A. Substantive Discussion Exemption of Positions

18 U.S.C. 207(c) prohibits a former “senior employee” for a period of one year from knowingly making, with the intent to influence, any communication to or appearance before an employee of the department or agency in which he served in any capacity during the one-year period prior to termination from senior service, if that communication or appearance is made on behalf of any other person, except the United States. For purposes of 18 U.S.C. 207, a “senior employee” is any employee (other than an individual covered by the “very senior employee” one-year restriction in 18 U.S.C. 207(d)) who was employed in a position for which the rate of pay is specified in or fixed according to the Executive Schedule, in a position for which the rate of basic pay is equal to or greater than 86.5 percent of the rate of basic pay payable for level II of the Executive Schedule, or in a position which is held by an active duty commissioned officer of the uniformed services who is serving in a grade or rank for which the pay grade is O-7 or above. The term includes those individuals appointed by the President to a position under 3 U.S.C. 105(a)(2)(B) or by the Vice President to a position under 3 U.S.C. 106(a)(1)(B). The term also includes any person who was assigned from a private sector organization to an agency under the Information Technology Exchange Program, 5 U.S.C. chapter 37. An individual is subject to section 207(c) as a result of service as a special Government employee only if the individual served 60 or more days as a special Government employee during the one-year period before terminating service as a senior employee.

The representational bar of 18 U.S.C. 207(c) usually applies to all senior positions. However, 18 U.S.C. 207(c)(2)(C) provides that whenever the Director of OGE determines, after a review requested by the department or agency concerned, that the imposition of the restrictions with respect to a particular position or positions would create an undue hardship on the department or agency in obtaining qualified personnel to fill such position or positions, and granting the waiver would not create the potential for use of undue influence or unfair advantage, the position or category of positions is exempted from the one-year representational prohibition.

Any senior employee position is eligible for exemption except persons: Employed at a rate of pay specified in or fixed according to subchapter II of 5 U.S.C. chapter 53 (the Executive Schedule); in positions whose occupants are appointed by the President pursuant to 3 U.S.C. 105(a)(2)(B); in positions whose occupants are appointed by the Vice President pursuant to 3 U.S.C. 106(a)(1)(B); or assigned by a private sector organization to an agency under the Information Technology Exchange Program. Positions exempted from 18 U.S.C. 207(c) are listed in appendix A to 5 CFR part 2641, OGE's regulation governing the executive branch post-employment conflict of interest restrictions.

The Director of OGE regularly reviews the position exemptions and, in consultation with the department or agency concerned, makes such additions and deletions as are necessary. As specified in 5 CFR 2641.201(d)(3)(iii), the Director shall respond to each initial exemption request from agency ethics officials and annually publish a compilation of all exempted positions or categories of positions. Section 2641.201(d)(5) further provides that, before exempting a position or positions from 18 U.S.C. 207(c), the Director must find: (1) That granting the exemption would not create the potential for use by former senior employees of undue influence or unfair advantage based on past Government service; and (2) that the imposition of the restriction would create an undue hardship on the particular department or agency in obtaining qualified personnel to fill such positions. Relevant factors for the second finding may include the payment of a special rate of pay to the incumbent of the position pursuant to specific statutory authority or a requirement that the incumbent of the position have outstanding qualifications in a scientific, technological, or other technical discipline.

Pursuant to the procedures prescribed in 5 CFR 2641.201(d), one agency forwarded two written requests in 2003 to OGE requesting that its listing in appendix A be amended.

In 2003, the Securities and Exchange Commission (SEC) requested that the Director of OGE exempt various new positions (termed “SK” positions) from 18 U.S.C. 207(c). These positions previously had been classified at GS-15 and below. However, when the SEC implemented “pay parity” authority under Pub. L. 107-123 to improve recruitment and retention, these positions then exceeded the pay threshold of 18 U.S.C. 207(c)(2)(A)(2) despite no increase in duties or responsibilities. Also included in one of the SEC requests was the position of Deputy Chief Litigation Counsel, Division of Enforcement, a position which itself is supervised by a position that was already exempted by OGE effective on October 29, 1991.

After carefully reviewing the changes requested by the SEC in light of the criteria in 18 U.S.C. 207(c)(2)(C) as implemented in 5 CFR 2641.201(d)(5), the then-Director of OGE granted these requests by letters dated November 10, 2003 and December 4, 2003. OGE is now amending appendix A to part 2641 to include these additional exempted SEC positions, retroactively effective to those respective dates (as parenthetically indicated in the amended appendix listing for the SEC positions concerned). An exemption “shall be effective as of the effective date of the Director's written response to the designated agency ethics official indicating that the request for exemption has been granted.” 5 CFR 2641.201(d)(4). Once granted, the exemptions inured to the benefit of the individuals who held the positions when the exemptions took effect and their successors, but were not effective as to employees who terminated senior service from such positions prior to the effective date of the exemptions.

The representational bar of 18 U.S.C. 207(c) also usually extends to the whole of any department or agency in which a former senior employee served in any capacity during the year prior to termination from a senior employee position. However, 18 U.S.C. 207(h) provides that whenever the Director of OGE determines that an agency or bureau within a department or agency in the executive branch exercises functions which are distinct and separate from the remaining functions of the department or agency and there exists no potential for use of undue influence or unfair advantage based on past Government service, the Director shall by rule designate such agency or bureau as a separate component of that department or agency. As a result, a former senior employee who served in a “parent” department or agency is not barred by 18 U.S.C. 207(c) from making communications to or appearances before any employees of any designated component of that parent, but is barred as to employees of that parent or of other components that have not been separately designated. Moreover, a former senior employee who served in a designated component of a parent department or agency is barred from communicating to or making an appearance before any employee of that component, but is not barred as to any employee of the parent or of any other component.

Under 18 U.S.C 207(h)(2), component designations do not apply to persons employed at a rate of pay specified in or fixed according to subchapter II of 5 U.S.C. chapter 53 (the Executive Schedule). Component designations are listed in appendix B to 5 CFR part 2641.

The Director of OGE regularly reviews the component designations and determinations and, in consultation with the department or agency concerned, makes such additions and deletions as are necessary. Specifically, the Director “shall by rule make or revoke a component designation after considering the recommendation of the designated agency ethics official.” 5 CFR 2641.201(e)(3)(iii). Before designating an agency component as distinct and separate for purposes of 18 U.S.C. 207(c), the Director must find that there exists no potential for use by former senior employees of undue influence or unfair advantage based on past Government service, and that the component is an agency or bureau within a department or agency that exercises functions which are distinct and separate from the functions of the parent department or agency and from the functions of other components of that parent. 5 CFR 2641.201(e)(6).

Pursuant to the procedures prescribed in 5 CFR 2641.201(e), two departments have forwarded written requests to OGE to amend their respective listings in appendix B. After carefully reviewing the requested changes in light of the criteria in 18 U.S.C. 207(h) as implemented in 5 CFR 2641.201(e)(6), the Director of OGE has determined to grant these requests and amend appendix B to 5 CFR part 2641 as explained below.

The Department of Homeland Security (DHS) has requested that OGE remove all separate components from the DHS listing as designated at 69 FR 68053-68056 (November 23, 2004). The Department has determined that a single, undifferentiated organization for purposes of 18 U.S.C. 207(c) is in the best interest of DHS, the Government, and the public as DHS strives to establish a single, unified workforce.

Accordingly, because the former components no longer exercise functions which are distinct and separate, the OGE Director is granting the request of DHS and is amending appendix B to part 2641 to remove the entire listing for DHS, including all of the DHS components.

As 5 CFR 2641.201(e)(4) provides, a component designation “shall be effective as of the effective date of the rule that creates the designation, but shall not be effective as to employees who terminated senior service prior to that date.” Initial component designations were effective as of January 1, 1991. The effective date of subsequent designations is indicated by means of parenthetical entries in appendix B to part 2641, November 23, 2004 in the case of DHS components as noted above.

A revocation is effective 90 days after the effective date of the rule that revokes the designation. Accordingly, the component designation revocations made in this rulemaking will take effect June 6, 2007. Revocations are not effective as to any individual terminating senior service prior to the expiration of the 90-day period.

The Department of Justice has requested that OGE designate the Office on Violence Against Women (OVW) as a distinct and separate component of the Department of Justice (DOJ) except as to the Office of Justice Programs (OJP) for purposes of 18 U.S.C. 207(c). Legislation passed in 2002 established OVW as a separate and distinct office within DOJ. Pub. L. 107-273, codified at 42 U.S.C. 3796gg-0(b). However, because OVW continues to work closely with OJP on a number of initiatives, DOJ has not requested that OVW be considered separate from OJP, but only from other designated DOJ components.

Accordingly, the Director is granting the request of DOJ and therefore is amending the DOJ listing in appendix B to part 2641 to designate OVW as a new component as discussed.

Pursuant to 5 U.S.C. 553, as the Director of the Office of Government Ethics, I find that good cause exists for waiving the general requirements for notice of proposed rulemaking, opportunity for public comment, and, except as to the component designation revocations (see the preamble discussion above), a 30-day delayed effective date. It is important and in the public interest that the codification of OGE's previous designations of additional exempted positions as well as the designation revocations and new designation herein by OGE of the specified separate departmental components, which reflect the current organization of the concerned departments, be published in the Federal Register and take effect as promptly as possible.

As Director of the Office of Government Ethics, I certify under the Regulatory Flexibility Act (5 U.S.C. chapter 6) that this rule will not have a significant economic impact on a substantial number of small entities because it affects only Federal departments and agencies and current and former Federal employees.

The Paperwork Reduction Act (44 U.S.C. chapter 35) does not apply to this rule because it does not contain information collection requirements that require the approval of the Office of Management and Budget.

For purposes of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. chapter 25, subchapter II), the final rule will not significantly or uniquely affect small governments and will not result in increased expenditures by State, local and tribal governments, in the aggregate, or by the private sector, of $100 million or more (as adjusted for inflation) in any one year.

The Office of Government Ethics has determined that this rulemaking involves a non-major rule under the Congressional Review Act (5 U.S.C. chapter 8) and will submit a report thereon to the U.S. Senate, House of Representatives and Government Accountability Office in accordance with that law at the same time this rulemaking document is sent to the Office of the Federal Register for publication in the Federal Register .

In promulgating this final rule, the Office of Government Ethics has adhered to the regulatory philosophy and the applicable principles of regulation set forth in section 1 of Executive Order 12866, Regulatory Planning and Review. This rule has not been reviewed by the Office of Management and Budget under that Executive order since it deals with agency organization, management, and personnel matters and is not “significant” under the order.

As Director of the Office of Government Ethics, I have reviewed this rule in light of section 3 of Executive Order 12988, Civil Justice Reform, and certify that it meets the applicable standards provided therein.

The FAA is implementing a new process for streamlining the issuance of ADs related to MCAI. The streamlined process will allow us to adopt MCAI safety requirements in a more efficient manner and will reduce safety risks to the public. This process continues to follow all FAA AD issuance processes to meet legal, economic, Administrative Procedure Act, and Federal Register requirements. We also continue to meet our technical decision-making responsibilities to identify and correct unsafe conditions on U.S.-certificated products.

This AD references the MCAI and related service information that we considered in forming the engineering basis to correct the unsafe condition. The AD contains text copied from the MCAI and for this reason might not follow our plain language principles.

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on December 7, 2006 (71 FR 70908). That NPRM proposed to require a detailed inspection of the aileron control cable pulleys and brackets, and apply corrective actions as necessary.

We gave the public the opportunity to participate in developing this AD. We have considered the comments received.

EADS SOCATA believes the FAA should reference the changes in the NPRM of the compliance time from 10 hours time-in-service (TIS) in the MCAI and service bulletin to 50 hours TIS in the NPRM in the “FAA AD Differences” section.

The FAA sometimes needs to change compliance times for enforceability reasons. We normally do not include that as an FAA AD Difference in an AD action, unless it affects the actions being done. However, since this compliance time change was significant, we will note it as a difference. The difference will state that the MCAI and service bulletin requires the action at 10 hours TIS. Typically, this short of a compliance time would indicate an unsafe condition requiring urgent action. However, we did not consider this unsafe condition to be an urgent safety of flight condition and issued this action through the normal notice of proposed rulemaking (NPRM) AD process. The time of 50 hours TIS is an adequate compliance for this AD action and met the FAA requirements of an NPRM followed by a final rule.

EADS SOCATA comments that EADS SOCATA TBM Aircraft Mandatory Service Bulletin SB 70-134, dated July 2005, is not an Alert.

The FAA agrees and changes the reference to the service information in the final rule.

EADS SOCATA states that the costs of the required parts is about $450 per product and not the $8,600 per product that is in the Costs of Compliance section of the NPRM. EADS SOCATA also estimates that it would take 2.5 work-hours to inspect and 8.5 work-hours to replace the nonconforming parts, if necessary. This total of 11 work-hours is less than the 12 work-hours that the FAA estimates in the NPRM.

The FAA agrees and has changed the Costs of Compliance section in the final rule to reflect the above costs.

We reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We determined that these changes will not increase the economic burden on any operator or increase the scope of the AD.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable in a U.S. court of law. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have required different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are described in a separate paragraph of the AD. These requirements, if any, take precedence over the actions copied from the MCAI.

We estimate that this AD will affect 55 products of U.S. registry. We also estimate that it will take about 11 work-hours per product to comply with this AD. The average labor rate is $80 per work-hour. Required parts will cost about $450 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these parts. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $73,150, or $1,330 per product.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

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

For the reasons discussed above, I certify this AD:

(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.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD Docket.

You may examine the AD docket on the Internet at http://dms.dot.gov ; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone (800) 647-5227) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

You may examine the AD docket on the Internet at http://dms.dot.gov or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone (800) 647-5227) is located on the plaza level of the Nassif Building at the street address stated in the ADDRESSES section.

The FAA proposed to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) with an airworthiness directive (AD) to revise AD 2005-24-03, amendment 39-14383 (70 FR 70713, November 23, 2005). The existing AD applies to certain Boeing Model 737-600, -700, -700C, and -800 series airplanes. The proposed AD was published in the Federal Register on June 13, 2006 (71 FR 34026). That action proposed to continue to require inspecting/measuring the length of the attachment fasteners between the nacelle support fittings and the lower wing skin panels, and related investigative/corrective actions if necessary. That action also proposed to correct errors found in the existing AD.

We provided the public the opportunity to participate in the development of this AD. We have considered the comment received.

Boeing states that, subsequent to the drafting of the subject AD, Boeing Service Bulletin 737-57-1275, Revision 2, dated July 12, 2006, was issued. Boeing notes that Revision 2 will aid operators in completing the required tasks by more effectively and efficiently performing the inspections, while reducing the likelihood of introducing damage reported during completion of the previous revisions. Boeing recommends that Boeing Service Bulletin 737-57-1275, Revision 3, dated October 17, 2006, be incorporated into the NPRM, which further improves ease in completing the required tasks. (Revision 3 was not yet issued when the comment was submitted, but has since been issued.)

We agree with this request. We have reviewed Revision 3 of the referenced service bulletin which specifies that no more work is necessary on airplanes changed as shown in the original issue, dated September 4, 2003; Revision 1, dated August 18, 2005; and Revision 2, dated July 12, 2006. (We referred to Revision 1 in the NPRM as the appropriate source of service information for accomplishing the required actions.) We have determined that Revision 3 shows changes of operators in the effectivity and clarifies the oversize limits for replacement fasteners, but does not add any further actions or increase the economic burden on operators. Therefore, we have changed the AD to add Boeing Service Bulletin 737-57-1275, Revision 3, dated October 17, 2006, as the appropriate source of service information for accomplishing the requirements in paragraph (f) of this AD after the effective date of this AD.

We have carefully reviewed the available data, including the comment received, and determined that air safety and the public interest require adopting the AD with the change described previously. We have determined that this change will neither increase the economic burden on any operator nor increase the scope of the AD.

There are about 751 airplanes of the affected design in the worldwide fleet. The following table provides the estimated costs for U.S. operators to comply with this AD. The requirements that were previously required by AD 2005-24-03 are retained in this AD; this AD adds no additional economic burden on U.S. operators. The current costs are repeated for the convenience of affected operators, as follows:

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

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

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

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

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

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

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation.

On August 4, 2006, we issued a proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an AD that would apply to all Glasflugel Models H 301 “Libelle,” H 301B “Libelle,” Standard “Libelle,” and Standard Libelle-201B sailplanes. This proposal was published in the Federal Register as a notice of proposed rulemaking (NPRM) on August 11, 2006 (71 FR 46128). The NPRM proposed to require you to replace the rudder actuator arm (manufactured according to drawing No. 301-45-10) with an improved design rudder actuator arm (manufactured following drawing No. 301-45-13).

We provided the public the opportunity to participate in developing this AD. The following presents the comment received on the proposal and FAA's response to the comment:

Jack Buster of the Modification and Replacement Parts Association (MARPA) requests the following be incorporated into the regulatory action:

We agree that the service documents are essential and should be incorporated by reference. However, we do not incorporate by reference any document in a proposed AD action; instead we incorporate by reference the document in the final rule. Since we are issuing the proposal as a final rule AD action, the service information referenced in this action will be incorporated by reference.

We are currently reviewing issues surrounding the posting of service bulletins in the Department of Transportation's DMS as part of the AD docket. Once we have thoroughly examined all aspects of this issue and have made a final determination, we will consider whether our current practice needs to be revised.

On the PMA issue, Mr. Buster's comments are timely in that the FAA is currently reviewing this issue as it applies to all products: Transport airplanes, commuter airplanes, general aviation airplanes, engines and propellers, rotorcraft, and appliances. The FAA acknowledges that there are different ways of addressing this issue to ensure that unsafe PMA parts are identified and addressed. Once we have thoroughly examined all aspects of this issue including input from industry and have made a final determination, we will consider developing a standardized approach and standardized language on how to address PMA parts in airworthiness directives.

We have determined that to delay this AD action would be inappropriate since an unsafe condition exists and that replacement of certain parts must be done to ensure continued safety. Therefore, we have made no change to the AD in this regard.

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

• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

We estimate that this AD affects 160 airplanes in the U.S. registry.

We estimate the following costs to do the replacement of the rudder actuator arm (manufactured according to drawing No. 301-45-10):

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this AD.

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

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

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

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

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

We prepared a summary of the costs to comply with this AD (and other information as included in the Regulatory Evaluation) and placed it in the AD Docket. You may get a copy of this summary by sending a request to us at the address listed under ADDRESSES . Include “Docket No. FAA-2006-24709; Directorate Identifier 2006-CE-28-AD” in your request.

You may examine the airworthiness directive (AD) docket on the Internet at http://dms.dot.gov or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone (800) 647-5227) is located on the plaza level of the Nassif Building at the street address stated in the ADDRESSES section.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to certain Airbus Model A319, A320, and A321 airplanes. That NPRM was published in the Federal Register on December 28, 2006 (71 FR 78105). That NPRM proposed to require installing spacer assemblies at the attachment points of the YZ-latches of the cargo loading system in the forward and aft cargo compartments, as applicable.

We provided the public the opportunity to participate in the development of this AD. We have considered the one comment received. The commenter, Airbus, the manufacturer, supports the NPRM.

Since we issued the NPRM, we have received Revision 02 of Airbus Service Bulletin A320-25-1294, dated September 5, 2006. Revision 02 was issued to update the effectivity and kit information. We have updated the service bulletin reference in paragraph (f) of the AD to be Revision 02, and added Revision 01 of the service bulletin to paragraph (g) of the AD, “Credit for Actions Done According to Previous Issues of Service Bulletin.”

We have carefully reviewed the available data, including the single comment received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We have determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD.

This AD affects about 1 airplane of U.S. registry. The required actions take about 4 work hours per airplane, at an average labor rate of $80 per work hour. Required parts cost about $2,049 per airplane. Based on these figures, the estimated cost of this AD for the U.S. operator is $2,369.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

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

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

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

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

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

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation.

Discussion

On February 5, 2007, the FAA issued AD 2007-04-01, Amendment 39-14932 (72 FR 6931, February 14, 2007), which applies to certain Pacific Aerospace Corporation Ltd Model 750XL airplanes. AD 2007-04-01 requires you to inspect the rivets in the fuselage roof at STN 180.85, BL 19.67, WL 86.2, and replace undersize rivets. Current language in § 39.13 [Amended] of AD 2007-04-01 references “* * *” instead of “2007-04-01.”

This correction is needed to specify the correct AD number (2007-04-01) for AD 2007-04-01.

The FAA proposed to amend 14 CFR part 39 with a proposed AD. The proposed AD applies to PW JT9D series turbofan engines. We published the proposed AD in the Federal Register on November 2, 2005 (70 FR 66300). That action proposed to modify the JT9D series engines ALS sections of the manufacturer's manuals and an air carrier's approved continuous airworthiness maintenance program to incorporate additional inspection requirements. PW has added mandatory eddy current inspections (ECIs) for the web cooling holes in high pressure turbine (HPT) stage 1 disks installed in engine models JT9D-7R4D, -7R4D1, -7R4E, and -7R4E1, and for web tie-rod holes in HPT stage 2 disks installed in JT9D-3A, -7, -7A, -7H, -7AH, -7F, -7J, -20, and -20J engines. The mandatory inspections are needed to identify those critical rotating parts with conditions, which if allowed to continue in service, could result in uncontained failures.

You may examine the docket that contains the AD, any comments received, and any final disposition in person at the Docket Management Facility Docket Office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Office (telephone (800) 647-5227) is located on the plaza level of the Department of Transportation Nassif Building at the street address stated in ADDRESSES . Comments will be available in the AD docket shortly after the DMS receives them.

We provided the public the opportunity to participate in the development of this AD. We have considered the comments received.

One commenter, Japan Airlines, requests that we delete the ECIs for JT9D-59A, -70A, -7Q, and -7Q3 engines from the table in the proposed AD compliance section. The commenter points out that the proposed AD preamble paragraph entitled “FAA's Determination and Requirements of the Proposed AD” does not include ECIs for JT9D-59A, -70A, -7Q, and -7Q3 engines.

We do not agree. We inadvertently omitted listing the requirement of ECI of the HPT stage 1 disk web cooling holes on JT9D-59A, -70A, -7Q, and -7Q3 engines, under the proposed AD preamble paragraph entitled “FAA's Determination and Requirements of the Proposed AD”. The proposed AD compliance section and the compliance section in this AD, correctly list those engine models. We did not change the AD.

Japan Airlines requests that we wait to issue the AD until Pratt & Whitney provides the ECI procedure to the operators. The commenter states that the JT9D-7 Engine Manual Section 72-51-02, Inspection 05, has not been published yet.

We do not agree. Although the ECI procedure was not published in the JT9D-7 Engine Manual as of December 26, 2005 when the comment was sent, it was incorporated into the JT9D-7 Engine Manual on February 15, 2006. We do not need to wait to issue the AD.

Japan Airlines requests that we recommend to Pratt & Whitney to revise the JT9D engine manual to remove the specific manufacturer's name of the ECI equipment required to perform ECIs, and to only list the technical specifications required to perform the ECIs. The commenter states that operators may not own the ECI equipment specified in the Pratt & Whitney JT9D engine manual, but may have similar equipment capable of performing the inspections.

We partially agree. This AD requires operators to revise the Airworthiness Limitations Section of the engine manual to include a mandatory opportunistic inspection. We do not intend for the AD to specify only one vendor's inspection equipment to accomplish the inspection. Nor do we intend that this AD change the way operators seek approval for alternative methods of inspections. We did not change the AD.

Upon review of the proposed AD, we discovered that the JT9D-3A model was inadvertently left out of the compliance table. We added the JT9D-3A model to the compliance table in the AD.

Since we published the proposed AD on November 2, 2005, the number of engines affected and the hourly labor rate have changed. We updated this information in this AD preamble.

Upon review of the proposed AD, we discovered that the compliance table needs correcting in the section for the -3A/7/7A/7AH/7F/7H/7J/20/20J engine models. “All HPT Stage 2 Disk Web Cooling Holes 71-51-02 Inspection-05” is corrected to read “All HPT Stage 2 Disk Web Tie-rod Holes 72-51-02 Inspection-05”.

We have carefully reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We have determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD.

We estimate that 504 JT9D series turbofan engines are installed on U.S.-registered airplanes and will be affected by this AD. We also estimate that 87 engines will require this inspection per year and about one work-hour per engine is needed to perform the actions, and that the average labor rate is $80 per work-hour. Since this is an added inspection requirement that will be part of the normal maintenance cycle, no additional parts costs are involved. Based on these figures, we estimate the total annual cost of the AD to U.S. operators to be $6,960.

We are transferring the docket for this AD to the Docket Management System as part of our on-going docket management consolidation efforts. The new Docket No. is FAA-2007-27023. The old Docket No. became the Directorate Identifier, which is 98-ANE-47-AD. This AD might get logged into the DMS docket, ahead of the previously collected documents from the old docket file, as we are in the process of sending those items to the DMS.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

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

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

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

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

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

We prepared a summary of the costs to comply with this AD and placed it in the AD Docket. You may get a copy of this summary at the address listed under ADDRESSES .

History

On July 17, 2006, a final rule was published in the Federal Register , Docket No. FAA-2006-24813, Airspace Docket No. 06-AAL-16, that amended Title 14 Code of Federal Regulations part 71 by modifying the legal description of Class D and E airspace; Fairbanks, Fort Wainwright Army Airfield, AK (71 FR 40394). In that rule, the reference to FAA Order 7400.9 was published as FAA Order 7400.9N. The correct reference is FAA Order 7400.9P. In addition, the corresponding dates that refer to the Order are incorrect. Instead of “* * * September 1, 2005, and effective September 15, 2005”, the dates should read “ * * * September 1, 2006, and effective September 15, 2006 * * *”.

On August 1, 2006, a final rule was published in the Federal Register , Docket No. FAA-2006-24003, Airspace Docket No. 06-AAL-12, that amended Title 14 Code of Federal Regulations part 71 by revising Class E Airspace; Adak, AK (71 FR 43357). In that rule, the reference to FAA Order 7400.9 was published as FAA Order 7400.9N. The correct reference is FAA Order 7400.9P. In addition, the corresponding dates that refer to the Order are incorrect. Instead of “* * * September 1, 2005, and effective September 15, 2005”, the dates should read “* * * September 1, 2006, and effective September 15, 2006 * * *”.

History

On June 30, 2006, a final rule was published in the Federal Register , Docket No. FAA-2005-225010, Airspace Docket No. 06-AAL-17 that amended Title 14 Code of Federal Regulations part 71 by revoking a low altitude reporting point, AK (71 FR 37492). In that rule, the reference to FAA Order 7400.9 was published as FAA Order 7400.9O. The correct reference is FAA Order 7400.9P.

On July 24, 2006, a final rule was published in the Federal Register , Docket No. FAA-2006-23926, Airspace Docket No. 06-AAL-10 that amended Title 14 Code of Federal Regulations part 71 by modifying Norton Sound Low Offshore Airspace Area, AK (71 FR 41728). In that rule, the reference to FAA Order 7400.9 was published as FAA Order 7400.9O. The correct reference is FAA Order 7400.9P. In addition, the corresponding effective date that refers to the Order is incorrect. Instead of “* * * September 16, 2006”, the date should read “* * * September 15, 2006”.

This amendment to Title 14 of the Code of Federal Regulations, Part 97 (14 CFR part 97), establishes, amends, suspends, or revokes SIAPs and/or Weather Takeoff Minimums. The complete regulatory description of each SIAP and/or Weather Takeoff Minimums is contained in official FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA Forms are identified as FAA Forms 8260-3, 8260-4, 8260-5 and 8260-15A. Materials incorporated by reference are available for examination or purchase as stated above.

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

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP and/or Weather Takeoff Minimums as contained in the transmittal. Some SIAP and/or Weather Takeoff Minimums amendments may have been previously issued by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts. The circumstances which created the need for some SIAP, and/or Weather Takeoff Minimums amendments may require making them effective in less than 30 days. For the remaining SIAPs and/or Weather Takeoff Minimums, an effective date at least 30 days after publication is provided.

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

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

FDA is amending its regulations for parts 71, 73, 74, 170, 171, 172, 180 and 184 (21 CFR parts 71, 73, 74, 170, 171, 172, 180 and 184). Specifically, as a result of an FDA reorganization, the Office of Premarket Approval was renamed the Office of Food Additive Safety. Therefore, this rule updates the name and contact information for this office in §§ 71.1 and 171.1. In addition, FDA discovered that minor errors were inadvertently published in the CFR affecting its regulations that address food and color additives (parts 71, 73, 74, 170, 171, 172, and 180) and GRAS substances (part 184). This document makes the needed corrections.

The final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. The changes addressed in this document are as follows:

1. In §§ 71.1 Petitions and 171.1 Petitions the agency is updating contact information. In § 71.1 Petitions , the regulations currently identify the Office of Premarket Approval as the FDA office responsible for receiving petitions. The new name for the Office of Premarket Approval is the Office of Food Additive Safety. In § 171.1 Petitions , the regulations currently identify the Petitions Control Branch, Food and Drug Administration, Department of Health and Human Services, Washington, DC 20204 as the FDA office responsible for receiving petitions. The correct name and contact information is the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740.

2. Section 73.1128 Mica-based pearlescent pigments is redesignated as § 73.1350.

3. In § 73.2396 Lead acetate , the regulatory section citation for the labeling requirements for color additives (other than hair dye) is currently erroneously written as § 170.25 and is corrected to read § 70.25.

4. In § 74.2052 D&C Black No. 2 , the agency is correcting a typographical error in the spelling of the chemical nomenclature. “Benzo[ e ]pyrene” is being corrected to read “Benzo[ a ]pyrene.”

5. In §§ 170.45 Fluorine-containing compounds and 184.1769a Sodium metasilicate , the agency is updating references to a regulatory section citation which has been recodified. Section 103.35 has been recodified as § 165.110. Accordingly, in § 170.45, reference to “§ 103.35(d)” is corrected to read “§ 165.110(d)” and in § 184.1769a, reference to “§ 103.35” is corrected to read “§ 165.110”.

6. The agency is also updating § 170.45 Fluorine-containing compounds to correct a reference to a section of the agency's regulations which has been removed from the CFR. In § 170.45 the reference to “§ 250.203” is removed.

7. In § 172.510 Natural flavoring substances and natural substances used in conjunction with flavors , the agency is correcting a typographical error. The incorrect nomenclature “concretes” is being corrected to read “concentrates”.

8. In § 180.37 Saccharin, ammonium saccharin, calcium saccharin and sodium saccharin , the agency is correcting references to a regulatory section citation which has been removed from the CFR. In § 180.37, reference to “§ 100.130” is removed.

Publication of this document constitutes final action of these changes under the Administrative Procedure Act (5 U.S.C. 553). FDA has determined that notice and public comment are unnecessary because these amendments are merely correcting nonsubstantive errors. FDA therefore, for good cause, finds under 5 U.S.C. 553(b)(3)(B) and (d)(3) that notice and public comment are unnecessary.

Ivy Laboratories, Division of Ivy Animal Health, Inc., 8857 Bond St., Overland Park, KS 66214, filed ANADA 200-448 for use of HEIFERMAX 500 (melengestrol acetate) Liquid Premix, OPTAFLEXX (ractopamine hydrochloride), and RUMENSIN (monensin sodium) single-ingredient Type A medicated article to make dry and liquid, three-way combination drug Type C medicated feeds for heifers fed in confinement for slaughter. Ivy Laboratories' ANADA 200-448 is approved as a generic copy of Elanco Animal Health's NADA 141-234 for combination feed use of MGA 500, OPTAFLEXX, and RUMENSIN. The application is approved as of January 29, 2007, and the regulations are amended in 21 CFR 558.500 to reflect the approval. The basis of approval is discussed in the freedom of information summary.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

The agency has determined under 21 CFR 25.33(a)(2) 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 rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

The Route 82 Bridge, across the Connecticut River, mile 16.8, at East Haddam, Connecticut, has a vertical clearance in the closed position of 22 feet at mean high water and 25 feet at mean low water. The existing drawbridge operation regulations are listed at 33 CFR 117.205(c).

The owner of the bridge, Connecticut Department of Transportation, requested a temporary deviation to facilitate scheduled bridge maintenance, drive gear repairs. The bridge will not be able to open while the bridge maintenance is underway.

Under this temporary deviation the Route 82 Bridge may remain in the closed position between 8:30 p.m. and 4:30 a.m., for two nights, between March 19, 2007 and March 23, 2007. The exact two closure dates will be selected depending upon favorable weather necessary to perform the required repairs.

In accordance with 33 CFR 117.35(c), this work will be performed with all due speed in order to return the bridge to normal operation as soon as possible.

This deviation from the operating regulations is authorized under 33 CFR 117.35.

We are publishing this document to provide notice that under the provisions of 33 CFR 165.909(a)(11), the St. Patrick's Day Fireworks safety zone on the Manitowoc River will be enforced on March 17, 2007 from 5:30 p.m. through 7 p.m. The safety zone consists of all waters and adjacent shoreline across from the World War II U.S. Cobia submarine, Manitowoc River encompassed by the arc of a circle with a 70-foot radius with its center in approximate position 44°05.30′ N, 087°39.15′ W (NAD 1983).

In order to ensure the safety of spectators and transiting vessels, this safety zone will be in effect for the duration of the event. In the event that this safety zone affects shipping, commercial vessels may request permission from the Captain of the Port Lake Michigan to transit through the safety zone.

Requests must be made in advance and approved by the Captain of the Port before transits will be authorized. The Captain of the Port may be contacted via U.S. Coast Guard Sector Lake Michigan on channel 16, VHF-FM. The Coast Guard will give notice to the public via a Broadcast Notice to Mariners that the regulation is in effect.

On February 23, 2007, the Coast Guard published a temporary final rule (72 FR 8112) to establish a temporary safety zone in all navigable waters of the Captain of the Port Baltimore Zone. The temporary safety zone restricts vessels from transiting the zone during ice season. Due to a drafting error in the temporary final rule the Captain of the Port's requirements associated with different levels of ice conditions were unclear. This correction document makes corrections to the temporary final rule to provide clarification.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. The details of this project were not provided to the Coast Guard until January 25, 2007 making it impossible to publish a NPRM or a final rule 30 days in advance.

Similarly, Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Any delay in implementing this rule would be contrary to the public interest since immediate action is necessary to protect persons, facilities, vessels and others in the maritime community from the safety hazards associated with the handling, detonation, and transportation of explosives.

The explosives loading and blasting operations will occur at various times during the period between February 20, 2007 and March 31, 2007. The blasting plan calls for the drilling, blasting, and dredging of various areas within the berthing area of the Gulf Oil Terminal in South Portland, Maine. The explosives loading will occur at East End Beach at the Eastern Promenade, Portland, Maine, or at the municipal boat ramp at Bug Light Park, South Portland, Maine. The explosives will be transported via truck and M/V RELIANCE to the Gulf Oil Terminal in South Portland where the blasting and dredging project will be conducted. This regulation establishes a moving safety zone in all waters of the Fore River and Casco Bay in a 100 yard radius around the M/V RELIANCE as it transits from the East End Beach or Bug Light Park to the Gulf Facility and from the Gulf Facility back to the East End Beach or Bug Light Park. It also establishes a 100 yard safety zone around the perimeter of the affected portion of the berthing area of the Gulf Oil Terminal while blasting operations are being conducted. This area is defined as all of the waters enclosed by a line starting from a point located at the western side of the Gulf Oil Terminal Dock at latitude 43°39′12.537″ N, longitude 70°14′25.923″ W; thence to latitude 43°39′10.082″ N, longitude 70°14′26.287″ W; thence to latitude 43°39′10.209″ N, longitude 70°14′27.910″ W; thence to latitude 43°39′12.664″ N, longitude 70°14′27.546″ W; thence to the point of beginning.(DATUM:NAD 83). These safety zones are required to protect the maritime community from the hazards associated with the loading, detonation, and transportation of explosives. Entry into this zone will be prohibited unless authorized by the Captain of the Port.

This rule is effective from 7 a.m. EST on February 20, 2007 until 4 p.m. EDT on March 31, 2007. This safety zone is needed to safeguard mariners from the hazards associated with blasting operations on the designated waters in the Fore River. During the effective period of the safety zone, vessel traffic will be restricted in various portions of the Fore River and Casco Bay while the M/V RELIANCE is in transit and around the perimeter of the affected portion of the Gulf Oil Terminal when blasting operations are taking place. Although the safety zone will be in effect for seven weeks, it will only be enforced during actual transit and blasting times. Entry into those zones by any vessel is prohibited unless specifically authorized by the Captain of the Port, Northern New England.

The Captain of the Port anticipates negligible negative impact on vessel traffic from this temporary safety zone as it will be in effect only during transit and blasting operations. Blasting operations are anticipated to occur only two to three times per week between the hours of 7 a.m. and 4 p.m. The moving safety zone around the M/V RELIANCE will be enforced only during the transit of explosives to the site and from the site back to shore with unused explosives. The zone around the perimeter of the work site extends only minimally into the channel and will not effect vessels transiting in or out of the port. The zone around the worksite will be enforced only during the actual blasting times. The enhanced safety to life and property provided by this rule greatly outweighs any potential negative impacts. Public notifications will be made during the entire effective period of this safety zone via marine information broadcasts.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. The Coast Guard expects the economic impact of this rule to be so minimal that a full regulatory evaluation is unnecessary. The effect of this rule will not be significant for the following reasons: the safety zone will be enforced only during the transit of the M/V RELIANCE and during blasting operations. There is adequate room in the channel for vessels to transit during the blasting operations. Vessels will be permitted to transit and navigate in the effected waters when no blasting is taking place, minimizing any adverse impact. Additionally, extensive maritime advisories will be broadcast during the duration of the effective period.

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

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

This rule may affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit in the safety zone during this demolition event. However, this rule will not have a significant economic impact on a substantial number of small entities due to the minimal time that vessels will be restricted from the area, the ample space available for vessels to maneuver and navigate around the zone, and advance notifications will be made to the local community by marine information broadcasts.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule so that they can better evaluate its effects on them and participate in the rulemaking process. If this rule will affect your small business, organization or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact LTJG Jarrett Bleacher at (207)741-5421, Sector Northern New England, Waterways Management Division.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any police or action of the Coast Guard.

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

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

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

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

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

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

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

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

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

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

We have analyzed this rule under Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction, from further environmental documentation. This rule fits the category selected from paragraph (34)(g), as it establishes a safety zone. A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” will be available in the docket where indicated under ADDRESSES.

On December 22, 2005, VA published an interim final rule in the Federal Register (70 FR 75940) to implement section 1032 of Public Law 109-13.

We provided a 30-day comment period on the interim final rule, which ended on January 23, 2006. We received comments from only one organization, the Wounded Warrior Project (WWP). WWP stated that it was pleased with the regulation as a whole and with the decision to implement it immediately as an interim final rule, but raised issues WWP believed should be addressed in future versions of the regulation. WWP expressed concern that the definition of “incurred in Operation Enduring Freedom” in § 9.20(b)(2)(i) and “incurred in Operation Iraqi Freedom” in § 9.20(b)(2)(ii) would allow TSGLI benefits for injuries incurred prior to December 1, 2005, only if the service member was deployed outside the United States on orders in support of OEF or OIF. WWP states that TSGLI benefits should be paid to all members of the uniformed services who suffered a loss as a result of a traumatic injury prior to December 1, 2005, irrespective of the service member's location or orders at the time of the injury. This suggested change to § 9.20 would require a statutory amendment. Section 9.20(b)(2)(i) and (ii) implement section 1032(c)(1) of Public Law 109-13, which limited TSGLI benefits for injuries incurred prior to December 1, 2005, to members injured in OEF and OIF. To the extent that this comment suggests that VA could define the terms “Operation Enduring Freedom” and “Operation Iraqi Freedom” to encompass service in any location occurring at the same time as OEF and OIF, such a definition would be inconsistent with the plain meaning of section 1032(c) of Public Law 109-13 because it would deprive those statutory terms of any meaning or effect.

WWP also commented that the interim final rule should be amended to increase the period after a traumatic injury within which a scheduled loss must occur, from the current 365 days to 2 years. We concur with WWP's comment. In adopting the 365-day period in § 9.20(d)(4) of the interim rule, we acknowledged the Department of Defense's (DoD) advice that physicians and service members go to great lengths to preserve a member's injured limb and that amputation of a limb frequently occurs only after a significant period of time passes after a traumatic injury. 70 FR 75942. WWP informed us in its comments that there are several cases in which severely injured service members are still attempting to save their injured limbs more than a year after the traumatic injury because of sophisticated medical treatment currently available. Based on the new information, we believe that it is entirely reasonable to amend § 9.20(d)(4) to increase the period of time following a traumatic injury in which a scheduled loss must occur from 365 days to 2 years for all scheduled losses. When we issued the interim final rule, section 1032(a)(2) of Public Law 109-13, which this rule implements, specifically provided that a member must suffer a scheduled loss before the end of the period prescribed by the Secretary of Veterans Affairs, “except, if the loss is quadriplegia, paraplegia, or hemiplegia, the member suffers the loss not later than 365 days after sustaining the traumatic injury.” However, on June 16, 2006, Congress enacted the Veterans' Housing Opportunity and Benefits Improvement Act of 2006, Public Law 109-233, section 501(a)(3) of which eliminated the requirement that a scheduled loss due to quadriplegia, paraplegia, or hemiplegia occur within 365 days after a traumatic injury. Accordingly, extending the time period to 2 years for all scheduled losses is consistent with current statutory requirements.

Congress did not specify whether the change made by section 501(a)(3) would apply to claims filed or injuries suffered prior to the date of that change in law. Under established rules of statutory construction, a new statute is presumed not to operate retroactively unless its language requires that result. See Landgraf v. USI Film Prods., 511 U.S. 244 (1994). However, a statute does not operate retroactively merely because it is applied to a claim filed before the statute was enacted. Id. at 269. Rather, a statute would have a disfavored retroactive effect only if it impairs previously established rights, imposes new duties with respect to transactions already completed, or imposes some similar alteration with respect to past events. Id. at 280. Determining whether application of a new statute would have retroactive effect requires consideration of the nature and degree of the change in law, the degree of connection between the new law and a relevant past event, and notions of fair notice and reasonable reliance. Princess Cruises, Inc. v. United States, 397 F.3d 1358, 1362-63 (Fed. Cir. 2005). Under this analysis, we conclude that applying the change made by section 501(a)(3) of Public Law 107-103 to previously filed claims or previously incurred injuries would not have a disfavored retroactive effect.

In establishing the TSGLI program, Congress made clear its intent to authorize payment for some injuries and losses incurred before that program took effect. The change made by section 501(a)(3) would work a relatively minor change in the TSGLI eligibility criteria and applying that change to prior claims or injuries would appear to be consistent with the objectives of the TSGLI provisions authorizing payments based on injuries preceding the program's creation. Further, because TSGLI is intended to provide a source of income for expenses during periods of disablement and convalescence following a loss due to traumatic injury, we believe the application of the new law is more directly connected to those persistent circumstances than to the past date on which an injury or loss was incurred or a claim was filed. We also note that the change in law would not have affected conduct prior to the date of its enactment, nor would it upset any settled expectations in any meaningful way. The service member's traumatic injury, the scheduled loss due to the injury, and the resulting economic burdens on the service member were not within any party's control and obviously actions were not taken in reliance on prior law. Although application of the new law would increase the government's economic burden, we believe the additional burden is relatively small and is countered in this instance by the other considerations discussed above. Accordingly, we conclude that section 501(a)(3) of Public Law 109-233 may be applied to claims that were filed before the date that statute was enacted and which remained pending on that date.

Finally, WWP expressed concern that the DoD points of contact in each branch of service are unable to certify service member claims for retroactive payment in which the member's scheduled loss is based upon the inability to perform activities of daily living (ADL) because the “service member medical records do not adequately reflect the amount of time the claimant was unable to perform the requisite ADL.” WWP urges DoD and VA to give the benefit of the doubt to members in this situation due to the difficulty in substantiating a scheduled loss when medical records do not contain the necessary ADL documentation. For purposes of deciding a case before the Secretary of Veterans Affairs, a statute provides that, when there is an “approximate balance of positive and negative evidence” concerning an issue, the Secretary must give the benefit of the doubt to the claimant (38 U.S.C. 5107(b)). If there is no evidence on a particular issue or if the evidence is not deemed to be in approximate balance, the benefit-of-the-doubt standard under the statute does not apply. See Ortiz v. Principi, 274 F.3d 1361, 1365 (Fed. Cir. 2001). Decisions about entitlement to TSGLI, unlike decisions regarding entitlement to VA compensation and pension, are made by each uniformed service. 38 CFR 9.20(f). It would therefore be inappropriate for VA to promulgate a benefit-of-the-doubt rule in this rulemaking to be applied by DoD in making decisions about TSGLI entitlement.

WWP also states that DoD should be more cognizant of the need to document a member's inability to conduct ADL in future cases. We agree that verification of a service member's inability to perform ADL has in some instances been difficult. We have taken steps to address the need for complete documentation in future cases. DoD service branch points of contacts, physicians, and other medical care providers have been given detailed, clarifying guidance on the definition of the term “inability to carry out activities of daily living” in § 9.1(k). They have also been instructed by the branches of military service on where and how to request supporting documentation regarding a member's ability to perform ADL. We therefore do not believe that any amendment to § 9.1(k) is required at this time.

The interim final rule stated, in § 9.20(d)(1), that a servicemember must be insured under SGLI to be eligible for TSGLI. We neglected to explain that this requirement does not apply to payments of retroactive TSGLI based on traumatic injuries occurring on or after October 7, 2001, though and including November 30, 2005. Section 1032(c)(1) of Public Law 109-13 provided that “[a]ny member” who experienced a traumatic injury between October 7, 2001, and December 1, 2005, is eligible for TSGLI if the qualifying loss is a direct result of injuries incurred in Operation Enduring Freedom or Operation Iraqi Freedom. The term “member” is defined in 38 U.S.C. 1965(5), for purposes of subchapter III of chapter 19, title 38, United States Code, and whether a person is insured under SGLI is not one of the criteria of the definition. We are therefore amending § 9.20(d)(1) to clarify that, if a member had a traumatic injury on or after October 7, 2001, through and including November 30, 2005, and if the qualifying loss is a direct result of injuries incurred in Operation Enduring Freedom or Operation Iraqi Freedom, the member is eligible for TSGLI even if he or she was not insured under SGLI.

Also, former 38 U.S.C. 1980A(h) provided that “[c]overage for loss resulting from traumatic injury * * * shall cease at midnight on the date of the member's separation from the uniformed service.” Section 501(a)(8) of Public Law 109-233 amended 38 U.S.C. 1980A(h) to provide that TSGLI coverage terminates at midnight on the date of the “termination of the member's duty status in the uniformed services that established eligibility for Servicemembers' Group Life Insurance,” notwithstanding the extension of SGLI coverage provided under 38 U.S.C. 1968(a). This statutory amendment clarifies when TSGLI coverage terminates. We are amending the parenthetical at the end of § 9.20(d)(1) to conform to the clarifying change made by section 501(a)(8) of Public Law 109-233.

We have also revised § 9.20(f) to conform to section 501(a)(6) of Public Law 109-233, which amended 38 U.S.C. 1980A(f) to explain in more detail the nature of the uniformed services' certification. This amendment relates to non-substantive, procedural matters.

Finally, we note that section 501(c)(2) of Public Law 109-233 repealed section 1032(c) of Public Law 109-13 pertaining to TSGLI eligibility for service members who suffered scheduled losses as a result of injuries incurred in OEF or OIF between October 7, 2001, and December 1, 2005, and instead provides TSGLI to service members who suffered scheduled losses as a direct result of a traumatic injury incurred in the theater of operations for OEF or OIF beginning on October 7, 2001, and ending at the close of November 30, 2005. That change may implicate matters beyond the scope of the interim final rule and the public comments received to date. Accordingly, we will publish a rule implementing section 501(c)(3) of Public Law 109-233 in the future.

To the extent an intervening statutory change may apply to a particular claim, VA must follow statutory requirements even if it has not yet revised its regulations. We are therefore adding § 9.20(j) to explain that the TSGLI program will be administered in accordance with the provisions of § 9.20, except to the extent that any provision in the rule is inconsistent with subsequently enacted applicable law.

For the reasons stated above and in the interim final rule notice, VA will adopt the interim final rule as final, with the changes to § 9.20(d)(1) and (4) and addition of § 9.20(j) discussed above. We are also adding information to the end of § 9.20 regarding the Office of Management and Budget information collection control number for this rule.

In the December 22, 2005, Federal Register notice, we determined that there was a basis under the Administrative Procedure Act for issuing the interim final rule with immediate effect. We invited and received public comment on the final rule. This document affirms the interim final rule as a final rule with the changes to § 9.20(d)(1) and (4) and (f) and the addition of § 9.20(j). The amendment to § 9.20(d)(1) is interpretative and clarifies the eligibility criteria for TSGLI. The amendment to the parenthetical at the end of § 9.20(d)(1) makes the regulation consistent with a clarifying amendment to 38 U.S.C. 1980A(h) made by section 501(a)(8). The amendment to § 9.20(d)(4) in this rule is liberalizing and will make more injured service members eligible for TSGLI. Section 1032 of Public Law 109-13 went into effect on December 5, 2005, and the final rule is necessary to implement the TSGLI program. The purpose of TSGLI is to ensure that payment is made to severely injured service members as soon as possible following a traumatic injury in order to reduce the financial burden resulting from a severe loss. The amendment to § 9.20(f) relates to non-substantive, procedural matters and makes the regulation consistent with 38 U.S.C. 1980A(f) as amended by section 501(a)(6) of Public Law 109-233. The amendment to § 9.20(j) is interpretative and is intended only to explain that applicable law will be applied to decide TSGLI claims. Accordingly, we have concluded under 5 U.S.C. 553 that there is good cause for dispensing with prior notice and comment regarding the amendments to § 9.20(d), (f), and (j) because such a procedure is impracticable, unnecessary and contrary to the public interest.

The Unfunded Mandates Reform Act requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before developing any rule that may result in an expenditure by State, local, and tribal governments, in the aggregate, or by the private sector of $100 million or more (adjusted annually for inflation) in any given year. This rule would have no effect on State, local, or tribal governments or the private sector.

Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Order classifies a rule as a significant regulatory action requiring review by the Office of Management and Budget if it meets any one of a number of specified conditions, including: having an annual effect on the economy of $100 million or more, creating a serious inconsistency or interfering with an action of another agency, materially altering the budgetary impact of entitlements or the rights of entitlement recipients, or raising novel legal or policy issues. VA examined the economic, legal, and policy implications of this final rule and stated in the December 22, 2005, Federal Register notice that it is a significant regulatory action because it exceeds the $100 million threshold.

The collection of information under the Paperwork Reduction Act (44 U.S.C. 3501-3521) referenced in this final rule has been approved under OMB control number 2900-0671.

The Secretary of Veterans Affairs hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act (5 U.S.C. 601-612). Only service members and their beneficiaries could be directly affected. Therefore, pursuant to 5 U.S.C. 605(b), this rule is exempt from the final regulatory flexibility analysis requirements of 5 U.S.C. 604.

In a document published in the Federal Register on February 1, 2006 (71 FR 5204), VA proposed to amend 38 CFR 17.32 to authorize the designation of additional categories of health care professionals to obtain the informed consent of patients or their surrogates and to sign the consent form. The comment period for this proposed rule ended April 3, 2006. We received one comment and now issue this final rule.

This rule amends VA medical regulations on informed consent and brings VA practice in line with current professional standards of care. Specifically, it allows VA to designate appropriately trained health care professionals ( e.g. , advanced practice nurses and physician assistants), who have primary responsibility for the patient or who will perform a particular procedure or provide a treatment, to conduct the informed consent discussion and sign the consent form. These changes and the specific requirements that define “appropriately trained health care professionals” will be documented in a revision to VHA Handbook 1004.1, Informed Consent for Clinical Treatments and Procedures.

The current definition of practitioner encompasses any health care professional who has been granted specific clinical privileges to perform the treatment or procedure. It also includes medical and dental residents who may not be clinically privileged but who, under the current regulation, may obtain the informed consent and sign the consent form. This rule extends the exception regarding clinical privileging to other appropriately trained health care professionals, which will be clearly defined in national VA policy.

This change is required because clinical privileges are not granted to all health care professionals in VA who provide treatments and procedures. Some health care professionals work under specific “scope of practice” agreements or other formal delineations of job responsibility that specify which treatments and procedures the individual can provide based on his or her training, certification, knowledge, skills, and/or licensure. These agreements are developed and signed at the local facility level based on national policy requirements. Under the current regulatory definition of practitioner, physician assistants, advanced practice nurses and other appropriately trained health care professionals who are not clinically privileged but are performing procedures or providing treatments, as approved by their facility and supported by the standards of their respective professions, may not obtain informed consent from the patient. This rule would allow these treating practitioners to obtain informed consent from the patient and sign the consent form. This scope of practice will be limited to those specific individuals who meet detailed requirements set by VA national policy and who also gain approval from their local facility to carry out these duties.

No change is made to the general requirements for informed consent in this rule. The practitioner, who has primary responsibility for the patient or who will perform the particular procedure or provide the treatment, must obtain consent from the patient as described in the regulation.

VA received one comment asking that we omit reference to designated “health care professionals” and expand the definition of “practitioner” to include advanced practice nurses and physician assistants only. The commenter suggested that other health care professionals may lack the qualifications necessary to obtain patients' informed consent. VA recognizes that many health care professionals may lack appropriate qualifications to obtain informed consent. Indeed, some advanced practice nurses and physician assistants may not be qualified to do so. However, the commenters' proposed change neither ensures quality nor allows VA to remedy the problem that non-privileged providers are currently prohibited from obtaining consent from the patients they treat. We believe that promoting direct communication between the treating practitioner and the patient improves informed consent and improves patient care. Ensuring that providers are appropriately qualified to conduct informed consent discussions with patients will be addressed through establishing national requirements in VA policy and holding local VHA facilities accountable for making certain that each individual provider assigned those duties is competent to perform them. In our view, the rule's proviso, that designation is authorized only for other appropriately trained health care professionals, when combined with the regulation's requirement that consent be obtained by the health care professional who has primary responsibility for the patient or who will perform the particular procedure or provide the treatment, allows VA a necessary level of control over quality through the specification in policy and certification in practice of “appropriately trained health care professionals.” Accordingly, we made no change based on this comment.

We are also making nonsubstantive changes to make the terminology used in the regulation consistent with current Department practice. These include changing “health-care” to “health care” and “medical record” to “health record” throughout the section.

Based on the rationale set forth in the proposed rule and those contained in this document, we are adopting the provisions of the proposed rule as a final rule without change.

The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in an expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any given year. This rule would have no such effect on State, local, and tribal governments, or the private sector.

This document contains no provisions constituting a collection of information under the Paperwork Reduction Act (44 U.S.C. 3501-3521). The existing information collections associated with the informed consent process have been approved by OMB under control number 2900-0583.

Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Order classifies a rule as a significant regulatory action requiring review by the Office of Management and Budget if it meets any one of a number of specified conditions, including: having an annual affect on the economy of $100 million or more, creating a serious inconsistency or interfering with an action of another agency, materially altering the budgetary impact of entitlements or the rights of entitlement recipients, or raising novel legal or policy issues. VA has examined the economic, legal, and policy implications of this final rule and has concluded that it is a significant regulatory action because it raises novel policy issues.

The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act (5 U.S.C. 601-612). The rule will affect only individuals and will not directly affect any small entities. Therefore, pursuant to 5 U.S.C. 605(b), this rule is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.

I. General Information A. Does This Action Apply to Me?

Entities affected by this rule include sources in all industry groups. The majority of sources potentially affected are expected to be in the following groups:

Entities affected by the rule also include States, local permitting authorities, and Indian tribes whose lands contain new and modified major stationary sources.

In addition to being available in the docket, an electronic copy of this final rule is also available on the World Wide Web. Following signature by the EPA Administrator, a copy of this final rule will be posted on the EPA's NSR Web site, under Regulations & Standards, at http://www.epa.gov/nsr.

The information presented in this preamble is organized as follows:

In this action, we are finalizing previously proposed changes to the regulations that govern NSR permitting of major stationary sources in nonattainment areas in appendix S of 40 CFR part 51. Appendix S contains the permitting program for major stationary sources that are located either in nonattainment areas or in the Ozone Transport Region (OTR), in transition periods before EPA approves a SIP to implement the NSR requirements in part D of title I. These final rules revise appendix S to generally conform it to regulations at 40 CFR 51.165 for SIP programs for nonattainment major NSR, as those regulations were revised to implement NSR reform. 67 FR 80816 (December 31, 2002) (2002 NSR reform rules). However, the U.S. Court of Appeals for the D.C. Circuit, in New York v. EPA, 413 F.3d 3 (DC Cir. 2005) ( New York ), vacated the Clean Unit provision and the Pollution Control Project (PCP) exemption in the 2002 NSR reform rules. Therefore, these final rules do not conform appendix S to the 2002 rules with respect to Clean Units or PCPs. The New York case also remanded the “reasonable possibility” recordkeeping and reporting provision of the 2002 NSR reform rules for the EPA either to provide an acceptable explanation or to devise an appropriately supported alternative. In a separate Federal Register notice published on this date, we are proposing clarification of the “reasonable possibility” standard to address under which circumstances records must be kept for projects that do not trigger NSR. In the interim, the “reasonable possibility” standard remains in effect in our major NSR regulations and we provide an interpretation that indicates one set of circumstances under which the “reasonable possibility” standard is met. States may provide different recordkeeping requirements provided that the recordkeeping requirements address the concerns noted in the Court's remand.

The major NSR program contained in parts C and D of title I of the Act is a preconstruction review and permitting program applicable to new and modified major stationary sources of air pollutants regulated under the Act. In areas not meeting health-based national ambient air quality standards (NAAQS) and in ozone transport regions, the program is implemented under the requirements of section 110(a)(2)(C) and part D of title I of the Act. We call this program the “nonattainment” NSR program. Subpart 1 of part D of title I contains general requirements for nonattainment areas for any pollutant for which there is a NAAQS.

In areas meeting the NAAQS (“attainment” areas) or for which there is insufficient information to determine whether they meet the NAAQS (“unclassifiable” areas), the NSR requirements under part C of title I of the Act apply. This program is called the Prevention of Significant Deterioration (PSD) program. Collectively, we also commonly refer to the attainment and nonattainment programs as the major NSR program. Regulations comprising the major NSR program are contained in 40 CFR 51.165, 51.166, 52.21, 52.24, and part 51, appendix S. Of these, the nonattainment area regulations are contained in 40 CFR 51.165, 52.24, and part 51, appendix S.

The NSR provisions of the Act are implemented primarily through State preconstruction permitting programs. As provided in section 172(c)(4) of the Act, the SIP must require permits for the construction and operation of new or modified major stationary sources in accordance with section 173 of the Act. The permitting requirements for SIPs for major stationary sources locating in nonattainment areas are found in 40 CFR 51.165. 40 CFR 52.24(k) specifies that appendix S governs permits to construct and operate when such permits were applied for during the period between the date of designation as nonattainment and the date we approve the part D major NSR plan. Appendix S states that it is an interpretation of 40 CFR subpart I (including § 51.165), and it has historically reflected substantially the same requirements as the part D NSR requirements. This includes the requirement to comply with the lowest achievable emission rate (LAER) and obtain offsetting emission reductions, with a limited exemption in section VI of the appendix that applies to sources that will not interfere with an area's attainment deadline and that will meet applicable SIP emissions limitations. Thus, consistent with section 110(a)(2)(C) of the Act, permitting of new and modified stationary sources in the area will be regulated as necessary to ensure that they do not interfere with attaining the NAAQS.

As we describe further in section III.B of this preamble, these final regulations generally conform the regulatory language of appendix S to the major NSR program as revised on December 31, 2002, except for the provisions of that program vacated by the New York case. For a summary of the regulatory development process and stakeholder development for that rulemaking, see 67 FR 80188.

On July 23, 1996, we proposed changes to the major NSR program, including the regulations contained in 40 CFR 51.165, 51.166, 52.21, 52.24, and part 51 appendix S (61 FR 38250). The 1996 proposal concerned, in part, five major changes to the NSR program-baseline emissions, actual-to-projected-actual methodology, Clean Units, Plantwide Applicability Limitations (PALs), and PCPs.

On December 31, 2002 (67 FR 80187), we promulgated final changes concerning baseline emissions, actual-to-projected-actual methodology, Clean Units, PALs, and PCPs. We promulgated these changes in the regulations at 40 CFR 51.165, 51.166, and 52.21, and at the same time stated our intention to later conform the regulatory language in appendix S (and 40 CFR 52.24) to the final regulations.

We published final rules addressing implementation of the 8-hour ozone NAAQS, on April 30, 2004 (69 FR 23951) and November 29, 2005 (70 FR 71612). In the November 2005 final rule, in part, we revised appendix S to incorporate the major stationary source thresholds, significant emission rates, and offset ratios for sources of ozone precursors pursuant to part D, subpart 1 and subpart 2 of title I of the 1990 CAA Amendments, but we did not at that time include the regulatory changes we had proposed to conform appendix S language to that of the NSR reform rules.

In this final action, we have revised appendix S as proposed to generally conform the regulatory language in appendix S to that of the NSR reform rules. Specifically, the changes proposed in 1996 concerning baseline emission determinations, actual-to-projected-actual methodology, and PALs have been incorporated in sections II and IV of appendix S. As indicated at 67 FR 80187, it was our intent to finalize the changes to appendix S precisely as we have finalized requirements for other parts of the program. However, subsequently, the New York case vacated the Clean Unit provision and the PCP exemption in the 2002 NSR reform rules. Therefore, these final rules do not conform appendix S to the 2002 rule revisions relating to Clean Units and PCPs. In addition, as discussed later, these final rules conform appendix S to the “reasonable possibility” standard in the NSR reform rules. In a separate Federal Register notice published on this date, we are proposing clarification of the “reasonable possibility” standard to address under which circumstances records must be kept for projects that do not trigger NSR. We provide, in this preamble, an interim interpretation which addresses the issues raised by the Court in its remand. Table 1 shows where to find the changes being made to appendix S.

Appendix S provides on its face that it is an interpretation of the NSR permitting rules in subpart I, including (51.165. Therefore, it is necessary to have appendix S reflect substantially the same requirements as are in § 51.165. 1 Thus, we proposed to amend appendix S in this manner in the 1996 NSR proposal.

The legal basis for these changes is the same as that set forth in the preamble to the December 31, 2002, final rule providing NSR reforms for the other major NSR regulations. Additionally, we believe it is necessary to have appendix S reflect substantially the same requirements as codified at 40 CFR 51.165 because appendix S is an interpretation of the NSR permitting rules at 40 CFR part 51 subpart I, including § 51.165, as discussed earlier. As explained in section IV.A of this preamble, we are not amending appendix S to adopt the Clean Unit provision and PCP exemption that are in § 51.165, because the D.C. Circuit Court of Appeals vacated those provisions in the New York decision.

Section 110(a)(2)(C) of the Act does not define specific requirements States must follow for issuing major source permits during the interim period between nonattainment designation and EPA approval of a nonattainment NSR SIP. However, we have historically recognized that the SIP development period provided for in section 172(b) of the Act leaves a gap in part D major NSR permitting and have determined that this gap is to be filled with an interim major NSR program that is substantially similar to the requirements of part D, including the LAER and offset requirements from part D, subject to a limited exemption where the attainment deadline will be met (57 FR at 18070, 18076). This interim NSR program has been implemented to date through appendix S. 2 Our regulations at 40 CFR 52.24(k) require States to follow appendix S during the time period between the date of designation as nonattainment and the date the part D major NSR plan is approved. Additionally, in the 1977 CAA Amendments, Congress indicated its intent that major NSR permitting apply during the SIP development period. [See Pub. L. No. 95-95, § 129(a), 91 Stat. 685 (1977).] Specifically, in 1977, when Congress enacted a moratorium on construction in any area lacking an approved part D NSR SIP, with a delayed effective date of July 1, 1979, Congress provided that appendix S govern permitting of sources constructing in such areas prior to that date, subject to a limited waiver by the Administrator. Id. 108(b), 129(a). We subsequently codified the use of appendix S as the interim major NSR program in 40 CFR 52.24(k), reasoning (in the context of implementing a delay in the construction ban for then-recently designated nonattainment areas) that Congress had provided that appendix S would remain in effect to protect air quality while State plans were being designed (45 FR 91604). When Congress removed the construction ban (except as provided in section 110(n)(3) of the Act), it left in place 40 CFR 52.24(k), implementing the interim major NSR program under appendix S.

The continued application of appendix S through § 52.24(k) is also supported by the purpose of the CAA, specifically, section 101(b)(1), “to protect and enhance the quality of the Nation's air resources so as to promote the public health and welfare and the productive capacity of its population.” This provision was the basis for the original judicial finding that the Act imposed an obligation to prevent significant deterioration in areas that meet the NAAQS, prior to Congress' enactment of the PSD program at part C of the Act. 3 This policy of non-degradation and promoting productive capacity applies with even greater force in areas that fail to meet the NAAQS. Thus, we believe that an interim major NSR program for the SIP development period—as codified at appendix S—is supported by section 110(a)(2)(C), section 101(b)(1), Congressional intent, and our gapfilling authority under section 301(a) of the Act.

These appendix S rules include the “reasonable possibility” standard of the 2002 NSR reform rules. In response to the remand of that standard handed down by the D.C. Circuit in the New York case, EPA provides an interim interpretation of “reasonable possibility” that is consistent with the Court's decision. We note that in a separate Federal Register notice published on this date, we are proposing clarification of the “reasonable possibility” standard to address under which circumstances a source that does not trigger NSR may nonetheless still be required to keep records.

A major stationary source in a nonattainment area (or in the OTR) triggers the application of NSR when it makes a “modification,” which is defined as “any physical change * * * or change in the method of operation * * * which increases the amount of any air pollutant emitted” for which an area is in nonattainment or results in the emission of any such air pollutant not previously emitted by the source. CAA sections 172(c)(5), 171(4), 111(a)(4). The amount of the increase must be significant, and EPA, through rulemaking, has determined significance levels for various pollutants where the Act does not independently specify a significance threshold. See 40 CFR 51.165(a)(1)(x), 51.166(b)(23)(i), paragraph II.A.10 of appendix S to Part 51, and 52.21(b)(23)(i).

To determine the amount of increase from the change, the NSR rules prior to revision by the 2002 NSR reform rules generally required a source other than an electric utility steam generating unit (EUSGU) to compare the amount of the source's actual emissions during a baseline period to the amount the source would emit after the change based on the source's potential to emit (PTE) to determine if a “significant net emissions increase” has occurred. The 2002 NSR reform rules provided non-EUSGU sources a choice in how to determine the post-change amount: these sources could continue to use the PTE amount (the actuals-to-potentials test), or they could use the amount of actual emissions the sources projected to occur (the actuals-to-projected-actuals test). The preamble to the NSR reform rules contains a more detailed discussion, 67 FR at 80,187.

For a source that elects the actuals-to-projected-actuals test and calculates that the amount of any increase would not exceed the significance levels and therefore does not trigger NSR, the NSR reform rules provide requirements to maintain records of the calculations and post-change emissions if the source determines that there is “a reasonable possibility that [the change] may result in a significant emissions increase * * *. ” 40 CFR 52.21(r)(6).

In the New York case, the DC Circuit remanded this provision, stating:

In a separate Federal Register notice published on this date, we are proposing clarification of the “reasonable possibility” standard to identify when a source must keep records despite the fact that a physical or operational change does not trigger NSR. The EPA intends, as part of that rulemaking, to revise appendix S to the extent necessary to conform to the results of that rulemaking.

In the interim, until EPA completes the rulemaking, EPA announces that it interprets the standard so that a source may conclude there is no “reasonable possibility” that the change will result in a significant increase in emissions only if the change's projected actual emissions increase is below 50 percent of the applicable NSR significance level for any pollutant. This test may be termed the “percentage increase trigger.” We base our conclusion on an assumption that the magnitude of projected actual emissions correlates positively to the likelihood of a significant emissions increase. The EPA believes that this interpretation addresses the issues identified by the Court in the New York case.

As we noted in section III.B of this preamble, we proposed changes to appendix S and the other major NSR regulations in 1996. Thus, the comments and responses concerning the final regulations on December 31, 2002 also apply to these final changes to appendix S. You will find the major comments and responses at 67 FR 80186. For a complete summary of the comments and responses, please see our Technical Support Document for the December 31, 2002 final rules, which is posted on the World Wide Web, on the EPA's New Source Review Web site, at http://www.epa.gov/nsr/documents/nsr-tsd_11-22-02.pdf.

These final changes to appendix S of 40 CFR part 51 will take effect in the NSR permitting programs for nonattainment areas on May 7, 2007. This means that appendix S as amended in this final action will apply on May 7, 2007 in any nonattainment area without an approved part D NSR SIP that applies to major sources in the nonattainment area for the nonattainment pollutant.

Under Executive Order (EO) 12866 (58 FR 51735, October 4, 1993), this action is a “significant regulatory action.” Accordingly, EPA submitted this action to the Office of Management and Budget (OMB) for review under EO 12866 and any changes made in response to OMB recommendations have been documented in the docket for this action.

This action does not impose any new information collection burden. The OMB has previously approved the information collection requirements contained in the existing regulations (40 CFR parts 51 and 52) under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501, et seq. , and has assigned OMB control number 2060-0003, EPA ICR number 1230.17. A copy of the OMB-approved Information Collection Request (ICR) may be obtained from Susan Auby, Collection Strategies Division, U.S. Environmental Protection Agency (2822T), 1200 Pennsylvania Ave., NW., Washington, DC 20460, or by calling (202) 566-1672.

Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.

The EPA has determined that it is not necessary to prepare a regulatory flexibility analysis in connection with this final rule. For purposes of assessing the impacts of this final rule on small entities, small entity is defined as: (1) A small business as defined by the Small Business Administration's (SBA) regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; or (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.

After considering the economic impacts of this final rule on small entities, EPA has concluded that this action will not have a significant economic impact on a substantial number of small entities. We are imposing no new requirements on small entities.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), P.L. 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local, and tribal governments, in the aggregate, or to the private sector, of $100 million or more in any one year.

Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost-effective, or least burdensome alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted.

Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed under section 203 of the UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements.

As this final rule generally incorporates the December 31, 2002 final rules into appendix S, we believe these rule changes will actually reduce the regulatory burden associated with the major NSR program by improving the operational flexibility of owners or operators and clarifying the requirements. Additionally, States are not required to revise their SIPs with respect to appendix S. The EPA will act as the reviewing authority where the State lacks authority to issue permits that meet the conditions of appendix S. Thus, this final rule is not subject to the requirements of sections 202 and 205 of the UMRA.

Because we have not required any new Federal mandates, EPA has also determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments.

Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.”

This final rule does not have federalism implications. Nevertheless, as described in section III.B of this preamble, in developing this rule, we consulted with affected parties and interested stakeholders, including State and local authorities, to enable them to provide timely input in the development of this rule. The rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. The revisions to appendix S do not have substantial direct effects on State and local agencies because State and local agencies are not required to revise their programs with respect to appendix S. The EPA will act as the reviewing authority where the State lacks authority to issue permits that meet the conditions of appendix S. Moreover, this revision provides sources permitted by States under appendix S greater certainty in application of the program, which should in turn reduce the overall burden of the program on State and local authorities. Thus, Executive Order 13132 does not apply to this final rule.

Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” This final rule does not have tribal implications, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply.

The purpose of this final rule, like that for the December 31, 2002 rules, is to add greater flexibility to the existing major NSR regulations. These changes have been incorporated into appendix S. Appendix S affects sources located in Indian country but has no direct effect on Indian tribes. Although major stationary sources affected by this final rule could be located in or near Indian country and/or be owned or operated by tribal governments, such sources would not incur additional costs or compliance burdens as a result of this rule. Instead, the only effect on such sources should be the benefit of the added certainty and flexibility provided by the rule.

Although Executive Order 13175 does not apply to this rule, EPA afforded Tribal officials the opportunity to comment on the December 31, 2002 final rules, which were developed largely prior to issuance of Executive Order 13175. Two tribes submitted comments on that action. We recognize the importance of including tribal consultation as part of the rulemaking process. We will continue to consult with tribes on future rulemaking to assess and address tribal implications, and will work with tribes interested in seeking TIP approval to implement the NSR program to ensure consistency of tribal plans with this rule.

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

This final rule is not subject to the Executive Order because it is not economically significant as defined in Executive Order 12866 and because the Agency does not have reason to believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. Based on our Supplemental Analysis, we believe that the December 31, 2002 rules that have been incorporated into this final action will result in equal or better environmental protection than provided by the prior regulations, and do so in a more streamlined and effective manner.

This rule is not a “significant energy action” as defined in Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355; May 22, 2001), because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. This final rule improves the ability of sources to undertake pollution prevention or energy efficiency projects, switch to less polluting fuels or raw materials, maintain the reliability of production facilities, and effectively utilize and improve existing capacity. The rule also includes a number of provisions to streamline administrative and permitting processes so that facilities can quickly accommodate changes in supply and demand. The regulations provide several alternatives that are specifically designed to reduce administrative burden for sources that use pollution prevention or energy efficient projects.

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), P.L. 104-113, 12(d) (15 U.S.C. 272 note), directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g. , materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.

Although this rule does involve the use of technical standards, it does not preclude the State, local, and tribal reviewing agencies from using voluntary consensus standards. This final rule is an improvement of the existing NSR permitting program. As such, it only ensures that promulgated technical standards are considered and appropriate controls are installed, prior to the construction of major sources of air emissions. Therefore, EPA did not consider the use of any voluntary consensus standards.

Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994), establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.

The EPA has determined that this final rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations. Based on our Supplemental Analysis, we believe that the December 31, 2002 rules that have been incorporated into this final action will result in equal or better environmental protection than provided by the prior regulations, and do so in a more streamlined and effective manner.

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This action will be effective May 7, 2007.

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by May 7, 2007. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review, nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See CAA section 307(b)(2).

Pursuant to section 307(d)(1)(U) of the CAA, the Administrator determines that this action is subject to the provisions of section 307(d). Section 307(d)(1)(U) provides that the provisions of section 307(d) apply to “such other actions as the Administrator may determine.” This action finalizes elements of previous proposed actions that were determined to be subject to section 307(d)—the NSR rules published on December 31, 2002 (67 FR at 80244). Therefore, the procedural requirements of section 307(d) have been complied with for purposes of this action.

The statutory authority for this action is provided by sections 101, 112, 114, 116, and 301 of the Act as amended (42 U.S.C. 7401, 7412, 7414, 7416, and 7601). This rulemaking is also subject to section 307(d) of the Act (42 U.S.C. 7407(d)).

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This section provides additional information by addressing the following questions:

EPA is making a revision to the SIP for the purpose of approving the IDNR's actions to address the requirements of the Clean Air Act (CAA) section 110(a)(2)(D)(i). This CAA section requires each state to submit a SIP that prohibits emissions that could adversely affect another state. The SIP must prevent sources in the state from emitting pollutants in amounts which will: (1) Contribute significantly to nonattainment of the NAAQS, (2) interfere with maintenance of the NAAQS in another state, (3) interfere with provisions to prevent significant deterioration of air quality, and (4) interfere with efforts to protect visibility.

EPA issued guidance on August 15, 2006, relating to SIP submissions to meet the requirements of section 110(a)(2)(D)(i). As discussed below, Iowa's analysis of its SIP with respect to the statutory requirements is consistent with the guidance.

The IDNR has addressed the first two of these elements by the adoption of the Clean Air Interstate Rule (CAIR) model rules that require Iowa sources to participate in the EPA-administered cap and trade program for nitrogen oxides (NO X ) and sulfur dioxide. Participation in this program will prohibit emissions from the state that will contribute significantly to nonattainment or interfere with the maintenance of the NAAQS in any downwind state. As previously determined by EPA, submittal of a SIP revision to satisfy CAIR also fulfills the state's obligations that pertain to “significant contribution” and “interference with maintenance” (70 FR 25162). It should be noted that EPA will act on Iowa's CAIR SIP in a separate rulemaking, and this action makes no conclusion with respect to approvability of that submittal.

The third element IDNR addressed was prevention of significant deterioration (PSD). For 8-hour ozone, the state has met the obligation by confirming that major sources in the state are currently subject to PSD programs that implement the 8-hour ozone standard and that the state is on track to meet the June 15, 2007, deadline for SIP submissions adopting any relevant requirements of the Phase II ozone implementation rule. For PM 2.5 , the state has confirmed that the state's PSD program is being implemented in accordance with EPA's interim guidance calling for the use of PM 10 as a surrogate for PM 2.5 for the purposes of PSD review. Controlling PM 10 emissions and analyzing impacts on the environment serves as a surrogate approach for reducing PM 2.5 emissions and minimizing impacts to air quality. Once PM 2.5 guidance is finalized by EPA, IDNR commits to transitioning from use of the interim PM 2.5 guidance to the final PM 2.5 implementation guidance after approval of the PM 2.5 SIP revision (The submittal is due in April 2008).

It should be noted that Iowa is currently designated attainment/unclassifiable for both the 8-hour ozone and PM 2.5 NAAQS.

At this time, it is not possible for IDNR to accurately determine whether there is interference with measures in another state's SIP designed to protect visibility, which is the fourth element that was addressed. Technical projects relating to visibility degradation source-receptor relationships are under development. Iowa will be in a more advantageous position to address the visibility projection requirements once the initial regional haze SIP has been developed. IDNR intends to meet the December 17, 2007, submittal deadline for the regional haze SIP.

A public hearing with regard to this action was held by the state. No comments were received.

With this action, the non-regulatory text in 40 CFR 52.820(e) is revised to reflect that IDNR addressed the elements of the CAA section 110(a)(2)(D)(i) submittal.

EPA is approving this revision submitted by Iowa and is revising 40 CFR 52.820 to reflect that the IDNR has adequately addressed the required elements of the CAA section 110(a)(2)(D)(i) SIP. Please note that if EPA receives adverse comments on part of this rule, and if that part can be severed from the remainder of the rule, EPA may adopt as final those parts of the rule that are not the subject of an adverse comment.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this action will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because this action approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

This action also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the CAA. This action also is not subject to Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it approves a state rule implementing a Federal standard.

In reviewing state submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. In this context, in the absence of a prior existing requirement for the state to use voluntary consensus standards (VCS), EPA has no authority to disapprove a state submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a state submission, to use VCS in place of a state submission that otherwise satisfies the provisions of the CAA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by May 7, 2007. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

The Federal Emergency Management Agency (FEMA) makes the final determinations listed below of the modified BFEs for each community listed. These modified BFEs have been published in newspapers of local circulation and ninety (90) days have elapsed since that publication. The Mitigation Division Director of FEMA resolved any appeals resulting from this notification.

The modified BFEs are not listed for each community in this notice. However, this final rule includes the address of the Chief Executive Officer of the community where the modified BFEs determinations are available for inspection.

The modified BFEs are made pursuant to section 206 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq. , and with 44 CFR part 65.

For rating purposes, the currently effective community number is shown and must be used for all new policies and renewals.

The modified BFEs are the basis for the floodplain management measures that the community is required to either adopt or to show evidence of being already in effect in order to qualify or to remain qualified for participation in the National Flood Insurance Program (NFIP).

These modified BFEs, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own, or pursuant to policies established by other Federal, State, or regional entities.

These modified BFEs are used to meet the floodplain management requirements of the NFIP and are also used to calculate the appropriate flood insurance premium rates for new buildings built after these elevations are made final, and for the contents in these buildings. The changes in BFEs are in accordance with 44 CFR 65.4.

National Environmental Policy Act. This final rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. An environmental impact assessment has not been prepared.

Regulatory Flexibility Act. As flood elevation determinations are not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-612, a regulatory flexibility analysis is not required.

Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 13132, Federalism. This final rule involves no policies that have federalism implications under Executive Order 13132, Federalism.

Executive Order 12988, Civil Justice Reform. This final rule meets the applicable standards of Executive Order 12988.

The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the modified BFEs for each community listed. These modified elevations have been published in newspapers of local circulation and ninety (90) days have elapsed since that publication. The Mitigation Division Director of FEMA has resolved any appeals resulting from this notification.

This final rule is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.

Interested lessees and owners of real property are encouraged to review the proof Flood Insurance Study and FIRM available at the address cited below for each community.

The BFEs and modified BFEs are made final in the communities listed below. Elevations at selected locations in each community are shown.

National Environmental Policy Act. This final rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. An environmental impact assessment has not been prepared.

Regulatory Flexibility Act. As flood elevation determinations are not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-612, a regulatory flexibility analysis is not required.

Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 13132, Federalism. This final rule involves no policies that have federalism implications under Executive Order 13132.

Executive Order 12988, Civil Justice Reform. This final rule meets the applicable standards of Executive Order 12988.

The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the modified BFEs for each community listed. These modified elevations have been published in newspapers of local circulation and ninety (90) days have elapsed since that publication. The Mitigation Division Director of FEMA has resolved any appeals resulting from this notification.

This final rule is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.

Interested lessees and owners of real property are encouraged to review the proof Flood Insurance Study and FIRM available at the address cited below for each community. The BFEs and modified BFEs are made final in the communities listed below. Elevations at selected locations in each community are shown.

National Environmental Policy Act. This final rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. An environmental impact assessment has not been prepared.

Regulatory Flexibility Act. As flood elevation determinations are not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-612, a regulatory flexibility analysis is not required.

Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 13132, Federalism. This final rule involves no policies that have federalism implications under Executive Order 13132.

Executive Order 12988, Civil Justice Reform. This final rule meets the applicable standards of Executive Order 12988.

The Debt Collection Act of 1982 (DCA), Public Law No. 97-365, was implemented on a government-wide basis by the FCCS, set forth at 4 CFR part 101 et seq. , issued by Justice and the General Accounting Office on March 9, 1984. See 49 FR 8889 (1984). HHS implemented the FCCS at 45 CFR part 30. As mandated by the DCIA, Justice and Treasury jointly promulgated the revised FCCS at 31 CFR parts 900-904 to reflect the legislative changes to the Federal debt collection procedures enacted by the DCIA. The revised FCCS superseded the current FCCS, and removed the Comptroller General as promulgator of the FCCS. HHS is required to implement regulations, consistent with the DCIA and the regulations promulgated by Justice and Treasury. The following changes to the Department's current debt collection regulation are incorporated in the proposed regulation to reflect the DCIA and the implementing final rule:

1. Demand Letter. One demand should be sufficient. It will include the applicable standards for imposing any interest, penalties, or administrative costs; use of collection agencies, Federal salary offset, tax refund offset, administrative offset, and litigation; any rights the debtor may have to seek review of the Department's determination of the debt and to enter into a reasonable repayment agreement; and information regarding the Department's remedies to enforce payment of the debt.

2. Mutual Releases. HHS and debtors will exchange mutual releases of non-tax liabilities, in all appropriate instances, when a claim is compromised.

3. Increase in Amounts. The principal claim amount that HHS is authorized to compromise or to suspend or terminate collection activity thereon, without concurrence by Justice, is increased from $20,000 to $100,000. In addition, the minimum amount of a claim that may be referred to Justice for litigation is increased from $600 to $2,500.

4. Transferring or Referring Delinquent Debt. There are new debt collection procedures for transferring or referring delinquent debt to Treasury or a Treasury-designated debt collection center for collection.

5. Centralized Administrative Offset. There are new debt collection procedures for mandatory, centralized administrative offset by disbursing officials.

6. Mandatory Credit Bureau Reporting. There are new debt collection procedures for mandatory credit bureau reporting.

7. Prohibition Against Federal Financial Assistance. There are new debt collection procedures prohibiting Federal financial assistance in the form of loans, loan guarantees, or loan insurance to debtors, unless waived by the Secretary. Disaster loans are exempt from this prohibition.

8. Army Hold-up List. The use of the Army hold-up list to report indebted contractors to the Department of the Army has been discontinued.

Additionally, we note that the current HHS claims collection regulations at 45 CFR 30.13(d) provided: “[u]nless specifically authorized by statute, regulation or written agreement, or unless the debts arise from, or involve, fraud or criminal activity, the Secretary will not charge interest on debts arising from payments to beneficiaries under Titles II, XVI, and XVIII of the Social Security Act.” This rule will not change this Departmental practice. For debts arising from payments to beneficiaries under Titles XVI and XVIII of the Social Security Act (Title II is now administered by the Social Security Administration), the Secretary will not assess interest unless specifically required to do so by statute, regulation or written agreement, or unless the debts arise from, or involve, fraud or criminal activity.

To the extent any provision of this rule is inconsistent with a more specific provision ( e.g. , certain provisions in 45 CFR parts 31, 32, and 33 and 42 CFR parts 401 and 405), the more specific provision shall apply.

In accordance with the requirements of the DCIA and the implementing regulations promulgated by Justice and Treasury at 31 CFR parts 900-904, this final rule establishes the procedures for the administrative collection, offset, compromise, suspension and termination of collection activity for civil claims for money, funds, or property, as defined by 31 U.S.C. 3701(b), and the process by which HHS can refer civil claims to Treasury, Treasury-designated debt collection centers, or Justice for collection by further administrative action or litigation, as applicable. The rule does not apply to claims between Federal agencies. The rule affects HHS's debtors. This rule revises the current Department regulation in accordance with the substantive and procedural requirements of the DCIA and the implementing final rule.

We received the following comments on the proposed rule.

Comment: One commenter asserted that the mandatory demand letter statements required by § 30.11 of the proposed rule potentially conflicted with validation disclosures of § 809 of the Fair Debt Collection Practices Act (FDCPA) that private collection contractors are required to deliver in their initial demand letters.

Response: We do not agree that the requirements of § 30.11 of the final rule conflict with the FDCPA and have made no changes to the final rule based on this comment. Section 30.11(b)(1) provides a listing of the information that must be included in a demand letter. The specific clauses that concerned the commenter are found in § 30.11(b)(2) which provides the listing of the information which should be included in a demand letter, including the statements of fact that: (1) A debtor delinquent on a debt is ineligible for Government loans, loan guarantees, or loan insurance until the debtor resolves the debt; (2) when seeking to collect statutory penalties, forfeiture or other similar types of claims, the debtor's licenses, permits, or other privileges may be suspended or revoked if failure to pay the debt is inexcusable or willful; and (3) knowingly making false statements or bringing frivolous actions may subject the debtor to civil or criminal penalties under 31 U.S.C. 3729-3731, 18 U.S.C. 286, 287, 1001, and 1002, or any other applicable statutory authority, and, if the debtor is a Federal employee, to disciplinary action under 5 CFR part 752 or other applicable authority.

Comment: One commenter noted that in the Medicare Secondary Payer (MSP) context, the Centers for Medicare & Medicaid Services (CMS) currently utilizes two demand letters and requested either the section 30.11(b) statement, “[g]enerally one demand letter should suffice * * *” be deleted or recognize that in the MSP context two demand letters are generally appropriate.

Response: We are making no changes to the final rule based on this comment. Under the FCCS, agencies are permitted to use more than one demand letter to meet the requirements at 31 CFR 901.2. Therefore, there is no need to change the current language of § 30.11(b) to accommodate the use of more than one demand letter.

Comment: One commenter stated that in the MSP context, initial demand letters and intent to refer letters are not often directed to the appropriate, responsible party. As a result, the entity bearing responsibility for the debt may not have an opportunity to respond prior to the referral of the debt to Treasury for collection. The commenter recommended HHS:

(1) Amend proposed § 30.11(a)(2) to state that demand letters “shall be sent by first class mail to the debtor's last known address, as confirmed through reasonable efforts”;

(2) Add a new sentence stating that if a letter is returned as undeliverable, the Secretary shall take reasonable steps to determine the appropriate address of the alleged debtor and send a second letter; and

(3) Add a new provision stating that the Secretary shall provide alleged debtors (generally employers, insurers or third party administrators) with the opportunity to designate a central agent (at a specific location) to receive MSP demand letters.

Response: We are making no changes to the final rule based on this comment. As to the first two suggestions, CMS uses the most recent address information in its system specific to a particular debt. As to the third suggestion, the final rule would not prohibit an employer, insurer, or third party administrator from reaching an agreement with CMS on a designated agent for the receipt of MSP demand letters to the extent that CMS systems can handle the request and the specific debtor information can be appropriately matched. Employers, insurers, and third party administrators should have internal procedures which ensure correct internal routing of such letters if the letter is received at any address of the entity.

Comment: In another comment relating to MSP debts, a commenter urged HHS to amend proposed § 30.11(b)(1) to state that the written demand for payment “shall include sufficient information to allow the recipient to identify the specific debt involved.” The commenter noted in the MSP context, sufficient information includes: beneficiary name, HIC number, basis for Medicare eligibility, policy number, services included in the claim, dates of service, provider type, amount due, and member name/company.

Response: We are making no changes to the final rule based on this comment. The current CMS process is adequate because most of the information listed is already included in the demand letter package. The demand package contains sufficient information to allow the recipient to identify the specific debt involved. The intent to refer letter package includes the initial demand letter (including attachments) when it is issued. However, the content of the initial demand letter is dependent on the debtor responding to CMS's requests, if any, for additional information. Finally, CMS has no control over what information Treasury includes in its first letter to the debtor and the information Treasury instructs the private collection agency to include in its collection letter.

Comment: One commenter requested HHS to modify proposed § 30.11 to add new text (modeled directly on the FCCS at 31 CFR 901.2(e)) that reads “the Secretary should respond promptly to communications from debtors, within 30 days whenever feasible, and should advise debtors who dispute debts to furnish available evidence to support their contentions.”

Response: We have made this change requested by the commenter and have added a new 30.11(f) providing: Communications from debtors. The Secretary should respond promptly to communications from debtor, within 30 days where feasible, and should advise debtors who dispute debts to furnish available evidence to support their contentions.

Comment: One commenter noted that § 30.11(b)(1)(ii) would require that demand letters state “[t]he date by which payment should be made to avoid late charges and enforced collection, which generally shall be no later than 30 days from the date the demand letter is mailed.” The commenter sought confirmation that the proposed regulation will not (1) Require CMS to shorten the period allowed by the MSP statute for entities to respond to demands for payment before the imposition of interest or (2) prohibit the Secretary from exercising discretion to waive interest, where appropriate.

Response: We are making no changes to the final rule based on this comment. We confirm that the regulation does not require CMS to shorten the period allowed by the MSP statute for MSP debtors to respond to demands for payment before the imposition of interest, or prohibit the Secretary from exercising discretion to waive interest, where appropriate (see § 30.18(g), Waiver). Proposed § 30.11(b)(1)(ii) is not intended to alter any existing CMS policies and procedures on when entities must respond to demands for payment to avoid interest in the MSP context (currently, 60 days), nor is it intended to limit the Secretary from waiving interest where appropriate and where consistent with government-wide and agency-specific debt collection standards. The language in proposed 30.11(b)(1)(ii) states payment “should” be made “generally” no later than 30 days to avoid late charges and enforced collection. Based on this language, CMS may exercise discretion in extending the time frame for entities to respond for specific types of debt such as MSP debts.

Comment: Proposed § 30.10(c)(1) states that “[t]he Secretary shall transfer debts 180 days or more delinquent to the Treasury in accordance with the requirements of 31 CFR 285.12.” A commenter requested that the regulation be amended, consistent with the Treasury regulations, to make clear that debt is not required to be transferred to Treasury unless and until a final agency determination has been made. Accordingly, the commenter requested that HHS amend section 30.10 to read: “(c) The Secretary shall transfer debts 180 days or more delinquent to Treasury, where appropriate, in accordance with the requirements of 31 CFR 285.12 when there is a final agency determination that the debt, in the amount stated, is due and there are no legal bars to collection action.” The commenter believed that premature referral of debt would not only violate the terms of the Treasury regulation, but also undermine efficient administration of debt collection since alleged MSP debtors, whom the commenter incorrectly asserted do not receive final agency determinations prior to referral, generally seek reconsideration at the Treasury level. The commenter contended that this adds an unnecessary level of complication to the debt collection process and typically results in claims being sent back to CMS for further review and verification of the validity of the debt.

Response: We are making no changes to the final rule based on this comment. It is implicit in the regulatory language that, before transfer to Treasury, there will have been a final agency determination that the debt, in the amount stated, is due.

Comment: One commenter urged HHS to modify the proposed regulation to clearly state the specific process with which CMS must comply before transferring MSP debt to Treasury for administrative offset and/or other cross-servicing. The commenter believed that the proposed regulations do not include all of the criteria set forth in the Treasury regulations as prerequisites to transfer, and recommended that HHS amend proposed § 30.12(b)(2) to state: “When referring delinquent debt to the Secretary of the Treasury for centralized administrative offset or other debt collection activity, the appropriate agency official must certify, in written form acceptable to the Secretary of the Treasury, that (i) The debt is valid, past due and legally enforceable; and (ii) the Department has complied with all due process requirements under 31 U.S.C. 3716(a) and paragraph (c)(2) of this section and all prerequisites to a particular collection action under the laws, regulations or policies applicable to the agency (unless the Secretary of the Treasury has agreed to comply with such requirements on the Department's behalf).”

Response: We are making three changes to the final rule based on this comment. First, we are changing the definition of “Legally enforceable” in § 30.2 to add on to the end “(for example, the debt is not the subject of a pending administrative review required by statute or regulation and collection action during the review process is prohibited.)” Second, we are adding “legally enforceable” before the word “debts” in 30.10(c)(1). While we believe the requirement that the debt not be transferred, under mandatory transfer, if it is the subject of a pending administrative review required by statute or regulation and collection action during the review process is prohibited was clear, as previously drafted, since this is a requirement of 31 CFR 285.12(c)(3)(i) and 30.10(c)(1) specified that transfers to Treasury would be made in accordance with the requirements of 31 CFR 285.12, the regulation is more complete with this clarification. Related to the part of the comment that 30.10(c)(2) did not include all of the criteria set forth in the Treasury regulations as prerequisites to transfer, we are also amending 30.10(c)(2) to include “in accordance with the requirements of 31 CFR 285.12.” Therefore, the requirements of Treasury's regulations are clearly included.

Comment: One commenter suggested that the Claims Collection regulations be amended to state that the Secretary may, where appropriate, in the MSP debt context, explore the use of alternative dispute resolution to resolve disputed debt.

Response: We are making no changes to the final rule based on this comment because we believe that CMS's current regulations and processes provide adequate opportunity for the debtor to dispute a debt.

Comment: One commenter recommended that HHS define the term “valid debt” under § 30.2 to mean debt where the government has a reasonable expectation of being able to prove the existence of the debt in court, based on the legal issues and the facts.

Response: We are making no changes to the Final Rule based on this comment. We do not agree that it is necessary to define “valid debt.”

Comment: One commenter noted the proposed Claims Collection regulations state that the term “legally enforceable” means “there has been a final agency determination that the debt, in the amount stated, is due and there are no legal bars to collection action.” Proposed § 30.2, Definitions. The commenter requested HHS amend the proposed regulations to expressly state that, when an alleged debtor has disputed a debt, the appropriate agency official may not refer the debt to Treasury unless and until a written determination explaining the basis for the decision has been issued (and a copy provided to the alleged debtor) concerning the validity of the alleged debt.

Response: We are making no changes to the final rule based on this comment. First, in response to a previously discussed comment, we are changing the definition of “Legally enforceable” in § 30.2 to add on to the end “(for example, the debt is not the subject of a pending administrative review required by statute or regulation and collection action during the review process is prohibited.)” Also, a final determination that a debt, in the amount stated, is due and there are no legal bars to collection action does not require issuing a formal written determination, separate from and in addition to the demand letter, explaining the basis for such decision. Also, the regulations provide, in the definition of a debt (§ 30.2, Definitions) that an appropriate official of the Federal Government determined an amount of funds or other property is owed to the Government. Such a determination, therefore, is needed before a demand letter would be sent and before the debt would be referred to Treasury for collection.

Comment: One commenter noted that proposed section 30.12(b) states that when referring delinquent debts to the Secretary of Treasury for centralized administrative offset, the Department must certify that the Department has complied with all due process requirements under 31 U.S.C. 3716(a) and § 30.12(c)(2) of the proposed rule. 31 U.S.C. 3716(a)(3) states that the head of an administrative agency may collect by offset only after, among other things, giving the debtor “an opportunity for a review within the agency of the decision of the agency related to the claim.” The commenter noted that the proposed HHS regulations state that where review is required, the Secretary must afford the alleged debtor an oral or paper hearing. See Proposed § 30.12(e). The commenter supported this provision of the regulation, but noted the need for clarification regarding the specific due process rights that will be afforded to employers/unions and health plans/insurers disputing alleged MSP debt. The commenter noted that CMS has published proposed Medicare claims appeal regulations which expressly allow beneficiaries and providers/suppliers to appeal Medicare contractor determinations that they owe the government monies under the MSP statute, but has not provided any specific due process appeal rights to employers/unions or health plans/insurers in similar circumstances. See 67 FR 69311, 69317-20 (Nov. 15, 2003). The commenter asserted that, as a matter of law, employers/unions and health plans/insurers are entitled to independent review of an alleged MSP debt determination by a Medicare contractor prior to referral of the debt to Treasury for offset. The commenter strongly urged HHS to identify the specific due process rights to be afforded such entities challenging the existence of MSP debt, particularly the nature of any associated appeal rights. The commenter noted that the FCCS encourages agencies to use “all authorized remedies, including alternative dispute resolution,” for claims collection, 31 CFR 900.1(c), and requested HHS to amend the Claims Collection regulation to state that the Secretary may, in appropriate circumstances, explore the use of alternative dispute resolution mechanisms to resolve disputed debt. While the commenter does not request that CMS be required to use such alternative dispute resolution mechanisms, the commenter believes CMS should be granted the flexibility through regulation to develop creative and cost-effective ways of resolving disputed claims short of transfer to Treasury (and without incurring the significant costs associated with use of private collection agencies).

Response: We are making no changes to the final rule based on this comment. We believe that current CMS procedures provide adequate opportunity for the non-beneficiary or non-provider/supplier MSP debtor ( e.g. , employers/unions or health plans/insurers) to dispute a debt. Employers, insurers, third party administrators, plans, or other plan sponsors that are issued a demand letter are provided adequate notice of the debt and an opportunity to rebut the debt prior to CMS referring the MSP debt to Treasury.

Comment: One commenter stated that it is aware of numerous situations in which offset of a claim occurred after CMS had determined that monies were not in fact due with respect to the particular claim. Accordingly, the commenter recommended HHS amend the Claims Collection regulations to include the following language adapted from 31 CFR 285.12 of the Treasury regulations: “Once a debt is referred to Treasury, the Secretary must promptly notify Treasury of any change in the status of the debt, including any decision that the debt is not in fact owed.”

Response: We are making no changes to the final rule based on this comment. As noted by the commenter, Treasury's current regulations already provide for notification to Treasury of changes in the status of the legal enforceability of a debt. Since 30.10(c) states that the transfer of debts be in accordance with 31 CFR 285.12, and 31 CFR 285.12(i) includes this notification of status requirement, it is unnecessary to restate that requirement here.

Comment: One commenter noted that proposed § 30.18 requires the Department to assess administrative costs incurred for processing and handling delinquent debts and, “[u]nless otherwise established by contract, repayment agreement, or statute,” to impose a penalty of six percent a year on the amount due on a debt that is delinquent for more than 90 days. The commenter asserted that the mandatory imposition of administrative costs and penalties is not appropriate for MSP debt since the interest and penalty provision of the Debt Collection Improvement Act, 31 U.S.C. 3717, does not (with limited exceptions not here relevant) apply to “a claim or debt under, or an amount payable under * * * the Social Security Act,” 31 U.S.C. 3701(d). Accordingly, commenter requested that HHS amend § 30.18 to incorporate language from the current HHS Claims Collection regulations which states: “[t]he Secretary will charge administrative costs or late payment penalties on debts arising under the Social Security Act where authorized by statute, regulations, or written agreement.” See 45 CFR 30.13(d)(2).

Response: We are making no changes to the final rule based on this comment. The proposed regulation did not change the current CMS process for assessing administrative fees. As to comments on MSP debts not being subject to the interest and penalties provisions of the DCIA, the MSP provisions of the Medicare statute (section 1862(b) of the Social Security Act) and implementing regulations (42 CFR 411.24(m)) provide CMS separate, independent authority for assessing interest on delinquent MSP debts.

Comment: One commenter noted that proposed § 30.24(b) states “[t]he Secretary will ensure that a compromise agreement with one debtor does not release the Department's claim against the remaining debtors.” The commenter requested that given the unique nature of MSP claims, HHS delete or modify the text of the proposed regulation to expressly authorize the Secretary to release all potential debtors, where appropriate with respect to a particular debt. The commenter expressed a belief that historically, MSP settlements with the government have released claims against all potential debtors. The commenter urged HHS to amend the regulations to allow the Secretary to retain the flexibility to execute similar agreements in the future. The commenter believed that such comprehensive settlements are particularly appropriate in the MSP context where it is not cost-effective to adjudicate claims twice and health plans/insurers will have significantly less incentive to enter into MSP settlement agreements if potential claims against their group health plan customers are not released.

Response: The proposed regulation is intended to govern situations where agency (in this case, CMS) regulations are silent or fail to govern a specific debt situation. The proposed language in § 30.24(b) would not prohibit the Secretary from executing a compromise of selected debts where an insurer is negotiating on its own behalf and on behalf of others as authorized. However, HHS will insert the word “automatically” before the word “release” to make clear that some action could take place which would release all parties.

Comment: A commenter requested that HHS amend proposed § 30.11(b)(2)(vi) to provide that “[a]ny amounts collected and ultimately found not to have been owed by the debtor will be refunded promptly.” The commenter explained the proposed modification is fair and appropriate where monies are not in fact due. In addition, the commenter requested that HHS modify the proposed regulation to require individual agencies, including CMS, to establish clearly publicized processes for debtors to request reimbursement of disputed amounts that were paid in order to avoid the imposition of interest or were taken by offset and specific timelines for prompt adjudication of the amounts in dispute.

Response: We are making no changes to the final rule based on this comment. Applicable statutes and regulations do not mandate that the above quoted language be included in demand letters, nor do they mandate a specific time frame or published process for debtors to request reimbursement of disputed amounts or for refunding amounts previously collected. HHS will revisit this suggestion if it is problematic in practice.

Comment: One commenter stated that, when a debt is contested at the Treasury/private collection agency level, Treasury will often seek input from CMS concerning the validity of the underlying debt. The commenter submitted that when this occurs, it is appropriate for Treasury to suspend all collection efforts, including offset. Accordingly, the commenter requested that HHS add a provision to the regulation authorizing suspension of all collection activities by Treasury or a private collection agency when Treasury seeks guidance from HHS regarding the validity of a particular debt in dispute.

Response: We are making no changes to the final rule based on this comment. This comment addresses current Treasury procedures and is outside the scope of the Claims Collection regulations.

Comment: One commenter supported HHS's proposed modifications of the regulations which would authorize HHS to compromise, suspend or terminate collection activity on a debt under $100,000 in principal amount without the concurrence of Justice. See Proposed §§ 30.21 and 30.28. The commenter also supports amendments set forth in proposed § 30.36 which raise the minimum amount of debt necessary for referral for litigation.

Response: No response to this comment is necessary.

Comment: One commenter supported proposed § 30.22(a)(3)(i) which authorizes the Secretary to compromise a debt where the cost of collecting the debt does not justify the enforced collection of the full amount, but requested that the regulation be amended to state that “[t]he amount accepted in compromise of such cases may reflect an appropriate discount for the administrative and litigation costs of collection, with consideration given to the time it will take to effect collection and the age of the delinquent debt.” Likewise, the commenter requested that proposed § 30.19 be amended to direct that the age of delinquent debt be considered in developing data on costs and corresponding recovery rates to be used (among other things) in establishing guidelines with respect to points at which costs of further collection efforts are likely to exceed recoveries. The commenter believed the age of alleged MSP debt directly affects the demand letter processing and collection costs for both the government and the alleged debtors and should be expressly considered in establishing collection guidelines. The commenter requested that HHS amend the Claims Collection regulation to expressly recognize that it is appropriate for agencies to (1) Take the age of a debt into account when determining what documentation must be provided by the alleged debtor to mount a defense, and (2) exercise flexibility in determining whether additional collection efforts are appropriate or justified concerning old debt.

Response: We are making no changes to the final rule based on this comment. We do not agree that it is necessary or appropriate to specifically require consideration of the age of the delinquent debt as a factor in pursuing or compromising a debt.

Comment: There were several comments related to the rule's impact on state collection activities when states seek to collect debts due under a program authorized under the Social Security Act for which Federal funds were provided ( i.e. , Temporary Assistance to Needy Families (TANF), State Children's Health Insurance Program (SCHIP) and Medicaid). Certain commenters explained the difficulties and increased burdens on states in following the proposed rule. For example, one commenter offered that the particular state would need to change its computer system and the current way it did business. Other commenters explained the benefits of interpreting the rule to allow TANF debts to be collected pursuant to the rule and strongly recommended the rule be interpreted to include state debts and authorize states to submit TANF debts to the Treasury Offset Program.

Response: We are making no changes to the final rule based on these comments, but draw the commenters' attention to several points. In the TANF program, there is no direct Federal share in recipient overpayments because TANF is a block grant program. Therefore, these regulations would not affect state collection activities with respect to recipient families. In addition, states are not subject to the FCCS when seeking to collect state overpayments made to providers in the Medicaid and SCHIP programs. Because we do not believe that this regulation imposes any new requirement related to state collection activities in the referenced Social Security Act programs that are related to overpayments or other debts to or on behalf of individual recipients, we do not find any burden on states related to such collection activities.

Comment: One commenter recommended that many mandates in the regulation be made permissive ( i.e. , changing “shall” to “may” in certain places in the regulation text) so as not to mandate certain state action.

Response: We are making no changes to the final rule based on this comment because, as explained in the response to the previous comments (directly above), the HHS regulation does not place these mandates on states.

Comment: One commenter asked whether states administering TANF, SCHIP or Medicaid should refer cases to the HHS Office of the Inspector General.

Response: The proposed rule was not intended to change the current way states refer to law enforcement entities claims that are suspected to involve fraud, false information, or misrepresentation on the part of the debtor. States should continue to refer such claims to the appropriate governmental entity pursuant to applicable Federal and State laws and agency guidance.

We have also changed § 30.18(b)(2), regarding the percentage of interest to be charged on debts. The NPRM requirement that the Department document in writing the reasons for charging a higher rate was omitted and the following language was added: “Any such higher rate of interest charged will be based on Treasury's quarterly rate certification to the U.S. Public Health Service for delinquencies in the National Research Services Awards and the National Health Services Corps Scholarship Program. The Department publishes this rate in the Federal Register quarterly.”

We have analyzed this final rule in accordance with the principles set forth in Executive Order (EO) 13132 (Federalism). We have 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, we have concluded that the rule does not contain policies that have federalism implications as defined in the EO and, consequently, a federalism summary impact statement is not required.

For purposes of the Paperwork Reduction Act, 44 U.S.C. chapter 35, this proposed rule will impose no new reporting or recordkeeping requirements on any member of the public.

We have examined the impact of this rule as required by EO 12866 (Regulatory Planning and Review), the Regulatory Flexibility Act (RFA) (September 19, 1980; Pub. L. No. 96-354); the Unfunded Mandates Reform Act of 1995 (UMRA, Pub. L. No. 104-4); and the Truth in Regulating Act of 2000 (5 U.S.C. 801 note). EO 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize the benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in 1 year). We have determined that the rule is consistent with the principles set forth in EO 12866, and we find that the rule would not have an effect on the economy that exceeds $100 million in any one year. In addition, this rule is not a major rule as defined at 5 U.S.C. 804(2). In accordance with the provisions of the EO 12866, the rule was reviewed by the Office of Management and Budget.

Under the RFA, 5 U.S.C. 605(b), if a rule has a significant impact on a substantial number of small entities, an agency must analyze regulatory options that would minimize any significant impact of the rule on small entities. The agency has considered the effect that this rule would have on small entities. I hereby certify, under 5 U.S.C. 605(b), that the rule will not have a significant economic impact on a substantial number of small entities, including small businesses, small organizations and small local governments. Therefore, a regulatory flexibility analysis is not required by 5 U.S.C. 603. Section 202 of the UMRA also requires that agencies assess anticipated costs and benefits before issuing any rule that may result in expenditure in any one year by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million. As noted above, we find that the rule would not have an effect of this magnitude on the economy. Therefore, no further analysis is required under the UMRA.

EO 12866 and the President's memorandum of June 1, 1998, require all rules to be written in plain language. We believe we have done so.

Current HHS regulations at 45 CFR part 30 provide standards and procedures for the collection and disposition of debts owed the United States, including collection by administrative offset. Standards and procedures for collection of debts from the current pay of federal employees by involuntary salary offset had been included in the administrative offset provisions of part 30. Those regulations, which this final rule replaces, are based on the Debt Collection Act of 1982 (DCA), Public Law No. 97-365, and were implemented on a government-wide basis by the Federal Claims Collection Standards (FCCS), set forth at 4 CFR part 101, issued by the Department of Justice and General Accounting Office on March 9, 1984 (49 FR 8889 (1984)), and the salary offset regulations set forth at 5 CFR part 550, subpart K, issued by the Office of Personnel Management on July 3, 1984 (49 FR 27472). The current HHS rules are in the process of being amended to comply with the Debt Collection Improvement Act of 1996 (DCIA), Public Law No. 104-134, as implemented by the Department of Treasury and the Department of Justice at 31 CFR 900-904. Since there are specific rules that apply to salary offset that go beyond those applicable to administrative offset generally, and because salary offset has a separate statutory basis, the Department takes this opportunity to segregate the salary offset provisions and provide separate guidance to specifically address the standards and procedures applicable to salary offset.

This rule prescribes the Department's standards and procedures for the collection of debts owed by Federal employees to the United States through involuntary salary offset, including changes made by the DCIA. Briefly, such changes provide for centralized computer matching through the Department of Treasury, an exclusion from the prior notice and hearing requirements for certain pay adjustments, and a priority for Federal tax levies. This regulation is inapplicable to U.S. Public Health Service Commissioned Corps officers and retirees, as, pursuant to 37 U.S.C. 1001, the U.S. Public Health Service Commissioned Corps follows regulations relating to active duty and retired pay and allowances, including the collection of indebtedness, set forth in the Department of Defense Financial Management Regulation, DOD 7000.14-R.

This rule was published as a proposed rule on July 13, 2004 (69 FR 42022) and provided for a 60-day comment period ending on September 13, 2004. We received no comments concerning the proposed rule and are finalizing the rule as proposed with only minor clarifying changes to § 33.10. In § 33.10(b), we clarify that the employee can agree in writing to a greater deduction, as outlined in § 33.8. In § 33.10(c)(2), we inserted the word “deemed” in front of “financially unable to pay.”

For purposes of the Paperwork Reduction Act, 44 U.S.C. chapter 35, this rule will impose no new reporting or recordkeeping requirements on any member of the public.

We have examined the impact of this rule as required by Executive Order (EO) 12866 (September 1993, Regulatory Planning and Review), as amended by EO 13258 (February 2002, Amending EO 12866 on Regulatory Planning and Review), the Regulatory Flexibility Act (RFA) (September 19, 1980; Pub. L. No. 96-354); the Unfunded Mandated Reform Act of 1995 (UMRA, Pub. L. No. 104-4); and EO 13132 (August 1999, Federalism). EO 12866, as amended by EO 13258, directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize the benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis must be prepared for major rules with economically significant effects ($100 million or more in 1 year). We have determined that the rule is consistent with the principals set forth in the EO, and we find that the rule would not have an effect on the economy that exceeds $100 million in any one year. In addition, this rule is not a major rule as defined at 5 U.S.C. 804(2). In accordance with the provisions of the EO, the rule has been reviewed by the Office of Management and Budget.

Under the RFA, 5 U.S.C. 605(b), if a rule has a significant impact on a substantial number of small entities, an agency must analyze regulatory options that would minimize any significant impact of the rule on small entities and determined it will not have any effect. This rule only affects Federal employees. The agency has considered the effect that this rule would have on small entities. I hereby certify, under 5 U.S.C 605(b), that the rule will not have a significant economic impact on a substantial number of small entities, including small businesses, small organizations and small local governments. Therefore, a regulatory flexibility analysis is not required by 5 U.S.C. 603. Section 202 of the UMRA also requires that agencies assess anticipated costs and benefits before issuing any rule that may result in expenditure in any one year by State, local, or tribunal governments, in the aggregate, or by the private sector, of $100 million. As noted above, we find that the rule would not have an effect of this magnitude on the economy. Therefore, no further analysis is required under the UMRA. EO 13132 establishes certain requirements that an agency must meet when it promulgates a final rule that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has federalism implications. We have reviewed the rule under the threshold criteria of EO 13132 and have determined that this proposed rule would not have substantial direct impact on States, or on the distribution of power and responsibilities among the various levels of government. As there are no federalism implications, a federalism impact statement is not required.

Title 5 CFR part 550, subpart K, provides the standards to be used by Federal agencies to prepare regulations implementing 5 U.S.C. 5514. There is little room for us to consider alternatives, but where the Department has discretion (i.e., in § 33.1, specifying that the regulations cover Government-wide collections and in § 33.6, specifying that if the petition for hearing is untimely, the Secretary may grant the request if the employee can establish that the delay was the result of circumstances beyond the employee's control, or that the employee failed to receive actual notice of the filing deadline), we drafted the rule to maximize the Department's debt collection ability and make the process fair as possible to debtors.

These regulations were submitted to the Office of Personnel Management for review prior to publication of this final rule, as required by 5 CFR part 550, subpart K.