Rules and Regulations. Notice of proposed rulemaking (NPRM)

Agency: Federal Aviation Administration (FAA), Department of Transportation (DOT)
Action: Notice of proposed rulemaking (NPRM)
Citation: 72 FR (No. 225) · FR Doc. 07-5833 · RIN 2120-AA64 · Docket No. FAA-2007-0223; Directorate Identifier 2007-NM-156-AD · 14 CFR 39

Summary

The FAA proposes to supersede an existing airworthiness directive (AD) that applies to certain Boeing Model 727 series airplanes. The existing AD currently requires repetitive inspections to detect cracks and loose brackets of the elevator rear spar, and corrective actions if necessary. The existing AD also provides for an optional terminating action for the repetitive inspections. This proposed AD would reduce the repetitive intervals of the inspections, mandate the previously optional terminating action for the repetitive inspections, and no longer allow stop-drilling. This proposed AD results from new reports of cracks, elongated fastener holes, and loose fittings of the elevator rear spar. We are proposing this AD to prevent cracking of the elevator rear spar at the tab hinge locations, which could cause excessive freeplay of the elevator control tab and possible tab flutter, and consequent loss of control of the airplane.

Dates

We must receive comments on this proposed AD by January 7, 2008.

Supplementary Information

Comments Invited We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2007-0223; Directorate Identifier 2007-NM-156-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD because of those comments. We will post all comments we receive, without change, to http://www.regulations.gov , including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD. Discussion On March 12, 1996, we issued AD 96-06-05, amendment 39-9542 (61 FR 11529, March 21, 1996), for certain Boeing Model 727 series airplanes. That AD requires repetitive inspections to detect cracks and loose brackets of the elevator rear spar and repair if necessary, and provides an optional terminating modification for the inspections. That AD was prompted by reports of cracking in the spar radii at the tab hinge location of the elevator rear spar. We issued that AD to prevent cracking in elements of the elevator rear spar assembly, which could result in excessive freeplay of the elevator control tab and possible tab flutter. Actions Since Existing AD Was Issued Since we issued AD 96-06-05, we have received reports of additional cracks, elongated fastener holes, and loose fittings on airplanes on which the repetitive detailed inspections required by that AD have been initiated. We have determined that the existing long-term repetitive detailed inspections do not provide an acceptable level of safety. This determination, along with a better understanding of the human factors associated with numerous continual inspections, has led us to consider placing less emphasis on inspections and more emphasis on design improvements. Therefore, we have determined that it is necessary to reduce the repetitive intervals of certain inspections and to require replacement of the elevator rear spar with a new elevator rear spar and new support fittings to adequately address the identified unsafe condition of this proposed AD. In addition, we have determined that the stop-drilling required by AD 96-06-05 does not provide an adequate level of safety. Therefore, in this proposed AD, stop-drilling of cracks of the elevator rear spar assembly is no longer considered to be an acceptable method of repair. Relevant Service Information We have reviewed Boeing Service Bulletin 727-55-0089, Revision 1, dated March 2, 2000. (We referred to the original release of the service bulletin in AD 96-06-05 as the appropriate source of service information for the required actions.) The repetitive detailed inspections, stop-drill if necessary, and optional terminating action (i.e., replacement of the elevator rear spar with a new elevator rear spar and support fittings) are identical to those actions specified in the original service bulletin. Revision 1 changes the part accountability paragraph and the list of airplane operators. No more work is necessary on airplanes changed per the original release of the service information, if the optional terminating action was done. Accomplishing the actions specified in the service information is intended to adequately address the unsafe condition. FAA's Determination and Requirements of the Proposed AD We have evaluated all pertinent information and identified an unsafe condition that is likely to develop on other airplanes of the same type design. For this reason, we are proposing this AD, which would supersede AD 96-06-05 and would retain the requirements of the existing AD. This proposed AD would also require accomplishing the actions specified in service information described previously, except as discussed under “Differences Between the Proposed AD and Service Information.” Differences Between the Proposed AD and Service Information Paragraph 1.A, “Effectivity,” of Boeing Service Bulletin 727-55-0089, Revision 1, contains an error in that it identifies only Model 727-100 and -200 series airplanes as the affected airplanes. Although Model 727, 727C, 727-100C, and 727-200F series airplanes were inadvertently omitted from that paragraph, those airplanes were identified by variable numbers in the effectivity listing. Therefore, the applicability of this proposed AD would affect Model 727, 727C, 727-100, 727-100C, 727-200, and 727-200F series airplanes. As discussed previously, this proposed AD would require replacement of the elevator rear spar with a new elevator rear spar and support fittings, which would terminate the repetitive inspection requirements. The service information provides the terminating action as an option. Where the service information describes stop-drilling as an interim method of repair, this proposed AD would not permit stop-drilling as an interim method of repair. As discussed previously, we have determined that, for the purposes of this proposed AD, stop-drilling does not provide an adequate level of safety. Additionally, the service information recommends that certain repetitive inspection intervals be done within 1,600 flight hours or within 18 months, whichever occurs first. This proposed AD would require a repetitive interval not to exceed 1,600 flight hours for those inspections. Calendar time (i.e., “18 months”) is not appropriate for addressing problems associated with fatigue such as the cracking addressed by this proposed AD. The determination that calendar time is not appropriate for addressing problems associated with fatigue also was addressed in the preamble of AD 96-06-05. We have coordinated these differences with Boeing. Change to Existing AD This proposed AD would retain all requirements of AD 96-06-05. Since AD 96-06-05 was issued, the AD format has been revised, and certain paragraphs have been rearranged. As a result, the corresponding paragraph identifiers have changed in this proposed AD, as listed in the following table: Revised Paragraph Identifiers Requirement in AD 96-06-05 Corresponding requirement in this proposed AD paragraph (a) paragraph (f). paragraph (b) paragraph (g). paragraph (c) paragraph (h). paragraph (d) paragraph (i). paragraph (e) paragraph (j). paragraph (f) paragraph (k). paragraph (g) paragraph (l). We have revised the applicability of the existing AD to identify model designations as published in the most recent type certificate data sheet for the affected models. In addition, we have revised the applicability of the existing AD to refer to the latest service bulletin (i.e., Boeing Service Bulletin 727-55-0089, Revision 1), and refer to affected models not identified in the referenced service bulletin, as discussed previously. We have changed all references to a “visual inspection” in AD 96-06-05 to “detailed inspection” in this proposed AD. We also added a new note defining that inspection and renumbered subsequent notes. Costs of Compliance There are about 815 airplanes of the affected design in the worldwide fleet. The following table provides the estimated costs for U.S. operators to comply with this proposed AD. Estimated Costs Action Work hours Average labor rate per hour Parts Cost per airplane Number of U.S.-registered airplanes Fleet cost Detailed Inspection (required by AD 96-06-05) 17 $80 None $1,360, per inspection cycle 448 $609,280, per inspection cycle. Terminating action (new proposed action) 416 80 $14,975 $48,255 448 $21,618,240. Authority for This Rulemaking 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. Regulatory Findings We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify that the proposed regulation: 1. Is not a “significant regulatory action” under Executive Order 12866; 2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and 3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Safety. The Proposed Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The Federal Aviation Administration (FAA) amends § 39.13 by removing amendment 39-9542 (61 FR 11529, March 21, 1996) and adding the following new airworthiness directive (AD): Boeing: Docket No. FAA-2007-0223; Directorate Identifier 2007-NM-156-AD. Comments Due Date (a) The FAA must receive comments on this AD action by January 7, 2008. Affected ADs (b) This AD supersedes AD 96-06-05. Applicability (c) This AD applies to Boeing Model 727, 727C, 727-100, 727-100C, 727-200, and 727-200F series airplanes, certificated in any category, as identified in Boeing Service Bulletin 727-55-0089, Revision 1, dated March 2, 2000. Unsafe Condition (d) This AD results from new reports of cracks, elongated fastener holes, and loose fittings of the elevator rear spar. We are issuing this AD to prevent cracking of the elevator rear spar at the tab hinge locations, which could cause excessive freeplay of the elevator control tab and possible tab flutter, and consequent loss of control of the airplane. Compliance (e) You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done. Requirements of AD 96-06-05 Repetitive Inspections and Follow-On Actions (f) For airplanes on which the modification or repair described in Boeing Service Bulletin 727-55-0085, dated August 31, 1984 (specified as terminating action in AD 84-22-02, amendment 39-4951), has not been accomplished and the repetitive inspections required by AD 84-22-02 have not been initiated: Prior to the accumulation of 8,000 total flight hours since date of manufacture, or within 300 flight hours after April 22, 1996 (the effective date of AD 96-06-05), whichever occurs later, perform a detailed inspection to detect cracks and loose hinge brackets of the elevator rear spar in the area along the upper and lower edges at the shear plate, in accordance with Boeing Service Bulletin 727-55-0089, dated June 29, 1995. Then accomplish the follow-on actions (i.e., repetitive inspections, stop-drilling, modification) in accordance with that service bulletin, at the times specified as follows: Note 1: For the purposes of this AD, a detailed inspection is: “An intensive examination of a specific item, installation, or assembly to detect damage, failure, or irregularity. Available lighting is normally supplemented with a direct source of good lighting at an intensity deemed appropriate. Inspection aids such as mirror, magnifying lenses, etc., may be necessary. Surface cleaning and elaborate procedures may be required.” Note 2: AD 84-22-02 pertains to the one-piece elevator rear spar. (1) Repeat the detailed inspection thereafter at intervals not to exceed 1,600 flight hours. (2) If any crack is detected and stop-drilled as a result of any inspection required by this paragraph, accomplish the requirements of paragraph (l) of this AD, except as provided by paragraph (o) of this AD, at the times specified in paragraph (l) of this AD. Repetitive Inspections and Follow-On Actions (g) For airplanes on which the modification or repair described in Boeing Service Bulletin 727-55-0085, dated August 31, 1984 (specified as terminating action in AD 84-22-02), has not been accomplished and the repetitive inspections required by AD 84-22-02 have been initiated: Accomplish either paragraph (g)(1) or (g)(2) of this AD, as applicable. (1) If no crack has been detected as a result of inspections required by AD 84-22-02: Within 1,600 flight hours after the last inspection required by that AD, perform a detailed inspection to detect cracks and loose brackets of the elevator rear spar in the area along the upper and lower edges at the shear plate, in accordance with the Boeing Service Bulletin 727-55-0089, dated June 29, 1995. Accomplish follow-on actions (i.e., repetitive inspection, stop-drilling, modification) in accordance with that service bulletin, except as provided by paragraph (o) of this AD, at the times specified as follows: (i) Repeat the detailed inspection thereafter at intervals not to exceed 1,600 flight hours. (ii) If any crack is detected and stop-drilled as a result of any inspection required by this paragraph, accomplish the requirements of paragraph (l) of this AD, except as provided by paragraph (o) of this AD, at the times specified in paragraph (l) of this AD. (2) If any crack has been stop-drilled in accordance with AD 84-22-02, accomplish the requirements of paragraph (l) of this AD, except as provided by paragraph (o) of this AD, at the times specified in paragraph (l) of this AD. (h) For airplanes on which the modification or repair described in Boeing Service Bulletin 727-55-0085, dated August 31, 1984 (specified as terminating action in AD 84-22-02, amendment 39-4951), has been accomplished: Within 4,000 flight hours after April 22, 1996, perform a detailed inspection to detect cracks and loose hinge brackets of the elevator rear spar in the area along the upper and lower edges at the shear plate, in accordance with Boeing Service Bulletin 727-55-0089, dated June 29, 1995. Accomplish follow-on actions (i.e., repetitive inspections, stop-drilling, modification) in accordance with that service bulletin, except as provided by paragraph (o) of this AD, at the times specified as follows: (1) Repeat the detailed inspection thereafter at intervals not to exceed 4,000 flight hours, except as provided by paragraph (n) of this AD. (2) If any crack is detected and stop-drilled as a result of any inspection required by this paragraph, accomplish the requirements of paragraph (l) of this AD, except as provided by paragraph (o) of this AD, at the times specified in paragraph (l) of this AD. (i) For airplanes on which the modification or repair described in Boeing Service Bulletin 727-55-087, dated June 20, 1986 (specified as terminating action in AD 87-24-03, amendment 39-5769), has not been accomplished and the repetitive inspections required by AD 87-24-03 have not been initiated: Accomplish the requirements of paragraph (i)(1) of this AD at the earliest of the times specified in paragraph (i)(2) of this AD. Note 3: AD 87-24-03 pertains to the two-piece elevator rear spar. (1) Perform a detailed inspection to detect cracks and loose hinge brackets of the elevator rear spar in the area along the upper and lower edges at the shear plate, at the earliest of the times specified in paragraph (i)(2) of this AD, and in accordance with Boeing Service Bulletin 727-55-0089, dated June 29, 1995. Accomplish follow-on actions (i.e., repetitive inspection, stop-drilling, modification) in accordance with that service bulletin, at the times specified as follows: (i) Repeat the detailed inspection thereafter at intervals not to exceed 4,000 flight hours, except as provided by paragraph (n) of this AD. (ii) If any crack is detected and stop-drilled as a result of any inspection required by this paragraph, accomplish the requirements of paragraph (l) of this AD, except as provided by paragraph (o) of this AD, at the times specified in paragraph (l) of this AD. (2) Accomplish the initial detailed inspection required by paragraph (i)(1) of this AD at the earliest of the following times: (i) Prior to the accumulation of 27,000 total flight hours since date of manufacture, or within 4,000 flight hours after December 24, 1987 (the effective date of AD 87-24-03), whichever occurs later; or (ii) Prior to the accumulation of 12,000 total flight hours since date of manufacture, or within 4,000 flight hours after April 22, 1996, whichever occurs later; or (iii) Prior to the accumulation of 27,300 total flight hours since date of manufacture, or within 300 flight hours after April 22, 1996, whichever occurs later. (j) For airplanes on which the modification or repair described in Boeing Service Bulletin 727-55-087, dated June 20, 1986 (specified as terminating action in AD 87-24-03), has not been accomplished and the repetitive inspections required by AD 87-24-03 have been initiated: Accomplish either paragraph (j)(1) or (j)(2) of this AD, as applicable. (1) If no crack has been detected as a result of inspections required by AD 87-24-03: Within 4,000 flight hours after the last inspection required by that AD, perform a detailed inspection to detect cracks and loose brackets of the elevator rear spar in the area along the upper and lower edges at the shear plate, in accordance with Boeing Service Bulletin 727-55-0089, dated June 29, 1995, except as provided by paragraph (m) of this AD. Accomplish follow-on actions (i.e., repetitive inspection, stop-drilling, modification) in accordance with that service bulletin, except as provided by paragraph (o) of this AD, at the times specified as follows: (i) Repeat the detailed inspection thereafter at intervals not to exceed 4,000 flight hours, except as provided by paragraph (n) of this AD. (ii) If any crack is detected and stop-drilled as a result of any inspection required by paragraph (j)(1) of this AD, accomplish the requirements of paragraph (l) of this AD, except as provided by paragraph (o) of this AD, at the times specified in paragraph (l) of this AD. (2) If any crack has been detected and stop-drilled in accordance with AD 87-24-03, accomplish the requirements of paragraph (l) of this AD, except as provided by paragraph (o) of this AD, at the times specified in paragraph (l) of this AD. (k) For airplanes on which the modification or repair described in Boeing Service Bulletin 727-55-087, dated June 20, 1986 (specified as terminating action in AD 87-24-03), has been accomplished: Within 4,000 flight hours after April 22, 1996, perform a detailed inspection to detect cracks and loose hinge brackets of the elevator rear spar in the area along the upper and lower edges at the shear plate, in accordance with Boeing Service Bulletin 727-55-0089, dated June 29, 1995. Accomplish follow-on actions (i.e., repetitive inspection, stop-drilling, modification) in accordance with the service bulletin, except as provided by paragraph (o) of this AD, at the times specified as follows: (1) Repeat the detailed inspection thereafter at intervals not to exceed 4,000 flight hours, except as provided by paragraph (n) of this AD. (2) If any crack is detected and stop-drilled as a result of any inspection required by this paragraph, accomplish the requirements of paragraph (l) of this AD, except as provided by paragraph (o) of this AD, at the times specified in that paragraph. (l) If any crack is detected and stop-drilled in accordance with paragraph (f)(2), (g)(1)(ii), (g)(2), (h)(2), (i)(1)(ii), (j)(1)(ii), (j)(2), or (k)(2) of this AD, accomplish the following, except as provided by paragraphs (o) and (p) of this AD: (1) Within 1,600 flight hours after stop-drilling, perform a detailed inspection to detect cracks and loose hinge brackets of the elevator rear spar in the area along the upper and lower edges at the shear plate, and accomplish follow-on actions (i.e., stop-drilling, modification) in accordance with the service bulletin. If any crack growth is detected after stop-drilling, prior to further flight, modify the elevator rear spar in accordance with Part II of the Accomplishment Instructions of Boeing Service Bulletin 727-55-0089, dated June 29, 1995. Accomplishment of this modification constitutes terminating action for the repetitive inspection requirements of this AD. (2) Within 3,200 flight hours after stop-drilling, modify the elevator rear spar in accordance with Part II of the Accomplishment Instructions of Boeing Service Bulletin 727-55-0089, dated June 29, 1995. Accomplishment of this modification constitutes terminating action for the repetitive inspection requirements of this AD. New Actions Required by This AD New Service Information (m) As of the effective date of this AD, use only the Accomplishment Instructions of Boeing Service Bulletin 727-55-0089, Revision 1, dated March 2, 2000, to do the repetitive detailed inspections required by this AD. Certain Repetitive Inspections at Reduced Intervals (n) For airplanes being inspected at intervals not to exceed 4,000 flight hours in accordance with paragraphs (h)(1), (i)(1)(i), (j)(1)(i), and (k)(1) of this AD: As of the effective date of this AD, do those inspections within 1,600 flight hours since the last detailed inspection or 6 months after the effective date of this AD, whichever occurs later, and thereafter at intervals not to exceed 1,600 flight hours. Stop-Drilling Prohibited (o) As of the effective date of this AD, stop-drilling required by paragraphs (f) through (l) inclusive of this AD is prohibited. Replacement of Cracked Rear Spars/Loose Brackets (p) As of the effective date of this AD, if any cracked rear spar or loose bracket is detected during any inspection required by this AD, before further flight, do the replacement specified in paragraph (q) of this AD. Terminating Replacement (q) Within 18 months after the effective date of this AD, replace the elevator rear spar with a new elevator rear spar and support fittings, in accordance with Part II of the Accomplishment Instructions of Boeing Service Bulletin 727-55-0089, Revision 1, dated March 2, 2000. Accomplishing the replacement constitutes terminating action for the requirements of this AD. (r) Accomplishing the replacement before the effective date of this AD in accordance with Boeing Service Bulletin 727-55-0089, dated June 29, 1995, is considered acceptable for compliance with the corresponding action specified in paragraph (q) of this AD. Alternative Methods of Compliance (AMOCs) (s)(1) The Manager, Seattle Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19. (2) To request a different method of compliance or a different compliance time for this AD, follow the procedures in 14 CFR 39.19. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector (PI) in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO. (3) An AMOC that provides an acceptable level of safety may be used for any repair required by this AD, if it is approved by an Authorized Representative for the Boeing Commercial Airplanes Delegation Option Authorization Organization who has been authorized by the Manager, Seattle ACO, to make those findings. For a repair method to be approved, the repair must meet the certification basis of the airplane, and the approval must specifically refer to this AD. (4) AMOCs approved previously in accordance with AD 96-06-05 are approved as AMOCs for the corresponding provisions of this AD. Issued in Renton, Washington, on November 7, 2007. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E7-22814 Filed 11-21-07; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 300 [REG-134923-07] RIN 1545-BG88 User Fees Relating to Enrollment To Perform Actuarial Services; Hearing AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Cancellation of notice of public hearing on proposed rulemaking. SUMMARY: This document cancels a public hearing on proposed regulations relating to user fees for the initial and renewed enrollment to become an enrolled actuary. DATES: The public hearing, originally scheduled for November 26, 2007, at 10 a.m., is cancelled. FOR FURTHER INFORMATION CONTACT: Richard A. Hurst of the Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel (Procedure and Administration), at Richard.A.Hurst@irscounsel.treas.gov. SUPPLEMENTARY INFORMATION: A notice of public hearing that appeared in the Federal Register on Wednesday, October 31, 2007 (72 FR 61583), announced that a public hearing was scheduled for November 26, 2007, at 10 a.m., in room 3716, Internal Revenue Building, 1111 Constitution Avenue, NW., Washington, DC. The subject of the public hearing is under sections 7 and 8 of the Internal Revenue Code. The public comment period for these regulations expires on November 30, 2007. The notice of proposed rulemaking and notice of public hearing instructed those interested in testifying at the public hearing to submit a request to speak and an outline of the topics to be addressed. As of Tuesday, November 20, 2007, no one has requested to speak. Therefore, the public hearing scheduled for November 26, 2007, is cancelled. LaNita Van Dyke, Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel (Procedure and Administration). [FR Doc. E7-22893 Filed 11-21-07; 8:45 am] BILLING CODE 4830-01-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 81 [EPA-R09-2007-OAR-1109; FRL-8498-7] Determination of Nonattainment and Reclassification of the Imperial County Nonattainment Area: 8-Hour Ozone AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: EPA is proposing to find that the Imperial County marginal 8-hour ozone nonattainment area has failed to attain the 8-hour ozone national ambient air quality standard (NAAQS or standard) by June 15, 2007, the attainment deadline set forth in the Clean Air Act (CAA) and Code of Federal Regulations (CFR) for marginal nonattainment areas. If EPA finalizes this finding, the Imperial County area will be reclassified, by operation of law, as a moderate 8-hour ozone nonattainment area. The moderate area attainment date for the Imperial County area would then be as expeditiously as practicable but no later than June 15, 2010. Once reclassified, California must submit State Implementation Plan (SIP) revisions that meet the 8-hour ozone nonattainment requirements for moderate areas as required by the CAA. In this action, EPA is also proposing the schedule for the State's submittal of the SIP revisions required for moderate areas once the area is reclassified. DATES: Comments must be received on or before December 24, 2007. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-2007-OAR-1109 by one of the following methods: 1. www.regulations.gov: Follow the on-line instructions for submitting comments. 2. E-mail: priselac.adrienne@epa.gov. 3. Fax: 415-947-3579. 4. Mail or deliver: Adrienne Priselac (AIR-2), U.S. Environmental Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA 94105-3901. Instructions: All comments will be included in the public docket without change and may be made available online at www.regulations.gov , including any personal information provided, unless the comment includes Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Information that you consider CBI or otherwise protected should be clearly identified as such and should not be submitted through the www.regulations.gov or e-mail. www.regulations.gov is an anonymous access system, and EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send e-mail directly to EPA, your e-mail address will be automatically captured and included as part of the public comment. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Docket: The index to the docket for this action is available electronically at www.regulations.gov and in hard copy at EPA Region IX, 75 Hawthorne Street, San Francisco, California. While all documents in the docket are listed in the index, some information may be publicly available only at the hard copy location (e.g., copyrighted material), and some may not be publicly available in either location (e.g., CBI). To inspect the hard copy materials, please schedule an appointment during normal business hours with the contact listed directly below. FOR FURTHER INFORMATION CONTACT: Adrienne Priselac, EPA Region IX, (415) 972-3285, priselac.adrienne@epa.gov . SUPPLEMENTARY INFORMATION: Throughout this document “we,” “us,” and “our” refer to EPA. Table of Contents I. What is the background for this proposed action? A. What are the National Ambient Air Quality Standards? B. What is the standard for 8-hour ozone? C. What is a SIP and how does it relate to the NAAQS for 8-hour ozone? D. What is the Imperial County nonattainment area, and what is its current 8-hour ozone nonattainment classification? E. What are the CAA provisions regarding determinations of nonattainment and reclassifications? II. What is EPA's evaluation of the Imperial County area's 8-hour ozone data? III. What action is EPA proposing? A. Determination of Nonattainment, Reclassification of Imperial County Nonattainment Area and New Attainment Date B. Proposed Date for Submitting a Revised SIP for the Imperial County Area IV. Proposed Action V. Statutory and Executive Order Reviews I. What is the background for this proposed action? A. What are the National Ambient Air Quality Standards? The CAA requires EPA to establish a NAAQS for pollutants that “may reasonably be anticipated to endanger public health and welfare” and to develop a primary and secondary standard for each NAAQS. The primary standard is designed to protect human health with an adequate margin of safety and the secondary standard is designed to protect public welfare and the environment. EPA has set NAAQS for six common air pollutants referred to as criteria pollutants: Carbon monoxide, lead, nitrogen dioxide, ozone, particulate matter, and sulfur dioxide. These standards present state and local governments with the air quality levels they must meet to comply with the CAA. Also, these standards allow the American people to assess whether or not the air quality in their communities is healthful. B. What is the standard for 8-hour ozone? On July 18, 1997, EPA promulgated a revised 8-hour ozone standard of 0.08 parts per million (ppm). This new standard is more stringent than the previous 1-hour ozone standard. Under EPA regulations at 40 CFR part 50, the 8-hour ozone standard is attained when the 3-year average of the annual fourth highest daily maximum 8-hour average ambient air quality ozone concentrations is less than or equal to 0.08 ppm (i.e., 0.084 ppm when rounding is considered). (See 69 FR 23857 (April 30, 2004) for further information). Ambient air quality monitoring data for the 3-year period must meet a data completeness requirement. The ambient air quality monitoring data completeness requirement is met when the average percent of days with valid ambient monitoring data is greater than 90 percent, and no single year has less than 75 percent data completeness as determined in Appendix I of part 50. Specifically, section 2.3 of 40 CFR part 50, Appendix I, “Comparisons with the Primary and Secondary Ozone Standards” states: “The primary and secondary ozone ambient air quality standards are met at an ambient air quality monitoring site when the 3-year average of the annual fourth-highest daily maximum 8-hour average ozone concentration is less than or equal to 0.08 ppm. The number of significant figures in the level of the standard dictates the rounding convention for comparing the computed 3-year average annual fourth-highest daily maximum 8-hour average ozone concentration with the level of the standard. The third decimal place of the computed value is rounded, with values equal to or greater than 5 rounding up. Thus, a computed 3-year average ozone concentration of 0.085 ppm is the smallest value that is greater than 0.08 ppm.” The value of 0.085 ppm can also be expressed as 85 parts per billion (ppb). C. What is a SIP and how does it relate to the NAAQS for 8-hour ozone? Section 110 of the CAA requires states to develop air pollution regulations and control strategies to ensure that state air quality meets the NAAQS established by EPA. Each state must submit these regulations and control strategies to EPA for approval and incorporation into the Federally-enforceable SIP. Each Federally-approved SIP protects air quality primarily by addressing air pollution at its point of origin. These SIPs can be extensive. They may contain state regulations or other enforceable documents and supporting information such as emission inventories, monitoring networks, and modeling demonstrations. D. What is the Imperial County nonattainment area, and what is its current 8-hour ozone nonattainment classification? The Imperial County 8-hour ozone nonattainment area is located in the southeastern corner of California. It has borders with Mexico to the south, Arizona to the east, San Diego County to the west, and the Coachella Valley to the north. The local jurisdiction that is responsible for air pollution control is the Imperial County Air Pollution Control District (ICAPCD). For areas subject to Subpart 2 of the CAA, such as the Imperial County nonattainment area, the maximum period for attainment runs from the effective date of designations and classifications for the 8-hour ozone NAAQS (69 FR 23858, April 30, 2004) and will be the same periods as provided in Table 1 of CAA Section 181(a): Marginal—3 years; Moderate—6 years; Serious—9 years, Severe—15 or 17 years; and Extreme—20 years (40 CFR 51.903(a)). The effective date of designations and classifications for the 8-hour ozone NAAQS was June 15, 2004 (69 FR 23951, April 30, 2004). The Imperial County area was designated nonattainment for the 8-hour ozone standard on April 30, 2004, and classified “marginal” based on a 2001-2003 design value of 91 (ppb) with a maximum attainment date of June 15, 2007 (69 FR 23858). The design value of an area, which characterizes the severity of the air quality concern, is represented by the annual fourth-highest daily maximum 8-hour average ozone concentration measured at each monitor averaged over any three-year period. E. What are the CAA provisions regarding determinations of nonattainment and reclassifications? Section 181(b)(2) prescribes the process for making determinations upon failure of an ozone nonattainment area to attain by its attainment date, and for reclassification of an ozone nonattainment area. Section 181(b)(2)(A) of the Act requires that we determine, based on the area's design value (as of the attainment date), whether the area attained the ozone standard by that date. For marginal, moderate, and serious areas, if EPA finds that the nonattainment area has failed to attain the ozone standard by the applicable attainment date, the area is reclassified by operation of law to the higher of (1) the next higher classification for the area, or (2) the classification applicable to the area's design value as determined at the time of the required Federal Register notice. Section 181(b)(2)(B) requires EPA to publish in the Federal Register a notice identifying any area that has failed to attain by its attainment date and the resulting reclassification. II. What is EPA's evaluation of the Imperial County area's 8-hour ozone data? We make attainment determinations for ozone nonattainment areas using available quality-assured air quality data. Within the Imperial County area, ground-level ozone is measured at 6 monitors throughout the County. In recent years, the El Centro and Westmorland monitors have measured some of the highest 8-hour average ozone concentrations in the Imperial County area. For example, the fourth-highest daily maximum readings for 2004, 2005, and 2006 at the El Centro monitor were 79, 86, and 91 ppb, respectively. The fourth-highest daily maximum readings for 2004, 2005, and 2006 at the Westmorland monitor were 79, 90, and 86 ppb, respectively. For the Imperial County ozone nonattainment area, the attainment determination is based on 2004-2006 air quality data. The area has a 2004-2006 design value of 85 ppb. Therefore, pursuant to section 181(b)(2) of the CAA, we find that the Imperial County area did not attain the 8-hour ozone NAAQS by the June 15, 2007, deadline for marginal areas. Table 1.—Imperial County Area Fourth Highest 8-Hour Ozone Concentrations and Design Values (ppb) 1 Site 4th highest daily max 2004 2005 2006 Design value 3 year average (2004-2006) Calexico-Grant (06-025-0004) 63 80 65 69 Calexico-Ethel (06-025-0005) 72 82 68 74 Calexico-East (06-025-0006) 74 77 78 76 El Centro (06-025-1003) 79 86 91 85 Westmorland (06-025-4003) 79 90 86 85 Niland (06-025-4004) 75 72 72 73 1 Unlike the 1-hour ozone standard, design value calculations for the 8-hour ozone standard are based on a rolling three-year average of the annual 4th highest values (40 CFR Part 50, Appendix I). Under Sections 172(a)(2)(C) and 181(a)(5) of the CAA, an area can qualify for up to two one-year extensions of its attainment date based on the number of exceedances in the attainment year and if the State has complied with all requirements and commitments pertaining to the area in the applicable implementation plan. For the 8-hour ozone standard, if an area's 4th highest daily 8-hour ozone average in the attainment year is 84 ppb or less (40 CFR 51.907), the area is eligible for the first of up to two one-year attainment date extensions. The attainment year is the year immediately preceding the nonattainment area's attainment date. For Imperial County the attainment year is 2006. In 2006, the area's 4th highest daily 8-hour ozone average value was 91 ppb. Based on this information, the Imperial County area currently does not qualify for a one-year extension of the attainment date. Section 181(b)(2)(A) of the Act provides that, when we find that an area failed to attain by the applicable date, the area is reclassified by operation of law to the higher of (1) the next higher classification or (2) the classification applicable to the area's ozone design value at the time of the required notice under Section 181(b)(2)(B). Section 181(b)(2)(B) requires EPA to publish a notice in the Federal Register identifying the reclassification status of an area that has failed to attain the standard by its attainment date. The classification that would be applicable to the Imperial County area's ozone design value at the time of today's notice is “marginal” since the area's 2006 calculated design value, based on quality-assured ozone monitoring data from 2004-2006, is 85 ppb. By contrast, the next higher classification for the Imperial County area is “moderate.” Because “moderate” is a higher nonattainment classification than “marginal” under the statutory scheme, upon the effective date of a final rulemaking, the Imperial County area would be reclassified by operation of law as “moderate,” for failing to attain the standard by the marginal area applicable attainment date of June 15, 2007. III. What action is EPA proposing? A. Determination of Nonattainment, Reclassification of Imperial County Nonattainment Area and New Attainment Date Pursuant to section 181(b)(2), EPA is proposing to find that the Imperial County area has failed to attain the 8-hour ozone NAAQS by the June 15, 2007, attainment deadline prescribed under the CAA for marginal ozone nonattainment areas. If EPA finalizes this finding and it takes effect, the Imperial County area will be reclassified by operation of law from marginal nonattainment to moderate nonattainment. Moderate areas are required to attain the standard “as expeditiously as practicable,” but no later than 6 years after designation, or June 15, 2010. The “as expeditiously as practicable” attainment date will be determined as part of the action on the required SIP submittal demonstrating attainment of the 8-hour ozone standard. EPA is proposing a schedule by which California will submit the SIP revisions necessary for the proposed reclassification to moderate nonattainment of the 8-hour ozone standard. B. Proposed Date for Submitting a Revised SIP for the Imperial County Area EPA must address the schedule by which California is required to submit a revised SIP. When an area is reclassified, we have the authority under section 182(i) of the Act to adjust the Act's submittal deadlines for any new SIP revisions that are required as a result of the reclassification. Pursuant to 40 CFR 51.908(d), for each nonattainment area, a state must provide for implementation of all control measures needed for attainment no later than the beginning of the “attainment year ozone season.” The “attainment year ozone season” is defined as the ozone season immediately preceding a nonattainment area's attainment date (40 CFR 51.900(g)). The “ozone season” in a given year for an ozone nonattainment area is defined as the ozone monitoring season shown for the state in 40 CFR Part 58, Appendix D, section 4.1, Table D-3 (40 CFR 51.900(n) and 71 FR 61236, October 17, 2006). The ozone monitoring season for all of California, including Imperial County, is the full calendar year, from January through December. A moderate 8-hour ozone nonattainment area must attain the ozone NAAQS as expeditiously as practicable, but no later than June 15, 2010 (40 CFR 51.903). As such, the attainment year ozone season for Imperial County is the ozone season in calendar year 2009, which begins on January 1. EPA therefore proposes to require a revised SIP submittal for the Imperial County moderate nonattainment area as expeditiously as practicable, but no later than December 31, 2008. A revised SIP must include the following moderate area requirements: (1) An attainment demonstration (40 CFR 51.908), (2) provisions for reasonably available control technology and reasonably available control measures (40 CFR 51.912), (3) reasonable further progress reductions in emissions (40 CFR 51.910), (4) contingency measures to be implemented in the event of failure to meet a milestone or attain the standard (CAA 172(c)(9)), and (5) NO ^X and VOC emission offsets of 1.15 to 1 for major source permits (40 CFR 51.165(a)). See also the requirements for moderate ozone nonattainment areas set forth in CAA section 182(b). 1 1 A vehicle inspection and maintenance (I/M) program would normally be listed as a requirement for an ozone moderate or above nonattainment area. However, the Federal I/M Flexibility Amendments of 1995 determined that urbanized areas with populations less than 200,000 for 1990 are not mandated to participate in the I/M program (60 FR 48027, September 18, 1995). IV. Proposed Action Pursuant to CAA section 181(b)(2), EPA is proposing to find that the Imperial County marginal 8-hour ozone area has failed to attain the 8-hour ozone NAAQS by June 15, 2007. If EPA finalizes its proposal, the area will by operation of law be reclassified as a moderate 8-hour ozone nonattainment area. Pursuant to section 182(i) of the CAA EPA is also proposing the schedule for submittal of the SIP revision required for moderate areas once the area is reclassified. We propose to require that this SIP revision be submitted as expeditiously as practicable, but no later than December 31, 2008. V. Statutory and Executive Order Reviews A. Executive Order 12866, Regulatory Planning and Review This action is not a “significant regulatory action” under the terms of Executive Order (EO) 12866 (58 FR 51735, October 4, 1993) and is therefore not subject to review under the EO. The Agency has determined that the finding of nonattainment would result in none of the effects identified in the Executive Order. Under section 181(b)(2) of the CAA, determinations of nonattainment are based upon air quality considerations and the resulting reclassifications must occur by operation of law. B. Paperwork Reduction Act This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. This proposed action to reclassify the Imperial County area as a moderate ozone nonattainment area and to adjust applicable deadlines does not establish any new information collection burden. 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. C. Regulatory Flexibility Act The Regulatory Flexibility Act (RFA) generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedures Act or any other statute unless the agency certifies the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions. For purposes of assessing the impacts of this action on small entities, small entity is defined as: (1) A small business that is a small industrial entity as defined in the U.S. Small Business Administration (SBA) size standards (see 13 CFR part 121); (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; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field. Determinations of nonattainment and the resulting reclassification of nonattainment areas by operation of law under section 181(b)(2) of the CAA do not in and of themselves create any new requirements. Instead, this rulemaking only makes a factual determination, and does not directly regulate any entities. After considering the economic impacts of today's action on small entities, I certify that this rule will not have a significant economic impact on a substantial number of small entities. D. Unfunded Mandates Reform Act Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 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 as to 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. This proposed action does not include a Federal mandate within the meaning of UMRA that may result in expenditures of $100 million or more in any one year by either State, local, or Tribal governments in the aggregate or to the private sector, and therefore, is not subject to the requirements of section 202 and 205 of the UMRA. Also, EPA has determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments and therefore, is not subject to the requirements of section 203. EPA believes, as discussed previously in this document, that the finding of nonattainment is a factual determination based upon air quality considerations and that the resulting reclassification of the area must occur by operation of law. Thus, EPA believes that the proposed finding does not constitute a Federal mandate, as defined in section 101 of the UMRA, because it does not impose an enforceable duty on any entity. E. Executive Order 13132: Federalism 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 proposed rule does not have federalism implications. It 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. This action merely proposes to determine that the Imperial County area has not attained by its applicable attainment date, and to reclassify the Imperial County area as a moderate ozone nonattainment area and to adjust applicable deadlines. Thus, Executive Order 13132 does not apply to this rule. F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments 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 action does not have “Tribal implications” as specified in Executive Order 13175. This action merely proposes to determine that the Imperial County area has not attained by its applicable attainment date, and to reclassify the Imperial County area as a moderate ozone nonattainment area and to adjust applicable deadlines. The Clean Air Act and the Tribal Authority Rule establish the relationship of the Federal government and Tribes in developing plans to attain the NAAQS, and this rule does nothing to modify that relationship. Thus, Executive Order 13175 does not apply to this rule. G. Executive Order 13045: Protection of Children From Environmental Health and Safety Risks Executive Order 13045, “Protection of Children From Environmental Health and Safety Risks” (62 FR 19885, April 23, 1997) applies to any rule that (1) is determined to be “economically significant” as defined under Executive Order 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have disproportionate effects 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 action is not subject to Executive Order 13045 because it is not economically significant as defined in E.O. 12866, and because the Agency does not have reason to believe the environmental health risks or safety risks addressed by this rule present a disproportionate risk to children. This action merely proposes to determine that the Imperial Valley area has not attained the standard by the applicable attainment date, and to reclassify the Imperial Valley area as a moderate ozone nonattainment area and to adjust applicable deadlines. H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use This action is not subject to Executive Order 13211, “Actions That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), because it is not a significant regulatory action under Executive Order 12866. I. National Technology Transfer Advancement Act As noted in the proposed rule, section 12(d) of the National Technology Transfer Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards (VCS) 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 VCS bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable VCS. This action merely proposes to determine that the Imperial County area has not attained by the applicable attainment date, and to reclassify the Imperial County area as a moderate ozone nonattainment area and to adjust applicable deadlines. Therefore, EPA did not consider the use of any voluntary consensus standards. J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations Executive Order 12898 (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. EPA has determined that this proposed rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment. This action merely proposes to determine that the Imperial County area did not attain the 8-hour ozone NAAQS by the applicable attainment date, to reclassify the Imperial County area as a moderate ozone nonattainment area and to adjust applicable deadlines. List of Subjects in 40 CFR Part 81 Environmental protection, Air pollution control. Authority: 42 U.S.C. 7401 et seq. Dated: November 14, 2007. Laura Yoshii, Acting Regional Administrator, Region IX. [FR Doc. E7-22868 Filed 11-21-07; 8:45 am] BILLING CODE 6560-50-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 455 [CMS-2271-P] RIN 0938-AO97 Medicaid Integrity Program; Eligible Entity and Contracting Requirements for the Medicaid Integrity Audit Program AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Proposed rule. SUMMARY: Section 1936 of the Social Security Act (the Act) (as added by section 6034 of the Deficit Reduction Act of 2005 (DRA)) established the Medicaid Integrity Program to promote the integrity of the Medicaid program by requiring CMS to enter into contracts with eligible entities to: Review the actions of individuals or entities furnishing items or services (whether on a fee-for-service, risk, or other basis) for which payment may be made under an approved State plan and/or any waiver of such plan approved under section 1115 of the Act; audit claims for payment of items or services furnished, or administrative services rendered, under a State plan; identify overpayments to individuals or entities receiving Federal funds; and educate providers of services, managed care entities, beneficiaries, and other individuals with respect to payment integrity and quality of care. This proposed rule would provide requirements for an eligible entity to enter into a contract under the Medicaid integrity audit program. The proposed rule would also establish the contracting requirements for eligible entities. The requirements would include procedures for identifying, evaluating, and resolving organizational conflicts of interest that are generally applicable to Federal acquisition and procurement; competitive procedures to be used; and procedures under which a contract may be renewed. DATES: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on December 24, 2007. ADDRESSES: In commenting, please refer to file code CMS-2271-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. You may submit comments in one of four ways (no duplicates, please): 1. Electronically . You may submit electronic comments on specific issues in this regulation to http://www.cms.hhs.gov/eRulemaking . Click on the link “Submit electronic comments on CMS regulations with an open comment period.” (Attachments should be in Microsoft Word, WordPerfect, or Excel; however, we prefer Microsoft Word.) 2. By regular mail . You may mail written comments (one original and two copies) to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-2271-P, P.O. Box 8010, Baltimore, MD 21244-1850. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. By express or overnight mail . You may send written comments (one original and two copies) to the following address only: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-2271-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. 4. By hand or courier . If you prefer, you may deliver (by hand or courier) your written comments (one original and two copies) before the close of the comment period to one of the following addresses. If you intend to deliver your comments to the Baltimore address, please call telephone number (410) 786-8148 in advance to schedule your arrival with one of our staff members. Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security Boulevard, Baltimore, MD 21244-1850. (Because access to the interior of the HHH Building is not readily available to persons without Federal Government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.) Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period. Submission of comments on paperwork requirements . You may submit comments on this document's paperwork requirements by mailing your comments to the addresses provided at the end of the “Collection of Information Requirements” section in this document. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Barbara Rufo, 410-786-5589 or Crystal High, 410-786-8366. SUPPLEMENTARY INFORMATION: Submitting Comments: We welcome comments from the public on all issues set forth in this rule to assist us in fully considering issues and developing policies. You can assist us by referencing the file code CMS-2271-P. Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: http://www.cms.hhs.gov/eRulemaking . Click on the link “Electronic Comments on CMS Regulations” on that Web site to view public comments. Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951. I. Background A. Current Law States and the Federal government share in the responsibility for safeguarding Medicaid program integrity. States must comply with Federal requirements designed to ensure that Medicaid funds are properly spent (or recovered, when necessary). CMS is the primary Federal agency responsible for providing oversight of States' activities and facilitating their program integrity efforts. B. Medicaid Integrity Program Section 6034 of the Deficit Reduction Act (DRA) of 2005 (Pub. L. 109-171, enacted on February 8, 2006) added a new section 1936 to the Act that established the Medicaid Integrity Program, referenced as the “Program” hereafter, to combat Medicaid fraud and abuse. The Program is intended to identify, recover, and prevent Medicaid overpayments. It is also intended to support the efforts of the State Medicaid agencies through a combination of oversight and technical assistance. Although individual States work to ensure the integrity of their respective Medicaid programs, the Program represents CMS' first national strategy to detect and prevent Medicaid fraud and abuse. The Program would provide CMS with the ability to more directly ensure the accuracy of Medicaid payments and to deter those who would exploit the program. Section 6034 of the DRA amends title XIX of the Act by redesignating the former section 1936 as section 1937; and inserting the new 1936 “Medicaid Integrity Program.” The new section 1936 states the Secretary will promote the integrity of the Medicaid program by entering into contracts with eligible entities to carry out the following activities: Review of actions of individuals or entities furnishing items or services (whether on a fee-for-service, risk, or other basis) for which payment may be made under the State plan approved under title XIX (or under any waiver of such plan approved under section 1115 of the Act) to determine whether fraud, waste, or abuse has occurred, or is likely to occur, or whether such actions have a potential for resulting in an expenditure of funds under title XIX in a manner which is not intended under the provisions of title XIX. Audit of claims for payment for items or services furnished, or administrative services rendered, under a State plan under title XIX, including cost reports, consulting contracts, and risk contracts under section 1903(m) of title XIX. Identification of overpayments to individuals or entities receiving Federal funds under title XIX. Education of providers of services, managed care entities, beneficiaries, and other individuals with respect to payment integrity and quality of care. Section 1936 of the Act also mandates that the Secretary will by regulation establish procedures which will include the following: • Procedures for identifying, evaluating, and resolving organizational conflicts of interest that are generally applicable to Federal acquisition and procurement. • Competitive procedures to be used when entering into new contracts under this section; when entering into contracts that may result in the elimination of responsibilities under section 202(b) of the Health Insurance Portability and Accountability Act of 1996; and any other time considered appropriate by the Secretary. • Procedures under which a contract under this section may be renewed without regard to any provision of law requiring competition if the contractor has met or exceeded the performance requirements established in the current contract. CMS has determined not to address in this proposed rule the above bullet that references the Health Insurance Portability and Accountability Act of 1996 (HIPAA). We have determined that section 202(b) of HIPAA addressed certain Medicare contracting issues which, because of structural differences between the Medicare and Medicaid programs, such as the fact that the Federal government does not utilize carriers or fiscal intermediaries in the Federal administration of the Medicaid program, do not pertain to the Medicaid contracting environment. Moreover, we have also determined that the provisions of the Social Security Act established by section 202(b) of HIPAA have since been repealed by section 911 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. We invite public comment on this approach. II. Provisions of the Proposed Regulations In accordance with section 1936 of the Act, we would, through this proposed rule at new subpart D, § 455.200, define eligible entities that may enter into contracts under this Program to carry out activities as described above as well as establish contracting requirements for such entities. The approach taken in this proposed rule is consistent with a similar approach taken in the Medicare Integrity Program, which has very similar statutory requirements. A. Basis and Scope Following the mandate of section 1936 of the Act, this proposed rule, in subpart C, § 455.200(b), Basis and Scope, would add additional language stating that part of the Medicaid Integrity Program's scope is to carry out the Medicaid integrity audit functions. Subpart C would apply to entities that seek to compete for, or receive an award of, a contract under section 1936 of the Act. B. Definition of Eligible Entity In accordance with section 1936 of the Act, the proposed § 455.230 would describe that an eligible entity may enter into a Medicaid integrity audit program contract if it: • Demonstrates the capability to carry out the contractor activities; • In carrying out such activities, agrees to cooperate with the Inspector General of the Department of Health and Human Services, the Attorney General, and other law enforcement agencies, as appropriate, in the investigation and deterrence of fraud and abuse in relation to title XIX and in other cases arising out of such activities; • Maintains an appropriate written code of conduct and compliance policies that include, without limitation, an enforced policy on employee conflicts of interest; • Complies with such conflict of interest standards as are generally applicable to Federal acquisition and procurement; and, • Meets other requirements the Secretary may impose. It would not be possible to identify in this rule every possible contractor requirement that may appear in a future solicitation. In order to permit maximum flexibility to tailor our contractor eligibility requirements to specific solicitations while satisfying section 1936 of the Act, any additional requirements would be contained in the applicable solicitation. In addition, we propose that a contractor under section 1936 of the Act may perform any or all of the contractor functions as are listed and described under “contractor functions.” C. Contractor Functions In accordance with section 1936 of the Act, section 455.232 would identify the functions of the Medicaid integrity audit program contractor as follows: • Review of the actions of individuals or entities furnishing items or services (whether on a fee-for-service, risk, or other basis) for which payment may be made under a State plan approved under title XIX (or under any waiver of such plan approved under section 1115 of the Act) to determine whether fraud, waste, or abuse has occurred, is likely to occur, or whether such actions have the potential for resulting in an expenditure of funds under title XIX in a manner which is not intended under the provisions of title XIX. • Audit of claims for payment for items or services furnished, or administrative services rendered, under a State plan under title XIX, including (a) cost reports; (b) consulting contracts; and (c) risk contracts under section 1903(m) of the Act. • Identification of overpayments to individuals or entities receiving Federal funds under title XIX. • Educating providers of service, managed care entities, beneficiaries, and other individuals with respect to payment integrity and quality of care. D. Competitive Procedures and Requirements Section 455.234 would specify that a Medicaid integrity audit contract will be awarded in accordance with 48 CFR chapters 1 and 3 (the Federal Acquisition Regulation (FAR) and the Health and Human Services Acquisition Regulation, respectively), this subpart, and all other applicable laws and regulations. In accordance with section 1936 of the Act, we would specify that these competitive procedures and requirements will be used as follows: • When entering into new contracts under this section. • At any other time considered appropriate by the Secretary. In addition, we propose to specify in § 455.234 that an entity must meet the eligibility requirements established in proposed § 455.230 to become eligible to be awarded a Medicaid integrity audit program contract. E. Renewal of Contracts Renewing a contract, when appropriate, results in continuity for both CMS and the contractor and can be in the best interest of the Program. If a contract is not renewed, we must ensure that sufficient time is provided to transfer and reassign the Medicaid integrity audit program functions as described in this subpart. Therefore, in § 455.236, we would specify that an initial contract term will be defined in the Medicaid integrity audit program contract and a renewal clause may be included in the contract. We also would specify that we may, but are not required to, renew the Medicaid integrity audit program contracts without regard to any provision of law requiring competition if the contractor has met or exceeded the performance requirements established in the current contract. In accordance with sections 1936(c)(2) and (3) of the Act, we would specify in § 455.236(b) that we may renew a Medicaid integrity audit program contract without competition if the contractor continues to meet all requirements of the proposed subpart C, the contractor meets or exceeds the performance requirements established in its current contract, and it is in the best interest of the government. At § 455.236(a) we propose that if CMS does not renew a contract, the contract will end in accordance with its terms. The contractor will not have a right to a hearing or judicial review regarding our renewal decision. F. Conflict of Interest This proposed rule would establish at § 455.238 the process for identifying, evaluating, and resolving conflicts of interest as mandated by sections 1936(c)(2) and (3) of the Act. Establishing such a process would ensure that business arrangements of potential contractors do not inhibit competition between providers, suppliers, or other types of business related to the Medicaid program, or have the potential of harming the government's interests. We would adhere to the requirements of the FAR's organizational conflict of interest requirements found at 48 CFR subpart 9.5 when soliciting contracts for the Medicaid integrity audit program. Due to the sensitive nature of the work to be performed under the contract, the need to preserve public trust, and the history of fraud and abuse in the Medicaid program, we would maintain the presumption that each prospective contract involves a significant potential organizational conflict of interest. Prior to awarding a Medicaid integrity audit program contract, the contracting officer will draft an organizational conflict of interest clause specific to the contractor for inclusion in the contract. In general we would not enter into a Medicaid integrity audit program contract with an offeror or an existing Medicaid integrity audit program contractor that has been determined to have, or that has the potential for, an unresolved organizational conflict of interest. At § 455.238(a), we would specify that an offeror for a Medicaid integrity audit program contract is, and the Medicaid integrity audit program contractors are, subject to the conflict of interest standards and requirements of the FAR organizational conflict of interest guidance found at 48 CFR subpart 9.5, and the requirements and standards that are contained in each individual contract awarded to perform the functions described under section 1936 of the Act. In § 455.238(b), we would include post award discussions. We would specify that we consider that a post award conflict of interest has developed if, during the term of the contract, the contractor or any of its employees, agents, or subcontractors received, solicited, or arranged to receive any fee, compensation, gift, payment of expenses, offer of employment, or any other thing of value from any entity that is reviewed, audited, investigated, or contacted during the normal course of performing activities under a Medicaid integrity audit program contract. We incorporate the definition of “gift” from the Standards of Ethical Conduct for Employees of the Executive Branch [5 CFR 2635.203(b)]. In addition, in § 455.238(c) we propose that if CMS has determined that a contractor's activities are creating a conflict, then a conflict of interest has occurred during the term of the contract. If such an event has occurred, among other actions, we may, as we deem appropriate: • Not renew the contract for an additional term; • Modify the contract; or • Terminate the contract. The proposed provisions do not describe all of the information that may be required, or the level of detail that would be required. We wish to have the flexibility to tailor the requirements to each individual procurement. Because potential offerors may have questions about whether information submitted in response to a solicitation, including information regarding potential conflicts of interest, may be redisclosed under the Freedom of Information Act (FOIA), we provide the following information. To the extent that a proposal containing information is submitted to us as a requirement of a competitive solicitation under 41 U.S.C. Chapter 4, Subchapter IV, we would withhold the proposal when requested under the FOIA. This withholding is based upon 41 U.S.C. 253b(m). However, there is one exception to this policy. It involves any proposal that is set forth or incorporated by reference in the contract awarded to the proposing offeror. Such a proposal may not receive categorical protection. Rather, we would withhold, under 5 U.S.C. 552(b)(4), information within the proposal that is required to be submitted that constitutes trade secrets or commercial or financial information that is privileged or confidential, provided the criteria established by National Parks & Conservation Association v. Morton, 498 F.2d 765 (D.C. Cir. 1974), as applicable, are met. For any such proposal, we would follow pre-disclosure notification procedures set forth at 45 CFR 5.65(d). Any proposal containing the information submitted to us under an authority other than 41 U.S.C. Chapter 4, Subchapter IV, and any information submitted independent of a proposal would be evaluated solely on the criteria established by National Parks & Conservation Association v. Morton and other appropriate authorities to determine if the proposal in whole or in part contains trade secrets or commercial or financial information that is privileged or confidential and protected from disclosure under 5 U.S.C. 552(b)(4). Again, for any such proposal, we would follow pre-disclosure notification procedures set forth at 45 CFR 5.65(d) and will also invoke 5 U.S.C. 552(b)(6) to protect information that is of a highly sensitive personal nature. It should be noted that the protection of proposals under FOIA does not preclude us from releasing contractor proposals when necessitated by law, such as in the case of a lawful subpoena. G. Conflict of Interest Resolution We propose to describe at § 455.240(a) how a conflict of interest may be resolved. We would state that a Conflicts of Interest Review Board may be established and convened at any time during the term of the contract, as well as during the procurement process, to evaluate and assist the contracting officer in resolving conflicts of interest. We would determine when or if the Board will be convened. We would, at § 455.240(b), specify that a resolution of an organizational conflict of interest is a determination by the contracting officer that: • The conflict is mitigated; • The conflict precludes award of a contract to the offeror; • The conflict requires that we modify an existing contract; • The conflict requires that we terminate an existing contract; or • It is in the best interest of the government to contract with the offeror or contractor even though the conflict of interest exists. An offeror's or contractor's method of mitigating conflicts of interest will be evaluated on a case by case basis. We have provided examples of methods an offeror or contractor may use to mitigate organizational conflicts of interest. The examples are not an all-inclusive list of possible methods of mitigation nor are we obligated to approve a mitigation method that uses one of the provided examples. Possible methods of mitigation include: • Divestiture, or reduction in the amount, of the financial relationship the organization has in another organization to a level acceptable to us and appropriate for the situation. • If shared responsibilities create the conflict, a plan, subject to our approval, to separate lines of business and management or critical staff from work on the Medicaid integrity audit program contract. • If the conflict exists because of the amount of financial dependence upon the Federal Government, negotiating a phasing out of other contracts or grants that continue in effect at the start of the Medicaid integrity audit program contract. • If the conflict exists because of the financial relationships of individuals within the organization, divestiture of the relationships by the individual involved. • If the conflict exists because of an individual's indirect interest, divestiture of the interest to levels acceptable to us or removal of the individual from the work under the Medicaid integrity audit program contract. By providing a process for the identification, evaluation, and resolution of conflicts of interest, we not only protect the government's interests but help to ensure that the contractors do not hinder competition in their service areas by misusing their position as a Medicaid integrity audit program contractor. III. Collection of Information Requirements This document does not impose any information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 35). IV. Response to Comments Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document. V. Regulatory Impact Statement [If you wish to comment on issues in this section, please include the caption “Regulatory Impact Statement” at the beginning of your comments.] We have examined the impact of this rule as required by Executive Order 12866 (September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132. Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net 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 any 1 year). This rule would not reach the economic threshold and thus is not considered a major rule. The RFA requires agencies to analyze options for regulatory relief of small businesses. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $6.5 million to $31.5 million in any 1 year. Individuals and States are not included in the definition of a small entity. We are not preparing an analysis for the RFA because we have determined, and the Secretary certifies, that this rule would not have a significant economic impact on a substantial number of small entities. In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Core-Based Statistical Area and has fewer than 100 beds. We are not preparing an analysis for section 1102(b) of the Act because we have determined, and the Secretary certifies, that this rule would not have a significant impact on the operations of a substantial number of small rural hospitals. Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. That threshold level is currently approximately $120 million. This proposed rule would not exceed this established threshold level. This rule would have no consequential effect on State, local, or tribal governments or on the private sector. Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. Since this regulation would not impose any costs on State or local governments, the requirements of E.O. 13132 are not applicable. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget. List of Subjects in Part 455 Fraud, Grant programs—health, Health facilities, Health professions, Investigations, Medicaid, Reporting and recordkeeping requirements. For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services would amend 42 CFR chapter IV as set forth below: PART 455—PROGRAM INTEGRITY; MEDICAID 1. The authority citation for part 455 continues to read as follows: Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 1302). 2. A new § 455.200 is added to read as follows: § 455.200 Basis and scope. (a) Statutory basis. This subpart implements section 1936 of the Act that establishes the Medicaid Integrity Program, under which the Secretary will promote the integrity of the program by entering into contracts with eligible entities to carry out the activities under this subpart C. (b) Scope. This subpart provides for the limitation on a contractor's liability to carry out a contract under the Medicaid Integrity Program and to carry out the Medicaid integrity audit program functions. 3. A new § 455.230 is added to read as follows: § 455.230 Eligibility requirements. CMS may enter into a contract with an entity to perform the activities described at § 455.232, if it meets the following conditions: (a) The entity has demonstrated capability to carry out the activities described below. (b) In carrying out such activities, the entity agrees to cooperate with the Inspector General of the Department of Health and Human Services, the Attorney General, and other law enforcement agencies, as appropriate, in the investigation and deterrence of fraud and abuse in relation to Title XIX of the Social Security Act and in other cases arising out of such activities. (c) Maintains an appropriate written code of conduct and compliance policies that include, without limitation, an enforced policy on employee conflicts of interest. (d) The entity complies with such conflict of interest standards as are generally applicable to Federal acquisition and procurement. (e) The entity meets such other requirements the Secretary may impose. 4. A new § 455.232 is added to read as follows: § 455.232 Medicaid integrity audit program contractor functions. The contract between CMS and a Medicaid integrity audit program contractor specifies the functions the contractor will perform. The contract may include any or all of the following functions: (a) Review of the actions of individuals or entities furnishing items or services (whether on a fee-for-service, risk, other basis) for which payment may be made under a State Plan approved under title XIX of the Act (or under any waiver of such plan approved under section 1115 of the Act) to determine whether fraud, waste, or abuse has occurred, is likely to occur, or whether such actions have the potential for resulting in an expenditure of funds under title XIX in a manner which is not intended under the provisions of title XIX. (b) Auditing of claims for payment for items or services furnished, or administrative services rendered, under a State Plan under title XIX to ensure proper payments were made. This includes: Cost reports, consulting contracts, and risk contracts under section 1903(m) of the Act. (c) Identifying if overpayments have been made to individuals or entities receiving Federal funds under title XIX. (d) Educating providers of service, managed care entities, beneficiaries, and other individuals with respect to payment integrity and quality of care. 5. A new § 455.234 is added to read as follows: § 455.234 Awarding of a contract. (a) CMS awards and administers Medicaid integrity audit program contracts in accordance with acquisition regulations set forth at 48 CFR chapters 1 and 3, this subpart, and all other applicable laws and regulations. These competitive procedures and requirements for awarding Medicaid integrity audit program contracts are to be used as follows: (1) When entering into new contracts under this section. (2) At any other time considered appropriate by the Secretary. (b) An entity is eligible to be awarded a Medicaid integrity audit program contract only if it meets the eligibility requirements established in § 455.202, 48 CFR chapter 3, and all other applicable laws and requirements. 6. A new § 455.236 is added to read as follows: § 455.236 Renewal of a contract. (a) CMS specifies the initial contract term in the Medicaid integrity audit program contract. CMS may, but is not required to, renew a Medicaid integrity audit program contract without regard to any provision of law requiring competition if the contractor has met or exceeded the performance requirements established in the current contract. (b) CMS may renew a Medicaid integrity audit program contract without competition if all of the following conditions are met: (1) The Medicaid integrity audit program contractor continues to meet the requirements established in this subpart. (2) The Medicaid integrity audit program contractor meets or exceeds the performance requirements established in its current contract. (3) It is in the best interest of the government. (c) If CMS does not renew a contract, the contract will end in accordance with its terms. The contractor will not have a right to a hearing or judicial review regarding CMS' renewal or non-renewal decision. 7. A new § 455.238 is added to read as follows: § 455.238 Conflict of interest. (a) Offerors for Medicaid integrity audit program contracts, and Medicaid integrity audit program contractors, are subject to the following requirements: (1) The conflict of interest standards and requirements of the Federal Acquisition Regulation organizational conflict of interest guidance, found under 48 CFR subpart 9.5. (2) The standards and requirements that are contained in each individual contract awarded to perform activities described under section 1936 of the Act. (b) Post-award conflicts of interest: CMS considers that a post-award conflict of interest has developed if, during the term of the contract, one of the following occurs: (1) The contractor or any of its employees, agents, or subcontractors received, solicited, or arranged to receive any fee, compensation, gift (defined at 5 CFR 2635.203(b)), payment of expenses, offer of employment, or any other thing of value from any entity that is reviewed, audited, investigated, or contacted during the normal course of performing activities under the Medicaid integrity audit program contract. (2) CMS determines that the contractor's activities are creating a conflict of interest. (c) If CMS determines that a conflict of interest exists during the term of the contract, among other actions, CMS may: (1) Not renew the contract for an additional term. (2) Modify the contract. (3) Terminate the contract. 8. A new § 455.238 is added to read as follows: § 435.240 Conflict of interest resolution. (a) Review Board: CMS may establish a Conflicts of Interest Review Board to assist in resolving organizational conflicts of interest. (b) Resolution: Resolution of an organizational conflict of interest is a determination by the contracting officer that: (1) The conflict is mitigated. (2) The conflict precludes award of a contract to the offeror. (3) The conflict requires that CMS modify an existing contract. (4) The conflict requires that CMS terminate an existing contract. (5) It is in the best interest of the government to contract with the offeror or contractor even though the conflict of interest exists and a request for waiver is approved in accordance with 48 CFR 9.503. (Catalog of Federal Domestic Assistance Program No. 93.778, Medical Assistance Program) Dated: June 15, 2007. Leslie V. Norwalk, Acting Administrator, Centers for Medicare & Medicaid Services. Approved: August 20, 2007. Michael O. Leavitt, Secretary. [FR Doc. E7-22773 Filed 11-21-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 483 [CMS-2266-P] RIN 0938-AO82 Medicare and Medicaid Programs; Waiver of Disapproval of Nurse Aide Training Program in Certain Cases and Nurse Aide Petition for Removal of Information for Single Finding of Neglect AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Proposed rule. SUMMARY: This proposed rule would permit a waiver of nurse aide training disapproval as it applies to skilled nursing facilities, in the Medicare program, and nursing facilities, in the Medicaid program, that are assessed a civil money penalty of at least $5,000 for noncompliance that is not related to quality of care. This is a statutory provision enacted by section 932 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173, enacted December 8, 2003.) In addition, this proposed rule would codify an additional statutory provision enacted by section 4755 of the Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33, enacted on August 5, 1997) that requires the State to establish a procedure to permit a nurse aide to petition the State to have a single finding of neglect removed from the nurse aide registry if the State determines that the employment and personal history of the nurse aide does not reflect a pattern of abusive behavior or neglect and the neglect involved in the original finding was a single occurrence. DATES: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on December 24, 2007. ADDRESSES: In commenting, please refer to file code CMS-2266-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. You may submit comments in one of four ways (no duplicates, please): 1. Electronically. You may submit electronic comments on specific issues in this regulation to http://www.cms.hhs.gov/eRulemaking. Click on the link “Submit electronic comments on CMS regulations with an open comment period.” (Attachments should be in Microsoft Word, WordPerfect, or Excel; however, we prefer Microsoft Word.) 2. By regular mail. You may mail written comments (one original and two copies) to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-2266-P, P.O. Box 8017, Baltimore, MD 21244-8017. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. By express or overnight mail. You may send written comments (one original and two copies) to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-2266-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. 4. By hand or courier. If you prefer, you may deliver (by hand or courier) your written comments (one original and two copies) before the close of the comment period to one of the following addresses. If you intend to deliver your comments to the Baltimore address, please call telephone number (410) 786-7195 in advance to schedule your arrival with one of our staff members. Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security Boulevard, Baltimore, MD 21244-1850. (Because access to the interior of the HHH Building is not readily available to persons without Federal Government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.) Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period. Submission of comments on paperwork requirements. You may submit comments on this document's paperwork requirements by mailing your comments to the addresses provided at the end of the “Collection of Information Requirements” section in this document. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Pat Miller, (410) 786-6780. SUPPLEMENTARY INFORMATION: Submitting Comments: We welcome comments from the public on all issues set forth in this rule to assist us in fully considering issues and developing policies. You can assist us by referencing the file code CMS-2266-P and the specific “issue identifier” that precedes the section on which you choose to comment. Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: http://www.cms.hhs.gov/eRulemaking . Click on the link “Electronic Comments on CMS Regulations” on that Web site to view public comments. Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951. I. Background A. Waiver of Disapproval of Nurse Aide Training Program in Certain Cases To participate in the Medicare and or Medicaid programs, long-term care facilities must be certified as meeting Federal participation requirements. Long-term care facilities include skilled nursing facilities (SNFs) for Medicare and nursing facilities (NFs) for Medicaid. The Federal participation requirements for these facilities are specified in regulations at 42 CFR part 483, subpart B. Section 1864(a) of the Social Security Act (the Act) authorizes the Secretary to enter into agreements with State survey agencies to determine whether SNFs meet the Federal participation requirements for Medicare. Section 1902(a)(33)(B) of the Act provides for State survey agencies to perform the same survey tasks for facilities participating or seeking to participate in the Medicaid program. The results of Medicare and Medicaid related surveys are used by the Centers for Medicare & Medicaid Services and the State Medicaid agency, respectively, as the basis for a decision to enter into or deny a provider agreement, recertify facility participation in one or both programs, or impose remedies on a noncompliant facility. To assess compliance with Federal participation requirements, surveyors conduct onsite inspections (surveys) of facilities. In the survey process, surveyors directly observe the actual provision of care and services to residents and the effect or possible effects of that care to evaluate whether the care furnished meets the assessed needs of individual residents. Sections 1819(b)(5) and 1919(b)(5) of the Act and implementing regulations at § 483.75(e) require that all individuals employed by a facility as nurse aides must have successfully completed a nurse aide training program. Sections 1819(f)(2) and 1919(f)(2) of the Act provide that facility-based nurse aide training could be offered either by the facility or in the facility by another entity approved by the State. In other words, a facility in good standing (that is, one that is not subject to an event that results in disapproval of a nurse aide training program) may offer a facility-based program in one of two ways: It can either conduct its own facility-based State-approved nurse aide training and have the State or a State-approved entity administer the nurse aide competency evaluation program, or it can offer the entire nurse aide training and competency evaluation program through an outside entity which has been approved by the State to conduct both components. Further, these sections prohibit States from approving a nurse aide training and competency evaluation program or a nurse aide competency evaluation program offered by or in a SNF or NF when any of the following specified events have occurred in that facility— • The facility has operated under a nurse staffing waiver; • The facility has been subject to an extended or partial extended survey unless the survey shows the facility is in compliance with the participation requirements; or • The facility has been assessed a civil money penalty of not less than $5,000, or has been subject to a denial of payment, the appointment of a temporary manager, termination, or in the case of an emergency, been closed and had its residents transferred. Program disapproval is a required, rather than a discretionary, response whenever any of these events occur. Since facilities are required to employ nurse aides who have successfully completed a training program, when a facility loses its ability to conduct facility-based training, it must, for the duration of the 2 year program disapproval, provide the required training through either the State or another State-approved outside organization as provided by § 483.151(a). However, sections 1819(f)(2)(D) and 1919(f)(2)(D) of the Act permit a waiver for program disapproval of programs offered in (but not by) a facility if the State— • Determines that there is no other such program offered within a reasonable distance of the facility; • Assures that an adequate environment exists for operating the program in the facility; and • Notifies the State Long Term Care Ombudsman of this determination and these assurances. Section 932(c)(2)(B) of the MMA added sections 1819(f)(2)(D) and 1919(f)(2)(D) of the Act which allows the Secretary to waive a facility's disapproval of its nurse aide training program upon application of a facility if the disapproval resulted from the imposition of a civil money penalty of at least $5000 and that is not related to quality of care provided to residents in the facility. The statutory provision being implemented in this proposed rule pertains specifically and only to the civil money penalty disapproval trigger under sections 1819(f)(2)(B)(iii)(I)(c) and 1919(f)(2)(B)(iii)(I)(c) of the Act and establishes authority for CMS to approve a facility's request to waive disapproval of its nurse aide training program when that facility has been assessed a civil money penalty of at least $5,000 for deficiencies that are not related to quality of care. B. Nurse Aide Petition for Removal of Information for Single Finding of Neglect The nurse aide registry is one of the tools to ensure that nursing homes are employing qualified nurse aides who are properly trained, appropriately tested, and have no adverse findings against them of abuse, neglect, or misappropriation of property. Sections 1819(e)(2) and 1919(e)(2) of the Act and the implementing regulations at § 483.156 require each State to establish and maintain a registry of nurse aides who have successfully completed a nurse aide training and competency evaluation program and have been found by the State to be competent. The nurse aide registry also includes information for any nurse aides who have had an adverse finding of abuse, neglect, or misappropriation of resident property substantiated by the State survey agency. This information must be included in the registry within 10 working days of the finding and remain in the registry permanently unless the finding was made in error, the individual was found not guilty by a court of law, or the State is notified of the individual's death. Nursing homes are required to verify with State nurse aide registries (in the State where the facility is located and in other States that may have information on the individual) that prospective nurse aide employees have not abused, neglected, or mistreated residents nor misappropriated their property. A nursing home must not employ individuals who have been found guilty of abusing, neglecting, or mistreating residents by a court of law or who have had a finding entered into the State nurse aide registry concerning abuse, neglect, mistreatment of residents or misappropriation of their property. Section 483.13 of the regulations provides that if there has been a finding of abuse, neglect, mistreatment of residents or misappropriation of their property entered into the nurse aide registry against a nurse aide, the nurse aide is permanently prohibited from working in a nursing home. The additional purpose of this proposed rule is to implement a legislative provision enacted as part of the BBA and included in the statutory language at sections 1819(g)(1)(D) and 1919(g)(1)(D) of the Act which reads in part, “Removal of name from nurse aide registry.” However, since the nurse aide registry must also include information about nurse aides who have successfully completed a nurse aide training and competency evaluation program and have been found by the State to be competent, the name of the nurse aide would not be removed completely from the registry. Rather, it is technically the removal of the single adverse finding itself against a nurse aide from the nurse aide registry in limited circumstances under specific conditions that is contemplated. II. Discussion of the Issues A. Waiver of Disapproval of Nurse Aide Training Program in Certain Cases Some participation requirements for nursing homes, if unmet and which result in the assessment of a civil money penalty of at least $5,000, results in the loss of the facility's nurse aide training program for 2 years. For example, § 483.13, Resident behavior and facility practices, requires in paragraph (a) that the resident has the right to be free from any physical or chemical restraints imposed for purposes of discipline or convenience, and not required to treat the resident's medical symptoms. Another example, § 483.25, Quality of care, requires in paragraph (c) that the facility must ensure that residents who enter the facility without pressure sores do not develop them unless they are unavoidable and that residents having pressure sores receive necessary treatment and services to promote healing, prevent infection, and prevent new sores from developing. These are facility failures of direct care-giving requirements that could compromise the facility's ability to provide quality health care services directly to residents and could lead us to conclude that the facility is not providing positive role models for the training of its nurse aides. On the other hand, there are other participation requirements that are not directly related to the provision of hands-on health care services or to the training of nurse aides. Thus, even if unmet, these facility failures would have no direct negative impact on care furnished to residents or the facility's ability to provide a positive role model for the training of its aides regarding appropriate care for residents. For example, § 483.10, Resident rights, requires in paragraph (b)(2) that a resident or his or her legal representative, has the right, after inspecting all of his or her records, to purchase, at a cost not to exceed the community standard, photocopies of the records or any portions of them upon request, with 2 working days advance notice to the facility. Another example, § 483.12, Admission, transfer and discharge rights, requires in paragraph (a)(5) that a facility must provide notice of transfer or discharge to a resident at least 30 days before the transfer or discharge occurs. While failure to meet these requirements may subject the facility to a civil money penalty of $5,000 or more, these facility failures concern administrative and procedural requirements which are not directly related to the provision of hands-on health care services to residents, and, therefore, would not be indicative of a poor facility model for its nurse aide training program. There is currently no regulatory distinction between care-giving and non care-giving participation requirements for purposes of the nurse aide training program disapproval. Rather, the disapproval automatically results when there is any noncompliance for which a civil money penalty of $5,000 or more is assessed. Currently, facilities assessed a civil money penalty of at least $5,000 for noncompliance with any Federal participation requirement are prohibited from offering such a training program for a period of 2 years. The purpose of this proposed rule is to implement the legislative waiver provision enacted on December 8, 2003 as part of the MMA and which amended the Act. This revision would improve the applicability of the training disapproval requirement as it applies to assessed civil money penalty sanctions of at least $5,000, by distinguishing between facility noncompliance that warrants the training program disapproval and noncompliance that does not. As a result of these issues, the Congress concluded that the compliance assessment and response system for nursing homes needed to be improved to distinguish between what does and does not relate to the quality of care furnished to residents for purposes of determining whether disapproval of a facility's nurse aide training program should result when assessment of a civil money penalty of at least $5,000 is the only basis for disapproving the program. This proposed rule would implement section 932 of the MMA such that the additional consequence of program disapproval need not necessarily result if we determine that the noncompliance is not related to direct hands-on resident care, and as such, would not likely compromise the facility's ability to provide successful role modeling for its training program. However, we wish to emphasize that our authority to approve a facility's request for such a waiver does not assure that a waiver would be granted. These waiver determinations would be made by CMS upon application of a nursing facility on a case-by-case basis after considering the recommendation and facts of that case as provided by the State. We do not foresee this process of noncompliance—fact gathering, analysis, and subsequent recommendation for action to CMS for purposes of determining program disapproval waivers—as an additional workload burden for States. States currently perform these functions under their agreements with CMS when they perform survey functions. They currently evaluate facility noncompliance scope, severity, nature, and impact on residents whenever they make a determination about the seriousness of a facility's noncompliance as well as when they make enforcement remedy recommendations to CMS. This proposed rule simply acknowledges that these State activities currently occur and that they would now also be used by CMS in making nurse aide training program disapproval waiver determinations. The plain language of the statute permits waiver of training program disapproval based on the imposition of at least a $5,000 CMP that was not related to the quality of care furnished to residents. However, it does not provide guidance for what this means. On page 776 of the Conference Report to the MMA (H.R. Rep. No. 108-391 (2003), reprinted in 2004 U.S.C.C.A.N. 1808, 2130), it states that, “* * * Quality of care in such instances refers to direct, hands on care furnished to residents of a facility.” We believe that this proposed rule proposes an appropriate and rational way to implement the legislative intent of evaluating noncompliance with “quality of care furnished to residents” in order to determine what impact it may have on the facility's ability to provide a positive training model to its nurse aides. In order to assess the “quality of care being furnished to residents,” we needed to find a way to differentiate between care-giving and non-care-giving requirements. So, for purposes of implementing this new legislative provision, we are proposing to define “quality of care furnished to residents” as direct care and treatment that a health care professional or direct care staff provides to a resident. We also emphasize that a finding of noncompliance with a direct care giving requirement is not necessary in order to assess a civil money penalty of at least $5,000 or to disapprove a facility's nurse aide training program. Regardless of whether or not the noncompliance is with a direct care giving requirement, the existence of the noncompliance, itself, may result in the imposition of a civil money penalty or another remedy from the menu of available sanctions. Once a remedy or remedies are imposed, a facility's ability to provide nurse aide training is prohibited for 2 years unless a waiver is approved. In response to a facility's request for a waiver of its nurse aide training program disapproval when a civil money penalty of at least $5,000 has been assessed, the nature of the facility's deficiencies would be evaluated to determine if they are central to furnishing direct hands-on care to residents. “Assessed” is defined in our State Operations Manual , (Pub. 100-07), section 7536 A as, “* * * the final amount determined to be owed after a hearing, waiver of right to hearing, or settlement.” Civil money penalties can be assessed for specific instances of noncompliance (per instance) as well as for aggregate facility noncompliance (per day), we needed a method of determining how discrete and aggregate noncompliance should be evaluated for purposes of applying this waiver provision. When a per instance civil money penalty of at least $5,000 is assessed for noncompliance with a specific participation requirement, the evaluation of that specific deficiency's direct impact on residents is clear-cut. However, when the civil money penalty of at least $5,000 is per day, the evaluation becomes more difficult. In the latter case, all of the facility's deficiencies would need to be reviewed to determine if individually or, in total, they are indicative of an overall facility failure or inability to directly provide quality care to its residents. The resulting determination would allow us to conclude whether the facility is still likely to provide a positive nurse aide training model. Although a single care-giving deficiency, among other non care-giving deficiencies, may result in a conclusion that the facility, overall, is providing quality care to its residents, it is also possible that the seriousness of that single facility failure could cause us to conclude otherwise. While we do not intend to provide specific detail in this rule about how to operationalize this decision making process, we will provide guidance and examples in the CMS State Operations Manual . We wish to reiterate that this proposal would not automatically mandate a waiver of a nurse aide training program disapproval in cases when a civil money penalty of $5,000 or more is assessed for non care-giving noncompliance. Rather, it implements the legislative flexibility to evaluate the noncompliance in context with other factors in order for CMS to make better decisions, on a case-by-case basis, about whether or not to waive the training program disapproval. While we do not intend to include instructions in this rule about which participation requirements would be considered to be related to the direct care and hands-on treatment that a health care professional or direct care staff provides to the resident, we have included examples of our intent earlier in this preamble and will provide operational guidance in our State Operations Manual . The examples we have furnished simply illustrate the distinctions we believe exist between noncompliance that realistically constitutes direct hands-on care and noncompliance that does not. We encourage public comment regarding examples or issues that should be addressed in CMS operational guidance. In consideration of the issues described, we believe that the regulation change we propose below to implement the new legislative provision strikes a fair balance between characteristics of care that a reasonable person would expect to be indicative of quality health care services. This determination would then lead us to conclude whether the facility, despite its deficiencies, is still likely to provide a positive role model for its nurse aides. B. Nurse Aide Petition for Removal of Information for Single Finding of Neglect A nurse aide is defined in § 483.75 of the regulations as any individual providing nursing or nursing-related services to residents in a facility who is not a licensed health professional, a registered dietician, or someone who volunteers to provide these services without pay. Although the efforts of all nursing home staff are required to provide care to residents, the role of the nurse aide is vital. Nurse aides provide much of the direct hands-on care that residents receive and are actively involved in their daily lives. Competent and caring nurse aides are essential to providing quality care to nursing home residents. Federal regulations at 42 CFR part 483, subpart D establish standards for training nurse aides and for evaluating their competency to assure that they have the education, practical knowledge, and skills needed to care for nursing home residents. Section 483.13 of the regulations prohibits nursing homes from employing individuals who have been found guilty of abusing, neglecting, or mistreating residents by a court of law or have had a finding entered into the State nurse aide registry concerning resident abuse, neglect, or misappropriation of resident property. This information must be included in the registry within 10 working days of the finding and must remain in the registry permanently unless the finding was made in error, the individual was found not guilty by a court of law, or the State is notified of the individual's death. Nursing homes are required to verify with State nurse aide registries (in the State where the facility is located and in other States that may have information on the individual) that nurse aides they are considering for employment have not abused, neglected, or mistreated residents nor misappropriated their property. Initially, a specific incident in one State raised a concern regarding the severe effects of an adverse finding on the nurse aide registry. This led to an examination of the current regulations and subsequently to an addition to the Act addressing one specific aspect of the existing regulations. This incident involved a nurse aide with a long and exemplary work record. While assisting a resident, the nurse aide was distracted by another work demand, and the resident fell and suffered an injury. This nurse aide was found guilty of neglect and, per the current regulations, would be barred for life from ever working in a nursing home for this isolated incident. We believe permanently barring a nurse aide from working in a nursing home in this type of circumstance is inappropriate, limited, and not the kind of abuse that the original legislation was intended to prevent. This proposed regulation incorporates statutory language at sections 1819(g)(1)(D) and 1919(g)(1)(D) (Removal of name from nurse aide registry) of the Act and requires every State to establish a procedure to permit a nurse aide to petition for removal of a finding of neglect from the registry if the State determines that the employment and personal history of the nurse aide does not reflect a pattern of abusive behavior or neglect and the neglect involved in the original finding was a single occurrence. The determination on a petition for removal of the finding of neglect can not be made before the expiration of the 1-year period beginning on the date on which the name of the nurse aide who is petitioning for removal was added to the nurse aide registry as a result of an investigation. As long as the State's process addresses the elements specified in the regulation, States may use a variety of methods to assure compliance with this requirement. For example, some States may choose a formal process through their State legislature while other States may choose an informal process, such as sending a letter to notify the nurse aide of this opportunity to petition. III. Provisions of the Proposed Regulation A. Waiver of Disapproval of Nurse Aide Training Program in Certain Cases For the reasons discussed above, we propose to redesignate the current § 483.151 (c), (d), and (e) as § 483.151 (d), (e), and (f), respectively. We propose to add a new paragraph (c)(1) in § 483.151 where a facility may request that we waive the disapproval of its nurse aide training program when the facility has been assessed a civil money penalty of not less than $5,000 if the civil money penalty was not related to the quality of care furnished to residents in the facility. We propose to add a new paragraph (c)(2) in § 483.151 to define the term quality of care furnished to residents, as the direct hands-on care and treatment that a health care professional or direct care staff provides to a resident. We propose to add a new paragraph (c)(3) in § 483.151 to specify that any waiver of disapproval of a nurse aide training program does not waive any civil money penalty imposition. B. Nurse Aide Petition for Removal of Information for Single Finding of Neglect We propose to redesignate the current § 483.156(d) as § 483.156(e). We propose to add a new paragraph (d)(1) in § 483.156 to require the States to establish a procedure for permitting a nurse aide to petition for removal of a finding of neglect from the nurse aide registry if the State determines that the employment and personal history of the nurse aide does not reflect a pattern of abusive behavior or neglect and the neglect involved in the original finding was a single finding. We propose to add a new paragraph (d)(2) in § 483.156 to require that the petition for removal can not be made before the expiration of the 1-year period beginning on the date on which the name of the petitioner was added to the nurse aide registry as a result of an investigation. An individual may petition a State for review of any finding made by a State under sections 1819(g)(1)(c) or 1919(g)(1)(C) of the Act after January 1, 1995. IV. Collection of Information Requirements Under the Paperwork Reduction Act (PRA) of 1995, we are required to provide 60-day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the PRA of 1995 requires that we solicit comment on the following issues: • The need for the information collection and its usefulness in carrying out the proper functions of our agency. • The accuracy of our estimate of the information collection burden. • The quality, utility, and clarity of the information to be collected. • Recommendations to minimize the information collection burden on the affected public, including automated collection techniques. Therefore, we are soliciting public comments on each of these issues for the information collection requirements discussed below. Section 483.151 State review and approval of nurse aide training and competency evaluation programs and competency evaluation programs. Section 483.151(c)(1) states that a facility may request that CMS waive the disapproval of its nurse aid training program when the facility has been assessed a civil money penalty of not less than $5,000 if the civil money penalty was not related to the quality of care furnished to residents in the facility. The burden associated with this requirement is the time and effort put forth by the facility to request a waiver. While this requirement is subject to the PRA, we believe it meets the exemption requirements for the PRA found at 5 CFR 1320.4(a)(2). If you comment on any of these information collection and record keeping requirements, please mail copies directly to the following: Centers for Medicare & Medicaid Services, Office of Strategic Operations and Regulatory Affairs, Regulations Development Group, Attn.: Melissa Musotto, CMS-2266-P Room C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850; and Office of Information and Regulatory Affairs, Office of Management and Budget, Room 10235, New Executive Office Building, Washington, DC 20503, Attn: Carolyn Lovett, CMS Desk Officer, (CMS-2266-P), carolyn_lovett@omb.eop.gov . Fax (202) 395-6974. V. Response to Comments Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document. VI. Regulatory Impact Statement We have examined the impact of this rule as required by Executive Order 12866 (September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132. Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net 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 any 1 year). These two regulatory proposals would not reach the economic threshold and thus are not considered major rules. The RFA requires agencies to analyze options for regulatory relief of small business. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $6.5 million to $31.5 million in any 1 year. Individuals and States are not included in the definition of a small entity. We are not preparing an analysis for the RFA for either of these regulatory proposals because we have determined, and the Secretary certifies, that neither rule would have a significant economic impact on a substantial number of small entities. In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area and has fewer than 100 beds. We are not preparing an analysis for section 1102(b) of the Act for either of these regulatory proposals because we have determined, and the Secretary certifies, that neither rule would have a significant impact on the operations of a substantial number of small rural hospitals. Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. That threshold level is currently approximately $120 million. These regulatory proposals would have no consequential effect on State, local, or tribal governments or on the private sector. Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. Since these regulations would not impose costs on State or local governments, the requirements of E.O. 13132 are not applicable. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget. List of Subjects in Part 483 Grant programs—health, Health facilities, Health professions, Health Records, Medicaid, Medicare, Nursing homes, Nutrition, Reporting and recordkeeping requirements, Safety. For the reasons set forth in the preamble, the Centers for Medicare and Medicaid Services would amend 42 CFR chapter IV as set forth below: PART 483—REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES 1. The authority citation for part 483 continues to read as follows: Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh). § 483.150 [Amended] 2. Section 483.150(a) is revised to read as follows: § 483.150 Statutory basis: deemed meeting or waiver of requirements. (a) Statutory basis. This subpart is based on sections 1819(b)(5), 1819(f)(2), 1919(b)(5), and 1919(f)(2) of the Act, which establish standards for training nurse-aides and for evaluating their competency. § 483.151 [Amended] 3. Section 483.151 is amended by— A. Redesignating paragraphs (c), (d), and (e) as paragraphs (d), (e), and (f), respectively. B. Adding new paragraph (c). The addition reads as follows: § 483.151 State review and approval of nurse aide training and competency evaluation programs and competency evaluation programs. (c) Waiver of disapproval of nurse aide training programs. (1) A facility may request that CMS waive the disapproval of its nurse aide training program when the facility has been assessed a civil money penalty of not less than $5,000 if the civil money penalty was not related to the quality of care furnished to residents in the facility. (2) For purposes of this provision, “quality of care furnished to residents” means the direct hands-on care and treatment that a health care professional or direct care staff furnished to a resident. (3) Any waiver of disapproval of a nurse aide training program does not waive any requirement upon the facility to pay any civil money penalty. § 483.156 [Amended] 4. Section 483.156 is amended by— A. Redesignating paragraph (d) as paragraph (e). B. Adding new paragraph (d). The addition reads as follows: § 483.156 Registry of nurse aides. (d) Nurse aide petition for removal of information for a single finding of neglect. (1) The State must establish a procedure to permit a nurse aide to petition for removal of a finding of neglect from the nurse aide registry if the State determines that both of the following conditions exist: (i) The employment and personal history of the nurse aide does not reflect a pattern of abusive behavior or neglect. (ii) The neglect involved in the original finding was a single occurrence. (2) The determination on a petition for removal cannot be made before the expiration of the 1-year period beginning on the date on which the name of the petitioner was added to the nurse aide registry as a result of an investigation. (Catalog of Federal Domestic Assistance Program No. 93.778, Medical Assistance Program) Dated: May 16, 2007. Leslie V. Norwalk, Acting Administrator, Centers for Medicare & Medicaid Services. Approved: July 31, 2007. Michael O. Leavitt, Secretary. [FR Doc. E7-22629 Filed 11-21-07; 8:45 am] BILLING CODE 4120-01-P 72 225 Friday, November 23, 2007 Notices DEPARTMENT OF AGRICULTURE Food and Nutrition Service Agency Information Collection Activities: Proposed Collection; Comment Request—Child Nutrition Database AGENCY: Food and Nutrition Service, USDA. ACTION: Notice. SUMMARY: In accordance with the Paperwork Reduction Act of 1995, this notice announces the intention of the Food and Nutrition Service to request a revision of a currently approved collection. This collection is the voluntary submission of data including nutrient data from the food service industry to update and expand the Child Nutrition Database in support of the School Meals Initiative for Healthy Children. DATES: Comments on this notice must be received by January 22, 2008 to be assured of consideration. ADDRESSES: Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (b) the accuracy of the Agency's estimate of the burden of the proposed collection of information including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. All responses to this notice will be summarized and included in the request for OMB approval and will become a matter of public record. Comments may be sent to: Timothy Vezquez, Acting Team Leader, Technical Assistance Section, Nutrition Promotion and Training Branch, Child Nutrition Division, Room 632, Food and Nutrition Service, United States Department of Agriculture, 3101 Park Center Drive, Alexandria, VA 22302. FOR FURTHER INFORMATION CONTACT: Requests for additional information or copies of the information collection instrument and instruction should be directed to Timothy Vezquez at (703) 305-2609. SUPPLEMENTARY INFORMATION: Title: Child Nutrition Database. OMB Number: 0584-0494. Expiration Date: April 30, 2008. Type of Request: Revision of currently approved collection. Abstract: The development of the Child Nutrition (CN) Database is regulated by the United States Department of Agriculture (USDA), School Meals Initiative for Healthy Children. This database is designed to be incorporated in USDA-approved nutrient analysis software programs and provide an accurate source of nutrient data. The software allows schools participating in the National School Lunch (NSLP) and School Breakfast (SBP) Programs to analyze meals and measure the compliance of the menus to established nutrition goals and standards specified in 7 CFR 210.10 for the NSLP and 7 CFR 220.8 for the SBP. The information collection for the CN Database is conducted using an outside contractor. The CN Database needs to be updated with an extensive database of brand name or manufactured foods commonly used in school food service. The Food and Nutrition Service's contractor collects this data from the food industry to update and expand the CN Database. The submission of data from the food industry will be strictly voluntary, and based on analytical, calculated, or nutrition facts label sources. Collection of this information is accomplished by form FNS-710, CN Database Qualification Report. The revised FNS-710 will have a feature that does not allow a respondent to submit an incomplete form. Form FNS-709, CN Database Report: Products Missing Nutrient Information will be discontinued as a result of this new feature. Affected Public: Manufacturers of food produced for school food service. Estimate of Burden: Form FNS—710. Number of Respondents: 32. Estimated Number of Responses per Respondent: 35. Estimated Total Annual Responses: 1120. Estimated Time per Response: 2 Hours. Total Annual Burden: 2240 Hours. Total Annual Burden for Form FNS-710: 2240 Hours. Dated: November 16, 2007. Roberto Salazar, Administrator, Food and Nutrition Service. [FR Doc. E7-22889 Filed 11-21-07; 8:45 am] BILLING CODE 3410-30-P COMMITTEE FOR PURCHASE FROM PEOPLE WHO ARE BLIND OR SEVERELY DISABLED Procurement List; Additions and Deletion AGENCY: Committee for Purchase From People Who Are Blind or Severely Disabled. ACTION: Additions to and Deletion From the Procurement List. SUMMARY: This action adds to the Procurement List services to be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes from the Procurement List a service previously furnished by such agencies. DATES: Effective Date: December 23, 2007. ADDRESSES: Committee for Purchase From People Who Are Blind or Severely Disabled, Jefferson Plaza 2, Suite 10800, 1421 Jefferson Davis Highway, Arlington, Virginia 22202-3259. FOR FURTHER INFORMATION CONTACT: Kimberly M. Zeich, Telephone: (703) 603-7740, Fax: (703) 603-0655, or e-mail CMTEFedReg@jwod.gov. SUPPLEMENTARY INFORMATION: Additions On September 14, September 21 and September 28, the Committee for Purchase From People Who Are Blind or Severely Disabled published notice (72 FR 52542; 53989; 55173) of proposed additions to the Procurement List. After consideration of the material presented to it concerning capability of qualified nonprofit agencies to provide the services and impact of the additions on the current or most recent contractors, the Committee has determined that the services listed below are suitable for procurement by the Federal Government under 41 U.S.C. 46-48c and 41 CFR 51-2.4. Regulatory Flexibility Act Certification I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were: 1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will furnish the services to the Government. 2. The action will result in authorizing small entities to furnish the services to the Government. 3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 46-48c) in connection with the services proposed for addition to the Procurement List. End of Certification Accordingly, the following services are added to the Procurement List: Services Service Type/Location: Base Supply Center, Fort Belvoir, Fort Belvoir, VA. NPA: Virginia Industries for the Blind, Charlottesville, VA. Contracting Activity: Department of the Army, Capital District Contracting Center (CDCC), Fort Belvoir, VA. Service Type/Location: Call Center Operations, (Tele-Services-Tier 1 & Other Support Services, not to exceed 1% of the total requirement), Centers for Medicare and Medicaid Services, Beneficiary Contact Center Facility (BCC), 2400 Oakdale Boulevard, Coralville, IA. NPA: Peckham Vocational Industries, Inc., Lansing, MI. Contracting Activity: Department of Health and Human Services, Centers for Medicare and Medicaid Services, Baltimore, MD. Service Type/Location: Custodial Services, U.S. Army Reserve Center, Camp Bullis, Building 6143, San Antonio, TX. NPA: Professional Contract Services, Inc., Austin, TX. Contracting Activity: Army Contracting Agency, Southern Region, Fort Sam Houston, TX. Service Type/Location: Custodial Services, U.S. Coast Guard Office, 110 Mount Elliot Street, Detroit, MI. NPA: New Horizons Rehabilitation Services, Inc., Auburn Hills, MI. Contracting Activity: U.S. Coast Guard, Cleveland, OH. Service Type/Location: Document Destruction, Social Security Administration, 1301 Young Street, Dallas, TX. NPA: Expanco, Inc., Fort Worth, TX. Contracting Activity: Social Security Administration, Dallas, TX. Service Type/Location: Grounds Maintenance, Naval Support Activity, 2300 General Meyers Avenue, Algiers, LA. NPA: Goodworks, Inc., Metairie, LA. Contracting Activity: Naval Facilities Engineering Command (NAVFAC)-SE, New Orleans, LA. Deletion On September 28, 2007, the Committee for Purchase From People Who Are Blind or Severely Disabled published notice (72 FR 55174) of proposed deletions to the Procurement List. After consideration of the relevant matter presented, the Committee has determined that the services listed below are no longer suitable for procurement by the Federal Government under 41 U.S.C. 46-48c and 41 CFR 51-2.4. Regulatory Flexibility Act Certification I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were: 1. The action may result in additional reporting, recordkeeping or other compliance requirements for small entities. 2. The action may result in authorizing small entities to furnish the service to the Government. 3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 46-48c) in connection with the service deleted from the Procurement List. End of Certification Accordingly, the following service is deleted from the Procurement List: Service Service Type/Location: Janitorial/Custodial, Social Security Building, 350 Donmoor, Baton Rouge, LA. NPA: Louisiana Industries for the Disabled, Inc., Baton Rouge, LA. Contracting Activity: General Services Administration. Kimberly M. Zeich, Director, Program Operations. [FR Doc. E7-22850 Filed 11-21-07; 8:45 am] BILLING CODE 6353-01-P COMMISSION ON CIVIL RIGHTS Agenda and Notice of Public Meeting of the Florida Advisory Committee Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a planning meeting of a Sub-Committee of the Florida Advisory to the Commission will convene at 2 p.m. and adjourn at 5 p.m. on Monday, December 11, 2007, at the University of Central Florida, Downtown Center, 36 West Pine Street, Room 105, Orlando, FL 32801. The purpose of the meeting is to discuss the restoration of voting rights for ex-felons in Florida. Members of the public are entitled to submit written comments; the comments must be received in the regional office by December 31, 2007. The address is 61 Forsyth St., SW., Suite 18T40, Atlanta, Georgia, 30303. Persons wishing to e-mail their comments, or to present their comments verbally at the meeting, or who desire additional information should contact Peter Minarik, Regional Director, at (404) 562-7000 or 800-877-8339 for individuals who are deaf, hearing impaired, and/or have speech disabilities or by e-mail to pminarik@usccr.gov . Hearing-impaired persons who will attend the meeting and require the services of a sign language interpreter should contact the Regional Office at least ten (10) working days before the scheduled date of the meeting. Records generated from this meeting may be inspected and reproduced at the Southern Regional Office, as they become available, both before and after the meeting. Persons interested in the work of this advisory committee are advised to go to the Commission's Web site, http://www.usccr.gov , or to contact the Southern Regional Office at the above e-mail or street address. The meeting will be conducted pursuant to the provisions of the rules and regulations of the Commission and FACA. Dated at Washington, DC, November 19, 2007. Ivy L. Davis, Acting Chief, Regional Programs Coordination Unit. [FR Doc. E7-22859 Filed 11-21-07; 8:45 am] BILLING CODE 6335-02-P COMMISSION ON CIVIL RIGHTS Sunshine Act Notice AGENCY: United States Commission on Civil Rights. ACTION: Notice of meeting and briefing. Date and Time: Monday, December 3, 2007; 9 a.m. Meeting. 10 a.m. Briefing. Place: U.S. Commission on Civil Rights, 624 Ninth Street, NW., Rm. 540, Washington, DC 20425. Meeting Agenda I. Approval of Agenda. II. Approval of Minutes of October 12, Meeting. III. Program Planning. • Racial Preferences and the California Department of Transportation. IV. Adjourn Meeting. Briefing Agenda Topic: Minorities in Special Education. I. Introductory Remarks by Chairman. II. Speakers' Presentations. III. Questions by Commissioners and Staff Director. IV. Adjourn Briefing. Contact Person for Further Information: Robert Lerner, Press and Communications, (202) 376-8582. Dated: November 20, 2007. David Blackwood, General Counsel. [FR Doc. 07-5833 Filed 11-20-07; 3:14 pm]