acceptable medical sources” for establishing the existence of medically determinable impairments, focused on the proposal as it affected § § 404.1526 and 416.926. This commenter indicated that the sources were “nonqualified.” The commenter provided a number of specific reasons that they should not be permitted to make determinations of medical equivalence, primarily because they would be making decisions regarding areas for which they have no training or expertise and for which they are unlicensed under the law of any State. The commenter also recommended that we revise the medical equivalence regulations to clarify the various ways in which we make findings of medical equivalence. The commenter also stated that we should specify that all claims of combined mental and physical disorders should be reviewed by a psychiatrist to ensure that all aspects of mental and physical disorders are considered in rating the severity of impairment at any step of our process for determining disability.

Response: We are revising § § 404.1616 and 416.1016 in response to these comments. We are also adding a cross-reference to § § 404.1616 and 416.1016 for medical consultants who are not physicians at the end of § § 404.1526(c) and 416.926(c) as we have noted in the explanation of the changes.

As two of the commenters recognized, our intent in the NPRM was to limit the authority of licensed optometrists, licensed podiatrists, and qualified speech-language pathologists to evaluate impairments with regard to their areas of expertise delineated in proposed § § 404.1513(a) and 416.913(a). However, the comments made us realize that our intent was not clear and could be misinterpreted. Therefore, we have expanded final § § 404.1616 and 416.1016 to provide explicitly that acceptable medical sources other than physicians ( i.e., licensed optometrists, licensed podiatrists, and qualified speech-language pathologists) may function as medical consultants, but their authority in helping to make determinations and in providing opinions about medical equivalence and elsewhere is limited to their area of expertise.

Although it was unclear from the comment which disability redesign proposals one of the commenters referred to, we disagree with that comment. We believe that providing State agencies with the opportunity to use these additional specialists in a consulting capacity will improve their ability to make timely, accurate decisions.

With regard to the comment asking us to include the various ways we make findings of medical equivalence, we believe that the change is outside the scope of our authority because we did not propose the change. However, we will consider this comment when we propose other changes in the future.

In making the revisions to § § 404.1616 and 416.1016 in response to these comments, we added new paragraphs with letter and number designations. Therefore, we had to redesignate the paragraph letters and numbers from the prior rules that describe qualified psychologists. Apart from the change in the designations of the letters and numbers of the paragraphs, we did not change the language of those paragraphs.

In response to the last comment, regarding review by a psychiatrist of any case involving a combination of mental and physical disorders, we are providing in final paragraph (c) of § § 404.1616 and 416.1016 that a physician must evaluate the case record, except when the mental impairment alone would justify a finding of disability. However, we do not agree with the commenter that a psychiatrist will be the best physician to assess a combination of mental and physical disorders in all claims. There are claims in which it is more appropriate to use other specialists for the overall review in consultation with a psychiatrist or psychologist.

Comment: One of the foregoing commenters also pointed out that the first sentence of prior § § 404.1616 and 416.1016 seemed incomplete. The commenter noted that the heading of these regulations referred to “ Medical or psychological consultant ,” yet the first sentence referred only to medical consultants. The commenter provided a recommended revision that would include psychological consultants.

Response: We adopted the comment, although not in the exact way suggested by the commenter. In response to this, and the comments already noted, we have revised the entire sections to clarify their provisions.

Comment: One commenter suggested that we revise proposed § § 404.1513(e) and 416.913(e) (prior § § 404.1513(d) and 416.913(d)) to read: “The medical evidence, including the clinical and laboratory find[ing]s, and other evidence from other sources must be complete and detailed enough to allow us to make a determination about whether you are disabled or blind.” The commenter believed that it would be better to retain reference in our regulations to the medical and other evidence we need to establish the existence of a medically determinable impairment and its severity.

Response: We adopted the comment, but did not use the exact language proposed by the commenter. We believe that the commenter's proposed language could be misinterpreted to mean that each piece of evidence must be complete and detailed enough in and of itself for us to make the various findings listed in these regulation sections, or that we must try to obtain all available evidence, even after the record is complete and detailed enough for us to make a determination or decision.

Therefore, the final rule provides: “The evidence in your case record, including the medical evidence from acceptable medical sources (containing the clinical and laboratory findings) and other medical sources not listed in paragraph (a), information you give us about your medical condition(s) and how it affects you, and other evidence from other sources, must be complete and detailed enough to allow us to make a determination or decision about whether you are disabled or blind.” We changed the phrase near the end to “make a determination or decision” for technical reasons. Under our regulations § § 404.901 and 416.1401, the term “determination” means the initial or reconsidered determination, and the term “decision” means the decision made by an administrative law judge or the Appeals Council. This is not a substantive change in the rule, only a clarification of its meaning to show that it applies to all of our adjudicators.

We have consulted with the Office of Management and Budget (OMB) and determined that these final rules do not meet the criteria for a significant regulatory action under Executive Order (E.O.) 12866. Therefore, they were not subject to OMB review. We have also determined that these rules meet the plain language requirements of E.O. 12866 and the President's memorandum of June 1, 1998.

We certify that these final regulations will not have a significant economic impact on a substantial number of small entities because they affect only individuals. Therefore, a regulatory flexibility analysis as provided in the Regulatory Flexibility Act, as amended, is not required.

These final regulations impose no new reporting or recordkeeping requirements subject to OMB clearance.

Administrative practice and procedure, Aged, Blind, Disability benefits, Public assistance programs, Reporting and recordkeeping requirements, Supplemental Security Income (SSI).

FDA is amending the delegations of authority regulations in various sections of 21 CFR part 5, subpart B, Redelegations of Authority from the Commissioner of Food and Drugs , to reflect the most significant changes that resulted from the June 20, 1999, restructuring. (See 64 FR 36361-36368, July 6, 1999, and 64 FR 38675, July 19, 1999.) The changes are as follows:

1. Updating the order of succession and who may perform all of the functions of the Commissioner of Food and Drugs.

2. Clarifying certain delegations of authority to appropriately reflect the Deputy Commissioners' authorities—there will be one principal Deputy Commissioner; however, two other Deputy Commissioner titles (International and Constituent Relations and Management and Systems) will be retained for incumbents only.

3. Amending certain delegations of authority and associated position titles to reflect the establishment of the Office of the Senior Associate Commissioner and the transfer of the Ombudsman, Executive Secretariat, Advisory Committee Oversight, Public Affairs, and Orphan Products Development functions to that component.

4. Removing position titles and delegations of authority associated with the abolished Office of Operations.

5. Removing references to the abolished Offices of Policy and External Affairs and updating position titles and associated delegations of authority, where appropriate, to reflect their conversions to the Office of Policy, Planning, and Legislation and the Office of International and Constituent Relations, respectively.

6. Updating position titles and associated delegations of authority to reflect the transfer of the health assessment, patent term extension, and scheduling controlled substances functions to the Center for Drug Evaluation and Research.

7. Updating position titles and associated delegations of authority to reflect the transfer of 21 CFR part 16 hearings functions; and to reflect the delegation of authority to make due diligence determinations, which pertain to patent term extensions, to the Office of the Ombudsman.

Unless stated otherwise, these authorities may not be further redelegated. Authority delegated to a position by title may be exercised by a person officially designated to serve in such position in an acting capacity or on a temporary basis, unless prohibited by a restriction in the document designating him/her as “acting” or unless not legally permissible.

In the Federal Register of September 24, 1997 (62 FR 49946), FDA proposed to amend its regulations in § 312.42 (21 CFR 312.42) governing clinical holds. A clinical hold is an order that FDA may issue to a sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation for the development of a new drug or biological product (§ 312.42(a)). Under the proposed amendments, FDA could impose a clinical hold on any proposed or ongoing clinical trial for a life-threatening disease or condition that affects both genders if men or women with reproductive potential who have the disease or condition being studied were excluded from eligibility in any phase of the clinical investigation solely because of a risk or potential risk of reproductive toxicity or developmental toxicity from use of the investigational drug. As explained in the preamble to the proposed rule (62 FR 49946 at 49947), the amendments address the exclusion from clinical trials of members of either gender who have a life-threatening disease or condition. Because such exclusions have in the past been applied primarily to women, however, it is expected that the impact of the amendments will be to ensure that women who have a life-threatening disease or condition are not categorically excluded from investigational trials of drug products for that disease or condition solely because of a perceived risk or potential risk of reproductive or developmental toxicity from the use of the investigational drug. FDA provided 90 days for public comment on the proposed rule.

FDA regulations identify the grounds for placing a clinical hold on proposed or ongoing phase 1 studies (§ 312.42(b)(1)) and on proposed or ongoing phase 2 or phase 3 studies (§ 312.42(b)(2)). FDA is amending these clinical hold regulations to provide an additional ground for placing a phase 1, phase 2, or phase 3 study on clinical hold. Under these amendments, FDA may impose a clinical hold on any proposed or ongoing clinical trial for a life-threatening disease or condition that affects both genders if men or women with reproductive potential who have the disease being studied are excluded from eligibility in any phase of the investigation because of a risk or potential risk of reproductive or developmental toxicity from use of the investigational drug.

The proposed rule refers to studies under an IND involving a drug that is intended to treat a life-threatening illness or disease affecting both genders. As stated in the proposal (62 FR 49946 at 49951 ), the definition of life-threatening illness or disease is intended to be consistent with the agency's IND regulations (§ 312.81(a)(1)). Under the IND regulations, the term life-threatening is applied to “conditions” or “diseases.” To remain consistent with current terminology, the agency is amending the final rule to refer to “life-threatening diseases or conditions.”

The clinical hold under these amendments would not apply to clinical studies conducted under special circumstances, such as studies pertinent to only one gender (e.g., to evaluate the excretion of a drug in semen or its effects on menstrual function).

As described in the proposed rule, a clinical hold would not be applied to a clinical study conducted in men, as long as a study that does not exclude subjects with reproductive potential has been planned or is being conducted in women. The agency expects that in an active IND, studies that do not exclude women or men with reproductive potential will be underway or will commence in a timely manner. To clarify this expectation, the final rule has been modified to state that a clinical hold would not be ordered for a study conducted only in men or only in women, as long as a study that does not exclude members of the other gender with reproductive potential is being conducted concurrently or will take place within a reasonable time agreed upon by the agency (§ 312.42(b)(1)(v)(B)). FDA expects that a discussion between the sponsor and the agency concerning a reasonable time for carrying out the study would take place at a pre-IND meeting or with the submission of the IND.

As stated in the proposed rule, this amendment to the IND regulations would not apply to clinical studies conducted exclusively in healthy volunteers (62 FR 49946 at 49951). The final rule has been modified in § 312.42(b)(1)(v) by adding paragraph (C) to clarify that the rule applies to clinical investigations that are conducted only in subjects who have the disease or condition that the drug is intended to treat.

FDA received 26 letters, including letters from manufacturers, individuals, advocacy groups, and trade associations, commenting on the proposed rule. The majority of comments supported FDA's proposal to prohibit the exclusion of women from investigational studies through the clinical hold mechanism. Many comments suggested changes that would have narrowed or broadened the proposal.

1. Several comments indicated that if women with reproductive potential are capable of acquiring a disease, such women should be included in clinical trials regardless of their ability to become pregnant. Many comments stated that FDA's goal of ensuring that women with reproductive potential who have a life-threatening disease are not categorically excluded from trials in the future is “an unassailable position.” Another comment strongly recommended that FDA finalize the proposed rule, noting that despite FDA's 1993 “Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs,” there has been little improvement in opening enrollments (especially in phase 1 and phase 2 trials) to fertile women and in increasing enrollment of women overall. The agency agrees with these comments.

2. One comment stated that women of reproductive age with life-threatening diseases who are fully informed should be included in all stages of product development. The same comment urged FDA to closely monitor the implementation of the new rule and to continue the development of policies that would minimize risks while allowing productive research on women and men.

FDA will monitor the implementation of this final rule as part of the general IND process and will continue to encourage research on the treatment and prevention of diseases and conditions in all individuals.

3. Section 312.42(a) states that “[w]hen an ongoing study is placed on a clinical hold, * * * patients already in the study should be taken off therapy involving the investigational drug unless specifically permitted by FDA in the interest of patient safety.” One comment noted that FDA did not define “patient safety” in the preamble to the proposed rule. The comment requested that the agency consider indirect harm to patients in an evaluation of whether continuation of therapy involving an investigational drug is in the interest of patient safety.

Generally, studies are placed on clinical hold because FDA considers it unsafe to carry the studies forward. In the present case, the hold does not imply such a conclusion. FDA generally intends to place trials that inappropriately exclude individuals with reproductive potential on hold at the time of protocol submission. However, if a trial that has begun is placed on clinical hold under this rule, it usually should not be necessary to stop an individual subject's treatment.

4. Three comments discussed the definition of the term “life-threatening.” Two comments expressed concern that the definition could be construed to include acute and chronic illnesses, such as status asthmaticus, epilepticus, anaphylaxis, diabetes, hypertension, and severe hypercholesterolemia. One proposed narrowing the definition to encompass only those diseases identified in the proposed rule as being of concern to FDA. The third comment suggested broadening the definition to include chronic conditions such as epilepsy.

The definition of life-threatening is not intended to be limited to only those diseases and conditions where death is imminent, or broad enough to include acute or chronic diseases where death from the disease or condition is unlikely. The definition of life-threatening encompasses any disease or condition where the likelihood of death is high unless the course of the disease is interrupted. This rule is grounded in FDA's belief that people who are suffering from a disease or condition that is life-threatening despite available therapy should have an opportunity to participate in a clinical trial intended to address the disease or condition. Although many acute and chronic illnesses are adequately controlled by existing therapies, some of these illnesses may have stages or aspects that continue to carry a high likelihood of death despite existing therapies. Such a condition or disease would be considered life-threatening within the meaning of this rule.

5. The agency received two comments addressing the need to balance access to investigational drugs and risks to study participants. One comment stated that while risks can be minimized through mechanisms such as informed consent and study design, the rule needs to be sufficiently flexible to address exceptional circumstances where potential risks of a drug may outweigh the potential benefit. Another comment stated that balancing the need for access to investigational drugs and minimizing patient risk would be better served by data-driven dialogue between sponsors and FDA than by the rule.

The agency acknowledges that balancing access and patient risk is complex and that the specific circumstances of the trial may be pertinent. Physicians and patients are generally willing to accept greater risks from use of medical products that treat life-threatening diseases or conditions than they would accept from those that treat less serious conditions (53 FR 41516 at 41518, October 21, 1988; 62 FR 49946 at 49949). Nonetheless, institutional review boards (IRB's) must still determine that risks to study participants are minimized by the use of procedures consistent with sound research design and that the risks to study participants are reasonable in relation to anticipated benefits (21 CFR 56.111(a)(1) and (a)(2)).

FDA provides frequent opportunities for sponsors to meet with the agency to discuss the details of clinical investigations. For example, the clinical hold regulations specifically encourage discussion about deficiencies in an investigation. FDA will attempt to discuss and satisfactorily resolve the matter with the sponsor before issuing the clinical hold order (§ 312.42(c)). As stated in the proposed rule, a study would be placed on clinical hold only as a last resort (62 FR 49946 at 49953).

6. The agency received divergent comments about the scope of the rule. Two comments stated that FDA should expand the regulation to include all clinical trials.

The agency declines the suggestion to expand the scope of the regulation to include all trials. At this time, there is an ethical basis for seeking to ensure that women with reproductive potential are not categorically excluded from trials of products being developed to treat life-threatening diseases and conditions. As discussed in the preamble to the proposed rule (62 FR 49946 at 49949), FDA has concluded that all trials involving patients with life-threatening diseases or conditions should, for the purposes of the rule, be considered to have therapeutic benefit. The ethical principle of justice does not support categorical exclusion of one group that might benefit from participation in clinical research for life-threatening diseases and conditions. Although similar considerations might apply to all human drug trials, the agency recognizes that the potential detriment of being excluded from a trial is greater when the subjects have life-threatening diseases or conditions.

7. One comment stated that because all new drugs are potentially teratogenic, FDA should not permit administration of any drug to women with reproductive potential until there is evidence of general safety and effectiveness from phase 1 and phase 2 trials.

Although a risk or potential risk of developmental toxicity might exist from participation in a study, benefits that might accrue to a woman with reproductive potential who has the life-threatening disease or condition could outweigh such a risk. Furthermore, such risks can be reduced or eliminated (62 FR 49946 at 49949).

The risk of fetal exposure is eliminated by preventing pregnancy. Sponsors and IRB's can require the use of pregnancy testing to detect unsuspected pregnancy prior to initiation of study treatment and at intervals during the course of drug exposure. When the study design permits, sponsors can minimize potential fetal exposure in the short term by timing studies to coincide with the early follicular phase of the menstrual cycle. Women and men can eliminate the possibility of pregnancy through abstinence and can reduce the possibility of pregnancy through the use of one or more methods of contraception for the duration of drug exposure (62 FR 49946 at 49950). The agency finds that exclusion of women from early trials is not medically necessary because the risk of fetal exposure can be minimized. Initial determinations about whether the risk is adequately addressed are properly left to patients, physicians, local IRB's, and sponsors, with appropriate review and guidance by FDA (58 FR 39406 at 39408, July 22, 1993).

8. The agency received multiple comments stating that historically, IRB's have been a source of exclusionary policies without scientific justification, and FDA needs to be active in ensuring that IRB's do not wrongly exclude women with reproductive potential. One comment suggested that FDA adopt new procedures to carefully monitor IRB's and encouraged quick enforcement of this rule if women with reproductive potential are inappropriately excluded.

Initial determinations about risk and other aspects of the safety of proposed investigations are properly left to patients, physicians, sponsors, and local IRB's with appropriate review and guidance by FDA (58 FR 39408). FDA has established procedures for IRB's at part 56 (21 CFR part 56). Although IRB's play a role in the determination of eligibility criteria for investigations, FDA plans to ensure compliance with this rule primarily through review of IND submissions for drugs that are intended to treat life-threatening diseases and conditions. If the agency makes an initial determination that unwarranted restrictions were placed on the eligibility of women, FDA will attempt to discuss and satisfactorily resolve the matter with the sponsor prior to issuing the clinical hold order (§ 312.42(c)). If a satisfactory resolution cannot be found, an IND may be placed on clinical hold.

9. Another comment recommended that FDA encourage trial sponsors and IRB's to broadly interpret “de facto exclusion” to avoid unnecessarily excluding women with reproductive potential.

The exclusion of subjects with reproductive potential addressed by this rule includes both explicit exclusion and de facto exclusion. De facto exclusion would result from study criteria that are not essential to accomplish the goals of the study and that have the effect of precluding enrollment of participants with reproductive potential (e.g., requiring sterilization or requiring weight or other physical characteristics).

10. Two comments suggested that the agency strengthen its policies by requiring that data collected under IND's be analyzed by gender.

The suggestions are outside the scope of this rulemaking, but in the Federal Register of February 11, 1998 (63 FR 6854), FDA issued the demographic subgroup rule, which revised new drug application (NDA) content and format regulations at 21 CFR 314.50(d)(5). The regulation requires that effectiveness and safety data be presented in each NDA for demographic subgroups, including gender subgroups. This regulation will ensure that data collected under IND's and submitted to the agency will be analyzed by gender.

11. Many comments expressed disappointment that the proposed rule did not contain requirements to enroll or recruit a significant number of women with reproductive potential in clinical trials. Several other comments misunderstood the intent of the rule and questioned its adequacy in ensuring appropriate enrollment and retention of women in trials. An additional comment stated that the proposed rule did not address requirements for appropriate recruitment strategies to ensure that low-income women are represented in clinical trials.

As stated in the preamble to the proposed rule, the primary goal of the rule is to ensure that women with reproductive potential who have a life-threatening disease or condition are not categorically excluded from participation in clinical investigations because of their reproductive capacity (62 FR 49946 at 49947). This rule is thus concerned with eligibility criteria for individual studies. Issues related to the enrollment of significant numbers of women with reproductive potential in clinical trials are under consideration by the agency.

The demographic subgroup rule also includes a requirement (21 CFR 312.33(a)(2)) that IND annual reports provide demographic data on subjects of trials. Although the demographic subgroup rule does not require the inclusion of a particular number of individuals from specific subgroups, it will further focus sponsors' attention throughout the drug development process on clinical trial enrollment. The demographic subgroup rule should also help sponsors better evaluate in their applications the safety and efficacy profiles of drugs for various subgroups, including gender.

12. The agency received one comment stating that pregnant women have the same right to make informed decisions about their own treatment as other women with reproductive potential. The comment concluded by recommending that the proposed regulation also apply if pregnant women are excluded from clinical trials for life-threatening diseases.

For the purpose of this rulemaking, FDA does not intend the phrase “women with reproductive potential” to include pregnant women (62 FR 49946 at 49947). The agency does not question the ability of pregnant women to provide informed consent. There is, however, increased complexity in conducting clinical trials with pregnant women because of their changing physiology. FDA will continue to explore this issue in other forums.

13. One comment recommended that the final rule clearly state that it applies to the exclusion of men in clinical trials and that the agency will carefully monitor the use of the clinical hold in studies that exclude men.

As explained in the preamble to the proposed rule, although men have rarely been excluded from studies because of reproductive potential, the rule addresses the exclusion from clinical trials of members of either gender who have a life-threatening disease (62 FR 49946 at 49947). Section 312.42(b)(1)(v) and (b)(2)(i) state that FDA may place any phase of a proposed or ongoing investigation on clinical hold if

(emphasis added). As part of the IND process, FDA reviews protocol inclusion and exclusion criteria, including gender-related eligibility.

14. In the preamble to the proposed rule, the agency stated that it is important for potential study participants to be provided with an opportunity to discuss their involvement in a clinical trial with their sexual partner. FDA further stated that when deciding whether to participate in a clinical trial for an investigational drug, potential participants should be able to weigh the potential risks of their participation in consultation with their spouse or partner, their health care provider, and their researcher (62 FR 49946 at 49950). Two comments expressed concern that these statements could be construed to mean that such consultation with a partner must occur prior to enrollment. One comment indicated that many women are not sufficiently empowered to resist intimidation by their partner to make an independent decision if their partner agrees or disagrees with participation in a clinical trial. The second comment indicated that not all potential participants have one sexual partner and that no one should be excluded from participating in a clinical trial because of multiple sexual partners. This comment also indicated that women who are unable to negotiate the terms of sexual behavior or the cooperation of their partner(s) with contraceptives should not be categorically excluded from participation in clinical trials.

Women and men can eliminate the possibility of pregnancy through abstinence and can reduce the possibility of pregnancy through the use of contraception for the duration of drug exposure, which may exceed the length of the clinical trial. The cooperation of an individual's sexual partner(s) may be needed to ensure that abstinence occurs or that appropriate contraceptive methods are used, but such cooperation is not always essential. Potential participants should be able to make autonomous decisions about contraception. Potential study participants should discuss with investigators their ability to maintain adequate contraception prior to determining whether they should participate in the study. The rule is not intended to ignore the risks associated with an unintended pregnancy, including the potential for developmental toxicity; rather it is based on the view that IRB's, investigators, and subjects can manage those risks.

Risks to participants in early clinical trials can also be reduced through the proper use of the informed consent process. Potential participants who are heterosexually active must be aware of the need to ensure that appropriate contraceptive measures are taken to prevent pregnancy and of any additional risks in the event of pregnancy. While individuals should be encouraged to involve their sexual partner(s) in their decisionmaking process, the ultimate decision concerning whether to volunteer for a clinical trial should rest with the individual.

15. The agency received several comments on the discussion of the informed consent process in the preamble to the proposed rule. The majority of comments concerning informed consent supported the agency's reliance on this process and other mechanisms to protect participants in early clinical trials. Two comments stated that the informed consent process may encourage potential study participants to act responsibly and make their own risk-benefit analysis. One comment stated that participants need to be adequately informed about available information and about areas in which data are lacking. Two other comments noted the importance of animal reproductive toxicity studies and the inclusion of information obtained as a result of such studies in the informed consent process.

There are a number of mechanisms, including the proper use of informed consent, to protect participants in clinical trials. Sponsors, investigators, and IRB's have responsibility for ensuring participant safety and protecting the rights of participants. FDA's informed consent regulations require that potential study participants be adequately informed that the study involves research, that there may be foreseeable risks or discomforts, and that there may be unforeseeable risks, such as potential risks to the embryo or fetus if a female study participant becomes pregnant (§ 50.25(b)(1) (21 CFR 50.25)(b)(1)). The existence of appropriate alternative procedures or courses of treatment, if any, must also be disclosed to the potential study participant (§ 50.25(a)(4)). Any reasonably foreseeable risks to the participant shown from the results of completed animal reproductive toxicity studies must be discussed in informed consent. When preclinical teratology and reproductive toxicity studies are not completed prior to the initial studies in humans, male and female study subjects should be informed about the lack of full characterization of the test article as well as the potential and unknown effects of the test agent on conception and fetal development. All study subjects should be provided with new pertinent information arising from preclinical studies as it becomes available, and informed consent documents should be updated when appropriate. If there is no relevant information, the informed consent should explicitly state this fact and should indicate the risks that cannot be ruled out.

16. The agency stated in the preamble to the proposed rule (62 FR 49946 at 49950) that when the teratogenic effects of a drug are well established, the agency, sponsor, or IRB may require the use of contraception to prevent pregnancy in sexually active individuals with reproductive potential. One comment noted this statement and suggested that the regulation clearly state that all women in all clinical trials have the right to be fully informed and to balance the risks and benefits of participation.

In most circumstances, a study protocol does not need to require specific contraceptive approaches. In accordance with good medical practice, it is expected that volunteers in clinical trials will take appropriate precautions against becoming pregnant. The agency, sponsor, or IRB may require that a protocol provide for instructions to the volunteer about effective measures to avoid pregnancy. Other appropriate precautions include efforts to ensure that a woman volunteer is not pregnant at the time a trial begins, such as pregnancy testing to detect the beta subunit of the human chorionic gonadotropin molecule. Pregnancy testing may need to continue during the trial and after the drug administration portion of the trial has ended, based on the half-life of the drug under study and other considerations. Contraceptive counseling by a qualified health care provider should be offered and provided to trial participants with a focus on the use of highly effective contraception, allowing for abstinence if a woman has successfully used that as her chosen method of birth control. Although women retain control over their reproductive decisions, women and the investigator should consider together the benefits and risks of participation, including the risks resulting from an inability to maintain adequate contraception. In some cases, notably where a drug is clearly teratogenic, a protocol may need to require specific approaches to contraception.

17. One comment stated that sponsors must retain the right to exclude women of childbearing age from clinical trials involving compounds with the potential for teratogenic effects, unless Congress enacts meaningful protection against liability. The comment based its concern on the potential liability of sponsors for any adverse effect on the offspring of study participants. The comment noted that many States permit a child adversely affected by a parent's medical decision, who has reached the age of majority, to sue for injuries alleged to have been caused by the drug. The comment also noted that, in some States, a parent's consent based on information in an FDA-approved warning does not preclude lawsuits by adult children.

FDA recognizes that, in some States, a child who has reached the age of majority or spouse may have the right to sue for injuries caused by a parent's medical decision to use a drug. To succeed in such a lawsuit, the child or spouse must show, among other things, that warnings about the use of the drug were inadequate or that consent was not fully informed.

FDA also recognizes that, in some States, parental consent based on FDA-approved warnings for marketed drugs might not preclude a child from filing a lawsuit. In States permitting such lawsuits, the courts have described FDA standards for such warnings as minimum requirements for disclosing risk information. Because manufacturers and sponsors have the ultimate responsibility to provide risk information to FDA as well as to consumers, in some States, FDA approval of warning statements for marketed drugs is evidence of the warning's adequacy but is not dispositive. These cases suggest that a warning might be inadequate when a sponsor or manufacturer obscures or withholds risk information from FDA, or delays submission of supplemental risk information obtained after the product was approved.

The sponsor or investigator, with IRB oversight, is responsible for providing risk information to subjects and obtaining informed consent from them. (See § 312.50 and 21 CFR 312.53(c)(1)(vi)( d ); part 50 (21 CFR part 50) and part 56.) Few liability cases have been reported involving injuries from experimental drugs and even fewer involving such injuries to offspring. In those cases involving injuries to the offspring of mothers who ingested experimental drugs, the inadequacy of warnings, or the lack of informed consent, was an essential element of the lawsuit. (See Craft v. Vanderbilt University , 940 F. Supp. 1185 (M.D. Tenn. 1996); Wetherill v. iversity of Chicago , 570 F. Supp. 1124 (N.D. Ill. 1983); Mink v. University of Chicago , 460 F. Supp. 713 (N.D. Ill. 1978); and Diaz v. Hillsborough County Hospital Authority , 165 F.R.D. 689 (M.D. Fla. 1996).) Although these cases involved research subjects who were pregnant women, they show that liability can be precluded when patients are informed adequately about a study and its risks. The women who brought these lawsuits claimed that they were not told that research was being conducted, much less asked for informed consent. The present rule is firmly grounded on informed consent and a fully informed patient.

The agency has found no reported case in which a sponsor or manufacturer of a drug was held liable when warnings were found to be adequate or the consent to be informed. In all of the strict liability cases involving marketed drug products, the adequacy of the warnings remains an essential element for avoiding liability. In determining the adequacy of a warning for prescription drug products, the standard generally applied is the drug maker's actual or constructive knowledge of the risk at the time the product was sold or distributed.

Considering all the relevant cases, the comment's concern about liability for injuries to offspring of study participants appears overstated. If anything, these cases show that the risk of liability for injuries to offspring resulting from their mother's ingestion of an experimental drug is remote. Sponsors and manufacturers can generally avoid liability by providing adequate warnings and obtaining fully informed consent.

This final rule applies to one narrow category of beneficial drugs, that is, experimental drugs being studied for their safety and effectiveness in treating life-threatening diseases or conditions. The rule also reduces the exposure to liability lawsuits by applying only to studies that seek subjects who are suffering from the life-threatening disease or condition at issue. The risk of liability is further minimized when the sponsor uses informed consent with careful study design, pregnancy screening techniques, and counseling about contraception and abstinence.

18. One comment expressed concern that informed consent alone may not be adequate to reduce the risk of injury to a participant and, thus, the risk of liability to a sponsor. Specifically, the comment states that, in many situations, the full nature and extent of any potential reproductive toxicity may not be sufficiently characterized at the time of desired access to a given investigational therapy to allow IRB's, investigators, or potential study subjects to make a complete determination of any potential risk. To provide patients with complete risk and benefit information for certain developmental compounds or studies, consent forms would have to be worded in a way that could effectively discourage participation in these trials by the very population intended to benefit from the proposed regulation.

An inherent danger in the use of every experimental drug is that unknown safety risks may exist for human research subjects. The purpose of informed consent is to provide research volunteers with sufficient information to determine for themselves whether the risks are justified. Informed consent regulations require a sponsor, when appropriate, to describe the reasonably foreseeable risks, and currently unforeseeable risks, to the participant or to an embryo or fetus in the event the participant should become pregnant during the study (§ 50.26(b)(1)). That the disclosure of complete risk and benefit information might discourage participation is not a reason to withhold information or to preempt the opportunity to participate in a study. On the contrary, disclosure serves the interests of self-determination regarding a person's decision to participate in medical research and ensures informed decisionmaking as to whether the risks are indeed outweighed by the benefits.

19. One comment stated that exceptional circumstances may exist where the potential risk of the drug to the participant outweighs the potential benefit. As an example, the comment indicated that it may not be advisable to include treatment-naive human immunodeficiency virus (HIV)-infected women with reproductive potential in clinical trials for a drug that has a high (or undetermined) risk to a fetus if there are other effective and safe agents in the same class available for use in these women.

HIV-infected women who are treatment-naive should not be excluded from participating in clinical trials solely because of their reproductive potential. HIV-infected women should have a choice, as should HIV-infected men, of enrolling in clinical trials, as long as there is a proper informed consent process that acknowledges the availability of safe and effective treatment options and, if the potential participants are sexually active, abstinence or contraception is used. After sponsor, FDA, and local IRB decisions on the protocol, the ultimate risk-benefit analysis in such circumstances is best left to the patient and the physician.

20. Two comments supported the agency's position that the societal benefits outweigh the increased costs associated with the participation of women with reproductive potential who have a life-threatening disease in clinical trials. Both comments specifically highlighted the advantage of obtaining gender-specific data in this population.

Based on the analysis of economic impacts described in the proposed rule, the agency believes that the societal benefits outweigh the potential minimal additional costs because a considerable patient population (i.e., women with reproductive potential who have a life-threatening disease or condition) could receive a potentially beneficial new therapy (62 FR 49946 at 49953).

21. The agency received divergent comments about the use of a clinical hold to achieve the objectives of the proposal. One comment stated a belief that it is appropriate for FDA to use its ability to place a clinical trial on hold if the sponsor excludes women for inappropriate reasons. However, another comment asserted that the use of a clinical hold in these circumstances is not consistent with the original intent of the clinical hold regulations and turns a clinical hold into a punitive measure.

A clinical hold is an order that FDA may issue to a sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation for the development of a new drug or biological product (§ 312.42). The agency has determined that it is appropriate to impose a clinical hold on an investigation that categorically excludes women or men with reproductive potential who have a life-threatening disease or condition.

The imposition of a clinical hold under these amendments to § 312.42 is not punitive. The aim of these amendments is to ensure that women with reproductive potential who have a life-threatening disease or condition are not categorically excluded from participation in clinical trials. The rationale for this action, as discussed in the preamble to the proposed rule (62 FR 49946 at 49949 through 49951), is based on four factors: (1) FDA is committed to expanding access to and accelerating approval of new therapies for life-threatening diseases and conditions; (2) important ethical principles underlie the belief that neither gender should be excluded from early clinical trials involving a life-threatening disease or condition because of reproductive potential; (3) the mechanisms are in place, or are available, to protect individuals who participate in clinical trials from potential risks; and (4) FDA is committed to expanding the collection of gender-specific data on investigative therapies, especially for those populations who ultimately will be using the therapies. Furthermore, FDA intends to issue a clinical hold order as a last resort, only after the review division's attempt to discuss and satisfactorily resolve the matter with the sponsor (§ 312.42(c)). As explained in Center for Drug Evaluation and Research (CDER) internal policy statements, CDER experience is that most potential holds can be avoided through such discussion (CDER Manual of Policy and Procedure (MAPP) 6030.1).

In the preamble to the proposed rule (62 FR 49946 at 49951), FDA discussed its legal authority to issue this rule under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)). Since publication of the proposed rule, on November 21, 1997, the President signed into law the Food and Drug Administration Modernization Act of 1997 (the Modernization Act) (Public Law 105-115). Section 117 of the Modernization Act amends section 505(i) of the act to include specific provisions authorizing the imposition of a clinical hold on an investigation if “the drug involved represents an unreasonable risk to the safety of the persons who are the subjects of the clinical investigation * * * or * * * for such other reasons as the Secretary may by regulation establish” (section 505(i)(3)(B) of the act). The Modernization Act makes explicit the agency's authority to issue regulations for the imposition of a clinical hold for reasons other than unreasonable risks to the safety of the subjects involved in the investigation.

22. One comment noted a distinction between a clinical hold imposed for a regulatory purpose (e.g., because a sponsor has not made adequate provision for the inclusion of women with reproductive potential in a clinical trial) and one imposed due to safety concerns. The comment suggested that the agency establish a new set of regulations for this “regulatory clinical hold,” rather than provide for it in the already-established clinical hold regulations.

FDA's regulations governing IND's are located in part 312 (21 CFR part 312), and the agency's clinical hold regulations are in § 312.42. FDA declines the suggestion to create a new set of regulations to accommodate these amendments because this change would serve no purpose and would be confusing, placing bases for clinical holds in two locations although the procedures for holds in both cases are identical. Furthermore, since President Clinton issued the “Regulatory Reinvention Initiative” memorandum on March 4, 1995, FDA has sought to consolidate its regulations and to eliminate duplicative ones. The creation of a new set of clinical hold regulations would be contrary to the objectives of regulatory reinvention.

23. One comment proposed safeguards to protect the interests of subjects already participating in a clinical trial and to ensure that a clinical hold is used only as a last resort. The comment proposed the following safeguards: (1) A limitation of the rule to those clinical trials that are intended to demonstrate effectiveness and (2) procedures to ensure a dialogue between the sponsor and the agency to help avoid the imposition of the clinical hold. The comment recommended that when a clinical hold is issued for inadequate participation of women in the trial, procedural safeguards should include: (1) The concurrence of the Center Director after personal consultation between the Division Director and the sponsor; (2) communication of the reason for the hold to the sponsor in writing within 10 days of the imposition of a clinical hold; and (3) review by the Clinical Hold Review Committee at the first meeting following the hold.

The comment states that under this rule, a clinical hold may be issued for inadequate participation of women in a clinical trial. This statement erroneously implies that the rule imposes requirements to enroll or recruit a specific number of women in trials. To the contrary, the rule prohibits the exclusion of women with reproductive potential but does not require a quota or specific number of women for any trial.

The agency declines the suggestion to limit the scope of the rule to those clinical trials that are intended to demonstrate effectiveness. As explained in the preamble to the proposed rule (62 FR 49946 at 49949), many early clinical studies involving life-threatening diseases offer the potential for therapeutic benefit, especially when participation in an early clinical study is a prerequisite for enrollment in later studies. FDA has concluded that all trials involving patients with life-threatening diseases and conditions should, for purposes of this rule, be considered to have therapeutic potential. This rule, therefore, applies to studies in any phase of a clinical investigation that enroll participants with a life-threatening disease or condition.

The agency's clinical hold regulations provide a process for discussion between a sponsor and FDA about deficiencies in an investigation to ensure that a clinical hold is imposed as a measure of last resort. Whenever FDA concludes that a deficiency exists in a clinical investigation that may be grounds for the imposition of a clinical hold, FDA will, unless patients are exposed to immediate and serious risk, attempt to discuss and satisfactorily resolve the matter with the sponsor before issuing the clinical hold order (§ 312.42(c)).

Under FDA regulations, the Division Director that is responsible for reviewing the application for the underlying drug product has the authority to determine whether to impose a clinical hold (§ 312.42(d)). The agency does not find that concurrence by the Center Director is necessary to ensure that a clinical hold is imposed only as a last resort because, as discussed above, the agency's regulations and internal procedures already provide for discussion between the sponsor and the agency concerning the need for the clinical hold. Division directors in CDER and the Center for Biologics Evaluation and Research (CBER) have the authority to ensure that agency personnel follow these regulations and procedures.

FDA regulations state that the agency will communicate to the sponsor in writing the reasons for a clinical hold as soon as possible, and no more than 30 days after imposing the hold (§ 312.42(d)). A clinical hold is usually imposed only after discussion between FDA and a sponsor. Because the Division Director, or designee, generally provides a brief explanation of the reasons for the hold by telephone at the time the clinical hold is ordered, the agency finds it unnecessary to shorten the 30-day requirement for a written explanation.

CDER and CBER have established committees to review clinical holds and promote consistency throughout the Centers in issuing clinical holds. Under CDER policy, the CDER Clinical Holds Peer Review Committee meets quarterly to review all commercial IND clinical holds issued during the previous quarter (CDER MAPP 6030.1). The CBER Clinical Hold Oversight Committee reviews selected clinical holds that have been issued. The procedures for these committees will apply to clinical holds imposed by CDER or CBER under this rule.

24. Two comments indicated that this use of a clinical hold is not the optimal mechanism to achieve the agency's objectives and may threaten other agency goals (e.g., expediting the development of innovative therapies to treat life-threatening diseases and conditions in both men and women). One comment further noted that the best way to ensure that women and men of reproductive potential are able to participate in clinical trials is to address the issue during the development of the protocol for the trial early in the IND process. The comment recommended that a plan be developed in the IND process for including women of reproductive potential in clinical studies or articulating a clear rationale for their exclusion. The sponsor and the agency should agree on the plan as part of the IND with compliance tied to the plan and progress reported in routine annual reports to the IND.

Although developing data bases that include both men and women is an important goal, this rule does not address the content of an NDA or biologics license application (BLA) data set. Rather, this rule seeks to prevent exclusions of people suffering from life-threatening conditions or diseases from participation in trials based on reproductive potential.

Overall protocol development is addressed under several regulatory programs for the development and review of products that are intended to treat life-threatening diseases or conditions. The agency recognizes that agreement between a sponsor and FDA on a protocol for a clinical trial is an important step towards ensuring that women with reproductive potential who have a life-threatening disease or condition are not excluded from the clinical trial. Under the agency's regulations at §§ 312.80 through 312.88, sponsors are encouraged to work with the agency during the development of drugs intended to treat life-threatening and severely debilitating illnesses. Sponsors may ask to meet with FDA early in the drug development process to review and reach agreement on the design of necessary preclinical and clinical studies (§ 312.82). Such meetings may take place prior to the submission of the IND or at the end of phase 1. Furthermore, under section 112 of the Modernization Act, the agency has developed procedures to facilitate the development and expedite the review of products that are intended to treat serious or life-threatening conditions and demonstrate the potential to address an unmet medical need. Such procedures, described in the FDA guidance entitled “Fast Track Drug Development Programs—Designation, Development, and Application Review” (October 1998), encourage appropriately timed meetings and regular contact between sponsors and FDA.

Section 119(a) of the Modernization Act directs FDA to work towards, and achieve, agreement with sponsors and applicants on the design and size of clinical trials intended to form the primary basis of an effectiveness claim in an NDA or BLA. In conjunction with the reauthorization of the Prescription Drug User Fee Act in November 1997, FDA agreed to specific performance goals for the management of activities associated with the development and approval of products in human drug applications that are defined in section 735(1) of the act (21 U.S.C. 379g(1)). Under the goals, FDA will, upon request by a sponsor, evaluate certain protocols and issues relating to the protocols to assess whether their design is adequate to meet scientific and regulatory requirements identified by the sponsor. One type of protocol that is eligible for this special protocol assessment is a clinical protocol for a phase 3 trial whose data will form the primary basis for an efficacy claim. Section 119(a) of the Modernization Act and the performance goals recognize the importance of early agency review and agreement with sponsors regarding protocols for clinical trials.

Sponsors are required to submit information regarding the progress of IND's in their annual reports to the agency (§ 312.33). Any specific information regarding a clinical protocol agreement should be included in the annual report. Furthermore, sponsors of clinical studies for drug and biologic products are now required to tabulate in annual reports the numbers of subjects enrolled in the trial, specifying gender and other demographic subgroups (§ 312.33) (see 63 FR 6854).

25. FDA received two comments concerning the effect of the regulation on international drug development. One comment questioned how the regulation will affect compliance with the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) “Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals.” The comment stated that the impact of the rule on global drug development remains unclear and questioned whether data collected from trials conducted under the rule would be acceptable to the regulatory agencies in Europe or Japan. Another comment raised the possibility of regulatory difficulties in including women of reproductive potential in some early studies when those studies are subject to regulation by agencies in other countries. The comment urged FDA to consider the effects of the proposed rule on multicountry studies.

The final rule is consistent with ICH initiatives. In July 1997, FDA issued a final ICH guidance entitled “M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals” (ICH M3 guidance) (published in 62 FR 62922, November 25,1997). The ICH M3 guidance, which supersedes the draft guideline cited in the comment, notes that there are regional differences in the timing of reproductive toxicity studies to support the inclusion of women with reproductive potential in clinical trials for all pharmaceuticals. As described in the ICH M3 guidance, women with reproductive potential may be included in early, carefully monitored studies in the United States without reproduction toxicity studies provided appropriate precautions are taken to minimize risk. Such precautions include pregnancy testing, use of a highly effective method of birth control, and entry after a confirmed menstrual period. Continued testing and monitoring during the trial should be sufficient to ensure compliance with the measures for avoiding pregnancy during the period of drug exposure (which may exceed the length of the study). To support this approach, informed consent should include any known pertinent information related to reproductive toxicity, such as a general assessment of potential toxicity of pharmaceuticals with related structures or pharmacological effects. If no relevant information is available, the informed consent should clearly note the potential for risk (ICH M3 guidance, p. 7).

In multicountry studies, provided that there is not a categorical exclusion based on reproductive potential in the United States, FDA does not intend to impose a hold for such exclusions on studies in foreign sites. Foreign data with such exclusions may be submitted to the agency.

26. One comment discussed the Center for Disease Control's reports of a steady decline in AIDS incidence and mortality rates in the United States since 1993 and highlighted the disparities related to women. The comment noted that the number of AIDS deaths in 1996 declined among all racial/ethnic groups but increased 3 percent among women and among those who acquired the infection through heterosexual contact. The comment emphasized the treatment and prevention challenges affecting HIV-infected women, highlighted the need for gender-specific data, and advocated the enrollment of women in clinical trials in numbers equivalent to the prevalence of women with AIDS in America.

As discussed in the preamble to the proposed rule (62 FR 49946 at 49950 and 49951), FDA is committed to expanding the collection of gender-specific data on investigative therapies, especially for those populations who are likely to use an investigational agent once it is marketed. Because many of the women who are affected by HIV and AIDS are women with reproductive potential, this rule will prevent their exclusion from participation in clinical trials for such diseases solely because of a perceived risk or potential risk of reproductive or developmental toxicity.

The Division of Antiviral Drug Products in CDER and other components in CDER and CBER that review HIV/AIDS-related products encourage sponsors to include women of all age groups early in the drug development process and support the concept of allowing each eligible female participant to make her own informed decision regarding the risks and benefits of participating in a trial.

The comment suggested that women be enrolled in clinical trials for AIDS therapies in numbers equivalent to the prevalence of women with AIDS in America. The comment is outside the scope of this rule. The rule does not require that particular numbers of women be enrolled in trials for investigational therapies. The rule only prohibits the exclusion of women with reproductive potential from eligibility for a clinical trial.

27. One comment indicated that the proposal is a broad-based solution to a focused problem that the agency has identified within a single drug class—antiviral drugs.

Although FDA prepared this proposal largely in response to recommendations made by the National Task Force on AIDS Drug Development and the Presidential Advisory Council on HIV/AIDS, the recommendations are applicable to all life-threatening diseases and conditions, and the agency has concluded that this problem is a general one. Additionally, when conducting its cost analysis, the agency used a protocol data base that included information from four CDER review divisions. Of the 43 protocols involving life-threatening diseases or conditions that were identified as having precluded the opportunity for women with reproductive potential to participate in trials, 28 percent were from the Division of Antiviral Drug Products, 67 percent were from the Division of Cardio-Renal Drug Products, and the remaining 5 percent were from the Division of Medical Imaging, Surgical, and Dental Drug Products and the Pilot Drug Evaluation Staff. The project did not include representation of all divisions in CDER and CBER. However, it was assumed that the available data were representative of all CDER and CBER review divisions regarding the exclusion of women with reproductive potential.

FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (Public Law 96-354). Executive Order 12866 directs agencies to assess all costs and benefits or 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). Under the Regulatory Flexibility Act (5 U.S.C. 601-612), unless an agency certifies that a rule will not have a significant economic impact on small entities, the agency must analyze regulatory options that would minimize the impact of the rule on small entities. Title II of the Unfunded Mandates Reform Act (Public Law 104-7) (in section 202) requires that agencies prepare an assessment of anticipated costs and benefits before proposing any rule that may result in an expenditure in any 1 year by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation).

The agency has reviewed this rule and has determined that it is consistent with the regulatory philosophy and principles identified in Executive Order 12866, and in these two statutes. 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. With respect to the Regulatory Flexibility Act, the agency certifies that the rule will not have a significant effect on a substantial number or small entities. Because the final rule does not impose any mandates on State, local, or tribal governments, or the private sector that will result in a 1-year expenditure of $100 million or more, FDA is not required to perform a cost-benefit analysis under the Unfunded Mandates Reform Act.

The Costs section of the Analysis of Impacts in the proposed rule (62 FR 49952) remains essentially unchanged and is not repeated here. However, two items require additional comment.

None of the cost estimates in the proposed rule were corrected for the incidence of pregnant women having diseases under study (but not having been included in the studies). Hence, the cost estimates discussed in the proposed rule were overstated. The agency believes that the effect of this overstatement is relatively insignificant.

The agency is aware of industry's concerns about liability exposure associated with the inclusion of women with reproductive potential in clinical trials and the potential for harm to offspring. Although there are cases of injury to offspring of mothers who ingested experimental drugs, the inadequacy of warnings or the lack of informed consent has been an essential element of such lawsuits. The agency is not aware of any reported case in which a sponsor of an investigational drug was held liable for injuries to offspring when the sponsor provided adequate warnings and obtained fully informed consent. Therefore, the agency assumes that this rule adds nothing to current liability costs under existing law.

The analysis in the proposed rule identified protocols sponsored by small businesses. The largest additional pregnancy testing cost incurred by a small business in the reviewed protocols under the rule was $990. Projected across all CDER and CBER review divisions and annualized, FDA expects no more than 9 protocol submissions per year from small businesses that might incur increased costs. Few small firms are likely to be affected in any given year, and most of these firms would incur no significant additional costs. Therefore, under the Regulatory Flexibility Act, the Commissioner of Food and Drugs certifies that this rule will not have a significant effect on a substantial number of small entities.

The agency has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

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

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 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 order and, consequently, a federalism summary impact statement is not required.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(8), the Coast Guard finds that good cause exists for not publishing an NPRM. Good cause exists for not publishing an NPRM due to the following reasons: due to the date the Application for Approval of Marine Event was received, there was insufficient time to draft and publish an NPRM and still publish the final rule with more than 30 days before its effective date. Any delay encountered in this regulation's effective date would be contrary to public interest since immediate action is needed to close the waterway and protect the maritime public from the hazards associated with this fireworks display. This is a local event with minimal impact on the waterway, vessels may still transit through the East River during the event, the zone is only in affect for 1 1/2 hours and vessels can be given permission to transit the zone except for about 45 minutes during this time. Additionally, vessels would not be precluded from mooring at or getting underway from commercial or recreational piers in the vicinity of the zone.

The Coast Guard has received an application to hold a fireworks program on the waters of the East River, New York. This regulation establishes a safety zone in all waters of the East River within a 150-yard radius of the fireworks land shoot in approximate position 40°46′55.5″ N 073°55′33″ W (NAD 1983), about 200 yards northeast of the Triborough Bridge. The safety zone is in effect from 8:30 p.m. (e.s.t.) until 10 p.m. (e.s.t.) on Thursday, June 29, 2000. If the event is cancelled due to inclement weather, then this section is effective from 8:30 p.m. (e.s.t.) until 10 p.m. (e.s.t.) on Friday, June 30, 2000. The safety zone prevents vessels from transiting a portion of the East River and is needed to protect boaters from the hazards associated with fireworks launched from shore in the area. Recreational and commercial vessel traffic will be able to transit through the eastern 430 feet of the 1060-foot wide East River during the event. This safety zone precludes the waterway users from entering only the safety zone itself. Public notifications will be made prior to the event via the Local Notice to Mariners.

This event is currently regulated under 33 CFR 100.114 as an annually occurring event on July 1st. Due to the extensive increase of marine traffic in the Port of New York/New Jersey due to OPSAIL 2000 and the International Naval Review 2000 the sponsor is changing their event date for this year.

This final rule is not a significant regulatory action under section 3(f) of Executive Order 12866 and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. It has not been reviewed by the Office of Management and Budget under that Order. It is not significant under the regulatory policies and procedures of the Department of Transportation (DOT) (44 FR 11040; February 26, 1979). The Coast Guard expects the economic impact of this final rule to be so minimal that a full Regulatory Evaluation under paragraph 10e of the regulatory policies and procedures of DOT is unnecessary. This finding is based on the minimal time that vessels will be restricted from the zone, that vessels may still transit through the East River during the event, and advance notifications which will be made.

The size of this safety zone was determined using National Fire Protection Association and New York City Fire Department standards for 4″ mortars fired from shore combined with the Coast Guard's knowledge of tide and current conditions in the area.

Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), the Coast Guard considered whether this final rule will have a significant economic impact on a substantial number of small entities. “Small entities” include small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

For reasons discussed in the Regulatory Evaluation above, the Coast Guard certifies under section 605(b) of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) that this final rule will not have a significant economic impact on a substantial number of small entities.

This final rule does not provide for a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Coast Guard has analyzed this final rule under the principles and criteria contained in Executive Order 13132 and has determined that this final rule does not have implications for federalism under that Order.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) [Pub. L. 104-4, 109 Stat. 48] requires Federal agencies to assess the effects of certain regulatory actions on State, local, and tribal governments, and the private sector. UMRA requires a written statement of economic and regulatory alternatives for rules that contain Federal mandates. A Federal mandate is a new or additional enforceable duty imposed on any State, local, or tribal government, or the private sector. If any Federal mandate causes those entities to spend, in the aggregate, $100 million or more in any one year, the UMRA analysis is required. This final rule does not impose Federal mandates on any State, local, or tribal governments, or the private sector.

The Coast Guard considered the environmental impact of this final rule and concluded that under figure 2-1, paragraph 34(g), of Commandant Instruction M16475.1C, this final rule is categorically excluded from further environmental documentation. This rule fits paragraph 34(g) as it establishes a safety zone. A “Categorical Exclusion Determination” is available in the docket for inspection or copying where indicated under ADDRESSES.

NARA published a notice of proposed rulemaking on February 17, 2000, at 65 FR 8077. The comment period ended on April 17, 2000. NARA received comments from 9 Federal agencies and 1 professional organization. Of the comments from the Federal agencies, 3 concurred with the proposed rule, 5 recommended clarifications or changes and 1 offered “no comment.”

Following is a summary of the comments and a discussion of the changes that we made to the proposed rule to address those comments.

One commenter stated that we should add a provision to account for the automatic declassification provisions in section 3.4 of Executive Order 12958. Executive Order 13142, issued on November 19, 1999, amended Executive Order 12958 section 3.4 to delay the application of automatic declassification for records accessioned into NARA until April 17, 2003. We have made appropriate reference to the automatic declassification requirements in the regulation.

As we reviewed §§ 1260.20 and 1260.40 to incorporate the reference, we further clarified these sections by removing the distinctions between records that are older and younger than 25 years to focus on the responsibilities for declassifying the information.

One Federal agency commented that the regulation does not address declassification responsibilities for nuclear-related information classified as Restricted Data and Formerly Restricted Data. This type of information is classified under the Atomic Energy Act of 1954, as amended, and is exempt from all requirements under Executive Order 12958. We added the language suggested by the commenter as § 1260.28, which specifies that only designated individuals in the Department of Energy may declassify records containing Restricted Data, and that only designated officials within the Department of Defense or the Department of Energy may declassify Formerly Restricted Data.

The National Security Council recommended deleting § 1260.62 which explains how agencies should handle mandatory review requests for White House originated materials from a past administration that are in their custody. This section would have required agencies to forward the request, copies of the requested records, and a recommendation to grant or deny the request to the Archivist. The Archivist would then decide whether or not to declassify the information. The commenter noted that Federal agencies do not segregate White House originated information in their custody from their Federal records, and, therefore, follow the process for responding to Mandatory Review and FOIA requests for Federal records. We have accepted the comment after consulting with the Information Security Oversight Office.

One Federal agency commented that § 1260.50 should be modified in several ways. The commenter pointed out that at times, the association of an agency with a particular document can be in itself a classified fact requiring protection. NARA currently does not tell requesters which agencies it has referred documents to. We have modified § 1260.50(d) according to the commenter's suggestion to clarify this existing practice.

The agency also offered alternative language in this section to clarify when NARA would send a document back to an agency for declassification. The commenter suggested that we insert the phrase, “Where the originating agency has not provided systematic declassification guidance, or where there is a question regarding the declassification guidance provided” at the beginning of the second sentence in § 1260.50(b). We have accepted this comment with modification. We cannot specify that we will refer the information only if we are missing guidance from the originating agency. When NARA declassifies information using agency systematic guidance, we must use the guidance of every agency that has equities in the information. If we do not have guidance from an agency that has equities in the information, even when it is not the originating agency, we review the information using the guidance that we do have, and then refer the information to the agency(ies) for which we do not have guidance for final action.

We received a comment that NARA should act as the recipient for all appeals for adverse declassification decisions from other agencies. The commenter indicated that this would be more efficient and consistent, and it would also allow, in the case of multiple referrals, NARA to act as a central point of contact for the appeal. If an agency's association with a particular document is classified, the commenter argued that this would provide a mechanism for protecting that fact.

NARA does not have the resources to handle all appeals for the entire Executive branch. In addition, the public would perceive this as an attempt to delay the appeals process by inserting another layer of bureaucracy into it. In order to address the commenter's concern of masking the association of particular agencies with particular information, NARA will send to the requester whatever appeal contact information the agency desires. Agencies may request other agencies to act as a contact point for appeals.

A Federal agency commented that § 1260.26 improperly states that the Central Intelligence Agency (CIA) is “responsible” for declassifying information on intelligence sources and methods, and that the Secretary of Defense is “responsible” for declassifying information on cryptography. Sections 3.5(c) and 3.6(d) of Executive Order 12958 state that “the Director of Central Intelligence may establish special procedures for the declassification of information pertaining to intelligence.” It does not state that the CIA is the sole responsible entity for this action. The Executive Order also states that “the Secretary of Defense may establish special procedures for declassification of cryptologic information.” We have modified the regulation to more closely match the Executive Order.

This rule is not a significant regulatory action for the purposes of Executive Order 12866. As required by the Regulatory Flexibility Act, it is hereby certified that this rule will not have a significant impact on a substantial number of small entities because it applies to Federal agencies. This rule does not have any federalism implications.

NARA published a notice of proposed rulemaking on March 23, 2000 at 65 FR 15592. The comment period ended on May 22, 2000. NARA received no public comments.

Upon further consideration, we have withdrawn the proposed provisions for the use of the Exhibition Hall in the National Archives Building for outside events. Instead, we have modified Subpart D to clarify that we allow Federal, State, and local government entities to use the Exhibition Hall for official functions, with NARA as a cosponsor, and that we may use the Exhibition Hall for activities that further the NARA Strategic Plan. No other changes have been made to the rule.

The information collections in §§ 1280.48 and 1280.74 are subject to the Paperwork Reduction Act. Under this Act, no persons are required to respond to a collection of information unless it displays a valid OMB control number. OMB has approved the information collection in § 1280.48 with the control number 3095-0040. OMB has approved the information collection in § 1280.74 with the control number 3095-0043.

This rule is not a significant regulatory action for the purposes of Executive Order 12866. As required by the Regulatory Flexibility Act, it is hereby certified that this rule will not have a significant impact on a substantial number of small entities because this regulation will affect individuals wishing to visit a NARA facility, a small number of news organizations wishing to film, and organizations wishing to use NARA public areas for events. This rule does not have any federalism implications.

In rule document 00-11921 beginning on page 31218 in the issue of Tuesday, May 16, 2000, make the following correction:

The Health Insurance Portability and Accountability Act (HIPAA) of 1996, Public Law 104-191, requires the Secretary, acting through the Office of Inspector General (OIG) and the United States Attorney General, to establish a new health care fraud and abuse control program to combat health care fraud and abuse (see section 1128C of the Act, as enacted by section 201(a) of HIPAA). Among the major steps in this program is the establishment of a national data bank to receive and disclose certain final adverse actions against health care providers, suppliers, or practitioners (see section 1128C(a)(1)(E) of the Act). The establishment of the data bank is required by section 1128E of the Act (added by section 221(a) of HIPAA), which directs the Secretary to maintain a data base of such final adverse actions. Final adverse actions include: (1) Civil judgments against a health care provider, supplier, or practitioner in Federal or State court related to the delivery of a health care item or service; (2) Federal or State criminal convictions against a health care provider, supplier, or practitioner related to the delivery of a health care item or service; (3) actions by Federal or State agencies responsible for the licensing and certification of health care providers, suppliers, or practitioners; (4) exclusion of a health care provider, supplier, or practitioner from participation in Federal or State health care programs; and (5) any other adjudicated actions or decisions that the Secretary establishes by regulations. Settlements in which no findings or admissions of liability have been made will be excluded from reporting. However, any final adverse action that emanates from such settlements, and that would otherwise be reportable under the statute, is to be reported to the data bank. Final adverse actions are to be reported, regardless of whether such actions are being appealed by the subject of the report (see section 1128E(b)(2)(C) of the Act). Final regulations implementing the statutory requirements of section 1128E of the Act and establishing the new HIPDB were published in the Federal Register on October 26, 1999 (64 FR 57740).

Groups that have access to this new data bank system include Federal and State government agencies; health plans; and self queries from health care suppliers, providers and practitioners. Reporting is limited to the same groups that have access to the information. One of the primary purposes of these data will be use of this information by a Federal or State government agency charged with the responsibility of investigating or prosecuting a case where there is an indication of a violation or potential violation of law, whether civil, criminal or regulatory in nature. The information in this system may also be used in the preparation for a trial or hearing for such violation.

On October 26, 1999, the Department also published, through the Office of Inspector General, a proposed rule (64 FR 57619) to exempt this new records system from certain provisions of the Privacy Act. 1 This proposed exemption was intended to protect, from release to the record subject, information on law enforcement queries to the data bank, to exempt the data bank from Privacy Act access and amendment procedures in order to establish access and amendment procedures in the HIPDB regulations. The proposed rule specifically sought public comments on the proposed exemption.

In accordance with the rulemaking, record subjects would be guaranteed access to, and correction rights for, substantive information reported to the HIPDB. The procedures, set out in 45 CFR part 61, use the Privacy Act access and correction procedures as a basic framework while, at the same time, providing significant additional rights (such as automatic notification to the record subject of any report filed with the data bank). Data bank subjects would also have broader rights on HIPDB correction procedures, including the right to file a statement of disagreement as soon as a report is filed with the data bank.

In response to the proposed rule, we received timely-filed public comments from two health professional organizations. Set forth below is a summary of those comments and our response to those concerns.

Comment: One commenter believed that the provisions to exempt the HIPDB from provisions of the Privacy Act were duplicative and unnecessary. The commenter believed that this waiver was not necessary since the Privacy Act already contains an exemption for law enforcement queries.

Response: The commenter is correct that a law enforcement agency may request information from the HIPDB by having an appropriate official formally file a written request under 5 U.S.C. 552a(b)(7). Such queries are not available to the subject of the Privacy Act record under 5 U.S.C. 552a(c)(3). However, requiring law enforcement agencies to use the more cumbersome process of submitting requests in writing defeats one of the primary purposes of the HIPDB, which is to provide for instant, online access to data for its designated users, including law enforcement agencies. 2 Therefore, disclosures to law enforcement agencies will generally be made in accordance with the routine use provision of the Privacy Act, 5 U.S.C. 552a(b)(3), and this exemption is necessary to protect the queries from release to the record subject.

Comment: One commenter stated that the proposed modification to 45 CFR 5b.11(b)(2)(ii) appeared to exempt all queries from the history disclosure requirement of the Privacy Act, rather than just those that are made by law enforcement agencies. The commenter indicated, however, that nothing in proposed subparagraph (F) of this section would limit the exemption to law enforcement queries.

Response: As stated in the proposed rule, subjects will have access to information on all other queries to the data bank. The exemption is only intended to protect against harm to ongoing investigations. Under the HIPDB implementing regulations (October 26, 1999; 64 FR 57740), information reports made available to the report subjects will include all other query information.

Comment: One association indicated their support of the proposed modification regarding the exemption of law enforcement agencies from the Privacy Act, but recommended that the regulatory agencies, such as dental boards, also be included in the exemption.

Response: As indicated above, the exemption is designed to protect only law enforcement queries permitted by the statute. If a governmental agency is entitled to access the HIPDB for law enforcement purposes, that query would be covered by the exemption. Questions on what types of queries are “law enforcement” queries can always be raised with the OIG's Office of Investigations' Investigative Policy and Information Management Staff at (202) 205-5200.

The Office of Management and Budget has reviewed this final rule in accordance with the provisions of Executive Order 12866, the Unfunded Mandates Reform Act and Executive Order 13132, and has determined that this rule does not meet the criteria for an economically siginificant regulatory action.

Specifically, 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 maximize net benefits, including potential economic, environmental, public health, safety distributive and equity effects. Section 202 of the Unfunded Mandates reform Act, Public Law 104-4, requires that agencies prepare an assessment of anticipated costs and benefits on any rule that may result in an expenditure by State, local or tribe governments, or by the private sector, of $100 million or more in any given year. In addition, under the Small Business Enforcement Act (SBEA) of 1996, if a rule has a significant economic effect on a substantial number of small businesses, the Secretary must specifically consider the economic effect of a rule on small business entities and analyze regulatory options that could lessen the impact of the rule. Further, Executive Order 13132, Federalism, requires agencies to determine if a rule will have a significant effect on States, on their relationship with the Federal Government, and on the distribution of power and responsibility among the various levels of government.

In accordance with the exemption being set forth in this rule, while the reports of adverse actions to the HIPDB will be known to the subjects of the records in the data bank, the access and use of such information by law enforcement agencies would not be known to the subjects of the records. As indicated above, we believe that disclosure of this information could have a negative impact and compromise ongoing law enforcement activities.

We believe that the aggregate economic impact of this final rule is minimal and will have no effect of the economy or on Federal or State expenditures. Similarly, we believe that there are no significant costs associated with this Privacy Act exemption that will impose any mandates on State, local or tribal governments or on the private sector that will result in an expenditure of $100 million or more in any given year. In addition, in accordance with the provisions of the SEBA and the threshold criteria of Executive Order 13132, the Secretary certifies that this exemption will not have a significant impact on a substantial number of small entities, and will not significantly affect the rights, roles and responsibilities of States, and that a full analysis under these Acts is not necessary.

This is a synopsis of the Order in MM Docket No. 98-198 adopted May 18, 2000, and released May 19, 2000. The full text of this decision is available for inspection and copying during normal business hours in the FCC Reference Center at Portals ll, CY-A257, 445 12th Street, SW, Washington, D.C. The complete text of this decision may also be purchased from the Commission's copy contractor, International Transcription Service, Inc., (202) 857-3805, 1231 20th Street, NW, Washington, D.C. 20036.

This is a summary of the Commission's Report and Order, MM Docket No. 99-341, adopted May 3, 2000, and released May 12, 2000. The full text of this Commission decision is available for inspection and copying during normal business hours in the Commission's Reference Center, 445 12th Street, SW, Washington, DC. The complete text of this decision may also be purchased from the Commission's copy contractors, International Transcription Services, Inc., 1231 20th Street, NW., Washington, DC 20036, (202) 857-3800, facsimile (202) 857-3805.

This is a synopsis of the Commission's Report and Order, MM Docket No. 99-270, adopted May 3, 2000, and released May 12, 2000. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC Reference Center (Room 239), 445 12th Street, SW, Washington, DC. The complete text of this decision may also be purchased from the Commission's copy contractor, International Transcription Services, Inc., (202) 857-3800, 1231 20th Street, NW, Washington, DC 20036.

This is a summary of the Commission's Report and Order, MM Docket No. 99-337, adopted April 26, 2000, and released May 12, 2000. The full text of this Commission decision is available for inspection and copying during normal business hours in the Commission's Reference Center, 445 12th Street, SW, Washington, DC. The complete text of this decision may also be purchased from the Commission's copy contractors, International Transcription Services, Inc., 1231 20th Street, NW., Washington, DC. 20036, (202) 857-3800, facsimile (202) 857-3805.

This is a summary of the Commission's Report and Order, MM Docket No. 99-359, adopted May 3, 2000 and released May 12, 2000. The full text of this Commission decision is available for inspection and copying during normal business hours in the Commission's Reference Center, 445 12th Street SW, Washington, DC. The complete text of this decision may also be purchased from the Commission's copy contractors, International Transcription Services, Inc., 1231 20th Street NW, Washington, DC 20036; (202) 857-3800, facsimile (202) 857-3805.

This is a summary of the Commission's Report and Order, MM Docket No. 99-334, adopted May 3, 2000, and released May 12, 2000. The full text of this Commission decision is available for inspection and copying during normal business hours in the Commission's Reference Center, 445 12th Street, SW, Washington, DC. The complete text of this decision may also be purchased from the Commission's copy contractors, International Transcription Services, Inc., 1231 20th Street, NW., Washington, DC. 20036, (202) 857-3800, facsimile (202) 857-3805.

This is a synopsis of the Commission's Report and Order, MM Docket Nos. 98-130 and 99-56, adopted May 3, 2000, and released May 12, 2000. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC Reference Center (Room 239), 445 12th Street, SW., Washington, DC. The complete text of this decision may also be purchased from the Commission's copy contractor, International Transcription Services, Inc., (202) 857-3800, 1231 20th Street, NW., Washington, DC 20036.

Channel 259A can be allotted to Saratoga at coordinates 41-27-12 and 106-48-30, and Channel 259C1 can be allotted to Green River, Wyoming, at coordinates 41-31-36 and 109-28-06 in compliance with the Commission's minimum distance separation requirements, with respect to domestic allotments, without the imposition of a site restriction. A filing window for Channels 259A and 259C1 will not be opened at this time. Instead, the issue of opening a filing window for these channels will be addressed by the Commission in a subsequent Order.

This is a synopsis of the Commission's Report and Order, MM Docket Nos. 99-140 and 99-146, adopted May 10, 2000, and released May 19, 2000. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC Reference Center (Room 239), 445 12th Street, SW., Washington, DC. The complete text of this decision may also be purchased from the Commission's copy contractor, International Transcription Services, Inc., (202) 857-3800, 1231 20th Street, NW., Washington, DC 20036.

Channel 255C can be reallotted to Munford, Tennessee, at coordinates 35-46-53 and 89-36-46, at a site 41.2 kilometers (25.6 miles) northeast of the community, and Channel 254A can be allotted to Friars Point, Mississippi, at coordinates 34-24-09 and 90-38-51 at a site 4.2 kilometers (2.6 miles) north of the community, in compliance with the Commission's minimum distance separation requirements, with respect to domestic allotments. A filing window for Channels 254A at Friars Point will not be opened at this time. Instead, the issue of opening a filing window for this channel will be addressed by the Commission in a subsequent order.

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

The Pacific halibut bycatch allowance for the GOA trawl shallow-water species fishery, which is defined at § 679.21(d)(3)(iii)(A), was established by the Final 2000 Harvest Specifications for Groundfish for the GOA (65 FR 8298, February 18, 2000) for the second season, the period April 1, 2000, through July 3, 2000, as 100 metric tons.

In accordance with § 679.21(d)(7)(i), the Administrator, Alaska Region, NMFS, has determined that the second seasonal apportionment of the 2000 Pacific halibut bycatch allowance specified for the trawl shallow-water species fishery in the GOA has been caught. Consequently, NMFS is prohibiting directed fishing for species included in the shallow-water species fishery by vessels using trawl gear in the GOA, except for vessels fishing for pollock using pelagic trawl gear in those portions of the GOA open to directed fishing for pollock. The species and species groups that comprise the shallow-water species fishery are: pollock, Pacific cod, shallow-water flatfish, flathead sole, Atka mackerel, and “other species.”

Maximum retainable bycatch amounts may be found in the regulations at § 679.20(e) and (f).

This action responds to the best available information recently obtained from the fishery. It must be implemented immediately in order to prevent overharvesting the second seasonal apportionment of the 2000 Pacific halibut bycatch allowance specified for the trawl shallow-water species fishery in the GOA. A delay in the effective date is impracticable and contrary to the public interest. The fleet has already taken the second seasonal bycatch allowance of Pacific halibut. NMFS finds for good cause that the implementation of this action can not be delayed for 30 days. Accordingly, under 5 U.S.C. 553(d), a delay in the effective date is hereby waived.

This action is required by § 679.21 and is exempt from review under E.O. 12866.

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

The 2000 TAC of Greenland turbot in the Bering Sea subarea was established by Final 2000 Harvest Specifications of Groundfish for the BSAI (65 FR 8282, February 18, 2000) as 5,764 metric tons (mt). See § 679.20(c)(3)(iii).

In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the TAC for Greenland turbot in the Bering Sea subarea will be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 4,564 mt, and is setting aside the remaining 1,200 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Greenland turbot in the Bering Sea subarea.

Maximum retainable bycatch amounts may be found in the regulations at § 679.20(e) and (f).

This action responds to the best available information recently obtained from the fishery. It must be implemented immediately to prevent overharvesting the 2000 TAC of Greenland turbot for the Bering Sea subarea of the BSAI. A delay in the effective date is impracticable and contrary to the public interest. Further delay would only result in overharvest. NMFS finds for good cause that the implementation of this action should not be delayed for 30 days. Accordingly, under 5 U.S.C. 553(d), a delay in the effective date is hereby waived.

This action is required by § 679.20 and is exempt from review under E.O. 12866.