Food Safety and Inspection Service
Rural Utilities Service
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National Oceanic and Atmospheric Administration
Engineers Corps
Energy Efficiency and Renewable Energy Office
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Federal Energy Regulatory Commission
Centers for Disease Control and Prevention
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Food and Drug Administration
National Institutes of Health
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Indian Affairs Bureau
Land Management Bureau
Alcohol, Tobacco, Firearms, and Explosives Bureau
Copyright Office, Library of Congress
Federal Aviation Administration
Federal Highway Administration
Federal Motor Carrier Safety Administration
National Highway Traffic Safety Administration
Internal Revenue Service
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.
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Office of Personnel Management.
Interim rule with request for comments.
The Office of Personnel Management is issuing interim regulations to provide that a locality rate of pay is considered basic pay for the purpose of computing danger pay allowances and post differentials for certain employees temporarily assigned to work in foreign areas for which the Department of State has established danger pay allowances. These regulations will aid agencies in responding to emergency, mission-critical staffing needs in support of the Global War on Terrorism and other international activities in imminently dangerous overseas work locations by increasing the danger pay allowance and post differential benefits for employees temporarily assigned to such locations.
Send or deliver comments to Donald J. Winstead, Deputy Associate Director for Pay and Performance Policy, Office of Personnel Management, Room 7H31, 1900 E Street, NW., Washington, DC 20415-8200; FAX: (202) 606-4264; or e-mail:
Jeanne Jacobson, (202) 606-2858; FAX: (202) 606-0824; or e-mail:
The Office of Personnel Management (OPM) is issuing interim regulations that amend 5 CFR 531.606(b) to provide that a locality rate of pay is considered basic pay for the purpose of computing danger pay allowances under 5 U.S.C. 5928 and post differentials under 5 U.S.C. 5925(a) for certain employees temporarily assigned to work in foreign areas for which the Department of State has established danger pay allowances. These regulations will aid agencies in responding to emergency, mission-critical staffing needs in imminently dangerous overseas work locations in support of the Global War on Terrorism and other international activities by increasing the danger pay allowance and post differential benefits for employees temporarily assigned to such locations.
Under 5 U.S.C. 5928, the Department of State may establish a danger pay allowance for a foreign area on the basis of civil insurrection, civil war, terrorism, or wartime conditions in that area which threaten physical harm or imminent danger to the health or well-being of an employee. A danger pay allowance may not exceed 25 percent of an employee's rate of basic pay. Employees are entitled to receive a danger pay allowance if they work in an approved danger pay post for a minimum of 4 hours in one day (including while on detail or in a temporary duty travel status).
Under 5 U.S.C. 5925(a), the Department of State may establish a post differential for an overseas location based on conditions of environment that differ substantially from conditions of environment in the continental United States and warrant additional pay as a recruitment and retention incentive. A past differential may not exceed 25 percent of an employee's rate of basic pay. Employees working on extended detail or in a temporary duty travel status in an overseas location with an approved post differential are entitled to receive the post differential after working in a hardship post location for 42 days.
The allowance and differential rates established by the Department of State apply to all United States Government civilian employees overseas, regardless of agency affiliation. Additional information on danger pay allowances and post differentials may be obtained from the Department of State at
Locality rates of pay under 5 U.S.C. 5304 and 5 CFR part 531, subpart F, are authorized for employees whose official duty stations (as defined in 5 CFR 531.602) are located in one of the locality pay areas listed in 5 CFR 531.603, covering all locations in the 48 contiguous States and Washington, DC. Employees with official duty stations outside the 48 contiguous States are not entitled to locality pay. However, the official duty station of an employee who is temporarily assigned to work in a location outside the 48 contiguous States while on detail or in a temporary duty travel status generally remains the duty station of his or her permanent position of record as indicated on the most recent notification of personnel action. Such employees are entitled to receive the locality rate of pay associated with their official duty station while working overseas.
Under 5 U.S.C. 5304(c)(2), a locality rate of pay must be considered part of basic pay for purposes of retirement under 5 U.S.C. chapters 83 or 84, as applicable; life insurance under 5 U.S.C. chapter 87; premium pay under 5 U.S.C. chapter 55, subchapter V; and for such other purposes as may be expressly provided for by law or as OPM may prescribe by regulation. OPM regulations provide that a locality rate of pay is considered basic pay for purposes of severance pay under 5 CFR part 550, subpart G, and advances in pay under 5 CFR part 550, subpart B. (See 5 CFR 531.606(b).)
These interim regulations amend 5 CFR 531.606(b) to provide that a locality rate of pay is considered basic pay for the purpose of computing danger pay allowances under 5 U.S.C. 5928 and post differentials under 5 U.S.C. 5925(a) for employees temporarily assigned to work in a foreign area for which the Department of State has established a danger pay allowance. Covered employees must be temporarily assigned
Prior to the effective date of these regulations, a locality rate of pay under 5 U.S.C. 5304 and 5 CFR part 531, subpart F, cannot be considered part of an employee's basic pay for the purpose of computing any overseas allowance or differential, including those paid to employees detailed to or on official travel in a foreign area. Agencies must correct the payment of any danger pay allowance, post differential, or other overseas allowance or differential paid prior to the effective date of these regulations if it was computed using a locality rate of pay authorized under 5 U.S.C. 5304. An overpayment may be recovered under an agency's regulations for collection by offset from an indebted Government employee under 5 U.S.C. 5514 and 5 CFR part 550, subpart K, or through the appropriate provisions governing Federal debt collection if the individual is no longer a Federal employee. However, the head of an agency may waive an overpayment under 5 U.S.C. 5584, as appropriate.
In order to give practical effect to these regulations at the earliest possible moment, I find that good cause exists to waive the general notice of proposed rulemaking pursuant to 5 U.S.C. 553(b)(3)(B). Also, I find that good cause exists for making this rule effective in less than 30 days. The delay in effective date is waived so that affected agencies and employees may benefit from the new provisions as quickly as possible. Increasing the danger pay allowance and post differential benefits for employees temporarily assigned to imminently dangerous overseas work locations will help agencies respond to emergency, mission-critical staffing needs in support of the Global War on Terrorism and other important international activities.
The Office of Management and Budget has reviewed this rule in accordance with E.O. 12866.
I certify that these regulations will not have a significant economic impact on a substantial number of small entities because they will apply only to Federal agencies and employees.
Government employees, Law enforcement officers, Wages.
5 U.S.C. 5115, 5307, and 5338; sec. 4 of Pub. L. 103-89, 107 Stat. 981; and E.O. 12748, 56 FR 4521, 3 CFR, 1991 Comp., p. 316; Subpart B also issued under 5 U.S.C. 5303(g), 5333, 5334(a), and 7701(b)(2); Subpart C also issued under 5 U.S.C. 5304, 5305, and 5553; sections 302 and 404 of Federal Employees Pay Comparability Act of 1990 (FEPCA), Pub. L. 101-509, 104 Stat. 1462 and 1466; and section 3(7) of Pub. L. 102-378, 106 Stat. 1356; Subpart D also issued under 5 U.S.C. 5335(g) and 7701(b)(2); Subpart E also issued under 5 U.S.C. 5336; Subpart F also issued under 5 U.S.C. 5304, 5305(g)(1), and 5553; and E.O. 12883, 58 FR 63281, 3 CFR, 1993 Comp., p. 682 and E.O. 1306, 63 FR 68151, 3 CFR, 1998 Comp., p. 224; Subpart G also issued under 5 U.S.C. 5304, 5305, and 5553; section 302 of the FEPCA, Pub. L. 101-509, 104 Stat. 1462; and E.O. 12786, 56 FR 67453, 3 CFR, 1991 Comp., p. 376.
(b) * * *
(6) Post differentials under 5 U.S.C. 5925(a) and danger pay allowances under 5 U.S.C. 5928 for an employee temporarily assigned to work in a foreign area for which the Department of State has established a danger pay allowance under 5 U.S.C. 5928, when the employee's official duty station is located in a locality pay area under § 531.603.
Federal Aviation Administration (FAA), DOT.
Final special conditions; request for comments.
These special conditions are issued to Garmin AT, Inc., 2345 Turner Road, Salem, OR 97302, for a Supplemental Type Certificate for the Piper PA-32. This airplane, as modified by Garmin AT, Inc., will have novel and unusual design features when compared to the state of technology envisaged in the applicable airworthiness standards. These novel and unusual design features include the installation of an electronic flight instrument system (EFIS) display, Model G-1000, manufactured by Garmin AT, Inc., for which the applicable regulations do not contain adequate or appropriate airworthiness standards for the protection of these systems from the effects of high intensity radiated fields (HIRF). These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to the airworthiness standards applicable to this airplane.
The effective date of these special conditions is July 26, 2004. Comments must be received on or before September 7, 2004.
Comments may be mailed in duplicate to: Federal Aviation Administration, Regional Counsel, ACE-7, Attention: Rules Docket Clerk, Docket No. CE209, Room 506, 901 Locust, Kansas City, Missouri 64106. All comments must be marked: Docket No. CE209. Comments may be inspected in the Rules Docket weekdays, except Federal holidays, between 7:30 a.m. and 4 p.m.
Wes Ryan, Aerospace Engineer, Standards Office (ACE-110), Small Airplane
The FAA has determined that notice and opportunity for prior public comment hereon are impracticable because these procedures would significantly delay issuance of the design approval and thus delivery of the affected aircraft. In addition, the substance of these special conditions has been subject to the public comment process in several prior instances with no substantive comments received. The FAA, therefore, finds that good cause exists for making these special conditions effective upon issuance.
Interested persons are invited to submit such written data, views, or arguments, as they may desire. Communications should identify the regulatory docket or notice number and be submitted in duplicate to the address specified above. All communications received on or before the closing date for comments will be considered by the Administrator. The special conditions may be changed in light of the comments received. All comments received will be available in the Rules Docket for examination by interested persons, both before and after the closing date for comments. A report summarizing each substantive public contact with FAA personnel concerning this rulemaking will be filed in the docket. Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this notice must include a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. CE209.” The postcard will be date stamped and returned to the commenter.
On January 5, 2004, Garmin AT, Inc., 2345 Turner Road, Salem, OR 97302, made an application to the FAA for a new Supplemental Type Certificate for the Piper PA-32. The PA-32 is currently approved under TC No. A3SO. The proposed modification incorporates a novel or unusual design feature, such as digital avionics consisting of an EFIS that is vulnerable to HIRF external to the airplane.
Under the provisions of 14 CFR part 21, § 21.101, Garmin AT, Inc. must show that the Piper PA-32 aircraft meets the original certification basis for the airplane, as listed on Type Data Sheet A3SO; the additional certification requirements added for the G1000 system, exemptions, if any; and the special conditions adopted by this rulemaking action.
If the Administrator finds that the applicable airworthiness standards do not contain adequate or appropriate safety standards because of novel or unusual design features of an airplane, special conditions are prescribed under the provisions of § 21.16.
Special conditions, as appropriate, as defined in § 11.19, are issued in accordance with § 11.38 after public notice and become part of the type certification basis in accordance with § 21.101.
Special conditions are initially applicable to the model for which they are issued. Should the applicant apply for a supplemental type certificate to modify any other model already included on the same type certificate to incorporate the same novel or unusual design feature, the special conditions would also apply to the other model under the provisions of § 21.101.
Garmin AT, Inc. plans to incorporate certain novel and unusual design features into the Piper PA-32 airplane for which the airworthiness standards do not contain adequate or appropriate safety standards for protection from the effects of HIRF. These features include EFIS, which are susceptible to the HIRF environment, that were not envisaged by the existing regulations for this type of airplane.
Furthermore, the HIRF environment has undergone a transformation that was not foreseen when the current requirements were developed. Higher energy levels are radiated from transmitters that are used for radar, radio, and television. Also, the number of transmitters has increased significantly. There is also uncertainty concerning the effectiveness of airframe shielding for HIRF. Furthermore, coupling to cockpit-installed equipment through the cockpit window apertures is undefined. The combined effect of the technological advances in airplane design and the changing environment has resulted in an increased level of vulnerability of electrical and electronic systems required for the continued safe flight and landing of the airplane. Effective measures against the effects of exposure to HIRF must be provided by the design and installation of these systems. The accepted maximum energy levels in which civilian airplane system installations must be capable of operating safely are based on surveys and analysis of existing radio frequency emitters. These special conditions require that the airplane be evaluated under these energy levels for the protection of the electronic system and its associated wiring harness. These external threat levels, which are lower than previous required values, are believed to represent the worst case to which an airplane would be exposed in the operating environment.
These special conditions require qualification of systems that perform critical functions, as installed in aircraft, to the defined HIRF environment in paragraph 1 or, as an option to a fixed value using laboratory tests, in paragraph 2, as follows: (1) The applicant may demonstrate that the operation and operational capability of the installed electrical and electronic systems that perform critical functions are not adversely affected when the aircraft is exposed to the HIRF environment defined below:
(2) The applicant may demonstrate by a system test and analysis that the electrical and electronic systems that perform critical functions can withstand a minimum threat of 100 volts per meter, electrical field strength, from 10 kHz to 18 GHz. When using this test to show compliance with the HIRF requirements, no credit is given for signal attenuation due to installation.
A preliminary hazard analysis must be performed by the applicant for approval by the FAA to identify either electrical or electronic systems that perform critical functions. The term “critical” means those functions whose failure would contribute to, or cause, a failure condition that would prevent the continued safe flight and landing of the airplane. The systems identified by the hazard analysis that perform critical functions are candidates for the application of HIRF requirements. A system may perform both critical and non-critical functions. Primary electronic flight display systems, and their associated components, perform critical functions such as attitude, altitude, and airspeed indication. The HIRF requirements apply only to critical functions.
Compliance with HIRF requirements may be demonstrated by tests, analysis, models, similarity with existing systems, or any combination of these. Service experience alone is not acceptable since normal flight operations may not include an exposure to the HIRF environment. Reliance on a system with similar design features for redundancy as a means of protection against the effects of external HIRF is generally insufficient since all elements of a redundant system are likely to be exposed to the fields concurrently.
As discussed above, these special conditions are applicable to the Piper PA-32. Should Garmin AT, Inc. apply at a later date for a supplemental type certificate to modify any other model on the same type certificate to incorporate the same novel or unusual design feature, the special conditions would apply to that model as well under the provisions of § 21.101.
This action affects only certain novel or unusual design features on one model of airplane. It is not a rule of general applicability and affects only the applicant who applied to the FAA for approval of these features on the airplane.
The substance of these special conditions has been subjected to the notice and comment period in several prior instances and has been derived without substantive change from those previously issued. It is unlikely that prior public comment would result in a significant change from the substance contained herein. For this reason, and because a delay would significantly affect the certification of the airplane, which is imminent, the FAA has determined that prior public notice and comment are unnecessary and impracticable, and good cause exists for adopting these special conditions upon issuance. The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to the prior opportunities for comment described above.
Aircraft, Aviation safety, Signs and symbols.
49 U.S.C. 106(g), 40113 and 44701; 14 CFR 21.16 and 21.101; and 14 CFR 11.38 and 11.19.
1.
2. For the purpose of these special conditions, the following definition applies:
Federal Aviation Administration (FAA), DOT.
Final rule.
This final rule modifies Class E airspace at La Junta, CO. Additional controlled airspace is required for the new Area Navigation (RNAV) Global Position System (GPS) Standard Instrument Approach Procedures (SIAPs) recently developed. This additional Class E airspace will promote the safety of instrument flight rules (IFR) aircraft executing these new procedures when transitioning to/from the en route environment.
0901 UTC, October 28, 2004.
Ed Hawseker; Air Traffic Division, Federal Aviation Administration, 1601 Lind Avenue SW., Renton, Washington 98055-4056; telephone (425) 227-2527
On November 6, 2003, the FAA issued a notice of proposed rule making (NPRM) in which it proposed to amend Federal Aviation Regulation 14 CFR Part 71 by modifying Class E airspace extending upward from 700 feet or more above the surface of the earth at La Junta, CO (68 FR page 62760). The NPRM proposed to increase the Class E airspace to accommodate IFR aircraft executing the new RNAV GPS SIAPs and IFR aircraft transitioning to/from the en route environment.
Interested parties were invited to participate in this rule making proceeding by submitting written comments on the proposal to the FAA. No comments were received. Class E airspace areas extending upward from 700 feet or more above the surface of the earth are published in paragraph 6005 of FAA Order 7400.9L dated September 02, 2003, and effective September 16, 2003, which is incorporated by reference in 14 CFR Part 71.1. The Class E airspace designations listed in this document will be published subsequently in that Order.
This amendment to 14 CFR Part 71 will modify Class E airspace at La Junta, CO to accommodate IFR aircraft executing newly developed RNAV GPS SIAPs at La Junta Municipal Airport. Additional Class E airspace is necessary to provide adequate controlled airspace for the safety of IFR aircraft executing these new RNAV GPS SIAPs during the transition to/from the en route environment.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Airspace, Incorporation by reference, Navigation (air).
49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface of the earth bound by a line beginning at lat. 38°12′36″ n., long. 103°58′00″ W.; to lat. 38°10′24″ N., long. 103°22′24″ W.; to lat. 37°54′12″ N., long. 103°22′42″ W.; to lat. 37°54′05″ N., long. 103°58′25″ W.; thence to the point of origin; excluding that airspace within federal airways.
Federal Aviation Administration (FAA), DOT.
Direct final rule; request for comments; correction.
This action corrects a direct final rule; request for comments that was published in the
This direct final rule is effective on 0901 UTC, September 30, 2004.
Brenda Mumper, Air Traffic Division, Airspace Branch, ACE-520A, DOT Regional Headquarters Building, Federal Aviation Administration, 901 Locust, Kansas City, MO 64106; telephone: (816) 329-2524.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action establishes Restricted Areas 5802C, D, and E (R-5802C, D, and E), at Fort Indiantown Gap, PA. The FAA is taking this action to provide additional restricted airspace needed by the Department of Defense (DOD) to conduct realistic aircrew training and to maintain proficiency in modern tactics that are required for combat readiness.
Effective: 0901 UTC, September 30, 2004.
Paul Gallant, Airspace and Rules, Office of System Operations and Safety, Federal Aviation Administration, 800 Independence Avenue, SW., Washington, DC 20591; telephone: (202) 267-8783.
On August 14, 2003, the FAA published a notice in the
The notice proposed to establish R-5802C, extending from 500 feet above ground level (AGL) up to but not including 17,000 feet above mean sea level (MSL). R-5802C would consist primarily of that airspace currently designated as the Kiowa military operations area (MOA). Concurrent with the designation of R-5802C, the Kiowa MOA would be revoked through a separate non-rulemaking action. The FAA also proposed to establish R-5802D extending from 17,000 feet MSL to but not including flight level (FL) 220; and R-5802E extending from FL 220 to FL 250.
The notice further proposed to change the time of designation for the existing restricted areas, R-5802A and B, from the current “February 15 through May 10 and September 1 through December 15, 0800-2300 local time on Saturdays and 0800-1200 local time on Sundays; May 11 through August 31, 0800-2400 local time on Saturdays and 0800-2000 local time on all other days; other times by NOTAM issued at least 48 hours in advance,” to “daily, sunrise to 2200;” and to change the using agency from “Commander, Fort Indiantown Gap, Annville, PA,” to “ANG, 193rd SOW, Det 1, Fort Indiantown Gap Military Reservation, PA.” In addition, the FAA proposed to apply the revised time of designation and using agency to the proposed restricted areas R-5802C, D, and E. On August 22, 2003, the FAA published a correction in the
Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal. Comments were received from the Experimental Aircraft Association (EAA), the Aircraft Owners and Pilots Association (AOPA), and two individuals.
In response to the notice, the EAA did not oppose the proposed modifications, but commented that the FAA should make a graphic depiction of the proposed airspace available in an electronic format to make it easier for interested parties to review. The FAA currently provides “hard copy” graphics of special use airspace (SUA) proposals upon request and will explore options for making proposed SUA graphic depictions available via electronic means.
AOPA objected to the proposed increase in the restricted areas' time of designation stating that restricted area usage data do not indicate a need to increase the times of use. AOPA recommended that the currently published time of designation for R-5802A and B be retained for the Bollen Range airspace. In response to this comment, the Air National Guard (ANG) reevaluated its requirements and requested that the FAA not amend the time of designation for the restricted areas. Based on this request, the proposed change to the time of designation is hereby withdrawn. The time of designation currently published for R-5802A and B will remain unchanged and the same time period will be applied to R-5802C, D, and E.
The ANG also requested that the FAA not amend the name of the using agency for the Bollen Range restricted areas as proposed in the notice. Based on this request, the proposed change to the name of the using agency for the Bollen Range restricted areas is hereby withdrawn. The using agency for all Bollen Range restricted areas will remain “Commander, Fort Indiantown Gap, Annville, PA.” Consequently, R-5802A and B will not be modified by this action.
One commenter wrote that the notice did not provide a rationale for converting the Kiowa MOA to a restricted area. The FAA does not agree. As discussed in the notice, the FAA proposed these changes because the existing Bollen Range restricted areas are too small to permit essential aircrew training. For example, High Altitude Release Bomb (HARB) deliveries cannot be accomplished at the range because the existing restricted area ceiling (13,000 feet MSL) is too low to contain the required high altitude release bombing patterns. Further, the current restricted area lateral dimensions are too small to provide realistic training in other tactics such as covert lighting, night vision devices, and targeting laser systems. Since an MOA cannot be used for hazardous training activities, such as weapons delivery, use of target designation lasers, etc., these types of activities must be conducted in a restricted area. Therefore, the conversion of the Kiowa MOA to restricted airspace is necessary to provide sufficient SUA for realistic aircrew training at the Bollen Range.
Another commenter suggested that use of the restricted areas be limited to nighttime only because the stated justification for the proposal was based on “recent combat experience” wherein bombing was usually done at night. The FAA does not agree. The justification for expanding the airspace is only partly based on nighttime operations requirements. As discussed above, the purpose of the proposed expansion is to provide higher altitudes to contain HARB deliveries, and to provide sufficient lateral space for more realistic training in other tactics, including the use of target designation lasers, covert lighting, and night vision devices. Aircrew qualification and recurring proficiency training for HARB and other tactics requires both day and nighttime operations. In addition, there is a continuing requirement to use the range for ongoing day and night activities that have been conducted there for years.
AOPA and the other commenters opposed the restricted airspace expansion based on their belief that it would place unnecessary restrictions on general aviation operations, effectively eliminate general aviation aircraft overflights of this airspace, and disrupt and delay air traffic flowing into and out of the New York, Philadelphia, and Washington, DC areas. The FAA does not agree with these comments for the following reasons. The controlling agency (New York Air Route Traffic Control Center) negotiated modifications to the ANG's preliminary proposal to minimize air traffic disruptions and delay conflicts in the affected area. Air traffic flow in the area runs mainly to the north and east of both the existing and expanded Bollen Range SUA. Converting the Kiowa MOA to R-5802C will result in only a small lateral expansion of restricted airspace by approximately one, to one and one-half, nautical miles on the northwest side of the existing restricted area boundary. The expanded restricted airspace remains clear of all Federal airways in the vicinity of the range, and also remains clear of the boundary of the Harrisburg Terminal Radar Service Area (TRSA) located to the south of the range. Restricted areas R-5802A, B, C, and D, will encompass a relatively small area that is roughly 5 nautical miles by 7 nautical miles in size. Therefore, a minor flight path deviation would be required to avoid the airspace during periods when military activity precludes overflight of the range. Additionally, to minimize possible impact on nonparticipating aircraft operations that might result from the expansion of the range, the restricted areas will be subjected to “joint-use” procedures and will be scheduled only when needed for military activity. In consideration of the above, the FAA does not believe that these modifications will significantly affect aviation access in the vicinity of the Bollen Range.
Except for the above changes and editorial changes, this amendment is the same as that proposed in the notice.
The FAA Administrator has broad authority under Title 49 of the United States Code (49 U.S.C.) to regulate the use of the navigable airspace. In exercising that authority, the Administrator is required to give consideration to the requirements of national defense and commercial and general aviation, and the public right of freedom of transit through the navigable airspace (49 U.S.C. 40101). The Administrator is also empowered to develop plans and policy for the use of the navigable airspace and assign by regulation or order the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace (49 U.S.C. 40103(b)). Additionally, the Administrator shall, in consultation with the Secretary of Defense, establish areas in the airspace the Administrator decides are necessary in the interest of national defense (49 U.S.C. 40103(b)(3)(A)).
The FAA is amending Title 14 Code of Federal Regulations (14 CFR) part 73 (part 73) by establishing R-5802C, D, and E, at Fort Indiantown Gap, PA. Specifically, R-5802C will extend from 500 feet AGL to but not including 17,000 feet MSL and will be formed, in part, by converting the Kiowa MOA to restricted airspace. Concurrent with this action, the Kiowa MOA will be revoked. R-5802D will extend from 17,000 feet MSL to but not including FL 220, and R-5802E will extend from FL 220 to FL 250. The time of designation for the new restricted areas will be “February 15 through May 10 and September 1 through December 15, 0800-2300 local time on Saturdays and 0800-1200 local time on Sundays; May 11 through August 31, 0800-2400 local time on Saturdays and 0800-2000 local time on all other days; other times by NOTAM issued at least 48 hours in advance.” The using agency for the airspace will be the “Commander, Fort Indiantown Gap, Annville, PA,” and the Controlling Agency will be “FAA, New York ARTCC.”
The ANG requested the FAA to take this action because additional restricted airspace is needed at the Bollen Range to contain HARB training, and to enable more realistic aircrew training in various other tactics, involving both high and low altitudes, and day and nighttime operations. In addition to the aircraft activities described above, portions of the Fort Indiantown Gap/Bollen Range restricted airspace will continue to be used for the various fixed-wing and helicopter aircraft operations, ground-based weapons firings, and other activities that are currently conducted at the range. The FAA has determined that this rulemaking action is “necessary in the interest of national defense” as required under 49 U.S.C. 40103(b)(3)(A).
Section 73.58 of part 73 of the Federal Aviation Regulations was republished in FAA Order 7400.8L dated October 7, 2003.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this proposed regulation: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation, (DOT) Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The Pennsylvania ANG conducted an environmental impact analysis of the proposal and determined that the proposed action qualifies for a categorical exclusion in accordance with applicable U.S. Air Force directives. The FAA reviewed the proponent's environmental analysis documentation and determined that this airspace action is not expected to cause any potentially significant environmental impacts and does not trigger any extraordinary circumstances that would warrant preparation of an environmental assessment. The FAA determined, therefore, that this action qualifies for categorical exclusion from further environmental analysis under the National Environmental Policy Act in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and
Airspace, Navigation (air).
49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
Food and Drug Administration, HHS.
Final rule.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's address for Hess & Clark, Inc., a wholly-owned company of the Neogen Corp.
This rule is effective August 5, 2004.
David R. Newkirk, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail:
Hess & Clark, Inc., Seventh and Orange Sts., Ashland, OH 44805, has informed FDA of a change of sponsor's address to 944 Nandino Blvd., Lexington, KY 40511. Accordingly, the agency is amending the regulations in 21 CFR 510.600(c) to reflect the change.
This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.
Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.
21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
(c) * * *
(1) * * *
(2) * * *
Food and Drug Administration, HHS.
Final rule.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for one new animal drug application (NADA) from Chemdex, Inc., to Sparhawk Laboratories, Inc., and one NADA and two abbreviated new animal drug applications (ANADAs) from Veterinary Laboratories, Inc., to Sparhawk Laboratories, Inc.
This rule is effective August 5, 2004.
David R. Newkirk, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail:
Chemdex, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215, has informed FDA that it has transferred ownership of, and all rights and interest in, the following approved NADA to Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215:
Veterinary Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215, has informed FDA that it has transferred ownership of, and all rights and interest in, the following approved NADA and two approved ANADAs to Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215:
Accordingly, the agency is amending the regulations in 21 CFR 522.540, 522.1183, 522.1260, and 524.1580b to reflect the transfer of ownership.
Following these changes of sponsorship, Chemdex, Inc., and Veterinary Laboratories, Inc., are no longer the sponsor of an approved application. Accordingly, the agency is amending 21 CFR 510.600(c) to remove the entries for Chemdex, Inc., and Veterinary Laboratories, Inc.
This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.
Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.
Animal drugs.
21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
(c) * * *
(1) * * *
(2) * * *
21 U.S.C. 360b.
21 U.S.C. 360b.
(b)
Food and Drug Administration, HHS.
Final rule.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two supplemental new animal drug applications (NADAs) filed by Pharmacia & Upjohn Co. The supplemental NADAs provide for establishing a 4-day preslaughter withdrawal period in swine injected with either a solution made from ceftiofur sodium powder or with a ceftiofur hydrochloride suspension.
This rule is effective August 5, 2004.
Joan C. Gotthardt, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail:
Pharmacia & Upjohn Co., 7000 Portage Rd., Kalamazoo, MI 49001-0199, filed supplements to NADA 140-338 for NAXCEL (ceftiofur sodium) Sterile Powder for Injection and to NADA 140-890 for EXCENEL RTU (ceftiofur hydrochloride) Sterile Suspension. The supplemental NADAs provide for establishing a 4-day preslaughter withdrawal period in swine injected with either product. The supplemental applications are approved as of June 18, 2004, and the regulations are amended in 21 CFR 522.313 and 522.314 to reflect the approval. The basis of approval is discussed in the freedom of information summary.
In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), summaries of safety and effectiveness data and information submitted to support approval of these applications may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
The agency has determined under 21 CFR 25.33(a)(1) that these actions are of a type that do not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required for either.
This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.
Animal drugs.
21 U.S.C. 360b.
Food and Drug Administration, HHS.
Final rule.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Boehringer Ingelheim Vetmedica, Inc. The NADA provides for the veterinary prescription use of romifidine hydrochloride injectable solution in horses as a sedative and analgesic, and as a preanesthetic agent.
This rule is effective August 5, 2004.
Melanie R. Berson, Center for Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7543, e-mail:
Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Highway, St. Joseph, MO 64506-2002, filed NADA 141-229 that provides for the veterinary prescription use of SEDIVET (romifidine hydrochloride) 1% Injection as a sedative and analgesic to facilitate handling, clinical examinations, clinical procedures, and minor surgical procedures in adult horses. SEDIVET 1% Injection is also indicated as a preanesthetic to the induction of general anesthesia in adult horses. The NADA is approved as of June 3, 2004, and 21 CFR part 522 is amended by adding § 522.2076 to reflect the approval. The basis of approval is discussed in the freedom of information summary.
In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application
Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 5 years of marketing exclusivity beginning .
The agency has determined under 21 CFR 25.33(d)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.
Animal drugs.
21 U.S.C. 360b.
(a)
(b)
(c)
(2)
(3)
Food and Drug Administration, HHS.
Final rule.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Altana Inc. The ANADA provides for veterinary prescription use of gentamicin sulfate ophthalmic ointment on dogs and cats for topical treatment of conjunctivitis caused by susceptible bacteria.
This rule is effective August 5, 2004.
Lonnie W. Luther, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail:
Altana Inc., 60 Baylis Rd., Melville, NY 11747, filed ANADA 200-273 for veterinary prescription use of VETRO-GEN (gentamicin sulfate) Veterinary Ophthalmic Ointment on dogs and cats for topical treatment of conjunctivitis caused by susceptible bacteria. Altana Inc.'s VETRO-GEN Veterinary Ophthalmic Ointment is approved as a generic copy of Schering-Plough Animal Health's GENTOCIN Ophthalmic Ointment, approved under NADA 98-989. The ANADA is approved as of June 8, 2004, and 21 CFR 524.1044c is amended to reflect the approval and a current format. The basis of approval is discussed in the freedom of information summary.
In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
The agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.
Animal drugs.
21 U.S.C. 360b.
(a)
(b)
(c)
(2)
(3)
Internal Revenue Service (IRS), Treasury.
Temporary regulations.
This document contains temporary regulations relating to an election that may be made by noncorporate taxpayers to treat qualified dividend income as investment income for purposes of calculating the deduction for investment interest. The regulations reflect changes to the law made by the Jobs and Growth Tax Relief Reconciliation Act of 2003. The regulations affect taxpayers making the election under section 163(d)(4)(B) to treat qualified dividend income as investment income. The text of these temporary regulations also serves as the text of the proposed regulations set forth in the notice of proposed rulemaking on this subject in the Proposed Rules section in this issue of the
Amy Pfalzgraf, (202) 622-4950 (not a toll-free number).
Section 163(d)(1) provides that the investment interest deduction for a noncorporate taxpayer for any taxable year is limited to the net investment income of the taxpayer for the taxable year. Section 163(d)(4)(A) defines “net investment income” as the excess of investment income over investment expenses. Section 163(d)(4)(B)(iii) provides that an electing taxpayer may take all or a portion of certain net capital gain attributable to dispositions of property held for investment into account as investment income. Section 1(h)(2) provides that any net capital gain taken into account as investment income is not eligible to be taxed at the capital gains rates.
Section 302(b) of the Jobs and Growth Tax Relief Reconciliation Act of 2003, (Pub. L. 108-27, 117 Stat. 762) (JGTRRA 2003), amended section 163(d)(4)(B) to provide that an electing taxpayer may take all or a portion of qualified dividend income (as defined in section 1(h)(11)(B)) into account as investment income. Section 302(a) of JGTRRA 2003 added new section 1(h)(11)(D) to provide that any qualified dividend income taken into account as investment income is not eligible to be taxed at the capital gains rates.
Section 1.163(d)-1 of the Income Tax Regulations provides rules regarding the time and manner for making the net capital gain election under section 163(d)(4)(B)(iii). These regulations amend § 1.163(d)-1 to provide that the rules regarding the time and manner for making the qualified dividend income election under section 163(d)(4)(B) are the same as the rules for making the net capital gain election under section 163(d)(4)(B)(iii).
It has been determined that this Treasury decision is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required. It also has been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations. For application of the Regulatory Flexibility Act (5 U.S.C. chapter 6) please refer to the cross-reference notice of proposed rulemaking published elsewhere in this issue of the
The principal author of these regulations is Amy Pfalzgraf of the Office of Associate Chief Counsel (Income Tax & Accounting). However, other personnel from the IRS and Treasury Department participated in their development.
Income taxes, Reporting and recordkeeping requirements.
26 U.S.C. 7805 * * *
(a) [Reserved]. For further guidance, see § 1.163(d)-1T(a).
(b) [Reserved]. For further guidance, see § 1.163(d)-1T(b).
(c) [Reserved]. For further guidance, see § 1.163(d)-1T(c).
(d) [Reserved]. For further guidance, see § 1.163(d)-1T(d).
(a)
(b)
(c)
(d)
Environmental Protection Agency (EPA).
Final rule.
In this action, the EPA is approving the Central Puget Sound carbon monoxide (CO) and Ozone Second 10-Year Maintenance Plans. Specifically EPA is approving Washington's demonstration that the Central Puget Sound area will maintain air quality standards for CO and ozone through the year 2016; a revised CO motor vehicle emissions budget for transportation conformity purposes using the MOBILE6.2 emissions model and latest growth and planning assumptions; updates and enhancements of state implementation plan (SIP) control measures and contingency measures; and identification of emissions associated with the Seattle Tacoma International Airport included in the area-wide emissions inventory through the maintenance period.
This final rule is effective on September 7, 2004.
EPA has established a docket for this action under Docket ID No. WA-04-001. Publicly available docket materials are available in hard copy at the EPA, Region 10, Office of Air, Waste and Toxics, 1200 Sixth Avenue, Seattle, WA. This Docket facility is open from 8:30-4, Monday through Friday, excluding legal holidays. The Docket telephone number is (206) 553-4273.
Connie L. Robinson, Office of Air, Waste and Toxics (OAQ-107), EPA Region 10, 1200 Sixth Avenue, Seattle, WA; telephone number: (206) 553-1086; fax number: (206) 553-0110; e-mail address:
Throughout this document, wherever “we,” “us,” or “our” is used, we mean the EPA. Information is organized as follows:
On June 1, 2004, EPA published in the
EPA provided a 30-day review and comment period and solicited comments on our proposal published in the June 1, 2004,
In this action, the EPA is approving the Central Puget Sound CO and Ozone Second 10-Year Maintenance Plans. Specifically EPA is approving Washington's demonstration that the Central Puget Sound area will maintain air quality standards for CO and ozone through the year 2016; a revised CO motor vehicle emissions budget for transportation conformity purposes using the MOBILE6.2 emissions model and latest growth and planning assumptions; updates and enhancements of state implementation plan (SIP) control measures and contingency measures; and identification of emissions associated with the Seattle Tacoma International Airport included in the area-wide emissions inventory through the maintenance period. A Technical Support Document on file at the EPA Region 10 office contains a detailed analysis and rationale in support of the Central Puget Sound CO and Ozone Second 10-Year Maintenance Plans.
Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a State rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.
In reviewing SIP submissions, EPA's role is to approve State choices, provided that they meet the criteria of the Clean Air Act. In this context, in the
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by October 4, 2004. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Ozone, Reporting and recordkeeping requirements.
42 U.S.C. 7401
(c) * * *
(83) On December 17, 2003, the Washington Department of Ecology submitted carbon monoxide and ozone second 10-year maintenance plans. The State's maintenance plans, meet the requirements of the Clean Air Act.
(i) Incorporation by reference.
(A) Puget Sound Clean Air Agency, Regulation I, Section 8.06, Outdoor Burning Ozone Contingency Measure, as in effect December 19, 2002.
(B) Puget Sound Clean Air Agency, Regulation II, Section 2.09, Oxygenated Gasoline Carbon Monoxide Contingency Measures and Fee Schedule, as in effect December 19, 2002.
(C) Puget Sound Clean Air Agency, Regulation II, Section 2.10, Gasoline Station Ozone Contingency Measure, as in effect December 19, 2002.
(a) * * *
(3) Central Puget Sound.
(i) EPA approves as a revision to the Washington State Implementation Plan, the Central Puget Sound Carbon Monoxide and Ozone Second 10-Year Maintenance Plans submitted by the State on December 17, 2003.
(ii) [Reserved]
Environmental Protection Agency (EPA).
Withdrawal of direct final rule.
Due to adverse comments, EPA is withdrawing the direct final rule to amend Pennsylvania's ten-year plan to maintain the 1-hour ozone national ambient air quality standard (NAAQS) in the Pittsburgh-Beaver Valley ozone maintenance area (the Pittsburgh area). In the direct final rule published on July 1, 2004 (69 FR 39854), we stated that if we received adverse comment by August 2, 2004, the rule would be withdrawn and not take effect. EPA subsequently received adverse comments. EPA will address the comments received in a subsequent final action based upon the proposed action also published on July 1, 2004. EPA will not institute a second comment period on this action.
The Direct final rule is withdrawn as of August 5, 2004.
Larry Budney, Energy, Radiation and Indoor Environment Branch, Mail code 3AP23, U.S. Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103; or by phone at (215) 814-2184.
Environmental protection, Air pollution control, Incorporation by reference, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
Environmental Protection Agency (EPA).
Direct final rule.
EPA is taking direct final action to approve a State Implementation Plan (SIP) revision submitted by the State of Colorado on July 31, 2002, for the purpose of redesignating the Lamar, Colorado and Steamboat Springs, Colorado areas from
This rule is effective on October 4, 2004, without further notice, unless EPA receives adverse comment by September 7, 2004. If adverse comment is received, EPA will publish a timely withdrawal of the direct final rule in the
Written comments may be mailed to Richard R. Long, Director, Air and Radiation Program, Mailcode 8P-AR, Environmental Protection Agency, Region VIII, 999 18th Street, Suite 300, Denver, CO 80202. Comments may also be submitted electronically, or through hand delivery/courier. Please follow the detailed instructions described in section (I)(B)(1)(i) through (iii) of the
Libby Faulk, EPA, Region VIII, (303) 312-6083.
Throughout this document, wherever “we,” “us,” or “our” are used, we mean the Environmental Protection Agency (EPA).
1.
2.
3. Electronic Access. You may access this
For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing at the EPA Regional Office, as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in the official public rulemaking file. The entire printed comment, including the copyrighted material, will be available at the Regional Office for public inspection.
You may submit comments electronically, by mail, or through hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate rulemaking identification number by including the text “Public comment on proposed rulemaking CO-001-0076a, CO-001-0077a” in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments.
1. Electronically. If you submit an electronic comment as prescribed below, EPA recommends that you include your name, mailing address, and an e-mail address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket. 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.
i. E-mail. Comments may be sent by electronic mail (e-mail). Please send any comments to
ii. Regulations.gov. Your use of Regulations.gov is an alternative method of submitting electronic comments to EPA. Go directly to Regulations.gov at
iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Section 2, directly below. These electronic submissions will be accepted in WordPerfect, Word or ASCII file format. Avoid the use of special characters and any form of encryption.
2. By Mail. Send your comments to: Richard R. Long, Director, Air and Radiation Program, Mailcode 8P-AR, Environmental Protection Agency (EPA), Region 8, 999 18th Street, Suite 300, Denver, Colorado 80202-2466. Please include the text “Public comment on proposed rulemaking CO-001-0076a, CO-001-0077a” in the subject line on the first page of your comment.
3. By Hand Delivery or Courier. Deliver your comments to: Richard R. Long, Director, Air and Radiation Program, Mailcode 8P-AR, Environmental Protection Agency (EPA), Region 8, 999 18th Street, Suite 300, Denver, Colorado 80202-2466. Such deliveries are only accepted Monday through Friday, 8 a.m. to 4:55 p.m., excluding federal holidays.
Do not submit information that you consider to be CBI electronically to EPA. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI (if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.
In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the official public regional rulemaking file. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public file and available for public inspection without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified in the
We are approving the Governor's submittal of July 31, 2002, that requests redesignation for the Lamar and Steamboat Springs nonattainment areas to attainment for the 1987 PM
EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comments. However, in the “Proposed Rules” section of today's
In order for a nonattainment area to be redesignated to attainment, the following conditions in section 107(d)(3)(E) of the CAA must be met:
(i) We must determine that the area has attained the NAAQS;
(ii) The applicable implementation plan for the area must be fully approved under section 110(k) of the CAA;
(iii) We must determine that the improvement in air quality is due to permanent and enforceable reductions in emissions resulting from implementation of the applicable implementation plan and applicable Federal air pollutant control regulations and other permanent and enforceable reductions;
(iv) We must fully approve a maintenance plan for the area as meeting the requirements of CAA section 175A; and,
(v) The State containing such an area must meet all requirements applicable to the area under section 110 and part D of the CAA.
Our September 4, 1992 guidance entitled “Procedures for Processing Requests to Redesignate Areas to Attainment” outlines how to assess the adequacy of redesignation requests against the conditions listed above.
The following is a brief discussion of how Colorado's redesignation requests and maintenance plans meet the requirements of the CAA for redesignation of the Lamar and Steamboat Springs areas to attainment for PM
A state must demonstrate that an area has attained the PM
Colorado operates two PM
Colorado also operates two PM
Those States containing initial moderate PM
Section 107(d)(3(E)(iii) of the CAA provides that for an area to be redesignated to attainment, the Administrator must determine that the improvement in air quality is due to emission reductions which are permanent and enforceable. The Lamar PM
Recognizing that certain uncontrollable natural events, such as high winds, and wildfires, can have on the NAAQS, the EPA issued a Natural Events Policy (NEP) on May 30, 1996. The NEP sets forth procedures through the development of a Natural Events Action Plan (NEAP) for protecting public health in areas where the PM
Over the past eight years, the monitors located at the Municipal Power Plant and Municipal Building in Lamar, Colorado experienced exceedances of the 24-hour NAAQS for PM
In addition to the local and State control measures discussed above, the Federal Motor Vehicle Emission Control Program has helped reduce PM
The primary sources of PM
The City of Steamboat Springs and Routt County adopted local ordinance and resolutions that limit the number and types of woodburning devices in new construction in the Steamboat Springs area. Installation of new solid fuel burning devices is limited to one approved device for any building. The Steamboat Springs area adopted these measures in the late 1980s and early 1990s and the measures were included in State regulation in 1993 (Section VIII.E. of the “State Implementation Plan—Specific Regulations for Nonattainment—Attainment/Maintenance Areas (Local Areas)''). The rule was approved by EPA on December 31, 1997 (62 FR 68188).
The Steamboat Springs area adopted two street sanding control strategies for the nonattainment area. The first street sanding control strategy requires that any user that applies street sanding materials in the Steamboat Springs area must use materials containing less than two percent fines, except on U.S. Highway 40 from the junction of U.S. Highway 131 towards Rabbit Ears Pass. This strategy was included in State regulations in 1996 (Section VIII.B. of the “State Implementation Plan—Specific Regulations for Nonattainment—Attainment/Maintenance Areas (Local Areas)). The second street sanding control strategy requires that the Colorado Department of Transportation (CDOT) reduce the amount of sand applied on U.S. Highways 40 and 131 in the Steamboat Springs area by 10 percent. This strategy was included in State regulation in 1996 (Section VIII.C. of the “State Implementation Plan—Specific Regulations for Nonattainment—Attainment/Maintenance Areas (Local Areas)). Both the street sanding controls were approved by EPA on December 31, 1997 (62 FR 68188).
In addition, the Steamboat Springs area adopted street sweeping requirements for a defined section of Lincoln Avenue (Highway 40 in town). Street cleaning using vacuum sweepers or any other sweepers with equal efficiency must be performed four times within four days of the roadways becoming free and clear of snow and ice following each sanding deployment use. This strategy was included in State regulations in 1996 (Section VIII.D. of the “State Implementation Plan—Specific Regulations for Nonattainment—Attainment/Maintenance Areas (Local Areas)). The rule was approved by EPA on December 31, 1997 (62 FR 68188).
In addition to the local control measures that have been adopted in the Steamboat Springs area, Colorado's July 31, 2002 submittal did cite several Statewide regulations that limit emissions from any new source that may locate in the Steamboat Springs area. These rules are: “Air Pollution Emission Notices, Construction Permits and Fees, Operating Permits and Including the Prevention of Significant Deterioration” (Regulation No. 3), “Standards of Performance for New Stationary Sources” (Regulation No. 6), and the “Common Provisions Regulation.”
In addition to these State and Local control measures, the Federal Motor Vehicle Emission Control Program has helped reduce PM
Section 107(d)(3)(E) of the CAA requires that, for a nonattainment area to be redesignated to attainment, we must fully approve a maintenance plan which meets the requirements of section 175A of the CAA. The plan must demonstrate continued attainment of the relevant NAAQS in the area for at least 10 years after our approval of the redesignation. Eight years after our approval of a redesignation, Colorado must submit a revised maintenance plan demonstrating attainment for the 10 years following the initial 10 year period. The maintenance plan must also contain a contingency plan to ensure prompt correction of any violation of the NAAQS. (See sections 175A(b) and (d).) Our September 4, 1992 guidance outlines five core elements that are necessary to ensure maintenance of the relevant NAAQS in an area seeking redesignation from nonattainment to attainment. Those elements, as well as guidelines for subsequent maintenance plan revisions, are as follows:
The maintenance plan should include an attainment emission inventory to identify the level of emissions in the area which is sufficient to attain the NAAQS. An emission inventory for Lamar was developed for the attainment year 2000 as well as the projection inventory for the year 2015. The emission inventory incorporates emission estimates for woodburning (fireplaces and wood stoves), restaurant and mobile exhaust emissions, highway, arterial and local re-entrained road dust emissions, and gravel road emissions. Summary emission figures from the 2000 attainment year inventory and the 2015 projected inventory for the Lamar area are provided in Tables 1, 2, and 3 below.
More detailed descriptions of the 2000 attainment year inventory and the 2015 projected inventory for the Lamar area are documented in the maintenance plan in Chapter 3, section B and in the Colorado technical support documentation. Colorado's submittal contains detailed emission inventory information that was prepared in accordance with EPA emission inventory guidance.
An emission inventory for Steamboat Springs was developed for the attainment year 1999 as well as the projection inventory for the 2005 and 2010 interim years and the 2015 maintenance year. The emission inventory incorporates the emission estimates for aircrafts, restaurants, stationary sources, woodburning, mobile exhaust, and re-entrained road dust emissions from paved and unpaved roads that are contained in the nonattainment area SIP element that was approved by EPA on December 31, 1997 (62 FR 68188). Aircraft emissions were determined by using EPA and Colorado's Air Pollution Control Division (APCD) developed emission factors and activity data provided by the City of Steamboat Springs. Restaurant emissions were developed using emission factors and survey data of activity in the Steamboat Springs area. Woodburning emissions were determined by using EPA and APCD developed emission factors and survey data of woodburning activity and practices in the Steamboat Springs area. Re-entrained dust from paved and unpaved roads were developed using APCD and CDOT vehicle miles traveled data and emission factors that were calculated using the EPA-approved formula, local silt loading data, and the application of credits from street sweeping and street sand reduction control measures. Mobil exhaust was determined using EPA's PART5 model. Stationary source emission in the Steamboat Springs area were
More detailed descriptions of the 1999 attainment year inventory, the 2005 and 2010 interim years, and the 2015 projected inventory for the Steamboat Springs area are documented in the maintenance plan in Chapter 3, section B and in the Colorado technical support documentation. Colorado's submittal contains detailed emission inventory information that was prepared in accordance with EPA emission inventory guidance.
A state may generally demonstrate maintenance of the NAAQS by either showing that future emissions of a pollutant or its precursors will not exceed the level of the attainment inventory, or by modeling to show that the future mix of sources and emission rates will not cause a violation of the NAAQS. Colorado chose the chemical mass balance (CMB) modeling approach for the Lamar area and the dispersion modeling approach for the Steamboat Springs area.
The maintenance demonstration for the Lamar area uses the CMB roll-forward methodology, which is the same level of modeling used in the original attainment demonstration for the moderate PM
Although EPA would normally insist on some interim year projections between the attainment year and 2015, we have no reason to believe that total emissions for the Lamar area will be greater than the 2015 projections in any of the interim years. Colorado applied simple, environmentally conservative, growth rates to all source categories. Thus, total emissions in all years before 2015 in the Lamar area should be less than 2015 total emissions and no interim year projections are required.
Since no violation of the PM
The maintenance demonstration for the Steamboat Springs area relied on the dispersion modeling methodology, which is the same level of modeling used in the original attainment demonstration for the moderate PM
Since no exceedances of the PM
Once a nonattainment area has been redesignated to attainment, the State must continue to operate an appropriate air quality monitoring network, in accordance with 40 CFR part 58, to verify the attainment status of the area. The maintenance plan should contain provisions for continued operation of air quality monitors that will provide such verification. Colorado operates two PM
A state's maintenance plan submittal should indicate how it will track the progress of the maintenance plan. This is necessary due to the fact that the emission projections made for the maintenance demonstration depend on assumptions of point and area source growth. Colorado commits to operating both the Lamar and Steamboat Springs PM
Section 175A(d) of the CAA requires that a maintenance plan also include contingency provisions, as necessary, to promptly correct any violation of the NAAQS that occurs after redesignation of the area. For the purposes of section 175A, a state is not required to have fully adopted contingency measures that will take effect without further action by the State in order for the maintenance plan to be approved. However, the contingency plan is an enforceable part of the SIP and should ensure that contingency measures are adopted expeditiously when a violation of the NAAQS has occurred in a redesignated area. The plan should clearly identify the measures to be adopted, a schedule and procedure for adoption and implementation, and a specific time limit for action by the State. The State should also identify the specific indicators, or triggers, which will be used to determine when the contingency plan will be implemented.
Chapter 3, section H, of both the Lamar and Steamboat Springs maintenance plan contains the area's PM
If a violation of the PM
The Lamar PM
The Steamboat Springs PM
In accordance with section 175A(b) of the CAA, the State of Colorado is required to submit a revision to the maintenance plan eight years after the redesignation of the Lamar and Steamboat Springs areas to attainment for PM
In order for an area to be redesignated to attainment, section 107(d)(3)(E) requires that it must have met all applicable requirements of section 110 and part D of the CAA. We interpret this
Section 110(a)(2) contains general requirements for nonattainment plans. These requirements were met for Lamar with Colorado's May 7, 1993 submittal for the Lamar PM
Before a PM
The requirements of sections 172(c) and 189(a) regarding attainment of the PM
Although EPA's regulations (see 40 CFR 51.396) require that states adopt transportation conformity provisions in their SIPs for areas designated nonattainment or subject to an EPA-approved maintenance plan, we have decided that a transportation conformity SIP is not an applicable requirement for purposes of evaluating a redesignation request under section 107(d) of the CAA. This decision is reflected in EPA's 1996 approval of the Boston carbon monoxide redesignation. (See 61 FR 2918, January 30, 1996.)
We approved the requirements of the part D new source review (NSR) permit program for the Lamar moderate PM
Transportation conformity is required by section 176(c) of the CAA. Our conformity rule requires that transportation plans, programs and projects conform to SIPs and that transportation activities will not produce new air quality violations, worsen existing violations, or delay timely attainment of the NAAQS. On March 2, 1999, the United States Court of Appeals for the District of Columbia Circuit issued a decision in
In the Lamar maintenance plan, Colorado established a new mobile source emissions budget of 7,534 lbs./day for the year 2015 and beyond. In the Steamboat Springs maintenance plan, Colorado established a new mobile source emissions budget of 21,773 lbs./day for the year 2015 and beyond. The new mobile source emissions budgets for both Lamar and Steamboat Springs are the total of the 2015 mobile source PM
EPA sent a letter to the Colorado Air Pollution Control Division (APCD) on September 25, 2002 stating that the motor vehicle emission budgets that were submitted with the Lamar and Steamboat Springs PM
The CAA requires States to observe certain procedural requirements in developing implementation plans and plan revisions for submission. Section 110(a)(2) of the CAA provides that each implementation plan submitted by a State must be adopted after reasonable notice and public hearing. Section 110(l) of the CAA similarly provides that each revision to an implementation plan submitted by a State under the CAA must be adopted by such State after reasonable notice and public hearing.
Colorado held a public hearing for the proposed rule changes on November 15, 2001. The rulemaking was adopted by the Air Quality Control Commission (AQCC) directly after the November 15, 2001 hearing and was formally submitted to EPA by the Governor on July 31, 2002. We have evaluated the Governor's submittal and have determined that Colorado met the requirements for reasonable notice and public hearing under section 110(a)(2) of the CAA.
To implement our 1987 revisions to the particulate matter NAAQS, on August 7, 1987 (52 FR 29383), we categorized areas of the nation into three groups based on the likelihood that protection of the PM
The Lamar area was among several Group I PM
Pursuant to sections 107(d)(4)(B) and 188(a) of the Act, areas previously identified as Group I (55 FR 45799, October 31, 1990) and other areas which had monitored violations of the PM
EPA promulgated new standards for PM
Section 110(l) of the CAA states that a SIP revision cannot be approved if the revision would interfere with any applicable requirement concerning attainment and reasonable further progress towards attainment of a NAAQS or any other applicable requirement of the CAA. As stated above, the Lamar and Steamboat Springs area has shown continuous attainment of the PM
Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.
In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by October 4, 2004. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Particulate matter, Reporting and recordkeeping requirements.
Air pollution control.
42 U.S.C. 7401
(c) * * *
(101) On July 31, 2002, the State of Colorado submitted maintenance plans for the Lamar and Steamboat Springs PM
(A) Colorado Air Quality Control Commission, “State Implementation Plan—Specific Regulations for Nonattainment—Attainment/Maintenance Areas (Local Elements),” 5 CCR 1001-20, revisions adopted November 15, 2001, effective December 30, 2001 as follows: Section IV, which is titled “Lamar Attainment/Maintenance Area,” and Section VIII., which is titled “Steamboat Springs PM
(A) Colorado Department of Public Health and Environment, “Natural Events Action Plan for High Wind Events, Lamar, Colorado,” submitted to EPA on February 9, 1998 and subsequently approved by EPA, June 5, 1998 and Lamar's revised 2003 “Natural Events Action Plan for High Wind Events, Lamar, Colorado,” submitted to EPA on April 16, 2003 and subsequently approved by EPA, February 9, 2004.
(n) On July 31, 2002, the State of Colorado submitted maintenance plans for the Lamar and Steamboat Springs PM
42 U.S.C. 7401
Environmental Protection Agency.
Notice of deletion for the Hooker (102nd Street) Superfund Site from the National Priorities List.
The Environmental Protection Agency (EPA) Region II Office announces the deletion of the Hooker (102nd Street) Superfund Site from the National Priorities List (NPL). The Hooker (102nd Street) Site is located in the City of Niagara Falls, Niagara County, New York. The NPL is Appendix B to the National Oil and Hazardous Substances Pollution Contingency Plan (NCP), 40 CFR part 300, which the EPA promulgated pursuant to section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended. The EPA and New York State, through the Department of Environmental Conservation (NYSDEC) have determined that all appropriate response actions have been implemented and that no further response actions, other than operation, maintenance, and monitoring, are required. In addition, the EPA and the NYSDEC have determined that the remedial action taken at the Hooker (102nd Street) Site is protective of public health, welfare, and the environment.
August 5, 2004.
Paul J. Olivo, Remedial Project Manager, U.S. Environmental Protection Agency, Region II, 290 Broadway, 20th Floor, New York, New York 10007-1866, (212) 637-4280.
To be deleted from the NPL is the Hooker (102nd Street) Superfund Site, City of Niagara Falls, Niagara County, New York.
A Notice of Intent-to-Delete for the Hooker (102nd Street) Site was published in the
Environmental protection, Air pollution controls, Chemicals, Hazardous substances, Hazardous waste, Intergovernmental relations, Penalties, Reporting and recordkeeping requirements, Superfund, Water pollution control, Water supply.
42 U.S.C. 9601-9675; 33 U.S.C. 1321(c)(2); E.O. 12777, 56 FR 54757, 3 CFR., 1991 Comp., p. 351; E.O. 12580, 52 FR 2923, 3 CFR, 1987 Comp., p. 193.
Coast Guard, DHS.
Final rule.
The Coast Guard is establishing an alternative hull examination program for certain passenger vessels, and giving nautical school, offshore supply, passenger and sailing school vessels the option of having alternating drydock examinations with underwater surveys. It is also establishing examination processes, which give industry additional latitude in scheduling inspections and will create parity between passenger vessels and all other Coast Guard-inspected vessels.
This final rule is effective September 7, 2004.
Comments and material received from the public, as well as documents mentioned in this preamble as being available in the docket, are part of docket USCG-2000-6858 and are available for inspection or copying at the Docket Management Facility, U.S. Department of Transportation, room PL-401, 400 Seventh Street SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. You may also find this docket on the Internet at
If you have questions on this rule, call LCDR Martin Walker, Office of Compliance (G-MOC) Coast Guard, telephone 202-267-1047. If you have questions on viewing the docket, call Dorothy Beard, Chief, Dockets, Department of Transportation, telephone 202-366-5149.
The project was originally part of a notice of proposed rulemaking (NPRM) entitled “Frequency of Inspection, Alternate Hull Examination Program for Certain Passenger Vessels, and Underwater Surveys for Passenger, Nautical School, and Sailing School Vessels” that was published on November 15, 1999, in the
On April 29, 2002, we published an interim rule with request for comments entitled “Alternate Hull Examinations Program for Certain Passenger Vessels, and Underwater Surveys for Nautical School, Offshore Supply, Passenger and Sailing School Vessels” in the
Based on the results of an underwater survey demonstration performed in May 1997, the Coast Guard created a pilot program that allows owners or operators of qualified vessels to undergo an alternative hull examination process. This examination process includes an underwater survey and an internal structural examination along with annual condition assessments and scheduled preventative maintenance. The program allows owners and operators of qualified vessels to receive a credit hull exam of up to five years depending on the chosen method of hull examination.
Inspected U.S. passenger vessels, nautical school ships (public and civilian), off-shore supply vessels (OSVs) under 46 CFR chapter I, subchapter L, and sailing school vessels lacked the regulatory option of alternating drydock examinations with underwater surveys before the interim rule [67 FR 21062] was published in the
This rule, which adopts guidance from Navigation and Vessel Inspection Circular (NVIC) 1-89, allows owners or operators of U.S. passenger vessels, nautical school ships, OSVs, and sailing school vessels with steel or aluminum hulls the voluntary option of alternating underwater hull surveys with drydock examinations.
The Coast Guard received 51 comments in response to the interim rule with request for comment on the “Alternate Hull Examination Program for Certain Passenger, and Underwater Surveys for Nautical School, Offshore Supply, Passenger and Sailing School Vessels” published April 29, 2002, in the
Three commenters requested public meetings be held to discuss various aspects of Alternative Hull Examinations (AHE). We extended the original comment period by publishing the interim rule, rather than a final rule. We further stated that if the public felt that a public meeting was still necessary, it should submit a comment explaining why there should be a meeting. The relatively low number of comments we received did not state compelling reasons to hold a public meeting. Therefore, we believe that the public has been afforded ample opportunity to comment and that a public meeting is unnecessary.
One commenter said the frequency of internal exams of water ballast tanks is not mentioned in the interim rule. We disagree. The definition of “internal structural exam” includes ballast tanks, and § 71.50-3 discusses the intervals for conducting internal structural exams.
One commenter stated the phrase “at alternate intervals” should be deleted from the first sentence in § 71.50-5(c). We disagree. The wording was designed to be the same as found in existing Underwater Survey in Lieu of Drydocking (UWILD) regulations for other vessel types. Further, we believe that the meaning is clear when taken in context with the rest of the sentence, which discusses alternating underwater surveys and drydock exams.
One commenter stated it should be clarified in §§ 71.50-15, 115.620, and
One commenter stated filing a report on underwater cleanliness prior to an exam would unnecessarily increase the expense of a survey. We agree, and have changed §§ 71.50-19(d), 115.630(d), and 176.630(d) accordingly.
Two commenters made suggestions in regard to wording. One commenter stated the phrase “drydock extension” in §§ 71.50-29(a), 115.655(d), and 176.655 should instead be “drydock credit.” We agree and have changed the wording.
One commenter said the impact on small businesses, a cost assessment, or potential takings were not discussed in the interim rule. We disagree. Both the interim rule and this final rule include sections on impacts to small businesses, costs, and potential takings. The Coast Guard stands by its analyses of these issues.
One commenter stated that the interim rule is overly prescriptive. We disagree. The interim rule contains a level of direction and detail that we believe is necessary to preserve vessel safety while maximizing owner flexibility in the inspection of vessels.
Three commenters suggested changes in the definition for “adequate hull protection system” in §§ 71.50-1, 114.400, and 175.400. Of those, two said the phrase “sacrificial anodes” should be used instead of the word “zinc”. One commenter asked that the word “magnesium” be included in the definition. We agree, and have changed the definition to read “sacrificial anodes” versus “zinc anodes”. This new definition will allow for the inclusion of zinc or magnesium anodes.
Two commenters stated there is no need for inspections to be done by both the Coast Guard and the American Bureau of Shipping (ABS). We disagree. The delegation of Coast Guard inspection authority is outside the scope of this rulemaking.
Two commenters stated that the G-MOC Policy Letter 3-98 should be used as guidance in regard to hull marking instead of the language included in the interim rule. We agree and have changed §§ 71.50-27(a)(2), 115.650(a)(2), and 176.650(a)(2) to read similar to the policy letter.
Three commenters responded to the gauging of a vessel's hull. Of those, one stated multiple belts should be allowed as an alternative to five random shots per plate. We disagree. Belt gaugings are already required. The intent of the additional gaugings is to provide a greater probability of detecting thinning areas in the hull plating. We do not believe that gaugings taken 10 feet apart at the grid cables provide the same level of inspection as five readings per plate.
One commenter said there should be a minimum of five gaugings per plate, but that the third party examiner should be allowed to take the readings at any location. We disagree. The commenter said that some vessels do not have shell expansion diagrams, and that it is difficult to determine where to gauge these vessels. We acknowledge that spacing may not be easy, but believe that every effort should be made to spread the gaugings out as intended.
One commenter stated it is unclear in §§ 71.50-31(a), 115.660(a), and 176.660(a), who will do the audio gauging and conduct the internal exams for the annual hull condition assessment. We agree and have changed the wording to specify that vessel operators must do the audio gauging and conduct the internal exams during the hull condition assessment.
One commenter disagrees with the Coast Guard's assessment that there is a “significant limitation” in a diver's ability to inspect an entire hull. We disagree and believe that in anything other than ideal conditions, the diver will have some degree of difficulty seeing the surface, determining the exact location of a problem, and relaying it back to the third party examiner. The remotely operated vehicle (ROV) is able to overcome these difficulties to a greater degree.
Six commenters questioned the difference in inspection intervals allowed for a predominately used ROV exam versus a diver-only exam. In addition, a Risk Based Decision Making (RBDM) study to assess the effectiveness of Policy Letter 3-98, Drydock Extensions For Certain Passenger Vessels, recommended that the interval be extended from 30 months to five years. Some commenters stated that a diver is required for a portion of the ROV exam and that often the divers find problems in the areas that are examined by the ROV. One commenter stated that certain vessels on clear inland lakes have participated in a locally managed program with good success using the five-year interval for several years.
We agree in part. With the technology currently available, we concur that divers must be used during a percentage of the exams, and that, under some specific circumstances, a diver-only exam may achieve a level comparable to that of an exam done predominately by a ROV. We, however, do not believe the diver-only exam is as comprehensive as a ROV exam. Furthermore, it is our belief that an inspection equivalent to a drydock exam may be attained using a combination of the two methods with the ROV covering at least 80 percent of the hull and the diver examining those areas that are inaccessible for the ROV.
This is one of the reasons the authorized credit for the ROV exam is five years and the diver-only exam is three years, but not more than five years between exams.
The difference in the intervals was also part of the interim rule's intent to allow the Officer in Charge, Marine Inspection (OCMI) to grant a larger time frame between exams depending on the results. It is also why the regulations allow the OCMI to waive the annual hull condition assessment in cases where the results of the UWILD indicate that it would be reasonable to do so.
We are adding a provision in §§ 71.50-29(d), 115.655(d), and 176.655(d) to allow the OCMI to waive the mid-period exam and, in effect, grant the full five years of credit to a vessel when it is examined under ideal conditions, and it is safe to do. Owners seeking a waiver must submit a request at least 60 days before each scheduled underwater exam.
One commenter said the word “predominate” is ambiguous in the definition for “underwater survey portion conducted primarily by an approved underwater ROV” in § 71.50-1. We disagree. The note to § 71.50-15 below the paragraph clearly states that the hull coverage for the ROV is at least 80 percent.
Three commenters submitted views in regard to the OCMI's responsibilities. Of those, two stated individual OCMIs should make the final decision on eligibility requirements. We agree that the OCMI must make the final decision on eligibility. The interim rule granted the OCMI discretion to allow a vessel, which does not meet the eligibility requirements, to participate when “it is safe and reasonable to do so,” based on the vessel's history of safe operation.
One commenter stated OCMIs should make the decision on whether to require the preliminary exam. We disagree. The preliminary exam is necessary to ensure that the vessel is suitable for the program by surveying the underwater portion of the hull. This is not a requirement for a ROV exam, because we believe that an owner will take this step before contracting a ROV to perform the exam.
One commenter stated the limitations of operating 0.5 miles from shore and in shallow water should be eliminated from the regulations. We disagree. The interim rule was targeted at this group of vessels because they operate in a benign environment. The OCMI has the latitude to allow other vessels that operate beyond 0.5 miles into the program if it is safe and reasonable to do so.
Four commenters expressed views regarding sea valves. One commenter stated the requirements in §§ 71.50-25(a)(3) should be broadened to allow for equivalent methods of inspection and testing, especially for vessels operating in fresh water areas. We believe that the regulations should remain as written, and will address inspection procedures in a future NVIC.
One commenter said a clarification is needed that sea valves need to be examined only once every five years. We agree and are adding clarification to the regulations with regard to sea valve inspection intervals.
One commenter stated that large diameter sea valves pose a greater flooding risk and inspection should be allowed with the valves in place. We agree that there is a flooding risk when examining sea valves, which is why the passengers must be removed from the vessel if the OCMI deems it necessary. These regulations are consistent with, and reflect the existing standard in 46 CFR 61, required for a traditional drydock exam, as well as existing guidance in NVIC 1-89. We recognize, however, that it is common practice under certain circumstances, for the OCMI to accept Alternative inspection methods when dealing with large sea valves or unusual piping installations. Therefore, we have revised this section to allow the owner to propose alternatives to the OCMI. The OCMI may approve alternatives on a case-by-case basis, as is the practice already.
One commenter stated the OCMI should have the discretion to allow an alternative means of examining large sea valves. We agree, as stated above, the OCMI may approve alternatives on a case-by-case basis.
Nine commenters responded in regard to third party examiners. Two commenters stated there is no need for third party examiners. We disagree. The third party examiner is required to direct the underwater portion of the survey, and may serve as a representative of the owner while the marine inspector conducts the internal exam of the vessel.
Three commenters stated third party examiners should be required to take part in the examinations regardless of the method. We disagree. The third party examiner must participate in diver-only exams and during the diver portion of a predominate ROV exam. We do not believe that the third party examiner needs to be present when the ROV is operating. The third party examiner's main function is interpreting the results obtained by the diver, whereas the ROV data is immediately and graphically available to the marine inspector.
Two commenters said third party examiners should be required to prepare reports from the examinations that include a recommendation of fitness for service. We agree. The written report is required by the regulations, and is the tool that the OCMI uses to evaluate the examination results. The third party examiner may make recommendations, provide assessments, and include opinions of the vessel's overall condition. It is, however, the marine inspector's responsibility to ensure that the exam has been conducted in accordance with the regulations, while it is the OCMI's responsibility to determine the vessel's suitability for continued service.
One commenter stated better qualifications are needed for third party examiners. We disagree. The general qualification a third party examiner must possess is defined in the rule. We did not include a specific qualification, which would prevent someone who otherwise meets the requirements from acting as a third party examiner, potentially creating a large onus for small entities. The rule's approach will allow vessel owners the opportunity to act as a third party examiner on their own vessel, if they are acceptable to the OCMI.
One commenter stated that third party examiners should allow a pre-survey conference call in lieu of an on-site meeting. We agree and are modifying §§ 71.50-23(c), 115.640(c), and 176.640(c) to allow teleconferences if agreed to by the OCMI in advance.
Three commenters stated videotaping the tactile examinations of the hull is excessive. We disagree because this is the only record available to the OCMI of the extent, scope, and results of the underwater portion of the exam. The video and audio recording of the survey and the conditions will help the OCMI determine whether the annual condition assessments and mid-period exam may be waived.
This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS). A final Regulatory Evaluation under the regulatory policies and procedures of DHS is available in the docket as indicated under
Because the AHE Program is voluntary, no costs are associated with this component of the rulemaking. Each vessel owner is given the option to choose the most cost-effective hull examination process. We estimate that about 51 passenger vessels will take advantage of the increased flexibility of this rule.
The UWILD Program will provide increased flexibility to owners and operators for hull inspections of U.S. passenger vessels, nautical school ships, sailing school vessels, and offshore supply vessels. This program allows an underwater survey instead of a drydock examination on every other interval for the described vessels, and is currently available to most other classes of inspected vessels.
There are no additional costs to the vessel owners or operators with this component of the rulemaking because the use of underwater survey is completely voluntary. We estimate that 6,224 vessels could take advantage of the increased flexibility of this rule.
Under the Regulatory Flexibility Act [5 U.S.C. 601-612], we considered whether this rule will have a significant
The regulatory options in both the AHE and UWILD programs will make it more cost-efficient and beneficial for small entities by greatly decreasing the amount of time and resources associated with traditional drydock inspections. Additionally, because both programs are voluntary, it is expected that small entities will only participate when it is beneficial for them to do so.
Therefore, the Coast Guard certifies under 5 U.S.C. 605(b) that this final rule will not have a significant economic impact on a substantial number of small entities.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 [Pub. L. 104-121], we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking. The NPRM and the interim rule provided small businesses, organizations, or governmental jurisdictions a Coast Guard contact to ask questions concerning this rule's provisions or options for hull inspections.
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).
This rule calls for a new collection of information under the Paperwork Reduction Act of 1995 [44 U.S.C. 3501-3520]. We received no comments on the collection of information in our request for comments in the interim rule [67 FR 21062].
As required by 44 U.S.C. 3507(d), we submitted a copy of this rule to the Office of Management and Budget (OMB) for its review of the collection of information. OMB has approved the collection. The section numbers are (§§ ) 71.50-5(b), 71.50-23(b), 71.50-29(b), 71.50-31(b), 71.50-31(c), 71.50-31(d)(1), 115.615(b), 115.630, 115.640(b), 115.655(a), 115.655(b), 115.660(c), 115.660(d), 126.140(f), 126.140(g)(1), 126.140(g)(3), 167.15-33(b), 167.15-33(c), 169.230(b), 169.230(c), 176.615(b), 176.615(c), 176.630, 176.640(b), 176.655(a), 176.660(b), 176.660(c), and 176.660(d)(1), and the corresponding approval number from OMB is OMB Control Number 1625-0032, which expires on June 30, 2005. A notice announcing the effective date for this collection of information was published on August 28, 2002 [67 FR 55162].
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them.
It is well settled that States may not regulate in categories reserved for regulation by the Coast Guard. It is also well settled, now, that all of the categories covered in 46 U.S.C. 3306, 3703, 7101, and 8101 (design, construction, alteration, repair, maintenance, operation, equipping, personnel qualification, and manning of vessels), as well as the reporting of casualties and any other category in which Congress intended the Coast Guard to be the sole source of a vessel's obligations, are within the field foreclosed from regulation by the States. (See the decision of the Supreme Court in the consolidated cases of
This rule falls into the category of maintenance of vessels. Because the States may not regulate within this category, preemption under Executive Order 13132 is not an issue.
The Unfunded Mandates Reform Act of 1995 [2 U.S.C. 1531-1538] requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
This rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.
This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.
We have considered the environmental impact of this rule and concluded that under section 6(a) of the “Appendix to National Environmental Policy Act: Coast Guard Procedures for Categorical Exclusions, Notice of Final Agency Policy,” [67 FR 48244 (July 23, 2002)], this rule is categorically excluded from further environmental documentation. This final rule deals exclusively with changing inspection intervals and providing voluntary dry-docking alternatives for certain passenger vessels. A “Categorical Exclusion Determination” is available in
Marine safety, Passenger vessels, Reporting and recordkeeping requirements.
Incorporation by reference, Marine safety, Passenger vessels, Reporting and recordkeeping requirements.
Fire prevention, Marine safety, Passenger vessels, Reporting and recordkeeping requirements.
Administrative practice and procedure, Cargo vessels, Hazardous materials transportation, Marine safety, Seamen.
Authority delegation, Hazardous materials transportation, Marine safety, Offshore supply vessels, Oil and gas exploration, Reporting and recordkeeping requirements, Vessels.
Fire prevention, Marine safety, Reporting and recordkeeping requirements, Schools, Seamen, Vessels.
Fire prevention, Marine safety, Reporting and recordkeeping requirements, Schools, Vessels.
Marine safety, Passenger vessels, Reporting and recordkeeping requirements.
Fire prevention, Marine safety, Passenger vessels, Reporting and recordkeeping requirements.
33 U.S.C. 1321(j); 46 U.S.C. 2113, 3205, 3306, 3307; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; E.O. 12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; Department of Homeland Security Delegation No. 0170.
The Alternative Hull Examination (AHE) Program provides you with an alternative to a drydock examination by allowing your vessel's hull to be examined while it remains afloat. If completed using only divers, this program has four steps: the application process, the preliminary examination, the pre-survey meeting, and the hull examination. If the vessel is already participating in the program or if a remotely operated vehicle (ROV) is used during the program, the preliminary exam step may be omitted. Once you complete these steps, the Officer in Charge, Marine Inspection (OCMI), will evaluate the results and accept the examination as a credit hull exam if the vessel is in satisfactory condition. If only divers are used for the underwater survey portion of the examination process, you may receive credit for a period of time such that subsequent AHEs would be conducted at intervals of twice in every five years, with no more than three years between any two AHEs. The OCMI may waive an underwater survey in accordance with § 71.50-29(d) provided that the interval does not exceed five years between any two underwater surveys. If an underwater ROV is used as the predominate method to examine the vessel's underwater hull plating, you may receive credit up to five years. At the end of this period, you may apply for further participation under the AHE Program.
(c) The pre-survey meeting may be conducted by teleconference, if agreed to in advance by the OCMI.
(a) * * *
(2) Provide permanent hull markings, a temporary grid system of wires or cables spaced not more than 10 feet apart and tagged at one-foot intervals, or any other acoustic or electronic positioning system approved by the OCMI to identify the diver's location with respect to the hull, within one foot of accuracy;
(a) If you use only divers for the underwater survey portion of the Alternative Hull Examination (AHE), you must provide the Officer in Charge, Marine Inspection (OCMI), with a written hull examination report. This report must include thickness gauging results, bearing clearances, a copy of the audio and video recordings, and any other information that will help the OCMI evaluate your vessel for a credit hull exam. The third party examiner must sign the report and confirm the validity of its contents.
(d) At least 60 days prior to each scheduled underwater exam, the owner may request a waiver from the OCMI if:
(1) A satisfactory exam has been completed within the last three years;
(2) The conditions during the last exam allowed at least 80 percent of the bottom surface to be viewed and recorded; and
(3) The results of the last exam indicated that an extended interval is safe and reasonable.
(a) To continue to participate in the AHE Program, vessel operators must conduct an annual hull condition
(d) * * *
(1) The owner may submit to the OCMI a plan for conducting the assessment, or a request for a waiver of this requirement, no fewer than 30 days before the scheduled assessment; and
46 U.S.C. 2103, 3306, 3703; Pub. L. 103-206, 107 Stat. 2439; 49 U.S.C. App. 1804; Department of Homeland Security Delegation No. 0170; § 114.900 also issued under 44 U.S.C. 3507.
(b) * * *
33 U.S.C. 1321(j); 46 U.S.C. 2103, 3205, 3306, 3307; 49 U.S.C. App. 1804; E.O. 11735, 38 FR 21243, 3 CFR, 1971-1975 Comp., p. 743; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; Department of Homeland Security Delegation No. 0170.
The Alternative Hull Examination (AHE) Program provides you with an alternative to a drydock examination by allowing your vessel's hull to be examined while it remains afloat. If completed using only divers, this program has four steps: the application process, the preliminary examination, the pre-survey meeting, and the hull examination. If the vessel is already participating in the program or if a remotely operated vehicle (ROV) is used during the program, the preliminary exam step may be omitted. Once you complete these steps, the Officer in Charge, Marine Inspection (OCMI), will evaluate the results and accept the examination as a credit hull exam if the vessel is in satisfactory condition. If only divers are used for the underwater survey portion of the examination process, you may receive credit for a period of time such that subsequent AHEs would be conducted at intervals of twice in every five years, with no more than three years between any two AHEs. The OCMI may waive an underwater survey in accordance with § 115.655(d) provided that the interval does not exceed five years between any two underwater surveys. If an underwater ROV is used as the predominate method to examine the vessel's underwater hull plating, you may receive credit up to five years. At the end of this period, you may apply for further participation under the AHE Program.
(c) The pre-survey meeting may be conducted by teleconference, if agreed to in advance by the OCMI.
(a) * * *
(2) Provide permanent hull markings, a temporary grid system of wires or cables spaced not more than 10 feet apart and tagged at one-foot intervals, or any other acoustic or electronic positioning system approved by the OCMI to identify the diver's location with respect to the hull, within one foot of accuracy;
(a) If you use only divers for the underwater survey portion of the Alternative Hull Examination (AHE), you must provide the Officer in Charge, Marine Inspection (OCMI), with a written hull examination report. This report must include thickness gauging results, bearing clearances, a copy of the audio and video recordings, and any other information that will help the OCMI evaluate your vessel for a credit hull exam. The third party examiner must sign the report and confirm the validity of its contents.
(d) At least 60 days prior to each scheduled underwater exam, the owner may request a waiver from the OCMI if:
(1) A satisfactory exam has been completed within the last three years;
(2) The conditions during the last exam allowed at least 80 percent of the bottom surface to be viewed and recorded; and
(3) The results of the last exam indicated that an extended interval is safe and reasonable.
(a) To continue to participate in the AHE Program, vessel operators must conduct an annual hull condition assessment. At a minimum, vessel operators must conduct an internal examination and take random hull gaugings internally during the hull condition assessment, unless waived by the Officer in Charge, Marine Inspection (OCMI). If the annual hull assessment reveals significant damage or corrosion, where temporary repairs have been made, or where other critical areas of concern have been identified, the OCMI may require an expanded examination to include an underwater hull examination using divers. If an underwater examination is required, the examination must focus on areas at higher risk of damage or corrosion and
(d) * * *
(1) The owner may submit to the OCMI a plan for conducting the assessment, or a request for a waiver of this requirement, no fewer than 30 days before the scheduled assessment; and
46 U.S.C. 2103, 3205, 3306, 3703; Pub. L. 103-206, 107 Stat. 2439; 49 U.S.C. App. 1804; Department of Homeland Security Delegation No. 0170; § 175.900 also issued under authority of 44 U.S.C. 3507.
33 U.S.C. 1321(j); 46 U.S.C. 2103, 3205, 3306, 3307; 49 U.S.C. App. 1804; E.O. 11735, 38 FR 21243, 3 CFR, 1971-1975 Comp., p. 743; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; Department of Homeland Security Delegation No. 0170.
The Alternative Hull Examination (AHE) Program provides you with an alternative to a drydock examination by allowing your vessel's hull to be examined while it remains afloat. If completed using only divers, this program has four steps: the application process, the preliminary examination, the pre-survey meeting, and the hull examination. If the vessel is already participating in the program, or if a remotely operated vehicle (ROV) is used during the program, the preliminary exam step may be omitted. Once you complete these steps, the Officer in Charge, Marine Inspection (OCMI), will evaluate the results and accept the examination as a credit hull exam if the vessel is in satisfactory condition. If only divers are used for the underwater survey portion of the examination process, you may receive credit for a period of time such that subsequent AHEs would be conducted at intervals of twice in every five years, with no more than three years between any two AHEs. The OCMI may waive an underwater survey in accordance with § 176.655(d) provided that the interval does not exceed five years between any two underwater surveys. If an underwater ROV is used as the predominate method to examine the vessel's underwater hull plating, you may receive credit up to five years. At the end of this period, you may apply for further participation under the AHE Program.
(c) The pre-survey meeting may be conducted by teleconference, if agreed to in advance by the OCMI.
(a) * * *
(2) Provide permanent hull markings, a temporary grid system of wires or cables spaced not more than 10 feet apart and tagged at one-foot intervals, or any other acoustic or electronic positioning system approved by the OCMI to identify the diver's location with respect to the hull, within one foot of accuracy;
(a) If you use only divers for the underwater survey portion of the Alternative Hull Examination (AHE), you must provide the Officer in Charge, Marine Inspection (OCMI), with a written hull examination report. This report must include thickness gauging results, bearing clearances, a copy of the audio and video recordings, and any other information that will help the OCMI evaluate your vessel for a credit hull exam. The third party examiner must sign the report and confirm the validity of its contents.
(d) At least 60 days prior to each scheduled underwater exam, the owner may request a waiver from the OCMI if:
(1) A satisfactory exam has been completed within the last three years;
(2) The conditions during the last exam allowed at least 80 percent of the bottom surface to be viewed and recorded; and
(3) The results of the last exam indicated that an extended interval is safe and reasonable.
(a) To continue to participate in the AHE Program, vessel operators must conduct an annual hull condition assessment. At a minimum, vessel operators must conduct an internal examination and take random hull gaugings internally during the hull condition assessment, unless waived by the Officer in Charge, Marine Inspection (OCMI). If the annual hull assessment reveals significant damage or corrosion, where temporary repairs have been made, or where other critical areas of concern have been identified, the OCMI may require an expanded examination to include an underwater hull examination using divers. If an underwater examination is required, the examination must focus on areas at higher risk of damage or corrosion and must include a representative sampling of hull gaugings.
(d) * * *
(1) The owner may submit to the OCMI a plan for conducting the assessment, or a request for a waiver of this requirement, no fewer than 30 days before the scheduled assessment; and
Federal Communications Commission.
Final rule.
The Commission, at the request of Liberty County Educational, allots DTV channel 3 to Apalachicola, Florida, as the community's first local commercial television service.
Effective September 13, 2004.
Pam Blumenthal, Media Bureau, (202) 418-1600.
This is a synopsis of the Commission's Report and Order, MB Docket No. 04-32, adopted July 23, 2004, and released July 30, 2004. The full text of this document is available for public inspection and copying during regular business hours in the FCC Reference Information Center, Portals II, 445 12th Street, SW., Room CY-A257, Washington, DC. This document may also be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone 301-816-2820, facsimile 301-816-0169, or via e-mail
This document does not contain (new or modified) information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. In addition, therefore, it does not contain any new or modified “information collection burden for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198,
The Commission will send a copy of this (Report & Order,
Digital television broadcasting, Television.
47 U.S.C. 154, 303, 334 and 336.
Federal Communications Commission.
Final rule.
The Commission, on its own motion, editorially amends the Table of TV Allotments and the Digital Table of Allotments to specify the conversion from an analog to a DTV channel at El Dorado, Arkansas. This amendment is necessary to reflect the change that has be authorized in response to an application filed by Arkansas Educational Television Commission, permittee of Station KETZ-TV, channel *30+, now permittee of station KEDZ-DT authorized to operate on DTV channel *30 at El Dorado. This action is taken pursuant to the Memorandum Opinion and Order on Reconsideration of the Fifth Report and Order, 13 FCC Rcd 6860 (1998).
Effective August 13, 2004.
Pam Blumenthal, Media Bureau, (202) 418-1600.
This is a synopsis of the Commission's Report and Order, adopted July 23, 2004, and released July 30, 2004. The full text of this document is available for public inspection and copying during regular business hours in the FCC Reference Information Center, Portals II, 445 12th Street, SW., Room CY-A257, Washington, DC. This document may also be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone 301-816-2820, facsimile 301-816-0169, or via e-mail
This document does not contain [new or modified] information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. In addition, therefore, it does not contain any new or modified “information collection burden for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198,
The Commission will send a copy of this [Report & Order,
Digital television broadcasting, Television.
47 U.S.C. 154, 303, 334 and 336.
Federal Motor Carrier Safety Administration, DOT.
Correcting amendments.
The Federal Motor Carrier Safety Administration (FMCSA) published in the
Effective on August 5, 2004.
Mr. James Keenan, Office of Commercial Enforcement, (202) 385-2400, Federal Motor Carrier Safety Administration, Suite 600, 400 Virginia Avenue, SW., Washington, DC 20024.
On June 11, 2003, FMCSA published an interim final rule revising the requirements governing the interstate transportation of household goods (68 FR 35064). On March 5, 2004, we issued technical amendments to the interim final rule and its appendix—Appendix A to Part 375, the consumer pamphlet
In May 2004, attorneys for both Atlas World Group, Inc. and Wheaton Van Lines, Inc. contacted us concerning an incorrect statutory citation in four sections of Appendix A to Part 375. These sections of the consumer pamphlet advise individual shippers of their right to seek restitution for loss of or damage to their household goods by bringing a civil action against the mover. Ms. Marian Weilert Sauvey, General Counsel for Atlas World Group, informed us of the incorrect citation in electronic mail correspondence of May 6, 2004; Mr. James P. Reichert, General Counsel for Wheaton Van Lines, Inc., noted the error in a letter of May 10, 2004.
As Ms. Sauvey and Mr. Reichert stated, it is 49 U.S.C 14706, not section 14704, that establishes carrier liability for loss and damage and sets forth the minimum period for bringing a civil action against a carrier. Section 14704, in contrast, entitles a person to file a civil action against a carrier to enforce an order of the U.S. Department of Transportation or the Surface Transportation Board, or to seek redress for certain regulatory violations. We have corrected Appendix A to Part 375 by replacing each of the four occurrences of “49 U.S.C. 14704” with “49 U.S.C. 14706.” In the last of these revisions (the third paragraph of the section
In his letter, Mr. Reichert also brought to our attention certain language in subpart E of Appendix A that is not fully consistent with 49 CFR 375.501(h) and 375.505(e), as amended on March 5, 2004. The amended regulations make clear that household goods carriers have the option of placing the Surface Transportation Board's required released rates valuation statement, and any charges for optional valuation coverage, on either the order for service or the bill of lading. In contrast, subparagraph (10) of the section
Finally, we have corrected an error in the introductory sentence to a list of requirements in the section
Section 375.213 requires movers to furnish the information in the rule appendix to prospective customers as the consumer pamphlet
Advertising, Arbitration, Consumer protection, Freight, Highways and roads, Insurance, Motor carriers, Moving of household goods, Reporting and recordkeeping requirements.
5 U.S.C. 553; 49 U.S.C. 13301, 13704, 13707, 14104, 14706; and 49 CFR 1.73.
Interstate movers are also required to offer neutral arbitration as a means of resolving consumer loss or damage disputes involving loss of or damage to household goods. Your mover is required to provide you with information regarding its arbitration program. You have the right to pursue court action under 49 U.S.C. 14706 to seek judicial redress directly rather than participate in your mover's arbitration program.
Your mover must have an arbitration program for your use in resolving disputes concerning loss or damage to your household goods. You have the right not to participate in the arbitration program. You may pursue court action under 49 U.S.C. 14706 to seek judicial remedies directly. Your mover must establish and maintain an arbitration program with the following 11 minimum elements:
Other requirements of non-binding estimates include the following 10 elements:
(10) If not provided in the bill of lading, the Surface Transportation Board's required released rates valuation statement, and the charges, if any, for optional valuation coverage. The STB's required released rates may be increased annually by your mover based on the U.S. Department of Commerce's Cost of Living Adjustment.
(12) If not provided in the order for service, the Surface Transportation Board's required released rates valuation statement, and the charges, if any, for optional valuation coverage. The Board's required released rates may be increased annually by your mover based on the U.S. Department of Commerce's Cost of Living Adjustment.
If your mover fails to pick up and deliver your shipment on the date entered on the bill of lading and you have expenses you otherwise would not have had, you may be able to recover those expenses from your mover. This is what is called an inconvenience or delay claim. Should your mover refuse to honor such a claim and you continue to believe you are entitled to be paid damages, you may take your mover to court under 49 U.S.C. 14706.
While the Federal Government maintains regulations governing the processing of loss and damage claims (49 CFR part 370), it cannot resolve those claims. If you cannot settle a claim with the mover, you may file a civil action to recover your claim in court under 49 U.S.C. 14706. You may obtain the name and address of the mover's agent for service of legal process in your state by contacting the Federal Motor Carrier Safety Administration. You may also obtain the name of a process agent via the Internet by going to
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to adopt a new airworthiness directive (AD) for certain McDonnell Douglas Model DC-9-10, -20, -30, -40, and -50 series airplanes; and Model DC-9-81 (MD-81) and DC-9-82 (MD-82) airplanes. This proposed AD would require repetitive detailed inspections of the upper and lower caps of the rear spar of the left and right wings, and corrective action if necessary. This proposed AD also provides an optional modification that would end the repetitive inspections. This proposed AD is prompted by reports of fatigue cracks in the upper and lower caps of the wing spar. We are proposing this AD to detect and correct fatigue cracking in the upper and lower caps of the rear spar of the left and right wings, which could result in structural failure of the wings.
We must receive comments on this proposed AD by September 20, 2004.
Use one of the following addresses to submit comments on this proposed AD.
• DOT Docket web site: Go to
• Government-wide rulemaking web site: Go to
• Mail: Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street SW., Nassif Building, room PL-401, Washington, DC 20590.
• Hand Delivery: room PL-401 on the plaza level of the Nassif Building, 400 Seventh Street SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
For the service information identified in this proposed AD, contact Boeing Commercial Airplanes, Long Beach Division, 3855 Lakewood Boulevard, Long Beach, California 90846, Attention: Data and Service Management, Dept. C1-L5A (D800-0024).
You can examine the contents of this AD docket on the Internet at
Wahib Mina, Aerospace Engineer, Airframe Branch, ANM-120L, FAA, Los Angeles Aircraft Certification Office, 3960 Paramount Boulevard, Lakewood, California 90712-4137; telephone (562) 627-5324; fax (562) 627-5210.
The FAA has implemented new procedures for maintaining AD dockets electronically. As of May 17, 2004, new AD actions are posted on DMS and assigned a docket number. We track each action and assign a corresponding directorate identifier. The DMS AD docket number is in the form “Docket No. FAA-2004-99999.” The Transport Airplane Directorate identifier is in the form “Directorate Identifier 2004-NM-999-AD.” Each DMS AD docket also lists the directorate identifier (“Old Docket Number”) as a cross-reference for searching purposes.
We invite you to submit any written relevant data, views, or arguments regarding this proposed AD. Send your comments to an address listed under
We will post all comments we receive, without change, to
We are reviewing the writing style we currently use in regulatory documents. We are interested in your comments on whether the style of this document is clear, and your suggestions to improve the clarity of our communications that affect you. You can get more information about plain language at
You can examine the AD docket in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone (800) 647-5227) is located on the plaza level of the Nassif Building at the DOT street address stated in the
We have received a report of cracks found in the lower cap of the rear spars of the left and right wing near station Xrs=267.000 during fatigue testing of fuselage number 3 on a McDonnell Douglas DC-9-14 airplane. Fuselage number 3 had accumulated 42,900 total flight hours and 66,504 total flight cycles before being removed from service for fatigue testing. An operator of McDonnell Douglas DC-9-30 series
The subject area on certain Model DC-9-20, -40, and -50 series airplanes is almost identical to that on the affected Model DC-9-10 and -30 series airplanes and Model DC-9-81 (MD-81) and DC-9-82 (MD-82) airplanes. Therefore, those Model DC-9-20, -40, and -50 series airplanes may be subject to the unsafe condition revealed on the DC-9-10 and -30 series airplanes and Model DC-9-81 (MD-81) and DC-9-82 (MD-82) airplanes.
We have reviewed McDonnell Douglas DC-9 Service Bulletin 57-179, Revision 1, dated December 21, 1994. The service bulletin describes procedures for initial and repetitive detailed inspections of the upper and lower caps of the rear spar of the left and right wings at station Xrs=267.000 for cracks, and corrective action if necessary. The corrective action includes doing the permanent repair modification or the temporary repair modification of the upper and lower caps of the rear spar. The permanent repair modification extends the compliance time for the next repetitive detailed inspection. The temporary repair modification includes doing repetitive detailed, eddy current, and ultrasonic inspections for any crack progression or any new crack, and doing the permanent repair modification if any crack progression or any new crack is found.
The service bulletin also specifies that doing the crack preventative modification described in other service bulletins eliminates the need for the repetitive inspections.
McDonnell Douglas DC-9 Service Bulletin 57-160, dated December 7, 1987; MD-80 Service Bulletin 57-177, Revision 1, dated June 12, 1989; and MD-80 Service Bulletin 57-178, Revision 1, dated June 12, 1990; describe procedures for the crack preventative modification at station Xrs=267.000. The procedures include replacing/modifying the flap hinge fitting, brace fitting, and rear spar area, as applicable.
We have determined that doing the actions specified in McDonnell Douglas DC-9 Service Bulletin 57-179, Revision 1, dated December 21, 1994, will adequately address the unsafe condition.
We have evaluated all pertinent information and identified an unsafe condition that is likely to exist or develop on other airplanes of this same type design. Therefore, we are proposing this AD, which would require repetitive detailed inspections of the upper and lower caps of the rear spar of the left and right wings, and corrective action if necessary. The proposed AD would require you to use McDonnell Douglas DC-9 Service Bulletin 57-179, Revision 1, dated December 21, 1994, described previously to do these actions, except as discussed under “Differences Between the Proposed AD and the Service Bulletin.”
Operators should note that McDonnell Douglas DC-9 Service Bulletin 57-179, Revision 1, dated December 21, 1994, specifies that, if any crack progression or any new crack is found after the temporary repair, the permanent repair modification must be done within 3,000 landings. However, this proposed AD would require that if any crack progression or new crack is detected, repair must be done before further flight per a method approved by the FAA. This difference has been coordinated with the manufacturer.
In addition, McDonnell Douglas DC-9 Service Bulletin 57-160, dated December 7, 1987; MD-80 Service Bulletin 57-177, Revision 1, dated June 12, 1989; and MD-80 Service Bulletin 57-178, Revision 1, dated June 12, 1990; specify that operators may contact the manufacturer for specific modification information. However, this proposed AD would require operators to repair those conditions per a method approved by the FAA.
This proposed AD would affect about 583 airplanes of U.S. registry and 1,163 airplanes worldwide. The proposed inspection would take about 4 work hours per airplane, at an average labor rate of $65 per work hour. Based on these figures, the estimated cost of the proposed AD for U.S. operators is $151,580 or $260 per airplane, per inspection cycle.
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. See the
Air transportation, Aircraft, Aviation safety, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
1. The authority citation for part 39 continues to read as follows:
49 U.S.C. 106(g), 40113, 44701.
2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD):
(a) The Federal Aviation Administration (FAA) must receive comments on this AD action by September 20, 2004.
(b) None.
(c) This AD applies to the models listed in Table 1 of this AD, certificated in any category; as listed in McDonnell Douglas DC-
(d) This AD was prompted by reports of fatigue cracks in the upper and lower caps of the wing spar. We are issuing this AD to detect and correct fatigue cracking in the upper and lower caps of the rear spar of the left and right wings, which could result in structural failure of the wings.
(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.
(f) Unless otherwise stated, the term “service bulletin,” as used in this AD, means McDonnell Douglas DC-9 Service Bulletin 57-179, Revision 1, dated December 21, 1994.
(g) At the time specified in paragraph (g)(1) or (g)(2) of this AD, as applicable, do a detailed inspection of the upper and lower caps of the rear spar of the left and right wings at station Xrs=267.000 for cracks, in accordance with the Accomplishment Instructions of the service bulletin.
(1) For Group 1 airplanes identified in paragraph 1.A.(1) of the service bulletin: Inspect prior to the accumulation of 50,000 total landings or within 3,000 landings after the effective date of this AD, whichever occurs later.
(2) For Group 2 airplanes identified in paragraph 1.A.(1) of the service bulletin: Inspect prior to the accumulation of 20,000 total landings or within 3,000 landings after the effective date of this AD, whichever occurs later.
For the purposes of this AD, a detailed inspection is “An intensive visual examination of a specific structural area, system, installation, or assembly to detect damage, failure, or irregularity. Available lighting is normally supplemented with a direct source of good lighting at intensity deemed appropriate by the inspector. Inspection aids such as mirror, magnifying lenses, etc., may be used. Surface cleaning and elaborate access procedures may be required.”
(h) If no crack is detected during any detailed inspection required by paragraph (g) of this AD, repeat the inspection thereafter at intervals not to exceed 3,000 landings until the crack preventative modification specified in paragraph (m) of this AD is done.
(i) If any crack is detected during any detailed inspection required by paragraph (g) of this AD, before further flight, do the actions in paragraph (j) of this AD, except as provided by paragraph (k) of this AD.
(j) If required by paragraph (i) of this AD, do the permanent repair modification of the upper and lower caps of the rear spar; and at the times specified in paragraph (j)(1) or (j)(2) of this AD, as applicable, do the detailed inspection specified in paragraph (g) of this AD. Do the actions in accordance with the Accomplishment Instructions of the service bulletin.
(1) For Group 1 airplanes identified in paragraph 1.A.(1) of the service bulletin: Within 53,000 landings after accomplishing the permanent repair modification, do the detailed inspection. Repeat the detailed inspection thereafter at intervals not to exceed 3,000 landings until the crack preventative modification specified in paragraph (m) of this AD is done.
(2) For Group 2 airplanes identified in paragraph 1.A.(1) of the service bulletin: Within 33,000 landings after accomplishing the permanent repair modification, do the detailed inspection. Repeat the detailed inspection thereafter at intervals not to exceed 3,000 landings until the crack preventative modification specified in paragraph (m) of this AD is done.
(k) In lieu of the actions specified in paragraph (j) of this AD, for any crack that does not exceed the limits specified in the Accomplishment Instructions of the service bulletin: Before further flight, do the temporary repair modification of the upper and lower caps of the rear spar; and at the times specified in paragraphs (k)(1) and (k)(2) of this AD, do the detailed inspections specified in paragraphs (k)(1) and (k)(2) of this AD. Do the actions in accordance with the Accomplishment Instructions of the service bulletin.
(1) Within 1,500 landings after accomplishing the temporary repair modification, do a detailed inspection of the temporary repair for any new crack or crack progression and repeat the inspection thereafter at intervals not to exceed 1,500 landings until the permanent repair modification specified in paragraph (j) of this AD is done.
(2) Within 3,000 landings after accomplishing the temporary repair modification, do detailed, eddy current, and ultrasonic inspections of the temporary repair for any new crack or crack progression and repeat the inspections thereafter at intervals not to exceed 3,000 landings until the permanent repair modification specified in paragraph (j) of this AD is done.
(l) If any crack progression or new crack is detected during any inspection required by paragraph (k)(1) or (k)(2) of this AD, before further flight, repair per a method approved by the Manager, Los Angeles Aircraft Certification Office (ACO), FAA. For a repair method to be approved by the Manager, Los Angeles ACO, as required by this paragraph, the Manager's approval letter must specifically refer to this AD.
(m) Except as provided by paragraph (n) of this AD, accomplishment of the crack preventative modification in accordance with the applicable service bulletin listed in Table 2 of this AD ends the repetitive inspections required by this AD. If the applicable service bulletin specifies to contact the manufacturer for specific modification information: Repair per a method approved by the Manager, Los Angeles Aircraft Certification Office (ACO), FAA. For a repair method to be approved by the Manager, Los Angeles ACO, as required by this paragraph, the Manager's approval letter must specifically refer to this AD.
(n) For airplanes on which the temporary repair modification specified in paragraph (k) of this AD has been done: Before or concurrently with the crack preventative modification specified in paragraph (m) of this AD, do the permanent repair modification specified in paragraph (j) of this AD.
(o) The Manager, Los Angeles ACO, FAA, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to supersede an existing airworthiness directive (AD) for certain Airbus Model A320 series airplanes. That AD currently requires repetitive inspections to detect fatigue cracking in certain areas of the fuselage, and corrective action if necessary. That AD also provides for an optional terminating action for the repetitive inspections. This proposed AD would reduce the compliance threshold and repetitive intervals for the inspections required by the existing AD, and would reduce the allowable time for the optional terminating action. This proposed AD is prompted by a full-scale fatigue survey on the Model A320 fleet. We are proposing this AD to detect and correct fatigue cracking of the fuselage, which could result in reduced structural integrity of the airplane.
We must receive comments on this proposed AD by September 7, 2004.
Use one of the following addresses to submit comments on this proposed AD.
• DOT Docket Web site: Go to
• Government-wide rulemaking Web site: Go to
• Mail: Docket Management Facility; U.S. Department of Transportation, 400 Seventh Street SW., Nassif Building, room PL-401, Washington, DC 20590.
•
• Hand Delivery: room PL-401 on the plaza level of the Nassif Building, 400 Seventh Street SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
You can get the service information identified in this proposed AD from Airbus, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France.
You may examine the contents of this AD docket on the Internet at
Dan Rodina, Aerospace Engineer, International Branch, ANM-116, FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, Washington 98055-4056; telephone (425) 227-2125; fax (425) 227-1149.
The FAA has implemented new procedures for maintaining AD dockets electronically. As of May 17, 2004, new AD actions are posted on DMS and assigned a docket number. We track each action and assign a corresponding directorate identifier. The DMS AD docket number is in the form “Docket No. FAA-2004-99999.” The Transport Airplane Directorate identifier is in the form “Directorate Identifier 2004-NM-999-AD.” Each DMS AD docket also lists the directorate identifier (“Old Docket Number”) as a cross-reference for searching purposes.
We invite you to submit any written relevant data, views, or arguments regarding this proposed AD. Send your comments to an address listed under
We will post all comments we receive, without change, to
We are reviewing the writing style we currently use in regulatory documents. We are interested in your comments on whether the style of this document is clear, and your suggestions to improve the clarity of our communications that affect you. You can get more information about plain language at
You may examine the AD docket in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone (800) 647-5227) is located on the plaza level of the Nassif Building at the DOT street address stated in the
On December 30, 1998, we issued AD 99-01-19, amendment 39-10987 (64 FR 1114, January 11, 1999), for certain Airbus Model A320 series airplanes. That AD requires repetitive inspections to detect fatigue cracking in certain areas of the fuselage, and corrective action if necessary. That AD also provides for an optional terminating action for the repetitive inspections. That AD was prompted by issuance of mandatory continuing airworthiness information by a foreign civil airworthiness authority. We issued that AD to detect and correct fatigue cracking of the fuselage, which could result in reduced structural integrity of the airplane.
Since we issued AD 99-01-19, the Direction Générale de l'Aviation Civile (DGAC), which is the airworthiness authority for France, advises that a full-scale fatigue survey on the Model A320 fleet revealed that the weight of fuel at landing and the average flight duration are higher than those defined for the analysis of fatigue-related tasks. This has led to an adjustment of the fatigue mission for the A320 fleet, in that the
Airbus has issued Service Bulletin A320-53-1032, Revision 02, dated December 5, 2001. The procedures specified in Revision 02 are essentially the same as those in Revision 01 of the service bulletin, which was referenced in the existing AD for accomplishment of the inspections and corrective action. However, Revision 02 has a change that recommends a reduction in the compliance threshold from 30,000 total flight cycles to 24,800 total flight cycles and in the repetitive intervals from 6,000 flight cycles to 4,900 flight cycles. Airbus also has issued Service Bulletin A320-53-1031, Revision 02, dated December 5, 2001. The procedures in Revision 02 are essentially the same as those in the original issue of the service bulletin, which was referenced in the existing AD for accomplishment of the optional terminating action. However, Revision 02 recommends a reduction in the compliance threshold from 20,000 flight cycles to 16,000 flight cycles.
We have determined that accomplishment of the actions specified in the revised service information will adequately address the unsafe condition. The DGAC mandated the service information and issued French airworthiness directive 2002-259(B), dated May 15, 2002, to ensure the continued airworthiness of these airplanes in France.
This airplane model is manufactured in France and is type certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. Pursuant to this bilateral airworthiness agreement, the DGAC has kept us informed of the situation described above. We have examined the DGACs findings, evaluated all pertinent information, and determined that AD action is necessary for airplanes of this type design that are certificated for operation in the United States.
Therefore, we are proposing this AD, to supersede AD 99-01-19 to continue to require repetitive inspections to detect fatigue cracking in certain areas of the fuselage, and corrective action if necessary. This proposed AD would also continue to provide for an optional terminating action for the repetitive inspections. This proposed AD would reduce the compliance threshold and repetitive intervals for the inspections required by the existing AD, and would reduce the allowable time for the optional terminating action. The proposed AD would require using the revised service information described previously to do these actions.
The number of affected airplanes has changed since we issued the existing AD; therefore, we have changed the Cost Impact section in this proposed AD to reflect the correct number of airplanes.
We have changed all references to a “visual inspection” in the existing AD to a “detailed inspection” in this action. Additionally, we have added a note to define that inspection.
We have reviewed the figures we have used over the past several years to calculate AD costs to operators. To account for various inflationary costs in the airline industry, we find it necessary to increase the labor rate used in these calculations from $60 per work hour to $65 per work hour. The cost information, below, reflects this increase in the hourly labor rate.
This proposed AD would affect about 269 airplanes of U.S. registry.
The inspection that is required by AD 99-01-19 and retained in this proposed AD takes about 19 work hours per airplane, at an average labor rate of $65 per work hour. Based on these figures, the estimated cost of the currently required inspection is $1,235 per airplane.
The optional terminating action specified in Airbus Service Bulletin A320-53-1031, if done, would take about 1 work hour per fastener hole, at an average labor rate of $65 per work hour. The cost of required parts would be about $4,219 (for one modification kit). Based on these figures, the cost of the optional terminating action would be a minimum of $4,284 per airplane.
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. See the
Air transportation, Aircraft, Aviation safety, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
1. The authority citation for part 39 continues to read as follows:
49 U.S.C. 106(g), 40113, 44701.
2. The FAA amends § 39.13 by removing amendment 39-10987 (64 FR 1114, January 11, 1999) and adding the following new airworthiness directive (AD):
(a) The Federal Aviation Administration must receive comments on this AD action by September 7, 2004.
(b) This AD supersedes AD 99-01-19, amendment 39-10987.
(c) This AD applies to Airbus Model A320 A320-111, -211, -212, and -231 series airplanes on which Airbus Modification 21346 has not been done, certificated in any category.
(d) This AD was prompted by a full-scale fatigue survey on the Model A320 fleet. We are issuing this AD to detect and correct fatigue cracking of the fuselage, which could result in reduced structural integrity of the airplane.
(e) You are responsible for having the actions required by this AD performed within
(f) At the applicable time specified in paragraph (f)(1) or (f)(2) of this AD: Do a detailed inspection to find cracking on the outboard flanges around the fastener holes of frames 38 through 41, between stringers 12 and 21, using Airbus Service Bulletin A320-53-1032, Revision 02, dated December 5, 2001. Accomplishment of the inspection required by this paragraph ends the requirements of AD 99-01-19.
(1) For airplanes on which the inspection specified in Airbus Service Bulletin A320-53-1032, Revision 01, dated January 15, 1998, or Revision 02, dated December 5, 2001; has been done as of the effective date of this AD: Do the next inspection within 4,900 flight cycles after accomplishment of the last inspection, or within 1,100 flight cycles after the effective date of this AD, whichever is later.
(2) For airplanes on which no inspection specified in Airbus Service Bulletin A320-53-1032, Revision 01, dated January 15, 1998, or Revision 02, dated December 5, 2001; has been done as of the effective date of this AD: Do the inspection at the earlier of the times specified in paragraphs (f)(1)(i) and (f)(1)(ii) of this AD.
(i) Before the accumulation of 30,000 total flight cycles.
(ii) Before the accumulation of 24,800 total flight cycles, or within 3,500 flight cycles after the effective date of this AD, whichever is later.
(g) If no crack is found during the inspection required by paragraph (f)(1) or (f)(2) of this AD: Repeat the inspection thereafter at intervals not to exceed 4,900 flight cycles.
For the purposes of this AD, a detailed inspection is defined as: “An intensive visual examination of a specific structural area, system, installation, or assembly to detect damage, failure, or irregularity. Available lighting is normally supplemented with a direct source of good lighting at intensity deemed appropriate by the inspector. Inspection aids such as mirror, magnifying lenses, etc., may be used. Surface cleaning and elaborate access procedures may be required.”
(h) If any crack is found during any inspection required by paragraph (f) of this AD, before further flight, repair using Airbus Service Bulletin A320-53-1032, Revision 01, dated January 15, 1998, or Revision 02, dated December 5, 2001. Accomplishment of a repair using the service bulletin ends the repetitive inspection requirements for the area repaired. If any crack is found during any inspection required by this AD, and the service bulletin specifies to contact Airbus for appropriate action:
Before further flight, repair using a method approved by the Manager, International Branch, ANM-116, FAA, Transport Airplane Directorate.
(i) Accomplishment of Airbus Modification 21346 using Airbus Service Bulletin A320-53-1031, dated December 9, 1994, or Revision 02, dated December 5, 2001, constitutes terminating action for the repetitive inspection requirements of this AD.
(j) Accomplishment of the optional terminating action specified in AD 99-01-19 before the effective date of this AD, using Airbus Service Bulletin A320-53-1031, dated December 9, 1994, or Revision 02, dated December 5, 2001, is considered acceptable for compliance with paragraph (i) of this AD.
(k) The Manager, International Branch, ANM-116, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19.
(l) French airworthiness directive 2002-259(B), dated May 15, 2002, also addresses the subject of this AD.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to supersede an existing airworthiness directive (AD) for certain Airbus Model A320 series airplanes. That AD currently requires repetitive inspections to detect fatigue cracking in certain areas of the fuselage; and corrective action, if necessary. That AD also provides for an optional terminating action for the repetitive inspections. This proposed AD would reduce the compliance threshold and repetitive intervals for the inspections required by the existing AD and would add an allowable time for the optional terminating action. This proposed AD is prompted by a full-scale fatigue survey on the Model A320 fleet. We are proposing this AD to detect and correct fatigue cracking of the fuselage, which could result in reduced structural integrity of the airplane.
We must receive comments on this proposed AD by September 7, 2004.
Use one of the following addresses to submit comments on this proposed AD.
• DOT Docket Web site: Go to
• Government-wide rulemaking web site: Go to
• Mail: Docket Management Facility; U.S. Department of Transportation, 400 Seventh Street SW., Nassif Building, room PL-401, Washington, DC 20590.
• Hand Delivery: room PL-401 on the plaza level of the Nassif Building, 400 Seventh Street SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
You can get the service information identified in this proposed AD from Airbus, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France.
You may examine the contents of this AD docket on the Internet at
Dan Rodina, Aerospace Engineer, International Branch, ANM-116, FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, Washington 98055-4056; telephone (425) 227-2125; fax (425) 227-1149.
The FAA has implemented new procedures for maintaining AD dockets electronically. As of May 17, 2004, new AD actions are posted on DMS and assigned a docket number. We track each action and assign a corresponding directorate identifier. The DMS AD docket number is in the form “Docket No. FAA-2004-99999.” The Transport Airplane Directorate identifier is in the form “Directorate Identifier 2004-NM-999-AD.” Each DMS AD docket also lists the directorate identifier (“Old Docket Number”) as a cross-reference for searching purposes.
We invite you to submit any written relevant data, views, or arguments regarding this proposed AD. Send your comments to an address listed under
We will post all comments we receive, without change, to
We are reviewing the writing style we currently use in regulatory documents. We are interested in your comments on whether the style of this document is clear, and your suggestions to improve the clarity of our communications that affect you. You can get more information about plain language at
You may examine the AD docket in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone (800) 647-5227) is located on the plaza level of the Nassif Building at the DOT street address stated in the
On December 30, 1998, we issued AD 99-01-17, amendment 39-10985 (64 FR 1118, January 11, 1999), for certain Airbus Model A320 series airplanes. That AD requires repetitive inspections to detect fatigue cracking in certain areas of the fuselage; and corrective action, if necessary. That AD also provides for an optional terminating action for the repetitive inspections. That AD was prompted by issuance of mandatory continuing airworthiness information by a foreign civil airworthiness authority. We issued that AD to detect and correct fatigue cracking of the fuselage, which could result in reduced structural integrity of the airplane.
Since we issued AD 99-01-17, the Direction Generale de l'Aviation Civile (DGAC), which is the airworthiness authority for France, advises that a full-scale fatigue survey on the Model A320 fleet revealed that the weight of fuel at landing and the average flight duration are higher than those defined for the analysis of fatigue-related tasks. This has led to an adjustment of the fatigue mission for the A320 fleet, in that the DGAC has required shorter compliance thresholds and repetitive intervals for accomplishment of the inspections for fatigue cracking than those required by AD 99-01-17. Fatigue-related cracking in certain areas of the fuselage could result in reduced structural integrity of the airplane.
Airbus has issued Service Bulletin A320-53-1034, Revision 02, dated December 4, 2001. The procedures specified in Revision 02 are essentially the same as those in the original issue of the service bulletin, which was referenced in the existing AD for accomplishment of the inspections and corrective action. However, Revision 02 has a change that recommends a reduction in the compliance threshold from 30,000 total flight cycles to 24,200 total flight cycles, and in the repetitive intervals from 6,000 flight cycles to 5,200 flight cycles. Airbus also has issued Service Bulletin A320-53-1033, Revision 04, dated December 4, 2001. The procedures in Revision 04 are essentially the same as those in Revision 03 of the service bulletin, which was referenced in the existing AD for accomplishment of the optional terminating action. However, Revision 04 adds an allowable time for the optional terminating action specified in the Revision 03, and contains editorial changes.
We have determined that accomplishment of the actions specified in the revised service information will adequately address the unsafe condition. The DGAC mandated the service information and issued French airworthiness directive 2002-260(B), dated May 15, 2002, to ensure the continued airworthiness of these airplanes in France.
This airplane model is manufactured in France and is type certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. Pursuant to this bilateral airworthiness agreement, the DGAC has kept us informed of the situation described above. We have examined the DGACs findings, evaluated all pertinent information, and determined that AD action is necessary for airplanes of this type design that are certificated for operation in the United States.
Therefore, we are proposing this AD, to supersede AD 99-01-17 to continue to require repetitive inspections to detect fatigue cracking in certain areas of the fuselage, and corrective action if necessary. This proposed AD would also continue to provide for an optional terminating action for the repetitive inspections. This proposed AD would reduce the compliance threshold and repetitive intervals for the inspections required by the existing AD, and would add an allowable time for the optional terminating action. The proposed AD would require using the revised service information described previously to do these actions.
The number of affected airplanes has changed since we issued the existing AD; therefore, we have changed the Cost Impact section in this proposed AD to reflect the correct number of airplanes.
We have reviewed the figures we have used over the past several years to calculate AD costs to operators. To account for various inflationary costs in the airline industry, we find it necessary to increase the labor rate used in these calculations from $60 per work hour to $65 per work hour. The cost information, below, reflects this increase in the hourly labor rate.
This proposed AD would affect about 269 airplanes of U.S. registry.
The ultrasonic inspection that is required by AD 99-01-17 and retained in this proposed AD takes about 6 work hours per airplane, at an average labor rate of $65 per work hour. Based on these figures, the estimated cost of the currently required ultrasonic inspection is $390 per airplane, per inspection cycle.
The optional terminating action specified in Airbus Service Bulletin A320-53-1033, if done, would take about 5 work hours to do, at an average labor rate of $65 per work hour. The cost of required parts would be about
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. See the
Air transportation, Aircraft, Aviation safety, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
1. The authority citation for part 39 continues to read as follows:
49 U.S.C. 106(g), 40113, 44701.
2. The FAA amends § 39.13 by removing amendment 39-10985 (64 FR 1118, January 11, 1999), and adding the following new airworthiness directive (AD):
(a) The Federal Aviation Administration must receive comments on this AD action by September 7, 2004.
(b) This AD supersedes AD 99-01-17, amendment 39-10985.
(c) This AD applies to Airbus Model A320-111, -211, -212, and -231 series airplanes on which Airbus Modification 21202 has not been done, certificated in any category.
(d) This AD was prompted by a full-scale fatigue survey on the Model A320 fleet. We are issuing this AD to detect and correct fatigue cracking of the fuselage, which could result in reduced structural integrity of the airplane.
(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.
(f) At the applicable time specified in paragraph (f)(1) or (f)(2) of this AD: Do an ultrasonic inspection to detect cracking in the bottom panels of the keel beam (both left and right), in the area of the frame 46 and stringer 37 intersection at the pressure bulkhead, using Airbus Service Bulletin A320-53-1034, Revision 02, dated December 4, 2001. Thereafter, repeat the ultrasonic inspection at intervals not to exceed 5,200 flight cycles or 10,400 flight hours, whichever is first. Accomplishment of the inspection required by this paragraph ends the requirements of AD 99-01-17.
(1) For airplanes on which the inspection specified in Airbus Service Bulletin A320-53-1034, dated March 30, 1992; or Revision 02, dated December 4, 2001; has been done as of the effective date of this AD: Do the next inspection within 5,200 flight cycles after accomplishment of the last inspection, or within 800 flight cycles after the effective date of this AD, whichever is later.
(2) For airplanes on which no inspection specified in Airbus Service Bulletin A320-53-1034, dated March 30, 1992; or Revision 02, dated December 4, 2001; has been done as of the effective date of this AD: Do the inspection at the later of the times specified in paragraphs (f)(1)(i) and (f)(1)(ii) of this AD.
(i) Before the accumulation of 24,200 total flight cycles or 48,400 total flight hours, whichever is first.
(ii) Before the accumulation of 30,000 total flight cycles, or within 3,500 flight cycles after the effective date of this AD, whichever is first.
(g) If any crack is found during any inspection required by paragraph (f) of this AD, before further flight, repair using Airbus Service Bulletin A320-53-1034, dated March 30, 1992; or Revision 02, dated December 4, 2001. Accomplishment of a repair using the service bulletin ends the repetitive inspection requirements for the area repaired. If any crack is found during any inspection required by this AD, and the service bulletin specifies to contact Airbus for appropriate action: Before further flight, repair using a method approved by the Manager, International Branch, ANM-116, FAA, Transport Airplane Directorate.
(h) Accomplishment of Airbus Modification 21202 using Airbus Service Bulletin A320-53-1033, Revision 03, dated July 4, 1994; or Revision 04, dated December 4, 2001, constitutes terminating action for the repetitive inspection requirements of this AD.
(i) Accomplishment of the optional terminating action specified in AD 99-01-17 before the effective date of this AD, using Airbus Service Bulletin A320-53-1033, Revision 03, dated July 4, 1994; or Revision 04, dated December 4, 2001, is considered acceptable for compliance with paragraph (h) of this AD.
(j) The Manager, International Branch, ANM-116, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19.
(k) French airworthiness directive 2002-260(B), dated May 15, 2002, also addresses the subject of this AD.
Internal Revenue Service (IRS), Treasury.
Notice of proposed rulemaking by cross-reference to temporary regulations.
In the Rules and Regulations section of this issue of the
Written or electronic comments and requests for a public hearing must be received by November 3, 2004.
Send submissions to: CC:PA:LPD:PR (REG-171386-03), room 5203, Internal Revenue Service, POB 7604, Ben Franklin Station, Washington, DC 20044. Alternatively, submissions may be hand-delivered Monday through Friday between the hours of 8 a.m. and 4 p.m. to: CC:PA:LPD:PR (REG-171386-03), Courier's Desk, Internal Revenue Service, 1111 Constitution Avenue, NW., Washington, DC. Taxpayers also may submit comments electronically to the IRS Internet site at
Concerning submission of comments or requesting a hearing, LaNita Van Dyke, (202) 622-7180; concerning the proposed regulations, Amy Pfalzgraf, (202) 622-4950 (not toll-free numbers).
Temporary regulations in the Rules and Regulations section of this issue of the
It has been determined that this notice of proposed rulemaking is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required. It also has been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations, and because the regulations do not impose a collection of information on small entities, the Regulatory Flexibility Act (5 U.S.C. chapter 6) does not apply. Pursuant to section 7805(f) of the Internal Revenue Code, this notice of proposed rulemaking will be submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business.
Before these proposed regulations are adopted as final regulations, consideration will be given to any written comments (a signed original and eight (8) copies) or electronic comments that are submitted timely to the IRS. The IRS and Treasury Department request comments on the clarity of the proposed rules and how they can be made easier to understand. All comments will be available for public inspection and copying. A public hearing will be scheduled if requested in writing by any person that timely submits written comments. If a public hearing is scheduled, notice of the date, time, and place for the public hearing will be published in the
The principal author of these regulations is Amy Pfalzgraf of the Office of Associate Chief Counsel (Income Tax & Accounting). However, other personnel from the IRS and Treasury Department participated in their development.
Income taxes, Reporting and recordkeeping requirements.
Accordingly, 26 CFR part 1 is proposed to be amended as follows:
26 U.S.C. 7805 * * *
[The text of proposed paragraphs (a), (b), (c), and (d) is the same as the text of paragraphs (a), (b), (c), and (d) of § 1.163(d)-1T published elsewhere in this issue of the
Copyright Office, Library of Congress.
Notice of proposed rulemaking.
This notice is issued to inform the public that the Copyright Office of the Library of Congress is proposing to amend its regulations to permit the Library of Congress to record unpublished radio and other audio and audiovisual transmission programs. The Copyright Office regulations already provide for the Library of Congress to obtain copies of unpublished television transmission programs, either by recording fixations or by demanding copies in the form of a transfer, loan or sale at cost. This revised regulation makes similar provisions for audio transmission programs and includes transmission programs made available by radio broadcasts and by digital communications networks such as the Internet.
Comments are due by September 7, 2004.
If hand delivered by a private party, an original and five copies of any comment should be brought to: Room LM-401 of the James Madison Memorial Building and addressed as follows: Office of the General Counsel, U.S. Copyright Office, James Madison Memorial Building, Room LM-401, 101 Independence Avenue, SE., Washington, DC 20559-6000. If delivered by a commercial, non-government courier or messenger, an original and five copies of any comment must be delivered to the Congressional Courier Acceptance Site located at 2nd and D Streets, NE., between 8:30 a.m. and 4 p.m. The envelope should be addressed as follows: Copyright Office General Counsel, Room LM-403, James Madison Memorial Building, 101 Independence Avenue, SE., Washington, DC. If sent by mail, an original and five copies of any comment should be addressed to: Copyright GC/I&R, P.O. Box 70400, Southwest Station, Washington, DC 20024-0400. Comments may not be delivered by means of overnight delivery services such as Federal Express, United Parcel Service, etc., due to delays in processing receipt of such deliveries.
Charlotte Douglass, Principal Legal Advisor to the General Counsel, Office of the Copyright General Counsel, Telephone: (202) 707-8380; Fax: (202) 707-8366.
The collections of the Library of Congress serve as a repository of a vast number of works. The largest library in the world, the Library of Congress comprises more than 127 million items. In addition to acquiring works by purchase, gift and exchange, the Library acquires copies of works submitted to the Copyright Office for registration or mandatory deposit. 17 U.S.C. 408, 407. In fiscal year 2003, the incentives of voluntary copyright registration made nearly one million copies of works available to the Library of Congress for its collections. Of the 962,119 copies and phonorecords the Office transferred to the Library of Congress, 491,219 arrived under the mandatory deposit provisions of the copyright law. U.S. Copyright Office,
Late in deliberations on the bill that became the 1976 Copyright Act, concern arose about whether mandatory deposit of only published works would be sufficient for the Library's collections, given that owners of publicly disseminated broadcasts were not obligated to deposit their works in the Library of Congress. The Register of Copyrights expressed that concern in the Second Supplementary Report, observing that transmission programs “are disseminated widely to the public and reproductions of them should be maintained in an archive in the Library of Congress.* * *” U.S. Copyright Office,
The copyright law defines a transmission program as a body of material that, as an aggregate, has been produced for the sole purpose of transmission to the public in sequence and as a unit. 17 U.S.C. 101. Under section 407(e), the Librarian of Congress may make a fixation of an unpublished transmission program that has been fixed and transmitted to the public in the United States. The Library may make the fixation directly from a transmission to the public, and may reproduce one copy or phonorecord from such fixation for archival purposes. 17 U.S.C. 407(e)(1). With respect to the registration of these programs, when copyright applications and fees are timely and properly submitted, the recorded or demanded fixations can be used as registration deposits.
In 1983, the Copyright Office promulgated regulations under section 407(e) to permit the Library to record unpublished television programs. 48 FR 37208 (Aug. 17, 1983). The amendment proposed today expands existing regulations for television to radio and other audio and audiovisual transmission programs. As is currently the case, the regulation establishes a presumption that noncommercial television programs are unpublished, while it provides a procedure for the copyright owner to overcome that presumption. Commercial television programs are not presumed to be unpublished under the existing regulation. However, consistent with the Library's acquisition experience through registration and deposit, this amendment presumes that both commercial and noncommercial radio transmission programs are unpublished. The presumption regarding radio transmission programs is based on empirical Office experience, factual information from surveys conducted in the Copyright Office and surveys of databases covering registered works. For example, a recent survey of the Performing Arts Section of the Examining Division in the Office revealed that all of the applications for registration of radio programs on hand during the two week period in question were for registration in unpublished form. The applications were for radio broadcasts of recent vintage,
A feature of the original regulation, which would be retained, is the cost-saving option that copyright owners may choose to register a copyright claim using the Library's recording as the deposit copy. The copyright owner need only submit, within 90 days of the Library's recording, a completed application for registration, and the appropriate fee, together with a notice to the Copyright Office that the Library's recording is to be used to satisfy the deposit requirement, to thereby save the cost of the deposit copy. In view of the significant number of programs the Library seeks to record, it will not be practical as a matter of course to provide specific advance notice to the copyright owner that the Library plans to record an unpublished radio program. Such action would constitute a major administrative burden for the Library. Should the copyright owner wish to register a claim using the Library's recording, the owner may obtain information about whether the Library has recorded a radio program by making a written request of the Chief, Motion Picture, Broadcasting and Recorded Sound Division at the Library of Congress.
When the regulation on off-the-air videotaping was originally promulgated more than two decades ago, the Office observed that it had not exhausted the authority conferred by section 407(e), particularly noting that the regulation had intentionally omitted radio transmissions. 47 FR 5259 (Feb. 4, 1982). In recognition of the great change in the world of communications over the last twenty years and to specifically acknowledge today's Internet age environment, the Office is updating the regulation to meet the new world of cultural communications by including audio transmission programs within its reach as well as Internet and other audiovisual transmission programs. This action is in keeping with Congress's intent to grant the Library broad authority to record unpublished transmission programs. 17 U.S.C. 407(e).
The definition of “transmit”—to communicate a performance or display “by any device or process whereby images or sound[s] are received beyond the place from which they are sent”—is broad enough to include all conceivable forms and combinations of wired or wireless communications media, including but by no means limited to radio and television broadcasting as we know them. Each and every method by which the images or sounds comprising a performance or display are picked up and conveyed is a “transmission” * * *.
H.R. Report No. 94-1476, at 64 (1976). Congress's recognition in 1976 that transmission programs would not be confined to radio and television has been realized as the Internet has become a major medium for the transmission of programs, and the Library's collections will be enriched by including many programs now being transmitted on the Internet. By expanding the scope of works to include radio, Internet,
Copyright, Registration.
In consideration of the foregoing, the Copyright Office proposes to amend part 202 of 37 CFR chapter II as follows:
1. The authority citation for part 202 continues to read as follows:
17 U.S.C. 702, 407 and 408.
2. Section 202.22 is amended as follows:
a. by revising the section heading;
b. by revising paragraph (a);
c. by revising paragraph (b)(1);
d. in paragraph (b)(2), by removing “by Pub. L. 94-553”;
e. by revising the heading of paragraph (c);
f. by revising paragraph (c)(1);
g. in paragraph (c)(2), by removing “copied off-the-air” and adding “recorded” in its place;
h. in paragraph (c)(3), by removing “copy off-the-air” and adding “record” in its place, by removing “television” before “transmission program”, and by removing “copying” and adding “recording” in its place;
i. by revising paragraph (c)(4);
j. in paragraph (c)(5) introductory text, by removing “off the air copying” and adding “recording” in its place;
k. in paragraph (c)(5)(iii), by removing “with notice of copyright”;
l. in paragraph (c)(6) introductory text, by removing “off-the-air” and by adding “or phonorecord” after “copy”;
m. in paragraph (c)(7), by adding “or phonorecord” after “copy”;
n. in paragraph (c)(8) introductory text, by adding “television” before “transmission programs”, “television” before “network stations” and “television” before “broadcasting station”;
o. in the heading for paragraph (d), by removing “television”;
p. in paragraph (d)(1), by adding “or phonorecord” after “copy”;
q. in paragraph (d)(3)(ii), by adding “or phonorecord” after “copy” each place it appears;
r. in paragraph (d)(3)(iv), by removing “copies'” and adding “of the copies or phonorecords” after “use”;
s. in paragraph (d)(3)(v), by removing “(a) and (c)”;
t. in paragraph (d)(3)(vi), by adding “, or, in the case of an audio transmission program, a
u. in paragraph (d)(4), by adding “or phonorecord” after “copy” each place it appears;
v. in paragraph (d)(5), by adding “and phonorecords” after “Copies”;
w. in paragraph (d)(6)(iii), by removing “shall be granted” and adding “should be granted” in its place;
x. in the heading of paragraph (e) and paragraph (e)(1), by adding “and phonorecords” after “copies” each place it appears, and by adding “or phonorecord” after “copy”;
y. by revising paragraph (e)(2);
z. in paragraph (f)(1), by adding “and phonorecords” after “Copies”;
aa. in paragraph (f)(1)(ii), by adding “or phonorecord” after “copy”;
bb. in paragraph (f)(2), by adding “and phonorecords” after “Copies”, and by adding “or phonorecord” after “copy” each place it appears; and
cc. in paragraph (g)(1), by adding “, or phonorecords” after “copies”, and by removing “television” and by adding “audio or audiovisual” in its place.
The additions and revisions to § 202.22 read as follows:
(a)
(b) * * *
(1) The terms
(c)
(4) The Library of Congress is entitled under this paragraph (c) to presume that a radio program transmitted to the public in the United States has been fixed but not published at the time of transmission, and that a television program transmitted to the public in the United States by a noncommercial educational broadcast station as defined in section 397 of title 47 of the United States Code has been fixed but not published.
(e) * * *
(2) All copies and phonorecords acquired or made under this section, except copies and phonorecords of transmission programs consisting of a regularly scheduled newscast or on-the-spot coverage of news events, shall be subject to the following restrictions concerning copying and access: in the case of television or other audiovisual transmission programs, copying and access are governed by Library of Congress Regulation 818-17,
Environmental Protection Agency (EPA).
Proposed rule.
EPA is taking direct final action to approve a State Implementation Plan (SIP) revision submitted by the State of Colorado on July 31, 2002, for the purpose of redesignating the Lamar, Colorado and Steamboat Springs, Colorado areas from nonattainment to attainment for particulate matter with an aerodynamic diameter less than or equal to a nominal 10 micrometers (PM
Written comments must be received in writing on or before September 7, 2004.
Written comments may be mailed to Richard R. Long, Director, Air and Radiation Program, Mailcode 8P-AR, Environmental Protection Agency (EPA), Region 8, 999 18th Street, Suite 300, Denver, Colorado 80202-2466. Comments may also be submitted electronically, or through hand delivery/courier. Please follow the detailed instructions (sections (I)(B)(1)(i) through (iii) of the
Libby Faulk, EPA, Region VIII, 999 18th Street, Suite 300, Mailcode 8P-AR, Denver, Colorado, 80202, (303) 312-6083, e-mail
See the information provided in the Direct Final action of the same title which is located in the Rules and Regulations section of this
42 U.S.C. 7401
Federal Communications Commission.
Proposed rule.
The Commission requests comments on a petition filed by Montana State University proposing the allotment and reservation of DTV channel 46 for noncommercial educational use at Kalispell, Montana. DTV Channel *46 can be allotted to Kalispell at reference coordinates 48-00-48 N. and 114-21-55 W. with a power of 186, a height above average terrain HAAT of 830 meters. Since the community of Kalispell is located within 400 kilometers of the U.S.-Canadian border, concurrence from the Canadian government must be obtained for this allotment.
Comments must be filed on or before September 23, 2004, and reply comments on or before October 11, 2004.
The Commission permits the electronic filing of all pleadings and comments in proceeding involving petitions for rule making (except in
Pam Blumenthal, Media Bureau, (202) 418-1600.
This is a synopsis of the Commission's Notice of Proposed Rule Making, MB Docket No. 04-283, adopted July 23, 2004, and released July 30, 2004. The full text of this document is available for public inspection and copying during regular business hours in the FCC Reference Information Center, Portals II, 445 12th Street, SW., Room CY-A257, Washington, DC 20554. This document may also be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone 301-816-2820, facsimile 301-816-0169, or via e-mail
Provisions of the Regulatory Flexibility Act of 1980 do not apply to this proceeding.
This document does not contain proposed information collection(s) subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. In addition, therefore, it does not contain any new or modified “information collection burden for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198,
Members of the public should note that from the time a Notice of Proposed Rule Making is issued until the matter is no longer subject to Commission consideration or court review, all
For information regarding proper filing procedures for comments,
Digital television broadcasting, Television.
For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR part 73 as follows:
1. The authority citation for part 73 continues to read as follows:
47 U.S.C. 154, 303, 334 and 336.
2. Section 73.622(b), the Table of Digital Television Allotments under Montana is amended by adding DTV channel *3 at Kalispell.
Food Safety and Inspection Service, USDA.
Notice.
This notice announces that the U.S. Department of Agriculture (USDA) is soliciting nominations for membership on the National Advisory Committee on Meat and Poultry Inspection (NACMPI). The full Committee consists of 16-18 members, and each person selected is expected to serve a 2-year term.
The names of the nominees and their typed curricula vitae or resumes must be postmarked no later than September 7, 2004. Applications are available on-line at
Nominations should be submitted to Dr. Barbara J. Masters, Acting Administrator, Food Safety and Inspection Service, USDA, Room 405-Aerospace Building, 1400 Independence Avenue, SW., Washington, DC 20250-3700.
Ms. Sonya L. West, Advisory Committee Specialist, Strategic Initiatives, Partnerships and Outreach Staff, FSIS, telephone (202) 690-1079; FAX (202) 690-6519; E-mail:
USDA is seeking nominees for membership on the National Advisory Committee on Meat and Poultry Inspection. The Committee provides advice and recommendations to the Secretary on the meat and poultry inspection programs, pursuant to sections 7(c), 24, 205, 301(a)(3), 301(a)(4), and 301(c) of the Federal Meat Inspection Act, 21 U.S.C. 607(c), 624, 645, 661(a)(3), 661(a)(4), and 661(c)) and the sections 5(a)(3), 5(a)(4), 5(c), 8(b), and 11(e) of the Poultry Products Inspection Act, 21 U.S.C. 454(a)(3), 454(a)(4), 454(c), 457(b), and 460(e)). Nominations for membership are being sought from persons representing producers; processors; exporters and importers of meat and poultry products; academia; Federal and State government officials; and consumers.
Appointments to the Committee will be made by the Secretary. To ensure that recommendations of the Committee take into account the needs of the diverse groups served by the Department, membership should include, to the extent practicable, persons with demonstrated ability to represent minorities, women, and persons with disabilities. It is anticipated that the Committee will meet at least twice annually.
Public awareness of all segments of rulemaking and policy development is important. Consequently, in an effort to ensure that the public and in particular minorities, women, and persons with disabilities, are aware of this notice, FSIS will announce it on-line through the FSIS web page located at
FSIS also will make copies of this
Rural Utilities Service, USDA.
Notice of intent to hold public meetings and prepare an environmental assessment.
Notice is hereby given that the Rural Utilities Service (RUS), an agency delivering the U.S. Department of Agriculture's Rural Development Utilities Programs, pursuant to the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Bob Quigel, Engineering and Environmental Staff, Rural Utilities Service, at (202) 720-0468, or
North Carolina Electric Membership Corporation proposes to construct a natural gas fired electric generation plant at two of four potential sites. One site is in Anson County, North Carolina, located southwest of Blewett Falls Lake. Approximately one-half mile of natural gas pipeline will be constructed from the existing Sandhills pipeline to the plant site. No new electric transmission lines will be constructed at this site. The second site is located in Richmond County, North Carolina, just south of U.S. 74 and adjacent to the Progress Energy facility. Approximately one-half mile of natural gas pipeline and one-half mile of new electric transmission line would be associated with a plant at this site. The third site is located in Person County, North Carolina, approximately two miles southwest of Roxboro. Approximately 1,000 feet of natural gas pipeline and no new electric transmission line would be associated with a plant at this site. The fourth site is located in southwestern Wake County, North Carolina, on a parcel bounded by U.S. Highway One and Friendship Road. Approximately three miles of natural gas pipeline and 0.8 miles of new electric transmission line would be associated with a plant at this site.
The proposed projects will be composed of five or six Pratt & Whitney FT-8 Swift-Pac
An alternative evaluation and site selection study for the project was prepared by North Carolina Electric Membership Corporation. The alternative evaluation and site selection study are available for public review at RUS in Room 2244 South Building, 1400 Independence Avenue, SW., Washington, DC, and at the headquarters of NCEMC located at 3400 Sumner Boulevard, Raleigh, North Carolina. This documents will also be available at the Hampton B. Allen Library, 120 South Greene Street, Wadesboro, North Carolina, (704) 694-5177, Pee Dee Electric Membership Corporation, Highway 52 South, Wadesboro, North Carolina, (704) 694-2114, at the Person County Library, 319 South Main Street, Roxboro, North Carolina, (336) 597-7881, at the Office of the County Manager, 304 South Morgan Street, Room 212, Roxboro, North Carolina, (336) 597-1720, at the Leath Memorial Library, 412 East Franklin Street, Rockingham, North Carolina, (910) 895-6337, Pee Dee Electric Membership Corporation, Rockingham District Office, U.S. 22 South & Midway Road, Rockingham, North Carolina, (910) 997-4441, at the Fuquay-Varina Library, 133 South Fuquay Avenue, Fuquay-Varina, North Carolina, (919) 557-2788, at the Eva H. Perry Library, 2100 Shepherd's Vineyard Drive, Apex, North Carolina, (919) 387-2100, and at the Office of the Town Clerk, Holly Springs Town Hall, 128 South Main Street, Holly Springs, North Carolina, (919) 557-3900.
Government agencies, private organizations, and the public are invited to participate in the planning and analysis of the proposed project. The purpose of the meetings is to describe the projects and alternatives under consideration, discuss the scope of environmental issues to be considered, answer questions, and accept oral and written comments. Written comments will be accepted for at least 30 days after the public scoping meeting.
From information provided in the alternative evaluation and site selection study, input that may be provided by government agencies, private organizations, and the public, NCEMC will prepare an environmental analysis to be submitted to RUS for review. RUS will use the environmental analysis to determine the significance of the impacts of the projects and may adopt it as its environmental assessment of the projects. RUS' environmental assessment of the projects would be available for review and comment for 30 days.
Should RUS determine, based on the environmental assessment of the project, that the impacts of the construction and operation of the plant would not have a significant environmental impact, it will prepare a finding of no significant impact. Public notification of a finding of no significant impact would be published in the
Any final action by RUS related to the proposed project will be subject to, and contingent upon, compliance with environmental review requirements as prescribed by CEQ and RUS environmental policies and procedures.
The Department of Commerce has submitted to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).
Copies of the above information collection proposal can be obtained by calling or writing Diana Hynek, Departmental Paperwork Clearance Officer, (202) 482-0266, Department of Commerce, Room 6625, 14th and Constitution Avenue, NW, Washington, DC 20230 (or via the
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to David Rostker, OMB Desk Officer, FAX number 202-395-7285, or
The Department of Commerce has submitted to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).
Copies of the above information collection proposal can be obtained by calling or writing Diana Hynek, Departmental Paperwork Clearance Officer, (202) 482-0266, Department of Commerce, Room 6625, 14th and Constitution Avenue, NW, Washington, DC 20230 (or via the Internet at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to David Rostker, OMB Desk Officer, FAX number 202-395-7285, or
The Department of Commerce has submitted to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).
Copies of the above information collection proposal can be obtained by calling or writing Diana Hynek, Departmental Paperwork Clearance Officer, (202) 482-0266, Department of Commerce, Room 6625, 14th and Constitution Avenue, NW, Washington, DC 20230 (or via the Internet at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to David Rostker, OMB Desk Officer, FAX number (202) 395-7285, or
The Department of Commerce has submitted to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).
Copies of the above information collection proposal can be obtained by calling or writing Diana Hynek, Departmental Paperwork Clearance Officer, (202) 482-0266, Department of Commerce, Room 6625, 14th and Constitution Avenue, NW, Washington, DC 20230 (or via the Internet at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to David Rostker, OMB Desk Officer, FAX number (202) 395-7285, or
Import Administration, International Trade Administration, Department of Commerce.
Notice of extension of time limit for final results of expedited sunset reviews: frozen concentrated orange juice from Brazil and stainless steel plate in coils from Belgium, Italy, and the Republic of Korea.
The Department of Commerce (“the Department”) is extending the time limit for its final results in the expedited sunset review of the antidumping duty orders on frozen concentrated orange juice (“FCOJ”) from Brazil and stainless steel plate in coils (“SSPC”) from Belgium, Italy, and the Republic of Korea. As a result of this extension, the Department intends to issue final results of these sunset reviews on or about August 30, 2004.
August 5, 2004.
Hilary E. Sadler, Esq., Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street & Constitution Avenue, NW., Washington, DC 20230; telephone: (202) 482-4340.
On April 1, 2004, the Department initiated sunset reviews of the antidumping duty orders of FCOJ from Brazil and SSPC from Belgium, Italy, and Korea.
In accordance with section 751(c)(5)(C)(ii) of the Tariff Act of 1930, as amended (“the Act”), the Department may treat sunset reviews as extraordinarily complicated if the issues to be considered are complex. In these reviews, the Department is analyzing the magnitude of dumping margins likely to prevail for several companies from multiple countries and additional issues surrounding import volume. Because the Department has determined that these issues are complex according to 751(c)(5)(C)(ii) of the Act, we are extending the deadline for issuance of the final results. The Department intends to issue the final results on or about August 30, 2004 in accordance with section 751(c)(5)(B) of the Act.
Import Administration, International Trade Administration, Department of Commerce.
Expedited sunset review of antidumping duty order on barbed wire and barbless fencing wire From Argentina; final results.
On April 1, 2004, the Department of Commerce (“the Department”) initiated a sunset review of the antidumping duty order on barbed wire and barbless fencing wire (“barbed wire”) from Argentina. On the basis of the notice of intent to participate, and an adequate substantive response filed on behalf of the domestic interested parties and an inadequate response,
Martha V. Douthit, Office of Policy, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW., Washington, DC 20230; telephone: (202) 482-5050.
On April 1, 2004, the Department initiated a sunset review of the antidumping duty order on barbed wire from Argentina pursuant to section 751(c) of the Tariff Act of 1930, as amended (“the Act”).
The antidumping duty order remains in effect for all Argentine manufacturers, producers, and exporters of the subject merchandise.
The merchandise covered by this order is barbed wire and barbless
All issues raised in this review are addressed in the “Issues and Decision Memorandum” (“Decision Memo”) from Ronald K. Lorentzen, Acting Director, Office of Policy, Import Administration, to Joseph A. Spetrini, Acting Assistant Secretary for Import Administration, dated July 30, 2004, which is hereby adopted by this notice. The issues discussed in the Decision Memo include the likelihood of continuation or recurrence of dumping and the magnitude of the margin likely to prevail if the order were revoked. Parties can find a complete discussion of all issues raised in this sunset review and the corresponding recommendations in this public memo, which is on file in room B-099 of the main Commerce Building.
In addition, a complete version of the Decision Memo can be accessed directly on the Web at
We determine that revocation of the antidumping duty order on barbed wire from Argentina would likely lead to continuation or recurrence of dumping at the following percentage weighted-average percentage margins:
This notice also serves as the only reminder to parties subject to administrative protective orders (“APO”) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305 of the Department's regulations. Timely notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
We are issuing and publishing the results and notice in accordance with sections 751(c), 752, and 777(i)(1) of the Act.
Import Administration, International Trade Administration, Department of Commerce.
Notice of continuation of antidumping duty order: barium chloride from The People's Republic of China.
The Department of Commerce (“the Department”) has determined that revocation of the antidumping duty order on barium chloride from The People's Republic of China (“PRC”), would be likely to lead to continuation or recurrence of dumping. Therefore the Department is publishing notice of the continuation of the antidumping duty order on barium chloride from the PRC.
August 5, 2004.
Martha V. Douthit, Office of Policy, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Ave., NW., Washington, DC 20230; telephone: (202) 482-5050.
On February 2, 2004, the Department initiated and the International Trade Commission (“ITC”) instituted a sunset review of the antidumping duty order on barium chloride from The People's Republic of China (“PRC”), pursuant to section 751(c) of the Act.
The merchandise covered by this order is barium chloride, a chemical compound having the formula BaCl
As a result of the determinations by the Department and ITC that revocation of this antidumping duty order would be likely to lead to continuation or recurrence of dumping and material injury to an industry in the United States, pursuant to section 751(d)(2) of the Act, the Department hereby orders the continuation of the antidumping duty order on barium chloride from the PRC. The effective date of continuation of this order will be the date of publication in the
Import Administration, International Trade Administration, Department of Commerce.
On May 6, 2003, the Department published the notice of initiation of the new shipper review of the antidumping duty order on glycine
August 5, 2004.
Scot Fullerton or Matthew Renkey at (202) 482-1386 and (202) 482-2312, respectively; Office of AD/CVD Enforcement VII, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW., Washington, DC 20230.
We issued the preliminary results of this new shipper review on February 24, 2004.
On May 3, 2004, we sent New Donghua a fourth supplemental questionnaire, which again included a request for information from its U.S. importer. We received New Donghua's response to this supplemental questionnaire in two submissions, one dated May 13, 2004, and the other dated May 20, 2004. On May 20, 2004, the Department extended the due date for the final results to July 23, 2004.
We received case briefs from petitions (Dow Chemical Company and Chattem Chemicals, Inc.) and New Donghua on June 17, 2004, and on June 22, 2004, both parties filed rebuttal briefs. On June 30, 2004, we sent a letter to New Donghua stating that we were rejecting its case brief on the basis that is contained new factual information. On July 16, 2004, after evaluating comments from New Donghua and petitioners on the rejection issue, we confirmed our decision to reject New Donghua's case brief. New Donghua re-filed its case brief, minus the new factual information, on July 19, 2004.
In addition to commenting on the
The product covered by this antidumping duty order is glycine, which is a free-flowing crystalline material, like salt or sugar. Glycine is produced at varying levels of purity and is used as a sweetener/taste enhancer, a buffering agent, reabsorbable amino acid, chemical intermediate, and a metal complexing agent. Glycine is currently classifiable under subheading 2922.49.4020 of the Harmonized Tariff Schedule of the United States (HTSUS). This order covers glycine of all purity levels. Although the HTSUS subheading is provided for convenience and customs purposes, the written description of the scope of this order is dispositive.
The Department takes its responsibility to review the
The Department will notify U.S. Customs and Border Protection (CBP) that bonding is no longer permitted to fulfill security requirements for shipments from New Donghua of glycine from the PRC entered, or withdrawn from warehouse, for consumption in the United States on or after the publication of this notice of rescission of antidumping duty new shipper review in the
The Department shall instruct CBP to assess antidumping duties on all appropriate entries. Since we are rescinding this antidumping duty new shipper review with respect to New Donghua, the PRC-wise rate of 155.89 percent in effect at the time of entry applies to all exports of glycine from the PRC by New Donghua entered or withdrawn from warehouse for
This notice also serves as a reminder to importers of their responsibility under § 351.402(f) of the Department regulations to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
This notice also serves as a reminder to parties subject to administrative protective orders (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with section 351.305(a)(3) of the Department regulations. Timely written notification of the return/destruction of APO material or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanctions.
We are issuing and publishing this determination and notice in accordance with sections 751(a)(2)(B) and 777(i)(1) of the Tariff Act of 1930, as amended.
Import Administration, International Trade Administration, Department of Commerce.
August 5, 2004.
Steve Williams at (202) 482-4619 or Jim Nunno at (202) 482-0783, respectively; Antidumping and Countervailing Duty Enforcement Group III, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW., Washington, DC 20230.
The Department received a timely request from Foodworld International Club Limited (“Foodworld”) in accordance with 19 CFR 351.214 (c), for a new shipper review of the antidumping duty order on honey from The People's Republic of China (“PRC”), which has a December annual anniversary month and a June semiannual anniversary month.
On July 13, 2004 and July 16, 2004 the Department issued pre-initiation supplemental questionnaires to Foodworld to clarify company information submitted in their requests to the Department for a new shipper review. In Foodworld's supplemental questionnaire response, dated July 21, Foodworld adequately responded to the Department's request for clarification on Customs documents attached to Foodworld's new shipper review request. Foodworld also provided state incorporation documents for the importer of record at the Department's request.
The Department conducted Customs database queries to determine whether Foodworld's shipment had officially entered the United States via assignment of an entry date in the Customs database by the U.S. Customs and Border Protection (CBP). In addition, the Department confirmed through research in PIERS and State incorporation records that Foodworld International and the importer of record appear to be bona fide companies.
The merchandise under review is honey from the PRC. The products covered are natural honey, artificial honey containing more than fifty percent natural honey by weight, preparations of natural honey containing more than fifty percent natural honey by weight, and flavored honey. The subject merchandise includes all grades and colors of honey whether in liquid, creamed, comb, cut comb, or chunk form, and whether packaged for retail or in bulk form. The merchandise under review is currently classifiable under item 0409.00.00, 1702.90.90, and 2106.90.99 of the Harmonized Tariff Schedule of the United States (HTSUS). Although the HTSUS subheading is provided for convenience and customs purposes, the written description of the merchandise under review is dispositive.
In accordance with section 751(a)(2)(B) of the Act, as amended, and 19 CFR 351.214(d)(1), and based on information on the record, we are initiating a new shipper review for Foodworld.
Pursuant to 19 CFR 351.214(g)(1)(i)(A) of the Department's regulations, the period of review (“POR”) for a new shipper review initiated in the month immediately following the anniversary month will be the twelve-month period immediately preceding the anniversary month. Therefore, the POR for this new shipper review is:
In accordance with section 751(a)(2)(B)(iii) of the Act and 19 CFR 351.214(e), we will instruct the CBP to allow, at the option of the importer, the posting, until the completion of the review, of a single entry bond or security in lieu of a cash deposit for certain entries of the merchandise exported by Foodworld. Specifically, since Foodworld has identified Anhui Tianxin as the producer of the subject merchandise for the sale under review, we will instruct CBP to limit the bonding option only to entries of merchandise from Foodworld that were produced by Anhui Tiaxin Bee Products.
Interested parties that need access to proprietary information in this new shipper review should submit applications for disclosure under administrative protective orders in accordance with 19 CFR 351.305 and 351.306.
This initiation and notice are in accordance with section 751(a) of the Act (19 U.S.C. 1675(a)) and 19 CFR 351.214(d).
Import Administration, International Trade Administration, Department of Commerce.
Notice of final results of administrative review and partial rescission of review.
On April 16, 2004, the Department of Commerce published the preliminary results of the 2002/2003 administrative review of the antidumping duty order on pure magnesium from Canada with respect to Norsk Hydro Canada Inc. This review covers sales of pure magnesium from Canada to the United States during the period August 1, 2002, through July 31, 2003. We provided interested parties with an opportunity to comment on the preliminary results of this review, but received no comments. The final results do not differ from the preliminary results of this review, in which we found that the respondent made sales in the United States at prices not below normal value.
Scott Holland, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW., Washington, DC 20230; telephone: (202) 482-1279.
The Department of Commerce (“the Department”) published the preliminary results of this review on April 16, 2004 (
We invited interested parties to comment on the preliminary results of this review. No comments were received.
The product covered by this order is pure magnesium. Pure unwrought magnesium contains at least 99.8 percent magnesium by weight and is sold in various slab and ingot forms and sizes. Granular and secondary magnesium are excluded from the scope currently classifiable under subheading 8104.11.0000 of the Harmonized Tariff Schedule (“HTS”). The HTS item number is provided for convenience and for customs purposes. The written description of the scope of the order remains dispositive.
The period of review (“POR”) is August 1, 2002, through July 31, 2003.
In accordance with 19 CFR 351.213(d)(3), and consistent with the
To determine whether sales of pure magnesium from Canada to the United States were made at less than normal value (“NV”), we compared export price (“EP”) to NV. Our calculations followed the methodologies described in the
We made currency conversions in accordance with section 773A of the Tariff Act of 1930, as amended (“the Act”) in the same manner as in the
We have determined that no changes to our analysis are warranted for purposes of these final results. As a result of this review, we determine that the following percentage weighted-average margin exists for the period August 1, 2002, through July 31, 2003:
The Department shall determine, and U.S. Customs and Border Protection (“CBP”) shall assess, antidumping duties on all appropriate entries. In accordance with 19 CFR 351.212(b)(1), we have calculated importer (or customer)-specific assessment rates for merchandise subject to this review. To determine whether the duty assessment rates were
Pending the final disposition of a NAFTA panel review, the Department
The following antidumping duty deposits will be required on all shipments of pure magnesium from Canada entered, or withdrawn from warehouse, for consumption, on or after the publication date of the final results of this administrative review, as provided by section 751(a)(1) of the Act: (1) No cash deposit rate will be required for NHCI because its weighted-average margin is
This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of doubled antidumping duties.
This notice also serves as a reminder to parties subject to administrative protective orders (“APOs”) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305, which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
We are issuing and publishing these results in accordance with sections 751(a)(1) and 777(i)(1) of the Act.
Import Administration, International Trade Administration, Department of Commerce.
The Department of Commerce is conducting an administrative review of the antidumping duty order on sebacic acid from The People's Republic of China (PRC) in response to a request by SST Materials, Inc. d/b/a Genesis Chemicals, Inc., a domestic producer of the subject merchandise. The period of review is July 1, 2002, through June 30, 2003. We have preliminarily determined that Guangdong Chemicals Import and Export Corporation (Guangdong) has sold subject merchandise at less than normal value. If these preliminary results are adopted in our final results of administrative review, we will instruct Customs and Border Protection (CBP) to assess antidumping duties on entries subject to this review by these exporters.
John Conniff, AD/CVD Enforcement, Group II, Office 4, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW., Washington, DC 20230; telephone: (202) 482-1009.
On July 2, 2003, the Department of Commerce (the Department) published in the
On July 31, 2003, in accordance with 19 CFR 351.213(b)(1), SST Materials, Inc. d/b/a Genesis Chemicals, Inc. (Genesis), a domestic producer of the subject merchandise, requested an administrative review of Tianjin Chemical Import and Export Corporation (Tianjin) and Guangdong.
On August 13, 2003, the Department issued antidumping questionnaires to Guangdong and Tianjin.
We received timely responses from Guangdong to sections A, C, and D of the initial antidumping questionnaire and associated supplemental questionnaires, and we received a timely certification from Tianjin that all of its exports of sebacic acid were manufactured by Hungshui Donfeng Chemical Co. (Hengshui), and thus were excluded from the antidumping duty order. For further information,
On March 15, 2004, the Department extended the time period for the preliminary results in this review.
The Department previously revoked, in part, the antidumping duty order on sebacic acid from The PRC, with respect to Tianjin's sales of subject merchandise produced by Hengshui.
On February 10, 2004, Genesis alleged that, subsequent to the revocation of the order, Tianjin resumed dumping sebacic acid in the United States with respect to its U.S. sales of sebacic acid produced by Hengshui. Accordingly, Genesis requested that the Department reinstate the antidumping duty order on exports of this merchandise. On February 17, 2004, Tianjin submitted a letter to the Department in which it argued that Genesis' request should be rejected because: (1) it is outside the scope of the 2002-2003 administrative review; and (2) it was untimely filed in that segment of the proceeding. Tianjin argued that Genesis' allegation should instead be considered in the context of a changed circumstances review, pursuant to 19 CFR 351.216.
On June 25, 2004, the Department initiated a changed circumstances review of the antidumping duty order on sebacic acid from the PRC to consider whether the Department should reinstate the order with respect to subject merchandise produced by Hengshui and exported to the United States by Tianjin.
The products covered by this order are all grades of sebacic acid, a dicarboxylic acid with the formula (CH2)
It is the Department's policy to assign all exporters of the merchandise subject to review in non-market-economy (NME) countries a single rate, unless an exporter can demonstrate an absence of government control, both in law and in fact, with respect to its exports to the United States. To establish whether an exporter is sufficiently independent of government control to be entitled to a separate rate, the Department analyzes the exporter in light of the criteria established in the
With respect to Guangdong, in our final results for the most recently completed review period (
We calculated export price (EP) in accordance with section 772(a) of the Tariff Act of 1930, as amended (the Act) because the subject merchandise was sold directly to the first unaffiliated purchaser in the United States prior to importation and constructed export
For foreign inland freight, we obtained publicly-available information which was published in the October 2002 through March 2003 editions of
Section 773(c)(4) of the Act requires the Department to value an NME producer's factors of production, to the extent possible, in one or more market economy countries that: (1) are at a level of economic development comparable to that of the NME country, and (2) are significant producers of comparable merchandise.
For purposes of the most recent segment of this proceeding, we found that India is a producer of oxalic acid, a product comparable to sebacic acid.
In accordance with 19 CFR 351.408(c)(1), the Department will normally use publicly available information to value factors of production. However, the Department's regulations also provide that where a producer purchases an input from a market economy supplier and pays for it in market economy currency, the Department employs the actual price paid for the input to the market economy supplier to calculate the factors-based NV.
In accordance with section 773(c) of the Act, we calculated NV based on factors of production reported by Guangdong for the POR. To calculate NV, the reported per-unit factor quantities were multiplied by publicly available Indian surrogate values. Factors of production include, but are not limited to: (1) Hours of labor required; (2) quantities of raw materials employed; (3) amounts of energy and other utilities consumed; and (4) representative capital cost, including depreciation. In examining surrogate values, we selected, where possible, the publicly available value which was: (1) An average non-export value; (2) representative of a range of prices within the POR or most contemporaneous with the POR; (3) product-specific; and (4) tax-exclusive. For a more detailed explanation of the methodology used in calculating various surrogate values, see the
In selecting the surrogate values, we considered the quality, specificity, and contemporaneity of the data. Where appropriate, we adjusted surrogate values to reflect inflation up to the POR using the WPI published by the IMF. In accordance with this methodology, we valued the factors of production as follows:
To value caustic soda, cresol, phenol, sulfuric acid, and zinc oxide, we obtained information from the Indian publication
Consistent with the methodology employed in
We also allocated a by-product credit for glycerine to the production cost for the co-product capryl alcohol. We deducted a by-product credit for glycerine from sebacic acid based on the ratio of the value of sebacic acid to the total value of both sebacic acid and capryl alcohol.
Consistent with the methodology employed in the previous administrative review, we have determined that capryl alcohol is a co-product and have allocated the factor inputs based on the relative surrogate
To value electricity, we used data from the
We made adjustments to account for freight costs between the suppliers and the respective manufacturing facilities for each of the factors of production identified above. In accordance with our practice, for inputs for which we used cost-insurance-freight import values from India, we calculated a surrogate freight cost using the shorter of the reported distances either from the closest PRC ocean port to the factory or from the domestic supplier to the factory.
For truck freight, we obtained publicly-available information which was published in the October 2002 through March 2003 editions of
We valued labor based on a regression-based wage rate, in accordance with 19 CFR 351.408(c)(3). This information is available on the Department's Web site at
To value factory overhead, selling, general, and administrative expenses, and profit, we obtained data from the
We preliminarily determine that the following margin exists for the period July 1, 2002, through June 30, 2003:
The Department will disclose to parties the calculations performed in connection with these preliminary results within five days of the date of publication of this notice. Interested parties may request a hearing within 30 days of the publication. Any hearing, if requested, will be held 44 days after the publication of this notice, or the first workday thereafter. Interested parties may submit case briefs not later than 30 days after the date of publication of this notice. Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than 35 days after the date of publication of this notice. The Department will publish a notice of the final results of this administrative review, which will include the results of its analysis of issues raised in any such written briefs, within 120 days of the publication of these preliminary results.
The Department will determine and CBP shall assess antidumping duties on all appropriate entries. The Department will issue appropriate appraisement instructions directly to CBP upon completion of this review. The final results of this review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by this review and for future deposits of estimated duties.
For assessment purposes, we do not have the information to calculate an estimated entered value. Accordingly, we have calculated importer-specific duty assessment rates for the merchandise by aggregating the dumping margins calculated for all U.S. sales and dividing this amount by the total quantity of those sales. To determine whether the duty assessment rates were
Furthermore, the following deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided by section 751(a)(1) of the Act: (1) The cash deposit rate for Guangdong will be that established in the final results of this administrative review; (2) for a company covered by the antidumping duty order, previously found to be entitled to a separate rate and for which no review was requested, the cash deposit rate will be the rate established in the most recent review of that company; (3) the cash deposit rate for all other PRC exporters (
This notice serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
This administrative review is issued and published in accordance with sections 751(a)(1) and 777(i) of the Act.
Import Administration, International Trade Administration, Department of Commerce.
Notice of amended initiation and amended preliminary results of antidumping duty administrative review.
August 5, 2004.
Constance Handley or James Kemp, Office 5, AD/CVD Enforcement, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW., Washington, DC 20230; telephone: (202) 482-0631 or (202) 482-5346, respectively.
The Department of Commerce is amending its notice of initiation of administrative review of the antidumping duty order on certain softwood lumber products from Canada, covering the period May 22, 2002, through April 30, 2003 (the POR) and its notice of preliminary results in the administrative review of the antidumping duty order on certain softwood lumber products from Canada for the POR.
On May 1, 2003, the Department of Commerce (the Department) published a notice of opportunity to request the first administrative review of this order.
On July 1, 2003, the Department published a notice of initiation of administrative review of the antidumping duty order on certain softwood lumber products from Canada, covering the POR.
On June 14, 2004, the Department published a notice of preliminary results of antidumping duty administrative on certain softwood lumber products from Canada, covering the POR.
We are initiating an administrative review of the antidumping duty order on Certain Softwood Lumber Products from Canada, covering the period May 22, 2002, through April 30, 2003 for the following companies. We intend to issue the final results of this review no later than December 13, 2004.
The products covered by this order are softwood lumber, flooring and siding (softwood lumber products). Softwood lumber products include all products classified under headings 4407.1000, 4409.1010, 4409.1090, and 4409.1020, respectively, of the Harmonized Tariff Schedule of the United States (HTSUS), and any softwood lumber, flooring and siding described below. These softwood lumber products include:
(1) coniferous wood, sawn or chipped lengthwise, sliced or peeled, whether or not planed, sanded or finger-jointed, of a thickness exceeding six millimeters;
(2) coniferous wood siding (including strips and friezes for parquet flooring, not assembled) continuously shaped (tongued, grooved, rabbeted, chamfered, v-jointed, beaded, molded, rounded or the like) along any of its edges or faces, whether or not planed, sanded or finger-jointed;
(3) other coniferous wood (including strips and friezes for parquet flooring, not assembled) continuously shaped (tongued, grooved, rabbeted, chamfered, v-jointed, beaded, molded, rounded or the like) along any of its edges or faces (other than wood moldings and wood dowel rods) whether or not planed, sanded or finger-jointed; and
(4) coniferous wood flooring (including strips and friezes for parquet flooring, not assembled) continuously shaped (tongued, grooved, rabbeted, chamfered, v-jointed, beaded, molded, rounded or the like) along any of its edges or faces, whether or not planed, sanded or finger-jointed.
Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the merchandise under review is dispositive.
Softwood lumber products excluded from the scope:
• Trusses and truss kits, properly classified under HTSUS 4418.90.
• I-joist beams.
• Assembled box spring frames.
• Pallets and pallet kits, properly classified under HTSUS 4415.20.
• Garage doors.
• Edge-glued wood, properly classified under HTSUS 4421.90.97.40 (formerly HTSUS 4421.90.98.40).
• Properly classified complete door frames.
• Properly classified complete window frames.
• Properly classified furniture.
Softwood lumber products excluded from the scope only if they meet certain requirements:
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•
•
•
•
•
(A) The imported home package or kit constitutes a full package of the number of wooden pieces specified in the plan, design or blueprint necessary to produce a home of at least 700 square feet produced to a specified plan, design or blueprint;
(B) The package or kit must contain all necessary internal and external doors and windows, nails, screws, glue, subfloor, sheathing, beams, posts, connectors and if included in purchase contract decking, trim, drywall and roof shingles specified in the plan, design or blueprint;
(C) Prior to importation, the package or kit must be sold to a retailer of complete home packages or kits pursuant to a valid purchase contract referencing the particular home design plan or blueprint, and signed by a customer not affiliated with the importer;
(D) The whole package must be imported under a single consolidated entry when permitted by CBP, whether or not on a single or multiple trucks, rail cars or other vehicles, which shall be on the same day except when the home is over 2,000 square feet;
(E) The following documentation must be included with the entry documents:
• a copy of the appropriate home design, plan, or blueprint matching the entry;
• a purchase contract from a retailer of home kits or packages signed by a customer not affiliated with the importer;
• a listing of inventory of all parts of the package or kit being entered that conforms to the home design package being entered;
• in the case of multiple shipments on the same contract, all items listed immediately above which are included in the present shipment shall be identified as well.
We have determined that the excluded products listed above are outside the scope of this order provided the specified conditions are met. Lumber products that CBP may classify as stringers, radius cut box-spring-frame components, and fence pickets, not conforming to the above requirements, as well as truss components, pallet components, and door and window frame parts, are covered under the scope of this order and may be classified under HTSUS subheadings 4418.90.40.90, 4421.90.70.40, and 4421.90.98.40. Due to changes in the 2002 HTSUS whereby subheading 4418.90.40.90 and 4421.90.98.40 were changed to 4418.90.45.90 and 4421.90.97.40, respectively, we are adding these subheadings as well.
In addition, this scope language has been further clarified to now specify that all softwood lumber products entered from Canada claiming non-subject status based on U.S. country of origin will be treated as non-subject U.S.-origin merchandise under the countervailing duty order, provided that these softwood lumber products meet the following condition: upon entry, the importer, exporter, Canadian processor and/or original U.S. producer establish to CBP's satisfaction that the softwood lumber entered and documented as U.S.-origin softwood lumber was first produced in the United States as a lumber product satisfying the physical parameters of the softwood lumber scope.
In the preliminary results, the Department determined a preliminary weighted-average margin for those companies that requested, but were not selected for, individual review. As a result of this review, we preliminarily determine that the following review-specific weighted-average margin exists for the period covering the POR, for the following additional companies:
Upon completion of this administrative review, pursuant to 19 CFR 351.212(b), the Department will calculate an assessment rate on all appropriate entries. For the companies requesting a review, but not selected for examination and calculation of individual rates, we will calculate a weighted-average assessment rate based on all importer-specific assessment rates excluding any which are
The following deposit rate will be effective upon publication of the final results of this administrative review of all shipments of certain softwood lumber products from Canada entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided by section 751(a)(1) of the Tariff Act of 1930 (the Act): (1) for the non-selected companies we will calculate a weighted-average cash deposit rate based on all the company-specific cash deposit rates, excluding
This notice serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entities during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
This determination is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act.
Import Administration, International Trade Administration, Department of Commerce.
Notice of continuation of antidumping duty order: Sorbitol from France.
The Department of Commerce (“the Department”) has determined that revocation of the antidumping duty order on sorbitol from France, would be likely to lead to continuation or recurrence of dumping. Therefore, the Department is publishing notice of the continuation of the antidumping duty order on sorbitol from France.
On February 2, 2004, the Department initiated and the Commission instituted a sunset review of the antidumping duty order on sorbitol from France, pursuant to section 751(c) of the Act.
The merchandise covered by this order is crystalline sorbitol, a polyol produced by the hydrogenation of sugars (glucose), used in the production of sugarless gum, candy, groceries, and pharmaceuticals, currently classifiable under U.S. Harmonized Tariff Schedule item number 2905.44.00.
As a result of the determinations by the Department and ITC that revocation of this antidumping duty order would likely lead to continuation or recurrence of dumping and material injury to an industry in the United States, pursuant to section 751(d)(2) of the Act, the Department hereby orders the continuation of the antidumping duty order on sorbitol from France. The effective date of continuation of this order will be the date of publication in the
Import Administration, International Trade Administration, Department of Commerce.
Notice of expedited sunset review on stainless steel plate in coils from Canada, South Africa, and Taiwan; final results.
On April 1, 2004, the Department of Commerce (“the Department”) initiated a sunset review of the antidumping duty orders on stainless steel plate in coils (“SSPC”) from Canada, Taiwan, and South Africa pursuant to section 751(c) of the Tariff Act of 1930, as amended (“the Act”). On the basis of a notice of intent to participate and an adequate substantive response filed on behalf of domestic interested parties and inadequate response (in this case, no response) from respondent interested parties, the Department conducted an expedited (120-day) sunset review. As a result of this sunset review, the Department finds that revocation of the antidumping duty orders would likely lead to continuation or recurrence of dumping. The dumping margins are identified in the
Martha V. Douthit, Office of Policy for Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street & Constitution Avenue, NW., Washington, DC 20230; telephone: (202) 482-5050.
On April 1, 2004, the Department published the notice of initiation of the sunset reviews of the antidumping duty orders on SSPC from Canada, South Africa, and Taiwan.
The merchandise subject to these orders is stainless steel plate in coils. Stainless steel is an alloy steel containing, by weight, 1.2 percent or less of carbon and 10.5 percent or more of chromium, with or without other elements. The subject plate products are flat-rolled products, 254 mm or over in width and 4.75 mm or more in thickness, in coils, and annealed or otherwise heat treated and pickled or otherwise descaled. The subject plate may also be further processed (
All issues raised in these reviews are addressed in the “Issues and Decision Memorandum” (“Decision Memo”) from Ronald K. Lorentzen, Acting Director, Office of Policy, Import Administration, to Joseph A. Spetrini, Acting Assistant Secretary for Import Administration, dated July 30, 2004, which is hereby adopted by this notice. The issues discussed in the Decision Memo include the likelihood of continuation or recurrence of dumping and the magnitude of the margin likely to prevail if the order were to be revoked. Parties can find a complete discussion of all issues raised in these reviews and the corresponding recommendations in this public memorandum, which is on file in room B-099 of the main Commerce Building.
In addition, a complete version of the Decision Memo can be accessed directly on the Web at
We determine that revocation of the antidumping duty orders on SSPC from Canada, South Africa, and Taiwan would likely lead to continuation or recurrence of dumping at the following percentage weighted-average percentage margins:
This notice also serves as the only reminder to parties subject to administrative protective orders (“APO”) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305 of the Department's regulations. Timely notification of the return or
We are issuing and publishing the results and notice in accordance with sections 751(c), 752, and 777(i)(1) of the Act.
Import Administration, International Trade Administration, Department of Commerce.
Catherine Bertrand or Robert Bolling, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW., Washington, DC 20230; telephone: (202) 482-3207, or 482-3434, respectively.
Pursuant to 19 CFR 351.224(g)(1) and (g)(2), the Department of Commerce (“Department”) is amending the preliminary determination of sales at less than fair value in the antidumping duty investigation of wooden bedroom furniture from the People's Republic of China (“PRC”) to reflect the correction of significant ministerial errors it made in the margin calculations regarding the following mandatory respondents: Rui Feng Woodwork Co., Ltd., Rui Feng Lumber Development Co., Ltd., and Dorbest Limited (collectively “Dorbest Group”); Starcorp Furniture (Shanghai) Co., Ltd., Orin Furniture (Shanghai) Co., Ltd., and Shanghai Starcorp Furniture Co., Ltd. (collectively “Starcorp”). A ministerial error is defined as an error in addition, subtraction, or other arithmetic function, clerical error resulting from inaccurate copying, duplication, or the like, and any other similar type of unintentional error which the Secretary considers ministerial.
Additionally, the Department is amending the preliminary determination of sales at less than fair value in the antidumping duty investigation of wooden bedroom furniture from the PRC to reflect the correction of ministerial errors it made regarding certain Section A respondents that have applied for a separate rate and provided information for the Department to consider for the preliminary determination but were denied a separate rate at the preliminary determination stage. Memorandum to Laurie Parkhill, Office Director, AD/CVD Enforcement, Antidumping Duty Investigation of Wooden Bedroom Furniture From the People's Republic of China: Analysis of Allegations of Ministerial Errors for Section A Respondents dated July 29, 2004.
On June 24, 2004, the Department published its affirmative preliminary determination in this proceeding.
On June 29, 2004, the Department received timely allegations of ministerial errors in the
We agree with certain ministerial errors made with respect to the mandatory respondents. However, not all of the alleged ministerial errors for each mandatory respondent when taken in totality meet the definition of a ministerial error under 19 CFR 351.224. Due to the large number of mandatory respondents and the extraordinary number of alleged ministerial errors in this case we have summarized all comments in company-specific memoranda. For a complete listing of all comments, please see the individual memorandum for each mandatory respondent (
On June 29, 2004, the Department received timely allegations of ministerial errors in the
Additionally, on July 6, 2004, the Department received additional timely information from certain Section A Respondents. The Department will address these comments in the Final Determination.
Further, the Department received several new Section A filings from companies requesting a separate rate after the preliminary determination. We have determined to return these filings because they were untimely. As the Department stated in the
The collection of bonds or cash deposits and suspension of liquidation will be revised accordingly and parties will be notified of this determination, in accordance with section 733 (d) and (f) of the Tariff Act of 1930, as amended, (the Act).
As a result of our correction of ministerial errors in the Preliminary Determination, we have determined that the following weighted-average dumping margins apply:
The PRC-wide rate has not been amended.
In accordance with section 733(f) of the Act, we have notified the International Trade Commission (“ITC”) of our amended preliminary determination. If our final determination is affirmative, the ITC will determine before the later of 120 days after the date of the preliminary determination or 45 days after our final determination whether the domestic industry in the United States is materially injured, or threatened with material injury, by reason of imports, or sales (or the likelihood of sales) for importation, of the subject merchandise.
This determination is issued and published in accordance with sections 733(f) and 777(I)(1) of the Act and 19 CFR 351.224(e).
Import Administration, International Trade Administration, Department of Commerce.
Notice of final results of the expedited sunset review of the countervailing duty order on stainless steel plate in coils from South Africa.
On April 1, 2004, the Department of Commerce (“the Department”) initiated a sunset review of the countervailing duty order on stainless steel plate in coils (“SSPC”) from South Africa pursuant to section 751(c) of the Tariff Act of 1930, as amended (“the Act”). On the basis of a notice of intent to participate and an adequate substantive response filed on behalf of domestic interested parties and an inadequate response,
Martha V. Douthit, Office of Policy for
August 5, 2004.
On April 1, 2004, the Department of Commerce (“the Department”) initiated a sunset review of the countervailing duty order on SSPC from South Africa pursuant to section 751(c) of the Act.
The merchandise subject to this countervailing duty order is stainless steel plate in coils. Stainless steel is an alloy steel containing, by weight, 1.2 percent or less of carbon and 10.5 percent or more of chromium, with or without other elements. The subject plate products are flat-rolled products, 254 mm or over in width and 4.75 mm or more in thickness, in coils, and annealed or otherwise heat treated and pickled or otherwise descaled. The subject plate may also be further processed (
All issues raised in this case are addressed in the “Issues and Decision Memorandum” (“Decision Memo”) from Ronald K. Lorentzen, Acting Director, Office of Policy, Import Administration, to Joseph A. Spetrini, Acting Assistant Secretary for Import Administration, dated July 30, 2004, which is hereby adopted by this notice. The issues discussed in the Decision Memo include the likelihood of continuation or recurrence of subsidization and the magnitude of the margin likely to prevail if the order were revoked. Parties can find a complete discussion of all issues raised in this review and the corresponding recommendations in this public memorandum, which is on file in room B-099 of the main Commerce Building.
In addition, a complete version of the Decision Memo can be accessed directly on the Web at
We determine that revocation of the countervailing duty order on SSPC from South Africa would likely lead to continuation or recurrence of subsidization at the following weighted-average percentage margins:
This notice also serves as the only reminder to parties subject to administrative protective orders (“APO”) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305 of the Department's regulations. Timely notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
We are issuing and publishing the results and notice in accordance with sections 751(c), 752, and 777(i)(1) of the Act.
Commodity Futures Trading Commission.
Notice.
The Commodity Futures Trading Commission (CFTC) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501
Comments must be submitted on or before October 4, 2004.
Comments may be mailed to David Van Wagner, Division of Market Oversight, U.S. Commodity Futures Trading Commission, 1155 21st Street, NW., Washington, DC 20581.
David Van Wagner at (202) 418-5481; FAX: (202) 418-5536; e-mail:
Under the PRA, Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA, 44 U.S.C. 3506(c)(2)(A), requires Federal agencies to provide a 60-day notice in the
With respect to the following collection of information, the CFTC invites comments on:
• Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have a practical use;
• The accuracy of the Commission's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Ways to enhance the quality, usefulness, and clarity of the information to be collected; and
• Ways to minimize the burden of collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technology;
Rule 40.4 establishes a procedure for designated contract markets to submit certain rules concerning agricultural contracts to the Commission for prior approval. Rule 40.5 establishes a procedure for any registered entity (designated contract markets, registered derivatives transaction execution facilities and registered derivatives clearing organizations) to request that the Commission review and approve any rule or proposed rule or rule amendment. Rules 40.2 and 40.6 establishes procedures for designated contract markets and registered derivatives clearing organization to self-certify rules.
The Commission estimates the burden of this collection of information as follows:
There are no capital costs or operating and maintenance costs associated with this collection.
This estimate is based on the Commission's experience over the last three years.
Corporation for National and Community Service.
Notice.
The Corporation for National and Community Service (hereinafter the “Corporation”), has submitted the two following public information collection requests (ICRs) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13), (44 U.S.C. Chapter 35). Copies of these individual ICRs (one for AmeriCorps and one for Learn and Serve America), with applicable supporting documentation, may be obtained by calling the Corporation for National and Community Service, LaMonica Shelton, (202) 606-5000, ext. 464 for the AmeriCorps collection and Kimberly Spring, ext. 543 for the Learn and Serve collection. Individuals who use a telecommunications device for the deaf (TTY-TDD) may call (202) 565-2799 between 8:30 a.m. and 5 p.m. Eastern time, Monday through Friday.
Comments may be submitted, identified by the title of the information collection activity, to the Office of Information and Regulatory Affairs, Attn: Ms. Katherine Astrich, OMB Desk Officer for the Corporation for National and Community Service, by any of the following two methods within 30 days from the date of this publication in the
(1) By fax to: (202) 395-6974, Attention: Ms. Katherine Astrich, OMB Desk Officer for the Corporation for National and Community Service; and
(2) Electronically by e-mail to:
The initial 60-day
In direct response to the 60-day
As a result of this feedback, we better modified questions to address the proper audiences and revised questions so that we can capture more information on the effects that volunteer service has upon members.
The Corporation received no comments from the general public regarding the Learn and Serve Program and Performance Reporting System as a
The OMB is particularly interested in comments which:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Corporation, including whether the information will have practical utility;
• Evaluate 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;
• Propose ways to enhance the quality, utility, and clarity of the information to be collected; and
• Propose ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Learn and Serve has designed a Program Reporting and Performance Measurement form and a Customer Satisfaction Survey. The Program Reporting and Performance Measurement form is designed to collect information on (a) the characteristics of grantee and subgrantee organizations; (b) the scope and structure of service-learning activities in the funded organizations; (c) numbers of participants in service learning and hours of service provided; (d) institutional supports for service learning, and (e) program outcomes. There are three different versions of the form, corresponding to the three major funding streams under Learn and Serve America: K-12 school-based programs, Higher Education-based programs, and Community-Based programs. The Learn and Serve America Customer Satisfaction Survey will gather data on grantee satisfaction with the Learn and Serve program.
Department of Defense, Defense Security Cooperation Agency.
Notice.
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated 21 July 1996.
Ms. J. Hurd, DSCA/OPS-ADMIN, (703) 604-6575.
The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 04-27 with attached transmittal, policy justification, and Sensitivity of Technology.
Department of Defense, Defense Security Cooperation Agency.
Notice.
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated 21 July 1996.
Ms. J. Hurd, DSCA/OPS-ADMIN, (703) 604-6575.
The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 04-13 with attached transmittal and policy justification.
Department of Defense Education Activity (DoDEA), DoD.
Open meeting notice.
Pursuant to the Federal Advisory Committee Act, Appendix 2 of title 5, United States Code, Public Law 92-463, notice is hereby given that a meeting of the Advisory Council on Dependents' Education (ACDE) is scheduled to be held on September 24, 2004, from 8 a.m. to 5 p.m. The meeting will be held at the DoDEA headquarters building at 4040 North Fairfax Drive, Arlington, Virginia 22203. The purpose of the ACDE is to recommend to the Director, DoDEA, general policies for the operation of the Department of Defense Dependents Schools (DoDDS); to provide the Director with information about effective educational programs and practices that should be considered by DoDDS; and to perform other tasks as may be required by the Secretary of Defense. The meeting emphases will be the current operational qualities of DoDDS and the institutionalized school improvement processes, as well as other educational matters. For further information contact Mr. Jim Jarrard, at (703) 588-3121 or at
Department of the Army—U.S. Army Corps of Engineers, DoD.
Notice of availability.
The U.S. Army Corps of Engineers, Los Angeles District (Regulatory Branch), in coordination with the Port of Long Beach, has completed a Final Environmental Impact Statement/Environmental Impact Report (EIS/EIR) for the Pier J South Marine Terminal Expansion project. The Port of Long Beach requires authorization pursuant to section 404 of the Clean Water Act and section 10 of the Rivers and Harbors Act for 115 acres
Questions or comments concerning the Final EIS/EIR should be directed to Dr. Aaron O. Allen, Senior Project Manager, Regulatory Branch, U.S. Army Corps of Engineers, P.O. Box 532711, Los Angeles, CA 90053-2325, (805) 585-2148.
None.
Energy Information Administration (EIA), Department of Energy (DOE).
Agency Information Collection Activities: Submission for OMB Review; comment request.
The EIA has submitted the new survey form EIA-914, “Monthly Natural Gas Production Report” to the Office of Management and Budget (OMB) for review and a three-year approval under section 3507(h)(1) of the Paperwork Reduction Act of 1995 (Pub. L. 104-13) (44 U.S.C. 3501
Comments must be filed by September 7, 2004. If you anticipate that you will be submitting comments but find it difficult to do so within that period, you should contact the OMB Desk Officer for DOE listed below as soon as possible.
Send comments to OMB Desk Officer for DOE, Office of Information and Regulatory Affairs, Office of Management and Budget. To ensure receipt of the comments by the due date, submission by fax (202) 395-7285) is recommended. The mailing address is 726 Jackson Place, NW., Washington, DC 20503. (A copy of your comments should also be provided to EIA's Statistics and Methods Group at the address below.)
Requests for additional information should be directed to Herbert Miller. To ensure receipt of the comments by the due date, submission by fax (202) 287-1705) or e-mail (
This section contains the following information about the energy information collection submitted to OMB for review: (1) The collection numbers and title; (2) the sponsor (
1. EIA-914, “Monthly Natural Gas Production Report”.
2. Energy Information Administration.
3. OMB Number—Not applicable.
4. New.
5. Mandatory.
6. The purpose of the survey is to collect monthly data on the production of natural gas in seven geographical areas (Texas (including State offshore), Louisiana (including State offshore), Oklahoma, New Mexico, Wyoming, Federal Gulf of Mexico offshore and Other States (defined as all remaining states, except Alaska, in which the operator produced natural gas during the report month). Data will be used to monitor natural gas supplies. Survey respondents would be a sample of well operators.
Since EIA's main goal is to have timely overall production information, at this time the agency is not proposing to collect information on gas used for repressuring and reinjection, gas vented and flared, fuel used on the lease, or nonhydrocarbons removed on the lease, as proposed in the
7. Business or other for-profit.
8. 15,517 hours.
Please refer to the supporting statement as well as the proposed forms and instructions for more information about the purpose, who must report, when to report, where to submit, the elements to be reported, detailed instructions, provisions for confidentiality, and uses (including possible nonstatistical uses) of the information. For instructions on obtaining materials, see the
Section 3507(h)(1) of the Paperwork Reduction Act of 1995 (Pub. L. 104-13) (44 U.S.C. 3501
Energy Information Administration (EIA), Department of Energy (DOE).
Agency Information Collection Activities: Submission for OMB Review; comment request.
The EIA has submitted the EIA-910, “Monthly Natural Gas Marketers Report”, part of the Natural Gas Data Collection Program package to the Office of Management and Budget (OMB) for review and a three-year extension under section 3507(h)(1) of the Paperwork Reduction Act of 1995 (Pub. L. 104-13) (44 U.S.C. 3501
Comments must be filed by September 7, 2004. If you anticipate that you will be submitting comments but find it difficult to do so within that period, you should contact the OMB Desk Officer for DOE listed below as soon as possible.
Send comments to OMB Desk Officer for DOE, Office of Information and Regulatory Affairs, Office of Management and Budget. To ensure receipt of the comments by the due date, submission by FAX (202-395-7285) is recommended. The mailing address is 726 Jackson Place, NW., Washington, DC 20503. (A copy of your comments should also be provided to EIA's Statistics and Methods Group at the address below.)
Requests for additional information should be directed to Herbert Miller. To ensure receipt of the comments by the due date, submission by FAX (202-287-1705) or e-mail (
This section contains the following information about the energy information collection submitted to OMB for review: (1) The collection numbers and title; (2) the sponsor (
1. EIA-176, 191, 857, 895, 910 and 912.
2. Energy Information Administration.
3 .OMB Number 1905-0175.
4. Revision.
5. Mandatory.
6. The Natural Gas Data Collection Program Package forms collect basic and detailed natural gas production, processing, transmission, storage, consumption, and price data. The data are published by the Energy Information Administration and are used by both public and private analysts. Respondents include natural gas pipeline companies, distributors, storage operators, processing plant operators, and State agencies.
With respect to its natural gas survey forms, the Energy Information Administration (EIA) is proposing to add seven States and the District of Columbia to the EIA-910, “Monthly Natural Gas Marketers Report” survey frame, which currently includes five States.
7. Business or other for profit.
8. 47,522 hours.
Please refer to the supporting statement as well as the proposed forms and instructions for more information about the purpose, who must report, when to report, where to submit, the elements to be reported, detailed instructions, provisions for confidentiality, and uses (including possible nonstatistical uses) of the information. For instructions on obtaining materials, see the
Section 3507(h)(1) of the Paperwork Reduction Act of 1995 (Pub. L. 104-13)(44 U.S.C. 3501 et seq).
The following filings have been made with the Commission. The filings are listed in ascending order within each docket classification.
Take notice that on July 20, 2004, Public Service Company of Colorado (PSCo) and Southwestern Public Service Company (SPS) submitted for Commission review a supplemental market power analysis which addresses the effects of a transmission interconnection that PSCo and SPS are constructing between their systems.
Take notice that on July 26, 2004, Allegheny Energy, Inc. (Allegheny) and Allegheny Energy Supply Company, LLC (AE Supply) (collectively, Applicants) filed an application for disposition of jurisdictional facilities under section 203 of the Federal Power Act. Applicants request Commission approval to sell to Buckeye Power Generating, LLC (BPG) a wholly-owned subsidiary of Buckeye Power, Inc., an Ohio non-profit corporation, certain jurisdictional assets. The applicants have requested privileged treatment of certain agreements submitted in support of the application.
Take notice that on July 27, 2004, Pittsfield Generating Company, L.P. (Pittsfield) submitted an application pursuant to section 203 of the Federal Power Act for authorization of a disposition of jurisdictional facilities whereby Altresco, Inc. (Altresco) and Pittsfield Partners, Inc. (PPI) will transfer their respective limited partner interests in Pittsfield to SFG CLA Pittsfield, LLC (SFG) or its affiliated nominees and assignees. Pittsfield states that it is a public utility and exempt wholesale generator in Massachusetts, with a nominal capacity of 163 MW. Pittsfield requested privileged treatment of certain agreements pertaining to a settlement entered into by, among others, Pittsfield, SFG, Altresco, PPI, and General Electric Capital Corporation, pursuant to which the transfer of limited partner interests will occur.
Take notice that on July 27, 2004, White Pine Copper Refinery, Inc. (White Pine Copper) and White Pine Electric Power, L.L.C. (White Pine Electric) (collectively, the Applicants), filed with the Federal Energy Regulatory Commission an application for authorization under sections 203 and 205 of the Federal Power Act to transfer, by a sale of assets for nominal amount, market based rate authority and certain jurisdictional facilities, to establish rate schedule and to cancel rate schedule. White Pine Copper seeks approval for an intra-corporate transfer of jurisdictional facility assets to White Pine Electric. The Applicant states that transfer of assets is related to White Pine Copper's concurrent disposition to White Pine Electric of three coal-fired steam-turbine generating units located in White Pine, MI, capable of delivering a total of 60 MW. Additionally, White Pine Electric seeks approval of its market-based rate tariff in order to make wholesale electric power and energy sales. Lastly, White Pine Copper seeks approval to cancel its market-based tariff, approved in Docket No. ER04-262-000, by letter order dated January 1, 2004.
Take notice that on July 27, 2004, White Pine Electric Power, L.L.C. (White Pine), P.O. Box 695, 1 Willow Road, White Pine, MI 49971, filed with the Federal Energy Regulatory Commission an application for determination of exempt wholesale
Take notice that, on July 26, 2004, Public Service Company of Colorado (PS Colorado) tendered for filing revised power sales agreements with Holy Cross Electric Association, Inc., Yampa Valley Electric Association, Inc., Grand Valley Rural Power Lines, Inc., the Town of Julesburg, Colorado, the City of Burlington, Colorado and the Town of Center, Colorado in compliance with the Commission's order issued February 27, 2004, in Docket No. ER03-971-000,
PS Colorado states that copies of the filing were served on parties on the official service list in the above-captioned proceeding, as well as on the Colorado Public Utility Commission.
Take notice that on July 26, 2004 Sierra Pacific Resources Operating Companies (SPR) submitted a refund report in compliance with the Commission's order issued July 8, 2004, in Docket No. ER03-1328-000, 108 FERC ¶ 61,023.
Take notice that on July 26, 2004, PacifiCorp, submitted a compliance filing pursuant to the Commission's order issued June 25, 2004, in Docket No. ER04-767-000, 107 FERC ¶ 61,318.
Take notice that on July 23, 2004, PJM Interconnection, L.L.C. (PJM), submitted for filing an executed interconnection service agreement among PJM, National Institute of Health, and Potomac Electric Power Company designated as Original Service Agreement No. 1049 under PJM's FERC Electric Tariff Sixth Revised Volume No. 1. PJM requests an effective date of June 23, 2004.
PJM states that copies of this filing were served upon the parties to the agreement and the State regulatory commissions within the PJM region.
Take notice that on July 23, 2004, PJM Interconnection, L.L.C. (PJM), submitted for filing an executed interim interconnection service agreement (ISA) among PJM, Calvert Cliffs Nuclear Power Plant, Inc. and Baltimore Gas and Electric Company designated Original Service Agreement No. 1050 under PJM's FERC Electric Tariff Sixth Revised Volume No. 1. PJM requests an effective date of June 23, 2004.
PJM states that copies of this filing were served upon the parties to the agreement and the State regulatory commissions within the PJM region.
Take notice that on July 26, 2004, NorthWestern Corporation (NorthWestern) submitted an application pursuant to section 204 of the Federal Power Act seeking authorization to issue: (1) Debt comprised of a senior secured credit facility in an amount up to $250 million and senior secured notes in an amount up to $350 million, which, collectively, will be secured by up to $600 million of first mortgage bonds; and (2) up to 35.5 million shares of common stock. NorthWestern also requests a waiver from the Commission's competitive bidding and negotiated placement requirements at 18 CFR 34.2.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “Filing” link at
This filing is accessible on-line at
Environmental Protection Agency (EPA).
Notice.
In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
Comments must be submitted on or before October 4, 2004.
Submit your comments, referencing docket ID number OW-2004-0015, to EPA online using EDOCKET (our preferred method), by e-mail to
Clifford Yee, Office of Wastewater Management, Mail Code, 4204M, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 202-564-0598; fax number: 202-501-2403; e-mail address:
EPA has established a public docket for this ICR under Docket ID number OW-2004-0015, which is available for public viewing at the Water Docket in the EPA Docket Center (EPA/DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is (202) 566-1744, and the telephone number for the Water Docket is (202) 566-2426. An electronic version of the public docket is available through EPA Dockets (EDOCKET) at
Any comments related to this ICR should be submitted to EPA within 60 days of this notice. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket,
The 1987 Act declares that water pollution control revolving funds shall be administered by an instrumentality of the State subject to the requirements of the act. This means that each State has a general responsibility for administering its revolving fund and must take on certain specific responsibilities in carrying out its administrative duties. The information collection activities will occur primarily at the program level through the State Intended Use Plan and Annual Report. The information is needed annually to implement section 606 of the Clean Water Act (CWA). The Act requires the information to ensure national accountability, adequate public comment and review, fiscal integrity and consistent management directed to achieve environmental benefits and results. The individual information collections are: (1) Capitalization Grant Application and Agreement/State Intended Use Plan, (2) Annual Report, (3) State Annual Audit, and (4) Application for SRF Financial Assistance.
(1)
(2)
(3)
(4)
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.
The EPA would like to solicit comments to:
(i) Evaluate 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;
(ii) Evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information,
(iii) Enhance the quality, utility, and clarity of the information to be collected; and
(iv) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology,
Burden Statement: The information collection will involve about an estimated 2,805 respondents per year, with about 2,754 average annual responses per year. The time required for the responses will vary depending on the respondent, but the total average annual number of hours requested is estimated to be about 339,405 hours. The total average annual respondent (State and Local) cost is estimated to be about $6,830,850.
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.
Environmental Protection Agency.
Notice and request for public comment.
This Notice requests public comments on the efforts of the United States Environmental Protection Agency (EPA) to promote the adoption of environmental management systems (EMS) by local governments and other public entities through the establishment of EMS Local Resource Centers. EPA is seeking comments particularly from not-for-profit organizations interested in providing technical assistance to public entities that are considering adopting EMSs for their operations.
The EPA, through a cooperative agreement with the Global Environment and Technology Foundation (GETF), is interested in providing financial and technical assistance for up to three additional not-for-profit organizations who would then work with various public entities, primarily local governments, that are interested in developing EMSs. The financial and technical assistance provided to these not-for-profit organizations could include help with developing business plans, providing relevant EMS materials to facilitate each organization's existing EMS assistance activities, train-the-trainer sessions on ways to address the needs of public agencies, and other marketing services. Each not-for-profit organization would also gain increased attention, and recognition of the key role they can play in meeting the growing needs of public agencies wishing to adopt EMSs through a Web site managed by GETF at
This Notice is soliciting comments from not-for-profit organizations interested in becoming part of an existing program involving seven organizations around the country. These EMS Local Resource Centers, which were first designated in 2002, are now working with public agencies around the country to educate and assist them to develop EMSs. A list of these Local Resource Centers and more information about their services can be found at
Responses to this Notice, identified by docket identification (ID) number OW-2004-0018, must be received on or before September 7, 2004.
Comments may be submitted electronically, by mail, or through hand delivery/courier. Follow the instructions as provided in Section I of the
In addition, a copy of the comments should also be submitted to Nick Martin, Global Environment and Technology Foundation (GETF), 2900 South Quincy Street, Suite 410, Arlington, Virginia 22206, (703) 379-2713, Ext. 290,
Jim Horne, U.S. EPA, Office of Water, by phone at (202 564-0571, or by e-mail at
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2.
Certain types of information will not be placed in EDOCKET. Information claimed as Confidential Business Information (CBI) and other information whose disclosure is restricted by statute, and which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket, but will be available only in printed, paper form in the official public docket. Publicly available docket materials that are not available electronically may be viewed at the docket facility identified in Section I.A.
For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, confidential business information (CBI), or other information whose disclosure is restricted in statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the Docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic pubic docket along with a brief description written by the docket staff.
You may submit comments electronically, by mail, or through hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate docket identification number in the subject line on the first page of your comments. The docket identification number for this Notice is OW-2004-0018. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late”. EPA is not required to consider these late comments.
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iii.
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Finally, please provide an additional copy of your submission to: Nick Martin, Global Environment and Technology Foundation (GETF), 2900 South Quincy Street, Suite 410, Arlington, Virginia 22206,
3.
Regardless of the method you choose, please provide the name of a person in your organization that EPA may contact, along with that person's mailing address, phone number, and E-mail address. This information is needed for EPA to selectively follow up with commenters, as explained in the Section V. of this Notice.
Public entities, including local governments and local authorities, are responsible for managing and maintaining large-scale physical plants. These may include power systems, wastewater treatment operations, water systems, and roadways. Local authorities are also responsible for managing solid and hazardous waste. As the front line implementers of environmental programs, they protect the health and safety of hundreds of millions of citizens. Faced with shrinking resources and aging infrastructure, public entities must manage their operations in a more efficient manner, at lower cost, and with less environmental impact. EMSs are an important emerging tool to help public entities do this.
EMSs follow Stewart and Deming's plan, do, check and act systems methodology and can be implemented by organizations of all sizes and types. They provide a set of problem identification and problem-solving tools that can be implemented in an organization in many different ways, depending on its activities and needs. Based on the organization's core values, business goals, and environmental commitments, employees examine their environmental footprint and the
Key elements of the EMS include:
• An environmental policy statement endorsed and actively promoted by senior management;
• A planning process that identifies the organization's environmental impacts and integrates their management into the organization's regular business and operations decisions;
• An organizational structure that places environmental responsibilities directly with employees in operational functions that deal with significant environmental impacts;
• An implementation process that stresses training, communication, operational controls, and reaching measurable goals—all oriented toward reducing risks of significant environmental impacts and continually improving environmental management;
• Measurement and auditing procedures that focus on finding and fixing problems and reducing the chances of their recurring; and,
• Periodic top management review of the EMS to ensure continual improvement.
Since 1996, the most commonly used framework for an EMS is the ISO 14001 Environmental Management Standard developed by the International Organization for Standardization (ISO). The ISO was established in 1947 with the mission of developing voluntary technical standards to promote international trade in goods and services.
For the last several years the EPA has been promoting the adoption of EMSs to help public entities, particularly local governments, improve their environmental performance beyond compliance, prevent pollution, promote greater environmental stewardship across the workforce, and improve their overall efficiency. EPA has issued an overall EMS Position Statement and is using EMSs in a wide variety of voluntary programs. More information about EPA's position on EMSs can be found at
The EPA's Office of Water (OW) has played a leadership role in bringing EMS capacity to local governments. This leadership has continued and expanded to include other Headquarters and Regional Offices. Since 1997, through a cooperative agreement with GETF, OW has supported three EMS initiatives helping local governments test the applicability and benefits of an EMS on environmental performance, compliance, pollution prevention, and stakeholder involvement in government operations. In total, 32 local governments have participated in developing and implementing their own EMSs through these two initiatives.
The agencies participating in these three initiatives have realized a wide range of benefits including improved environmental performance and compliance, reduced operational costs, increased recycling, improved relations with their communities and regulatory agencies, and improved operational controls and internal communication. More information about these projects and the specific benefits the participating agencies have seen can be found at
The EMS initiatives described above have helped to demonstrate the relevance of EMSs in the public sector and established a solid basis for expanding EMS adoption for public agencies, especially local governments. The strong enthusiasm and tangible environmental results demonstrated through these initiatives suggest substantial long-term benefits from EMS implementation and ensure the parallel development of sustainable management practices in both the private and public sectors. Public entity EMS implementation has sparked interest from government leaders around the world. Building on the successes of these efforts, EPA, through a cooperative agreement with GETF, launched the National Public Entity Environmental Management System Resource Center—the National PEER Center in 2002.
The PEER Center's goals are three-fold:
• To promote the understanding and adoption of EMSs by public entities;
• To facilitate peer-to-peer exchange of information and experiences and build awareness of EMSs as a tool to improve environmental performance; and
To build regional EMS competence and technical assistance capacity through EMS Local Resource Centers.
The PEER Center consists of two major components: A national clearinghouse and seven EMS Local Resource Centers.
The National PEER Center Clearinghouse is currently in place (
Critical to the effectiveness and success of the PEER Center are seven existing EMS Local Resource Centers (LRCs) that advance the use of EMSs in public entities. Building on individual EMS skills and competencies, and leveraging the successes and skills of the other LRCs and the National PEER Center, each LRC serves as a high-quality EMS resource center for the public entities in their area. The LRCs facilitate information transfer, provided training, and government-to-government mentoring in order to maximize public entities' time and resource investment in EMS implementation. The joint efforts of the National PEER Center and the LRCs are helping an increasing number of public entities, particularly local governments, that develop EMSs for various operations. More information about each Center can be found at
Activities that the existing Centers are currently providing include:
• Leveraging their existing EMS expertise to provided training, technical assistance, tools and materials that will facilitate EMS implementation on the public sector;
• Using their data, information, resources and key contacts to encourage EMS information transfer and facilitate government-to-government mentoring;
• Leading regular and frequent outreach activities to increase awareness and understanding of EMS applicability
• Collecting data and information and preparing case studies about EMS implementation in public entities and assisting in the dissemination of this information across public organizations;
• Facilitating information transfer between the PEER Center Clearinghouse and other Local Resource Centers to ensure access to the most current data, information, tools, keys to success, and lessons learned; and
• Facilitating EMS workshops and conferences in their local/regional area
Based on the experiences of these existing Centers, EPA is interested in receiving feedback from other not-for-profit organizations that are already providing some degree of EMS services in their respective areas, and may now wish to become a Local Resource Center. EPA is especially interested in hearing from organizations in areas of the country not now served by an existing Center, primarily in EPA Regions VII, VIII, and IX. Any additional Local Resource Center will be expected to offer a menu of EMS services, including: EMS training, technical expertise, field-tested tools, information, speakers/mentors, workshops and conferences, outreach, and EMS implementation assistance.
Each Local Resource Center will receive, at no cost, extensive start-up support, including a full catalogue of EMS implementation tools from GETF and materials that have already been field-tested and used in the public sector, including:
• National attention, visibility, and partnership opportunities from EPA, GETF, and other partners and stakeholders;
• Assistance in developing a business plan, and business development materials;
• An extensive suite of field-tested, high-quality and successful materials for public entities: training techniques, implementation strategies, document samples, outreach and presentation toolkits;
• Regular train-the-trainer work sessions on EMS implementation in public sector organizations with other LRCs and national partners;
• An extensive database of national mentors and experts with hands-on experience to assist in local/regional EMS outreach and implementation;
• Support services and mentoring from existing public entities that are implementing an EMS; and
• Assistance with marketing services and opportunities.
Based on the information provided above, EPA is interested in receiving public comment from not-for-profit organizations that may wish to serve as an EMS Local Resource Center, especially organizations located in areas not now served by an existing Center, primarily in EPA Regions VII, VIII, and IX. Based on these comments up to three additional not-for-profit organizations could participate with the other Centers and provide high quality EMS assistance to public entities, especially local governments. Providing comment based on this Notice does not guarantee that the organization will participate.
When reviewing comments, EPA considers a number of factors.
The most important of these include: (1) A clear understanding of EMSs, (2) demonstrated experience and delivery mechanisms in providing EMS services to various organizations, (3) commitment by the organization's top management to the goals of the PEER Center initiative, (4) adequate staffing to support both start up and ongoing activities, (5) a willingness to proactively reach out to public entities in their area, (6) strong web literacy and functionality, and (7) a willingness and ability to share data and other information with other Local Resource centers and the PEER Clearinghouse.
Organizations are also encouraged to provide a more general statement outlining why they are interested in becoming a Local Resource Center and describing how their participation could benefit the program as a whole. Finally, organizations are encouraged to provide a letter from top management accompanying their comments that includes the name and contact information of the individual that would represent your organization on possible follow up calls with GETF.
Following the receipt of this feedback, staff from GETF may schedule follow up calls, as appropriate, with each applicant's management and appropriate staff at a mutually convenient time and will consult with EPA. Following this, staff from GETF will begin work with each new Local Resource Center to develop business plans, materials, processes, marketing strategies, information transfer, data collection, etc.
Environmental Protection Agency (EPA).
Notice.
In accordance with section 6(f)(1) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended, on December 23, 2003, the Agency issued a Cancellation Order announcing its approval of the requests submitted by Sumitomo Chemical Company, Limited and Bayer Environmental Science to voluntarily cancel the registrations for all of their products containing 4-chloro-alpha-(1-methylethyl)benzeneacetic acid, cyano(3-phenoxyphenyl)methyl ester (fenvalerate). Any distribution, sale or use of the products subject to this cancellation order is only permitted in accordance with the terms of the existing stocks provisions of this cancellation order.
Wilhelmena Livingston; Special Review and Reregistration Division (7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460-0001; telephone number: (703) 308-8025; fax number: (703) 308-8041; e-mail address:
This action is directed to the public in general. Although this action may be of particular interest to persons who produce or use pesticides, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the information in this notice, consult the person listed under
1.
2.
An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at
This notice announces that EPA approved the Cancellation Order requests from Sumitomo Chemical Company, Limited and Bayer Environmental Science to cancel the registrations of three pesticide products registered under section 3 of the FIFRA. These three registrations constitute all registrations held by Sumitomo Chemical Company, Limited and Bayer Environmental Science of products containing 4-chloro-alpha-(1-methylethyl)benzeneacetic acid, cyano(3-phenoxyphenyl)methyl ester (fenvalerate).
On March 27, 2003, Sumitomo Chemical Company, Limited, and on April 1, 2003, Bayer Environmental Science submitted a letter to the Agency requesting voluntary cancellation of their fenvalerate technical registrations. This order follows up a
No comments were received during the 30-day comment period, so therefore, EPA has decided to accept the voluntary cancellation requests. Accordingly, on December 23, 2003, the Agency issued an order canceling the three registrations identified in Table 1.
Table 2 of this unit includes the name and address of record for the registrants of the products in Table 1 of this unit.
Pursuant to section 6(f) of FIFRA, EPA hereby approved the requested cancellations of fenvalerate product registrations identified in Table 1 of this notice. Accordingly, the Agency ordered that the fenvalerate product registrations identified in Table 1 were hereby canceled as of December 23, 2003.
Section (6)(f)(1) of FIFRA provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be canceled. FIFRA further provides that before acting on the request, EPA must publish a notice of receipt of any such request in the
EPA did not receive any comments on the voluntary cancellation requests for the fenvalerate products during the comment period.
For purposes of this Cancellation Order, the term “existing stocks” is defined, pursuant to EPA's existing stocks policy (56 FR 29362, June 26, 1991), as those stocks of a registered pesticide product which are currently in the United States and which have been packaged, labeled and released for shipment prior to the effective date of the cancellation. The existing stocks provisions of the Cancellation Order are as follows:
The orders affecting these requested cancellations permit a registrant to sell or distribute existing stocks for 1 year after the date the cancellation was requested. Sumitomo Chemical Company, Limited was not able to sell or distribute exiting stocks after March 27, 2004, and Bayer Environmental Science was not able to sell or distribute exiting stocks after April 1, 2004, which marks 1 year after the date the cancellation was requested. The product
Environmental protection, Pesticides and pests.
Environmental Protection Agency (EPA).
Notice of availability.
This notice announces final agency action on 2 TMDLs prepared by EPA Region 6 for waters listed in Louisiana's Barataria river basin, under section 303(d) of the Clean Water Act (CWA). Documents from the administrative record file for the 2 TMDLs, including TMDL calculations and responses to comments, may be viewed at
Ellen Caldwell, Environmental Protection Specialist, Water Quality Protection Division, U.S. EPA Region 6, 1445 Ross Avenue, Dallas, TX 75202-2733, telephone (214) 665-7513.
In 1996, two Louisiana environmental groups, the Sierra Club and Louisiana Environmental Action Network (plaintiffs), filed a lawsuit in Federal Court against the EPA, styled
By this notice EPA is taking final agency action on the following 2 TMDLs for waters located within the Barataria river basin:
EPA requested the public to provide EPA with any significant data or information that may impact the 2 TMDLs in 69 FR 5985-5986 (February 9, 2004). The comments received and EPA's response to comments may be found at
This notice is to inform the public that the Export-Import Bank of the United States has received an application to finance the export of approximately $500 million in U.S. semiconductor manufacturing equipment to dedicated foundries in China. The U.S. exports will enable the dedicated foundries to produce 60,000 300-mm wafers per month across advanced process technology nodes. Available information indicates that some of this new production will be exported from China and consumed globally. Interested parties may submit comments on this transaction by e-mail to
999 E Street, NW., Washington, DC.
This meeting will be closed to the public.
Compliance matters pursuant to 2 U.S.C. 437g.
Audits conducted pursuant to 2 U.S.C. 437g, 438(b), and Title 26, U.S.C.
Matters concerning participation in civil actions or proceedings or arbitration.
Internal personnel rules and procedures or matters affecting a particular employee.
999 E Street, NW., Washington, DC (ninth floor).
This meeting will be open to the public.
Correction and Approval of Minutes.
Advisory Opinion 2004-21: Give to USA, Inc. by Matthew L. Ginsberg, Chief Executive Officer, On Time Systems, Inc.
Advisory Opinion 2004-23: U.S. Oncology, Inc. Good Government Committee (“USON-GGC”) by counsel, Thomas J. Spulak.
Advisory Opinion 2004-24: NGP Software, Inc. by Nathaniel Pearlman, President.
Advisory Opinion 2004-25: Senator Jon Corzien by counsel, Marc E. Elias.
Routine Administrative Matters.
Mr. Robert Biersack, Acting Press Officer, Telephone: (202) 694-1220.
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The application also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Additional information on all bank holding companies may be obtained from the National Information Center website at
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than August 30, 2004.
Board of Governors of the Federal Reserve System, August 2, 2004.
Initial.
93.990.
Applications are due no later than September 9, 2004.
This notice announces the availability of fiscal year (FY) 2004 grant funds for the Safe and Bright Futures for Children Initiative—a program to diminish the damaging effects of domestic violence on children and adolescents and to stop the cycles of abuse and intentional injury. Approximately $2.2 million in funding is available on a competitive basis for a maximum of up to 30 grants for Phase One of the Safe and Bright Futures for Children Initiative. Phase One consists of 2 years strategic planning (as outlined in Application and Submission Information—Section IV). It is expected that the first year award will begin on or about September 30, 2004 and will be for a 12-month budget period. The second year award will require a non-competing continuation application and be made on or about September 30, 2005, depending on grantee performance and availability of funds and be for a 12-month budget period. Each grantee will be funded approximately $ 75,000 each year of the 2-year project period. Applicants must demonstrate direct experience with domestic violence prevention or show ability to partner with relevant domestic violence prevention community agencies. Phase Two—Safe and Bright Futures for Children Implementation Grants—will be competitively awarded, under a separate announcement, to approximately 8 of the Phase One planning grantees in FY 2006. It is anticipated that approximately $500,000 a year for each of the three years, depending on availability of funds, will be awarded. Implementation plans, as developed in the planning years would be submitted as a competing application for objective competitive peer review; implementation (continuation) funding will be contingent on peer review approval, score, and award preferences criteria.
The Office of Public Health and Science (OPHS) of the Department of Health and Human Services (DHHS) announces the availability of funds for FY 2004 and requests applications for grants for Phase One of the Safe and Bright Futures for Children Initiative—a program to diminish the damaging effects of domestic violence on children and adolescents and to stop the cycles of abuse and intentional injury.
The OPHS is under the direction of the Assistant Secretary for Health (ASH), who serves as the Senior Advisor on public health and science issues to the Secretary of the Department of Health and Human Services. The Office serves as the focal point for leadership and coordination across the Department in public health and science, provides direction to program offices within OPHS; and provides advice and counsel on public health and science issues to the Secretary.
The prosperity of our nation rests upon the health of our children. Accordingly, securing a bright future must begin with ensuring the health and safety of our children. Of the many threats to their well being, one of the most devastating is the trauma experienced by witnessing parent conflict and the violation of safety and security in the home. Domestic violence is also a generational problem that perpetuates a dangerous cycle of both abusers and victims of abuse. As such, it is important to recognize that the primacy of safety first for children relies on providing safety and assistance to the non-abusing parent or primary caregiver, in ending violence in the home. Providing safety and preventive or intervention services to the non-abusing caregiver(s) and teaching children and adolescents by example that it is unacceptable to resolve the problems of life by violent means is essential for their well-being.
Too often children who reside in homes where domestic violence occurs are not identified; when they are, they do not receive the necessary and appropriate help, either related to the trauma surrounding the precipitating event or with regard to long term follow-up and follow-through needs. The systems of support for battered parents/caregivers and the systems of accountability for those perpetrating interpersonal violence are often not well geared for addressing the developmental, social, emotional, or behavioral needs of children or adolescents. New promising approaches for working with children exposed to violence and their parents/caregivers are emerging. This initiative seeks to encourage communities to plan for, develop, implement and sustain a coordinated system of prevention, intervention, treatment, and follow-through services for children who have witnessed or been exposed to domestic violence and their families.
The Safe and Bright Futures for Children Initiative is a multi-agency collaboration within the DHHS which builds on the President's existing efforts to combat violence against women and families. Resources will be competitively available to support the implementation of projects that will become models of community prevention and intervention for children/adolescent who are witnesses of or those exposed to domestic
In order to produce the coordinated system and service enhancement design, grantees will be required to accomplish tasks based on strategic planning that targets specific child/adolescent service outcomes which are community specific and appropriate for the population to be served. This initiative and planning phase also provides a vehicle for communities to integrate existing Federal programs focused on this population. (Applicants are directed to
This DHHS-sponsored Safe and Bright Futures for Children Initiative is announced in concert with a related activity being undertaken by the Department of Justice (DOJ) which also supports the President's domestic violence prevention efforts. The DOJ will award grants to 12 communities for the creation of Family Justice Centers to provide medical care, counseling, law enforcement, social services, employment assistance, and housing assistance together in one location. To the extent applicable, communities that receive a Safe and Bright Futures for Children grant, will be required to demonstrate linkage with a DOJ-sponsored Family Justice Center either as a planning partner or during the implementation phase of this initiative.
Sections 1701-1704 of the Public Health Service (PHS) Act authorize the Secretary to undertake and support, through improved planning and implementation of tested models and evaluation of results, effective and efficient programs respecting health information and health promotion, preventive health services, and the education in the appropriate use of health care. Additional applicable program authorities of the Department of Health and Human Services relevant to the implementation of this activity include: Sections 301 (general authority), 392(b), 393 (relating to violence prevention) and 501(d) (relating to substance abuse prevention and treatment and mental health services) of the PHS Act. Title V of the Social Security Act (relating to maternal and child health) is also applicable.
To qualify for funding, an applicant must be a public or private non-profit entity, including but not limited to child/adolescent-serving local government agency, community-based or faith-based entity or organization located in a State or U.S. Territory, or Federally recognized Tribe or Tribal Organization. States may only apply on behalf of a coalition of entities for a State-defined community to develop or enhance a community system. Since this initiative is intended to be a community effort with focus on diminishing the impact of domestic violence, it is required that a primary partner be from the domain of service providers in a community that engage in domestic violence prevention or intervention services. Other organizations that are experienced in the areas of injury/violence prevention, protection, safety, identification, assessment and treatment of children and adolescents who have witnessed or been exposed to domestic violence and in working with victims and perpetrators, mental health providers with expertise in trauma-related services are encouraged to be included as partners.
None.
Applicants are required to have a Dun and Bradstreet Data Universal Numbering System (DUNS) number to apply for a grant or Cooperative Agreement from the Federal Government. The DUNS number is a nine digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, access either the web site:
Application kits are available from and shall be submitted to the Department of Health and Human Services, Office of Public Health and Science, Office of Grants Management, 1101 Wootton Parkway, Suite 550, Rockville, MD 20853. Send the original and 2 copies of the complete application to this address. Application kits may also be obtained by calling the Office of Grants Management, (301) 594-0758 between the hours of 8 a.m. and 5 p.m. EST. For Further Programmatic Information Contact: Woodie Kessel, M.D., M.P.H.,
For this grant, applications must be submitted on the Form PHS-5161-1 (Revised 07/00) and in the manner prescribed in the application kit. An applicant is advised to pay close attention to the specific program guidelines and general instructions provided in the kit.
Applicants are required to submit an original application signed by an individual authorized to act for the applicant agency or organization and to assume for the organization the obligations imposed by the terms and conditions of the grant award. Applicants are required to submit an original application and two copies. Applications are limited to 25 double-spaced pages, not including appendices and be in 12-point font. Appendices may include curriculum vitae and other evidence of organizational capabilities.
Applications must include a one-page abstract of the proposed project. The abstract will be used to provide reviewers with an overview of the application, and will form the basis for the application summary in grants management documents.
It is the practice of the Office of Disease Prevention and Health Promotion (ODPHP), in the Office of Public Health and Science, to maintain a summary of grants and to post this information on the ODPHP web site.
Grantees under this program will implement a strategic planning and design process that yields a realistic coordinated service system model with service enhancements. The strategic plan will guide implementation, monitoring, and evaluation of ongoing modifications which will result from feedback and influence future system development. Applicants must address each of the areas below and in similar sequence in the application:
Understanding of Methodologies for planning a continuous and coordinated system of identification, protection, and care for children and adolescents, including those with special needs, who witness or are exposed to domestic violence. Specifically, the applicant must address how it will:
(a) Establish an inclusive and participatory format that ensures engagement in and acceptance of the planning process and specific outcome expectations by key community stakeholders, including but not limited to:
(b) Design an approach to assessing need and organizing a coordinated system of intervention and care for children, adolescents and their families, including children with special needs and the non-abusing primary caregiver(s), that includes mental health services such as child trauma services or victim counseling, child/adolescent/family counseling; protection and safety; health care services; substance abuse prevention and treatment services; and supportive and/or ancillary services (
(c) Identify the evaluation parameters (as designated by the community) and outcome measures that will be used to determine the level of success of the implemented service system model (such as ranking priorities from among topics like access to services, rate of emergency department use, school success and connectedness, enhancing resilience, juvenile justice involvement, family stability, change in service capacity, and cost offsets) and its level of functioning (such as ranking priorities from topics such as client/community/staff satisfaction, identification and severity of diagnosis, financial stability). Note that both outcome and process evaluations should be considered in the planning effort. Identified evaluation processes should be evidenced-based and rely on current research, to the extent possible.
(d) Describe how the collaboration will support non-offending parents (or primary caregivers) in seeking greater safety for their children and themselves as a step in the process of ameliorating the effects of domestic violence on children.
(e) Develop a resource strategy, including cost offsets from other systems, that creates a realistic framework for implementation and shows how community agencies/stakeholders will obtain and invest various resources, both public and private, into the integrated services system model with a goal of financial sustainability.
(f) To the extent applicable, identify and demonstrate collaboration and linkages with other related DHHS and Federal initiatives or programs in the applicant's community that address prevention, early intervention and treatment for children who are exposed to or witness domestic violence and their families, and how these programs will be incorporated into the planning process; how they will be involved with implementation; and their role with maintaining the established integrated model of coordinated care. (See
The applicant should describe how the following dimensions will be addressed in the planning process:
(a) Governance and executive leadership.
(b) Coordination of organizational structures and staff; configurations of staff.
(c) Operations and management; accountability.
(d) Facilities and equipment; materials and supplies.
(e) Financing and allocation of resources; blending of funds and resources; fiscal management; fiscal sustainability.
(f) Legal and regulatory issues, including confidentiality and safety issues for the target population and non-offending parents or primary caregivers.
(g) Involvement and interactions among diverse disciplines; human resources development and management; organizational culture and work climate; relationships with external care providers.
(h) Education, training and supervision of clinicians, administrators, social workers, teachers, and support staff; needs of health professions students and professionals-in-training.
(i) Information systems and medical record keeping including confidentiality of client/family information.
(j) Quality assessment and strategies for improvement, evaluation (process and outcomes), and performance results.
(k) On-going strategic planning for future development and growth; flexibility and ability to accommodate a changing environment should also be addressed.
Understanding the issues of the target population and community as an essential part of planning for a coordinated services system model. Applicant will describe a vision of the existing and enhanced services for the target population based on the service needs and outcome expectations of the target community and describe the challenges, in terms of both opportunities and barriers, related to designing a coordinated system, filling service gaps, and sustaining a coordinated system, across the various child/adolescent-serving agencies which address the target population, including but not limited to: Police, emergency rooms, child welfare, family and juvenile court judges, child protective services, domestic abuse shelters, schools, and health and mental health service providers.
The applicant will demonstrate that it has the capacity to engage the relevant local agency stakeholders in the planning process. Application will address:
(a) Experience with similar planning activities and experience with the target population of children, adolescents, and their families/caregivers;
(b) Experience of proposed leadership, including past endeavors that involved relationships with multiple stakeholders;
(c) Commitment to developing and sustaining working relationships among key stakeholders, with the goal of designing and ultimately implementing a coordinated services program. The demonstration of explicit leadership commitment to this collaborative project will be established through jointly signed letters from the applicant organization with the directors of each participating agency/organization. Each letter should state: (a) Which organization/agency/program will be responsible for the grant award (that is, serve as the grantee and assume fiscal and managerial responsibility for the funding); (b) how planning and leadership will be organized; (c) commitment to full engagement in the planning process, and if selected for Phase Two of this initiative, full commitment to the future implementation of the developed integrated services system that was produced from the planning process. These letters should be contained in the Appendix, “Letters of Agreement.”
(d) Description of its organizational structure in relation to: sponsoring organizations, designated planning and support personnel, the target community, and specifically with regard to leading the planning in terms of: (1) Time frames for performance; (2) resources proposed for each task (
(e) How proposed planning activities will be monitored and tracked.
(f) Description of contingency efforts that might be undertaken to implement the plan in part or as a whole if implementation funding is not available.
Applicant will describe qualifications and experience of the designated planning director and other key personnel as well as the qualifications and experience of staff from the partnering organizations, agencies and programs, consultants, and subcontractors. Resumes and/or curricula vitae should be included in Appendices.
Applicant will submit a detailed budget on form SF-424a with complete budget justification for each line item in the budget categories of the application. See Form PHS-5161-1 (Revised 7/00). Budget should reflect appropriate costs of up to $150,000.00 for the entire 2 year planning process. Submit year 1 and year 2 budgets separately.
Budget must reflect costs travel costs for up to 2 key personnel to attend one 2-day meeting in Washington, DC at mid-project period.
To receive consideration, applications must be received by the Office of Public Health and Science, Office of Grants Management by 5 p.m. EDT on September 9, 2004. Applications received after the exact date and time specified for receipt will not be accepted. The application due date requirement specified in this announcement supercedes the instruction in the PHS 5161-1. Applications submitted by facsimile transmission (FAX) or any other electronic format will not be accepted. Applications which do not meet the deadline or format requirements, specified under Content and Form of Application Submission, will not be accepted for review and will be returned to the applicant unread.
Applicants under this announcement are not subject to the requirements of Executive Order 12372, “Intergovernmental Review of Federal Programs.”
Funds cannot be used for construction or renovation, to purchase or lease vehicles or vans, to purchase a facility to house project staff or carry out project activities, or to substitute new activities and expenditures for current ones. The allowability, allocability, reasonableness, and necessity of direct and indirect costs that may be charged to OPHS grants are outlined in the following documents: OMB Circular A-21 (Institutions of Higher education); OMB Circular A-87 (State and Local Governments); OMB Circular A-122 (Non-Profit Organizations); and 45 CFR Part 74, Appendix E (Hospitals). Copies of the Office of Management and Budget (OMB) Circulars are available on the internet at
Applications must be submitted to the U.S. Department of Health and Human Services, Office of Public Health and Science, Officer of Grants Management, 1101 Wootton Parkway, Suite 550, Rockville, Maryland, 20852; (301) 594-0758. Attention: Ms. Karen Campbell.
Each application will be evaluated individually against the following criteria by a panel of independent reviewers appointed by OPHS. Before the review panel convenes, each application will be screened for applicant organization eligibility, as well as to make sure the application contains all the essential elements. Applications received from ineligible organizations and applications received after the deadline will be withdrawn from further consideration. Applications that do not conform to the requirements of this program announcement will not be accepted for review and will be returned to the applicant. Applications sent via facsimile or electronic mail will not be accepted for review. Applicants that meet the requirements of this program announcement will be notified by the Office of Grants Management. A panel of at least three reviewers will use the evaluation criteria listed below to determine the strengths and weaknesses of each application, provide comments and assign numerical scores. Applicants should address each criterion in the project application. The point value (summing up to 100) indicated the maximum numerical weight each criterion will be accorded in the review process.
The extent to which the applicant understands the methodologies for planning and designing an effective, organized and coordinated system of comprehensive services for children and adolescents, including those with special needs, who witness or are exposed to domestic violence, and their families.
That applicant has demonstrated an inclusive and participatory process which involves the key community stakeholders, and includes a local provider(s) of domestic violence prevention and intervention services as a primary partner.
If applicable, the appropriateness of using an existing partnership or
The extent to which the proposed planning process will determine need and guide development of a coordinated services system that includes the required and supportive services to meet the comprehensive needs of the target population and with attention to age, development stages, racial/ethnic, cultural, language, gender, sexual orientation, socio-economic status and other community-specific issues identified in the proposed service model design.
The extent to which applicant describes a process for developing an evaluation (of success) and reasonable outcome expectations and measures that the stakeholders will likely adopt and which define the proposed evaluation measures of the expected outcomes. Note that both outcome and process evaluations are to be a part of the planning effort.
The adequacy and appropriateness of the proposed activities to develop a resource strategy which is likely to create a realistic framework for implementation and shows how community agencies/stakeholders will obtain and invest various resources, both public and private, into the coordinated services system model with a goal of financial sustainability.
The extent to which the methodology is appropriate to the applicant's community (will be able to address any problems and barriers associated with the community's current system for children and adolescents and their families) and can be relied upon to yield a clear description of a proposed system.
The extent to which the proposed methodology accommodates a process for assessing the cost of the current and proposed services, including cost offsets from other systems.
The extent of applicant's previous experiences in designing integrated systems and/or integrated services models; those that have involved multiple stakeholders, especially with the organizations, agencies, and programs designated as partners to this activity.
Stability of applicant organizational in terms of structure and history, including its relationships to the partnering organizations, among proposed personnel, with the target community, and its ability to obtain and sustain interagency coordination, collaboration and resources. The applicant should affirm the commitment of each collaborating and cooperating agency and describe the intended roles that each agency will play in planning.
Applicant should describe its plan for monitoring and tracking planning activities.
Feasibility of contingency efforts that might be undertaken to implement the plan in part or as a whole if implementation funding is not available.
Qualification and experience of key personnel: Planning director; designated personnel from partnering organizations, agencies and programs; consultants and subcontractors, with domestic violence prevention/intervention programs and activities, especially those for children and adolescents who have been exposed to or witnessed domestic violence and their families.
Feasibility and appropriateness of the planning process in terms of: (a) Time frames, (b) adequacy and availability of resources (
Appropriateness of budget and the justification in relation to the proposed activities.
Reasonableness of costs and other necessary details to facilitate the determination of cost allowability and the relevance of these costs to the proposed planning process.
Inclusion of appropriate travel costs for up to 2 key personnel to attend one 2-day meeting in Washington, DC at mid-project period.
Each application submitted to the OPHS Office of Grants management will be screened to determine whether it was received by the closing date and time.
The results of a competitive review are a primary factor of the applications and, in light of the results of the competitive review, will recommend applications for funding to the ASH. The ASH reserves the option of discussing applications with other funding sources when this is in the interest of the Federal government. The ASH may also solicit and consider comments from Public Health Services Regional Office staff and others within DHHS in making funding decision. Final grant award decisions will be made by the ASH. The ASH will fund those projects which will, in his/her judgement, best promote the purposes of this program, within the limits of funds available for such projects.
Final funding decisions for OPHS grants are the responsibility of the Assistant Secretary for Health (ASH). In considering approved applications for funding, preferences may be exercised for groups of applications. Selection preference will be given to the approved applications, under this initiative, based on the following:
Availability of funds.
Evidence of non-supplantation of funds.
Evidence of commitment by the identified stakeholders through letters of commitment which include the defined roles and responsibilities during the planning period.
Evidence of formal coordination/collaboration with a Federal and/or non-Federal organization that has the recognized capacity to provide resources to support/assist in this project. Specifically, and to the extent applicable, linkage with a DOJ supported Family Justice Center.
Equitable distribution of awards in terms of geography, project size, and rural/urban locality; including location of current HHS grantees.
The OPHS does not release information about individual applications during the review process. When final decisions have been made, successful applicants will be notified by letter of the outcome of the final funding decisions. The official document
In accepting this award, the grantee stipulates that the award and any activities thereunder are subject to all provisions in 45 CFR parts 74 (non-governmental) and 92 (governmental) currently in effect or implemented during the period of the grant.
The Buy American Act of 1933, as amended (41 U.S.C. 10a-10d), requires that Government agencies give priority to domestic products when making purchasing decisions. Therefore, to the greatest extent practicable, all equipment and products purchased with grant funds should be American-made.
A Notice providing information and guidance regarding the “Government-wide Implementation of the President's Welfare-to-Work Initiative for Federal Grant Programs” was published in the
The HHS Appropriations Act requires that when issuing statements, press releases, requests for proposals, bid solicitations, and other documents describing projects or programs funded in whole or in part with Federal money, grantees shall clearly state the percentage and dollar amount of the total costs of the program or project which will be financed with Federal money and the percentage and dollar amount of the total costs of the project or program that will be financed by non-governmental sources.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and to promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children.
A successful applicant under this notice will submit: (1) Semi-annual progress reports; (2) a final progress report in the form of the Plan; and (3) a Financial Status Report in the format established in accordance with the provisions of the general regulations which apply under “Monitoring and Reporting Program Performance,” 45 CFR 74.51-74.52, with the exception of State and local governments to which 45 CFR part 92, Subpart C reporting requirements apply. Applicants must submit all required reports in a timely manner, in recommended formats (to be provided) and submit a final report on the project, including any information on evaluation results, at the completion of the project period. Agencies receiving $500,000 or more in total Federal funds are required to undergo an annual audit as described in OMB Circular A-133, “Audits of States, Local Governments, and Non-Profit Organizations.”
This program is subject to Public Health System reporting Requirements. Under these requirements, a community-based nongovernmental applicant must prepare and submit a Public Health System Impact Statement (PHSIS). The PHSIS is intended to provide information to State and local health officials to keep them apprised of proposed health services grant applications submitted by community-based organizations within their jurisdictions.
Community-based nongovernmental applicants are required to submit, no later than the Federal due date for receipt of the application, the following information to the head of the appropriate State and local health agencies in the area(s) to be impacted: (a) A Copy of the face page of the applications (SF 424), and (b) a summary of the project (PHSIS), not to exceed one page, which provides: (1) a description of the population to be served, (2) a summary of the services to be provided, and (3) a description of the coordination planned with the appropriate State or local health agencies. Copies of the letters forwarding the PHSIS to these authorities must be contained in the application materials submitted to the Office of Public Health and Science.
Grants Management Office Contact: Karen Campbell, Department of Health and Human Services, Office of Public Health and Science, OPHS Grants Management Office, 1101 Wootton Parkway, Suite 550, Rockville, Maryland, 20852. E-mail:
The Centers for Disease Control and Prevention (CDC) announces the intent to fund fiscal year (FY) 2004 funds for a cooperative agreement program to support and ensure the implementation of tuberculosis (TB) control activities that are designed to develop, establish, and coordinate systems and procedures to address the obstacles to achieving control of TB and multi-drug resistant tuberculosis (MDR-TB) in metropolitan Manila, the Philippines. The Catalog of Federal Domestic Assistance number for this program is 93.116.
Assistance will be provided only to the Tropical Disease Foundation, Inc. (TDF) located in Manila, the Philippines. No other applications will be solicited.
The TDF is the only qualified organization that has the technical and administrative capacity to conduct the specific set of activities requested to support CDC TB and MDR-TB prevention and control activities in the Philippines under this cooperative agreement because:
1. The TDF is uniquely positioned, in terms of legal authority, ability, track record, infrastructure and credibility in the Philippines to develop and support TB and MDR-TB control activities in both public and non-governmental organization sites throughout the country.
2. The TDF has already established a framework and mechanisms to develop and implement TB and MDR-TB treatment and control activities in the Philippines, enabling it to immediately become engaged in the activities listed in this announcement.
3. The TDF has demonstrated its ability to coordinate and implement TB treatment and control activities including MDR-TB and TB/HIV co-infection within the country.
4. The TDF has a unique and unparalleled relationship with the Makati Medical Center (MMC), the Department of Health (DOH), NTP, the Tropical Disease Foundation (TDF), and the Philippines Coalition Against Tuberculosis (PhilCAT), based on a rich history of collaboration.
5. The TDF Directly Observed Treatment Short Course (DOTS) Clinic has been in existence since February 1999, in response to the need for public-private partnership in the management of TB patients in the Philippines. The clinic is a collaboration between the TDF and MMC.
6. The TDF was approved as the first pilot project worldwide to undertake DOTS-Plus by the Green Light Committee (GLC), a subgroup of the Scientific Working Group on Multi-Drug Resistant Tuberculosis of the WHO. The MMC DOTS-Plus clinic is the only facility in the Philippines providing treatment to MDR-TB patients.
7. The TDF has the ability to collect information, train staff and advocate for policy based on the experiences learned implementing DOTS-Plus activities.
8. The specific services that the TDF will deliver are directly associated with, and compliment, other ongoing CDC prevention strategies and activities in the Philippines.
Approximately $110,000 is available in FY 2004 to fund this award. It is expected that the award will begin on or before September 1, 2004, and will be made for a 12-month budget period within a project period of up to five years. Funding estimates may change.
For general comments or questions about this announcement, contact: Technical Information Management, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone: (770) 488-2700.
For program technical assistance, contact: Dr. Charles Wells, Project Officer, Division of Tuberculosis Elimination, National Center for HIV, STD, and TB Prevention, Centers for Disease Control and Prevention (CDC), 1600 Clifton Road Mailstop E-10, Atlanta, Georgia 30333, Telephone: (404) 639-8485, E-mail:
For budget assistance, contact: Steward Nichols, Grants Management Specialist, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, Georgia 30341, Telephone: (770) 488-2788, E-mail:
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC), National Center for Health Statistics (NCHS) announces the following committee meeting.
Agenda items are subject to change as priorities dictate.
Robert Weinzimer, Executive Secretary, NCHS, 3311 Toledo Road, Room 7108, Hyattsville, Maryland 20782, telephone (301) 458-4565, fax (301) 458-4021.
The Director, Management Analysis and Services Office, has been delegated the authority to sign
Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (DHHS).
Notice of meeting.
In accordance with section 10(a) of the Federal Advisory Committee Act (FACA)(5 U.S.C. Appendix 2), this notice announces the second biannual meeting of the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel) for 2004.
The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary, DHHS, (the Secretary) and the Administrator, CMS, (the Administrator) concerning the clinical integrity of the APC groups and their associated weights. The Secretary and the Administrator consider the Panel's advice as CMS prepares its annual updates of the hospital Outpatient Prospective Payment System (OPPS) through rulemaking.
The second biannual meeting for 2004 is scheduled for the following dates and times: Wednesday, September 1, 2004, 1 p.m.-5 p.m. (e.d.t.); Thursday, September 2, 2004, 8 a.m.-5 p.m. (e.d.t.); Friday, September 3, 2004, 8 a.m.-12 noon (e.d.t.).
• 5 p.m. (e.d.t.), Wednesday, August 18, 2004.
• 5 p.m. (e.d.t.), Wednesday, August 18, 2004.
• 5 p.m. (e.d.t.), Monday, August 23, 2004.
• 5 p.m. (e.d.t.), Monday, August 23, 2004.
Because of staffing and resource limitations, we cannot accept written comments/presentations by facsimile (FAX), nor can we print written comments/presentations received electronically for dissemination at the meeting.
Only hardcopy comments and presentations will be accepted for placement in the meeting booklets.
We are also requiring electronic versions of the written comments and presentations (in addition to the hardcopies) for the Panel's review prior to the meeting.
Therefore,
The meeting will be held in the Multipurpose Room, 1st Floor, at the CMS Central Office, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.
For inquiries regarding the meeting; meeting registration; and hardcopy submissions of oral presentations, agenda items, and comments, please use the following:
News media representatives should contact our Public Affairs Office at this phone number.
To obtain Charter copies, search our Internet Web site at
The Secretary, DHHS, is required by section 1833(t)(9)(A) of the Social Security Act (the Act), as amended by section 201(h)(1)(B) and redesignated by section 202(a)(2) of the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act (BBRA) of 1999 (Pub. L. 106-113), to establish and consult with an expert, outside advisory panel on APC groups. The Panel meets up to three times annually to review the APC groups and to provide technical advice to the Secretary and the Administrator concerning the clinical integrity of the groups and their associated weights. We will consider the technical advice provided by the Panel as we prepare the proposed rule that proposes changes to the OPPS for the next calendar year.
The Panel may consist of up to 15 representatives who are full-time employees (not consultants) of Medicare providers, which are subject to the OPPS, and a Chair/Acting Chair. Panel members must have technical expertise that will enable them to fully participate in the Panel's work. The Administrator selected the Panel membership based upon either self-nominations or nominations submitted by providers or interested organizations. The Panel presently consists of the following members and an Acting Chair: Edith Hambrick, M.D., J.D.; Acting Chair, Marilyn Bedell, M.S., R.N., O.C.N.; Albert Brooks Einstein, Jr., M.D.; Robert E. Henkin, M.D.; Lee H. Hilborne, M.D., M.P.H. Stephen T. House, M.D.; Kathleen Kinslow, C.R.N.A., Ed.D.; Mike Metro, R.N., B.S.; Sandra J. Metzler, M.B.A., R.H.I.A., C.P.H.Q.*; Gerald V. Naccarelli, M.D.; Frank G. Opelka, M.D., F.A.C.S.; Beverly K. Philip, M.D.; Lou Ann Schraffenberger, M.B.A., R.H.I.A., C.C.S.-P*; Lynn R. Tomascik, R.N., M.S.N., C.N.A.A.; Timothy Gene Tyler, Pharm.D.; William Van Decker, M.D. (*New member as of April 1, 2004).
The agenda for the September 2004 meeting will provide for discussion and comment on the following topics as designated in the Panel's Charter:
• Reconfiguration of APCs (for example, splitting of APCs, moving Healthcare Common Procedure Coding System HCPCS) codes from one APC to another and moving HCPCS codes from new technology APCs to clinical APCs).
• Evaluation of APC weights.
• Packaging devices and drug costs into APCs: methodology, effect on APCs, and need for reconfiguring APCs based upon device and drug packaging.
• Removal of procedures from the inpatient list for payment under the OPPS.
• Use of single and multiple procedure claims data.
• Packaging of HCPCS codes.
• Other technical issues concerning APC structure.
The DFO must receive the electronic and hardcopy written comments and suggested agenda topics by 5 p.m. (e.d.t.), Wednesday, August 18, 2004.
Additionally, the written comments and suggested agenda topics must fall within the subject categories listed above that are outlined in the Panel's Charter.
Individuals or organizations wishing to make 5-minute oral presentations must contact the DFO. The DFO must receive the electronic and hardcopy presentations by 5 p.m. (e.d.t.), on Wednesday, August 18, 2004, in order to be scheduled.
The number of oral presentations may be limited by the time available. Oral presentations must not exceed 5 minutes in length.
The Acting Chair may further limit time allowed for presentations due to the number of oral presentations scheduled, if necessary.
The additional criteria below must be supplied to the DFO by the August 18 deadline (along with hardcopies of presentations).
• Required personal information regarding presenter(s):
• Name of presenter(s),
• Title(s),
• Organizational affiliation,
• Address,
• E-mail address, and
• Telephone number(s).
All presentations must contain, at a minimum, the following supporting information and data:
• Financial relationship(s) of presenter(s), if any, with any company whose products, services, or procedures that are under consideration;
• Physicians' Current Procedural Terminology (CPT) codes involved;
• APC(s) affected;
• Description of the issue(s);
• Clinical description of the service under discussion (with comparison to other services within the APC);
• Recommendations and rationale for change;
• Expected outcome of change; and
• Potential consequences of not making the change(s).
Form CMS-20017, Presenter/Presentation Information Checklist.
To assist presenters in meeting the above criteria, Form CMS-20017, which identifies the specific standard for Panel presentations, can be found on our Internet Web site at:
In addition to formal oral presentations, there will be opportunity during the meeting for public oral comments that will be limited to 1 minute for each individual and a total of 5 minutes per organization.
The meeting is open to the public; however, attendance is limited to space available. Attendance will be determined on a first-come, first-served basis.
Persons wishing to attend this meeting, which is located on Federal property, must call or e-mail the Panel DFO to register in advance no later than 5 p.m. (e.d.t.), Monday, August 23, 2004.
The following information must be e-mailed or telephoned to the DFO by the date and time above:
• Name(s) of attendee(s),
• Title(s),
• Organization,
• E-mail address(es), and
• Telephone number(s).
Persons attending the meeting must present photographic identification to the Federal Protective Service or Guard Service personnel before they will be allowed to enter the building.
All visitors must be escorted in areas other than the lower-lobby and first floor levels in CO building.
Parking permits and instructions are issued upon arrival by the guards at the main entrance on Security Boulevard.
Individuals requiring sign-language interpretation or other special accommodations must send a request for these services to the DFO by 5 p.m. (e.d.t.), Monday, August 23, 2004.
Section 1833(t) of the Act (42 U.S.C. 1395l(t), as amended by section 201(h) of the BBRA of 1999 (Pub. L. 106-113). The Panel is governed by the provisions of Pub. L. 92-463, as amended (5 U.S.C. Appendix 2).
Office of Family Assistance, ACF, DHHS.
Grant award announcement.
Notice is hereby given that an award is being made to the Center for Economic Progress of Chicago, IL in the amount of $50,000 to provide outreach on the Earned Income Tax Credit to TANF recipients and other low income individuals. After the appropriate reviews, it has been determined that this unsolicited proposal qualifies for funding.
The goal of the Center for Economic Progress is to increase access to tax credits and asset building opportunities for low and moderate income individuals, families and communities. The Center serves hundreds of thousands of low income taxpayers each tax filing season, and has developed critical knowledge and understanding of the experiences of the taxpayers and the barriers they face accessing the EITC and other low income tax credits.
The Center for Economic Progress is the only organization in the country that has a statewide contract with a State TANF Agency to provide EITC outreach to TANF recipients. They have distinguished itself as a Chicago, statewide and national leader through its innovative programs, partnerships with community organizations, corporate allies, and government agencies. The Center for Economic Progress is uniquely qualified to conduct this project because of its many successes in EITC outreach.
The period of this funding will extend through September 30, 2004.
Paul Maiers, Office of Family Assistance, Administration for Children and Families, 370 L'Enfant Promenade, SW., Washington, DC 20447, Telephone: 202-401-5438.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).
Fax written comments on the collection of information by September 7, 2004.
OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for FDA, FAX: 202-395-6974.
Peggy Robbins, Office of Management Programs (HFA 250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
This document provides guidance on the voluntary use of selected symbols in place of text to convey some of the information required for in vitro diagnostic devices (IVDs) intended for professional use under § 809.10 (21 CFR 809.10) (FDA's labeling requirements for IVDs) and parts 610 and 660 (21 CFR parts 610 and 660) (FDA's labeling requirements for biologics (including IVDs)) that are licensed under the Public Health Service Act. Use of these symbols will not result in a new collection of information but is a means of fulfilling underlying labeling requirements that are subject to OMB clearance. Under section 502(c) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 352), a drug or device is misbranded
If any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
This guidance document recommends that a glossary of terms accompany each IVD to define the symbols used on that device's labels and/or labeling. Furthermore, this guidance recommends an educational outreach effort to enhance the understanding of newly introduced symbols. Both the glossary and the educational outreach help to ensure that IVD users will have enough general familiarity with the symbols, as well as quick reference materials available, to be likely to understand the symbols used in IVD labeling, further ensuring that such labeling satisfies the requirements of section 502(c) of the act.
In the
FDA estimates the burden for this collection of information as follows:
The glossary and educational outreach activities would be carried out by domestic and foreign IVD manufacturers. The Center for Devices and Radiological Health Information Retrieval System's Registration and Listing Information database provided the number of IVD manufacturers as 1,742; 1,206 are domestic IVD manufacturers and 536 are foreign manufacturers. Consequently, FDA has based its burden estimate on the maximum possible number of manufacturers choosing to implement the use of symbols in labeling. The number of hours per response for the glossary and educational outreach activities were derived from consultation with a trade association and FDA personnel. The 4-hour estimate for a glossary is based on the average time necessary for a manufacturer to modify the glossary, as shown in the draft guidance, for the specific symbols used in labels or labeling for the IVDs they manufacture. The 16-hour estimate for educational outreach includes activities manufacturers will use to educate the various professional users of IVDs about the meaning of the IVD symbols. This estimate is based on FDA 's expectation that IVD manufacturers will jointly sponsor many educational outreach activities.
The draft guidance document also refers to labeling requirements, annual reporting requirements, and other information collections established under existing regulations. The collections of information described in section III of the guidance that result from § 809.10 were approved under OMB control number 0910-0485. The collections of information described in
Food and Drug Administration, HHS.
Notice; withdrawal.
The Food and Drug Administration (FDA) is withdrawing a notice that published in the
This notice is withdrawn on August 5, 2004.
May D. Nelson, Center for Food Safety and Applied Nutrition (HFS-024), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1722.
In the
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the National Institute of Health (NIH), National Cancer Institute (NCI) will public periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
The CHIS is a telephone survey designed to provide population-based, standardized health-related data to assess California's progress in meeting Healthy People 2010 objectives for the nation and the state. The CHIS sample is designed to provide statistically reliable estimates statewide, for California counties, and for California's ethnically and racially diverse population. Initiated by the UCLA Center for Health Policy Research, the California Department of Health Services, and the California Public Health Institutes, the survey is funded by a number of public and private sources. It was first administered in 2001 to 55,428 adults and subsequently in 2003 to 42,043 adults. These adults are a representative sample of California's non-institutional population living in households.
CHIS 2005, the third bi-annual survey, is planned for administration to 55,000 adult Californians. The cancer control module, which is similar to that administered in CHIS 2001 and CHIS 2003, will allow NCI to examine trends in breast cancer screening and diagnosis, as well as to study other cancer-related topics, such as, diet, physical activity and obesity.
Because California is the most populous and the most racially and ethnically diverse state in the nation, the CHIS 2005 sample will yield adequate numbers of respondents in key ethnic and racial groups, including African Americans, Latinos, Asians, and American Indian/Alaska Natives. The Latino group will include large numbers of Mexican-origin, Central Americans, South Americans, and other Latino subgroups; the Asian group will include large numbers of respondents in the Chinese, Filipino, Japanese, Vietnamese, and Korean subgroups. NCI will compare the CHIS and National Health Interview Survey (NHIS) data in order to conduct comparative analyses and better estimate cancer risk factors and screening among racial/ethnic minority populations. The CHIS sample size also permits NCI to create estimates for ethnic subdomains of the population, for which NHIS has insufficient numbers for analysis.
There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.
To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Nancy Breen, Ph.D., Project Officer, National Cancer Institute, EPN 4005, 6130 Executive Boulevard MSC 7344. Bethesda, Maryland 20852-7344, or call non-toll free number (301) 496-8500 or FAX your request, including your address to
Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of this publication.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations impsoed by the review and funding cycle.
Coast Guard, DHS.
Notice with request for comments.
The Coast Guard seeks consultation with all interested and affected parties in establishing a program to approve ballast water treatment systems. The intent of this program is to ensure that ballast water treatment systems approved for use on-board vessels will meet the ballast water discharge standard the Coast Guard will be implementing in the near future to prevent the introduction and spread of nonindigenous species via ballast water discharges, as authorized by the Nonindigenous Aquatic Nuisance Prevention and Control Act and the National Invasive Species Act.
Comments and related material must reach the Docket Management Facility on or before December 3, 2004.
To make sure your comments and related material are not entered more than once in the docket, please submit them by only one of the following means:
(1) By mail to the Docket Management Facility (USCG-2001-10486), U.S. Department of Transportation, room PL-401, 400 Seventh Street, SW., Washington, DC 20590-0001.
(2) By delivery to room PL-401 on the Plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The telephone number is (202) 366-9329.
(3) By fax to the Docket Management Facility at (202) 493-2251.
(4) Electronically through the Web site for the Docket Management System at
In choosing among these means, please give due regard to the recent difficulties and delays associated with the delivery of mail through the U.S. Postal Service to Federal facilities. Delivery methods 2-4 of those listed above are the preferred methods because security measures taken by the U.S. Postal Service and Coast Guard mail reception facilities may seriously damage or render unreadable comments sent via regular mail.
The Docket Management Facility maintains the public docket for this rulemaking. Comments and material received from the public, as well as documents mentioned in this notice as being available in the docket, will become part of this docket and will be available for inspection or copying at room PL-401 on the Plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. You may also find this docket at the following Web site address:
Electronic forms of all comments received into any of our dockets can be searched by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor unit, etc) and is open to the public without restriction. You may review the Department of Transportation's complete Privacy Act Statement in the
For information concerning this notice, call Mr. Bivan Patnaik, Project Manager, Environmental Standards Division, U.S. Coast Guard, telephone (202) 267-0995 or via e-mail
The Coast Guard encourages interested persons to submit written data, views, or comments. Persons submitting comments should please include their name and address and identify the docket number (USCG-2001-10486). You may submit your comments and material by mail, hand delivery, fax, or electronic means to the Docket Management Facility at the address under
The Nonindigenous Aquatic Nuisance Prevention and Control Act of 1990, as reauthorized and amended by the National Invasive Species Act of 1996, authorizes the Coast Guard to approve alternative ballast water management methods in lieu of ballast water exchange to prevent the introduction and spread of nonindigenous species (NIS) in U.S. waters via ballast water discharge. The Coast Guard will use information gathered from this notice to develop a comprehensive approval program to ensure ballast water treatment systems meet the ballast water discharge standard regulations, which we intend to promulgate in the near future. Commenters should note that the approval program will have to accommodate many different technologies as ballast water treatment options, as well as different types of vessels, and the costs associated with establishing this program. Commenters should also consider that treated ballast water may be sampled for the life of the treatment system as part of compliance measures to enforce ballast water discharge standards. In addition, commenters should be aware that the Environmental Protection Agency's Environmental Technology Verification Program (
The development of an approval program presents a complex challenge for the Coast Guard. We currently approve some equipment as a result of only land-based testing. The public should comment on if this is an adequate approach for approving ballast water treatment systems or should approval of these systems involve shipboard testing. The public should comment on appropriate water quality conditions, whether or not testing should include testing from both fresh water and salt water sources, and other environmental conditions that treatment systems should be subjected to as part of the approval program. The development of this program will require close collaboration between government agencies, the scientific community, water treatment experts, the shipping industry, and a wide range of stakeholders.
At this time, the Coast Guard is looking into holding a public meeting, and the various types of venues for the meeting. You may submit requests and/or comments for a public meeting to the Docket Management Facility at the address under
Coast Guard, DHS.
Notice and request for public comment.
The U.S. Coast Guard Captain of the Port (COTP), Port Arthur, is preparing a letter of recommendation as to the suitability of the Sabine Pass Channel waterway for liquefied natural gas (LNG) marine traffic. The COTP is looking for comments and related material pertaining specifically to the Maritime Operation, Waterways Management, and Port Security aspects of the proposed LNG Facility.
Comments and related material pertaining specifically to the Maritime Operation, Waterways Management, and Port Security aspects of the proposed LNG Facility must reach the Coast Guard on or before September 7, 2004.
You may mail comments and related material to: Commanding Officer, U.S. Coast Guard Marine Safety Office, 2875 Jimmy Johnson Blvd., Port Arthur, TX 77640, ATTN: Waterways Management Branch.
You may send comments and related material by fax to: U.S. Coast Guard Marine Safety Office (MSO) Port Arthur Attention: Waterways Management Branch (409) 723-6534. U.S. Coast Guard MSO Port Arthur maintains a file for this notice. Comments and material received from the public during the comment period will become part of this file and will be available for inspection or copying at U.S. Coast Guard MSO Port Arthur, Waterways Management Branch, between the hours of 7:30 a.m. to 4 p.m., Monday through Friday, excluding Federal holidays.
Lieutenant (Junior Grade) Jennifer Hnatow at U.S. Coast Guard MSO Port Arthur, (409) 723-6501.
We encourage you to participate by submitting comments and related material pertaining specifically to the Maritime Operation, Waterways Management, and Port Security aspects of the proposed LNG Facility. If you do so, please include your name and address, identify the docket number [COTP Port Arthur-04-011], indicate the specific section of this document to which each comment applies, and give the reason for each comment. Please submit all comments and related material in an unbound format, no larger than 8
We do not now plan to hold public meetings. But you may submit a request for meetings by writing to Commanding Officer, U.S. Coast Guard MSO Port Arthur at the address under
The Federal Energy Regulatory Commission (FERC) is responsible for authorizing the siting and construction of onshore LNG facilities under Section 3 of the Natural Gas Act (NGA) (15 U.S.C. 717
In accordance with the requirements in 33 CFR 127.009, the U.S. Coast Guard COTP Port Arthur, is preparing a letter of recommendation as to the suitability of the Sabine Pass Channel waterway for liquefied natural gas (LNG) marine traffic. The letter of recommendation is in response to a Letter of Intent to operate a LNG facility in Cameron Parish, LA. This facility would consist of an LNG import terminal and storage facilities and approximately 16 miles of 42-inch-diameter pipeline in Cameron Parish. The Letter of Intent is available in the docket where indicated under
Sabine Pass LNG, L.P. and Cheniere Sabine Pass Pipeline Company (collectively referred to as Cheniere Sabine) propose to build a new LNG import, storage, and vaporization terminal in a rural part of Cameron Parish, Louisiana, across the Sabine Pass Channel from Sabine Pass, Texas; and a natural gas pipeline to transfer up to 2.6 billion cubic feet per day of imported natural gas. Cheniere Sabine has acquired 568 acres of land, formerly used for dredge spoil placement by the U.S. Army Corps of Engineers, for the proposed LNG terminal facility. The LNG import terminal would import, store, and vaporize an average of approximately 2,600 million standard cubic feet per day (MMscfd) of LNG, with an installed capacity of 2,880 MMscfd, for supply to U.S. natural gas markets. Cheniere Sabine seeks authority to construct and operate the following new facilities:
1. A new marine basin connected to the Sabine Pass Channel that would include a ship maneuvering area and two protected berths to unload up to 300 LNG ships per year with a ship capacity ranging up to 250,000 cubic meters (m
2. Two 30-inch-diameter stainless steel insulated LNG transfer lines to transfer the LNG from the berth facilities to the LNG storage tanks;
3. Three all-metal, double-walled, single containment, top-entry LNG storage tanks, each with a nominal working volume of approximately 160,000 m
4. Sixteen high-pressure submerged combustion LNG vaporizers with a capacity of approximately 180 MMscfd each, as well as other associated vaporization equipment, including pumps, boil-off gas compressors, instrumentation, and safety systems;
5. Ancillary utilities, buildings, and service facilities, including hazard detection and fire response systems;
6. Approximately 16 miles of 42-inch-diameter natural gas pipeline extending from the LNG import terminal to an interconnection with four existing pipelines at Johnson's Bayou;
7. Three metering stations, one at the LNG terminal site, one at an interconnection with Natural Gas Pipeline Company of America, and one at the interconnection with the existing pipelines at Johnson's Bayou; and
8. Associated pipeline facilities including a pig launcher receiver
Construction of the LNG terminal facilities would take approximately 3 years, and the pipeline would take approximately 4 to 6 months. Cheniere Sabine proposes to place the project in service before the 2007 winter heating season.
In preparation for issuance of the letter of recommendation, the COTP will consider all information submitted by the owner or operator under the requirements of 33 CFR 127.007, as well as comments received from the public.
Additional information can be found in the Federal Energy Regulatory Commission Document entitled “Notice of Intent To Prepare an Environmental Impact Statement for the Proposed Sabine Pass LNG and Pipeline Project and Request for Comments on Environmental Issues and Notice of Public Scoping Meeting and Site Visit”, Docket Nos. CP04-47-000, CP04-38-000, CP04-39-000, and CP04-40-000 dated February 20, 2004, which is available for download at
Bureau of Indian Affairs, Interior.
Notice.
This notice advises the public that the Bureau of Indian Affairs (BIA) as lead agency, with the Navajo Nation as cooperating agency, intends to prepare a Supplemental Programmatic Environmental Impact Statement (SPEIS) for the proposed Navajo Nation Ten-Year Forest Management Plan. The purpose of the proposed action is to pursue forest management in a manner that is both environmentally sound and economically beneficial to the Navajo Nation.
Written comments must arrive by September 7, 2004.
You may mail written comments to Mr. Jonathan Martin, Regional Forester, Bureau of Indian Affairs, Navajo Regional Office, P.O. Box 1060, Gallup, New Mexico 87305.
Jonathan Martin, (928) 729-7228.
The proposed action is to adopt a ten-year forest management plan for the Navajo Forest. The Navajo Forest lies in the Chuska Mountains and Defiance Plateau areas of the Navajo Nation, along the Arizona-New Mexico border. The forest area encompasses nearly 600,000 acres.
A Final Programmatic Environmental Impact Statement (FPEIS) for the proposed action was originally issued in April 2002. The Environmental Protection Agency published a Notice of Availability of the FPEIS and the BIA published a Supplemental Notice in the
The original FPEIS included five alternatives, as follows: (1) Even-aged and uneven-aged management for timber harvesting with Special Management Areas (SMAs) protecting critical wildlife habitat and vital watersheds (preferred); (2) even-aged management with SMAs; (3) uneven-aged management without SMAs; (4) no commercial harvesting; and (5) no action, which would continue current harvest levels with even-aged management and without SMAs. Areas of environmental concern addressed in the FPEIS included timber and other forest resources, biological, water and cultural resources, air quality and socio-economics. The SPEIS will further elaborate on alternatives considered, but eliminated from detailed study, such as homesites, grazing and range conditions, distribution and condition of riparian systems, wildlife occurrence and habitat, water quality and cumulative impacts.
Comments, including names and addresses of respondents, will be available for public review at the mailing address shown in the
This notice is published in accordance with section 1503.1 of the Council on Environmental Quality Regulations (40 CFR parts 1500 through 1508) implementing the procedural requirements of the National Environmental Policy Act of 1969, as amended (42 U.S.C. 4321
Bureau of Indian Affairs, Interior.
Notice.
This notice publishes the Seneca Nation Liquor Control Code. The Code regulates and controls the possession, sale and consumption of liquor on the Seneca Nation. The land is located on trust land and this Code allows for the possession and sale of alcoholic beverages on the Seneca Nation and will increase the ability of the tribal government to control the Nation's liquor distribution and possession, and at the same time will provide an important source of revenue for the continued operation and strengthening of the tribal government and the delivery of tribal services.
This Code is effective on August 5, 2004.
Harold Spears, Eastern Regional Office, Division of Tribal Government, 711 Stewarts Ferry Pike, Nashville, Tennessee 37214, Telephone (615) 467-2953 or Ralph Gonzales, Office of Tribal Services, 1951 Constitution Avenue, NW., MS-320-SIB, Washington, DC 20240; Telephone (202) 513-7629.
Pursuant to the Act of August 15, 1953, Public Law 83-277, 67 Stat. 586, 18 U.S.C. 1161, as interpreted by the Supreme Court in
The purpose of this Code is to govern the sale, possession and distribution of alcohol on the Seneca Nation.
This notice is published in accordance with the authority delegated by the Secretary of the Interior to the Assistant Secretary—Indian Affairs.
I certify that this Liquor Ordinance, a Legislative Code of the Seneca Nation, was duly adopted by the Seneca Nation Tribal Council on March 15, 2004.
The Seneca Nation Liquor Control Code, CN:R-04-10-04-19 reads as follows:
This Code shall be known as the “Seneca Nation of Indians Alcoholic Beverage Control Code.”
The authority for this Code and its adoption by the Council of the Seneca Nation of Indians (“Nation Council”) is found in Article XIII of the Constitution of the Seneca Nation of Indians of 1848, as amended, and in the Act of August 15, 1953, Public Law 83-277, 18 U.S.C. 1161.
Pursuant to the inherent sovereignty of the Nation and in the exercise of the Nation's powers for the purpose of protecting the welfare, health, peace, morals and safety of Nation members, the Nation adopts this Code for the purpose of regulating and controlling the possession, sale and consumption of alcoholic beverages within the boundaries of the Seneca Nation Territory. This Code is enacted in conformity with the Nation's concurrent jurisdiction with the State of New York over alcoholic beverage regulation within the Seneca Nation Territory pursuant to the Act of August 15, 1953, Public Law 83-277, 18 U.S.C. 1161.
Nation Council resolution CN: R-11-16-02-17, duly adopted by the Nation Council on November 16, 2002, is hereby repealed and replaced. Any and all prior ordinances, resolutions, regulations or other form of control of the Nation, whether written or unwritten, which authorize, prohibit, or deal with the sale of alcohol are hereby repealed and have no further force and effect. No Nation ordinance or regulation shall be applied in a manner inconsistent with the provisions of this Code.
The Seneca Nation lands to which this Code applies is the Indian Country that is subject to the jurisdiction of the Nation, including those lands acquired by the Nation in restricted fee status pursuant to the Seneca Nation Land Claims Settlement Act of 1990, 25 U.S.C. 1774f(c). For the purposes of this Code only, all lands to which this Code applies shall be referred to herein as the “Seneca Nation Territory.”
The possession, sale and consumption of alcoholic beverages within the Seneca Nation Territory shall be lawful provided that such possession is in conformity with both this Ordinance and the laws of the State of New York pursuant to 18 U.S.C. 1161.
To the extent that definitions are consistent with Nation and federal law, terms used herein shall have the same meaning as defined in New York Consolidated Laws, Chapter 3-B (Alcoholic Beverage Control Law) and in Title 9, Subtitle B, Chapter I of the New York Regulations (Rules of the New York State Liquor Authority).
(a) “Alcohol” shall mean ethyl alcohol, hydrated oxide of ethyl or spirit of wine from whatever source or by whatever process produced.
(b) “Alcoholic beverage” shall mean any liquid suitable for human consumption, which contains one-half of one percent or more of alcohol by volume.
(c) “Beer” shall mean and include any fermented beverages of any name or description, manufactured from malt, wholly or in part, or from any substitute therefore.
(d) “Distilled spirits” shall mean any alcoholic beverage that is not beer, wine, sparkling wine or alcohol.
(e) “Liquor” shall mean and include any and all distilled or rectified spirits, brandy, whiskey, rum, gin, cordials or similar distilled alcoholic beverages, including all dilutions and mixtures of one or more of the foregoing.
(f) “Minor” shall mean any person under age twenty-one (21) years of age.
(g) “Nation Council” shall mean the duly elected governing body of the Seneca Nation of Indians.
(h) “Nation Enterprise,” for purposes of this Code only, shall mean those corporations chartered by the Nation and authorized to conduct Class II or III gaming and related commercial activities within Seneca Nation Territory pursuant to the Nation's Gaming Compact with New York State and that is licensed by the Nation Council after paying the appropriate fee set forth by the Nation Council by Resolution at not less than two hundred ($200.00) Dollars and not more than Five Thousand ($5,000) Dollars annually.
(i) “Possession or possessing” shall mean over one's person, vehicle or other property and includes constructive possession through control without regard to ownership.
(j) “Purchase” shall mean the exchange, barter, traffic, receipt, with or without consideration in any form.
(k) “Sale” shall mean the exchange, barter, traffic, donation, with or without consideration, in addition to the selling, supplying or distribution by any means, by any person to any person.
(l) “State” means the State of New York.
(m) “Transport” shall mean the introduction of alcoholic beverage onto the Seneca Nation Territory by any means of conveyance for the purpose of sale, or distribution, to any licensed dealer.
(a) The Nation Council, or other designee as authorized by the Nation Council by Resolution, has primary regulatory authority over the subject matter of this Code. The Nation Council, or its duly authorized designee, shall have the following powers and duties:
(b) To establish, publish and enforce rules and regulations governing the sale of alcoholic beverages within Seneca
(c) To employ managers, accountants, security personnel, inspectors, and other such persons as may be reasonably necessary to ensure adequate enforcement of this Code;
(d) To issue licenses permitting the sale of alcoholic beverages within Seneca Nation Territory;
(e) To hold hearings on violations of this Code or for the issuance or revocation of licenses hereunder;
(f) To bring suit to enforce this Code as necessary;
(g) To determine penalties for violations of this Code;
(h) To make such reports as may be required;
(i) To collect fees levied or set in relation to this Code and keep accurate records, books and accounts; and
(j) To exercise such other powers as is necessary and appropriate to fulfill the purposes of this Code.
(2) The Marshals, the Seneca Nation Conservation officers, and the officers of the Seneca Nation Law Enforcement Department are authorized to enforce this Code within the Seneca Nation Territory. Such officials are authorized to confiscate and preserve evidence of all alcoholic beverages sold, introduced for purposes of sale, or possessed in violation of this Code within the Seneca Nation Territory.
(a) License Required. The sale and introduction for purposes of sale of alcoholic beverages shall be unlawful within the Seneca Nation Territory unless pursuant to an alcoholic beverage license issued by the Nation Council or its duly authorized designee. Any person who is not licensed pursuant to this Code who sells, or introduces for sale, alcoholic beverages within the Seneca Nation Territory, whether in the original container or not, shall be guilty of a violation of this Code and shall be subject to a fine under this Code.
(b) Unlawful Possession. The possession and consumption of alcoholic beverages shall be unlawful on the public lands of the Seneca Nation Territory, including public highways, bridges, Nation property, parking lots, driveways and surrounding Nation Buildings. Any person who possesses or consumes alcoholic beverages in violation of this provision shall be guilty of a violation of this Code and shall be subject to a fine under this Code.
(c) Possession by minors. It shall be unlawful for any person under the age of twenty-one to possess or consume alcoholic beverages, or for any person to give alcoholic beverages to any person under the age of twenty-one, within the Seneca Nation Territory. Any person in violation of this provision shall be guilty of a violation of this Code and shall be subject to a fine under this Code.
(d) Sale to minors. It shall be unlawful for any person to maintain a premises within the Seneca Nation Territory where alcoholic beverages are consumed, possessed or served to any person under the age of twenty-one. Any person in violation of this provision shall be guilty of a violation of this Code and shall be subject to a fine under this Code.
(a) The Nation may bring an action in the Peacemakers' Court against any person for violation of the provisions of this Code within Seneca Nation Territory. The action shall be initiated by the filing of a written complaint with the court of the tribal prosecutor, sworn to by a person having personal knowledge of the charged violation, or by a Marshal or Seneca Nation Law Enforcement officer having personal knowledge of the charged violation. The complaint shall set forth the essential facts charging that named individual has violated the Code. Such action, including any appeal which is taken from the decision of the Peacemakers' Court, shall be governed by the Seneca Nation of Indians Peacemakers' Court and surrogate's court civil procedure rules.
(b) Any person found to have violated the Code shall pay a fine of:
(1) No more than $5000 and no less than $0 for a Section 8(a) violation, plus court costs.
(2) No more than $5000 and no less than $0 for a Section 8(b) violation, plus court costs.
(3) No more than $5000 and no less than $0 for a Section 8(c) violation, plus court costs.
(4) No more than $5000 and no less than $0 for a Section 8(d) violation, plus court costs.
In addition to the penalty described for such violation, all alcoholic beverages confiscated from any person found to have violated this Code shall be destroyed.
(c) In lieu of imposing a fine pursuant to subsection (b) above, the Peacemakers' Court may employ the procedure provided in section 4-102(a), (b) of the Seneca Nation of Indians Peacemakers' Court and surrogate's court civil procedure rules.
(d) Any person found to have violated this Code who is charged with a second subsequent violation may be referred to any other jurisdiction which the Peacemakers' Court determines has concurrent jurisdiction over the charge.
(e) In addition to other remedies, the Peacemakers' Court may enjoin any person in violation of this Code.
(1) License Requirements. No license shall be issued under this Code except upon a sworn application filed with the Nation Council, or its duly authorized designee, containing a full and complete showing of the following:
(a) Satisfactory proof that the applicant is duly licensed by the State of New York to sell alcoholic beverages.
(b) Satisfactory completion of a background investigation including but not limited to a determination that the applicant is of good character and reputation and that the applicant is financially responsible.
(c) The description and location of the premises in which the alcoholic beverages are to be sold and proof that the applicant is entitled to use such premises for such purposes for the duration of the time period of the license.
(d) Agreement by the applicant to accept and abide by all conditions of the license as established by the Nation Council.
(e) Payment of a fee established by the Nation Council.
(f) Satisfactory proof that neither the applicant, nor the applicant's spouse, nor any principal owner, officer, shareholder, or director of the applicant, has ever been convicted of a felony or a crime of moral turpitude as defined by the laws of the State of New York.
The Nation Council will consider the merits of applications for alcoholic beverages licenses based on the following factors:
(1) whether the requirements of Section 10 have been met; and
(2) whether granting the license is in the best interests of the Nation.
No member of the Nation Council shall be a part of the decision making process of an application submitted by a Nation Council member or any person in the immediate family of a Nation Council member.
The Nation Council may grant a temporary permit for the sale of alcoholic beverages, in any form, for a period not to exceed 3 days to any persons applying for the same in connection with a tribal or community activity, provided that the conditions prescribed in Sections 8 of this Code shall be observed by the permittee. Each permit issued shall specify the types of alcoholic beverages to be sold, the time, date and location permitted. A fee, as set by the Nation Council, will be assessed on temporary permits.
(1) Any license issued under this Code shall be subject to such reasonable conditions, as the Nation Council shall fix, including, but not limited to the following:
(a) The license shall be for a term not to exceed 2 years.
(b) The licensee shall at all times maintain an orderly, clean, and neat establishment, both inside and outside the licensed premises.
(c) The licensed premises shall be open to inspection by duly authorized tribal officials at all times during regular business hours.
(d) Alcoholic beverages shall be sold, served, disposed of, delivered or given to any person, and consumed on the licensed premises in conformity with the hours and days prescribed by the laws of the State, and in accordance with the hours fixed by the Nation Council.
(e) All acts and transactions under authority of a alcoholic beverages license shall be in conformity with State and Federal law, and shall be in accordance with this Code and any license issued pursuant to this Code.
(f) No person under the age permitted under the laws of the State (21 years) shall be sold, served, delivered, given, or allowed to consume alcoholic beverages.
(g) There shall be no discrimination in the operations under the license by reason of race, color, or creed.
Notwithstanding any other provision of this Code, a alcoholic beverages license is a mere permit for a fixed duration of time. An alcoholic beverages license shall not be deemed a property right or vested right of any kind, nor shall the granting of a alcoholic beverages license give rise to a presumption of legal entitlement to the granting of such license for a subsequent time period.
No license issued under this Code shall be assigned or transferred without the written approval of the Nation Council expressed in a formal resolution.
The premises upon which alcoholic beverages is sold or distributed shall be open to inspection by the Nation Council or its authorized designee during all hours of operation for the purposes of ascertaining compliance with this Code.
Nothing in this Code is intended nor shall be construed as a waiver of sovereign immunity by the Nation. No officer, manager or employee of any Nation Enterprise shall be authorized nor shall attempt to waive the sovereign immunity of the Nation.
Nothing in this Code shall be construed to authorize or require the criminal trial and punishment of non-Indians by the Nation except to the extent allowed by an applicable present or future Act of Congress or any applicable laws.
The Nation Council shall have the exclusive authority to adopt and enforce the rules and regulations to implement this Code on the Seneca Nation Territory and to further the purposes of this Code. Such rules and regulations shall have the force of law upon promulgation by Nation Council Resolution.
If any clause, part or section of this Code shall be adjudged as invalid, such judgment shall not affect or invalidate the remainder of the ordinance but shall be confined in its operation to the clause, part or section directly involved in the controversy in which such judgment was rendered.
This Code shall be effective upon the date that the Secretary of Interior certifies this Code and it is published in the
The duration of this Code shall be perpetual until repealed or amended by Nation Council Resolution.
Bureau of Indian Affairs, Interior.
Notice of approved Tribal—State Compact.
This notice publishes an approved Class III Gaming Compact between the Mescalero Apache Tribe and the State of New Mexico. Under the Indian Gaming Regulatory Act of 1988, the Secretary of the Interior is required to publish notice in the
August 5, 2004.
George T. Skibine, Director, Office of Indian Gaming Management, Office of the Deputy Assistant Secretary—Policy and Economic Development, Washington, DC 20240, (202) 219-4066.
Under Section 11 of the Indian Gaming Regulatory Act of 1988 (IGRA) Public Law 100-497, 25 U.S.C. 2710, the Secretary of the Interior shall publish in the
The Principal Deputy Assistant Secretary—Indian Affairs, Department of the Interior, through her delegated authority, is publishing notice that the Tribal—State Compact between the Mescalero Apache Tribe and the State of New Mexico is now in effect.
Bureau of Land Management, Interior.
Notice.
The plats of survey of the following described lands were officially filed in the Oregon State Office, Portland, Oregon, on July 1, 2004.
A copy of the plats may be obtained from the Public Room at the Oregon State Office, Bureau of Land Management, 333 SW. 1st Avenue, Portland, Oregon 97204, upon required payment. A person or party who wishes to protest against a survey must file a notice that they wish to protest. (at the above address) with the State Director, Bureau of Land Management, Portland, Oregon.
For further information contact: Chief, Branch of Geographic Sciences, Bureau of Land Management, (333 SW. 1st Avenue) P.O. Box 2965, Portland, Oregon 97208.
U.S. International Trade Commission.
Institution of investigation pursuant to 19 U.S.C. 1337.
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on July 2, 2004 under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of Seagate Technology, LLC. Letters supplementing the complaint were filed on July 21 and 26, 2004. The complaint, as supplemented, alleges violations of section 337 in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain disc drives, components thereof, and products containing same by reason of infringement of claims 1-4 of U.S. Patent No. 5,452,159, claims 1 and 5-7 of U.S. Patent No. 5,596,461, claims 1, 5-22, and 28-48 of U.S. Patent No. 5,600,506, claims 1, 6, 7 and 10-13 of U.S. Patent No. 6,146,754, claims 1-4, 15-17, and 19-22 of U.S. Patent No. 6,324,054, claims 5-7, 9, 11, 12, 14, and 15 of U.S. Patent No. 6,545,845, and claims 1, 2, 4-6, 9-15, and 17-20 of U.S. Patent No. 6,744,606. The complaint further alleges that there exists an industry in the United States as required by subsection (a)(2) of section 337.
The complainant requests that the Commission institute an investigation and, after the investigation, issue a permanent exclusion order and a permanent cease and desist order.
The complaint and supplemental letters, except for any confidential information contained therein, are available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street, SW., Room 112, Washington, DC 20436, telephone (202) 205-2000. Hearing-impaired individuals are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on (202) 205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at (202) 205-2000. General information concerning the Commission may also be obtained by accessing its internet server at
Thomas S. Fusco, Esq., Office of Unfair Import Investigations, U.S. International Trade Commission, telephone (202) 205-2571.
The authority for institution of this investigation is contained in section 337 of the Tariff Act of 1930, as amended, and in section 210.10 of the Commission's Rules of Practice and Procedure, 19 CFR 210.10 (2004).
(1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain disc drives, components thereof, or products containing same by reason of infringement of one or more of claims 1-4 of U.S. Patent No. 5,452,159, claims 1 and 5-7 of U.S. Patent No. 5,596,461, claims 1, 5-22, and 28-48 of U.S. Patent No. 5,600,506, claims 1, 6, 7, and 10-13 of U.S. Patent No. 6,146,754, claims 1-4, 15-17, and 19-22 of U.S. Patent No. 6,324,054, claims 5-7, 9, 11, 12, 14, and 15 of U.S. Patent No. 6,545,845, and claims 1, 2, 4-6, 9-15, and 17-20 of U.S. Patent No. 6,744,606, and whether an industry in the United States exists as required by subsection (a)(2) of section 337.
(2) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:
(a) The complainant is—Seagate Technology, LLC, 920 Disc Drive, Scotts Valley, California 95066.
(b) The respondent is the following company alleged to be in violation of Section 337 and upon which the complaint is to be served—Cornice, Inc., 1951 South Fordham Street, Suite 105, Longmont, Colorado 80503.
(c) Thomas S. Fusco, Office of Unfair Import Investigations, U.S. International Trade Commission, 500 E Street, SW., Room 401-E, Washington, DC 20436, who shall be the Commission investigative attorney, party to this investigation; and
(3) For the investigation so instituted, the Honorable Sidney Harris is designated as the presiding administrative law judge.
A response to the complaint and the notice of investigation must be submitted by the named respondent in accordance with § 210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(d) and 210.13(a), such response will be considered by the Commission if received no later than 20 days after the date of service by the Commission of the complaint and notice of investigation. Extensions of time for submitting a response to the complaint will not be granted unless good cause therefor is shown.
Failure of the respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter both an initial
By order of the Commission.
United States International Trade Commission.
Institution of a proceeding under section 129(a)(4) of the Uruguay Round Agreements Act (URAA) (19 U.S.C. 3538(a)(4)).
The Commission hereby gives notice that it has instituted this proceeding following receipt on July 27, 2004, of a request from the United States Trade Representative (USTR) for a determination under section 129(a)(4) of the URAA that would render the Commission's action in connection with Investigations Nos. 701-TA-414 and 731-TA-928 not inconsistent with the findings of the dispute settlement panel of the World Trade Organization (WTO) in its report entitled, “United States—Investigation of the International Trade Commission in Softwood Lumber From Canada,” WT/DS277/R. A schedule for this proceeding will be established and announced at a later date. For further information concerning the conduct of this proceeding and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A through E (19 CFR part 201), and part 207, subpart A (19 CFR part 207).
August 5, 2004.
Jim McClure (202-205-3191), Office of Investigations, or Robin L. Turner (202-205-3103), Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its Internet server (
By order of the Commission.
In accordance with Departmental Policy, 28 CFR 50.7, notice is hereby given that a proposed consent decree in
The proposed Consent Decree requires the defendants to pay $106,250 to a wetland restoration fund as mitigation for the wetlands that were filled without a U.S. Army Corps of Engineers permit. The Consent Decree also requires payment of a civil penalty.
The Department of Justice will accept written comments relating to this proposed Consent Decree for thirty (30) days from the date of publication of this notice. Please address comments to Kurt Lindland, Assistant United States Attorney, United States Attorney's Office, 5th Floor, 219 S. Dearborn Street, Chicago, Illinois 60604 and refer to
The proposed Consent Decree may be examined at the Clerk's Office, United States District Court for the Northern District of Illinois, 219 S. Dearborn Street, Chicago, Illinois. In addition, the proposed Consent Decree may be viewed on the World Wide Web at
In accordance with Departmental Policy, 28 CFR 50.7, notice is hereby given that a proposed Consent Decree in
This proposed Consent Decree concerns a complaint filed by the United States against Peter Thorson, Managed Investments, Inc., and Construction Management, Inc., and Gerke Excavating, Inc., pursuant to sections 301 and 404 of the Clean Water Act, to obtain injunctive relief from and impose civil penalties against the Defendants for violating the Clean Water Act by discharging pollutants without a permit into waters of the United States. The proposed Consent Decree resolves the allegations against Peter Thorson, Managed Investments, Inc., and Construction Management, Inc. by requiring these Defendants to restore the impacted areas and to pay a civil penalty.
The Department of Justice will accept written comments relating to this proposed Consent Decree for thirty (30) days from the date of publication of this Notice. Please address comments to Leslie K. Herje, Assistant U.S. Attorney, PO Box 1585, Madison, Wisconsin 53701-1585 and refer to
The proposed Consent Decree may be examined at the Clerk's Office, United States District Court for the Western District of Wisconsin, 120 North Henry Street, Room 320, Madison, Wisconsin 53701-0432. In addition, the proposed Consent Decree may be viewed at
Under 28 CFR 50.7, notice is hereby given that on July 22, 2004, a proposed consent decree (“consent decree”) in
In this action the United States sought penalties and injunctive relief for: Failure to obtain a prevention of significant deterioration permit for two power boilers, as required by the Pennsylvania State Implementation Plan; failure to obtain an operating permit including best available control technology (BACT), as required by the state implementation plan; and failure to comply with federal new source performance standards.
Under the terms of the consent decree, Weyerhaeuser agrees to install wet gas scrubbers to control sulfur dioxide emissions, to operate them in accordance with the terms in the consent decree and to pay a civil penalty of $900,000 ($675,000 to the United States and $225,000 to Pennsylvania).
The Department of Justice will receive for a period of thirty (30) days from the date of this publication comments relating to the consent decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, P.O. Box 7611, U.S. Department of Justice, Washington, D.C. 20044-7611, and should refer to
The consent decree may be examined at the Office of the United States Attorney, 700 Grant Street, Suite 400 Pittsburgh, PA 15219, and at U.S. EPA Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103-2029. A copy of the consent decree may also be examined on the following Department of Justice Web site,
30-Day notice of information collection under review: Extension of a Currently Approved Collection Request for Disposition of Offense
The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection is published to obtain comments from the public and affected agencies. This proposed
The purpose of this notice is to allow for an additional 30 days for public comment until September 7, 2004. This process is conducted in accordance with 5 CFR 1320.10.
Written comments and/or suggestions regarding the items contained in this notice, especially the estimated public burden and associated response time, should be directed to The Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington, DC 20503. Additionally, comments may be submitted to OMB via facsimile to (202) 395-5806.
Request written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
(1) Evaluate 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;
(2) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
(1)
(2)
(3)
(4)
(5)
(6)
If additional information is required contact: Brenda E. Dyer, Clearance Officer, United States Department of Justice, Policy and Planning Staff, Justice Management Division, Suite 1600, Patrick Henry Building, 601 D Street, NW., Washington 20530.
30-Day Notice of Information Collection Under Review: Application for Tax-Exempt Transfer of Firearm and Registration to Special Occupational Taxpayer.
The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection is published to obtain comments from the public and affected agencies. This proposed information collection was previously published in the
The purpose of this notice is to allow for an additional 30 days for public comment until September 7, 2004. This process is conducted in accordance with 5 CFR 1320.10.
Written comments and/or suggestions regarding the items contained in this notice, especially the estimated public burden and associated response time, should be directed to The Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington, DC 20503. Additionally, comments may be submitted to OMB via facsimile to (202) 395-5806.
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
(1)
(2)
(3)
(4)
(5)
(6)
If additional information is required contact: Brenda E. Dyer, Clearance Officer, United States Department of Justice, Policy and Planning Staff, Justice Management Division, Suite 1600, Patrick Henry Building, 601 D Street NW., Washington, DC 20530.
30-Day Notice of Information Collection Under Review: Application for an Amended Federal Firearms License.
The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection is published to obtain comments from the public and affected agencies. This proposed information collection was previously published in the
The purpose of this notice is to allow for an additional 30 days for public comment until September 7, 2004. This process is conducted in accordance with 5 CFR 1320.10.
Written comments and/or suggestions regarding the items contained in this notice, especially the estimated public burden and associated response time, should be directed to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington, DC 20503. Additionally, comments may be submitted to OMB via facsimile to (202) 395-5806.
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
Overview of this Information Collection
(1)
(2)
(3)
(4)
(5)
(6)
If additional information is required contact: Brenda E. Dyer, Clearance Officer, United States Department of Justice, Policy and Planning Staff, Justice Management Division, Suite 1600, Patrick Henry Building, 601 D Street NW., Washington, DC 20530.
30-day notice of information collection under review: Implementation of Pub. L. 103-322, the Violent Crime Control and Law Enforcement Act of 1994.
The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection is published to obtain comments from the public and affected agencies. This proposed information collection was previously published in the
The purpose of this notice is to allow for an additional 30 days for public comment until September 7, 2004. This process is conducted in accordance with 5 CFR 1320.10.
Written comments and/or suggestions regarding the items contained in this notice, especially the estimated public burden and associated response time, should be directed to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington, DC 20503. Additionally, comments may be submitted to OMB via facsimile to (202) 395-5806.
Written comments and suggestions from the public and affected agencies
Overview of this Information Collection
(1)
(2)
(3)
(4)
(5)
(6)
Brenda E. Dyer, Clearance Officer, United States Department of Justice, Policy and Planning Staff, Justice Management Division, Suite 1600, Patrick Henry Building, 601 D Street, NW., Washington, DC 20530.
The Board of Directors of the Legal Services Corporation will meet August 12, 2004, from 9 a.m., until conclusion of the Board's agenda.
The Melrose Hotel, 2430 Pennsylvania Avenue, NW., Washington, DC 20037.
Closed. The meeting will be closed pursuant to a vote of the Board of Directors to hold an executive session. At the closed session, the Board will interview finalists for the position of Inspector General of the Legal Services Corporation and consider the qualifications of these individuals, options available for compensating the Inspector General as well as further steps to be taken in connection with the selection and hiring of that individual. The closing is authorized by 5 U.S.C. 552b(c)(6) and LSC's corresponding regulation 45 CFR 1622.5(e). A copy of the General Counsel's Certification that the closing is authorized by law will be available upon request.
Closed Session
1. Approval of agenda.
2. Interview finalists for the position of Inspector General.
3. Review and discuss qualifications of the finalists interviewed.
4. Consider and act on options available to compensate the Inspector General.
5. Consider and act on further steps to be taken in connection with the selection and hiring of an Inspector General.
6. Consider and act on adjournment of meeting.
Patricia Batie, Manager of Board Operations, at (202) 295-1500.
Entergy Operations, Inc. (Entergy or the licensee) is the holder of Facility Operating License No. NPF-38 which authorizes operation of Waterford Steam Electric Station, Unit 3 (Waterford 3). The license provides, among other things, that the facility is subject to all rules, regulations, and orders of the U.S. Nuclear Regulatory Commission (NRC or the Commission) now or hereafter in effect. The facility consists of a pressurized water reactor located in St. Charles Parish, Louisiana.
Pursuant to title 10 of the Code of Federal Regulations (10 CFR) section 50.12, “Specific Exemptions,” Entergy, in a letter dated April 30, 2004, as supplemented by letter dated June 8, 2004, requested an exemption to 10 CFR 50.46, “Acceptance Criteria for Emergency Core Cooling Systems for Light-Water Nuclear Power Reactors”, and Appendix K to 10 CFR part 50, “ECCS Evaluation Models.” The regulation in 10 CFR 50.46 contains acceptance criteria for the emergency core cooling system (ECCS) for reactors fueled with zircaloy or ZIRLO
Tin is a solid solution strengthener and α-phase stabilizer present entirely in the base α-phase zirconium crystalline structure. Potential impacts of a reduced tin content on material properties include: (1) A reduced tensile strength; (2) an increased thermal creep rate; (3) an increased irradiation growth rate; (4) a reduced α →α+β phase transition temperature; and (5) an improved corrosion resistance. The stated reduction in tin content of Optimized ZIRLO
In response to a Request for Additional Information (RAI), Entergy provided details of the planned post-irradiation examinations of the LTAs. Measured parameters include rod profilometry, rod wear, assembly and rod growth, assembly bow, grid cell dimensions, and oxide thickness. As a result of these post-irradiation examinations, any negative aspects of the low tin alloy's performance, including the potential impacts of a reduced tin content identified above, will be identified and resolved. Furthermore, significant deviations from model predictions will be reconciled.
The fuel rod burnup and fuel duty experienced by the LTAs in Waterford 3 will remain well within the operating experience base and applicable licensed limits for ZIRLO
Utilizing currently-approved fuel performance and fuel mechanical design models and methods, Entergy and Westinghouse Electric Corporation (Westinghouse) will perform cycle-specific reload evaluations to ensure that the LTAs satisfy design criteria.
Based upon LTA irradiation experience of similar low tin versions of ZIRLO
The Waterford 3 exemption request relates solely to the specific types of cladding material specified in the regulations. Due to similar material properties, any impact of Optimized ZIRLO
Fuel management guidelines will require that LTAs be placed in non-limiting core locations. In response to an RAI, Entergy described how power-peaking margins would be used to ensure that LTAs will not be limiting.
Based upon the use of approved models and methods, expected material performance, and the placement of LTAs in non-limiting core locations, the NRC staff finds that the irradiation of up to four LTAs in Waterford 3 will not result in unsafe operation or violation of specified acceptable fuel design limits. Furthermore, in the event of a design-basis accident, these LTAs will not promote consequences beyond those currently analyzed. Based upon results of metal-water reaction tests and ring-compression tests, which ensure the applicability of ECCS models and acceptance criteria and the use of approved LOCA models to ensure that the LTAs satisfy 10 CFR 50.46 acceptance criteria, the NRC staff considers the LTAs acceptable for use at Waterford 3 as proposed by Entergy.
Pursuant to 10 CFR 50.12, the Commission may, upon application by any interested person or upon its own initiative, grant exemptions from the requirements of 10 CFR Part 50 if: (1) The exemptions are authorized by law, will not present an undue risk to public health or safety, and are consistent with the common defense and security; and (2) special circumstances are present.
The underlying purpose of 10 CFR 50.46 is to establish acceptance criteria for ECCS performance. The applicability of the ECCS acceptance criteria has been demonstrated by Westinghouse. Ring-compression tests performed by Westinghouse on Optimized ZIRLO
Utilizing currently approved LOCA models and methods, Westinghouse will perform cycle-specific reload evaluations to ensure that the LTAs satisfy 10 CFR 50.46 acceptance criteria. Therefore, granting the proposed exemption will not defeat the underlying purpose of 10 CFR 50.46.
Paragraph I.A.5 of Appendix K to 10 CFR part 50 states that the rates of energy, hydrogen concentration, and cladding oxidation from the metal-water reaction shall be calculated using the Baker-Just equation. Since the Baker-Just equation presumes the use of zircaloy clad fuel, strict application of the rule would not permit use of the equation for the LTA cladding for determining acceptable fuel performance. Metal-water reaction tests performed by Westinghouse on Optimized ZIRLO
In summary, the NRC staff reviewed the licensee's request of proposed exemption to allow up to four LTAs containing fuel rods fabricated with Optimized ZIRLO
The staff examined the rest of the licensee's rationale to support the exemption request, and concluded that the use of Optimized ZIRLO
(1) The requested exemption is authorized by law:
No law precludes the activities covered by this exemption request. The Commission, based on technical reasons set forth in rulemaking records, specified the specific cladding materials identified in 10 CFR 50.46 and 10 CFR part 50, Appendix K. Cladding materials are not specified by statute.
(2) The requested exemption does not present an undue risk to the public
The LTA reload evaluation will ensure that these acceptance criteria [in the Commission's regulations] are met following the insertion of LTAs containing Optimized ZIRLO
The NRC staff has evaluated these considerations as set forth in Section 3.1 of this exemption. For the reasons set forth in that section, the NRC staff concludes that Optimized ZIRLO
(3) The requested exemption will not endanger the common defense and security:
The common defense and security are not affected and, therefore, not endangered by this exemption.
Accordingly, the Commission has determined that, pursuant to 10 CFR 50.12(a), the Exemption is authorized by law, will not present an undue risk to the public health and safety, and is consistent with the common defense and security. Also, special circumstances are present. Therefore, the Commission hereby grants Entergy an exemption from the requirements of 10 CFR 50.46 and 10 CFR part 50, Appendix K, to allow the use of Optimized ZIRLO
Pursuant to 10 CFR 51.32, the Commission has determined that the granting of this exemption will not have a significant effect on the quality of the human environment (69 FR 31848 dated June 7, 2004).
This exemption is effective upon issuance.
For the Nuclear Regulatory Commission.
The U.S. Nuclear Regulatory Commission (the Commission) is considering issuance of an amendment to Facility Operating License No. DPR-41, issued to Florida Power and Light (the licensee), for operation of the Turkey Point Unit 4 located in Miami-Dade County.
The proposed amendment would revise Technical Specifications (TSs) 3/4.1.3.1, 3/4.1.3.2 and 3/4.1.3.5 to allow the use of an alternate method of determining rod position for the control rod F-8 with the rod position indicator, until repairs can be conducted at the next outage which is scheduled for spring 2005.
The reason for the exigency is due to the unanticipated failure of the Turkey Point Unit 4 Analog Rod Position Indication for control rod F-8 in Shutdown Bank B, which was last declared inoperable on July 26, 2004, at 8:47 a.m. Additionally, there is a concern regarding excessive wear due to exercising the movable incore detectors every 8 hours (90 times per month) to comply with the compensatory actions required by the current Action Statement a. of TS 3.1.3.2.
Before issuance of the proposed license amendment, the Commission will have made findings required by the Atomic Energy Act of 1954, as amended (the Act) and the Commission's regulations.
Pursuant to 10 CFR 50.91(a)(6) for amendments to be granted under exigent circumstances, the NRC staff must determine that the amendment request involves no significant hazards consideration. Under the Commission's regulations in 10 CFR 50.92, this means that operation of the facility in accordance with the proposed amendment would not (1) involve a significant increase in the probability or consequences of an accident previously evaluated; or (2) create the possibility of a new or different kind of accident from any accident previously evaluated; or (3) involve a significant reduction in a margin of safety. As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:
1. Will operation of the facility in accordance with this proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
No. The proposed change provides an alternative method for verifying rod position of one shutdown rod. The proposed change meets the intent of the current specification in that it ensures verification of position of the control rod once every eight (8) hours. The proposed change provides only an alternative method of monitoring shutdown rod position and does not change the assumption or results of any previously evaluated accident.
Therefore, operation of the facility in accordance with the proposed amendment would not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Will operation of the facility in accordance with this proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
No. As described above, the proposed change provides only an alternative method of determining the position of one shutdown rod. No new accident initiators are introduced by the proposed alternative manner of performing rod position verification. The proposed change does not affect the reactor protection system or the reactor control system. Hence, no new failure modes are created that would cause a new or different kind of accident from any accident previously evaluated.
Therefore, operation of the facility in accordance with the proposed amendments would not create the possibility of a new or different kind of accident from any previously evaluated.
3. Will operation of the facility in accordance with this proposed change involve a significant reduction in a margin of safety?
No. The bases of Specification 3.1.3.2 state that the operability of the rod position indicators is required to determine control rod positions and thereby ensure compliance with the control rod alignment and insertion limits. The proposed change does not alter the requirement to determine rod position but provides an alternative method for determining the position of the affected rod. As a result, the initial conditions of the accident analysis are preserved and the consequences of previously analyzed accidents are unaffected.
Therefore, operation of the facility in accordance with the proposed amendments
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
The Commission is seeking public comments on this proposed determination. Any comments received within 14 days after the date of publication of this notice will be considered in making any final determination.
Normally, the Commission will not issue the amendment until the expiration of the 14-day notice period. However, should circumstances change during the notice period, such that failure to act in a timely way would result, for example, in derating or shutdown of the facility, the Commission may issue the license amendment before the expiration of the 14-day notice period, provided that its final determination is that the amendment involves no significant hazards consideration. The final determination will consider all public and State comments received. Should the Commission take this action, it will publish in the
Written comments may be submitted by mail to the Chief, Rules and Directives Branch, Division of Administrative Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, and should cite the publication date and page number of this
The filing of requests for hearing and petitions for leave to intervene is discussed below.
Within 60 days after the date of publication of this notice, the licensee may file a request for a hearing with respect to issuance of the amendment to the subject facility operating license and any person whose interest may be affected by this proceeding and who wishes to participate as a party in the proceeding must file a written request for a hearing and a petition for leave to intervene. Requests for a hearing and a petition for leave to intervene shall be filed in accordance with the Commission's “Rules of Practice for Domestic Licensing Proceedings” in 10 CFR part 2. Interested persons should consult a current copy of 10 CFR 2.309, which is available at the Commission's PDR, located at One White Flint North, Public File Area 01F21, 11555 Rockville Pike (first floor), Rockville, Maryland. Publicly available records will be accessible from the Agencywide Documents Access and Management System's (ADAMS) Public Electronic Reading Room on the Internet at the NRC Web site,
As required by 10 CFR 2.309, a petition for leave to intervene shall set forth with particularity the interest of the petitioner in the proceeding, and how that interest may be affected by the results of the proceeding. The petition should specifically explain the reasons why intervention should be permitted with particular reference to the following general requirements: (1) The name, address and telephone number of the requestor or petitioner; (2) the nature of the requestor's/petitioner's right under the Act to be made a party to the proceeding; (3) the nature and extent of the requestor's/petitioner's property, financial, or other interest in the proceeding; and (4) the possible effect of any decision or order which may be entered in the proceeding on the requestor's/petitioner's interest. The petition must also identify the specific contentions which the petitioner/requestor seeks to have litigated at the proceeding.
Each contention must consist of a specific statement of the issue of law or fact to be raised or controverted. In addition, the petitioner/requestor shall provide a brief explanation of the bases for the contention and a concise statement of the alleged facts or expert opinion which support the contention and on which the petitioner intends to rely in proving the contention at the hearing. The petitioner/requestor must also provide references to those specific sources and documents of which the petitioner/requestor is aware and on which the petitioner/requestor intends to rely to establish those facts or expert opinion. The petitioner/requestor must provide sufficient information to show that a genuine dispute exists with the applicant on a material issue of law or fact. Contentions shall be limited to matters within the scope of the amendment under consideration. The contention must be one which, if proven, would entitle the petitioner/requestor to relief. A petitioner/requestor who fails to satisfy these requirements with respect to at least one contention will not be permitted to participate as a party.
Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene, and have the opportunity to participate fully in the conduct of the hearing.
If a hearing is requested, the Commission will make a final determination on the issue of no significant hazards consideration. The final determination will serve to decide when the hearing is held. If the final determination is that the amendment request involves no significant hazards consideration, the Commission may issue the amendment and make it immediately effective, notwithstanding the request for a hearing. Any hearing held would take place after issuance of the amendment. If the final determination is that the amendment request involves a significant hazards consideration, any hearing held would take place before the issuance of any amendment.
Nontimely requests and/or petitions and contentions will not be entertained absent a determination by the Commission or the presiding officer of the Atomic Safety and Licensing Board that the petition, request and/or the contentions should be granted based on a balancing of the factors specified in 10 CFR 2.309(a)(1)(i)-(viii).
A request for a hearing or a petition for leave to intervene must be filed by: (1) First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemaking and Adjudications Staff; (2) courier, express mail, and expedited delivery services: Office of the Secretary, Sixteenth Floor, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852, Attention: Rulemaking and Adjudications Staff; (3) e-mail addressed to the Office of the Secretary, U.S. Nuclear Regulatory Commission,
For further details with respect to this action, see the application for amendment dated July 28, 2004, which is available for public inspection at the Commission's Public Document Room (PDR), located at One White Flint North, Public File Area O1 F21, 11555 Rockville Pike (first floor), Rockville, Maryland. Publicly available records will be accessible electronically from the Agencywide Documents Access and Management System's (ADAMS) Public Electronic Reading Room on the Internet at the NRC Web site
For the Nuclear Regulatory Commission.
The U.S. Nuclear Regulatory Commission (NRC) is considering amending an exemption from (1) Title 10 of the Code of Federal Regulations (10 CFR) part 50, Appendix K, section I.D.1, which requires that accident evaluations use the combination of emergency core cooling system (ECCS) subsystems assumed to be operative “after the most damaging single failure of ECCS equipment has taken place;” and (2) requirements of 50.46(a)(1)(ii), for Facility Operating License No. NPF-3, issued to FirstEnergy Nuclear Operating Company (FENOC or the licensee), for operation of the Davis-Besse Nuclear Power Station (DBNPS), located in Ottawa County, Ohio. Therefore, as required by 10 CFR 51.21, the NRC is issuing this environmental assessment and finding of no significant impact.
The original exemption issued on May 5, 2000, exempted the licensee from the single-failure requirement for the two systems for preventing boric acid precipitation during the long-term cooling phase following a loss-of-coolant accident (LOCA). Additionally, the action exempted the licensee from the calculation requirements of 50.46(b)(5) and Appendix K, section I.A.4 for the second or backup system for preventing boric acid precipitation. The proposed action would amend the existing exemption by approving a new system to prevent boric acid precipitation. This new system would become the primary system and the current primary system would become the backup system. The current backup system would no longer be credited as part of the licensing basis, although it would remain as a third option procedurally. As such, the part of the existing exemption related to the calculation requirements of 50.46(b)(5) and Appendix K, section I.A.4 would be removed from the exemption as it only applied to the current backup system and is no longer needed.
The proposed action is in accordance with the licensee's application dated February 13, 2004.
The proposed action provides a new active means of preventing boric acid precipitation within the reactor vessel core region following a LOCA. The new system has fewer vulnerabilities and meets calculation requirements without an exemption, unlike the system to be removed from the licensing basis.
The NRC has completed its evaluation of the proposed action and concludes that the proposed amended exemption would continue to satisfy the underlying purpose of 10 CFR 50.46 and 10 CFR part 50, Appendix K. Additionally, the proposed action does not involve radioactive wastes, release of radioactive material into the atmosphere, solid radioactive waste, or liquid effluents released to the environment.
The DBNPS systems were evaluated in the Final Environmental Statement (FES) dated October 1975 (NUREG 75/097). The proposed amended exemption will not involve any change in the waste treatment systems described in the FES.
The proposed action will not significantly increase the probability or consequences of accidents. No changes are being made in the types of effluents that may be released off site. There is no significant increase in the amount of any effluent released off site. There is no significant increase in occupational or public radiation exposure. Therefore, there are no significant radiological environmental impacts associated with the proposed action.
With regard to potential non-radiological impacts, the proposed action does not have a potential to affect any historic sites. It does not affect non-radiological plant effluents and has no other environmental impact. Therefore, there are no significant non-radiological environmental impacts associated with the proposed action.
Accordingly, the NRC concludes that there are no significant environmental impacts associated with the proposed action.
As an alternative to the proposed action, the staff considered denial of the proposed action (
The action does not involve the use of any different resources than those previously considered in the Final Environmental Statement for DBNPS, NUREG 75/097, dated October 1975.
On May 25, 2004, the staff consulted with the Ohio State official, C. O'Claire of the Ohio Emergency Management Agency, regarding the environmental impact of the proposed action. The State official had no comments.
On the basis of the environmental assessment, the NRC concludes that the proposed action will not have a significant effect on the quality of the human environment. Accordingly, the NRC has determined not to prepare an environmental impact statement for the proposed action.
For further details with respect to the proposed action, see the licensee's letter dated February 13, 2004 (ADAMS ML040490242), and the existing exemption approved by NRC letter dated May 5, 2000 (ADAMS ML003712264). Documents may be examined, and/or copied for a fee, at the NRC's Public Document Room (PDR), located at One White Flint North, 11555 Rockville Pike (first floor), Rockville, Maryland. Publicly available records will be accessible electronically from the Agencywide Documents Access and Management System (ADAMS) Public Electronic Reading Room on the NRC Web site,
For the Nuclear Regulatory Commission.
The following is a notice of applications for deregistration under section 8(f) of the Investment Company Act of 1940 for the month of July, 2004. A copy of each application may be obtained for a fee at the SEC's Public Reference Branch, 450 Fifth St., NW., Washington, DC 20549-0102 (tel. 202-942-8090). An order granting each application will be issued unless the SEC orders a hearing. Interested persons may request a hearing on any application by writing to the SEC's Secretary at the address below and serving the relevant applicant with a copy of the request, personally or by mail. Hearing requests should be received by the SEC by 5:30 p.m. on August 24, 2004, and should be accompanied by proof of service on the applicant, in the form of an affidavit or, for lawyers, a certificate of service. Hearing requests should state the nature of the writer's interest, the reason for the request, and the issues contested. Persons who wish to be notified of a hearing may request notification by writing to the Secretary, SEC, 450 Fifth Street, NW., Washington, DC 20549-0609. For Further Information Contact: Diane L. Titus at (202) 942-0564, SEC, Division of Investment Management, Office of Investment Company Regulation, 450 Fifth Street, NW., Washington, DC 20549-0504.
In 1993, applicant voluntarily registered under the Act. Applicant now states that it has experienced burdensome costs in operating in accordance with the requirements of the Act and seeks an order declaring that it has ceased to be an investment company. Applicant will rely on section 2(b) of the Act to remain exempt from the registration requirements of the Act. Applicant states that it is exempt under section 2(b) of the Act because it is an instrumentality of the State of Iowa.
For the Commission, by the Division of Investment Management, pursuant to delegated authority.
Notice is hereby given, pursuant to the provisions of the Government in the Sunshine Act, Public Law 94-409, that the Securities and Exchange Commission will hold the following meeting during the week of August 9, 2004:
A Closed Meeting will be held on Thursday, August 12, 2004, at 2 p.m.
Commissioners, Counsel to the Commissioners, the Secretary to the Commission, and recording secretaries will attend the Closed Meeting. Certain staff members who have an interest in the matters may also be present.
The General Counsel of the Commission, or his designee, has certified that, in his opinion, one or more of the exemptions set forth in 5 U.S.C. 552b(c)(3), (5), (7), (9)(B), and (10) and 17 CFR 200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the scheduled matters at the Closed Meeting.
Commissioner Campos, as duty officer, voted to consider the items listed for the closed meeting in a closed session.
The subject matter of the Closed Meeting scheduled for Thursday, August 12, 2004, will be:
Formal orders of investigations;
Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings of an enforcement nature; and
Litigation matter.
At times, changes in Commission priorities require alterations in the scheduling of meeting items. For further information and to ascertain what, if any, matters have been added, deleted or postponed, please contact:
The Office of the Secretary at (202) 942-7070.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934,
The Exchange proposes to extend for one (1) year until July 31, 2005, the current pilot program regarding transaction fees for trades executed through the intermarket options linkage (“Linkage”) on the Exchange.
The text of the proposed rule change is available at the Office of the Secretary, Amex, and at the Commission's Public Reference Room.
In its filing with the Commission, the Exchange included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item III below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
Amex is proposing to extend for one (1) year until July 31, 2005, the current pilot program establishing Exchange fees for Principal Orders (“P Orders”) and Principal Acting as Agent Orders (“P/A Orders”) executed through Linkage. The fees in connection with the pilot program are scheduled to expire on July 31, 2004.
As was the case in the original pilot program and subsequent extension, the Exchange believes that the existing fees currently charged to Exchange specialists and ROTs should also apply to executions resulting from Linkage Orders sent to the Exchange.
Based on the experience to date, the Exchange believes that an extension of the pilot program for one (1) year until July 31, 2005 is appropriate.
The Exchange believes that proposed rule change is consistent with Section 6(b)(4) of the Act
The Exchange believes that the proposed rule change will impose no burden on competition.
No written comments were solicited or received with respect to the proposed rule change.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an e-mail to
• Send paper comments in triplicate to Jonathan G. Katz, Secretary, Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549-0609.
All submissions should refer to File Number SR-Amex-2004-54. This file number should be included on the subject line if e-mail is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (
After careful consideration, the Commission finds that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder, applicable to a national securities exchange,
The Commission finds good cause, pursuant to Section 19(b)(2) of the Act,
It is therefore ordered, pursuant to Section 19(b)(2) of the Act
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange seeks to extend its original financial listing standards pilot program (the “Pilot Program”)
On January 29, 2004, the Commission granted accelerated approval of the Pilot Program on a six-month pilot basis through July 30, 2004.
On April 4, 2004, the Exchange filed File Number SR-NYSE-2004-20, which seeks permanent approval for the Pilot Program currently in effect with respect to the Exchange's original minimum listing standards, and approval of the continued minimum listing standards as originally proposed in File Number SR-NYSE-2003-43. File Number SR-NYSE-2004-20 was published in the
The Exchange believes that the proposed rule change is consistent with Section 6(b)(5) of the Act
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
Written comments were neither solicited nor received with respect to the proposed rule change.
Because the foregoing proposed rule change (1) does not significantly affect the protection of investors or the public interest; (2) does not impose any significant burden on competition; and (3) by its terms, does not become operative until 30 days from the date on which it was filed, or such shorter time as the Commission may designate if consistent with the protection of investors and the public interest, and the exchange provided the Commission with written notice of its intent to file the proposed rule change at least five business days prior to the date of filing of the proposed rule change, or such shorter time as designated by the Commission, it has become effective pursuant to Section 19(b)(3)(A) of the Act
Although Rule 19b-4(f)(6) under the Act
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an e-mail to
• Send paper comments in triplicate to Jonathan G. Katz, Secretary, Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The purpose of the proposed rule change is to amend the eligibility requirements for securities that may be the subject of stock loan/borrow transactions cleared through OCC's Stock Loan/Hedge Program (“Hedge Program”).
In its filing with the Commission, OCC included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. OCC has prepared summaries, set forth in sections (A), (B), and (C) below, of the most significant aspects of such statements.
In 2002 OCC proposed an additional eligibility criterion for equity securities that may be loaned in the Hedge Program. Specifically, OCC proposed that a loaned security be an underlying security for options unless (1) the loan was accepted by OCC prior to the implementation of the new requirement or (2) the security was deliverable upon the exercise of an outstanding option.
OCC, with the Commission's consent, deferred implementing this new standard pending completion of system enhancements by DTC and Loanet which would permit DTC and Loanet to confirm that the securities loaned in a transaction meet OCC's criteria in order to confirm that the transaction was eligible for clearance at OCC.
During the deferment period, OCC took the opportunity to reassess its eligibility criteria as approved by the Commission, and OCC determined that the criteria would preclude the lending of shares of certain exchange-traded funds (“ETFs”). There are a number of ETFs that track indexes underlying OCC-issued options but that are not themselves underlying securities for options. These ETFs are often used as hedges against the related index options. Without a change in the eligibility criteria, OCC would have to disqualify such ETFs from being loaned in the Hedge Program. OCC believes that excluding such ETFs would be inconsistent with the purpose of the Hedge Program, which is to give recognition to intermarket hedges between equity and options positions.
OCC believes that the proposed changes to its rules are consistent with the purpose and requirements of Section 17A of the Securities and Exchange Act of 1934, because it is designed to promote the prompt and accurate clearance and settlement of securities transactions, foster cooperation and coordination with persons engaged in the clearance and settlement of securities transactions, remove impediments to the mechanisms of a national system for the prompt and accurate clearance and settlement of securities transactions, and assure the safeguarding of securities and funds in the custody or control of OCC.
OCC does not believe that the proposed rule change would impose any burden on competition.
Written comments were not and are not intended to be solicited with respect to the proposed rule change, and none has been received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an e-mail to
• Send paper comments in triplicate to Jonathan G. Katz, Secretary, Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549-0609.
All submissions should refer to File Number SR-OCC-2004-09. This file number should be included on the subject line if e-mail is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (
For the Commission by the Division of Market Regulation, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The PCX proposes to amend the PCX sanctioning guidelines in order to effectively enforce compliance with the Exchange's Financial and Operational Combined Uniform Single (“FOCUS”) Reports filing requirements. The text of the proposed rule change is below. Proposed new language is in italics.
(a)-(e)—No change.
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for its proposal and discussed any comments it received regarding the proposal. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in Sections A, B and C below, of the most significant aspects of such statements.
The Exchange proposes to amend the PCX sanctioning guidelines in order to effectively enforce compliance with the Exchange's FOCUS Reports filing requirements.
Currently, PCX Rule 10.16 sets forth the general principles applicable to all sanction determinations, principal considerations in determining sanctions, and specific sanctioning guidelines for options order handling rules. The sanctioning guidelines are used by various PCX bodies that adjudicate disciplinary actions, including the Ethics and Business Conduct Committee (“EBCC”), the PCX Board of Directors, and the PCX Surveillance and Enforcement Departments, to determine appropriate remedial sanctions.
With the instant proposed rule change, the PCX proposes to establish specific sanctioning guidelines relating to disciplinary actions initiated as a result of late filings of FOCUS Reports. Currently, late filings of FOCUS Reports are handled by the assessment of late charges. While a specific late charge schedule is provided, Exchange staff also has the flexibility to refer repeated or aggravated failure to file such reports, or failure to file such reports, to the Enforcement Department. For example, Exchange staff may refer a failure to file FOCUS Reports after the first, second, or third occurrence, depending on the circumstances. Exchange staff has the responsibility to determine whether the circumstances involved are aggravated or repeated enough to warrant such failure to file FOCUS Reports to be taken out of the late charge schedule for disciplinary action. In other words, Exchange staff may refer such failures to the Enforcement Department without exhausting the late charge schedule set forth in PCX Rule 4.11(b)(1), if the circumstances warrant such action.
The PCX believes the proposed guidelines will assist the Exchange in determining appropriate remedial sanctions for violation(s) of FOCUS Report filing rules. The PCX also believes the guidelines will work to promote consistency and uniformity as each Exchange Department will use the same form and parameters set forth in the guidelines with respect to violation(s) of FOCUS Report filing. The fine amounts will differ depending on the number of disciplinary actions that have been brought by the PCX against the particular OTP Holder or OTP Firm and the Exchange will have a range of fines as well as non-monetary sanctions that could be assessed against offending OTP Holders or OTP Firms.
The PCX proposes the following monetary sanctions for disciplinary actions brought for violations of PCX Rule 4.11(b)(1):
1st Disciplinary Action—$1,000.00 to $5,000.00;
2nd Disciplinary Action—$2,000.00 to $10,000.00; and
Subsequent Disciplinary Actions-$3,000.00 to $50,000.00.
The proposed guidelines would also allow for non-monetary sanctions such as suspension, expulsion, or other sanctions in egregious cases. The Exchange believes that the proposed fine levels will help to deter violations of its FOCUS Report filing rules. These guidelines are not intended to be absolute, and sanctions may be imposed that fall outside the ranges recommended.
The Exchange believes that the proposed rule change is consistent with Section 6(b)
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
Written comments on the proposed rule change were neither solicited nor received.
Within 35 days of the date of publication of this notice in the
(A) By order approve the proposed rule change, or
(B) Institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an e-mail to
• Send paper comments in triplicate to Jonathan G. Katz, Secretary, Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549-0609.
All submissions should refer to File Number SR-PCX-2004-45. This file number should be included on the subject line if e-mail is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend its schedule of dues, fees and charges to adopt new charges applicable to Principal (“P”) Orders sent via the Intermarket Options Linkage (“Linkage”) under the Plan for the Purpose of Creating and Operating an Options Intermarket Linkage (“Plan”).
The Exchange intends to implement this fee on a pilot basis, ending July 31, 2005, for transactions settling on or after the first day following the Commission's approval of the proposal.
The proposed fee schedule is available at the principal office of the Exchange and at the Commission's Public Reference Room.
In its filing with the Commission, Phlx included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item III below. Phlx has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The purpose of the proposed rule change is to raise revenue for the Exchange by charging Exchange members for transactions involving inbound P Orders sent by such members via the Linkage pursuant to the Plan.
(i) “Principal Acting as Agent (“P/A”) Order,” which is an order for the principal account of a specialist (or equivalent entity on another Participant Exchange that is authorized to represent Public Customer orders), reflecting the terms of a related unexecuted Public Customer order for which the specialist is acting as agent;
(ii) “Principal (“P”) Order,” which is an order for the principal account of an Eligible Market Maker and is not a P/A Order; and
(iii) “Satisfaction Order,” which is an order sent through the Linkage to notify a member of another Participant Exchange of a Trade-Through and to seek satisfaction of the liability arising from that Trade-Through.
The Exchange will not assess any charges for P/A Orders and Satisfaction Orders.
Currently, the Exchange's schedule of dues, fees and charges includes the following charges applicable to Linkage P Orders on a pilot basis (“pilot”),
The Exchange has represented that its fees applicable to Linkage P Orders are consistent with other fees charged by the Exchange for non-Linkage Orders for the proprietary account(s) of off-floor
However, since the implementation of the pilot, the Exchange has amended its fees applicable to non-Linkage off-floor broker-dealer orders sent to the Exchange via AUTOM, the Exchange's electronic order delivery, routing, execution and reporting system.
The Exchange believes that its proposal to amend its schedule of dues, fees and charges is consistent with section 6(b) of the Act
The Exchange does not believe that the proposed rule change will impose any inappropriate burden on competition.
No written comments were either solicited or received.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an e-mail to
• Send paper comments in triplicate to Jonathan G. Katz, Secretary, Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549-0609.
All submissions should refer to File Number SR-Phlx-2004-44. This file number should be included on the subject line if e-mail is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (
After careful consideration, the Commission finds that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder, applicable to a national securities exchange,
The Commission finds good cause, pursuant to section 19(b)(2) of the Act,
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
The following Agreements were filed with the Department of Transportation under the provisions of 49 U.S.C. 412 and 414. Answers may be filed within 21 days after the filing of the application.
The following Applications for Certificates of Public Convenience and Necessity and Foreign Air Carrier Permits were filed under Subpart B (formerly Subpart Q) of the Department of Transportation's Procedural Regulations (
Federal Aviation Administration (FAA), DOT.
Notice of availability of proposed AC, and request for comments.
This notice announces the availability of and requests comments on a proposed AC that provides guidance on eligibility, application, and selection for the Charles Taylor “Master Mechanic” Award.
Submit comments on or before September 4, 2004.
Send all comments on the proposed AC to William O'Brien, Aircraft Maintenance Division (AFS-300), Federal Aviation Administration, Independence Ave., SW., Washington, DC 20591; facsimile (202) 267-5115; e-mail
William O'Brien, AFS-300, at the address, facsimile or e-mail listed above, or by telephone at (202) 267-3796.
The proposed AC 65-26C is available on the FAA's Regulatory Guidance Library Web site at
Federal Aviation Administration (FAA), DOT.
Notice of availability.
The Federal Aviation Administration (FAA) is giving notice that a FONSI/ROD has been issued addressing anticipated environmental impacts expected to occur from a decision to proceed with capital improvement projects at Dane County Regional Airport, Madison, WI.
Mr. Daniel J. Millenacker, Federal Aviation Administration, Airports District Office, 6020 28th Avenue South, Room 102,
This Notice is provided per 40 CFR 1506.6 notifying the public that a FONSI/ROD has been issued by the FAA identifying anticipated environmental impacts from a decision to proceed with airport capital improvement projects. Projects are intended to enhance compliance with Federal airport safety design standards including runway safety area, object free area, approach surfaces, and marking and lighting. The preferred alternative results in the following work items: relocation of a segment of rail line to the northwest from its current location; relocation of County Highway “CV” and Messerschmidt Road; relocation of the West Branch of Starkweather Creek; relocation of the airport perimeter road and perimeter fence; and extension of Runway 13/31 by 570 feet.
The FONSI/ROD is available for public examination from August 9, through August 23, 2004, at the following locations: Lakeview Branch of the Madison Public Library, 2845 N. Sherman Ave., Madison, WI; Office of Dane County Clerk, 210 Martin Luther King Blvd., Madison, WI 53703; Dane County Regional Airport, Office of Director, 4000 International Lane, Madison, WI; Town of Burke, Town Clerk, 5365 Reiner Rd, Madison, WI; DOT Transportation District 1, 2101 Wright Street, Madison, WI; Bureau of Aeronautics, 4802 Sheboygan Avenue, Room 701, Madison, Wisconsin; and FAA Airports District Office, 6020 28th Ave., So., Room 102, Minneapolis, MN.
Federal Aviation Administration (FAA), DOT
Notice of intent to rule on application.
The FAA proposes to rule and invites public comment on the application to impose and use the revenue from a PFC at Key West International Airport under the provisions of the Aviation Safety and Capacity Expansion Act of 1990 (Title IX of the Omnibus Budget Reconciliation Act of 1990) (Public Law 101-508) and part 158 of the Federal Aviation Regulations (14 CFR part 158).
Comments must be received on or before September 7, 2004.
Comments on this application may be mailed or delivered in triplicate to the FAA at the following address: Orlando Airports District Office, 5950 Hazeltine National Drive, Suite 400, Orlando, Florida 32822.
In addition, one copy of any comments submitted to the FAA must be mailed or delivered to Peter Horton, Director of Airports of the Monroe County Board of County Commissioners at the following address: Key West International Airport, 3491 S. Roosevelt Boulevard, Key West, Florida 33040.
Air carriers and foreign air carriers may submit copies of written comments previously provided to the Monroe County Board of County Commissioners under section 158.23 of part 158.
Susan Moore, Program Manager, Orlando Airports District Office, 5950 Hazeltine National Drive, Suite 400, Orlando FL 32822, (407) 812-6331, extension 120. The application may be reviewed in person at this same location.
The FAA proposes to rule and invites public comment on the application to impose and use the revenue from a PFC at key West International Airport under the provisions of the Aviation Safety and Capacity Expansion Act of 1990 (Title IX of the Omnibus Budget Reconciliation Act of 1990) (Public Law 101-508) and part 158 of the Federal Aviation Regulations (14 CFR part 158).
On July 23, 2004, the FAA determined that the application to impose and use the revenue from a PFC submitted by Monroe County Board of County Commissioners was substantially complete within the requirements of section 158.25 of part 158. The FAA will approve or disapprove the application, in whole or in part, no later than November 12, 2004.
The following is a brief overview of the application.
Any person may inspect the application in person at the FAA office listed above under
In addition, any person may, upon request, inspect the application, notice and other documents germane to the application in person at the Monroe County Board of County Commissioners.
Federal Aviation Administration (FAA), DOT.
Notice of intent to rule on application.
The FAA proposes to rule and invites public comment on the application to use PFC revenue at the Walker Field Airport under the
Comments must be received on or before September 7, 2004.
Comments on this application may be mailed or delivered in triplicate to the FAA at the following address: Craig A. Sparks, Manager; Denver Airports District Office, DEN-ADO; Federal Aviation Administration; 26805 E. 68th Avenue, Suite 224; Denver, Colorado 80249-6361.
In addition, one copy of any comments submitted to the FAA must be mailed or delivered to Ms. Corinne C. Nystrom, Airport Manager, at the following address: Walker Field Airport Authority, 2828 Walker Field Drive, Suite 301, Grand Junction, Colorado 81506.
Air Carriers and foreign air carriers may submit copies of written comments previously provided to the Walker Field Airport Authority, under § 158.23 of part 158.
Mr. Chris Schaffer, (303) 342-1258; Denver Airports District Office, DEN-ADO; Federal Aviation Administration; 26805 E. 68th Avenue, Suite 224; Denver, Colorado 80249-6361. The application may be reviewed in person at this same location.
The FAA proposes to rule and invites public comment on the application (04-06-U-00-GJT) to use a PFC at the Walker Field Airport, under the provisions of 49 U.S.C. 40117 and part 158 of the Federal Aviation Regulations (14 CFR part 158).
On July 23, 2004, the FAA determined that the application to use a PFC submitted by the Walker Field Airport Authority, Grand Junction, Colorado, was substantially complete within the requirements of § 158.25 of part 158. The FAA will approve or disapprove the application, in whole or in part, no later than October 29, 2004.
The following is a brief overview of the application.
Any person may inspect the application in person at the FAA office listed above under
In addition, any person may, upon request, inspect the application, notice and other documents germane to the application in person at the Walker Field Airport.
Federal Highway Administration (FHWA), DOT.
Notice of intent.
The FHWA is issuing this notice to advise the public that an environmental impact statement will be prepared for a proposed highway project in Cache County, Utah.
Jeffrey Berna, Environmental Specialist, Federal Highway Administration, 2520 West 4700 South, Suite 9A, Salt Lake City, Utah 84118, Telephone: (801) 963-0078 ext, 235; or Brad Humphreys, Utah Department of Transportation, Region 1, 166 West Southwell Road, Ogden, Utah 84404-4194, telephone: (801) 620-1684.
The FHWA, in cooperation with the Utah Department of Transportation (UDOT) and the City of Logan, Utah, will prepare an environmental impact statement (EIS) on a proposal to develop a new transportation corridor of approximately 1.2 miles between 300 South Street in the City of Logan to 100 North/Providence Lane in the City of Providence, Utah. The proposed new transportation corridor would consist of a new collector road built within an 80-foot right-of-way (ROW). The proposed transportation corridor would provide a transportation link between the City of Logan and the rapidly growing commercial and residential area of Providence, facilitating the economic expansion and residential development of south Logan and north Providence on the east side of Main Street. This purpose is consistent with the City of Logan and the City of Providence general plans.
The proposed new transportation corridor with a collector road within an 80-foot ROW is included in the current Long-Range Plan and the Transportation Improvement Plan for the Logan Urbanized Area (LUA). The Cache Metropolitan Planning Organization's (CMPO) Long-Range Plan and the Transportation Improvement Plan for the Logan Urbanized Area (LUA). The Cache Metropolitan Planning Organization's (CMPO) Long-Range Plan has identified the proposed new collector road on approximately 100 East Street as one of the highest priorities in preserving and improving transportation mobility within the LUA.
Alternatives under consideration include (1) taking no action, (2) using transportation system management strategies that would provide for transportation efficiency within the existing transportation network, and (3) constructing the new collector road on one of several alignments. These alignments could require widening existing roadways in south Logan, and would also require entirely new ROW for large segments of the alignments. Design variations of grade and alignment will be incorporated into, and analyzed with, the various build alternatives.
Information letters describing the proposed action and soliciting comments on the proposed project will be sent to appropriate Federal, State and local agencies, as well as to private organizations and individuals who have previously expressed, or that are expected to be interested, in the proposed project. An initial public scoping meeting will be held in the City of Logan during late August or September 2004. Notice of additional public meetings to present information and solicit comments relative to alternatives for consideration and possible impacts will be given as the proposed project proceeds. Upon release of the draft EIS for public and agency review and comment, public notice will be given of the time and place for a public hearing to be held to receive comments. The draft EIS will be available for public and agency review and comment for no less than two weeks prior to the public hearing.
To ensure that the full range of issues related to this proposed action are addressed and all significant issues are identified, comments and suggestions are invited from all interested parties. Comments or questions concerning this proposed action and the EIS should be directed to the FHWA or UDOT at the addresses provided above.
Coupled Products, Inc. (Coupled Products) has determined that certain hydraulic brake hose assemblies that it produced do not comply with S5.3.4 of 49 CFR 571.106, Federal Motor Vehicle Safety Standard (FMVSS) No. 106, “Brake hoses.” Coupled Products has filed an appropriate report pursuant to 49 CFR part 573, “Defect and Noncompliance Reports.”
Pursuant to 49 U.S.C. 30118(d) and 30120(h), Coupled Products has petitioned for an exemption from the notification and remedy requirements of 49 U.S.C. chapter 301 on the basis that this noncompliance is inconsequential to motor vehicle safety.
This notice of receipt of Coupled Product's petition is published under 49 U.S.C. 30118 and 30120 and does not represent any agency decision or other exercise of judgment concerning the merits of the petition.
A total of approximately 24,622 brake hose assemblies, consisting of 3,092 assemblies bearing Part Number 5478 and 21,530 assemblies bearing Part Number 5480 are affected. S5.3.4 of FMVSS No. 106, tensile strength, requires that “a hydraulic brake hose assembly shall withstand a pull of 325 pounds without separation of the hose from its end fittings.” The potentially affected hoses were manufactured using a “straight cup” procedure rather than the appropriate “step cup” procedure. Compliance testing by the petitioner of eight sample hose assemblies from two separate manufacturing lots of these hoses revealed that seven of the eight samples experienced hose separation from the end fittings at from 224 to 317 pounds.
Coupled Products believes that the noncompliance is inconsequential to motor vehicle safety and that no corrective action is warranted. Coupled Products states that these hoses were shipped exclusively to EZ Loader, a manufacturer of boat trailers, the sole customer of the affected hoses. Coupled Products states:
Both Part Numbers 5478 and 5480 are utilized in specific boat trailer applications of a single trailer manufacturer. * * * [T]he routing and placement of the hoses on the particular boat trailers involved, and the shielded nature of the end fittings on those trailers are such that a linear, end-to-end “straight pull” on the hose assembly, such as that specified in the FMVSS No. 106 tensile strength test procedure, is unlikely to occur in real-world use. Because of the manner in which these hose assemblies are installed, rather than a “straight pull,” it is more likely that the free length of the hose itself could be entangled or caught on a piece of road debris or other obstruction, resulting in a “side pull” on the assembly. With this potential in mind, [Coupled Products] conducted a side pull tensile test on a sample of the subject brake hose assemblies to simulate the possible effect of a side pull on the integrity of the assembly. This was accomplished by creating special mounting fixtures and apparatus to the standard testing equipment. * * * The “side pull” test results show that the tensile load achieved prior to the ends separating from the hose exceeded 530 pounds in each of the five samples tested—well in excess of the 325 pound requirement.
Coupled Products further states:
We believe that it is likely that in order for such a [side] pull to occur, the debris or obstacle in question would need to be of such size and/or weight that its encounter with the trailer would result in significant structural impact and thus have immediate effect on the operation of the trailer. While we have not been able to devise a test that would verify this theory, we believe that this is a realistic scenario. As a result, it seems likely that the trailer would likely incur an operational impact even before the possible loss of braking capability resulting from hose assembly failure.
The axles used in the trailers in question are stationary. Unlike sliding axles that are used in some trailers, the axles used in these trailers are in a fixed location. Consequently, the possibility that the sliding movement of the axle might result in unintended pull on the hose is remote. * * *
Because the braking system on the trailer is independent of the towing vehicle's braking system, any failure of the hose assembly due to excessive tensile force—unlikely as that may be—will not result in a loss of braking capability of the towing vehicle. Thus, in the unlikely event of separation, the driver would still retain full braking capability of the towing vehicle and would be able to stop the vehicle (although additional stopping distance may be required depending on the type of vehicle being used).
Coupled Products states that in other cases NHTSA determined that a FMVSS No. 106 noncompliance is inconsequential where, because of the specific vehicle application involved, the hose assembly would not be subject to the type of forces specified in the standard. Coupled Product says:
Coupled Products states it cannot estimate the percentage of the affected population that may be noncompliant, but the test results indicate that it is likely to be less than 100 percent. Coupled Products indicates that the problem has been corrected.
Interested persons are invited to submit written data, views, and arguments on the petition described above. Comments must refer to the docket and notice number cited at the beginning of this notice and be submitted by any of the following methods. Mail: Docket Management Facility, U.S. Department of Transportation, Nassif Building, Room PL-401, 400 Seventh Street, SW., Washington, DC 20590-0001. Hand Delivery: Room PL-401 on the plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC. It is requested, but not required, that two copies of the comments be provided. The Docket Section is open on weekdays from 10 a.m. to 5 p.m. except Federal holidays. Comments may be submitted electronically by logging onto the Docket Management System Web site at
The petition, supporting materials, and all comments received before the close of business on the closing date indicated below will be filed and will be considered. All comments and supporting materials received after the closing date will also be filed and will be considered to the extent possible. When the petition is granted or denied, notice of the decision will be published in the
The Department of Treasury has submitted the following public information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Copies of the submission(s) may be obtained by calling the Treasury Bureau Clearance Officer listed. Comments regarding this information collection should be addressed to the OMB reviewer listed and to the Treasury Department Clearance Officer, Department of the Treasury, Room 11000, 1750 Pennsylvania Avenue, NW., Washington, DC 20220.
Written comments should be received on or before September 7, 2004 to be assured of consideration.
Internal Revenue Service (IRS), Treasury.
Correction to notice and request for comments.
This document corrects a notice and request for comments that was published in the
Allan Hopkins, (202) 622-6665 (not a toll-free number).
The notice and request for comments that is the subject of this correction is required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)).
As published, the notice and request for comments contains an error that may prove to be misleading and is in need of clarification.
Accordingly, the notice and request for comments which was the subject of FR Doc. 04-16968, is corrected as follows:
On page 44567, column 2, under the caption
In proposed rule document 04-16575 beginning on page 45460 in the issue of Thursday, July 29, 2004, make the following correction:
On page 45465, in the table, in the column “Equipment type”, in the final entry, the phrase, “(Cooling Mode)” should read, “(Heating Mode).”
In notice document 04-15551 beginning on page 41327 in the issue of Thursday, July 8, 2004 make the following correction:
On page 41328, in the second column, in the first full paragraph, in the last line, “1,000 feet” should read “100 feet”.
Centers for Medicare & Medicaid Services (CMS), HHS.
Proposed rule.
This proposed rule would refine the resource-based practice expense relative value units (RVUs) and make other changes to Medicare Part B payment policy. The proposed policy changes concern: supplemental survey data for practice expense, updated geographic practice cost indices for physician work and practice expense, updated malpractice RVUs, revised requirements for supervision of therapy assistants, revised payment rules for low osmolar contrast media, changes to payment policies for physicians and practitioners managing dialysis patients, clarification of care plan oversight requirements, revised requirements for supervision of diagnostic psychological testing services, clarifications to the policies affecting therapy services, revised requirements for assignment of Medicare claims, addition to the list of telehealth services, and several coding issues.
We are proposing these changes to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. We solicit comments on these proposed policy changes.
This proposed rule also addresses the following provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA): coverage of an initial preventive physical examination; coverage of cardiovascular screening blood tests; coverage of diabetes screening tests; incentive payment improvements for physicians in shortage areas; payment for covered outpatient drugs and biologicals; payment for renal dialysis services; coverage of routine costs associated with certain clinical trials of category A devices as defined by the Food and Drug Administration; hospice consultation service; indexing the Part B deductible to inflation; extension of coverage of intravenous immune globulin (IVIG) for the treatment in the home of primary immune deficiency diseases; revisions to reassignment provisions; clinical conditions for payment of covered items of durable medical equipment; and payment for diagnostic mammograms.
In addition, we discuss physicians' services associated with drug administration services and payment for set-up of portable x-ray equipment.
To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on September 24, 2004.
In commenting, please refer to file code CMS-1429-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
You may submit comments in one of three ways (no duplicates, please):
1.
2.
3.
Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.
For information on viewing public comments, see the beginning of the
This
Information on the physician fee schedule can be found on the CMS homepage. You can access this data by using the following directions:
1. Go to the CMS homepage (
2. Place your cursor over the word “Professionals” in the blue area near the top of the page. Select “physicians” from the drop-down menu.
3. Under “Policies/Regulations” select “Physician Fee Schedule.”
To assist readers in referencing sections contained in this preamble, we are providing the following table of contents. Some of the issues discussed in this preamble affect the payment policies but do not require changes to the regulations in the Code of Federal Regulations. Information on the regulation's impact appears throughout the preamble and is not exclusively in section VII.
In addition, because of the many organizations and terms to which we refer by acronym in this proposed rule, we are listing these acronyms and their corresponding terms in alphabetical order below:
Since January 1, 1992, Medicare has paid for physicians' services under section 1848 of the Social Security Act (the Act), “Payment for Physicians' Services.” The Act requires that payments under the fee schedule be based on national uniform relative value units (RVUs) based on the resources used in furnishing a service. Section 1848(c) of the Act requires that national RVUs be established for physician work, practice expense, and malpractice expense. Section 1848(c)(2)(B)(ii)(II) of the Act provides that adjustments in RVUs may not cause total physician fee schedule payments to differ by more than $20 million from what they would have been had the adjustments not been made. If adjustments to RVUs cause expenditures to change by more than $20 million, we must make adjustments to ensure that they do not increase or decrease by more than $20 million.
The July 2000 and August 2003 proposed rules ((65 FR 44177) and (68 FR 49030), respectively), include a summary of the final physician fee schedule rules published through February 2003.
In the November 7, 2003 final rule, we refined the resource-based practice expense RVUs and made other changes to Medicare Part B payment policy. The specific policy changes concerned: The Medicare Economic Index; practice expense for professional component services; definition of diabetes for diabetes self-management training; supplemental survey data for practice expense; geographic practice cost indices; and several coding issues. In addition, this rule updated the codes subject to the physician self-referral prohibition. We also made revisions to the sustainable growth rate, the anesthesia conversion factor and finalized the CY 2003 interim RVUs and issued interim RVUs for new and revised procedure codes for CY 2004.
As required by the statute, we announced that the physician fee schedule update for CY 2004 would be −4.5 percent; the initial estimate of the sustainable growth rate for CY 2004 was 7.4 percent; and the conversion factor for CY 2004 was $35.1339.
Subsequent to the November 7, 2003 final rule, the Congress enacted the MMA (Pub. L. 108-17). On January 7, 2004, an interim final rule was published to implement provisions of the MMA applicable in 2004 to Medicare payment for covered drugs and physician fee schedule services. These provisions included—
• Revising the current payment methodology for Part B covered drugs and biologicals that are not paid on a cost or prospective payment basis;
• Making changes to Medicare payment for furnishing or administering drugs and biologicals;
• Revising the geographic practice cost indices;
• Changing the physician fee schedule conversion factor. The 2004 physician fee schedule conversion factor is $37.3374; and
• Extending the “opt-out” provisions of section 1802(b)(5)(3) of the Act to dentists, podiatrists, and optometrists.
The information contained in the January 7, 2004 interim final rule concerning payment under the physician fee schedule superceded information contained in the November 7, 2003 final rule to the extent that the two are inconsistent.
This proposed rule would affect the regulations set forth at Part 405, Federal Health Insurance for the Aged and Disabled; Part 410, Supplementary Medical Insurance (SMI) Benefits; Part 411, Exclusions from Medicare and Limitations on Medicare Payment; Part 414, Payment for Part B Medical and Other Health Services; Part 418, Hospice Care; Part 424, Conditions for Medicare Payment; Part 484, Home Health Services; and Part 486, Conditions for Coverage of Specialized Services Furnished by Suppliers.
Section 121 of the Social Security Act Amendments of 1994 (Pub. L. 103-432), enacted on October 31, 1994, amended section 1848(c)(2)(C)(ii) of the Social Security Act and required us to develop a methodology for a resource-based system for determining practice expense RVUs for each physician's service beginning in 1998. Until that time, physicians' practice expenses were established based on historical allowed charges.
In developing the methodology, we were to consider the staff, equipment, and supplies used in providing medical and surgical services in various settings. The legislation specifically required that, in implementing the new system of practice expense RVUs, we apply the same budget-neutrality provisions that we apply to other adjustments under the physician fee schedule.
Section 4505(a) of the Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33), enacted on August 5, 1997, amended section 1848(c)(2)(C)(ii) of the Act and delayed the effective date of the resource-based practice expense RVU system until January 1, 1999. In addition, section 4505(b) of the BBA provided for a 4-year transition period from charge-based practice expense RVUs to resource-based RVUs.
Further legislation affecting resource-based practice expense RVUs was included in the Medicare, Medicaid and State Child Health Insurance Program (SCHIP) Balanced Budget Refinement Act of 1999 (BBRA) (Pub. L. 106-113)
In the November 2, 1998 final rule (63 FR 58910), effective with services furnished on or after January 1, 1999, we established at 42 CFR 414.22(b)(5) a new methodology for computing resource-based practice expense RVUs that used the two significant sources of actual practice expense data we have available—the Clinical Practice Expert Panel (CPEP) data and the American Medical Association's (AMA) Socioeconomic Monitoring System (SMS) data. The CPEP data were collected from panels of physicians, practice administrators, and nonphysicians (for example registered nurses) nominated by physician specialty societies and other groups. The CPEP panels identified the direct inputs required for each physician service in both the office setting and out-of-office setting. The AMA's SMS data provided aggregate specialty-specific information on hours worked and practice expenses. The methodology was based on an assumption that current aggregate specialty practice costs are a reasonable way to establish initial estimates of relative resource costs for physicians' services across specialties. The methodology allocated these aggregate specialty practice costs to specific procedures and, thus, can be seen as a “top-down” approach.
Also in the November 2, 1998 final rule, in response to comments, we discussed the establishment of the Practice Expense Advisory Committee (PEAC) of the AMA's Specialty Society Relative Value Update Committee (RUC), which would review code-specific CPEP data during the refinement period. This committee would include representatives from all major specialty societies and would make recommendations to us on suggested changes to the CPEP data.
As directed by the BBRA, we also established a process (
A brief discussion of the major steps involved in the determination of the practice expense RVUs follows.
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(i) Direct costs—For direct costs (which include clinical labor, medical supplies, and medical equipment), we used the procedure-specific CPEP data on the staff time, supplies, and equipment as the allocation basis. For the separate practice expense pool for services without physician work RVUs, we have used, on an interim basis, 1998 practice expense RVUs to allocate the direct cost pools.
(ii) Indirect costs—To allocate the cost pools for indirect costs, including administrative labor, office expenses, and all other expenses, we used the total direct costs, or the 1998 practice expense RVUs, in combination with the physician fee schedule work RVUs. We converted the work RVUs to dollars using the Medicare CF (expressed in 1995 dollars for consistency with the SMS survey years).
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As an interim measure, until we could further analyze the effect of the top-down methodology on the Medicare payment for services with physician work RVUs equal to zero (including the technical components of radiology services and other diagnostic tests), we created a separate practice expense pool. We first used the average clinical staff time from the CPEP data and the “all physicians” practice expense per hour to create the pool. In the December 2002 final rule, we changed this policy and now use the total clinical staff time and the weighted average specialty-specific practice expense per hour for specialties with services in this pool. In the next step, we used the adjusted 1998 practice expense RVUs to allocate this pool to each service. Also, for all radiology services that are assigned physician work RVUs, we used the adjusted 1998 practice expense RVUs for radiology services as an interim measure to allocate the direct practice expense cost pool for radiology.
A specialty society may request that its services be removed from the nonphysician workpool. We have removed services from the nonphysician work pool if the requesting specialty predominates utilization of the service.
Since many specialties identified in our claims data did not correspond exactly to the specialties included in the SMS survey data, it was necessary to crosswalk these specialties to the most appropriate SMS specialty.
Because we believe that most physical therapy services furnished in physicians' offices are performed by physical therapists, we crosswalked all utilization for therapy services in the CPT 97000 series to the physical and occupational therapy practice expense pool.
As required by the BBRA, we established criteria to evaluate survey data collected by organizations to supplement the SMS survey data normally used in the calculation of the practice expense component of the physician fee schedule. By regulation (see 68 FR 63200), we provided that, beginning this year, supplemental survey data must be submitted by March 1 to be considered for use in computing practice expense RVUs for the following year. This allows us to publish our decisions regarding survey data in the proposed rule and provides the opportunity for public comment on these results before implementation.
To continue to ensure the maximum opportunity for specialties to submit supplemental practice expense data, we extended until 2005 the period that we would accept survey data that meet the criteria set forth in the November 2000 final rule. We will no longer accept supplemental practice expense data after that point. The deadline for submission of supplemental data to be considered in CY 2006 is March 1, 2005.
In the June 28, 2002
We received surveys from the American College of Cardiology (ACC), the American College of Radiology (ACR), and the American Society for Therapeutic Radiation Oncology (ASTRO). Our contractor, The Lewin Group, evaluated the data and made recommendations to us regarding use of the data in a report on May 26, 2004. We have made The Lewin Group report available on the CMS Web site at
Many of the procedures that are performed by radiology, cardiology, and radiation oncology are affected by the nonphysician work pool calculations. We created the nonphysician work pool as an interim measure because of a concern that the top-down methodology was having a large adverse impact on payment for services that do not have physician work RVUs. As we stated in the December 31, 2002 final rule (67 FR 79979), we believe a relatively low practice expense per hour explains the adverse impact on diagnostic and other services that would occur from eliminating the nonphysician work pool. The ACR, ACC, and ASTRO began undertaking surveys in 2003 following our analysis of options for eliminating the nonphysician work pool in the December 31, 2002 final rule. CMS’ interest is in using the supplemental survey data to eliminate the nonphysician work pool and use a single methodology to establish payments for all physician fee schedule services.
We appreciate the efforts of these three specialties to undertake surveys and assist CMS in finding a permanent resolution of issues related to the nonphysician work pool. While the radiology survey data do meet the criteria we have established for use of supplemental surveys, the ACR has written to us asking that we not use the data until we have a stable and global solution that is workable for all specialties that are currently paid using the nonphysician work pool. The ACC also requested that we use the supplemental survey for services that are in the cardiology pool. However, ACC also indicated if CMS determines that it would only be appropriate to use the survey data if cardiology services are removed from the nonphysician work pool or if the nonphysician work pool
At this time, we are not proposing to eliminate the nonphysician work pool or to remove selected radiology and cardiology codes from it. Since our interest is in using supplemental data in conjunction with pricing all services under the top-down methodology, we agree with the request from ACR to delay use of its supplemental survey until issues related to the nonphysician work pool can be addressed. Furthermore, we believe the high practice expense per hour for cardiology from the supplemental survey results from the inclusion of practices that do very high cost office-based cardiology services. Because the RVUs for these office-based cardiology services are currently determined using the nonphysician work pool methodology, we believe the ACC supplemental survey data should only be used in conjunction with removing cardiology services from the nonphysician work pool. For this reason, we are also delaying use of the ACC survey data as we continue to analyze elimination of the nonphysician work pool in conjunction with using supplemental survey data. As we complete our analysis, we look forward to working with the medical community to find a permanent resolution of this issue.
Since 1999, the PEAC, an advisory committee of the RUC, has been providing us with recommendations for refining the direct practice expense inputs (clinical staff, supplies, and equipment) for existing CPT codes. As we did last year, we are including our proposals regarding the PEAC recommendations in the proposed rule, to enable specialty groups to assess the impact of the proposed changes on their services and to make comments on them before the final rule.
These PEAC recommendations are the result of meetings held in March and August 2003 and January and March 2004, and account for over 2,200 codes from many specialties. (A list of these codes can be found in Addendum C.)
The PEAC held its last meeting in March 2004, and these are the last recommendations we will be receiving from the committee. The AMA established the PEAC to assist the RUC in refining the direct input data used in calculating the practice expense RVUs for established codes. Since its inception, the PEAC has provided recommendations on over 7,600 codes, which leaves only a few hundred physician fee schedule codes that we believe are still unrefined. The PEAC has also recommended standard times for many clinical staff activities and has established several supply and equipment packages that can be applied across wide ranges of codes. This has helped us ensure that the CPEP inputs have been assigned equitably across procedures performed by different specialties. The work of the PEAC has, therefore, contributed greatly to the refinement of the practice expense inputs, and we appreciate the 5 years of hard work by the specialty societies and the AMA that helped make the PEAC so successful. Future practice expense issues, including the refinement of the remaining codes not addressed by the PEAC, will be handled by the RUC. We anticipate the RUC will formulate the specific process at a future meeting, possibly as soon as October 2004. If possible, additional information on this process will be included in the final fee schedule rule.
We have reviewed the PEAC-submitted recommendations and propose to adopt nearly all of them. We have worked with the PEAC staff to correct any typographical errors and to make certain that the recommendations are in line with previously accepted standards. In addition, in order to prevent rank order anomalies, we reviewed those codes that are currently unrefined or that were refined early in the PEAC process to apply some of the major PEAC-agreed standards. For the unrefined 10-day global services, we are proposing to substitute for the original CPEP times the PEAC-agreed standard post-service office visit clinical staff times used for all 90-day and refined 10-day global services. We also are proposing to eliminate the discharge management clinical staff time from all but the 10 and 90-day global codes, substituting one post-service phone call if not already in the earlier data. Lastly, we are proposing to delete any extra clinical staff time for post-visit phone calls because that time is already included in the time allotted for the visits.
The complete PEAC recommendations and the revised practice expense database can be found on our web site. (See the “Supplementary Information” section of this proposed rule for directions on accessing our website.)
We disagree with the PEAC recommendation for clinical labor time for CPT 99183, Hyperbaric oxygen (HBO) therapy. During last year's rulemaking, we assigned, on an interim basis, 135 minutes of total clinical labor. The PEAC however, recommended 42 minutes of total clinical labor time, which allows for 20 minutes for the HBO chamber treatment (intra) time. We believe that 90 minutes is a more appropriate estimation of the clinical staff time actually needed for the intra time because, according to our data, a typical HBO treatment session billed under the outpatient prospective payment system is 90 minutes and the clinical staff is in constant attendance. Therefore, we are proposing a total clinical labor time of 112 minutes for this service.
The PEAC recommendations for CPT codes 91011 and 91052 included a supply input for methacholine chloride as the injected stimulant for these two services. In discussions with representatives from the gastroenterology specialty subsequent to receipt of the PEAC recommendations, we learned this is incorrect, since an injected form of methacholine chloride is not currently available. For CPT 91011, esophageal motility study, we are proposing to include edrophonium, 1 ml, as the drug typically used in this procedure. For CPT 91052, gastric analysis study, we were unable to identify the single drug that is most typically used with this procedure. We have added the edrophonium to the list of supplies where we need information from the specialty in order to price appropriately (see Table 3). We are also requesting that commenters, particularly the specialty organizations, provide us with information on the drug that is most typically used for CPT 91052, including drug dosage and price, so that it can be included in the practice expense database.
In last year's final rule, we indicated that we would not go forward with the 2003 PEAC recommendations on eight E/M codes for nursing home services, CPT codes 99301 through 99316 and on two E/M codes for home visits, CPT codes 99348 and 99350, to allow the PEAC to reconsider the clinical staff time for these codes based on the specific input from the representatives of the nursing home and home visit specialties. This year's PEAC recommendations for the E/M nursing home services included the views of the long-term care physicians and represent an overall decrease in clinical labor inputs for these codes. However, the home care physicians subsequently withdrew these codes from further PEAC consideration, which leaves the 2003 PEAC recommendation for these services unchanged. Therefore, we are proposing to adopt the direct practice expense input recommendations from
We use the practice expense inputs (the clinical staff, supplies, and equipment assigned to each procedure) to allocate the specialty-specific practice expense cost pools to the procedures performed by each specialty. The costs of the original equipment inputs assigned by the CPEP panels were determined in 1997 by our contractor, Abt Associates, based primarily on list prices from equipment suppliers. Subsequent to the CPEP panels, equipment has also been added to the CPEP data, with the costs of the inputs provided by the relevant specialty society. We only include equipment with costs equal to or exceeding $500 in our practice expense database because the cost per use for equipment costing less than $500 would be negligible. We also considered the useful life of the equipment in establishing an equipment cost per minute of use. This was discussed in our proposed rule published June 18, 1997 (62 FR 33164). The primary source of this information was the “Estimated Useful Lives of Depreciable Hospital Assets” (1993 edition) from the American Hospital Association (AHA).
We proposed updates and revisions to the clinical staff salary data and supply inputs and finalized these in the rules published November 1, 2001 (66 FR 55255) and November 7, 2003 (68 FR 63196), respectively. We also indicated that, in future rulemaking, we would be proposing updates to the equipment inputs that are used in the CPEP database.
We contracted with a consultant to assist us in obtaining the current price for each equipment item in our CPEP database. The consultant has been able to determine the current prices for most of the equipment inputs and, to ensure that accurate information was obtained, has submitted documentation from vendor catalogs or websites for nearly 600 equipment items.
Our contractor also clarified the specific composition of each of the various packaged and standardized rooms or ophthalmology “lanes” currently identified in the equipment practice expense database (for example, “mammography room” or “exam lane”). We are proposing to delete the current “room” designation for the radiopharmaceutical receiving area and, in its place, list separately the equipment necessary for each procedure as individual line items because there does not appear to be a standard configuration for such a room across the nuclear medicine codes.
Although individual equipment items valued under $500 are not included in the equipment database, we do include instrument packs or surgical trays that are maintained, stored, and used as a unit, where the aggregate cost of individual items equals or exceeds $500. We have adopted the PEAC recommendation based on consensus among specialties to establish two generic instrument packages rather than list a myriad of different packages for each specialty. The basic instrument pack, assigned a value of $500, includes instrument aggregate costs ranging from $500 to $1,499. The medium pack was assigned $1,500, for instrument packages priced at or above $1,500. We are proposing to replace all surgical packs and trays in the practice expense database with the appropriate standardized packs described above.
Our consultant worked closely with the specialty societies to obtain accurate information to identify equipment and applicable prices. The useful life for each equipment item has also been reviewed and updated as necessary. This update is primarily based on the AHA's “Estimated Useful Lives of Depreciable Hospital Assets” (1998 edition) by direct association with a listed item in the publication or by crosswalking from a reasonably similar item. We understand that AHA will publish updated guidelines this summer, and we plan to reflect any updates in our final rule.
Addendum D lists the proposed new prices for equipment items, instrument packs, and rooms/lanes, as well as new descriptions when needed. A more detailed spreadsheet can be found on our website,
Additionally, there are specific equipment items for which a source has not yet been identified or for which pricing information has not yet been found and documented. These are included in Table 2 below. In this table, we have identified the equipment code (if assigned), the existing description for the equipment item and current price, the procedures or specialties associated with the item, as well as the proposed new description and standardized life for the equipment's use, where this could be identified. We have also identified equipment for deletion from the database, such as equipment items less than $500 and items that have become obsolete. We are requesting that commenters, particularly the relevant specialty groups, provide us with the needed pricing information, including appropriate documentation. Whenever possible, commenters should provide multiple sources of documentation so that a typical price can be determined. If we are not able to obtain any verified pricing information for an item, we may eliminate it from the database.
In addition to reviewing and updating the cost information for equipment items in the database, our contractor also recommended the following revisions to provide uniformity and consistency in the CPEP equipment database. All of the following recommendations are noted in Addendum D:
These categories could also be used to establish a new numbering system for equipment that would more clearly identify them for practice expense purposes. We would assign a letter to each category and use this in conjunction with a number (000 through 999) to identify each item of equipment. This would enable specialty groups to identify more easily whether an item of equipment has already been included in the practice expense database and would help avoid duplication of references to the same item of equipment under different descriptions. If we proceed in the final rule with this proposed method for categorizing equipment, we will assign new identifying numbers to each equipment input item and these will be available on our website.
When items appear to be duplicative, we are proposing to combine the items. For example, for two cervical endoscopy procedures, our contractor identified that the price of the LEEP system includes a smoke evacuation system but that system is also listed separately. We propose to merge these two line items and reflect both prices in the price of the LEEP system. All proposed changes are specifically referenced in Addendum D.
We welcome any comments on the proposed pricing and all other proposed revisions. To help us evaluate the information provided, comments should include documentation from more than one source, where available, such as information from a vendor catalog or website or from a current invoice.
We received comments from a specialty organization on our November 7, 2003 rule stating that the $72.90 price assigned to the Seldinger needle, which is used in certain radiological procedures, is too high. The organization estimated that the cost is actually closer to $7.00; however, documentation was not provided to
We received requests from a manufacturer and physicians to price CPT code 56853, Hysteroscopy with endometrial ablation, in the office setting so that physicians providing this service in the nonfacility setting could receive an appropriate payment. (This service is currently valued only in the facility setting.) We have worked with the specialty society, the American College of Obstetricians and Gynecologists, to identify the required resources based on the typical practice. We propose to assign on an interim basis, the following direct practice expense inputs in the nonfacility setting for this service.
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We will request that the RUC review these inputs along with inputs of other codes still in need of refinement. iii. Photopheresis
We received a request from a supplier to review the direct practice expense inputs currently in our database for the photopheresis service, CPT code 36522. These inputs are based on the original CPEP panel recommendations and the supplier does not believe they are reflective of the resources now being used. This service was not reviewed by the PEAC during the refinement process, and we agree that the direct inputs need to be revised for this service. We propose to assign, on an interim basis, the following nonfacility practice expense inputs, and we will request that the RUC review them as part of the practice expense refinement process.
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As part of last year's rulemaking process, we reviewed and updated the prices for supply items in our practice expense database. During subsequent meetings of both the PEAC and the RUC, supply items were added that were not included in the supply pricing update. The following table, Proposed Practice Expense Supply Item Additions for 2005, lists these additional supply items and the proposed associated prices that we will use in the practice expense calculation.
We have identified certain supply items for which we were unable to verify the pricing information (see Table 4, Supply Items Needing Specialty Input for Pricing). Therefore, we are requesting commenters, particularly specialty organizations, to provide pricing information on items in this table along with documentation to support the recommended price. In addition, we are seeking information on the specific contents of the listed kits, so that we do not duplicate any supply items.
We received a request from a pathology society to add a DNA probe to the CPEP database for CPT 88365, tissue in situ hybridization. The society specified that 1.5 DNA probes are typically used in this service and the cost of one probe is $42.65. Documentation supporting this price was also provided. We are proposing to add, on an interim basis, this supply to the practice expense database with the understanding that the inclusion of the item will be subject to forthcoming RUC review.
In the CPEP equipment data for many of the ophthalmology procedures, there is a duplication of time assigned to the screening lane and exam lane. In a majority of these identified procedures, the same timeframe was assigned to both the screening and exam lanes. While some of the procedures had not been refined by the PEAC, others were refined early on in the PEAC process before the PEAC agreed to assign only one equipment lane to each procedure because a patient can be in only one room at a time. In cases where both the screening and exam lanes are included, we are proposing to adjust the lane assignment by defaulting to the exam lane and, thus, we will delete the screening lane from these procedures. For all of the above services where a lane change was made, time values were assigned to the exam lane in accordance with our established standard procedure. We are asking commenters, in particular, organizations representing ophthalmology, to review these proposed changes and submit specific comments on the appropriateness of the exam lane default.
We received comments from the RUC and the specialty society representing nuclear medicine that the practice expenses for CPT 78070, parathyroid imaging, which is valued in the nonphysician work pool, are too low. Because this procedure involves multiple imaging sessions, the organizations have requested that a different crosswalk of charge-based RVUs be used to more appropriately value the practice expenses involved with CPT 78070. We agree and are proposing to crosswalk the charge-based RVUs from CPT 78306, whole body imaging, to this procedure.
The Social Security Act (the Act) requires that payments vary among physician fee schedule areas according to the extent that resource costs vary as measured by the Geographic Practice Cost Indices (GPCIs). In general, the fee schedule areas that existed under the prior reasonable charge system were retained under the physician fee schedule from calendar years 1992 to 1996. We implemented a comprehensive revision in the physician fee schedule payment areas (localities) in 1997, reducing the number of localities from 210 to 89. A detailed discussion of physician fee schedule areas can be found in the July 2, 1996 proposed rule (61 FR 34615) and the November 22, 1996 final rule (61 FR 59494).
We are required by section 1848(e)(1)(A) of the Act to develop separate GPCIs to measure resource cost differences among localities compared to the national average for each of the three fee schedule components. While requiring that the practice expense and malpractice GPCIs reflect the full relative cost differences, section 1848(e)(1)(A)(iii) of the Act requires that the physician work GPCIs reflect only one-quarter of the relative cost differences compared to the national average.
Section 1848(e)(1)(C) of the Act requires us to review and, if necessary, to adjust the GPCIs at least every 3 years. This section of the Act also requires us to phase-in the adjustment over 2 years and implement only one-half of any adjustment if more than 1 year has elapsed since the last GPCI revision. The GPCIs were first implemented in 1992. The first review and revision was implemented in 1995, the second review was implemented in 1998, and the third review was implemented in 2001. This constitutes the fourth review of the work and practice expense GPCIs.
The malpractice GPCIs were reviewed and revised as part of the November 7, 2003 (68 FR 63196) physician fee schedule final rule. At the time of the publication of the November 2003 final rule, the U.S. Census data upon which the work and practice expense GPCIs are based were not yet available.
Section 412 of MMA amends section 1848(e)(1) of the Act and establishes a floor of 1.0 for the work GPCI for any locality where the GPCI would otherwise fall below 1.0. This 1.0 work GPCI floor will be used for purposes of payment for services furnished on or after January 1, 2004 and before January 1, 2007. In addition, section 602 of MMA further amended section 1848(e)(1) of the Act for purposes of payment for services furnished in Alaska under the physician fee schedule on or after January 1, 2004 and before January 1, 2006, and sets the work, practice expense, and malpractice expense GPCIs at 1.67 if any GPCI would otherwise be less than 1.67.
Based on these MMA provisions, we revised the addenda published in the November 7, 2003 final rule (68 FR 63196) that reflected both the transitional 2004 and 2005 malpractice GPCIs, as well as the work and practice expense GPCIs that were not updated (Addendum D and Addendum E, respectively) in an interim final rule with comment period entitled, “Changes to Medicare Payment for Drugs and Physician Fee Schedule Payments for Calendar Year 2004,” published January 7, 2004 (69 FR 1084). Due to the MMA provisions, no locality in these revised addenda has a work GPCI of less than 1.00. Additionally, the work, practice expense, and malpractice GPCIs for Alaska are set at 1.67.
We are proposing to revise the work and practice expense GPCIs beginning in 2005 based on updated U.S. Census data and Department of Housing and Urban Development fair market rent data.
The GPCIs were developed by a joint effort of the Urban Institute and the Center for Health Economics Research under contract to us. Indices were developed that measured the relative physician resource cost differences among areas compared to the national average in a “market basket” of goods. The market basket consists of the resources involved with operating a private medical practice. The resource inputs are—
• Physician work or net income (used to construct the physician work GPCI);
• Employee wages, office rents, medical equipment, supplies, and other miscellaneous expenses used to comprise the practice expense GPCI; and
• Professional liability insurance premiums (used to construct the malpractice GPCI).
The resource inputs and their respective weights for the resource costs associated with the work, practice expense, and malpractice expense associated with providing a physician service, were obtained from the 2003 AMA Physician Socioeconomic Characteristics publication (2003 Patient Care Physician Survey data) which measures physicians' earnings and overall practice expenses for 2000.
The weights for the 2004 GPCIs, as well as the proposed 2005 through 2007 GPCI revisions, are from the 2003 AMA survey and were used in the Medicare Economic Index (MEI) revision discussed in the November 2003 physician fee schedule final rule (68 FR 63245). Table 5 below shows the weights of the resource inputs, as defined by the MEI, those used for the original GPCIs, as well as the weights for the first, second, and third GPCI revisions. The MEI weights associated with the first and second GPCI updates (1995-2000 GPCIs) were not revised. In addition, the MEI weights for the proposed fourth GPCI revision are also shown.
As in previous GPCI updates, the median hourly earnings component is based on a 20 percent sample of U.S. Census data from workers in seven professional occupations. The actual reported earnings of physicians were not used to establish the GPCIs because Medicare payments (which are based on the GPCIs) are in part determinants of the earnings. Including physician wages in the physician work GPCI could, in effect, make the index dependent upon Medicare payments. Based upon analysis performed by Health Economics Research, we believe that in the majority of instances, the earnings of physicians will vary among areas to the same degree that the earnings of other professionals vary.
Data from the 2000 decennial U.S. Census by county of seven professional occupations (architecture and engineering; computer, mathematical, and natural sciences; social scientist, social workers, lawyers; education, library, training; registered nurses; pharmacists; writers, artists, editors) were utilized in the development of the proposed work GPCIs.
The Census Bureau has very specific criteria that tabulations must meet in order to be released to the public. To maximize the accuracy and availability of the data collection, the nonphysician professional wage data were aggregated into three geographic area categories:
1. By Individual Counties—The tabulations were requested for each county in a Consolidated Metropolitan Statistical Area (CMSA).
2. By Metropolitan Statistical Area (MSA)—The tabulations were requested by MSA for all counties that fall within an MSA.
3. By Rest of State—The tabulations were requested by rest of State for counties that are not in a CMSA or MSA.
The nonphysician professional wage data were subsequently assigned to each respective county within the MSA or Rest of State aggregations (or, in the case of CMSAs, the data were already at the county level), and a median wage by county was calculated for each occupational category. These median wages were then weighted by the total RVUs associated with a given county to ultimately arrive at locality-specific work GPCIs. This geographic aggregation of Census data is the same methodology that was utilized in previous updates to the GPCIs.
The work GPCIs reflect one-fourth of the relative cost differences, as required by statute, with the exception of those areas where MMA requires that the GPCI be set at no lower than 1.00 and that the Alaska GPCIs be set at 1.67.
As in the past, we are proposing that the practice expense GPCI would be comprised of several factors that represent the major expenses incurred in operating a physician practice. The factors and the data sources we propose to use are detailed below. The impact of each individual factor on the calculation of the practice expense GPCI is based on the relative weight for that factor consistent with the calculation of the MEI.
As with the current practice expense GPCIs, the Department of Housing and Urban Development (HUD) Fair Market Rental (FMR) data for the residential rents were again used as the proxy for physician office rents. The proposed 2005 through 2007 practice expense GPCIs reflect the final fiscal year 2004 HUD FMR data. See Addendum E for a more detailed illustration of the actual office rent indices.
We believe that the FMR data remain the best available source for constructing the office rent index. The FMR data are available for all areas, are updated annually, and retain consistency from area-to-area and from year-to-year. Additionally, physicians frequently locate their offices in areas that are residential, rather than commercial, in nature. Residential rates may, in fact, be a better measure of the differences among areas in the physician office market than a general commercial rental index. In developing FMRs for metropolitan areas, HUD assumes that all counties within an MSA have the same rent. However, we believe that the rents in the New York City MSA vary too widely and propose that the FMR for this metropolitan area should be adjusted to account for this variation. For the New York City MSA, we used median gross rent from the 2000 Census to adjust the individual rents within counties in this MSA.
A reduction in an area's rent index does not necessarily mean that rents have gone down in that area since the last GPCI update. Since the GPCIs measure area costs compared to the national average, a decrease in an area's rent index means that that area's rental costs are lower relative to the national average rental costs. Addendum E illustrates the changes in the rental index based upon the new FMR data.
The malpractice GPCIs were reviewed and revised as part of the November 7, 2003 (68 FR 63196) physician fee schedule final rule. Please refer to that
All three of the indices for a specific fee schedule locality are based on the indices for the individual counties within the respective fee schedule localities. As has been done in the past, fee schedule RVUs would again be used to weight the county indices (to reflect volumes of services within counties) when mapping to fee schedule areas and in constructing the national average indices. However, we propose to use more recent data, 2002 versus 1998 RVUs, in the county, locality, and national mapping in the proposed GPCIs. The payment effect associated with the use of these revised RVUs would generally be negligible, in most cases resulting in changes at the third decimal point, if at all.
Fee schedule payments are the product of the RVUs, the GPCIs, and the conversion factor. Updating the GPCIs changes the relative position of fee schedule areas compared to the national average. Since the changes represented by the proposed GPCIs could result in total payments either greater than or less than what would have been paid if the GPCIs were not updated, it would be necessary to apply scaling factors to the proposed GPCIs to ensure budget neutrality (prior to applying the provisions of MMA that change the work GPCIs to a minimum of 1.0 and increase the Alaska GPCIs to 1.67 because these provisions are exempted from budget neutrality). We determined that the proposed work and practice expense GPCIs would have resulted in slightly higher total national payments. Since the law requires that each individual component of the fee schedule—work, practice expense, and malpractice expense—is separately adjusted by its respective GPCI, we propose to scale each of the GPCIs separately. To ensure budget neutrality prior to applying the MMA provisions, it would be necessary to—
• Decrease the proposed work GPCI by 0.9965;
• Decrease the proposed practice expense GPCI by 0.9930; and
• Increase the malpractice GPCIs that were published in the November 7, 2003 final rule by 1.0021.
As all geographic payment areas would receive the same percentage adjustments, the adjustments do not change the new relative positions among areas indicated by the proposed GPCIs. After the appropriate scaling factors are applied, the MMA provision setting a 1.0 floor would be applied to all work GPCIs falling below 1.0. Additionally, the GPCIs for Alaska would all be set to 1.67 in accordance with MMA.
The locality specific effect of these proposed revisions to the work and practice expense GPCIs, as well as the revisions to the malpractice GPCIs published in the November 7, 2003 final rule, and the MMA provisions enacted December 8, 2003, are shown in Addendum F through Addendum H. Addendum F reflects the current GPCIs that were effective on January 1, 2004. Addendum F can be utilized as a baseline for purposes of comparison to the proposed GPCIs. Addendum H illustrates the proposed fully implemented 2006 GPCIs. Addendum G illustrates the proposed transitional 2005 GPCIs, which are one-half of the effect of the proposed fully implemented GPCI revisions as required by section 1848(e)(1)(C) of the Act.
Because the three GPCIs have different weights, the overall effect of the proposed changes cannot be achieved by summing the individual effects of the revisions on the work, practice expense, and malpractice expense GPCIs. The overall effect of all three revised GPCI components on an area can be estimated by a comparison of the area's geographic adjustment factors (GAFs). The GAF for a specific payment area is the weighted composite of the three separate components. The GAF illustrates an estimate of the general effect on total payments across a specific fee schedule locality. The effects on individual physicians would vary depending on each physician's mix and volume of services.
To illustrate a comparison of the overall effect of the current and proposed GPCIs, Addendum J contains a comparison of the current 2004 GAFs to the proposed fully-implemented 2006 GAFs. Addendum I contains a comparison of the proposed transitional GAFs (2005) to the current 2004 GAFs. Both Addenda I and J are sorted in descending order of change. As Addendum J shows, no fee schedule area would experience a total decrease in its respective GAF by more than 3.5 percent, or increase by more than 7 percent, if the proposed GPCI revisions are fully implemented in 2006. The majority of payment areas would change by considerably less than these amounts. Nearly 75 percent of payment areas would change by less than 2 percent with the majority of these payment areas changing by less than 1 percent. Consequently, as illustrated by Addendum I, no fee schedule area would experience a total decrease in its respective GAF of more than 1.6 percent, or an increase of more than 3.5 percent, in the transition year (2005).
The GPCIs measure relative cost differences among payment areas compared to the national average. The national average cost is represented by a value of about 1.000. A proposed GPCI revision showing a decrease from the current value does not necessarily mean that absolute costs in a payment area have decreased, only that the average costs of a payment area have decreased as compared to the national average costs.
In the August 15, 2003 proposed rule, we requested comments on the composition of the current 89 Medicare physician payment localities to which the GPCIs are applied. In the November 7, 2003 final rule, we indicated that we received comments from various parties requesting that specific counties be removed from their current locality. We further indicated that we are continuing to examine alternatives for reconfiguring the current locality structure.
While we have considered alternatives, we have not yet been able to come up with a policy and criteria that would satisfactorily apply to all situations. Any policy that we would propose would have to apply to all States and payment localities. For example, if we were to establish a policy that if adjacent county geographic indices exceeded a threshold amount, the lower county could be moved to the higher county or a separate locality could be created, that approach would cause redistributions within a State.
Locality changes are budget-neutral with respect to the aggregate amount of Medicare money in a State. That is, reconfigurations of localities within a State do not result in any more Medicare money for the State in the aggregate, but only redistributions of money within a State. Since there will be both winners and losers in any locality reconfiguration, the State medical associations should be the impetus behind these changes. Since 1996, we have moved to Statewide areas in several States after receiving resolutions from State medical societies including support from physicians in losing areas, and after going through Notice and Comment rulemaking. The support of State medical associations has been the basis for previous changes to Statewide areas, and continues to be equally important in our consideration of other future locality changes.
Section 1848(c)(2)(C) of the Act requires that each service paid under the physician fee schedule be comprised of three components: work, practice expense, and malpractice.
From 1992 to 1999, malpractice RVUs were charge-based, using weighted specialty-specific malpractice expense percentages and 1991 average allowed charges. Malpractice RVUs for new codes after 1991 were extrapolated from similar existing codes or as a percentage of the corresponding work RVU. Section 4505(f) of the BBA required us to implement resource-based malpractice RVUs for services furnished beginning in 2000. With the implementation of resource-based malpractice RVUs in 2000 and the full implementation of resource-based practice expense RVUs in 2002, all physician fee schedule RVUs were resource-based, eliminating the last vestiges of charged-based payment.
The methodology used in calculating the proposed resource-based malpractice RVUs is the same methodology that was used in the initial development of resource-based RVUs, the only difference being the use of more current data. The proposed resource-based malpractice expense RVUs are based upon:
• Actual 2001 and 2002 malpractice premium data;
• Projected 2003 premium data; and
• 2002 Medicare payment data on allowed services and charges.
As was done in the initial development of resource-based malpractice expense RVUs in the November 2, 1999 final rule, we are proposing to revise resource-based malpractice expense RVUs using specialty-specific malpractice premium data because they represent the actual malpractice expense to the physician. In addition, malpractice premium data are widely available. We propose to use actual 2001 and 2002 malpractice premium data and projected 2003 malpractice premium data for three reasons:
• These are the most current data available.
• These data capture the highly publicized and most recent trends in the specialty-specific costs of professional liability insurance.
• These are the same malpractice premium data that were utilized in the development of revised malpractice GPCIs in the November 7, 2003 final rule.
We were unable to obtain a nationally representative sample of 2003 malpractice premium data for two reasons: (1) The premium data that we collected from the private insurance companies had to “match” the market share data that were provided by the respective State Departments of Insurance. Because none of the State Departments of Insurance had 2003 market share information at the time of this data collection, 2003 premium data were not usable; and (2) the majority of private insurers were not amicable to releasing premium data to us. In the majority of instances, the private insurance companies would release their premium data only to the State Departments of Insurance.
Discussions with the industry lead us to conclude that the primary determinants of malpractice liability costs remain physician specialty, level of surgical involvement, and the physician's malpractice history. Malpractice premium data were collected for the top 20 Medicare physician specialties measured by total payments. Premiums were for a $1 million/$3 million mature claims-made policy (a policy covering claims made, rather than services provided during the policy term). We attempted to collect premium data from all 50 States, Washington, DC, and Puerto Rico. Data were collected from commercial and physician-owned insurers and from joint underwriting associations (JUAs). A JUA is a State government-administered risk pooling insurance arrangement in areas where commercial insurers have left the market. Adjustments were made to reflect mandatory patient compensation funds (PCFs) (funds to pay for any claim beyond the statutory amount, thereby limiting an individual physician's liability in cases of a large suit) surcharges in States where PCF participation is mandatory. The premium data collected represent at least 50 percent of physician malpractice premiums paid in each State.
For 2001, we were able to collect premium data from 48 States (for purposes of this discussion, State counts include Washington, DC and Puerto Rico). We were unable to obtain premium data from Kentucky, New Hampshire, New Mexico, and Washington DC. To calculate a proxy for the malpractice premium data for these four areas in 2001, we began with the most current malpractice premium data collected for these areas, 1996 through 1998 (the last premium data collection that was undertaken). An average premium price was calculated (using 1996 through 1998 data) for all States except Kentucky, New Hampshire, New Mexico, and Washington, DC. Similarly, an average premium price was calculated for the 1999 through 2001 period for all States except Kentucky, New Hampshire, New Mexico, and Washington, DC. The percentage change in these premium prices was calculated as the percent difference between the 1999 to 2001 calculated average premium price and the 1996 to 1998 calculated average premium price. This percentage change was then applied to the weighted average 1996 to 1998 malpractice premium price for these four areas to arrive at a comparable 1999 to 2001 average premium price.
For 2002, we were able to obtain malpractice premium data from 33 States. Many State Departments of Insurance had not yet obtained premium data from the primary insurers within their State at the time of this data collection. For those States for which we were unable to obtain malpractice premium data, we calculated a national average rate of growth for 2002 and applied this national rate of growth to the weighted average premium for 2001 to obtain an average premium for 2002 for each county for which we were unable to obtain malpractice premium data for 2002.
We projected premium values for 2003 based on the average of historical year-to-year changes for each locality (when locality level data were available) or by State (when only Statewide premium data projections were available). First, we calculated the percentage changes in the premiums from the 1999 through 2000, 2000 through 2001, and 2001 through 2002 periods for each payment locality. Next, we calculated the geometric mean of these three percentages and applied the mean to the 2002 premium to obtain the forecasted 2003 malpractice premium. We used the geometric mean to calculate the forecasted 2003 premium data because the geometric mean is commonly used to derive the mean of a series of values that represent rates of change. Because the geometric mean is based on the logarithmic scale, it is less impacted by outlying data.
Malpractice insurers generally use five-digit codes developed by the Insurance Services Office (ISO), an advisory body serving property and casualty insurers, to classify physician
Some physician specialties, nonphysician practitioners, and other entities (for example, independent diagnostic testing facilities) paid under the physician fee schedule could not be assigned an ISO code. We crosswalked these specialties to similar physician specialties assigned an ISO code and a risk class. The unassigned specialties and the specialty to which they were assigned are shown in Table 9.
In the development of the proposed resource-based malpractice RVU methodology, we considered two malpractice premium-based alternatives for resource-based malpractice RVUs, the dominant specialty approach and the specialty-weighted approach.
The dominant specialty approach bases the malpractice RVUs upon the risk factor of only the dominant specialty performing a given service as long as the dominant specialty accounted for at least 51 percent of the total utilization for a given service. When 51 percent of the total utilization does not comprise the dominant specialty, this approach uses a modified specialty-weighted approach. In this modified specialty-weighted approach, two or more specialties are collectively defined as the dominant specialty. Starting with the specialty with the largest percentage of allowed services, the modified specialty-weighted approach successively adds the next highest specialty in terms of percentage of allowed services until a 50 percent threshold is achieved. The next step is to sum the risk factors of those specialties (weighted by utilization) in order to achieve at least 50 percent of the total utilization of a given service and then use the factors in the calculation of the final malpractice RVU.
The dominant specialty approach produces modest increases for some specialties and modest decreases for other specialties. The largest increase for any given specialty, over the specialty-weighted approach, is less than 1.5 percent of total RVUs, while the largest decrease for any given specialty is less than 0.5 percent of total RVUs.
The approach that we adopted in the November 1999 final rule and are proposing to use in this proposed rule, bases the final malpractice RVUs upon a weighted average of the risk factors of all specialties performing a given service. The specialty-weighted approach ensures that all specialties performing a given service are accounted for in the calculation of the final malpractice RVU. Our proposed methodology is as follows:
(1)
Table 10 shows the national average premiums for the years 1999 through 2003 for the 20 specialties for which we collected premium data. As stated previously, we used an average of the 3 most current years, 2001 to projected 2003 malpractice premiums, in our calculation of the proposed malpractice RVUs.
(2)
(3)
As mentioned above, certain specialties may have more than one ISO rating class and risk factor. The surgical risk factor for a specialty was used for surgical services and the nonsurgical risk factor for evaluation and management services. Also, for obstetrics/gynecology, the lower gynecology risk factor was used for all codes except those obviously surgical services, in which case the higher, surgical risk factor was used.
Certain codes have no physician work RVUs. The overwhelming majority of these codes are the technical components (TCs) of diagnostic tests, such as x-rays and cardiac catheterization, which have a distinctly separate technical component (the taking of an x-ray by a technician) and professional component (the interpretation of the x-ray by a physician). Examples of other codes with no work RVUs are audiology tests and injections. These services are usually furnished by nonphysicians, in this example, audiologists and nurses, respectively. In many cases, the nonphysician or entity furnishing the TC is distinct and separate from the physician ordering and interpreting the test. We believe it is appropriate for the malpractice RVUs assigned to TCs to be based on the malpractice costs of the nonphysician or entity, not the professional liability of the physician.
Our proposed methodology, however, would result in zero malpractice RVUs for codes with no physician work, since we propose the use of physician work RVUs to adjust for risk-of-service. We believe that zero malpractice RVUs would be inappropriate because nonphysician health practitioners and entities such as independent diagnostic testing facilities (IDTFs) also have malpractice liability and carry malpractice insurance. Therefore, we are proposing to retain the current charge-based malpractice RVUs for all services with zero work RVUs. We are open to comments and suggestions for constructing resource-based malpractice RVUs for codes with no physician work.
(4)
The proposed resource-based malpractice RVUs are shown in Addendum B. These values have been adjusted for budget neutrality on the basis of the most recent available data. The values do not reflect the final budget-neutrality adjustment, which we will make in the final rule based upon the more current Medicare claims data. We do not believe, however, that the values will change significantly as a result of the final budget-neutrality adjustment.
Because of the differences in the sizes of the three fee schedule components, implementation of the proposed resource-based malpractice RVUs will have a smaller payment effect than the previous implementation of resource-based practice expense RVUs. On average, work represents about 52.5 percent of the total payment for a procedure, practice expense about 43.6 percent of the total payment, and malpractice expense about 3.9 percent of the total payment. Thus, a 20 percent change in practice expense or work RVUs would yield a change in payment of about 8 to 11 percent. In contrast, a corresponding 20 percent change in malpractice values would yield a change in payment of only about 0.6 percent. Estimates of the effects on payment by specialty and selected high-volume procedures can be found in the impact section of this rule.
We are requesting comments on our proposed methodology and resource-based malpractice RVUs.
This code was included in the November 2, 1999 physician fee schedule final rule and was effective for services beginning January 1, 2000. In that rule, and subsequent rules, we have applied a global indicator of “xxx” to this code, meaning that the global concept does not apply. It has been brought to our attention that this global indicator is incorrect. The global indicator should be 090 since the RUC valuation of this service reflected a global period of 90 days and we accepted this valuation. Therefore, we would correct the global indicator for this service to reflect a global period of 90 days (090).
Section 1834(m) of the Act defines telehealth services as professional consultations, office and other outpatient visits, and office psychiatry services identified as of July 1, 2000 by CPT codes 99241 through 99275, 99201 through 99215, 90804 through 90809, and 90862. In addition, the statute required us to establish a process for adding services to or deleting services from the list of telehealth services on an annual basis. In the CY 2003 final rule, we established a process for adding or deleting services to the list of Medicare telehealth services. This process provides the public an opportunity on an ongoing basis to submit requests for adding a service. For more information on submitting a request for addition to the list of Medicare telehealth services, visit our Web site at www.cms.hhs.gov/physicians/telehealth.
Requests for adding services to the list of Medicare telehealth services must be submitted and received no later than December 31st of each calendar year to be considered for the next proposed rule. For example, requests submitted in CY 2003 are considered for the CY 2005 proposed rule.
We received the following public requests for addition in CY 2003: Inpatient hospital care, emergency department visits, hospital observation services, inpatient psychotherapy, monthly management of patients with end-stage renal disease (ESRD), speech and audiologist services, case management, and care plan oversight.
Requests for additions submitted in CY 2003 are discussed below.
The American Telemedicine Association (ATA) and an individual practitioner submitted a request to add initial and subsequent inpatient hospital care as represented by CPT codes 99221 through 99223 and 99231 through 99233; hospital observation services (CPT codes 99217, 99218 through 99220); and individual psychotherapy furnished in an inpatient, partial hospitalization, or residential care facility setting (as defined by CPT codes 90816 through 90822). The requestors argue that the addition of hospital observation services, inpatient hospital care, and inpatient psychotherapy will reduce transfers from remote facilities to tertiary care facilities, decrease length of stay, improve diagnostic accuracy, plan of care strategies and patient outcomes, and also stabilize local health care systems. The requestors emphasize that adding individual psychotherapy in the inpatient and partial hospitalization setting is crucial for providing access to mental health services for the rural population. Additionally, the requestors believe that no current Medicare telehealth service can be billed when a patient is in observation status or is admitted as an inpatient. They also noted that the current psychiatry services paid for as telehealth services are not appropriate for mental health patients in the hospital, partial hospital, or residential facility settings.
The University of Kansas Medical Center requested that we add emergency department visits as defined by CPT codes 99281 through 99285 as telehealth services. The requestor stated that, for many rural hospitals, the attending physician in emergency cases is a local primary care or family physician who may not have sufficient experience with the complexities of emergent care. The requestor believes that adding emergency department visits will provide quicker access to an expert trauma or emergency physician and that the time saved could be life-saving for the patient.
As discussed in the June 28, 2002
Category 2 services would include services that are not similar to an office or other outpatient visit, consultation, or office psychiatry. Because of the potential acuity of the patient in the hospital setting, we consider inpatient hospital care, emergency department visits, hospital observation services, and inpatient psychotherapy to fall into the second category of requests. As discussed on our website, for category 2 services, requestors must provide evidence indicating that the use of a telecommunications system produces similar diagnostic findings or therapeutic interventions as would face-to-face delivery of the same service.
For inpatient hospital care, hospital observation services, and inpatient psychotherapy, the requestors did not submit evidence indicating that the use of a telecommunications system does not affect the diagnosis or treatment plan as compared to the face-to-face delivery of the service. The requestors instead submitted various studies and articles regarding: the psychiatric diagnostic interview examination; school-based pediatric acute care to children; child and adolescent psychotherapy in clinics and schools; the use of telehealth technology to simplify case management and prior authorization; consultation on neurology cases; and nursing care to reduce hospitalization for heart failure.
These data are not directly relevant to the services that the requesters wanted to have added. They do not address whether the use of a telecommunications system produces similar diagnoses or therapeutic interventions by physicians or practitioners, as would the face-to-face delivery of inpatient hospital care, hospital observation services, and inpatient psychotherapy. With respect to emergency department visits, the requestor submitted a comparison study between emergency department telemedicine and face-to-face emergency department visits. However, this study did not take into account complex emergent care. Study participants were pre-selected based on cases with limited clinical intervention, for example, animal bites with no skin laceration or puncture wounds, insect bites without evidence of wheezing or airway compromise, sore throat, first degree burns—less than 5 percent, and nonurgent medical problems requiring a referral.
In the absence of sufficient, well-designed comparison studies showing that the use of a telecommunications system produces similar diagnoses or therapeutic interventions as would the face-to-face delivery of the requested services, we are proposing not to add these services to the list of telehealth services.
We believe that the current list of Medicare telehealth services is appropriate for hospital inpatients, emergency room cases, and patients designated as observation status. If guidance or advice is needed in these settings, a consultation could be requested from an appropriate source.
The ATA and an individual practitioner submitted a request that we add the monthly management of patients on dialysis, as represented by HCPCS codes G0308 through G0319, to the list of Medicare telehealth services. Under these codes, Medicare pays an increased monthly capitated payment amount for additional visits during the month (up to four). The requestors noted the shortage of nephrologists and the difficulty they have in visiting face-to-face with all patients on dialysis. Additionally, the requestors stated that many States, including Alaska, Hawaii, Montana, and Wisconsin, have remote community-based dialysis centers with underserved populations located a considerable distance from a nephrologist. To address this issue, consultations and patient care conferences are currently being provided using a telecommunications system to manage patients on dialysis located in communities that do not have a nephrologist, including communities in Texas, where dialysis consultations and assessments using telecommunications are paid under the State's Medicaid program. Given the claims of a shortage of nephrologists and the new face-to-face visit requirements for physicians managing patients on dialysis, the requestors believe that permitting the management of dialysis patients through telehealth services is crucial.
The MCP G codes represent a range of services provided during a month, including a complete assessment of the patient and subsequent visits to monitor the patient's condition. We believe the types of services provided as part of the subsequent visits included in the codes are similar to the office and other outpatient visits currently on the list of Medicare telehealth services. Therefore, we believe these services would meet the criteria set forth in Category 1 of the process for adding services described above. However, we do not believe the complete assessment aspect of the MCP G codes is similar to existing telehealth services. For example, one aspect of a complete assessment would involve examination of the vascular access site. This is a specific clinical examination that is not similar to other services on the list.
Therefore, we consider the request for addition of the complete assessment to the list of telehealth services to be a Category 2 request, requiring comparative analyses. In submitting their requests for addition to the list of Medicare telehealth services, the requestors included summaries of many studies related to renal dialysis patient monitoring. However, we do not believe the requestor provided comparative analyses illustrating that the use of a telecommunications system is an adequate substitute for the clinical examination of the vascular access site. We do not believe that the use of a telecommunications system is an adequate method for conducting a complete assessment of the ESRD beneficiary. We believe that a clinical examination of the vascular access site can be adequately performed only with a face-to-face, “hands on” examination of the patient.
However, we do believe the subsequent visits meet the criteria for approving a Category 1 request. That is, we believe the roles and interactions between the patient and the physician (or practitioner) are similar to those of office and other outpatient visits currently on the telehealth list. This presents a unique scenario, wherein a portion of the services represented by the MCP G codes are eligible to add to the list, but one service (the complete assessment) is not. To address this issue, we propose to add the ESRD-related services with 2 or 3 visits per month and ESRD-related services with 4 or more visits per month as described by G0308, G0309, G0311, G0312, G0314, G0315, G0317, G0318 to the list of Medicare telehealth services. However, the complete assessment of the ESRD
As noted previously, the MCP G codes are unique in that they reflect the ongoing care provided to ESRD patients by the physician or practitioner, on a monthly basis. These codes also reflect a range of services, from a monthly comprehensive assessment to monitoring the patient's overall condition and addressing individual issues and concerns as they arise during the month. We believe these codes are distinguishable from other codes by the scope of services and the ongoing nature of the services provided. Therefore, we believe that it would be appropriate to permit the use of a telecommunications system for providing some of the visits required under the ESRD MCP and to add these codes to the list of Medicare telehealth services.
The MCP physician, for example, the physician or practitioner who provided the complete assessment, and other practitioners within the same group practice or employed by the same employer/entity, may furnish ESRD-related visits through a telecommunications system. However, the physician or practitioner who performs the complete assessment and establishes the plan of care should bill for the MCP in any given month.
The American Speech-Language Hearing Association (ASHA) requested that we add 36 audiology services (CPT code range 92541 through 92596) and 30 speech language pathology (SLP) services (CPT code range 31575 through 97703) to the list of Medicare telehealth services. The ASHA believes the cognitive nature of these services makes them well-suited for telehealth and noted several telehealth programs that have been successful at providing SLP and audiology services. For example, existing telehealth networks were cited as successfully providing diagnosis, treatment, and management recommendations for patients with speech language and hearing disorders.
Speech language pathologists and audiologists are not permitted under current law to provide and receive payment for Medicare telehealth services at the distant site. The statute permits only a physician, as defined by section 1861(r) of the Act or a practitioner as described in section 1842(b)(18)(C) of the Act (clinical nurse specialist, nurse practitioner, physician assistant, nurse midwife, clinical psychologist, and clinical social worker), to furnish Medicare telehealth services. We are exploring this issue as part of a report to Congress (required by section 223(d) of BIPA) on additional sites and settings, geographic areas, and practitioners that may be reimbursed for the provision of telehealth services. At this time, we are not adding speech and audiology services to the list of Medicare telehealth services.
Two requests were submitted asking that we add medical team conferences as identified by CPT codes 99361 and 99362 and physician supervision (CPT codes 99374 and 99375) as telehealth services. Requestors stated that for these services, the use of a telecommunications system provides interdisciplinary medical teams serving remote underserved populations better access to the clinical expertise and decision making of specialty physicians. The requestors note that the current list of Medicare telehealth services, for example, consultations or office visits, cannot be used for case management and care plan oversight services because the patient is not typically present.
Medical team conferences and monthly physician supervision are already covered Medicare services and do not require a face-to-face encounter with the beneficiary. Under the Medicare program, the use of a telecommunications system in furnishing a telehealth service is a substitution for the face-to-face requirements of a service. Since medical team conferences and monthly physician supervision do not require a face-to-face encounter with the patient, we cannot add these services to the list of Medicare telehealth services.
For the reasons stated above, we propose to add ESRD-related services as described by G0308, G0309, G0311, G0312, G0314, G0315, G0317 and G0318 to the list of Medicare telehealth services.
Moreover, we would add the term “ESRD-related visits” to the definition of Medicare telehealth services at CFR 410.78 and 414.65 as appropriate.
We do not propose to add any additional services discussed above to the list of Medicare telehealth services for CY 2005.
In the 2001 final rule, we created three G codes for respiratory therapy services: G0237
We assigned RVUs to one of the codes (G0237), and indicated that the other two codes (G0238 and G0239) would be carrier-priced. Since the services represented by these codes are frequently being performed in comprehensive outpatient rehabilitation facilities, and paid under the physician fee schedule through fiscal intermediaries, there has been some uncertainty surrounding the payment for the carrier-priced services. We believe assigning RVUs to G0238 and G0239 would alleviate some of this uncertainty. Since these services are typically performed by respiratory therapists, no physician work was assigned to G0237, and we are not proposing work RVUs for either G0238 or G0239.
Therefore, we are proposing to value these services using the nonphysician workpool.
We propose practice expense RVUS for G0238 equal to those for G0237. While these codes represent two different types of activities (G0237 involves therapeutic procedures specifically targeted at improving the strength and endurance of respiratory muscles such as pursed-lip breathing, diaphragmatic breathing, and paced breathing, and G0238 involves other activities such as teaching patients strategies for performing tasks with less respiratory effort and the performance of graded activity programs to increase endurance and strength of upper and lower extremities), we believe that the practice expense involved is substantially the same for both services and thus, propose to crosswalk the practice expense RVUs for G0237 to G0238.
G0239 represents situations in which two or more individuals are receiving services simultaneously (such as those described above in G0237 or G0238) during the same time period. Although the practitioner must be in constant attendance, he or she need not be providing one-on-one patient contact. For G0239, we believe a typical group session to be 30 minutes in length and to consist of 3 patients. Therefore, for the practice expense RVUs for G0239, we will use the practice expense RVUs of G0237 reduced by one-third to account for the fact that the service is being provided to more than one patient simultaneously and each patient in a group can be billed for the services of G0239.
We also propose a malpractice RVU of 0.02, the malpractice RVU assigned to G0237, for these two G codes.
In the physician fee schedule final rule published on June 28, 2002 (67 FR 43864), we proposed creation of a new G-code that reflects a bone marrow biopsy and aspiration procedure performed on the same date, at the same encounter, through the same incision. While some commenters were supportive of this proposal, other commenters felt that creation of a G-code was unnecessary and that any concerns with respect to payment could be addressed through application of the multiple procedure payment rules. In a final rule published on December 31, 2002 (67 FR 79992), we agreed that the code should go through the CPT process and did not make our proposal final.
To date, CPT has not addressed the issue. Therefore, we are proposing to create a G-code for this service in 2005. We believe that there is minimal incremental work associated with performing the second procedure through the same incision during a single encounter and are proposing an add-on G-code to reflect the additional physician work and practice expense. As we had stated in our previous proposal, if the two procedures, aspiration and biopsy, are performed at
The code would be used when a bone marrow aspiration and a bone marrow biopsy are performed on the same day through a single incision. The physician would use the CPT code for bone marrow biopsy (38221) and G0XX1 for the second procedure (
Based on our estimation that the time associated with this G-code is approximately 5 minutes and based on a comparison to CPT code 38220 which has 34 minutes of intraservice time and a work RVU of 1.08 work, we are proposing 0.16 work RVUs for this proposed G-code. The proposed malpractice RVUs are 0.04 which are the current malpractice RVUS assigned to CPT code 38220. We are proposing the following practice expense inputs:
We are also proposing a ZZZ global period for this add-on code since this code is related to another service and is included in the global period of the other service.
The Q-code for the set-up of portable x-ray equipment, Q0092, is currently paid under the physician fee schedule and is assigned an RVU of 0.33. In 2004, this produces a national payment of $12.32. This set-up code encompasses only a portion of the resources required to provide a portable x-ray service to patients. In 2003, portable x-ray suppliers received total Medicare payments of approximately $208 million. More than half of these payments (approximately $116 million) were for portable x-ray transportation (codes R0070 and R0075). The portable x-ray set-up code (Q0092) generated approximately $19 million in payments. The remainder of the Medicare payments for portable x-ray services (approximately $73 million) were for the actual x-ray services themselves.
Between 2002 and 2004, the Medicare carriers increased the average amount paid for portable x-ray transportation across the country from about $89 to $112, an increase of about 25 percent (transportation is carrier-priced). Nonetheless, the Conference Report accompanying the Consolidated Appropriations Bill, HR 2673 (Pub. L. 108-199, enacted January 23, 2004), urged the Secretary to review and update the RVUs for Q0092 utilizing existing data.
In 2002, the National Association of Portable X-ray Providers had requested that we use their cost data to develop practice expense RVUs for the physician fee schedule services they provide. We asked the Lewin Group to evaluate the data using the same standards of review applied to other specialty survey data. The Lewin Group found that the data as presented were not adequately detailed
This code is currently priced in the nonphysician work pool. Removing this code from the nonphysician work pool has an overall negative impact on payments to portable x-ray suppliers (as a result of decreases to radiology codes that remain in the nonphysician work pool) and has a negative impact on many of the codes remaining in the nonphysician workpool. An alternative to national pricing of portable x-ray set-up would be to require Medicare carriers to develop local pricing as they do currently for portable x-ray transportation. In 2002, we received a comment from a supplier of portable x-rays stating that the practice costs associated with set-up of portable x-ray equipment are not included in the Socioeconomic Monitoring System (SMS) and that there are sufficient differences among geographic regions in the performance of this procedure that warrant reclassifying this service as carrier-priced. We are interested in public comments on whether we should pursue national pricing for portable x-ray set-up outside of the nonphysician work pool or local carrier pricing for 2005 or whether we should continue to price the service in the nonphysician workpool.
We are proposing to create a new G-code (G0XX3:
This G code would only be billed by the operating surgeon in conjunction with the following CPT codes: 36819, 36821, 36825, and 36832. Because CPT code 93971 and the new G-code would be used to describe a similar service, we would propose that we not permit payment for CPT code 93971 when this G-code is billed, unless code 93971 were being performed for a separately identifiable clinical indication in a different anatomic region.
The physician work, practice expense and professional liability expense for this new G code would be the same as those for CPT code 93971. Thus, we propose to crosswalk the RVUs for the new G-code from those of CPT code 93971. We would also assign this new G-code a global period of “XXX”, which means that the global concept does not apply.
Section 611 of the MMA provides for coverage under Part B of an initial preventive physical examination for new beneficiaries, effective for services furnished on or after January 1, 2005, subject to certain eligibility and other limitations.
Previously, Medicare law had not allowed for payment for routine physical examinations or checkups. Section 1862(a)(7) of the Act states that routine physical checkups are excluded services. This exclusion is described in § 411.15(a) (Particular services excluded from coverage). In addition, we have interpreted section 1862(a)(1)(A) of the Act to exclude coverage for preventive physical examinations. This section provides that items and services must be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member as stated in § 411.15(k). Since preventive services are not provided for diagnosis or treatment of illness, injury, or malformation, we determined that these services are not reasonable and necessary within the meaning of the statute.
To conform the regulations to the MMA, we are specifying an exception to the list of examples of routine physical examinations excluded from coverage in § 411.15(a)(1) and § 411.15(k)(11) for initial preventive physical examinations that meet the eligibility limitation and the conditions for coverage that we are specifying under § 410.16—Initial Preventive Physical Examinations.
Coverage of initial preventive physical examinations is provided under Medicare Part B only. The MMA permits payment for one initial preventive physical examination within the first 6 months after the effective date of the beneficiary's first Part B coverage period, but only if that coverage period begins on or after January 1, 2005.
We are proposing to add § 410.16(b), Condition for Coverage of Initial Preventive Physical Examinations, and § 410.16(c), Limitation on Coverage of Initial Preventive Physical Examinations, to provide for coverage of the various initial preventive physical examination services specified in the statute.
We are proposing to define several terms, as described specifically in § 410.16, that would be used in implementing the statutory provisions, including definitions of the following terms—
(1) Eligible beneficiary;
(2) An initial preventive physical examination;
(3) Medical history;
(4) Physician;
(5) Qualified nonphysician practitioner.
(6) Social history;
(7) Review of the individual's functional ability and level of safety;
Section 611 of the MMA defines an “initial preventive physical examination” to mean physicians' and certain qualified nonphysician practitioners' services consisting of—
(1) A physical examination (including measurement of height, weight, blood pressure, and an electrocardiogram, but excluding clinical laboratory tests) with the goal of health promotion and disease detection; and
(2) Education, counseling, and referral with respect to screening and other covered preventive benefits separately authorized under Medicare Part B.
Specifically, section 611(b) of the MMA provides that the education, counseling, and referral of the individual by the physician or other qualified nonphysician practitioner should be with respect to the following statutory screening and other preventive services authorized under Medicare Part B:
(1) Pneumococcal, influenza, and hepatitis B vaccine and their administration.
(2) Screening mammography.
(3) Screening pap smear and screening pelvic exam services.
(4) Prostate cancer screening services.
(5) Colorectal cancer screening tests.
(6) Diabetes outpatient self-management training services;
(7) Bone mass measurements.
(8) Screening for glaucoma.
(9) Medical nutrition therapy services for individuals with diabetes or renal disease.
(10) Cardiovascular screening blood tests.
(11) Diabetes screening tests.
Based on the language of the statute, our review of the medical literature, current clinical practice guidelines, and United States Preventive Services Task Force recommendations, we are proposing to interpret the term, “initial preventive physical examination,” for purposes of this new benefit to include all of the following:
(1) Review of the individual's comprehensive medical and social history, as those terms are defined in paragraph (a) of proposed § 410.16.
(2) Review of the individual's potential (risk factors) for depression (including past experiences with depression or other mood disorders) based on the use of an appropriate screening instrument which the physician or other qualified nonphysician practitioner may select from various available standardized screening tests for this purpose, unless the appropriate screening instrument is defined through the national coverage determination (NCD) process.
(3) Review of the individual's functional ability and level of safety, as described in paragraph (a) of proposed § 410.16, (that is, at a minimum, a review of the following areas: hearing impairment, activities of daily living, falls risk, and home safety), based on the use of an appropriate screening instrument, which the physician or other qualified nonphysician practitioner may select from various available standardized screening tests for this purpose, unless the appropriate screening instrument is further defined through the NCD process.
(4) An examination to include measurement of the individual's height, weight, blood pressure, a visual acuity screen, and other factors as deemed appropriate by the physician or qualified nonphysician practitioner, based on the individual's comprehensive medical and social history and current clinical standards.
(5) Performance and interpretation of an electrocardiogram.
(6) Education, counseling, and referral, as appropriate, based on the results of the previous five elements of the initial preventive physical examination.
(7) Education, counseling, and referral, including a written plan provided to the individual for obtaining the appropriate screening and other preventive services, which are separately covered under Medicare Part B benefits; that is, pneumococcal, influenza, and hepatitis B vaccines and their administration, screening mammography, screening pap smear and screening pelvic exams, prostate cancer screening tests, diabetes outpatient self-management training services, bone mass measurements, screening for glaucoma, medical nutrition therapy services, cardiovascular screening blood tests, and diabetes screening tests.
We are requesting public comments on the definition of the term “initial preventive physical examination.” For example, we have chosen not to define the term, “appropriate screening instrument,” for screening individuals for depression, functional ability, and level of safety, as specified in the proposed rule, because we anticipate that the examining physician or qualified nonphysician practitioner will want to use the test of his or her choice, based on current clinical practice guidelines. We believe that any standardized screening test for depression, functional ability, and level of safety recognized by the American Academy of Family Physicians, the American College of Physicians-American Society of Internal Medicine, the American College of Preventive Medicine, the American Geriatrics Society, the American Psychiatric Association, or the United States Preventive Services Task Force, or other recognized medical professional group, would be acceptable for purposes of meeting the “appropriate screening instrument” provision. We ask that commenters making specific recommendations on this or any related issue provide documentation from the medical literature, current clinical practice guidelines, or the United States Preventive Services Task Force recommendations.
We recognize that the NCD process could be used to define more specifically the type or types of appropriate screening instruments for depression, functional ability, or level of safety and propose to include in § 410.16(a) in elements (2) and (3) of the definition of an initial preventive physical examination a reference that would allow us to define these screening instruments more specifically through the national coverage determination (“NCD”) process. The NCD process would include an opportunity for public comment on the medical and scientific issues related to the coverage of the new tests that may be brought to our attention in the future. Use of an NCD to establish a change in the scope of benefits is authorized by section 1871(a)(2) of the Act.
There is no current CPT code that contains the specific elements included in the initial preventive examination. Therefore, we are proposing to establish the following new HCPCS code, G0XX2,
Payment for this new HCPCS code will be based on the following:
1.
2.
3.
Since some of the components for a medically necessary E/M visit are reflected in this new HCPCS code, we are also proposing, when it is appropriate, to allow a medically necessary E/M service no greater than a level 2 to be reported at the same visit as the initial preventive physical examination. That portion of the visit must be medically necessary to treat the patient's illness or injury or to improve the function of a malformed body member and should be reported with modifier -25. The physician or qualified nonphysician practitioner could also bill for the screening and other preventive services currently covered and paid by Medicare Part B under separate provisions of section 1861 of the Act, if provided during this initial preventive physical examination.
MMA did not make any provision for the waiver of the Medicare coinsurance and Part B deductible for the initial preventive physical examination. Payment for this service would be applied to the required deductible, which is $110 for CY 2005, if the deductible has not been met, and the usual coinsurance provisions would apply.
Section 613 of the MMA adds section 1861(yy) to the Act and mandates coverage of diabetes screening tests.
The term “diabetes screening tests” is defined in section 613 as testing furnished to an individual at risk for diabetes including a fasting plasma glucose test and such other tests, and modifications to tests, as the Secretary determines appropriate, in consultation with appropriate organizations. In compliance with this directive, we consulted with the American Diabetes Association, the American Association of Clinical Endocrinologists, and the National Institute for Diabetes and Digestive and Kidney Diseases.
We are proposing in § 410.18 that Medicare cover—
• A fasting plasma glucose test; and
• Post-glucose challenge tests; either an oral glucose tolerance test with a glucose challenge of 75 grams of glucose for nonpregnant adults, or a 2-hour post-glucose challenge test alone.
We would not include a random serum or plasma glucose for persons with symptoms of uncontrolled diabetes such as excessive thirst or frequent urination in this benefit because it is already covered as a diagnostic service. This language is not intended to exclude other post-glucose challenge tests that may be developed in the future, including panels that may be created to include new diabetes and lipid screening tests. We also would include language that would allow Medicare to cover other diabetes screening tests, subject to a NCD process. We are requesting comments regarding the specific tests, definitions, and eligibility criteria. The comments that we receive will also be used to create the list of billing codes for covered tests and diagnosis codes that would be published in instructions for Medicare contractors.
The statutory provision describes an “individual at risk for diabetes” as having any of the following risk factors:
1. Hypertension.
2. Dyslipidemia.
3. Obesity, defined as a body mass index greater than or equal to 30 kg/m2.
4. Previous identification of an elevated impaired fasting glucose.
5. Previous identification of impaired glucose tolerance.
6. A risk factor consisting of at least two of the following characteristics:
(a) Overweight, defined as a body mass index greater than 25 kg/m2, but less than 30.
(b) A family history of diabetes.
(c) A history of gestational diabetes mellitus or delivery of a baby weighing greater than 9 pounds.
(d) 65 years of age or older.
The statutory language directs the Secretary to establish standards regarding the frequency of diabetes screening tests that will be covered and limits the frequency to no more than twice within the 12-month period following the date of the most recent diabetes screening test of that individual.
We are proposing that Medicare beneficiaries diagnosed with “pre-diabetes” be eligible for the maximum frequency allowed by the statute, that is, 2 screening tests per 12 month period. We propose to define “pre-diabetes” as a previous fasting glucose level of 100-125 mg/dL, or a 2-hour post-glucose challenge of 140-199 mg/dL. This definition of “pre-diabetes” was developed with the assistance of the American Association of Clinical Endocrinologists and complements the definition of diabetes that we published November 7, 2003 (68 FR 63195). We are specifically asking for comments regarding our new definition of “pre-diabetes.” We are also requesting suggestions for the definition of “a family history of diabetes.”
For individuals not meeting the “pre-diabetes” criteria, we are proposing that one diabetes screening test be covered per individual per year.
We are proposing to pay for the screening diabetes tests at the same amounts paid for these tests when performed to diagnose an individual with signs and symptoms of diabetes. We would pay for these tests under the clinical laboratory fee schedule. We propose to pay for these tests under CPT code 82947 Glucose; quantitative, blood (except reagent strip) and CPT code 82951 Glucose; tolerance test (GTT), three specimens (includes glucose). To indicate that the purpose of the test is for diabetes screening, we would require that the laboratory include a screening diagnosis code in the diagnosis section of the claim. We propose V77.1 Special screening for diabetes mellitus as the applicable ICD-9—CM code for this purpose. Because laboratories are required and accustomed to submitting diagnosis codes when requesting payment for testing, we believe including a screening diagnosis code is appropriate for this benefit.
The Act requires coverage of tests for cholesterol and other lipid or trigylcerides levels for this purpose. It also authorizes the Secretary to approve coverage of other screening tests for other indications associated with cardiovascular disease or an elevated risk for that disease, including indications measured by noninvasive testing, if the United States Preventive Services Task Force (USPSTF) recommended a blood test for that indication.
We invited comments about the types of tests from the American College of Physicians/ American Society of Internal Medicine, the American College of Cardiology, American Academy of
We also reviewed the following 2001 recommendations of the USPSTF regarding screening for lipid disorders that are associated with cardiovascular disease:
a. Clinicians should routinely screen men aged 35 years and older and women aged 45 years and older for lipid disorders and treat abnormal lipids in people who are at increased risk.
b. Clinicians should routinely screen younger adults (men aged 20 to 35 and women aged 20 to 45) for lipid disorders if they have other risk factors for coronary heart disease.
c. No recommendation was made for or against routine screening for lipid disorders in younger adults (men aged 20 to 35 or women aged 20 to 45) in the absence of known risk factors for coronary heart disease.
d. Screening for lipid disorders should include measurement of total cholesterol (TC) and high-density lipoprotein cholesterol (HDL-C).
e. Evidence is insufficient to recommend for or against trigylcerides measurement as a part of routine screening for lipid disorders.
Based on the statutory language and our review of the scientific literature, expert opinion, and the USPSTF recommendations, we are proposing coverage of the following three screening blood tests for conditions associated with cardiovascular disease:
(1) A total cholesterol test.
(2) A cholesterol test for high density lipoproteins.
(3) A triglycerides test.
These tests should be performed as part of a panel and should be done after a 12-hour fast. We are also proposing coverage of each of these tests once every 5 years. The statute provides that the Secretary shall establish frequency standards for the coverage of cardiovascular screening blood tests, provided the frequency is no more often than once every 2 years. However, the scientific literature shows that cholesterol levels are fairly stable and do not fluctuate drastically for those older than age 65. The USPSTF clinical considerations indicate that, while screening may be appropriate in older people, repeated screening is less important because lipid levels are less likely to increase after age 65. Under the USPSTF recommendations, routine measurement of total cholesterol and HDL cholesterol every 5 years is recommended by the National Cholesterol Education program Adult Treatment Panel II (ATP II), sponsored by the National Institutes of Health, and endorsed by the American Heart Association. In addition, the most recent Report of the Adult Treatment Panel (ATP III) includes similar recommendations. In all adults aged 20 years or older, a fasting lipoprotein profile (total cholesterol, LDL cholesterol, high density lipoprotein (HDL) cholesterol, and triglyceride) should be obtained once every 5 years. Since the LDL cholesterol can be calculated, the remaining tests, which are part of the lipid panel, are the tests we are proposing for coverage under this new benefit at a 5-year screening interval. We do not believe the evidence justifies or the statute allows for coverage of other cardiovascular screening blood tests at this time.
To facilitate our consideration of future coverage of other new types of cardiovascular screening blood tests, we have decided to add a provision to this proposed regulation that, in addition to the specific cardiovascular screening blood tests proposed for coverage in this proposed rule, would provide that other types of these tests may be covered under this new screening benefit, if we determine that this is appropriate through a National Coverage Determination (NCD). This provision would allow us to conduct a more timely assessment of other new types of cardiovascular screening blood tests that may have been approved for marketing by the Food and Drug Administration and recommended by the USPSTF than is possible under the standard rulemaking process. We intend to use the NCD process, which includes an opportunity for public comments, for evaluating the medical and scientific issues relating to the coverage of additional tests that may be brought to our attention in the future. Use of an NCD to establish a change in the scope of benefits is authorized by section 1871(a)(2) of the Act. These proposed coverage requirements are set forth in new section § 410.17.
Section 612 of the MMA provides for Medicare coverage of cardiovascular screening blood tests for the early detection of cardiovascular disease or abnormalities associated with an elevated risk for cardiovascular disease. The coverage is effective on or after January 1, 2005. We are proposing to pay for the screening cardiovascular disease tests at the same amounts paid for these tests when they are performed to diagnose an individual with signs and symptoms of cardiovascular disease. Medicare would pay for the tests under the clinical laboratory fee schedule. We propose to use the following CPT codes:
• 82465 Cholesterol, serum or whole blood, total.
• 83718 Lipoprotein, direct measurement; high density cholesterol (HDL cholesterol).
• 84478 Triglycerides.
• 80061 Lipid Panel.
To indicate that the purpose of the test is for cardiovascular screening, we propose that the laboratory include in the diagnosis section of the claim the diagnosis code that provides the highest degree of accuracy and completeness in describing the diagnosis. We propose that the applicable ICD-9-CM codes for cardiovascular screening blood tests be selected from the following:
• V81.0 Special screening for ischemic heart disease.
• V81.1 Special screening for Hypertension.
• V81.2 Special screening for other and unspecified cardiovascular conditions.
Because laboratories are required and accustomed to submitting diagnosis codes when requesting payment for testing, we believe including a screening diagnosis code for this purpose will not be unduly burdensome to them.
Section 4043 of the Omnibus Budget Reconciliation Act (OBRA) of 1987 added section 1833(m) to the Act to provide incentive payments to physicians who furnish services to
Eligibility for receiving the 10 percent incentive payment is based on whether the specific location at which the service is furnished is within an area that is designated (under section 332(a)(1)(A) of the Public Health Service Act (PHS)) as a HPSA. The Health Resources and Services Administration of the Department of Health and Human Services (HRSA) is responsible for designating shortage areas. HRSA designates several types of HPSAs. Some HPSAs are areas with shortages of primary care physicians, dentists, or psychiatrists. These shortage designations are referred to as geographic-based HPSAs. Also, there are HPSA designations based on underserved populations within an area, which are referred to as population-based HPSAs.
Section 1833(m) of the Act provides incentive payments for physicians who furnish services in areas designated as HPSAs under section 332(a)(1)(A) of the PHS Act. These include all three types of geographic-based HPSAs (primary medical care, dental, and mental health). Consequently, physicians, including psychiatrists, furnishing services in a primary medical care HPSA are eligible to receive bonus payments. Medicare HPSA bonus payments apply to all physicians who perform covered services within a primary medical care HPSA, regardless of specialty. In addition, psychiatrists furnishing services in mental health HPSAs are eligible to receive incentive payments. We do not recognize dental HPSAs for the Medicare HPSA payment program because Medicare does not cover general dental services for its beneficiaries.
Since the inception of the Medicare HPSA incentive payment program, physicians have been responsible for indicating their eligibility for the incentive payment on the Medicare billing form. To facilitate the verification of eligibility, physicians have been notified by their Medicare carriers when changes (withdrawals, revisions, or replacements) occur in HPSA designations. Using this information from carriers, physicians have been required to verify their eligibility and correctly code their Medicare claims using modifiers (QB for rural HPSAs and QU for urban HPSAs) to receive incentive payments.
Section 413(a) of the MMA, provides a new 5 percent incentive payment to physicians furnishing services in physician scarcity areas. The MMA adds a new section 1833(u) of the Act which provides for paying primary care physicians furnishing services in a primary care scarcity county and specialty physicians furnishing services in a specialist care scarcity county, an additional amount equal to 5 percent of the amount paid for these services. Eligible physicians furnishing services in an area qualified as a physician scarcity area (PSA) and HPSA would be entitled to receive both incentive payments, that is, a 15 percent bonus payment. Eligibility for receiving both incentive payments is time limited (January 1, 2005 to January 1, 2008) because the 5 percent PSA bonus is scheduled to sunset on December 31, 2007.
The Congress created the new 5 percent incentive payment program to make it easier to recruit and retain both primary and specialist care physicians for furnishing services to Medicare beneficiaries in PSAs.
The two measures of physician scarcity are defined by the statute as follows:
1. The primary care scarcity areas are determined by the ratio of primary care physicians to Medicare beneficiaries.
2. The specialist care scarcity areas are determined by the ratio of specialty care physicians to Medicare beneficiaries.
Consistent with section 1833(u) of the Act, we would identify eligible primary care scarcity counties by ranking each county by its ratio of primary care physicians to Medicare beneficiaries. From the list of primary care scarcity counties, only those counties with the lowest primary care ratios that represent 20 percent of the total number of Medicare beneficiaries residing in the counties will be considered eligible for the 5 percent incentive payment. For calculating the ratios, section 1833(u)(6) of the Act, as added by the MMA, defines a primary care physician as a general practitioner, family practice practitioner, general internist, obstetrician, or gynecologist. All other physicians will be considered specialists for purposes of the 5 percent incentive payment. Section 1833(u) of the Act, as added by the MMA, specifically defines “physician” as one described in section 1861(r)(1) of the Act. This statutory provision does not include dentists, podiatrists, optometrists, and chiropractors.
To identify eligible specialist care scarcity areas, we would rank each county by its ratio of specialty physicians to Medicare beneficiaries. From the list of specialist care scarcity counties, only those counties with the lowest ratios that represent 20 percent of the total number of Medicare beneficiaries residing in the counties will be considered eligible for the 5 percent incentive payment.
For purposes of counties identified as having a shortage of primary care or specialty care physicians, section 1833(u)(5) of the Act also requires that, to the extent feasible, we treat a rural census tract of a metropolitan statistical area (as determined under the most recent modification of the Goldsmith Modification) as an equivalent area. The Goldsmith modification evolved from an outreach grant program sponsored by the Office of Rural Health Policy of HRSA. This program was created to establish an operational definition of rural populations lacking easy access to health services in Large Area Metropolitan Counties (LAMCs). Dr. Harold F. Goldsmith and his associates created a methodology for identifying rural census tracts located within a large metropolitan county of at least 1,225 square miles. Using a combination of data on population density and commuting patterns, census tracts were identified as being so isolated by distance or physical features that they are more rural than urban in character.
The original Goldsmith Modification was developed using data from the 1980 census. In order to more accurately reflect current demographic and geographic characteristics of the nation, the Office of Rural Health Policy, in partnership with the Department of Agriculture's Economic Research
Once all the full county PSAs are determined, we would identify, consistent with section 1833(u)(4)(C)of the Act, eligible PSAs by their 5-digit zip code area for the purpose of automatically providing the 5 percent incentive payment to eligible physicians. The zip code of the place of service is the only data element reported on the Medicare claim form that would allow automation. For zip codes that cross county boundaries, the statute specifically requires the use of the dominant county of the postal zip code (as determined by the U.S. Postal Service) if the Secretary uses the 5-digit postal zip code to identify areas eligible to receive the 5 percent payment. The statute also requires us to publish a list of eligible areas as part of the proposed and final physician fee schedule rules for the years for which PSAs are identified or revised and to post a list of PSAs on the CMS Website. Lastly, the statute provides no administrative or judicial review under sections 1869 or 1878 of the Act or otherwise, regarding the identification of a county or area, the assignment of a specialty of any physician, the assignment of a physician to a county, or the assignment of a postal ZIP Code to a county or other area.
In addition to the creation of the 5 percent PSA incentive payment, section 413 of MMA amended section 1833(m) of the Act to mandate that we automate payment of the 10 percent HPSA incentive payment to eligible physicians for full county HPSAs without a requirement for the physician to identify the HPSA involved. When automation is not feasible, consistent with section 1833(m) of the Act as amended by section 413(b) of MMA, we plan to post a list of HPSAs on our website. When automation is not feasible, the billing of modifiers would still be required.
The statute provides for no administrative or judicial review of the identification of a county or area, the assignment of the individual physician's specialty, the assignment of a physician to a county or the assignment of a zip code to a county or area.
As the statute prescribes, PSAs for primary care would be determined by the ratio of primary care physicians to the Medicare beneficiaries residing in that county or area. A primary care physician is defined by statute as a general practitioner, family practice practitioner, general internist, obstetrician, or gynecologist. The physician definition for determining primary care PSAs will be based on HRSA's physician designations for primary medical care HPSAs, which include all of the above physicians. In other words, the PSA definition for primary care will be identical to HRSA's, except for pediatricians. Furthermore, the statute provides that the primary care ratio include only primary care doctors in the active practice of medicine. Physicians whose practice is exclusively for the Federal Government or who provide only administrative services would not be included in the physician tally. PSAs for specialty care would be determined by the ratio of physicians who are not primary care physicians to the Medicare beneficiaries residing in that county or area. The specialist care PSA ratio would include all physicians other than primary care physicians as defined in the statute. To the extent feasible, we also plan to include rural census tracts of metropolitan statistical areas (as determined under the most recent modification of the Goldsmith Modification), as identified at the zip code level, with sufficiently low physician-to-Medicare population ratios as equivalent to qualified full county scarcity areas. The calculation of physician scarcity ratios is being made by the North Carolina Rural Research and Policy Analysis Center using the most current Medicare beneficiary and physician data available. At this time, the North Carolina Rural Research and Policy Analysis Center can only determine physician scarcity for Goldsmith areas at the zip code level due to the fact that Medicare beneficiary data is currently unavailable at the census tract level.
As previously discussed, section 1833(u) of the Act requires the automation of incentive payments for all PSAs, which we can only achieve by assigning zip codes to eligible areas. We propose the identification of qualified PSAs by zip code for automatic payment as follows:
• For zip codes that fall within a full county PSA, the bonus would be paid automatically.
• For full county PSAs, the dominant county of the 5-digit zip code, as determined by the U.S. Postal Service, would be used when the zip code area is not entirely located within the county. In some cases, a service may be provided in a county that is considered to be a PSA, but the zip code is not considered to be dominant for that area, which would not permit automation of the bonus payment. In order to receive the bonus for those areas, physicians would need to include a new physician scarcity modifier on the claim. We plan to establish and implement the new modifier through the Medicare Claims Processing Manual.
• For partial county PSAs (Goldsmith Modification), all zip code areas that are entirely located within the qualified Goldsmith area and all zip code areas that are partially located within a qualified Goldsmith area as long as the majority (51 percent) of the population located within the zip code area resides in the qualified Goldsmith area would be able to receive automatic payment.
Due to the complex nature of processing available physician and Medicare beneficiary data into a usable format to identify counties and areas with the lowest ratios, we cannot make available a list of PSAs within this proposed rule. We are working closely with HRSA and its contractors to publish these lists in the physician fee schedule final rule.
Similar to the Medicare HPSA bonus payment program, eligibility for receiving the 5 percent bonus payment would be based on whether the specific location at which the service is furnished is within an area that is designated as a PSA. Furthermore, the statute requires us to restrict eligibility for receiving the incentive payments for physicians' services furnished within primary care PSAs to general practitioners, family practice practitioners, general internists, obstetricians, or gynecologists. Also prescribed by statute, dentists, podiatrists, optometrists, and chiropractors are not eligible to receive incentive payments for PSAs. Section 1833(u) of the Act specifically defines a physician as one described in section 1861(r)(1) of the Act, which does not include dentists, podiatrists, optometrists, and chiropractors.
To conform our regulations to the statute, we are proposing to add § 414.66 to provide a 5 percent incentive payment to eligible physicians furnishing covered services in eligible PSAs. We propose to add § 414.66(a)(1) to specify that primary care physicians furnishing services in primary care PSAs are entitled to an additional 5 percent incentive payment above the amount paid under the physician fee schedule for their professional services furnished on or after January 1, 2005, and before January 1, 2008. The new incentive payment would apply to the professional services performed by physicians, including evaluation and management, surgery, consultation, and home, office and institutional visits. The technical component of physicians' services is not eligible because this component is not included in the definition of physicians' services at section 1861(q) of the Act as applied by the MMA. We are also proposing to add § 414.66(b) to specify that physicians, other than primary care physicians, dentists, podiatrists, optometrists, and chiropractors, furnishing services in specialist care PSAs are entitled to an additional 5 percent payment above the amount paid under the physician fee schedule for their professional services furnished on or after January 1, 2005, and before January 1, 2008.
As of January 1, 2005, most physicians eligible for the 10 percent HPSA incentive payment would no longer be required to determine whether their service areas are eligible for incentive payments and to modify their claims to receive those payments. The MMA requires us to automate bonus payments for physicians' services furnished in full county HPSAs.
Automation of full county HPSA incentive payments involves the same issues of automation as PSA incentive payments: the zip code of the place of service is the only data element reported on the claim form that would allow automation. Similarly, zip codes need to be cross-walked to full county HPSAs. The statute allows use of the same method of automation of incentive payments for full county HPSAs as for full county PSAs. We are proposing the identification of HPSAs by zip code for automatic payment as follows:
• For zip codes that fall entirely within a full or partial county HPSA, the bonus would be paid automatically.
• When the zip code area is not entirely located within the full county HPSA, only the dominant county of the 5-digit zip code as determined by the U.S. Postal Service would be used for automatically paying the HPSA incentive payment.
• For all other zip code areas that are not entirely, but are to some extent, located within a designated HPSA (full county or partial), we would require physicians furnishing services in these areas to bill for the incentive payments by using the appropriate modifier on their Medicare claims. We propose to post on our website, prior to January 1, 2005, a list of zip codes that fully fall within a designated HPSA and a list of zip codes that partially fall within a designated HPSA, so that physicians can determine whether they would need to bill using a modifier.
Determination of zip codes eligible for automatic HPSA bonus payment would be made on an annual basis, and there would not be any mid-year updates. We would effectuate mid-year revisions made to designations by HRSA the following year for automatic bonus payment purposes.
The Medicare HPSA Incentive Payment program, which the Congress established under OBRA 1987, was implemented through the Medicare Claims Processing Manual. This proposed rule would create § 414.67 to conform the regulations to the law, as amended by OBRA 1987 and 1989.
We propose in § 414.67 to provide a 10 percent incentive payment to eligible physicians furnishing covered services in eligible HPSAs. Section 414.67(a) would specify that physicians, regardless of specialty, furnishing services in a primary medical care HPSA are entitled to a 10 percent incentive payment above the amount paid for their professional services under the physician fee schedule. We would also create § 414.67(c) to specify that psychiatrists furnishing services in a mental health HPSA are entitled to a 10 percent incentive payment above the amount paid for their professional services under the physician fee schedule. Psychiatrists furnishing services in mental health HPSAs that do not overlap with primary care HPSAs are the only physicians eligible to receive the 10 percent incentive payment in those areas. In other words, these stand-alone mental health HPSAs are eligible areas for psychiatrists only to receive incentive payments.
Medicare Part B covers a limited number of prescription drugs and biologicals. For the purposes of this proposed rule, the term “drugs” will hereafter refer to both drugs and biologicals. Medicare Part B covered drugs generally fall into the following three categories:
• Drugs furnished incident to a physician's service.
• Durable medical equipment (DME) drugs.
• Drugs specifically covered by statute (for example, immunosuppressive drugs).
Section 303(c) of the MMA revises the payment methodology for Part B covered drugs that are not paid on a cost or prospective payment basis. In particular, section 303(c) of the MMA amends Title XVIII of the Act by adding section 1847A. Beginning in 2005, section 1847A of the Act establishes a new ASP drug payment system. In 2005, almost all Medicare Part B drugs not paid on a cost or prospective payment basis will be paid under this system.
The new ASP drug payment system is based on data submitted to us quarterly by manufacturers. For calendar quarters beginning on or after January 1, 2004, the statute requires manufacturers to report their ASP data to us for almost all Medicare Part B drugs not paid on a cost or prospective payment basis. Manufacturers' submissions are due to us not later than 30 days after the last day of each calendar quarter.
For further information on the submission of manufacturers' ASP data, see the interim final rule titled “Manufacturer Submission of Manufacturer's Average Sales Price (ASP) Data for Medicare Part B Drugs and Biologicals' published in the
The methodology for developing Medicare drug payment allowances based on the manufacturer's submitted ASP data is described in this proposed rule and reflected in proposed revisions to the regulations at § 405.517 and new Subpart K in part 414.
Beginning in 2005, section 1847A of the Act establishes an ASP payment system for certain drugs and biologicals
As described in section 1847A(b)(3)(A) of the Act for multiple source drugs and section 1847A(b)(4)(A) for single source drugs, the ASP for all drug products included within the same billing and payment code [or HCPCS code] is the volume-weighted average of the manufacturer's average sales prices reported to us across all the NDCs assigned to the HCPCS code. Specifically, section 1847A(b)(3)(A) of the Act and section 1847A(b)(4)(A) of the Act require that this amount be determined by—
• Computing the sum of the products (for each National Drug Code assigned to those drug products) of the manufacturer's average sales price and the total number of units sold; and
• Dividing that sum by the sum of the total number of units sold for all NDCs assigned to those drug products.
Note that in the following discussions, the term “manufacturer's ASP” refers to the ASP data submitted to us by manufacturers at the NDC level and the term “ASP” used in isolation refers to the weighted average sales price for all drug products included within the HCPCS [billing and payment] code.
Section 1847A(b)(5) of the Act requires that the ASP be determined without regard to any special packaging, labeling, or identifiers on the dosage form or product or package.
Section 1847A(b)(1)(A) of the Act requires that the Medicare payment allowance for a multiple source drug included within the same HCPCS code be equal to 106 percent of the ASP for the HCPCS code. This payment allowance is subject to applicable deductible and coinsurance. The payment limit is also subject to the two limitations described below in section III.E.1.b.v of this preamble concerning widely available market prices and average manufacturer prices in the Medicaid drug rebate program. As described in section 1847A(e) of the Act, the payment limit may also be adjusted in response to a public health emergency under section 319 of the Public Health Service Act in which there is a documented inability to access drugs and a concomitant increase in the price of the drug which is not reflected in the manufacturer's average sales price.
Section 1847A(b)(1)(B) of the Act requires that the Medicare payment allowance for a single source drug HCPCS code be equal to the lesser of 106 percent of the average sales price for the HCPCS code or 106 percent of the wholesale acquisition cost of the HCPCS code. This payment allowance is subject to applicable deductible and coinsurance. The payment limit is also subject to the two limitations described below in section III.E.1.b.v concerning widely available market prices and average manufacturer prices in the Medicaid drug rebate program. As described in section 1847A(e) of the Act, the payment limit may also be adjusted in response to a public health emergency under section 319 of the Public Health Service Act.
It has been brought to our attention that some physicians have concerns about their ability to purchase drugs at the Medicare payment amount of 106 percent of the ASP as these physicians believe that they are small purchasers of the Medicare Part B drugs subject to this proposed rule and do not have access to the average discounts. It is our understanding that many physicians are members of purchasing groups, which do obtain discounts on drugs. We encourage physicians to consider participating in such groups in order to achieve advantageous prices. We are interested in comments regarding the extent to which physicians can become members of such buying groups and the possible effects of doing so.
Section 1847A(d)(1) of the Act states that “The Inspector General of the Department of Health and Human Services shall conduct studies, which may include surveys, to determine the widely available market prices of drugs and biologicals to which this section applies, as the Inspector General, in consultation with the Secretary, determines to be appropriate.” Section 1847A(d)(2) of the Act states that “Based upon such studies and other data for drugs and biologicals, the Inspector General shall compare the average sales price under this section for drugs and biologicals with—
• The widely available market price for such drugs and biologicals (if any); and
• The average manufacturer price (as determined under section 1927(k)(1)) for such drugs and biologicals.”
Section 1847A(d)(3) of the Act states that “The Secretary may disregard the average sales price for a drug or biological that exceeds the widely available market price or the average manufacturer price for such drug or biological by the applicable threshold percentage (as defined in subparagraph (B)).” Section 1847A(d)(3)(B) states that “the term ‘applicable threshold percentage’ means—
• In 2005, in the case of an average sales price for a drug or biological that exceeds widely available market price or the average manufacturer price, 5 percent; and
• In 2006 and subsequent years, the percentage applied under this subparagraph subject to such adjustment as the Secretary may specify for the widely available market price or the average manufacturer price, or both.”
Section 1847A(d)(3)(C) of the Act states that “If the Inspector General finds that the average sales price for a drug or biological exceeds such widely available market price or average manufacturer price for such drug or biological by the applicable threshold percentage, the Inspector General shall inform the Secretary (at such times as the Secretary may specify to carry out this subparagraph) and the Secretary shall, effective as of the next quarter, substitute for the amount of payment otherwise determined under this section for such drug or biological the lesser of—
• The widely available market price for the drug or biological (if any); or
• 103 percent of the average manufacturer price (as determined under section 1927(k)(1)) for the drug or biological.”
Section 1847A(c)(4) of the Act states that “In the case of a drug or biological during an initial period (not to exceed a full calendar quarter) in which data on the prices for sales for the drug or biological is not sufficiently available from the manufacturer to compute an average sales price for the drug or biological, the Secretary may determine the amount payable under this section for the drug or biological based on—
• The wholesale acquisition cost; or
• The methodologies in effect under this part on November 1, 2003, to determine payment amounts for drugs or biologicals.”
Section 1841(o)(1)(A)(iv) of the Act requires that influenza, pneumococcal, and hepatitis B vaccines described in subparagraph (A) or (B) of section 1861(s)(10) of the Act be paid based on 95 percent of the average wholesale price (AWP) of the drug. These AWP payments, which will be updated quarterly, have not been revised by the ASP provisions.
Section 1881(b)(13)(A)(ii) of the Act indicates that payment for a drug furnished during 2005 in connection with the furnishing of renal dialysis services, if separately billed by renal dialysis facilities, will be based on the acquisition cost of the drug as determined by the Inspector General (IG) report to the Secretary required by section 623(c) of the MMA or, insofar as the IG has not determined the acquisition cost with respect to a drug, the Secretary shall determine the payment amount for the drug. In the report, “Medicare Reimbursement for Existing End-Stage Renal Disease Drugs,” the IG found that, on average, in 2003 the four largest chains had drug acquisition costs that were 6 percent lower than the ASP of 10 of the top drugs, including erythropoietin. A sample of the remaining independent facilities had acquisition costs that were 4 percent above the ASP. Based on this information, the overall weighted average drug acquisition cost for renal dialysis facilities is 3 percent lower than the ASP. Therefore, payment for a drug or biological furnished during 2005 in connection with renal dialysis services and separately billed by renal dialysis facilities will be based on the ASP of the drug minus 3 percent. This will be updated quarterly based on the ASP reported to us by drug manufacturers.
In 2005, section 1841(o)(1)(D)(i) of the Act requires an infusion drug furnished through an item of DME covered under section 1861(n) of the Act be paid 95 percent of the average wholesale price for that drug in effect on October 1, 2003.
Section 1848(c)(2)(J) of the Act (as added by section 303(a) of the MMA) requires the Secretary to promptly evaluate existing drug administration codes for physicians' services to ensure accurate reporting and billing for those services, taking into account levels of complexity of the administration and resource consumption. According to section 1848(c)(2)(B)(iv) of the Act (also as amended by section 303(a) of the MMA), any changes in expenditures in 2005 or 2006 resulting from this review are exempt from the budget neutrality requirement of section 1848(c)(2)(B)(ii) of the Act. The statute further indicates that the Secretary shall use existing processes for the consideration of coding changes and, to the extent changes are made, shall use those processes to establish relative values for those services. The Secretary is also required to consult with physician specialties affected by the provisions that change Medicare payments for drugs and drug administration.
In the January 7, 2004 interim final rule with comment (69 FR 1094), we indicated that the Physicians Regulatory Issues Team (PRIT) will review Medicare payment policy for drug administration and that we plan to consult with the AMA's CPT Editorial Panel and physician specialties affected by changes in payment for drugs and drug administration. We requested that the CPT Editorial Panel review all codes related to the administration of drugs and consider whether any revisions or additional codes are needed. At its February 2004 meeting, the CPT Editorial Panel established a workgroup, with representatives from affected specialties, to make recommendations on drug administration coding to the full Panel. In addition, the workgroup will be reviewing issues related to drug administration that were identified in the public comments on the January 7, 2004 Physician Fee Schedule rule. These comments raised the following two major issues:
1. Can the current coding distinction between chemotherapy and nonchemotherapy infusions allow for recognition of the resources needed to administer drugs with high toxicity or potential for serious side effects for diagnoses other than cancer? If not, are code revisions or new codes needed?
2. Does the current coding for chemotherapy administration capture all the support services provided by oncology practices for chemotherapy patients? If not, are code revisions or new codes such as a cancer management code needed?
There were also a number of specific comments on individual codes raised by some specialties such as urology and ophthalmology. On June 21, 2004, the workgroup held a public meeting to receive input and comments about drug administration code changes under consideration. The workgroup is expected to report to the full CPT Editorial Panel on all these issues at its August 2004 meeting. Once we review the CPT Editorial Panel's work on this issue, we will consider whether it is necessary for us to make coding changes effective January 1, 2005 through the use of G codes, since the 2005 CPT book will already have been published. While the CPT Editorial Panel's work on this issue is important to us, we finally determine coding policy for Medicare; we also would welcome public comments on these issues. We would also welcome comments concerning any alternative methods of allocating practice expenses to the drug administration codes. (
We also plan to analyze any shift or change in utilization patterns once the payment changes for drugs and drug administration required by MMA go into effect. While we do not believe the changes will result in access problems, we plan to continue studying this issue. We also note that the MMA requires the Medicare Payment Advisory Commission (MedPAC) to study items and services furnished by oncologists and drug administration services furnished by other specialties.
For clotting factors furnished on or after January 1, 2005, we propose to establish a separate payment of $0.05 per unit to hemophilia treatment centers and homecare companies for the items and services associated with the furnishing of blood clotting factor.
Section 303(e)(1) of the MMA requires the Secretary, after review of the January 2003 report to the Congress by the Comptroller General of the United States, to establish a separate payment to hemophilia treatment centers and homecare companies for the items and services associated with the furnishing of blood clotting factor. In the proposed rule, Payment Reform for Part B Drugs
We received comments from hemophilia organizations and specialty pharmacy providers of blood clotting factor. Most comments questioned our position to create a separate payment of $0.05 per unit, stating that this amount would jeopardize the ability of these facilities to adequately supply the clotting factor. Commenters were concerned that the $0.05 amount was too low and would cause many entities to discontinue providing the clotting factors and severely impact beneficiaries' access to clotting factor.
Based on a review of the General Accounting Office (GAO) report and data received from various clotting factor providers, we believe a separate payment amount of $0.05 per unit would cover the administrative costs associated with supplying the clotting factor. As outlined in the MMA, any separate payment amount established may include the mixing and delivery of factors, including special inventory management and storage requirements, as well as ancillary supplies and patient training necessary for the self-administration of these factors. The MMA states that, in determining the separate payment, the total amount of payments and these separate payments shall not exceed the total amount of payments that would have been made for the factors if the amendments in section 303 of the MMA had not been enacted. As indicated in the GAO report, “[w]hen Medicare's payment for clotting factor more closely reflects acquisition costs, we recommend that the Administrator establish a separate payment for providers based on the costs of delivering clotting factor to Medicare beneficiaries. Effective January 1, 2005, payment for blood clotting factors will more closely reflect acquisition costs as payment will be based on the average sales price as reported by drug manufacturers plus 6 percent.”
Therefore, in the absence of additional data, we believe that a separate payment amount of $0.05 per unit for the cost of delivering clotting factor is an appropriate amount beginning CY 2005 and we are proposing revisions to § 410.63 to reflect this amount. However, we are also seeking updated data and comments on the GAO report, as well as information on the fixed and variable costs of furnishing clotting factor. We recognize that there may be alternatives to a fee, which varies entirely based on the number of units of clotting factor furnished. We will closely examine all data and information submitted in order to make a final determination with respect to the appropriateness of the $0.05 per unit amount. That information will enable us to effectively determine the appropriateness of the $0.05 per unit amount.
Section 1842(o)(6) of the Act, as added by section 303(e)(2) of the MMA, requires the Secretary to pay a supplying fee (less applicable deductible and coinsurance) to pharmacies for certain Medicare Part B drugs and biologicals, as determined appropriate by the Secretary. The types of Medicare Part B drugs and biologicals eligible for a supplying fee are immunosuppressive drugs described in section 1861(s)(2)(J) of the Act, oral anticancer chemotherapeutic drugs described in section 1861(s)(2)(Q) of the Act, and oral anti-emetic drugs used as part of an anticancer chemotherapeutic regimen described in section 1861(s)(2)(T) of the Act. As discussed in the interim final rule published on January 7, 2004 (69 FR 1084), we considered this fee to be bundled into the current payment for these drugs for 2004 where payment is based on the Average Wholesale Price (AWP).
We propose to establish a separately billable supplying fee, effective January 1, 2005, when Medicare implements a different payment system for these drugs. We believe that a separately billable supplying fee of $10 per prescription is an appropriate level, beginning CY 2005. We received data suggesting various amounts for the supplying fee. Retail chain pharmacies suggested a supplying fee of $12 to $15 per prescription. These pharmacies stated that on average it cost between $10 to $12 to dispense a prescription to a Medicare beneficiary. However, when supplying immunosuppressive and oral anti-cancer drugs to Medicare beneficiaries, they argued that costs increase due to factors such as coordination of benefits activities. The specialty pharmacies that exclusively or largely furnish immunosuppressive drugs submitted data indicating that they believe a supplying fee of $44 (weighted average) to $56 (unweighted average) was appropriate. Pharmacies have pointed to the additional Medicare billing requirements as additional costs they had to incur, in the form of extra staff and time required to fulfill the billing requirements. We believe that a supplying fee of $10 per prescription is appropriate, especially when combined with the savings the pharmacy will experience with the clarification and elimination of the billing and shipping requirements, as described below.
We point out that if we were to establish a supplying fee of $44, then we expect that Medicare would be spending more money in 2005 on the supplying fees and immunosuppressive drugs than Medicare would have paid for immunosuppressive drugs in 2005 under the former system at 95 percent of AWP, when the supplying fee was bundled into payment for the drug.
Our goal is to assure that each beneficiary who needs covered oral drugs has access to those medications. We seek comments about the appropriateness of our proposed supplying fee amount as well as the components of a supplying fee that would assure beneficiary access to oral drugs. We believe that a supplying fee is intended to cover a pharmacy's activities to get oral drugs to beneficiaries. We seek data and information on the additional services these pharmacies provide to Medicare beneficiaries, the extent to which oral drugs can be furnished without these additional services and the extent to which such services are covered under Medicare. We seek comment about whether the supplying fee should be somewhat higher during the initial month following a Medicare beneficiary's transplant to the extent that additional resources are required for example, due to more frequent changes in prescriptions for immunosuppressive drugs.
We propose to clarify or eliminate the following billing requirements in an effort to reduce a pharmacy's costs of supplying covered immunosuppressive and oral drugs to Medicare beneficiaries:
•
•
•
It has been suggested that Medicare guidelines for refill prescriptions allowed too short of a window between shipping the next month's prescription and the end of the current month. It has been argued that, as a result, a pharmacy “effectively” had to ship the product to a beneficiary using an overnight delivery service.
As indicated in section III.N of this preamble, on January 2, 2004, we revised the guidelines (effective February 2, 2004) regarding the time frame for subsequent deliveries of refills of DMEPOS products to occur no sooner than “approximately 5 days prior to the end of the usage for the current product” (see section 4.26.1 of Chapter 4—Benefit Integrity of the Medicare Program Integrity Manual). This change allows shipping of refills on “approximately” the 25th day of the month in the case of a month's supply. We emphasize the word “approximately'; while we believe that normal ground service shipping would allow delivery in 5 days, if there were circumstances where ground service could not occur in 5 days, the guideline would still be met if the shipment occurs in 6 or 7 days. (“Days” refers to business days or shipping days applicable to the shipper, that is, a 6-day week in the case of the U.S. Postal Service.) We believe that this change eliminates the need for suppliers to use overnight shipping methods and allows shipping of drugs by less expensive ground service.
Section 1842(b)(6) of the Act requires that payment may only be made to the physician or other person who furnished a service, or to the beneficiary for whom services were furnished, unless certain specified exceptions are met. Prior to the enactment of section 952 of the MMA, Medicare did not permit the reassignment of payments for services provided by an independent contractor physician or nonphysician practitioner unless the services were performed on the premises of the facility or health care delivery system that submitted the bill. Therefore, if the services were furnished offsite, reassignment was prohibited (see section 1842(b)(6)(A)(ii) of the Act).
Section 1842(b)(6)(A)(ii) of the Act, as amended by section 952 of the MMA, allows a physician or nonphysician practitioner to reassign payment for Medicare-covered services, regardless of the site of service, as long as there is a contractual arrangement between the physician and nonphysician practitioner and the entity through which the entity submits the bill for those services. Thus, the services may be provided on or off the premises of the entity receiving the reassigned payments. The MMA Conference Agreement states that entities that retain independent contractors may enroll in the Medicare program. We note that the expanded exception created by section 952 applies to those situations when an entity seeks to obtain the medical services of a physician or nonphysician practitioner.
Section 952 states that reassignment is permissible if the contractual arrangement between the entity that submits the bill for the service and the physician or nonphysician practitioner who performs the service “meets such program integrity and other safeguards as the Secretary may determine to be appropriate.” The Conference Agreement supports appropriate program integrity efforts for entities with independent contractors that bill the Medicare program, including joint and several liability (that is, both the entity accepting reassignment and the physician or nonphysician practitioner providing a service are both liable for any Medicare overpayments). The Conference Agreement also recommends that physician or nonphysician practitioners have unrestricted access to the billings submitted on their behalf by entities with which they contract. We incorporated these recommended safeguards in a change to the Medicare Manual, implementing section 952 of the MMA that was published on February 27, 2004. We are proposing to revise § 424.71 and § 424.80 to reflect these safeguards, as well as the expanded exception established by section 952.
Given the myriad relationships and financial arrangements potentially permitted by section 952, the purpose of
We note that section 952 of the MMA revises only the statutory reassignment exceptions relevant to services provided in facilities and clinics (section 1842(b)(6)(A)(ii) of the Act). Arrangements involving reassignment must not violate any other applicable Medicare laws or regulations governing billing or claims submission, including, but not limited to, those regarding “incident to” services, payment for purchased diagnostic tests, and payment for purchased test interpretations.
In addition, physician group practices should be mindful that compliance with the in-office ancillary services exception to the physician self-referral prohibition requires that a physician who is engaged by a group practice on an independent contractor basis must provide services to the group practice's patients in the group's facilities. As noted in the Phase I physician self-referral final rule (66 FR 887), “[w]e consider an independent contractor physician to be “in the group practice” if (1) he or she has a contractual arrangement to provide services to the group's patients in the group practice's facilities, (2) the contract contains compensation terms that are the same as those that apply to group members under section 1877(h)(4)(iv) of the Act or the contract fits in the personal services exception, and (3) the contract complies with the reassignment rules * * * .” See also 66 FR 886. This test is codified at § 411.351 in the definition of “physician in the group practice.”
We are aware that the changes in the reassignment rules based on section 952 of the MMA may create new fraud and abuse vulnerabilities, which may not become apparent until the program has experience with the new contractual arrangements addressed in section 952 of the MMA. Parties should be mindful that contractual arrangements involving reassignment may not be used to camouflage inappropriate fee-splitting arrangements or payments for referrals. We are soliciting public comment on potential program vulnerabilities and on possible additional program integrity safeguards to guard against such vulnerabilities. We intend to monitor reassignment arrangements for potential program abuse.
Beginning for dates of service on or after January 1, 2004, Medicare pays for intravenous immune globulin administered in the home. This benefit is for the drug and not for the items or services related to the administration of the drug when administered in the home, if deemed medically appropriate. Manual instructions implementing this MMA provision have been issued and can be found at
We are proposing changes affecting payments to ESRD facilities that result from enactment of the MMA and would be effective January 1, 2005. Section 1881(b) of the Act, as amended by section 623 of the MMA, directed the Secretary to revise the current composite rate payment system. The statute has several major provisions that require the development of revised composite payment rates, as follows:
• An update of 1.6 percent.
• An add-on to the composite rate for the difference between current payments for separately billable drugs and biologicals and payments based on the revised drug pricing methodology using acquisition costs.
• Case-mix adjustments for a limited number of patient characteristics.
• Application of a budget neutrality adjustment. The statute also allows the Secretary to adjust the payment rates by a geographic index as the Secretary determines to be appropriate which would be phased-in over a multiyear period.
By January 1, 2005, we plan to implement the proposed revisions affecting the composite payment rate which would include the following:
• An increase of 1.6 percent to the basic composite payment rate.
• Proposed revisions to the pricing of separately billable drugs and biologicals.
• A drug add-on to the composite rate to reflect the difference between current payments for separately billable drugs and biologicals, and payment based on the revised drug pricing methodology using acquisition costs.
We propose to implement the patient characteristics adjustments and the related budget neutrality adjustments by April 1, 2005. (
Section 2991 of the Social Security Amendments of 1972 (Pub. L. 92-603), established Medicare's End Stage Renal Disease (ESRD) Program. This law extended Medicare coverage to individuals who have permanent kidney failure, require either dialysis or transplantation, and meet certain other eligibility requirements. The End Stage Renal Disease Program Amendments of 1978 (Pub. L. 95-292) added section 1881(b)(2)(B) to title XVIII of the Act.
That legislation provided for the establishment of a prospective reimbursement methodology for the payment of dialysis treatments provided by renal dialysis facilities. Further changes to the ESRD payment system were made by section 2145 of Pub. L. 97-35, which amended section 1881 of the Act, requiring the development of a prospective reimbursement system for outpatient maintenance dialysis that promotes home dialysis. The payment system required either the reimbursement of home dialysis and in-facility dialysis under “composite” rates, or the use of some other more efficient method determined to promote home dialysis more effectively.
On February 12, 1982, we published a proposed rule on reimbursement for outpatient maintenance dialysis services (47 FR 6556) and we published the final rule on May 13, 1983 (48 FR 21254). This regulation implemented section 1881 of the Act, as amended by section 2145 of Pub. L. 97-35, and provided that each ESRD facility will receive a fixed composite payment rate per dialysis treatment, adjusted for geographic differences in area wage levels. Payment for in-facility and home dialysis treatments was established using a composite payment rate reflecting the costs of both modalities. Separate composite payment rates were established for hospital-based and independent dialysis facilities. The regulation also included a process under which facilities could obtain exceptions
The average composite payment rate per treatment, effective on August 1, 1983, was $123 for independent ESRD facilities and $127 for hospital-based facilities. The composite rate was designed to provide payment for a package of goods and services needed to furnish dialysis treatments that included certain routinely provided drugs, laboratory tests, supplies, and equipment. Unless specifically included in the composite payment rate, other injectable drugs and laboratory tests medically necessary for the care of the dialysis patient are separately billable.
Prior to January 1, 2004, drugs not paid on a cost or prospective payment basis were paid based on the lower of the actual charge or 95 percent of the AWP (section 1842(o)(1) of the Act, as added by section 4556 of the BBA of 1997 (Pub. L. 105-33)). Sections 303 through 305 of the MMA make revisions to payment methodology for Part B covered drugs that are not paid on a cost or prospective payment basis. For CY 2004, the MMA provides that drugs not paid on a cost or prospective payment basis will be paid at 85 percent of the AWP determined as of April 1, 2003. However, there are several exceptions to this general rule, including payment of ESRD drugs and biologicals. In CY 2004, drugs and biologicals furnished in connection with the furnishing of renal dialysis services if separately billed by renal dialysis facilities are paid at 95 percent of AWP. We note that hospital-based ESRD facilities are paid reasonable costs for separately billable drugs, except for Erythropoietin/Epoietin (EPO).
EPO is an anti-anemia drug administered to certain patients with ESRD. Medicare Part B pays for EPO and its administration if it is furnished by an approved ESRD facility as part of an outpatient dialysis service or by a supplier of home dialysis equipment and supplies to ESRD patients in their homes as part of home dialysis services. Most dialysis is furnished to ESRD patients on an outpatient basis or is self-administered in the home.
Section 1881(b)(11) of the Act expressly excludes payment for EPO furnished to ESRD patients from the composite rate for dialysis services. The costs of EPO are, therefore, billed separately by an ESRD facility or by a supplier of home dialysis equipment and supplies and are paid in addition to the facility's composite rate. Any EPO-related costs, such as the cost of its administration or overhead costs associated with its storage, however, are subsumed in the facility's composite rate.
Section 413.174(f)(3) requires that we prospectively determine the EPO amount pursuant to section 1881(b)(11)(B)(ii) of the Act. Section 4201(c) of the Omnibus Budget Reconciliation Act of 1990 (OBRA 90) (Pub. L. 101-508), however, amended section 1881(b)(11) of the Act to establish a new EPO payment methodology. OBRA 90 directed, effective January 1, 1991, that payment for EPO furnished to ESRD patients by Medicare-approved dialysis facilities or suppliers of home dialysis equipment and supplies for home use be made on a per-unit basis. OBRA 90 also established a maximum payment amount of $11 per 1,000 unit doses rounded to the nearest 100 units. Subsequently, section 13556(a)(2) of OBRA 93 was enacted, which further amended section 1881(11)(b)(B)(ii) of the Act to reduce the maximum payment level to $10 per 1,000 units effective January 1, 1994. Although we have the authority to revise the rate, we continue to pay at the rate of $10 per 1,000 units.
Section 9335(a) of Pub. L. 99-509 required the Secretary to reduce the initially established composite payment rates by $2.00 per treatment effective October 1, 1986. This reduction was partially reversed as a result of the enactment of section 4201(a)(2) of Pub. L. 101-508, which increased the composite payment rates in effect as of September 30, 1990 by $1.00 per treatment, but effectively froze the methodology for their calculation, including the data and definitions used, as of that date. Section 222 of Pub. L. 106-113, provided for a 1.2 percent increase to the payment rates effective January 1, 2000, and also provided for another 1.2 percent increase effective January 1, 2001. Section 422(a)(1) of Pub. L. 106-554, raised the amount of the January 1, 2001 payment increase by another 1.2 percent for a total increase of 2.4 percent effective January 1, 2001.
Section 422 of Pub. L. 106-554 also directed the Secretary to develop a Prospective Payment System (PPS) that expanded the bundle of routine services reflected in the composite rate to include separately billable laboratory tests and drugs “to the maximum extent feasible”. In addition, section 422(a) of Pub. L. 106-554 prohibited the granting of new composite rate payment exceptions for services furnished after December 31, 2000. Because a bundled ESRD payment system must be periodically updated, section 422(b) of Pub. L. 106-554 also required the development of an ESRD market basket to account for changes in price inflation, with discretionary consideration of other factors known to affect costs. Section 422(c) of Pub. L. 106-554 mandated the submission of a report to the Congress on the bundled payment system and ESRD market basket.
On May 12, 2003, the Secretary submitted the required report to the Congress. The report explained the major issues that must be addressed before a bundled ESRD PPS can be implemented, presented an ESRD composite rate market basket, and discussed the results from the first phase of our sponsored research to develop a bundled payment system. The report presented the following three major findings that are relevant to our efforts to revise the composite rate payment system:
• Current data sources are adequate for proceeding to develop a bundled ESRD PPS.
• Case-mix may be an important variable for risk adjusting payments, based on preliminary analysis.
• Current data provide a sound basis for monitoring patient outcomes in a revised ESRD payment system.
The following provisions in section 623 of the MMA, effective January 1, 2005, affect the composite payment rate methodology, as well as the pricing methodology for separately billable drugs and biologicals furnished by ESRD facilities:
a.
b.
c.
• Adjustments for a limited number of patient characteristics.
• An adjustment that reflects the difference between current payments for
• A geographic adjustment, if the Secretary determines such an adjustment is appropriate with the possibility of a phase-in.
• A budget neutrality adjustment, so that aggregate payments under the basic case-mix adjusted composite payment rates for 2005 equal the aggregate payments that would have been made for the same period if section 1881(b)(12) of the Act did not apply.
The current composite payment rates applicable to urban and rural hospital-based and independent ESRD facilities were effective January 1, 2002. The current wage-adjusted rates for each urban and rural area were published in Tables III and IV of Program Memorandum A-01-19 issued February 1, 2001 and are applicable through the end of 2004. Section 623(a)(3) of the MMA requires that the composite rates in effect on December 31, 2004 be increased by 1.6 percent. We are publishing revised wage-adjusted composite rates that reflect the statutorily required 1.6 percent increase. Those rates are set forth in Tables I and II at the end of this section. These tables reflect the updated hospital-based and independent facility composite rate of $132.40 and $128.35, respectively, adjusted by the current wage index. The rates will be effective January 1, 2005. The rates shown in the tables do not include any of the basic case-mix adjustments required under section 623 of the MMA.
Section 623(d) of the MMA requires the Secretary to establish a basic case-mix adjusted PPS for dialysis services that are furnished beginning on January 1, 2005 by providers of services and renal dialysis facilities to individuals in a facility and to individuals at home. This system will include services comprising the composite rate as well as the difference between payment amounts for separately billed drugs and biologicals (including erythropoietin) furnished by ESRD facilities and acquisition costs of such drugs and biologicals as determined by the OIG reports from the studies mandated by section 623(c) of the MMA.
For 2004, the payment amounts for separately billed drugs and biologicals (other than erythropoietin) furnished by ESRD facilities are determined by 95 percent of AWP. For 2005, the payment amounts for separately billed drugs and biologicals (including erythropoietin) furnished by ESRD facilities are described in section III.E of the NRPM. Insofar as the acquisition cost has not been determined by the OIG, then the Secretary shall determine the payment amount of the drug and biological.
For 2005 and subsequent years, the payment amounts for separately billed drugs and biologicals (including erythropoietin) furnished by ESRD facilities will be the acquisition cost or the amount that is derived from the ASP methodology in section 1847A of the Act, as the Secretary may specify.
See section III.E.1.d. of this proposed rule for further explanation of payment for separately billable drugs and biologicals furnished by renal dialysis facilities.
Section 1881(b)(12) of the Act, as added by section 623(d) of the MMA, contains two provisions that specify how the drug add-on adjustment is to be handled in the revised ESRD payment system. First, subparagraph (B)(ii) of such section requires an adjustment to the composite payment rates to account for the difference between payment amounts for separately billed drugs (including erythropoietin) under the current payment system and acquisition costs as determined by the OIG. Second, subparagraph (E)(i) requires that the drug add-on adjustment be budget-neutral, that is, that it be designed to result in the same aggregate amount of expenditures as would have been made without the statutory policy change.
We need to determine the composite rate adjustment for drug add-on amount that simultaneously deals with both statutory requirements. That is, the aggregate amount of the composite rate adjustment for drug add-on amount needs to equal the aggregate amount of the drug spread (the difference between drug payments under the old system and acquisition costs).
In order to ensure that we satisfy both constraints, it is necessary to consider the proposed drug pricing in developing the adjustment to the composite rates. As discussed in section III.E.1.d. of this proposed rule, we are proposing to pay for separately billable ESRD drugs using ASP minus 3 percent based on the average relationship of acquisition costs to average sales prices from the drug manufacturers as outlined in the OIG report. We have developed the proposed drug add-on adjustment using the ASP minus 3 percent drug prices. Section 2 below discusses the details of the calculation of the drug add-on adjustment. An alternative approach would be to use the 2003 acquisition prices from the OIG report, calculate the aggregate difference between such prices and payments for drugs under the AWP system, update this difference to 2005 and then apply the budget neutrality adjustment. Because the same budget-neutrality adjustment would be used in both calculations, we believe that the drug add-on adjustment for the drug spread would be the same with both approaches. Therefore, we are proposing to use the ASP minus 3 percent prices as the basis for developing the drug add-on adjustment to the composite rate.
Currently, separately billable ESRD drugs are paid differently to hospital-based and independent ESRD facilities. EPO is currently the only drug for which payment is uniform across ESRD facilities; EPO is paid at the current rate of $10 per 1000 units. All other separately billed ESRD drugs provided by independent ESRD facilities are currently paid 95 percent of AWP prices. However, hospital based ESRD facilities are paid their reasonable cost for the other separately billed drugs they provide. Because they are paid on cost, hospital-based facilities have not made the profits from drug payment that independent facilities have enjoyed.
The statutory language describing the add-on adjustment to the composite rate does not specifically differentiate between hospital-based and independent facility composite rate adjustments. However, the drug add-on provision is included with the other provisions related to the basic case-mix adjusted composite rate system; thus, it could be argued that the drug add-on provision was intended to address ESRD industry concerns about the inadequacy of the composite payment rate. We believe these concerns apply equally to hospital-based facilities and independent facilities. Therefore, we are proposing a single adjustment to the composite payment rates for both hospital based and independent facilities.
An alternative option would be to develop a separate adjustment for hospital-based facilities for EPO and one for independent facilities for all of their separately billed drugs. The IG's report provided the acquisition costs we are
To develop the drug add-on adjustment we used historical total aggregate payments for separately billed ESRD drugs for half of 2000 and all of 2001 and 2002. For EPO, these payments were broken down according to type of ESRD facility (hospital-based versus independent). We also used the number of dialysis treatments performed by these two types of facilities over the same period.
We updated the ASP minus 3 percent prices, for the first quarter of 2004, to represent 2005 prices. We used the projected annual price growth factor for National Health Expenditure prescription drugs of 3.39 percent.
We updated the first quarter 2004 Medicare payment amounts (95 percent of AWP), based on the January 2004 Single Drug Pricer, for drugs other than EPO, to estimate 2005 payment amounts by using an estimated AWP growth of 3 percent. These growth factors are based on historical trends of AWPs. We did not increase the price for Epogen since payment was maintained at $10.00 per thousand units prior to MMA.
We updated the number of dialysis treatments by actuarial projected growth in the number of ESRD beneficiaries. Since Medicare covers a maximum of three treatments per week, utilization growth is limited, and therefore any increase in the number of treatments should be due to enrollment. In 2005, we project there will be a total of 36.5 million treatments performed (5.1 million treatments will be performed by hospital-based facilities and 31.4 million treatments by independent facilities).
We updated the total aggregate Epogen drug payments for each hospital-based and independent facilities using historical trend factors. For 2003 through 2005, the 2002 payment level was increased each year by trend factors of 2.8 percent for hospital-based facilities and by 9.4 percent for independent facilities.
Using drug growth factors for drugs paid for by Medicare Part B carriers, which were calculated from historical data, we updated the aggregate spending for separately billable drugs, other than EPO, for independent facilities. We used 24.7 percent for 2003, 23.3 percent for 2004, and 21.4 percent for 2005 as factors because historical growth of ESRD drugs is similar to that for drugs paid for by Part B carriers. These factors are projected to approach the level of National Health Expenditure prescription drug growth. For 2005, we estimate that spending will reach $185 million for Epogen provided in hospital-based facilities, and $2,664 million for drugs provided in independent facilities ($1,568 million for Epogen and $1,096 million for other drugs).
For each of the ten drugs, we calculated the percent by which ASP minus 3 percent prices are projected to be less than reimbursement amounts under the current system for 2005. For Epogen, this amount is 10 percent. We applied this 10 percent figure to the total aggregate drug payments for Epogen in hospital-based facilities, resulting in a difference of $18 million. We then calculated a weighted average of the percentages by which ASP minus 3 percent would be below current Medicare reimbursement prices for the top 10 ESRD drugs. We weighted these percentages by using the 2002 Medicare reimbursement values contained in the OIG report for the ten drugs. This procedure resulted in a weighted average of 19 percent. Since these ten drugs represented 98 percent of drugs payments, we applied the weighted average to 100 percent or all of aggregate drug spending projections for independent facilities, producing a projected difference of $516 million.
Combining the 2005 figures of $18 million and $516 million, for a total of $534 million and then distributing this over a total projected 36.5 million treatments would result in a single add-on to the per treatment composite rate
Alternatively, we could produce separate drug add-on adjustments for hospital-based and independent facilities using the same methodology. Under this option, we could distribute the $18 million difference in EPO payments to hospital-based facilities based on data projecting 5.1 million treatments resulting in a hospital-based facility drug add-on adjustment of 2.7 percent. We would distribute the $516 million difference in drug payments (including EPO) to independent facilities using projected treatments of 31.4 million, resulting in a drug add-on adjustment of 12.8 percent for independent facilities.
Drug prices used in the computation of the proposed drug add-on adjustment to the ESRD composite payment rate, may be revised based on later data and will be reflected in the final rule.
We used a single drug add-on adjustment for both hospital-based and independent ESRD facilities, the proposed adjustment to the composite rate would be 1.113. Separate adjustments would provide a 1.128 adjustment for independent facilities and 1.027 for hospital-based facilities. The following table illustrates the effect on the composite payment rates under the two potential drug add-on options. (Case-mix budget neutrality adjustments are not reflected in this table).
Under the single add-on, the proportionately higher rate for hospital-based facilities would be consistent with section 1881(b)(7) which requires that our payment methods differentiate between hospital-based facilities and others. Separate add-on adjustments would result in a significantly higher composite payment rate for independent facilities, than hospital-based facilities, that is, $8.79 higher per treatment.
The current ESRD composite payment rates do not adjust for variation in patient characteristics or case mix. Section 1881(b)(12)(A) of the Act, as added by section 623(d)(1) of the MMA, requires that the outpatient dialysis services included in the composite rate be case-mix adjusted. Specifically, the statute states that “The Secretary shall establish a basic case-mix adjusted prospective payment system for dialysis services furnished by providers of services and renal dialysis facilities in a year to individuals in a facility and to individuals at home. The case-mix under the system would be for a limited number of patient characteristics.” In the following sections, we describe the development of the methodology for the proposed patient characteristic case-mix adjusters required under the MMA.
Case-mix measures utilizing patient characteristics have been used in a number of prospective payment systems. Use of a case-mix measure permits targeting of greater payments to facilities that treat more costly resource-intensive patients. However, the legislative mandate to establish a case-mix adjustment for services included in the composite rate based on a limited number of patient characteristics presents a unique challenge.
The composite rate represents payment for a fixed bundle of routine services provided to ESRD patients as part of a dialysis treatment. Generally, the items and services needed to provide a dialysis treatment do not vary significantly across patients. Moreover, the bills for composite payment rate services furnished to ESRD patients, which are generally submitted monthly, do not identify the specific items and services provided on a case-by-case basis. In addition, the Medicare cost reports identify only aggregate costs for composite rate services at the facility level. Therefore, any case-mix adjustment based on patient characteristics obtained from the bills for outpatient ESRD services and applied to the composite rate will reflect only variation in composite rate costs at the facility level.
Earlier research by Hirth (1999) and Dor (1992) found that if case-mix adjustments applied only to composite rate items and services the adjustments played a limited role in predicting variation in costs per treatment because case-mix and dialysis treatment patterns are very similar across facilities. However, more recent analyses conducted under our contract with the University of Michigan, Kidney, Epidemiology and Cost Center (KECC) found that patient level case-mix adjustment would be more relevant in a bundled payment system that includes both composite rate and separately billable items and services. KECC's research studies relied on an extensive set of variables to define patient case-mix. These variables included patient characteristics, a large number of specific comorbidities and clinical measures (including primary diagnosis) and other (non-Medicare) insurance coverage, as well as the duration of ESRD. We relied on linear regression analyses used in the studies to assess the relationship of patient characteristics and comorbidity measures to per session cost and Medicare payments to facilities. These studies relied on data from our administrative files.
We are continuing and expanding the research project in support of the development of a fully bundled case-mix adjusted system. We are continuing to explore alternative models and options with more detailed analysis of patient characteristics as part of the legislatively mandated report to the Congress in the fall of 2005.
Despite the difficulty in developing a patient characteristic case-mix adjustment, we were able to develop case-mix adjustment factors for a limited number of patient characteristics, consistent with the legislative mandate. As expected, these adjusters are only modest predictors of variation in average costs for composite services. In developing the proposed patient characteristic adjustments, we used our available administrative data. Because facilities do not list individual composite rate items and services on the dialysis bill, billing data do not identify resources used by each patient. In
Nonetheless, we found selected variables from the Form 2728 to be valid predictors of cost per treatment for the proposed case-mix adjustment, and the Form 2728 was also useful in developing our proposed case-mix adjustments. As discussed below, the Form 2728 variables were supplemented by additional information we obtained from billing records.
We are proposing a methodology to establish a basic case-mix adjusted composite rate system using a limited number of patient characteristic variables developed from existing our administrative files. We analyzed a number of patient level variables including age, gender, alcohol and drug dependence, inability to ambulate/transfer, current smoker, number of years since ESRD onset, weight, height, mean BUN, and mean creatinine clearance, as well as a number of comorbidities.
As a means to estimate how average cost variations among facilities are influenced by selected patient characteristics, extensive analyses were performed to develop a proposed “basic case-mix adjusted PPS, for a limited number of patient characteristics,” as specified in the statute. We analyzed the average cost per dialysis session (including both hemodialysis and Method I peritoneal dialysis converted to equivalent 3 times per week hemodialysis sessions) from national data gathered for the years 2000, 2001, and 2002.
A stepwise regression was used to select a limited set of variables that were predictive of average facility cost per treatment. We used data pooled over a three-year period because we found the regression coefficients to reflect a consistent pattern over three years. We used data pooled over a three-year period to minimize the potential for volatility in the regressive coefficients. The analysis controlled for selected variables that influence facility costs, but are not case-mix related. These variables included wage index, the natural log of the number of dialysis sessions provided annually by the facility, type of facility, chain affiliation, and percentage of patients with urea reduction ratio (URR) as a measure of dialysis dose equal to or greater than 65 percent. The proposed model is based not only on the predictive power of these measures, but also upon objectivity (for example, discrete variables: age/gender), clinical plausibility, and practicality (that is, availability) of data collection. The variables used were assessed for their clinical plausibility by clinicians from the University of Michigan and CMS. Physicians assessed a proposed list to determine relationship of the proposed comorbidities to ESRD patients, and clinical practice/patterns.
In addition to exploring a number of potential case-mix variables, we examined two methods, that is, linear and log linear models of the composite rate costs. We selected the log linear model in order to yield patient specific case-mix adjustments which can be multiplied by a dialysis facility's otherwise applicable composite rate payment. In this proposed rule, we provide a detailed example of the calculation of the proposed case-mix adjusted composite rate payments.
As discussed in the background section above, the basic case-mix system is constrained by the composite rate and the data available for these adjustments. While we analyzed a number of variables, four patient characteristic variables were found to be modest predictors of cost variation among ESRD facilities. These patient characteristic variables include gender, age, and two comorbidities (AIDs and PVD) (See table 3 for specific ICD 9 codes for these comorbidities). Each of the gender categories was also divided into three age categories so that one adjustment factor could be developed to encompass both gender and age. The proposed patient characteristic adjustments are discussed below.
We are proposing adjustments for both gender and age. We found that gender and age were strong predictors of facility cost variations. In addition, data on gender and age are readily available, and are objective measures. After examining a number of options for age, we are proposing under 65, 65-79, and over 80 as the three categories for age. We attempted to develop a case-mix adjuster specific to the under 18 age group. However, the population in that age group that was included in the data used to develop the case-mix adjustments was too small, and was generally concentrated in a very small number of facilities.
While we recognize that pediatric patients are more costly to treat, those patients are generally treated in specialized pediatric facilities. As provided in MMA, those facilities can request adjustments to their composite payment rates through the exceptions process. This process will enable pediatric facilities to obtain payments that specifically recognize the higher cost associated with treating these patients. In developing the age adjustments, data for those patients were grouped into the under 65 age category. We note that adjustments for both gender and age are consistent with the MA risk adjustment models for ESRD patients.
As discussed above, the effect of the costs of dialysis for a number of conditions were analyzed. These included several comorbidities that did not have a statistically significant relationship to facility costs. In other cases, the lack of data precluded inclusion of a comorbid condition in the proposed patient characteristic adjustments. That is, we are unable to propose any adjustments based on data that cannot be routinely reported, (for example, some data elements that are reported only on the Form 2728). For the reasons discussed above, the Form 2728 is not an appropriate source of information since it is not updated after a patient enters the ESRD program. Two variables not currently available on the Medicare bill are weight and height. Weight and height are used to compute a patient's body mass index (BMI). Our analysis indicates that patients with extremely low or high BMI are costly to treat. Since BMI is directly related to a patient's dialysis prescription, we believe this factor could be an important measure of resource consumption related to the composite payment rate. We also believe that the length of time a patient is dialyzed could directly affect composite rate costs. We are currently exploring the feasibility of developing a mechanism to collect these data on the ESRD bill. In addition, we are soliciting comments on other data elements that could be added to the bill
We also examined whether having cancer was predictive of higher resource used. We examined all cancers reported within the last 3 to 10 years as reported on our claims history file or the Form 2728. While a patient's history of cancer was associated with higher costs, we found this measure to be too broad to be clinically meaningful. We will continue to evaluate this condition as a potential variable for refinement purposes. As ESRD facilities begin reporting patient comorbidities, we expect that we will be in a better position to identify the specific cancer diagnoses that may be related to increased composite rate costs.
We also explored whether diabetes as a comorbidity is predictive of high resource use. We found that the predictive power of diabetes was dependent on whether PVD was part of the model. PVD was always statistically significant, when accounted for, while most measures of diabetes were not strongly associated with facility costs. Therefore, we are proposing a case-mix adjustment for PVD diagnoses. We believe this adjustment appropriately addresses the higher costs associated with sicker diabetic patients. We note that about 73 percent of diabetes patients included in our data also had PVD. Another comorbid condition that was found to be a significant predictor of facility cost is AIDs. This diagnosis is currently coded as part of the claims data.
Another Form 2728 variable we examined was the presence of a substance (alcohol and drugs) dependence diagnosis. While the presence of substance abuse was found to be predictive of higher facility level costs, we are not proposing an adjustment for this comorbidity at this time since the substance abuse diagnosis is underreported on the claims. We are soliciting comments on the variables included in the proposed patient characteristic adjustment as well as recommendations for the inclusion of other potential variables that may affect the costs of dialysis.
In summary, we are proposing to use a limited number of patient characteristics that do explain variation in reported costs for composite rate services consistent with the legislative requirement. The proposed adjustment factors are as follows:
While the magnitude of some of the patient specific case-mix adjustments appears to be significant, facility variation in the case-mix is limited. This is because of the overall similarity of the distribution of patients among the eight case-mix classification categories across facility classification groups. This is reflected by the average case-mix adjustment based on 2002 data for the various types of ESRD facilities shown in the table below.
As illustrated from this table, regardless of the type of provider, the average case-mix adjustments for patient characteristics do not vary significantly. We are continuing research to develop a more fully bundled proposed model that is not constrained by the existing composite rate. We will continue to study the predictive value of comorbidities and facility and patient level variables as part of the ongoing research. In addition, we are aware that by limiting the number of variables for the patient characteristics adjustment applicable to the composite payment rate, we are limiting the predictive power of the model. We are planning to consider additional variables to refine and update the proposed patient characteristics. Once we have implemented this basic case-mix system, we will continue to analyze comorbidities (on the reported claims file) and will consider expanding the list of variables used in the patient classification adjustment. In addition, we will be working with our fiscal intermediaries to improve the reporting of comorbidities on claims.
Both facility and patient level variables were used for the development of the proposed case-mix adjustment. Facility costs are based on Medicare allowable costs reported by facilities for dialysis and related services for which they are reimbursed through the composite rate. The sources of the cost data are the Medicare Independent Renal Dialysis Facility Cost Reports (Form CMS 265-94) and the Medicare Hospital Cost Reports (Form CMS 2552-96). We used the most current set of facility cost reports available (cost reports updated through December 2003 and made publicly available in March 2004).
All cost reports spanning any part of calendar years 2000, 2001 or 2002 were included in the development of the case mix adjusters. While for most facilities, especially independent facilities, a single cost report encompasses the entire calendar year; data for some facilities, most notably those whose reporting period spans two calendar years (for example, October through September rather than January through December) were pro-rated to calculate the average treatment cost during a calendar year. The resulting numbers of cost reports used in the analyses are shown in the table below by facility type and year. Note that currently there are fewer cost reports available for analysis in 2002 because many facilities have not yet submitted cost reports for that year. The final version of this regulation will contain the most recent data available.
The average treatment cost per dialysis session for each facility was calculated by dividing the total reported cost for dialysis and related services by the total number of dialysis treatments. The source of the reported cost for independent facilities was Worksheet B from Form CMS 265-94 and, for hospital-based facilities, Worksheet I-2 (Form CMS 2552-96). The source for the total number of dialysis treatments for independent facilities was worksheet Form CMS265-94 and, for hospital-based facilities, worksheet I-4 (Form CMS 2552-96). Note that, for CMS Form 2552-96 and CMS Form 265-94, values
This method created an average Medicare allowable cost per dialysis treatment for each facility year of observation. Using the facility's Medicare billing number, cost report data were linked to claims data. For some facilities more than one billing number appears on claims and a list of correspondence among billing was used to link the claims to the cost report facility identifiers. This linkage was somewhat ambiguous for hospital facilities with satellite centers.
Patient level data was obtained from the Medicare claims data, and the Medical Evidence Form (CMS 2728). ESRD patients were identified using the Renal Beneficiary and Utilization System (REBUS), Medical Evidence and Master Patient File Records. Dialysis-related services (for example, the number of dialysis sessions) were identified for ESRD patients by Billing source (72x: renal dialysis facility bills), revenue center codes and the Healthcare Common Procedure Coding System (HCPCS).
Regression models for the average cost per session were used to estimate the typical cost per session. The average cost per session can be influenced by facilities with exceptional costs or with exceptional case-mix measures. To insure that the sample would characterize the patterns across the majority of facilities rather than being influenced by a few exceptional, non-representative facilities, the following facilities were excluded:
• Facilities with missing data from the cost reports or claims data. Twelve percent of the facilities lacked reported data.
• Facilities with high or low average costs.
• Facilities with exceptions.
• Facilities with extremely high or low proportions of patients with relevant medical cormorbidities.
• Small facilities.
Facilities with high or low average costs were determined based upon their composite rate. Facilities, having values for the log of the ratio of average costs to the composite rate of less than minus 0.5 or greater than 1.0 were excluded. This excluded less than 1 percent of facilities. Some facilities, that is, those with extremely high or low values based on selected patient characteristics (for example, percent of patients having a specific comorbidities such as AIDs, HIV, or alcohol and drug dependence) and selected facility characteristics (for example, facility size or URR). As with average costs, facilities with extreme variables did not represent the normal distribution of patient characteristics across facilities. This excluded 1.6 percent of the facilities. In addition, we excluded small facilities with less than 20 full patient years of dialysis during the year because it was difficult to assess the relationship between case-mix and facility costs based on the experience of a small number of patients. Facilities treating a small number of patients represented approximately 6.9 percent of the total facilities.
The sample excluded facilities with exceptional reimbursement levels. These included facilities with exceptions, facilities with higher than average payments, for example, with $3.00 or greater than the predicted composite rate payments. We excluded facilities based on our list of exceptions granted from November 1993 to July 2001. Some facilities were not included within the sample because their average payments were greater than the calculated (predicted) composite rate for the individual facility. While for the majority of the facilities, average composite rate payments were exactly as predicted, for some facilities, the payments were $3.00 greater than the predicted rate. These facilities were excluded because they were likely to be facilities with errors in reporting or facilities with exceptions. Of all of the facilities in the sample, 7.5 of the facilities were excluded from the sample.
Facility-level case-mix measures were defined using certain demographic and comorbidity indicators for the Medicare dialysis patients in each facility for CYs 2000 to 2002. In aggregating patient data by facility, case-mix measures for each patient were weighted by the number of hemodialysis-equivalent dialysis sessions received in each facility. This process gives approximately 12 times as much weight to the characteristics of patients receiving a full year of dialysis care at a particular facility as compared to a patient receiving only one month of care at that facility. The resulting facility-level case-mix measures reflect how case-mix is distributed across individual treatments provided in the facility for Medicare dialysis patients. The number of dialysis sessions for each patient in each facility was obtained from Medicare outpatient institutional dialysis claims. The number of peritoneal dialysis patient days reported on each claim was multiplied by 3/7 to yield the number of hemodialysis-equivalent dialysis sessions provided during the time period covered by each claim. (For additional information see Phase I KECC Report, dated August 2002, p. 43).
We explored a number of statistical methods to model the relationship between composite rate costs and patient/facility characteristics. We explored both linear and log-linear ordinary least squares regression models for each year from 2000 to 2002 to predict the natural log of the ratio of each facility's composite rate costs divided by that facility's composite payment rate (without regard to exception payments).
We are proposing to use the log linear model in the methodology explained below in order to yield an easily administered case-mix adjuster which can be multiplied by the patient's otherwise applicable composite payment rate. This case-mix adjustment system also controls for selected variables.
We used the cost to payment ratio (that is, the natural log of the ratio of reported costs compared to the composite rate calculated for each facility) as the dependent variable in the models. The analysis that supports our decision is described in detailed below. In order to determine how reimbursement levels could be adjusted to reflect the costs of treating different patients, estimates of how the cost of providing dialysis services (that is, the composite rate) varies according to the patient characteristics (for example, age gender and comorbidities) were completed. Because the reported cost per treatment for each facility, in part, reflects the level of reimbursement (for example, Medicare payments) that the facility received, the measure of facility costs used is defined as the ratio relative to the current standard reimbursement level for each facility. For the purposes
As we have indicated, the costs of treatment varies from the composite rate payment for a number of reasons, including differences in the patient case-mix. The ratio of average reported costs at each facility were compared with the calculated composite rate payment in order to measure any variation in costs (that is, facility costs) from the composite rate. This cost to payment ratio measures the extent to which costs at a facility are higher or lower than the payment that would be expected based on their labor costs and facility type. Regression analysis was used to determine the extent to which the ratio varied with the average case-mix for each facility.
The analysis indicated that a log transformation of this cost to payment ratio was less skewed and a better fit (that is, the predicted variables were closer to the actual values using the log transformation).
Apart from patient clinical and demographic characteristics, the proposed model also controls for selected other variables. These selected control variables include the wage index, the natural log of facility size (number of annual treatments), hospital-based/independent status, chain affiliation, and percent of patients with urea reduction ratios (URRs) greater than or equal to 65 percent. These control variables were included in the proposed model in order to account for the separate effect of facility variables and one readily available outcome variable on composite rate costs. These control variables were included in order to reduce potential distortion in the patient specific case-mix adjustors attributable to facility characteristics. We included the wage index to account for differences among facilities in area wage levels. We used facility size as a control factor because larger facilities, on average, have lower per treatment costs than smaller facilities. The hospital-based/independent classification was used because hospital based providers tend to have higher self-reported costs. Chain ownership is included in the model to account for differences among chains due to reporting conventions, as well as reflect similarities among facilities within chains. The URR was included as a control variable to account for a quality of care outcome measure at each facility, thereby mitigating any potential bias between composite rate costs and quality of care on the model's coefficients.
We identified a limited number of comorbidities that are strong predictors of composite rate costs and developed an estimated adjustment factor for each of these comorbidities. In order to yield an adjustor that can be multiplied with the composite rate payment, the model was used to estimate the facility's reported composite rate costs per treatment, divided by the composite payment rate calculated for each facility. The resulting ratio was modeled using case-mix and control variables. Analysis indicated that a log transformation of this ratio was less skewed and was better fit by the model (that is, predicted values were closer to actual values using the log transformation, especially for high cost facilities).
For facility j, the case-mix is measured by a vector of values, denoted by X
An evaluation of individual case-mix factors as potential risk adjusters was performed using several criteria to explain variation in facility costs. Consideration was also given to the validity of these potential case adjustors to costs based on clinical judgment, the stability of this relationship over time, the objectivity and accuracy of the data used to compute the factors, the reliability of information reported by different providers, and the feasibility of including them as risk adjusters.
Case-mix factors that explained statistically significant variation in facility costs were identified based on a regression model that used a stepwise selection method. Unless otherwise specified, case-mix measures represent the fraction of dialysis sessions in each facility that were provided to patients having the relevant characteristic or comorbidity. Case-mix measures that were considered for selection in the model included age/gender groups (ages <65, 65-79 and 80+ years, separately for females and males), less than one year of treatment for ESRD, average weight among adult dialysis patients (ages≥20), low body mass index among adult dialysis patients (BMI<18.5 kg/m
The regression coefficients that are estimated using facility cost model we discuss above can be used to apply a patient-specific case mix adjustment to the composite rate. This is accomplished by re-transforming the estimated coefficients to obtain relative factors for case mix adjustment. Based on a facility level cost model, where X
The relative factors can then be applied multiplicatively to the composite rate in order to derive a case mix adjusted composite rate. Since these relative factors were all estimated to have values of 1.00 or greater, an adjustment to the composite rate based on these factors would necessarily lead to higher payments by Medicare. However, the MMA provision requires that the modification to the composite rate payment system be budget neutral. For the purpose of this example only, a budget neutrality factor that is less than 1.00 must, therefore, also be applied, with the same factor being applied to all patients and all facilities.
For patient i in facility j, a case-mix adjusted composite rate, AR
In the above equations, ρ is the fraction of costs attributed to labor and therefore subject to an adjustment for geographic differences in wages, 1-ρ is the fraction of costs attributed to non-labor inputs, B
As suggested by the equations above, the coefficients estimated by the cost model can be used to derive an aggregate relative adjustment factor for each patient (A
However, since this is equivalent to A
Where the individual factors for case-mix adjustment are age/gender, PVD and AIDS, the equation used to calculate the relative factor for case mix adjustment can then be expressed as A
To illustrate, the proposed adjustment factors in section 4. above were used to derive a case-mix multiplier for a 7-year old male who has been diagnosed with PVD, but not AIDS. Using the proposed adjustment factors that correspond to males between the ages of 65 and 79 years and the presence of PVD, the overall case-mix multiplier for this patient is calculated as A = e
A detailed example of the computation of the adjusted composite payment rate that includes the patient characteristics adjustments, as well as the applicable adjustments related to the ESRD drug payment revisions and budget neutrality, is provided later in this section I. below.
Section 623(d)(1) of the MMA provides that the Secretary shall adjust the payment rates under this section by a geographic index as the Secretary determines to be appropriate. This section also specifies that, if the Secretary revises the current geographic adjustments applied to the composite payment rate, the revised adjustments must be phased in over a period of time. The current geographic adjustment (wage index) is a blend of two wage indexes, one based on hospital wage data collected by us from fiscal year 1986 and the other developed from 1980 hospital wage and employment data from the Bureau of Labor Statistics (BLS). The hospital and BLS proportions of the blended wage index are 40 percent and 60 percent. The actual wage index values and MSA/non-MSA designations currently used in connection with the composite rates were published in the August 15, 1986
On June 6, 2003, OMB issued Bulletin 03-04 that announced new MSAs and two new sets of statistical areas, Micropolitan Statistical Areas and Combined Statistical Areas (CSAs). We recognize that the new OMB definitions will have implications for the various payment systems we administer that reflect payment distinctions based on geographic location. Any changes adopted will not only result in payment redistributions among ESRD facilities, but will also affect hospitals, home health agencies, skilled nursing facilities, and rehabilitation providers.
Therefore, it is essential that we evaluate any proposals to revise the area definitions and assess the impact of changes in geographical areas on those payment systems that incorporate adjusters for area wage levels among urban and rural locations.
Although the MMA gives the Secretary discretion to revise the outdated wage indexes used in the composite rates, we believe that we should take no action to replace them with revised measures pending completion of our assessments.
Therefore, we are proposing to take no action at this time to revise the current set of composite rate wage indexes and the urban and rural definitions used to develop them. Once revisions to the urban and rural definitions are adopted, we may be in a better position to propose revisions to the geographic adjustments applied to the case-mix adjusted composite payment rates.
For purposes of applying the required geographic adjustments to the case-mix adjusted composite rate payment system, we are proposing to continue using the wage index values and urban and rural designations that are currently applied to the composite payment rates.
Section 1881(b)(12)(E)(i) of the Act, as added by section 623(d)(1) of the MMA, requires that the basic case-mix adjusted composite rate system be designed to result in the same aggregate amount of expenditure for such services, as estimated by the Secretary, as would have been made for 2005 if that paragraph did not apply. Therefore, the drug add-on adjustment and the patient characteristics case-mix adjustment required by section 623(d)(1) of the MMA must result in the same aggregate expenditures for 2005 as if these adjustments were not made.
With respect to the drug payment add-on adjustment the total estimated difference between the current drug payment based on 95 percent of AWP and the payment amount generated from payment based on ASP minus 3 percent is reflected in the proposed adjustment which is designed so that aggregate
In order to account for the payment effect related to the case-mix adjustment, we standardized the composite rate by dividing the rate by the average case-mix modifier of 1.1919. (See section 4.ii Proposed Cormorbidity Adjustments). The resulting adjustment to the composite rate is .8390. However, we were not able to simulate the case-mix effects from the ESRD billing file because comorbidities are generally not included on the ESRD bill. (See section H.3. of this proposed rule for the discussion of the data issues.) We propose to refine our adjustments for case-mix once we have more complete data on the ESRD bill.
Before the enactment of BIPA, an ESRD facility could apply for and receive prospective adjustments or exceptions to its otherwise applicable composite payment rate under specified circumstances. Section 1881(b)(7) of the Act and § 413.182 contain the statutory and regulatory authorities for the provision of exceptions to the composite payment rates. Section 422(a)(2) of BIPA prohibited the granting of new exceptions to the composite payment rates on or after December 31, 2000, except under very limited circumstances, which expired July 1, 2001. That prohibition remains in effect, with one exception. Section 623(b) of the MMA amended section 422(a)(2) of BIPA to afford pediatric facilities the opportunity to seek exceptions provided they did not have an exception rate in effect as of October 1, 2002. The statute defines a pediatric facility as a renal facility, 50 percent of whose patients are under age 18. On April 1, 2004, we opened an exception window for pediatric facilities. The exception window closes September 27, 2004.
Section 422(a)(2)(C) of BIPA provided that any ESRD composite rate exception in effect on December 31, 2000 would continue as long as the exception rate exceeds the applicable composite payment rate. The MMA did not revise that provision. Comparisons of a provider's exception rate and the standard composite payment rate are straightforward, because each payment rate was applied on a facility specific basis, without any adjustments for case-mix. However, in this proposed rule, we are proposing revised composite payment rates that are case-mix adjusted. The wage adjusted composite payment rates listed for each urban and rural area noted in Tables I and II at the end of this section, although applied on a per treatment basis, are subject to case mix adjustments in accordance with section 623(d)(1) of the MMA. The proposed methodology for applying patient characteristic adjusters applicable to each treatment will determine the case-mix adjustment which will vary for each patient. Thus, an ESRD facility's average composite rate per treatment will depend on its unique case mix.
Our policy was not to increase any ESRD facility's exception rate when there has been a congressionally mandated update to the ESRD composite payment rates. When computing an exception amount, we take into consideration the ESRD facility's patient population and the higher costs relating to the patient mix. Since ESRD facilities can maintain their current exception rates, we would expect them to compare the exception rate to the basic case-mix adjusted composite rate to determine the best payment rate for their facility. We are proposing to allow each dialysis facility the option of continuing to be paid at its exception rate or at the basic case-mix adjusted composite rate (which includes all the MMA 623 payment adjustments). If the facility retains its exception rate, it would not be subject to any of the adjustments specified in section 623 of the MMA. Whether a provider's exception rate in effect on December 31, 2000 will exceed its average case-mix adjusted composite payment rate is impossible for us to accurately determine. We believe that projections as to whether an ESRD facility's exception rate per treatment will exceed its average case-mix adjusted composite rate per treatment are best left to the entities affected. Therefore, we are proposing that each ESRD facility with composite rate exceptions currently in effect, and each pediatric ESRD facility granted an exception, must notify its fiscal intermediary in writing if it wishes to withdraw its exception and be subject to the basic case-mix adjusted composite payment rate methodology set forth in this notice.
We are proposing to allow an ESRD facility to notify its fiscal intermediary at any time if it wishes to give up its exception rate. Once a facility has notified its fiscal intermediary of its election to give up its exception rate, it would lose that exception rate, regardless of basis or amount, and be subject to the proposed case-mix adjusted composite payment rates beginning 30 days after the intermediary's receipt of the facility's notification letter. Facilities with exception rates will be required to notify their fiscal intermediaries only if they wish to forego their exceptions. ESRD facilities electing to retain their exceptions do not need to notify their intermediaries. ESRD facilities without exceptions, of course, will be subject to the composite payment rates determined using the basic case-mix methodology described in this notice beginning January 1, 2005.
As set forth in this proposed rule, we will increase the ESRD composite payment rates by 1.6 percent effective January 1, 2005 in accordance with section 623(a) of the MMA. Also, the composite payment rates will be increased to reflect revisions to the drug pricing methodology for separately billable drugs, as discussed in section H.4.b. of this proposed rule. That increase represents the spread or difference between the payment amounts for separately billable drugs and biologicals and their acquisition costs based on the OIG's May 2004 report to the Secretary. The development and computation of the drug add-on adjustment are described in section H.4.c of this proposed rule. We have also proposed a basic case-mix methodology for adjusting the composite payment rates based on a limited number of patient characteristics, as prescribed in section 623(d) of the MMA. The development and application of the case-mix adjusters are explained in section H.4.d.4 of this proposed rule. The MMA requires that the basic case-mix adjusted composite payment rates be effective for services furnished beginning January 1, 2005. Despite the law's specificity with respect to effective date, the systems and operational changes necessary to apply the case-mix adjusters cannot be completed in time for a prospective January 1, 2005 effective date.
The 1.6 percent statutory increase and 11.3 drug add-on for independent and hospital-based facilities for separately billable drugs will be applied to the composite rates for all ESRD facilities beginning January 1, 2005. However, the computation of the case mix adjusters depends on age, sex, and specific comorbidities which must be obtained from the bills for each ESRD facility. Therefore, the combination of case-mix adjusters used to increase a provider's otherwise applicable composite payment rate depends on a provider's unique patient profile and is facility-specific. The correct computation of these facility-specific case-mix adjusters will require numerous programming,
Given these requirements, the lead time necessary for systems changes, and the anticipated time necessary for providers and their fiscal intermediaries to familiarize themselves with and correctly apply the basic case-mix adjustments, we are proposing an April 1, 2005 effective date.
As an alternative to an April 1, 2005 effective date for the patient characteristic case mix adjustments, we considered two options for an April 1, 2005 prospective implementation date that would effectively comply with the MMA's January 1, 2005 effective date. Under the first option, we would implement the patient characteristic adjustments on April 1, 2005 and reprocess bills and adjust payments to January 1, 2005. Under this option, the budget neutrality adjustment related to the patient characteristic factors would not be applied to the composite rate until bills are reprocessed.
The second option that we considered was to make payment to facilities starting January 1, 2005, at the budget neutralized composite rate, until the systems changes for the case-mix adjustment can be implemented, April 1, 2005. Payment at this rate would avoid overpayments, and thus, the need to recoup moneys that may occur when we retroactively process the claims for case-mix adjustments on April 1, 2005. Under this option, facilities would receive approximately 16 percent less than they would otherwise be entitled to on January 1, 2005.
We rejected both of these alternatives. Both options require the reprocessing and adjustment of bills for the first quarter of 2005. In addition, because of the likelihood of payment error due to the complexity of the process and costly implementation and potential disruption of payment to ESRD facilities, we believe that these options are problematic. Given that the expected impact of the patient characteristic adjustments on ESRD facility payments will, for the most part, be minimal, we believe that applying the adjustments prospectively from April 1, 2005 provides a smoother transition to the new payment methodology.
Finally, this notice provides for a budget neutrality reduction of .8390 percent to the case-mix adjusted composite payment rates. Our budget neutrality methodology is explained in section H.4.f. of this proposed rule. Because section 623(d) of the MMA requires that budget neutrality be applied in the context of implementing the case-mix adjusted composite rate payment system, we are proposing that the effective date of the budget neutrality adjustment should also be April 1, 2005. If we applied the budget neutrality adjustment in January, rather than when the case-mix adjustment is applied in April, the result would be that all the composite rates would go down.
We are specifically soliciting comments on these options of the proposed rule. However, the 1.6 percent statutory increase to the composite payment rates, and the drug add-on for separately billable drugs, will be effective January 1, 2005, as these adjustments are easily implemented prospectively.
The following example presents 2 patients dialyzing at Neighbor Dialysis, an independent facility in Baltimore, MD. Patient #1, John Smith, is a 71-year old male who has been diagnosed with PVD and AIDS. Patient #2, Jane Doe, is a 59-year old female who has been diagnosed with PVD.
Section 1862(m) of the Act, as added by Section 731(b) of the MMA, prohibits the Secretary from excluding payment for the routine costs of care furnished to a Medicare beneficiary participating in a clinical trial of a Category A device based on a determination that such care is not “reasonable and necessary” under section 1862(a)(1). In effect, this section authorizes Medicare to cover the routine costs of clinical trials involving Category A devices. Category A (experimental/investigational) devices are defined in § 405.201 as innovative medical devices about which the Food and Drug Administration (FDA) has major questions about safety and effectiveness.
For a trial to qualify for payment of routine costs, it must meet certain criteria established by the Secretary to ensure that the trial conforms to appropriate scientific and ethical standards. Current criteria are established in the National Coverage Determination Manual (CMS Pub. 100-3, Manual section 310.1).
In addition, the MMA established additional criteria for trials initiated before January 1, 2010 to ensure that the devices involved in these trials be intended for use in the diagnosis, monitoring, or treatment of an immediately life-threatening disease or condition. Guidelines for determining if a device meets this requirement will be defined through the NCD process.
Section 411.15(o) currently precludes Medicare payment for Category A devices. We would not revise this section because the MMA does not require Medicare to pay for the cost of the Category A device (as opposed to the cost of routine care associated with the trial of a Category A device).
We are proposing changes to § 405.207. As currently written, this section precludes coverage of services related to a noncovered device. Since the Category A device is noncovered, we would amend this section to allow coverage of routine care services related to a noncovered Category A device. In addition, we propose language to cross-reference § 405.201 concerning coverage of Category B (nonexperimental/investigational) devices. We would not be changing coverage of Category B devices, but providing consistency by placing information on Category A and Category B devices in the same section.
Section 629 of the MMA provides for regular updates to the Medicare Part B deductible in consideration of inflationary changes in the nation's economy. Since 1991, the Medicare Part B deductible has been $100 per year. The MMA stipulates that the Medicare Part B deductible will be $110 for calendar year 2005, and, for a subsequent year, the deductible will be the previous year's deductible increased by the annual percentage increase in the monthly actuarial rate under section 1839(a)(1) of the Act, ending with that subsequent year (rounded to the nearest dollar). Section 1839(a)(1) of the Act requires the Secretary of Health and Human Services to calculate the monthly actuarial rate for Medicare enrollees age 65 and over.
We propose to update § 410.160(f), “Amount of the Part B annual deductible,” to conform to the MMA and to reflect that the Medicare Part B deductible is $100 for calendar years
Effective January 1, 2005, section 512 of the MMA provides for payment to be made to a hospice for specified services furnished by a physician who is either the medical director of or employee of a hospice agency. Payment will be made on behalf of a beneficiary who is terminally ill (which is defined as having a prognosis of 6 months or less if the disease or illness runs its normal course), has not made a hospice election, and has not previously received the pre-election hospice services specified in section 1812(a)(1)(5) of the Act as added by section 512 of the MMA. These services comprise an evaluation of an individual's need for pain and symptom management, counseling the individual regarding hospice and other care options, and may include advising the individual regarding advanced care planning.
The decision to elect hospice services is a personal choice and is generally a decision made between the individual and his or her physician (probably the physician making the terminal diagnosis). Therefore, we believe that most individuals will seek this type of service from their own physician. Thus, we do not expect that the services of a hospice physician would be necessary for all individuals who elect hospice. However, a beneficiary, or his/her physician may seek the expertise of a hospice medical director or physician employee of a hospice to assure that a beneficiary's end-of-life options for care and pain management are discussed and evaluated.
Currently, beneficiaries are able to receive this evaluation, pain management, counseling, and advice through other Medicare benefits. For example, physicians, typically those who determine the beneficiary's terminal diagnoses, can provide for these evaluation and management services as well as for pain and symptom management under the physician fee schedule. Beneficiaries may also obtain assistance with decisions pertaining to end-of life issues through discharge planning in hospitals and through services of social workers, case managers, and other health care professionals. To the extent that beneficiaries have already received Medicare-covered evaluation and counseling with respect to end-of-life care, the hospice evaluation and counseling would seem duplicative. We intend to monitor data regarding these services to assess whether Medicare is paying for duplicative services.
We are proposing to cover the services described above for a terminally ill beneficiary, at the request of the beneficiary or the beneficiary's physician. The service would, in accordance with the statute, be available on a one-time basis to a beneficiary who has not elected or previously used the hospice benefit, but who might benefit from evaluation and counseling with a hospice physician regarding the beneficiary's decision-making process or to provide recommendations for pain and symptom management. Since the beneficiary or his/her physician decides to obtain this service from the hospice medical director or physician employee, the evaluation and counseling service may not be initiated by the hospice, that is, the entity receiving payment for the service.
The statute specifies that payment will be made to the hospice when the physician providing the service is an employee physician or medical director of a hospice. Therefore, other hospice personnel, such as nurse practitioners, nurses, or social workers, cannot furnish the services. The statute requires the physicians to be employed by a hospice; therefore, the service cannot be furnished by a physician under contractual arrangements with the hospice or by the beneficiary's physician, if that physician is not an employee of the hospice. Moreover, if the beneficiary's physician is also the medical director or physician employee of a hospice, that physician already possesses the expertise necessary to furnish end-of-life evaluation, management, and counseling services and is providing these services to the beneficiary and is receiving payment for these services through the use of evaluation and management (E&M) codes.
In the event that the individual's physician initiates the request for services of the hospice medical director or physician, we would expect that appropriate documentation guidelines would be followed. The request or referral would be in writing, and the hospice medical director or employee physician would be expected to provide a written note on the patient's medical chart. The hospice employee physician providing these services would be required to maintain a written record of this service. If the beneficiary initiates the services, we would expect that the hospice agency would maintain a written record of the service and that communication between the hospice medical director or physician and the beneficiary's physician would occur, with the beneficiary's permission, to the extent necessary to ensure continuity of care.
We propose to add new § 418.205 and § 418.304(d) to implement section 512 of the MMA.
Section 512(b) of the MMA amends section 1414(i) of the Act and establishes payment for this service at an amount “equal to an amount established for an office or other outpatient visit for evaluation and management associated with presenting problems of moderate severity and requiring medical decision-making of low complexity under the physician fee schedule, other than the portion of such amount attributable to the practice expense component.” No existing CPT or HCPCS code specifically represents these services. We are proposing to establish a new HCPCS code, G0xx4
In accordance with the statute, we are proposing that the payment amount for this service would be based on the work and malpractice expense RVUs for CPT code 99203 multiplied by the CF (1.34 Work RVU + 0.10 Malpractice RVU)* (CF). This CPT code for an office or outpatient visit for the evaluation and management of a new patient represents a detailed history, detailed examination and medical decision making of low complexity, which, we believe, is quite similar to the components of this new service provided by a medical director or physician employed by the hospice
Section 1832(a)(1)(E) of the Act, as added by section 302(a)(2) of the MMA, requires the Secretary to establish clinical conditions for payment of covered items of durable medical equipment (DME). The law requires the Secretary to establish types or classes of covered items that require a face-to-face examination of the individual by a physician or practitioner and also require a prescription for these items.
Covered items of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) have already been divided into classes of covered items, as established by the local medical review policies (LMRP) and local coverage determinations (LCD) issued by the durable medical equipment regional carriers (DMERCs). For example, the contractors have developed policies on long term home oxygen therapy, canes, crutches, wheelchairs, hospital beds, urological supplies, spinal orthoses, surgical dressing, and enteral and parenteral nutrition therapy. These and other policies for each of the four DMERCs are entered into the Medicare Coverage Database at
These policies are developed based on clinical evidence and after discussion with clinical experts in the area. There are already a number of local coverage determinations and national coverage determinations that outline the clinical conditions for which these items are covered. These determinations outline the conditions for coverage, payment, and the documentation or testing necessary to establish medical necessity. We propose to continue developing these clinical conditions of coverage through the local and national coverage determination process.
We are also proposing to expand the requirement for clinical conditions of coverage to medical supplies, appliances and devices defined in 42 CFR 410.36. These are commonly referred to as prosthetics, orthotics and supplies (POS). We believe items of POS require the same level of medical intervention and skill as DME. As with DME, there are already a number of local and national coverage determinations outlining appropriate clinical conditions for coverage and propose to continue this process.
From a clinical perspective, we believe that it is appropriate for beneficiaries requiring DMEPOS to be under the care of a physician and for DMEPOS orders to occur in the context of routine clinical care. We believe it is good clinical practice for the beneficiary to be seen by the physician for their medical condition and the physician to decide whether or not an item of DMEPOS is appropriate during the face-to-face examination of the beneficiary. Since we expect a beneficiary to be seen by their physician for a specific medical condition, we do not believe that a requirement for a face-to-face examination for initial orders and at the time of the prescription renewals for items of continued need (those DMEPOS items where an order is good for only a certain period of time and requires a follow-up examination by the physician) would place a burden on the physician or beneficiary, as it would be part of a necessary examination. We believe this to be the current practice in most cases.
Our goal is to encourage quality care, to mitigate any proliferation of use of these products and ensure that only patients that need items of DMEPOS receive them. To comply with the requirements of section 302(a)(2) of the MMA and to enhance quality and reduce fraud, we would establish basic requirements that apply to all items of durable medical equipment, prosthetics, orthotics, and supplies. We have identified a proliferation of use for some items of DMEPOS and we believe that engaging the physician or practitioner early in the process of ordering DMEPOS will assist us in mitigating any unnecessary proliferation of use.
This regulation proposes to make a face-to-face exam by the physician to determine the medical necessity and ordering an item of DMEPOS an explicit requirement for all initial orders of DMEPOS and at the time of prescription renewal for all DMEPOS continued need items. However, we seek specific comments about whether specific items of DMEPOS should be exempt from the face-to-face examination requirement.
In order for us to verify the medical necessity for an item, the prescribing physician's or practitioner's records must document the need at the time the physician or practitioner examines the beneficiary. For example, a letter to the supplier or to us dated months after the date the examination was conducted and the order was written would not be sufficient verification.
To implement the provisions of the MMA, we would—
• Establish a requirement for a face-to-face examination by a physician, physician assistant (PA), clinical nurse specialist (CNS), or nurse practitioner (NP), as they are defined in the Act (the prescribing physician or practitioner) to determine the medical necessity of durable medical equipment, orthotics and prosthetics.
• Require that the prescribing physician or practitioner be independent from the DMEPOS supplier and may not be a contractor or an employee of the supplier.
• Establish a requirement that the face-to-face examination should be for the purpose of evaluating and treating the patient's medical condition and not for the sole purpose of obtaining the prescribing physician's or practitioner's order for the DMEPOS. We expect the prescribing physician or practitioner to conduct a sufficient examination of the patient's medical condition to ascertain the appropriate overall treatment plan and to order the DMEPOS as only one aspect of that treatment plan.
• Require an order prior to delivery for all items of durable medical equipment, prosthetics, or orthotics.
• Require that the order be dated and signed within 30 days after the face-to-face examination and include verification of the examination. We are soliciting comments on the appropriate verification process.
• Require the prescribing physician or practitioner to maintain appropriate and timely documentation in the medical records that support the need for all DMEPOS ordered.
• Provide that we would promulgate through contractor instructions other criteria required for payment, such as for prescription renewal requirements, repair, minor revisions and replacement. We are interested in comments on whether the Agency should establish national renewal requirements or permit contractor discretion.
• Provide that we would promulgate through the national coverage determination process or through the local coverage determination process additional clinical conditions for items of DMEPOS.
We propose to revise language in § 410.36 and § 410.38 to implement section 302(a)(2) of the MMA.
Medicare covers an annual screening mammogram for all beneficiaries who are women age 40 and older, and one baseline mammogram for beneficiaries who are women age 35 through 39. Medicare also covers medically necessary diagnostic mammograms. Payment for screening mammography, regardless of setting, is paid under the physician fee schedule, but diagnostic mammography performed in the hospital outpatient department is currently paid under the hospital outpatient prospective payment system (OPPS).
Section 614 of the MMA amended section 1833(t)(1)(B)(iv) of the Act to exclude payment for screening and diagnostic mammograms from the OPPS. In the OPPS proposed rule, we will discuss our proposal for payment for diagnostic mammograms using the payments established under the physician fee schedule. This proposal will parallel the current practice used for the payment of screening mammography services provided in the OPPS setting and will be effective January 1, 2005.
Lung diseases such as chronic obstructive pulmonary disease (COPD) affect large numbers of Medicare beneficiaries. COPD is the fourth largest cause of death in America behind heart disease, certain cancers, and stroke. We hope to reduce the number of new COPD cases by educating Americans about the disease, its causes, and ways to prevent it. We hope to improve the lives of Medicare beneficiaries and improve beneficiary access to treatment for those who already suffer from these conditions.
Depending on an individual's age and health, a number of steps can be taken to treat or prevent this. Because approximately 85 percent of those with COPD are smokers, the first step to avoid the disease is to stop smoking. Smoking has been linked to a large number of health problems and is a leading cause of cancer and pulmonary disease. The Department of Health and Human Services (HHS) has been actively encouraging Americans to quit smoking through its smoking cessation initiatives. Americans who quit smoking will enjoy longer, healthier lives and avoid diseases such as COPD.
We have also recently approved services to address the needs of Americans suffering from COPD, including lung-volume reduction surgery, which, performed in more serious cases, removes the diseased lung tissue, allowing the rest of the lung to function better. Specifically, effective January 1, 2004, Medicare expanded coverage of lung volume reduction surgery to include patients, who are not high-risk surgical patients, who either have severe, upper-lobe emphysema, or have severe, non-upper-lobe emphysema with low exercise capacity.
A number of drugs are available to treat the persons with asthma or who develop COPD. These include agents, often inhaled, that expand the bronchial tubes, allowing the patient to breathe more freely. Access to these drugs for Medicare beneficiaries has been expanded by the MMA.
Nebulizers and metered dose inhalers (MDIs) are two different delivery methods to administer inhalation drugs to a beneficiary. A nebulizer works by aerosolizing liquefied inhalation drugs so that the medication can be more easily inhaled into the lungs. For about 10 to 30 minutes, a beneficiary breathes the mist via compressor tubing hooked up to the nebulizer. An MDI consists of a canister of pressurized medication that is propelled directly into the airways of the lungs when a beneficiary presses on the inhaler and breathes in through the mouth, thereby allowing the medicine to take effect quickly.
Medicare Part B currently pays for nebulizers and inhalation drugs. However, Medicare Part B does not cover MDIs and, therefore, does not pay for inhalation drugs delivered by an MDI. An MDI is considered to be an item of disposable medical equipment (for which there is no current Part B benefit category) while a nebulizer is considered to be an item of DME.
The Part D drug benefit improves beneficiary access to inhalation therapy by covering MDIs (including the inhalation drugs they furnish) beginning January 1, 2006. In addition, the prescription drug discount card began offering discounts on MDIs effective June 1, 2004.
Since Medicare currently covers inhalation drugs provided through nebulizers, but not alternative forms of inhalation therapy, there are strong financial incentives toward use of the former compared to alternatives. Our review of the literature over the past decade did not find that bronchodilators delivered via nebulizers were more effective than bronchodilators delivered via metered dose inhalers.
Since one delivery method is not clinically superior to the other, when Medicare covers both methods of delivery of inhalation therapy, the decision to prescribe one over the other will be made by the physician and beneficiary based on beneficiary needs and preferences consistent with applicable standards of medical practice. It would not be unlikely for many beneficiaries to choose the convenience of MDIs over nebulizers once the Medicare coverage imbalance is removed in 2006. Since MDIs are less expensive, very portable, and easier to use, it is likely there will be a substantial shift of Medicare beneficiaries from nebulizers to MDIs beginning in 2006, even absent the Medicare payment changes for nebulizers and inhalation drugs in 2005.
Medicare Part B currently covers and pays for five separate items related to nebulizers. All of the items are subject to the standard Part B deductible and coinsurance.
Medicare Part B currently covers the rental of nebulizers. Nebulizers are in the “capped rental” category of DME for payment purposes. Payment is made on a monthly basis during the period of medical need. Medicare pays 10 percent of the payment amount during the first three months and 7.5 percent during the next 12 months. Section 1834(a) of the Act specifies that the payment amount is equal to the amount paid for purchase of the nebulizer in 1986, indexed to current levels by the cumulative DME update factor specified in this subsection. Thus, Medicare will pay up to a cumulative total of 120 percent of the payment amount for 15 months of renting a nebulizer.
If the beneficiary needs a nebulizer for more than 15 months, and continues to rent it, Medicare makes no further payment for the equipment because the equipment has already been paid for. Medicare does continue to pay for maintenance and servicing of the nebulizer, as well as the inhalation drugs, but the supplier retains title to the equipment.
During the 10th month of continuous rental of a nebulizer, the supplier is required to offer the beneficiary a purchase option, and if the beneficiary accepts the offer and exercises the
In 2003, the average Medicare monthly rental payment for nebulizers was $19.07 for the first three months and $14.30 for the fourth through fifteenth month. Thus, Medicare would pay $228.81 for a nebulizer if the beneficiary's period of medical need were 15 months. There are various types of nebulizers (compressor, ultrasonic, portable, disposable) and nebulizer accessories (breathing circuits, air filters, tubing extensions, mouthpieces, spare battery packs, DC adapters) available. Internet prices for compressor nebulizers range from $50 to $100, and prices for portable nebulizers range from $100 to $200, depending on the specific features of the nebulizer. The Medicare payment amount includes payment for delivery of the equipment. (Shipping costs for nebulizers available for purchase on the Internet range from free shipping up to $25).
Medicare Part B makes an additional separate payment to the supplier for maintenance and servicing of the equipment (for parts and labor not covered by the supplier's or manufacturer's warranty). For nebulizers that are not purchased, but are used for more than 21 months, the servicing fee covers six-month periods beginning after the 21st month of use. As required by section 1834(a)(7) of the Act, Medicare's payment for maintenance and servicing is equal to the lesser of a reasonable and necessary maintenance and servicing fee, or 10 percent of the total purchase price of the equipment. For nebulizers that are purchased, Medicare may make a payment to the supplier for any necessary maintenance and servicing that is performed.
In 2003, the average service fee for nebulizers was $19.07 per six-month period. Other than routine cleaning of the unit (that is, cleaning and changing filters, cleaning and disinfecting nebulizers, tubing, and mouthpieces), very little maintenance is required to maintain a nebulizer's peak performance. There is usually no scheduled maintenance for the nebulizer. Medicare pays for the usual frequency for replacement of accessories. Maintenance kits and replacement parts are available through online suppliers for approximately $5 to $15.
Medicare Part B pays for drugs that the nebulizer furnishes to a beneficiary. Unlike nebulizers, inhalation drugs are not an explicit benefit covered by statute. However, there was an administrative decision made early in the program's history to cover inhalation drugs as a supply so that the nebulizer could work. Without the inhalation drugs, the nebulizer would not be effective for a beneficiary.
The two most common inhalation drugs used by beneficiaries are albuterol sulfate (a beta-adrenergic bronchodilator) and ipratropium bromide (an anticholinergic bronchodilator). A beneficiary may use one or the other of these inhalation drugs, and they are frequently prescribed together. Both albuterol sulfate and ipratropium bromide are manufactured in powder form, but are generally liquefied and furnished to beneficiaries in liquid form for use in a nebulizer. The beneficiary may use a solution of one drug, or a combination of both drugs, in addition to saline if necessary, with the nebulizer. The beneficiary may mix the solution, or the supplier may furnish the drug in a pre-mixed form (either commercially pre-mixed or pharmacy compounded). The shelf life of these drugs is at least 18 to 24 months, and they do not require any special storage arrangements such as refrigeration.
Medicare also pays for other inhalation drugs, such as budesonide (an inhaled corticosteroid), which are used in conjunction with albuterol sulfate and ipratropium bromide. These drugs can also be administered using a nebulizer or an MDI.
Medicare has paid a monthly $5 dispensing fee for each covered inhalation drug or combination of drugs used in a nebulizer. The dispensing fee is paid for each drug dispensed, not the number of unit dose vials provided to the beneficiaries. Additionally, if two or more drugs are combined in single unit dose vials, only one dispensing fee will be paid per drug combination per month. A dispensing fee for saline is not separately billable or payable. Inhalation drugs are the only drugs for which Medicare Part B currently pays a separate dispensing fee.
In 2003, CPT code 94664 was revised to include beneficiary training by a physician or physician's staff regarding use of a nebulizer, MDI, aerosol generator, or intermittent positive pressure breathing (IPPB) machine. The narrative terminology for the code currently is—Demonstration and/or evaluation of patient utilization of an aerosol generator, nebulizer, metered dose inhaler or IPPB machine.” The 2004 Medicare physician fee schedule payment for this service is $13.44. This service has no physician work relative value units reflecting that the training is typically performed by physician office staff. In 2004, this service has 0.32 practice expense relative value units (RVUs) and 0.04 malpractice RVUs. Additionally, the supplier of the nebulizer, under § 424.57(c)(12), must “document that it or another qualified party has at an appropriate time, provided beneficiaries with necessary information and instructions on how to use Medicare covered-items safely and effectively.” Beneficiary training by a physician or physician's staff regarding use of a nebulizer would meet the definition of “another qualified party” for purposes of this supplier requirement.
In 2003, Medicare spent about $1.6 billion for nebulizers and inhalation drugs. This amount includes—
(a) About $130 million for nebulizers (both rental and purchase) and nebulizer related accessories and supplies;
(b) About $13 million for servicing/maintenance fees;
(c) About $1.3 billion for albuterol sulfate and ipratropium bromide and another $120 million for other inhalation drugs for a total of approximately $1.4 billion. (This represents about 88 percent of Medicare spending for inhalation therapy.);
(d) About $35.5 million for 7.1 million dispensing fees; and
(e) About $4.5 million for beneficiary training under CPT code 94664 (though this figure also includes training for other items as well as nebulizers).
Medicare spending for inhalation drugs has grown rapidly. Preliminary data indicate that between 2001 and 2003, Medicare spending increased by 77 percent for albuterol sulfate and ipratropium bromide.
The HHS IG issued 10 reports between February 1996 and January 2004 about Medicare payments for albuterol sulfate and ipratropium bromide in excess of acquisition costs. In a report issued in September 2001,
Table 1 of the Interim Final Rule regarding Changes to Medicare Payment for Drugs and Physician Fee Schedule Payments for Calendar Year 2004, published in the January 7, 2004
The IG report issued in January 2004 again concluded that Medicare payments were far in excess of acquisition costs for both albuterol sulfate and ipratropium bromide. The IG found that the Medicare 2004 payment (and payment in prior years) was a multiple of the actual acquisition costs for both drugs based on a comparison to the median price that the drug was available through wholesalers/distributors and group purchasing organizations (GPOs) and comparison to the manufacturer-reported Wholesale Acquisition Cost (WAC).
In 2003, ipratropium bromide and albuterol sulfate were the third and seventh largest drugs in terms of Medicare spending for carrier paid drugs. The differences between Medicare's payment amount and acquisition costs (that is, spread) for albuterol sulfate and ipratropium bromide are among the largest spreads for drugs studied by the IG and GAO. Based on the actual acquisition costs determined by IG and GAO studies, in 2003, Medicare paid an estimated nearly $900 million in excess of acquisition costs for albuterol sulfate and ipratropium bromide.
The IG and GAO findings of large differences between Medicare payment amounts and acquisition costs for inhalation drugs provided the foundation for Congressional enactment of section 305 of the MMA. This section of the MMA sets Medicare payment for inhalation drugs at 106 percent of the ASP. (The Congressional Budget Office's November 20, 2003 pricing of the MMA estimated section 305 as having savings of $4.2 billion over 10 years.)
Suppliers argue that inhalation drug spread has allowed them to fund activities related to care for beneficiaries with asthma or COPD that otherwise do not have a Medicare Part B benefit category. These other activities may include the following:
• Respiratory therapists on staff or in networks available on-call for home visits or telephone consultations.
• On-call pharmacists.
• Monthly calls to schedule medication refills.
• Continuous education on disease states, including monthly follow-ups.
• 24-hour support lines.
• On-call and/or monthly home delivery of medication and supplies.
• Quality improvement programs.
Medicare Part B currently covers only one type of inhalation therapy, nebulizers and inhalation drugs. Although Medicare Part B does not cover MDIs and the inhalation drugs they furnish, the new Part D benefit beginning in 2006 will cover these alternative hand-held inhalation therapy devices (MDIs). In addition, the discount card and $600 transitional assistance payment for low-income beneficiaries will help seniors buy inhalers in 2004 and 2005, helping to bridge the gap until 2006 when coverage begins.
MDIs are the quickest and easiest way to take inhalation medication for most asthmatics and patients with COPD. The medication is propelled directly into the lungs, allowing it to take effect more quickly, and with fewer medication side effects. An MDI contains a specific number of “metered inhalations,” and is made to deliver the prescribed amount of medication for the labeled number of doses (typically 200 doses, which is 8 doses per day for 25 days). Inhalation accessory devices, such as holding chambers and spacers, are used to improve the direction and deposition of medication delivered by MDIs, making it easier for beneficiaries to use an MDI and making the MDI more effective in delivering the medicine to the lungs.
Since Medicare currently covers nebulizers and inhalation drugs, but not alternative forms of inhalation therapy, there are strong financial incentives toward use of the former compared to alternatives. Our review of the literature over the past decade, including two meta-analyses and over two dozen individual studies applicable to adults, did not find that bronchodilators delivered via nebulizer were more effective than when delivered via metered dose inhaler.
Since one delivery method is not clinically superior to the other, when Medicare covers both methods of delivery of inhalation therapy, the decision to prescribe one over the other will be made by the physician and beneficiary based on beneficiary needs and preferences consistent with applicable standards of medical practice. It would not be unlikely for many beneficiaries to choose the convenience of MDIs over nebulizers once the Medicare coverage imbalance is removed in 2006. Since MDIs are less expensive, very portable, and easier to use, it is likely there will be a substantial shift of Medicare beneficiaries from nebulizers to MDIs beginning in 2006, even absent the Medicare payment changes for nebulizers and inhalation drugs in 2005.
Some claim that beneficiaries cannot use MDIs because they do not have the dexterity to use them. Use of an MDI requires proper inhalation techniques in order to receive the full benefit possible from the amount of medication included in each dose. Spacers and holding chambers extend the mouthpiece of the inhaler and increase the air volume into which the medication is atomized, allowing more time for the patient to breathe the medication and avoid misdirecting the medication onto the soft tissues inside the mouth where it will have little effect on lung function.
A nebulizer may also require a certain level of dexterity (that is, operating, maintaining, and cleaning the nebulizer correctly). There may also be beneficiaries who do not have the dexterity to use either an MDI or nebulizer, which would require the availability of alternative therapies, such as an IPPB machine to aid in the delivery of aerosol medication by increasing the depth of breathing more than the patient alone can achieve.
Our goal is to assure that each beneficiary who needs inhalation therapy has access to the most appropriate medication and delivery method. We expect that the combined changes to cover MDIs, adjust payments for inhalation drugs, and provide for an appropriate dispensing fee will improve beneficiary access and choice. We seek comments about an appropriate amount for a dispensing fee that would assure beneficiary access to inhalation medications provided through nebulizers.
We believe that a dispensing fee is intended to cover a pharmacy's activities to get inhalation drugs to beneficiaries. We seek data and information on the additional services these pharmacies provide to Medicare beneficiaries, the extent to which inhalation drugs can be furnished without these additional services and the extent to which such services are covered under Medicare. We are concerned about significant shifts in beneficiary access to inhalation therapy prior to implementation of the Part D drug benefit in light of the reduction in Medicare payment for inhalation drugs beginning in 2005, and also seek comments about whether the dispensing fee should include a somewhat higher, transitional payment.
Below we discuss, changes in payment for inhalation drugs and nebulizers beginning in 2005.
Section 1834(a)(21) of the Act, as amended by section 302(c)(2) of the MMA, requires a reduction in Medicare payment, beginning with 2005, for specified items of DME, including nebulizers paid under code E0570. The reduction is the difference in payment amounts under Medicare and the median Federal Employees Health Benefits (FEHB) plan, as identified in IG testimony before the Senate Committee of Appropriations on June 12, 2002. Other codes for nebulizers and related equipment are not affected by the payment reduction.
Since the maintenance and servicing fee is equal to the first month's rental payment, the maintenance and servicing fee for nebulizers will also be reduced in 2005.
As discussed in the ASP payment section of this proposed rule, for the first quarter of 2005, the Medicare payment at ASP plus 6 percent is estimated to be $0.04 per milligram for albuterol sulfate and $0.30 per milligram for ipratropium bromide. While these figures represent estimated reductions from 2004 payment levels of about 90 percent, they are not necessarily the actual payment amounts for the first quarter of 2005. The actual payment amounts will be based on ASP's calculated from the manufacturer ASP to be submitted for the third quarter of 2004.
Both albuterol sulfate and ipratropium bromide are generic drugs that have multiple manufacturers. Since these ASPs are average figures across all manufacturers, a pharmacy should be able to acquire albuterol sulfate and ipratropium bromide at these prices. Moreover, to the extent there is price variation among manufacturers, there will be some manufacturers with lower prices than others. In this case, a pharmacy might be able to obtain albuterol sulfate and ipratropium bromide at a price below the average.
The Medicare payment amount includes a 6 percent add-on. Assuming that ASP remains constant between the first and third quarters of 2004, the 6 percent add-on would be about $1.00 for a typical month's supply of 450 milligrams of albuterol sulfate and about $3.00 for a 90-day supply. Similarly, the 6 percent add-on would be about $1.60 for a typical month's supply of 93 milligrams of ipratropium bromide and about $4.80 for a 90-day supply. Because albuterol sulfate and ipratropium bromide are often prescribed together, Medicare payment at 106 percent of ASP would include, as additional payments above the acquisition cost of the drugs, a total payment to the supplier of about $2.60 for a 30-day supply and about $7.80 for a 90-day supply of both drugs.
Given the overall reduction in payment for inhalation drugs, we are concerned about beneficiary access to these drugs. Because shipping, handling, compounding, and other pharmacy activities would usually exceed the 6 percent payment above the drug acquisition cost, we believe that it is appropriate for Medicare to continue to pay a separate dispensing fee to pharmacies that furnish inhalation drugs to beneficiaries.
We propose to establish a separate dispensing fee for inhalation drugs. This separate dispensing fee will be in addition to the difference between the supplier's acquisition cost and the Medicare payment for the drug. For example, if a supplier is acquiring albuterol and ipratropium bromide for the average sales price, the supplier would receive a separate dispensing fee amount plus their acquisition cost plus $7.80 for a 90-day supply. The $7.80 is the amount included in the payment for the drug itself since Medicare pays 6 percent above the average sales price.
As noted above, Medicare has paid a $5 monthly dispensing fee for each covered inhalation drug or combination of drugs used in a nebulizer. Dispensing fees are paid by Medicaid and private insurers; we seek information about these dispensing fees for inhalation drugs and their applicability to Medicare. In addition, we seek comments about an appropriate dispensing fee amount to cover the shipping, handling, compounding, and other pharmacy activities required to get these inhalation medications to Medicare beneficiaries. We seek data and information that explains the direct labor and non-labor costs as well as indirect costs of overhead for these pharmacy activities as they relate to dispensing of inhalation drugs.
Consideration of dispensing fees needs to be viewed in the context of several important changes and clarifications in Medicare policy and billing requirements.
First, we are proposing to allow a prescription for inhalation drugs covering a 90-day period to be written by a physician and filled by a pharmacy. Current guidelines are that a pharmacy generally should not fill a prescription for inhalation drugs for more than a month's supply for a beneficiary. We believe that this requirement needs revision in the case of inhalation drugs for two key reasons. Most beneficiaries who use inhalation drugs use them for extended periods of time and often use them for the rest of their lives. In addition, we understand that many inhalation drugs are delivered to a beneficiary through the mail. We understand that a mail-order prescription drug model works well for a 90-day prescription. We believe that there will be significant savings in shipping for a 90-day prescription rather than a monthly prescription.
We would expect that reasonableness would govern filling a monthly vs. a 90-day prescription with a physician writing and a pharmacy filling a monthly or a 90-day prescription depending on the circumstances of the beneficiary. For example, it would be reasonable to expect that the first time a beneficiary receives a prescription for a nebulizer and inhalation drugs that the prescription would be for a month. Similarly, it would be reasonable to expect that refill prescriptions for beneficiaries would be for a 90-day period. Carriers would continue to assess claims for dispensed quantities greater than what would be reasonable based on usual dosing guidelines. We would expect that the bulk of prescriptions would be for 90-day periods.
Second, we recently revised the guidelines regarding the time frame for delivery of refills of DMEPOS products to occur no sooner than “approximately 5 days prior to the end of the usage for the current product”. As previously noted, inhalation drugs are often furnished to a beneficiary by mail. It has
On January 2, 2004, we revised the guidelines (effective February 2, 2004) regarding the time frame for subsequent deliveries of refills of DMEPOS products to occur no sooner than “approximately 5 days prior to the end of the usage for the current product” (see section 4.26.1 of Chapter 4—Benefit Integrity of the Medicare Program Integrity Manual). This change allows shipping of inhalation drugs on “approximately” the 25th day of the month in the case of a month's supply, and on “approximately” the 85th day in the case of a 90-day supply. We emphasize the word “approximately”; while we believe that normal ground service shipping would allow delivery in 5 days, if there were circumstances where ground service could not occur in 5 days, the guideline would still be met if the shipment occurs in 6 or 7 days. (“Days” refers to business days or shipping days applicable to the shipper, that is, a 6 day week in the case of the U.S. Postal Service.). We believe that this change eliminates the need for suppliers to use overnight shipping methods and allows shipping of inhalation drugs by less expensive ground service.
Third, we understand that some pharmacies believe that Medicare has a requirement that a pharmacy must obtain an original signed prescription before each prescription is dispensed. The Program Integrity Manual (section 5.1 of Chapter 5) addresses the ordering requirement for DMEPOS items. The Manual indicates that most DMEPOS items, including drugs, can be dispensed based on a verbal order from a physician. The Manual further indicates that a written order must be obtained before submitting a claim, but that such written order may be faxed, photocopied, electronic or pen and ink. The order for inhalation drugs must specify the name of the drug, the concentration (if applicable), dosage, and frequency of administration. We hope that clarification of this requirement would reduce a pharmacy's costs of supplying covered inhalation drugs to Medicare beneficiaries to the extent that pharmacies are currently applying an original signed prescription requirement.
Fourth, Medicare regulations (§ 424.57) specify the requirements a DMEPOS supplier must meet in order to receive payment for a Medicare covered item. Section 424.57(c)(12) contains the proof of delivery requirement and indicates that a “supplier must be responsible for the delivery of Medicare covered items to beneficiaries and maintain proof of delivery.” We recently revised the Program Integrity Manual (section 4.26 of Chapter 4) to address proof of delivery requirements for suppliers. As discussed in the Manual, the burden of proving delivery is left to the supplier. The Manual provides examples of the types of proof that are reasonable and acceptable, but it does not provide an all-inclusive list. Other acceptable proof-of-delivery methods may exist and may be employed by suppliers. This documentation is normally only requested by the contractor when a complaint is received that the item was not provided or received. The documentation is necessary to investigate the allegation. We believe that the current provisions on proof of delivery are adequate and appropriate for inhalation drugs.
Fifth, in section IV.H (Assignment of Medicare Claims—Payment to the Supplier) of this proposed rule, we propose to change current regulations at § 424.55 to eliminate the requirement that beneficiaries assign claims to suppliers in situations where suppliers are required by section 1842(o)(3) of the Act to accept assignment. This change would eliminate the need for suppliers to have a signed Assignment of Benefits (AOB) form from a beneficiary in order for Medicare to make payment. Because such section of the Act requires Medicare to make payment for drugs only on an assigned basis, this change would eliminate a billing requirement for drugs, including inhalation drugs. We believe that this change would reduce a pharmacy's costs of supplying covered inhalation drugs to Medicare beneficiaries to the extent that pharmacies are requiring a signed AOB form before submitting a claim.
We believe that the amount of dispensing fee needs to be considered in conjunction with—
(1) Our proposal to allow 90-day prescriptions;
(2) Our recent revision to allow the next month's refill prescription to be shipped approximately 5 business days prior to the end of usage for the product, that is, to allow shipping on the 25th of the month for a month's supply, and shipping or 85th day in the case of a 90-day period;
(3) Our policy clarification regarding signed original orders before a prescription is filled;
(4) Our proof of delivery requirement revisions; and
(5) Our proposed change regarding the Assignment of Benefits form.
Medicare Part B will continue to pay for beneficiary training by a physician's staff regarding use of a nebulizer, MDI, aerosol generator, or IPPB machine. Section 424.57(c)(12) specifies that “The supplier must document that it or another qualified party has at an appropriate time, provided beneficiaries with necessary information and instructions on how to use Medicare covered-items safely and effectively.” Beneficiary training by a physician or physician's staff regarding use of a nebulizer would meet the definition of “another qualified party” for purposes of this supplier requirement.
In last year's proposed rule, we requested comments on clarifying that the personnel qualifications of therapists in home health settings at § 484.4 apply consistently to all therapy settings, including the offices of physical and occupational therapists, physicians, and nonphysician practitioners. We received comments from therapists, physicians, nontherapist health care providers and their representative organizations. After consideration of all comments, we now propose to revise 42 CFR 410.26, 410.59, 410.60 and 410.62 to reflect that physical therapy, occupational therapy, and speech-language pathology services provided incident to a physician's professional services are subject to certain limitations as described at section 1862(a)(20) of the Act.
Regulations in 42 CFR 485.705 specify that, in almost all settings, outpatient rehabilitative therapy services, (physical therapy (PT), occupational therapy (OT), or speech-language pathology (SLP)) can be furnished only by the following individuals meeting the qualifications in § 484.4: physical therapists, occupational therapists, appropriately supervised physical therapist assistants, appropriately supervised occupational therapy assistants, and speech-language pathologists. Some States permit licensed physicians, physician assistants, clinical nurse specialists, and nurse practitioners to furnish PT, OT,
Section 1862(a)(20) of the Act permits payment for therapy services furnished incident to a physician's professional services only if the practitioner meets the standards and conditions that would apply to such therapy services if they were furnished by a therapist, with the exception of the licensing requirement. We are proposing to amend the regulations to include the statutory requirement that only individuals meeting the existing qualification and training standards for therapists (with the exception of licensure) consistent with § 484.4 qualify to provide therapy services incident to physicians' services.
Section 1862(a)(20) of the Act refers only to PT, OT, and SLP services and not to any other type of therapy or service. This section applies to services of the type described in section 1861(p), 1861(g) and 1861(ll) of the Act; it does not, for example, apply to therapy provided by qualified clinical psychologists. This section also does not apply to services that are not covered either as therapy or as evaluation and management services provided incident to a physician or nonphysician practitioner such as recreational therapy, relaxation therapy, athletic training, exercise physiology, kinesiology, or massage therapy services.
Section 1861(p) includes services furnished to individuals by physical and occupational therapists meeting licensing and other standards prescribed by the Secretary if the services meet the necessary conditions for standards for health and safety. These services include those furnished in the therapist's office or the individual's home. By regulation, we have defined therapists under this provision as physical or occupational therapists in private practice (PTPPs and OTPPs).
Under Medicare Part B, outpatient therapy services, including physical and occupational therapy services, are generally covered when reasonable and necessary and when provided by physical and occupational therapists meeting the qualifications set forth at § 484.4. Services provided by qualified therapy assistants, including physical therapist assistants (PTAs) and occupational therapy assistants (OTAs), may also be covered by Medicare when furnished under the specified level of therapist supervision that is required for the setting in which the services are provided (institutions and private practice therapist offices). For PTPPs and OTPPs, the regulations specify that the PT or OT meets only State licensure or certification standards and do not currently refer to the professional qualification requirements at § 484.4.
Since 1999, when therapy services are provided by PTAs and OTAs in the PT or OT private practice setting, the services must be personally supervised by the PTPP or OTPP. In response to a requirement to report to Congress on State standards for supervision of PTAs, CMS contracted with the Urban Institute. The Urban Institute found that no State has the strict, full-time “personal” supervision requirement, for any setting, that Medicare places on PTAs in PTPPs (the report only examined PTAs, which are more heavily regulated than OTAs). The Urban Institute study found that only 7 States require any “personal” PTA supervision by the PT, and all 7 required this level of supervision only periodically, every 14, 30 or 60 days. The remaining States and Washington, DC all have less stringent PTA supervision requirements, including: 7 States and Washington, DC require full-time on-site supervision, which corresponds to Medicare's direct supervision level; 16 States require the equivalent of Medicare's general supervision level, which does not require the PT to be on site, but requires the PT to be in contact via telecommunication; and another 16 States have rules for periodic on-site PT visits. Most States permit a supervision level similar to the Medicare “general” supervision requirement for physical therapy services delivered in institutional settings. To provide a consistent therapy assistant supervision policy, we are proposing to revise the regulations at 410.59 and 410.60 to require direct supervision of PTAs and OTAs when therapy services are provided by PTs or OTs in private practice. This proposed change would no longer require the personal presence of the PTPP or OTPP when their PTAs or OTAs provide services in the private practice setting. We are particularly interested in receiving comments regarding the proposed PTA supervision change, from personal to direct, for the private practice setting as whether or not it will have implications for the quality of services provided, or for Medicare spending, either through increased capacity to provide these services, or, alternatively, in the event that the Congress again extends the moratorium on the implementation of the limits on Medicare reimbursement for therapy services imposed by the Balanced Budget Act of 1997.
Currently, the OTPP or PTPP regulations at § 410.59(c) and § 410.60(c) do not reference qualification requirements for therapy assistants, or other staff, working for PTs and OTs in private practices. These qualification requirements were removed during 1998 rulemaking—when the coverage conditions requiring survey and certification, at § 486 Subpart D, for independently practicing PTs and OTs were replaced with a simplified carrier enrollment process for PTPPs and OTPPs. In our 1998 rule, at 63 FR 58868, we deleted the references at § 410.59 and § 410.60 to the requirements at § 484.4 for PTs and OTs in private practice. At that time, the qualifications for the staff of the PTPP and OTPP, including PTAs and OTAs, were inadvertently removed because the coverage conditions at § 486 Subpart D were no longer applicable. In order to provide a consistent policy regarding requirements for therapists and therapy assistants, we are proposing to restore the qualifications by adding at § 410.59 and § 410.60 the cross-reference to the qualifications at § 484.4 for privately practicing therapists and their therapy assistants.
We are making technical corrections to § 410.62 to refer consistently to speech-language pathology in this section (currently the terms “speech pathology” and “speech-language pathology” are used interchangeably) and are revising § 410.62(a)(2)(iii) to appropriately reference § 410.61 (the current reference is to § 410.63).
We are also removing subpart D, Conditions for Coverage: Outpatient Physical Therapy Services Furnished by Physical Therapists, from part 486. Our November 1998 rule (63 FR 58868) discussed replacing this subpart with a simplified carrier enrollment process for physical or occupational therapists in private practice; however, the conforming regulatory change to remove Subpart D was never made.
In addition, we are making a technical change at § 484.4 to correct the title “physical therapy assistant” to “physical therapist assistant.”
We are also amending § 410.59(e) and § 410.60(e) to include a reference to the 2-year moratorium on the therapy caps established by section 624 of the MMA.
Contrast media are used to enhance the images produced by various types of diagnostic radiological procedures. High osmolar contrast media (HOCM), initially developed for use with these procedures, was relatively inexpensive and payment for HOCM is subsumed in the payment for the technical component of these procedures. When the more expensive low osmolar contrast media (LOCM) were developed, estimates showed that if
When the Medicare physician fee schedule was established, findings of studies of patients receiving both types of contrast media had been published, and the American College of Radiology (ACR) had adopted criteria for the use of LOCM. We determined that the older, less expensive contrast media (HOCM) could be used safely in a large percentage of the Medicare population. However, we also decided that separate payment for LOCM should be made for patients with certain medical characteristics. We adopted the ACR criteria, with some modification, as the basis for a policy that separate payments be made for the use of LOCM in radiological procedures for patients meeting certain criteria. These criteria were established at § 414.38. Specifically, separate payment is made for all intrathecal, intravenous, and intra-arterial injections of LOCM, when it is used for nonhospital patients who have one or more of the following five medical conditions—
• A history of previous adverse reactions to contrast media, with the exception of a sensation of heat, flushing, or a single episode of nausea or vomiting;
• A history of asthma or allergy;
• Significant cardiac dysfunction, including recent or imminent cardiac decompensation, severe arrhythmias, unstable angina pectoris, recent myocardial infarction, and pulmonary hypertension;
• Generalized debilitation;
• Sickle cell disease.
ACR has requested that we allow further separate payment for LOCM by either expanding or eliminating the conditions. According to ACR, use of LOCM has become the standard in most radiology practices and benefits both physicians and patients. The benefits of uniform use of LOCM would include—
• The reduction of patient discomfort arising when HOCM is used instead of LOCM; and
• A reduction in physician resources now required to screen for high-risk patients.
We are proposing to revise the regulations at § 414.38 to eliminate the restrictive criteria for the payment of LOCM. This proposal would make Medicare payment for LOCM consistent across settings. Before January 1, 2003, the criteria in § 414.38 were also used to determine payment in the hospital setting. However, as instructed in our Program Memorandum A-02-120, issued November 22, 2002, hospitals that are subject to the outpatient prospective payment system (OPPS) no longer use these criteria. Instead, payment for both ionic and non-ionic contrast media (including LOCM) is packaged into the APC payment for the procedure. Under OPPS there is no longer a payment difference between LOCM and other contrast materials.
Effective January 1, 2005, payment for LOCM would be made on the basis of the average sales price plus six percent in accordance with the standard methodology for drug pricing established by the MMA. However, because the technical portions of radiology services are currently valued in the nonphysician workpool and the CPEP inputs for these services are not used in calculating payment, we will continue to reduce payment for LOCM by eight percent to avoid any duplicate payment for contrast media.
In response to comments received on billing procedures when the patient is hospitalized during the month, we stated in the November 7, 2003
In comments on the August 15, 2003 proposed rule, the Renal Physicians Association (RPA) indicated that the observation area is not an uncommon setting for outpatient face-to-face encounters to occur and the observation area should be an approved site-of-service for physician-dialysis patient encounters that count toward the MCP visit total. We indicated in the final rule, however, that observation services would not be counted as a visit under the MCP, but would be paid separately. Prior to this, long-standing Medicare policy had subsumed ESRD-related observation visits within the MCP.
Upon further review of this issue, we now agree with RPA's comment and propose that ESRD-related visits provided to patients by the MCP physician in an observation setting would be counted as visits for purposes of billing the MCP codes.
Since changing our payments for managing patients on dialysis, we have received a number of comments from the nephrology community requesting guidance on billing for outpatient ESRD-related services provided to transient patients and in partial month scenarios where the comprehensive visit may not have been furnished: for example, when the patient is hospitalized during the month, or receives a kidney transplant before the monthly comprehensive visit is furnished. To address this issue, we propose to change the description of the G codes for ESRD-related home dialysis services, less than full month, as
“G0324: End stage renal disease (ESRD) related services for dialysis less than a full month of service, per day; for patients under two years of age.”
“G0325: End stage renal disease (ESRD) related services for dialysis less than a full month of service, per day; for patients between two and eleven years of age.”
“G0326: End stage renal disease (ESRD) related services for dialysis less than a full month of service, per day; for patients between twelve and nineteen years of age.”
“G0327: End stage renal disease (ESRD) related services for dialysis less than a full month of service, per day; for patients twenty years of age and over.”
The G codes G0324 through G0327 would be used to bill for outpatient ESRD-related services provided in the following scenarios:
• Transient patients—Patients traveling away from home (less than full month);
• Home Dialysis Patients (less than full month);
• Partial month where there was one or more face-to-face visits without the comprehensive visit and either the patient was hospitalized before a complete assessment was furnished, dialysis stopped due to death, or the patient had a transplant.
We believe that modifying the definition of the per diem G codes (as identified by G0324 through G0327) would provide a consistent way to bill for these partial month scenarios. However, this proposed change to the descriptions of G0324 through G0327 is intended to accommodate unusual circumstances when the outpatient ESRD-related services would not be paid for under the MCP. Use of these per diem codes would be limited to the scenarios listed above. Physicians who have an on-going formal agreement with the MCP physician to provide cursory visits during the month (for example “rounding physicians”) may not use the per diem codes.
For transient patients who are away from their home dialysis site, and at another site for fewer than 30 consecutive days, the revised per diem G codes (G0324 through G0327) would be billed by the physician or practitioner responsible for the transient patient's ESRD-related care. Only the physician or practitioner responsible for the traveling ESRD patient's care would be permitted to bill for ESRD-related services using the per diem G codes (G0324 through G0327).
If the transient patient is under the care of a physician or practitioner other than his or her regular MCP physician for a complete month, the physician or practitioner responsible for the transient patient's ESRD-related care cannot bill using the per diem codes. In this case the transient physician or practitioner treating the patient must furnish a complete assessment and bill for ESRD-related services under the MCP.
We are currently evaluating the criteria for defining a transient patient and welcome comments on when a patient should be considered transient.
In § 411.404, Medicare noncoverage of all obesity-related services is used as an example. Since we are currently revising this coverage policy, we are proposing to omit this example.
All diagnostic tests covered under section 1861(s)(3) of the Act and payable under the physician fee schedule must be furnished under the appropriate level of supervision by a physician as defined in section 1861(r) of the Act. Additionally, the physician or nonphysician practitioner who is treating the patient must order all diagnostic tests in order for these tests to be considered reasonable and necessary. These tests must be furnished under at least a general level of physician supervision, that is, the test is furnished under the physician's overall direction and control, but the physician's presence is not required during the performance of the procedure.
However, certain diagnostic tests require either direct or personal supervision. Direct supervision in the office setting means the physician must be present in the office suite and immediately available to furnish assistance and direction throughout the performance of the procedure. It does not mean that the physician must be present in the room when the procedure is performed. Personal supervision means the physician must be in attendance in the room during the performance of the procedure. Physician supervision at the specified level is required throughout the performance of the test. Services furnished without the required level of supervision are not reasonable and necessary, and Medicare payment is precluded.
Section 410.32(b)(2)(iii) does permit an exception to these physician supervision level requirements for clinical psychologists and independently practicing psychologists (who are not clinical psychologists) to personally perform diagnostic psychological testing services without physician supervision. However, diagnostic psychological tests performed by anyone other than a clinical psychologist or independently practicing psychologist must be provided under the general supervision of a physician as defined above. Accordingly, clinical psychologists and independently practicing psychologists have not been permitted to supervise others in the administration of diagnostic psychological tests.
In § 410.71(d), we require a clinical psychologist who furnishes diagnostic, assessment, preventive, and therapeutic services directly to individuals to hold a doctoral degree in psychology and to be licensed or certified, on the basis of the doctoral degree in psychology, by the State in which he or she practices. Program instructions define an independently practicing psychologist as an individual who is not a clinical psychologist and practices independently of an institution, agency, or physician's office. Examples include, but are not limited to, educational psychologists and counseling psychologists. Any psychologist who is licensed or certified to practice psychology in the State or jurisdiction where he or she is furnishing services may qualify as an independent psychologist. It is our understanding that all States, the District of Columbia, and Puerto Rico license psychologists, but that some trust territories do not. In the jurisdictions that do not issue licenses, an independently practicing psychologist may be any practicing psychologist.
The American Psychological Association (APA) requested that we re-evaluate our regulations regarding clinical psychologists' supervision of diagnostic psychological tests. The APA also provided additional information concerning provision of these services.
According to the APA, clinical psychologists generally have seven years of graduate education in the study of human behavior and are highly trained in the selection, administration,
Therefore, we are proposing to change the supervision requirements regarding who can supervise diagnostic psychological testing services.
Having ancillary staff supervised by clinical psychologists would enable these practitioners with a higher level of expertise to oversee psychological testing. It could also potentially relieve burdens on physicians and healthcare facilities.
Additionally, in rural areas, we anticipate that permitting psychologists to supervise diagnostic psychological testing services would reduce delays in testing, diagnosis, and treatment that could result from the unavailability of physicians to supervise the tests.
We propose that the appropriate level of supervision of diagnostic psychological tests by clinical psychologists be general supervision, the level required of physicians supervising the same services.
We are proposing to revise the regulations at § 410.32(b)(2)(iii) to permit clinical psychologists to supervise the performance of diagnostic psychological and neuropsychological testing services. This proposal extends solely to clinical psychologists, and it does not include independently practicing psychologists.
Care Plan Oversight (CPO) refers to the supervision of patients under Medicare-covered home health or hospice care requiring complex multi-disciplinary care modalities, including regular development and review of plans of care. In the December 8, 1994 physician fee schedule final rule (59 FR 63423), we established separate payment for CPO when performed by physicians. The Balanced Budget Act (BBA) of 1997 extended to nonphysician practitioners (NPPs) the right to receive payment for Medicare physicians' services that fall within their scope of practice under State law. In the November 1, 2000 final rule (65 FR 65407), we created HCPCS codes G0181 and G0182 for reporting home health and hospice CPO, respectively. We also clarified in that rule that services of NPPs, practicing within the scope of State law applicable to their services, could be billed as CPO services.
To certify a patient for home health services, a physician must review the patient records and sign the plan of care. Our policy has been that the physician who bills for CPO must be the same physician who signs the plan of care and that, according to the statute, (sections 1814(a)(2)(C) and 1835(a)(2)(A) of the Act), only a physician can sign the plan of care for home health services. The effect of these two provisions, both of which were in place prior to the BBA of 1997, created a problem with respect to an NPP billing for CPO in the home health setting.
We propose to revise § 414.39 to clarify that NPPs can perform home health CPO even though they cannot certify a patient for home health services and sign the plan of care. However, we are also proposing the conditions under which NPP services may be billed for CPO; we established these conditions in consultation with our contractor medical directors and CMS medical staff. In general, the proposed conditions are meant to ensure that the NPP has seen and examined the patient and that the appropriate and established relationship exists between the physician who certifies the patient for home health services and the NPP who will provide the home health CPO.
Current regulations require the beneficiary (or the person authorized to request payment on the beneficiary's behalf) to assign a claim to the supplier for an assignment to be effective. Over time, however, the Act has been amended in various sections to require suppliers, in some instances, to accept assignment for a Medicare covered service regardless of whether or not the beneficiary actually assigns the claim to the supplier. (This would include situations in which services are furnished by a participating physician or supplier.) In these instances, the requirement in our current regulations at § 424.55(a) that the beneficiary assign the claim to the supplier is now unnecessary. Therefore, we are proposing to create an exception to the general rule in § 424.55(a). New § 424.55(c) would eliminate the requirement that beneficiaries assign claims to suppliers in situations where suppliers are required by statute to accept assignment.
We believe the creation of this exception to the requirement for beneficiaries to assign benefits in situations where benefits can by statute only be paid on an assigned basis will reduce the paperwork burden on beneficiaries and suppliers.
Under the Paperwork Reduction Act of 1995 (PRA), we are required to provide 60-day notice in the
• 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.
Section 410.16 requires the furnishing of education, counseling, and referral services as part of an initial preventive physical examination, a written plan for obtaining the appropriate screening and other preventive services which are also covered as separate Medicare B Part services.
The burden associated with this requirement is the time required of the physician or practitioner to provide beneficiaries with education, counseling, and referral services and to develop and provide a written plan for obtaining screening and other preventive services.
While these requirements are subject to the PRA, we believe the burden associated with these requirements to be reasonable and customary business practice; therefore, the burden for this collection requirement is exempt under 5 CFR 1320.3(b)(2)&(3).
Section 411.404 requires that written notice must be given to a beneficiary, or someone acting on his or her behalf, that
Although this section is subject to the PRA, the burden associated with this requirement is currently captured and accounted for in two currently approved information collections under OMB numbers 0938-0566 and 0938-0781.
Sections 410.36 and 410.38 require that the physician must document in the medical records the need for the prosthetic, orthotic, durable medical equipment, and/or supplies being ordered.
While these information collection requirements are subject to the PRA, the burden associated with them is exempt as defined in 5 CFR 1320.3(b)(2).
If you comment on these information collection and recordkeeping requirements, please mail copies directly to the following:
Centers for Medicare & Medicaid Services, Office of Strategic Operations and Regulatory Affairs, Attn: Melissa Musotto (CMS-1429-P), Room C5-13-28, 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: Christopher Martin, CMS Desk Officer (CMS-1429-P),
Because of the large number of public comments we normally receive on
[If you choose to comment on issues in this section, please include the caption “IMPACT” 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 16, 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 (as amended by Executive Order 13258, which merely reassigns responsibilities of duties) directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis must be prepared for proposed rules with economically significant effects (that is, a proposed rule that would have an annual effect on the economy of $100 million or more in any 1 year, or would adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities). As indicated in more detail below, we estimate that the physician fee schedule provisions included in this proposed rule will redistribute more than $100 million in 1 year. We are also estimating that the combined effect of several provisions of the MMA implemented in this proposed rule will increase spending by more than $100 million. Other MMA provisions implemented in this proposed rule are estimated to reduce spending by more than $100 million. We are considering this proposed rule to be economically significant because its provisions are estimated to result in an increase, decrease or aggregate redistribution of Medicare spending that will exceed $100 million. Therefore, this proposed rule is a major rule and we have prepared a regulatory impact analysis.
The RFA requires that we analyze regulatory options for small businesses and other entities. We prepare a regulatory flexibility analysis unless we certify that a rule would not have a significant economic impact on a substantial number of small entities. The analysis must include a justification concerning the reason action is being taken, the kinds and number of small entities the rule affects, and an explanation of any meaningful options that achieve the objectives with less significant adverse economic impact on the small entities.
Section 1102(b) of the Act requires us to prepare a regulatory impact analysis for any proposed rule that 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 a Metropolitan Statistical Area and has fewer than 100 beds. We have determined that this proposed rule would have minimal impact on small hospitals located in rural areas. Of 431 hospital-based ESRD facilities located in rural areas, only 40 are affiliated with hospitals with fewer than 100 beds.
For purposes of the RFA, physicians, nonphysician practitioners, and suppliers are considered small businesses if they generate revenues of $6 million or less. Approximately 95 percent of physicians are considered to be small entities. There are about 875,000 physicians, other practitioners and medical suppliers that receive Medicare payment under the physician fee schedule. There are in excess of 20,000 physicians and other practitioners that receive Medicare payment for drugs. (As noted previously in this proposed rule and described further below, we are proposing significant changes to the payments for drugs.) These physicians are concentrated in the specialties of oncology, urology, and rheumatology. Of the physicians in these specialties, approximately 40 percent are in oncology and 45 percent in urology.
For purposes of the RFA, approximately 98 percent of suppliers of durable medical equipment (DME) and prosthetic devices are considered small businesses according to the Small Business Administration's (SBA) size standards. We estimate that 106,000 entities bill Medicare for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) each year. Total annual estimated Medicare revenues for DME suppliers exceed approximately $4.0 billion. Of this amount, approximately $1.6 billion are for DME drugs.
In addition, most ESRD facilities are considered small entities, either based on nonprofit status, or by having revenues of $29 million or less in any year. We consider a substantial number of entities to be affected if the proposed rule is estimated to impact more than 5 percent of the total number of small entities. Based on our analysis of the 697 nonprofit ESRD facilities considered small entities in accordance with the above definitions, we estimate that the combined impact of the proposed changes to payment for renal dialysis services included in this rule would have a 1.6 percent increase in payments relative to current composite rate payments.
The analysis and discussion provided in this section, as well as elsewhere in this proposed rule, complies with the RFA requirements. Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule that may result in expenditures in any year by State, local,
We have examined this proposed rule in accordance with Executive Order 13132 and have determined that this regulation would not have any significant impact on the rights, roles, or responsibilities of State, local, or tribal governments.
We have prepared the following analysis, which, together with the information provided in the rest of this preamble, meets all assessment requirements. It explains the rationale for and purposes of the rule; details the costs and benefits of the rule; analyzes alternatives; and presents the measures we propose to use to minimize the burden on small entities. As indicated elsewhere in this proposed rule, we propose to refine resource-based practice expense RVUs and make a variety of other changes to our regulations, payments, or payment policy to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. We are also proposing several changes resulting from the MMA, including changes to Medicare payment rates for outpatient drugs, changes to the payment for renal dialysis services, creating new preventive health care benefits and creating incentive payment program improvements for physician scarcity.
We are providing information for each of the policy changes in the relevant sections of this proposed rule. We are unaware of any relevant Federal rules that duplicate, overlap or conflict with this proposed rule. The relevant sections of this proposed rule contain a description of significant alternatives if applicable.
Under section 1848(c)(2) of the Act, adjustments to RVUs may not cause the amount of expenditures to differ by more than $20 million from the amount of expenditures that would have resulted without such adjustments. We are proposing several changes that would result in a change in expenditures that would exceed $20 million if we made no offsetting adjustments to either the conversion factor or RVUs.
With respect to practice expense, our policy has been to meet the budget-neutrality requirements in the statute by incorporating a rescaling adjustment in the practice expense methodologies. That is, we estimate the aggregate number of practice expense RVUs that will be paid under current and proposed policy in CY 2005. We apply a uniform adjustment factor to make the aggregate number of proposed practice expense RVUs equal the number estimated that would be paid under current policy.
Table 21 shows the specialty level impact on payment of changes being proposed for CY 2005. Our estimates of changes in Medicare revenues for physician fee schedule services compare payment rates for 2005 with payment rates for 2004 using 2003 Medicare utilization for both years. We are using 2003 Medicare claims processed and paid through June 30, 2004 that we estimate are 96.7 complete and have adjusted the figures to reflect a full year of data. Thus, because we are using a single year of utilization, the estimated changes in revenues reflect payment changes only between 2004 and 2005. To the extent that there are year-to-year changes in the volume and mix of services provided by physicians, the actual impact on total Medicare revenues will be different than those shown here. The payment impacts reflect averages for each specialty based on Medicare utilization. The payment impact for an individual physician would be different from the average, based on the mix of services the physician provides. The average change in total revenues would be less than the impact displayed here because physicians furnish services to both Medicare and non-Medicare patients and specialties may receive substantial Medicare revenues for services that are not paid under the physician fee schedule. For instance, independent laboratories receive approximately 80 percent of their Medicare revenues from clinical laboratory services that are not paid under the physician fee schedule. The table shows only the payment impact on physician fee schedule services.
We modeled the impact of changes to the practice expense methodology and illustrated the effect in table 21 below. The column labeled “Practice Expense RVU Refinements” shows the effect of the refinements we are making to the practice expense methodology for 2005. For instance, we are incorporating refined practice expense inputs recommended by the PEAC into the methodology as well as updating the prices of medical equipment. We are also adding 2003 utilization data for codes that did not exist in the 1997 through 2002 period.
In general, updating the methodology with 2003 utilization data has little or no impact on total payments to a specialty but the practice expense values for specific services may change. In general, the largest changes to a practice expense RVU will occur when a code was established after 2002 and we did not have any Medicare utilization data to determine the specialty that performs the service. In these cases, we either assigned the code to a specialty cost pool based on the specialty most likely to do the service or we used the “all physician” scaling factors to determine the code's practice expense RVUs. While we are trying to minimize instability in the practice expense RVUs for new services by assigning the specialty that is most likely to perform the service when we have no utilization data, the addition of utilization to the methodology may still result in some change to the practice expense RVUs during the first few years a code is in existence.
The practice expense refinements will reduce payments to audiologists by approximately 4 percent. Virtually all of the reduction in payment is due to the refinement of procedure code 92547. We accepted the PEAC recommendation to reduce the clinical staff time of the audiologist involved in this add-on service from 71 minutes to 1 minute. The refinement of clinical staff and equipment resulted in a reduction from 1.15 to 0.08 practice expense RVUs producing the nearly 4 percent reduction in payments shown in table 21.
Payments to vascular surgeons will increase approximately 3 percent as a result of the refinements. The increase in payment is attributed to the repricing of medical equipment used in performing noninvasive vascular diagnostic tests that will increase the practice expense RVUs for procedure codes 93880, 93923, 93925, 93970 and other codes in that family. The estimated 2 percent increase in payment from the practice expense refinements for interventional radiology is primarily due to the establishment of nonfacility pricing for procedure codes 35470 to 35476. The 3 percent increase in payment to oral and maxillofacial surgeons is largely attributed to the refinement of medical supplies for procedure codes 21210 and 21215. The 1 percent decrease in payment to nurse practitioners and geriatricians is attributed to the refinement of the nonfacility practice expense RVUs for
The column labeled “Survey Data” shows the impact on payment from using the supplemental practice expense survey from the College of American Pathologists (CAP). Using this survey together with making the technical component practice expense RVUs equal to the difference between the global and professional component practice expense RVUs and the other practice expense refinements will increase payments to pathologists by approximately 2 percent and independent laboratories by more than 6 percent. As we indicated above, independent laboratories receive approximately 20 percent of their total Medicare revenues from physician fee schedule services. The remaining 80 percent of their Medicare revenues are from clinical diagnostic laboratory services that will be unchanged by use of the CAP survey data. Thus, total Medicare revenues to independent laboratories as a result of using the CAP survey will increase by slightly more than 1 percent (or 20 percent of the 6 percent increase in physician fee schedule revenues). There will be little or no impact on all other specialties from use of the CAP survey.
The column labeled “Total” in Table 21 below shows the payment impact by specialty of all the changes described above. If we change any of these proposals following our consideration of comments, these figures may change.
As discussed in Section II.C of this rule, we are proposing changes to the malpractice RVUs based on more current malpractice premium data. As anticipated from past revisions to the malpractice RVUs, use of more current malpractice premium data results in minimal proposed impacts on the specialty level payments. See Table 22, “Specialty Impact of Malpractice RVUs Revisions”, for a breakdown of the impacts of these revisions on individual specialties. Of the 54 specialties shown, 15 specialties (representing a total of 40 percent of Medicare allowed charges) experience no estimated change. Total Medicare payments for an additional 32 specialties are estimated to increase or decrease between 0.1 percent and 0.5 percent. We estimate that 7 specialties will experience a total payment increase or decrease of more than 0.5 percent as a result of the malpractice RVU changes. If we change any of these proposals following our consideration of comments, these figures may change.
Section 1848(d) and (f) of the Act requires the Secretary to set the physician fee schedule update under the sustainable growth rate (SGR) system. For 2004 and 2005, the statute requires the update to be no less than 1.5 percent. We believe it is highly likely that the statutory formula in section 1848(d)(4) will produce an update of less than 1.5 percent for 2005. Therefore, we estimate that the physician fee schedule update for 2005 will be 1.5 percent. We are currently forecasting payment reductions under the SGR system for 2006 and later years. As in the past, we will include a complete discussion of our methodology for calculating the SGR in the final rule.
Table 23 below shows the estimated change in average payments by specialty resulting from changes to the practice expense and malpractice RVUs and the 2005 physician fee schedule update. (Please note that the table does not include the specialties of Hematology/Oncology, Urology, Rheumatology and Obstetrics/Gynecology. There are unique issues related to drug administration that will further affect these specialties that are presented in detail below).
Table 24 shows the impact on payments for selected high-volume procedures of all of the changes previously discussed. We selected these procedures because they are the most commonly provided procedures by a broad spectrum of physician specialties, or they are of particular interest to the physician community (for example, the preventive office visit, G0XX2). This table shows the combined impact of the change in the practice expense and malpractice RVUs and the estimated physician fee schedule update on total payment for the procedure. There are separate columns that show the change in the facility rates and the nonfacility rates. For an explanation of facility and nonfacility practice expense refer to § 414.22(b)(5)(i). The table shows the estimated change in payment rates based on provisions of this proposed rule and the estimated physician fee schedule update. If we change any of the provisions following the consideration of public comments, these figures may change.
Section 303(a)(1) of the MMA amended section 1848(c)(2) of the Act to require increased work and practice expense RVUs for drug administration services. Section 303(a)(4) of the MMA required an additional temporary increase in payment to specific drug administration services (procedure codes 90780 through 90788, 96400, 96408 through 96425, 96520, and 96530) of 32 percent for 2004 and 3 percent for 2005. Table 25 shows the payment amounts for selected high-volume drug administration CPT codes from 2002 to 2006 including the effect of the transition adjustment of 32 percent required for 2004 and 3 percent for 2005 and 0 percent for 2006. The amounts shown in the table include the effect of the 1.5 percent update for 2004 and 2005. The 2006 payment amount shown in the table reflects the 2005 conversion factor because the 2006 physician fee schedule update is currently unknown.
With the exception of procedure code 96412 declining by 17 percent (which occurred because resource-based pricing replaced the use of charge-based RVUs when the services were removed from the nonphysician work pool), the MMA permanently increases payment for all of these services from a low of 17 percent for procedure code 90781 to 321 percent for procedure code 90782. The volume-weighted average permanent increase in payment among these drug administration services is approximately 105 percent (109 percent for oncologists and 94 percent for other physicians). Including the effect of the transition makes the volume-weighted increase in payment for these codes more than 170 percent from 2003 to 2004 and 110 percent from 2003 to 2005. The payment amount for procedure code 96400 in 2002 was $5.07. Payment for this code increased substantially to $37.52 in 2003 when, at the request of the American Urological Association (see 67 FR 79981 published on December 31, 2002), we removed this code from the nonphysician work pool. Including the effect of the additional changes required by MMA, we expect payment for this code to be $49.65 by 2006. Thus, the payment increase for procedure code 96400 between 2002 and 2006 is 879 percent. As indicated earlier, we are continuing to consider coding and RVU changes for drug administration services for 2005 based on the results of the CPT review and our consideration of public comments. If we change any of the RVUs for these codes as a result of CPT's review or the consideration of public comments, these figures may change.
Table 26 below shows the impact of the drug and physician fee schedule changes for selected specialties that receive a significant portion of their total Medicare revenues from drugs. Table 27 shows the combined payment impact of the drug and physician fee schedule payment changes on combined Medicare revenues. The first column (“Estimated Medicare Drug Revenues”) shows estimated 2004 Medicare Drug Revenues using 2003 utilization adjusted for drug payment changes required in 2004 by the MMA. The next column (“% Change Medicare Drug Revenues”) shows the payment impact of the adoption of the average sales price plus 6 percent (ASP+6) drug payment methodology in 2005 relative to 2004 on specialty drug payments. The payment impacts are based on ASP submissions from the 1st quarter of 2004. The ASP prices that will be used to determine payment in 2005 will begin with the 3rd quarter 2004 ASP submission and will be updated quarterly. To model the impact illustrated, we assumed an average increase in ASP prices of 3.39 percent (the national health expenditure prescription drug price growth factor) from the 1st quarter 2004 submission to the prices that will be used to determine 2005 payments. Table xxxxxxx follows table xxxxxx and shows the drug prices we used to determine the payment impact. The drug payment impacts are based on those high volume drugs where we have validated the ASP price submission that represent the following percentages of 2003 drug payments: 72 percent for Hematology/Oncology, 94
Our estimates of changes in Medicare revenues for drugs and physician fee schedule services compare payment rates for 2005 with payment rates for 2004 using 2003 Medicare utilization for both years. We are using 2003 Medicare claims processed and paid through June 30, 2004 that we estimate are 96.7 complete and have adjusted the figures to reflect a full year of data. Thus, because we are using a single year of utilization, the estimated changes in revenues reflect payment changes only between 2004 and 2005. To the extent that there are year-to-year changes in the volume and mix of drugs and physician fee schedule services provided by physicians, the actual impact on total Medicare revenues will be different than those shown here.
Assuming no change in utilization, we estimate that Medicare drug revenues for oncologists would decline by less than 8 percent as a result of policies adopted in this proposed rule. Oncologists administer a number of drugs that are changing in payments by different amounts. For instance, oncologists' highest Medicare revenue drug, Q0136 (EPOGEN; PROCRIT), would decline in payment by 7 percent while its second highest revenue drug, J9310 (RITUXAN), would increase in payment by 7 percent. Three drugs supplied by oncologists, J9265 (ONXOL TAXOL), J2430 (PAMIDRONATE DISODIUM), and J9390 (NAVELBINE), are coming off patent and their price would decline respectively by 81 percent, 71 percent, and 12 percent. The 2004 Medicare payment amounts for these three drugs respectively were equal to 81, 85 and 81 percent of the April 1, 2003 average wholesale price levels that applied or did not decrease proportionally after the drugs came off patent. These three drugs are estimated to account for only 7 percent of oncologists adjusted 2004 Medicare drug revenues but contribute more than 5 percent of the approximate 8 percent total reduction in Medicare drug revenues that oncologists would experience as a result of adopting the ASP+6 payment methodology. While Medicare revenues to oncologists would decline from the reductions in payment for these three drugs, the cost to acquire these drugs has already declined. Thus, Medicare's payment, as with all other drugs experiencing payment changes, will be much closer to the cost the physician pays to acquire the drug.
Adoption of ASP+6 prices would reduce Medicare drug revenues for urologists by approximately 36 percent. This large reduction can be attributed to a 35 percent reduction in payment for two drugs: J9202 (ZOLADEX) and J9217 (LUPRON DEPOT-PED). While we estimate an even larger reduction in the ASP+6 price for J9217, our payment impact assumes that nearly all Medicare carriers are using the “least costly alternative” pricing and paying code J9217 at the J9202 price.
We estimate a 6 percent reduction in Medicare drug revenues for rheumatology. Nearly all of this reduction can be attributed to a 6 percent reduction in Medicare payment for J1745 (REMICADE).
We estimate less than an 18 percent decrease in Medicare drug revenues for obstetrics/gynecology. However, much of this revenue reduction can be attributed to an 81 percent reduction in payment for J9265 (ONXOL TAXOL) coming off patent. Even though this one drug is estimated to account for only 16 percent of obstetrics/gynecology adjusted 2004 Medicare drug revenues, it contributes 13 percent of the approximate 18 percent total reduction in Medicare drug revenues that obstetrics/gynecologists would experience as a result of adopting the ASP+6 payment methodology. As explained above, while Medicare revenues to obstetrics/gynecology would decline as a result of the price reduction for this code, Medicare's payment will be much closer to the price physicians pay to acquire the drug. We are estimating an average approximate reduction of 6 percent across other drugs supplied by obstetrics/gynecology.
The remaining columns of Table 26 show the potential impact on physician fee schedule services of changes being contemplated for 2005 for the specialties shown. The column labeled “Practice Expense and Malpractice RVU Changes” show the combined impact of the changes previously illustrated for these specialties in Tables 21 and 22. The column labeled “Drug Administration Payment Changes” shows a range of potential physician fee schedule impacts for 2005. The left side of this column shows the impact of the changes required in payment by section 303(a)(4) of the MMA (that is, the change in the transition payment from 2004 to 2005) if we were to make no further changes to the payments or codes for drug administration services. However, because we are considering further changes to the payments or codes for drug administration once the AMA's CPT Panel review of this issue is complete, the right hand side of the column labeled “Drug Administration Payment Changes” reflects the amount that physician fee schedule payments would have to increase to make the net reduction across all Medicare revenues for these specialties equal to 2 percent. The next column shows the physician fee schedule update of 1.5 percent and the final column labeled “Total Physician Fee Schedule” Changes” shows the combined effect of all of the changes previously described. The left hand side of the column shows the combined effect of (1) the practice expense and malpractice RVU changes, (2) the maximum reduction in payment that could occur if we made no further changes to payments for drug administration and (3) the physician fee schedule update. The right hand side of the column shows the combined effect of (1) the practice expense and malpractice RVU changes, (2) the amount physician fee schedule revenues would have to increase to make the reduction in total revenues equal to 2 percent and (3) the physician fee schedule update.
If we made no further changes to drug administration, physician fee schedule revenues would decline by 9 percent for oncology, be unchanged for urology and rheumatology, and increase by 1 percent for obstetrics/gynecology. Physician fee schedule revenues would have to increase by 12 percent for oncology, 19 percent for urology, 2 percent for rheumatology and 1 percent for obstetrics/gynecology for total revenues to these specialties to decline by 2 percent from adoption of the ASP+6 percent drug payment methodology.
Table 27 shows the combined impact of changes we are making to Medicare drug and physician fee schedule payments for the same specialties shown in table 26. The column labeled “% of Total Medicare Revenues from Drugs” shows the proportion of total Medicare revenues received from drugs, while the next column shows the payment impact from adoption of the ASP+6 drug payment methodology. The following columns show the proportion of total Medicare revenues received
For example, as indicated in the Table 27, we estimate that approximately 70 percent of total 2004 Medicare revenues for oncologists are attributed to drugs. We estimate that Medicare revenues from drugs will decline by approximately 8 percent for oncology as a result of policies adopted in this proposed rule. Physician fee schedule services account for approximately 28 percent of oncology's 2004 Medicare revenues. If we made no other changes to the RVUs or codes for drug administration services and if there is no change in the utilization of services, we estimate that physician fee schedule payments to oncology would decline by approximately 9 percent from 2004 to 2005. In this scenario, combined Medicare payments to oncology would decline approximately 8 percent. However, if we were to make further changes to physician fee schedule payments so they increased by 12 percent, we estimate the combined revenue reduction to oncology would be 2 percent.
We estimate that urology receives approximately 37 percent of their 2004 total revenues from drugs and 60 percent from physician fee schedule services. Because urology and other physician specialties receive a smaller share of their total Medicare revenues from drug administration services than oncology, they are less affected than oncology by the reduction in the drug administration transition payment percentage from 32 to 3 percent from 2004 to 2005. If we made no other changes to the RVUs or codes for drug administration services, we estimate that physician fee schedule revenues for urologists would increase by approximately 1 percent from 2004 to 2005. (While the reduction in payment for drug administration alone would slightly reduce urologists' physician fee schedule revenues, we estimate that any reduction would be offset by the physician fee schedule update). In this scenario, combined Medicare payments to urologists would decline approximately 13 percent. However, if we were to make further changes to physician fee schedule payments so that they increased by 19 percent, we estimate the combined revenue reduction to urology would be 2 percent.
Rheumatology revenues from drugs are estimated to account for approximately 46 percent of their total revenues and would decline approximately 6 percent from adoption of the ASP+6 drug payment methodology. If we made no other changes to the RVUs or codes for drug administration services, we estimate that physician fee schedule revenues would be either unchanged or decline slightly in the aggregate and estimate a reduction in total Medicare revenues to rheumatology of approximately 3 percent. However, if we were to make further changes to physician fee schedule payments so they increased by 2 percent, we estimate the combined revenue reduction to rheumatologists would be 2 percent.
Medicare drug revenues represent 13 percent of total Medicare revenues for obstetrics/gynecology while physician fee schedule revenues account for 85 percent. We estimate that Medicare drug revenues for obstetrics/gynecology would decline by 18 percent and physician fee schedule revenues would increase 1 percent if we make no further changes to the RVUs or codes for drug administration services. In this scenario, obstetrics/gynecology's combined Medicare revenues would decline by 2 percent. Any change to the drug administration codes that increases their payments would make the net revenue reduction equal to or less than 2 percent for obstetrics/gynecology.
The above tables show those specialties that receive significant revenues from drugs and physician fee schedule services that could be further affected by the review of drug administration coding currently undertaken by the CPT Editorial Panel and any changes we may make after further consideration of this effort and public comments.
Although infectious disease physicians do receive significant revenues from drugs and drug administration, we are not showing them in this table because we have validated only drug payment data accounting for 27 percent of their allowed charges for drugs. Based on these data, we estimate an 11 percent reduction in their Medicare drug payments that account for approximately 6 percent of their total Medicare revenues. If total drug payment were to decline by 11 percent, we estimate that net revenues to infectious disease physicians will remain unchanged, absent any further changes in drug and drug administration coding. We are not showing DME and Other Medical Suppliers in the above table because they do not receive significant revenues for physician fee schedule services and will be unaffected by any further changes made to drug administration coding or RVUs because they do not bill for these services. However, they do receive a substantial portion of their total Medicare revenues from drugs that are affected by the change to ASP+6 pricing. For DME/Other Medical Suppliers, 40 and 60 percent of Medicare revenues respectively are received from drugs and DME fee schedule services. These suppliers would receive an approximate reduction of 70 percent in their Medicare drug revenues from the adoption of ASP+6 drug prices due to the large reduction in payment for two high volume inhalation drugs (J7619 and J7644). These impacts will be reduced somewhat by the dispensing fee we are proposing for inhalation drugs. We estimate the total reduction in payment across all of the services provided by DME suppliers as a result of provisions of this proposed rule would be approximately 28 percent.
As discussed in section II.B, in this rule, we are proposing changes to the work and practice expense GPCIs based on new census data. The resulting geographic redistributions would not result in an overall increase in the current geographic adjustment indices by more than 3.5 percent or a decrease by more than 1.6 percent for any given locality in 2005. These geographic redistributions would not result in an overall increase in the current geographic adjustment indices by more than 7 percent or a decrease by more than 3.5 percent for any given locality in 2006. Addenda E and F illustrate the locality specific overall impact of this proposal. The GAF, as displayed in addenda E and F is a weighted composite index of the individual proposed revisions to the work, practice expense, and malpractice expense GPCIs, respectively. The malpractice GPCI was updated as part of the November 7, 2003 final rule, and the MMA provisions were addressed in the final rule published on January 7, 2004.
In section II.D.1, we are proposing a change in the global period for procedure code 77427,
In section II.D.2, we are proposing to add end stage renal disease (ESRD) services, as represented by HCPCS codes G0308, G0309, G0311, G0312, G0314, G0315, G0317, G03178 to the list of telehealth services. We believe that this change will have little effect on Medicare expenditures.
As discussed earlier in the preamble, we are proposing to use the nonphysician workpool to value two respiratory therapy service codes (G0238 and G0239) that are currently carrier priced. We believe that this proposed change will eliminate the uncertainty surrounding payment of these codes when performed in comprehensive outpatient rehabilitation facilities that are paid under the physician fee schedule through fiscal intermediaries. We do not anticipate that nationally pricing these services would have a significant impact on Medicare expenditures.
We are proposing a new HCPCS code for instances when a bone marrow aspiration and a bone marrow biopsy are performed on the same day through a single incision. Currently, we do not allow payment for both of these procedures on the same day. While this coding change will allow for a small additional payment for the second procedure performed through a single incision on the same day, we anticipate that the costs will be insignificant.
As stated earlier in the preamble, we are proposing a new HCPCS code for venous mapping for hemodialysis access placement. The primary reason for this new code is to enable us to track the use of venous mapping for quality improvement purposes. Since pricing for this service is not changing, there will be no impact on Medicare expenditures.
As discussed earlier in this preamble, the MMA authorizes coverage of an initial preventive physical examination effective January 1, 2005, subject to certain eligibility and other limitations. We estimate that this new benefit will result in an increase in Medicare expenditures. These new payments will be made to physicians and other practitioners who provide these examinations and for any medically necessary follow-up tests, counseling, or treatment that may be required as a result of the coverage of these examinations. The impact of this provision is shown in the following table.
Section 613 of the MMA adds subsection (yy) to section 1861 of the Social Security Act and mandates coverage of diabetes screening tests, effective on or after January 1, 2005. We estimate that this change in coverage for certain beneficiaries will result in an increase in Medicare payments. These payments will be made to physicians' office laboratories and other laboratory suppliers who perform these tests as a result of the increased frequency of coverage of these tests. The impact of this provision is shown in Table 30 that follows.
Section 612 of the MMA provides for Medicare coverage for cholesterol and other lipid or triglyceride levels of cardiovascular screening blood tests for the early detection of abnormalities associated with an elevated risk for such diseases effective on or after January 1, 2005. We estimate that this change in coverage for certain beneficiaries will result in an increase in Medicare payments. These payments will be made to physician office laboratories and other laboratory suppliers who perform these tests as a result of the increased frequency of coverage of these tests. Increased Medicare program expenditures for this provision are shown in Table 30 below.
Section 413(a) of the MMA provides a new 5-percent incentive payment to physicians who furnish services in physician scarcity areas. The MMA provides for paying primary care physicians furnishing services in a primary care scarcity area, and specialty physicians furnishing services in a specialist care scarcity county, an additional amount equal to 5 percent of the amount paid for their professional services under the fee schedule from January 1, 2005 to December 31, 2007. We estimate that this new incentive payment for physician services will result in an increase in Medicare payments that are shown in Table 31.
Section 413(b) of the MMA amended section 1833(m) of the Act to mandate that we automate payment of the 10 percent HPSA incentive payment to eligible physicians. Since the inception of the HPSA incentive payment program, physicians have been required to determine their eligibility and correctly code their Medicare claims using modifiers. We estimate that this change to the HPSA incentive payment program to provide for automation of payment will result in an increase in Medicare payments because many eligible physicians are not applying for bonuses due to the burden of verifying eligibility. The impact of this provision is shown in Table 31.
Sections 303 and 304 of the MMA make changes to Medicare payment for covered outpatient drugs and biologicals and changes to the administration of those drugs. Section 305 makes changes to payment for inhalation drugs. We implemented provisions of sections 303 through 305 changing payments in 2004 for drugs and their administration in the January 7, 2004
The reassignment provisions discussed in section III.F is currently estimated to have no significant impact on Medicare expenditures.
Because the proposed basic case mix adjusted composite payment rate and the revised payment for ESRD drugs must be budget neutral in accordance with section 623(d)(1) of the MMA, except for the statutorily required 1.6 percent increase set forth in section 623(a), we estimate that there would be no budgetary impact for the Medicare program beyond this increase. The impact of this provision (net of beneficiary liability) is shown in the following table.
In order to understand the impact of the proposed changes affecting payments to ESRD facilities that result from enactment of the MMA on different categories of ESRD facilities, it is necessary to compare estimated payments under the current payment system (current payments) to estimated payments under the proposed revisions to the composite rate payment system as set forth in this proposed rule (proposed payments). To estimate the impact among various classes of ESRD facilities, it is imperative that the estimates of current payments and proposed payments contain similar inputs. Therefore, we simulated proposed payments only for those ESRD facilities for which we are able to calculate both current payment and proposed payment.
Due to data limitations, we are unable estimate current and proposed payments for 592 facilities that bill for ESRD drugs. Of these 592 facilities, 174 are hospital based and 418 are independent. Therefore, 29 percent of hospital-based facilities and 11 percent of independent facilities are not shown in the impact table. ESRD providers were grouped into the categories based on characteristics provided in the Online Survey and Certification and Reporting (OSCAR) file and the most recent cost report data from HCRIS. We also used the December 2003 update of CY 2003 Standard Analytical File (SAF) claims as a basis for Medicare dialysis treatments and separately billable drugs and biologicals. While the December 2003 update of the 2003 SAF file is not complete, we wanted to use the most recent data available, and plan to use an updated version of the 2003 SAF file for the final rule.
Table 33 shows the impact of MMA Section 623 on hospital based and independent facilities. We have included both composite rate payments as well as payments for separately billable drugs and biologicals because both are effected by Section 623. The first column of Table 33 identifies the type of ESRD provider, the second column indicates the number of ESRD facilities for each type, and the third column indicates the number of dialysis treatments.
The fourth column shows the effect of the changes in drug payments to ESRD providers. The overall effect of changes in drug payments is budget-neutral as required by MMA. The drug add-on adjustment is designed to result in the same aggregate amount of expenditures as would have been made without the statutory policy change.
Current payments for drugs represent 2005 Medicare reimbursement using 95 percent of AWP prices for the top ten drugs. Medicare spending for drugs other than EPO is estimated using 2004 AWP prices updated by a 3 percent inflation factor times actual drug utilization from 2003 claims. EPO is priced $10 per 1000 units (EPO units are estimated using payments because the units field on bills represents the number of EPO administrations rather than the number EPO units). Spending under the proposed change is 2004 ASP minus 3 percent for the top ten drugs plus 3.39 percent inflation factor times actual drug utilization from 2003 claims.
Proposed payment for drugs under MMA also includes the 11.3 percent drug add-on to the composite rate. This amount is computed by multiplying the composite rate for each provider (with the 1.6 percent increase) times dialysis treatments from 2003 claims. Column 4 is computed by comparing spending under the proposed payment for drugs including the 11.3 percent drug add-on amount to spending under current payments for drugs. In order to make column 4 comparable with rest of Table 33, current composite rate payments to ESRD facilities were included in both current and proposed spending calculations.
Column 5 shows the effect of the 1.6 percent increase to the composite rate on total payments to ESRD providers. While all ESRD providers will get a 1.6 percent increase to their composite rate, this table shows the net effect of this increase on ESRD providers total Medicare revenues (both drug and composite rate payments combined), and therefore does not show a 1.6 percent increase.
On average, ESRD providers receive an average of 36 percent of their total revenues from separately billable drugs and 64 percent of their total revenues from composite rate payment. Since the 1.6 percent increase is applied to the 64 percent portion of their total Medicare revenues, the 1.6 percent composite rate increase is also arithmetically equal to a 1.0 percent increase in ESRD providers' total Medicare revenues. Column 5 is computed by combining proposed payment for drugs (including the 11.3 percent drug add-on amount) with: (1) Current composite rate times dialysis treatments from 2003 claims or (2) composite rate with 1.6 percent increase times dialysis treatments from 2003 claims. The difference between these two combinations is the net effect of the 1.6 percent increase on total payments to ESRD providers. In order to isolate the effect of the 1.6 percent increase, the computation in Column 5 assumes that drug payments to ESRD providers remain constant.
Column 6 shows the impact of the case-mix adjustments as described in section H.4.d of this proposed rule. Because MMA requires this adjustment be budget-neutral in the aggregate, there is no overall impact to the ESRD providers as a whole. While the case-mix adjustment will have an impact within the various provider types, Column 6 shows that the effect between provider groupings is minimal. Column 6 is computed as the difference between proposed payments to ESRD providers with the case-mix adjustments compared to payments to providers without the case-mix adjustments. As described in section H.4.f, we standardized the composite rate to meet the MMA requirement that payment be budget-neutral with respect to aggregate payments. Therefore, there is no change for ESRD providers in aggregate. We note that when applying the case-mix adjustments, we did so at the summary level as shown in Table 33.
Column 7 shows the overall effect of all changes in drug and composite rate payments to ESRD providers. The overall effect measured as the difference between proposed payment with all MMA changes as proposed in this rule and current payment. Proposed payment is computed by multiplying the composite rate for each provider (with both 1.6 percent increase and the 11.3 percent add-on) times dialysis treatments from 2003 claims times the appropriate case-mix adjustment by provider category. In addition, proposed payment includes payments for separately billable drugs under the revised pricing methodology as described in section III-E-Section 303-Payment Reform for Outpatient Drugs and Biologicals, Subsection 1.d. Current payment is the current composite rate for each provider times dialysis treatments from 2003 claims plus current drug payments for separately billable drugs.
The overall impact to ESRD providers in aggregate is 1.0 percent. Among the three separately shown effects, the effect
The coverage of routine costs associated with certain Category A clinical trials as discussed in MMA section 731(b) has no significant impact on Medicare expenditures.
As explained earlier in the preamble, section 629 of the MMA provides for annual updates to the Medicare Part B deductible. The MMA stipulates that the Medicare Part B deductible will be $110 for calendar year 2005, and, for subsequent years, the deductible will be the previous year's deductible increased by the annual percentage increase in the monthly actuarial rate under section 1839(a)(1) of the Act, ending with that subsequent year (rounded to the nearest dollar). We note that while this MMA provision results in a savings to the Medicare program, it also increases beneficiary costs by an equal amount.
As explained in section III.K, effective January 1, 2005, section 512 of the MMA provides for payment to be made to a hospice for specified services furnished by a physician who is either the medical director of, or an employee of, a hospice agency. We estimate that this MMA provision will increase Medicare expenditures by $10 million per year beginning in 2005.
As explained earlier in the preamble, to comply with the requirements of section 302 of the MMA and to enhance quality and reduce fraud, we are proposing to establish basic requirements that apply to all items of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). The impact to the Medicare program will be to improve quality of care because we are involving the physician early in the process when determining the medical necessity for items of DMEPOS. The physician community has stated that they are often asked to order an item of DMEPOS for their patient when they do not think the item is reasonable and necessary. We believe these requirements will result in no costs or savings to Medicare because if any additional spending from more physician visits occur it will be offset by savings from Medicare paying for less DMEPOS. However, we expect to continue evaluating this issue.
As discussed in section IV.A, we are proposing to amend the regulations to include the statutory requirement that only individuals meeting the existing qualification and training standards for therapists (with the exception of licensure) consistent with § 484.4 qualify to provide therapy services incident to physicians' services. We believe that while this will have little impact on Medicare expenditures, it will assist in ensuring the quality of services provided to beneficiaries.
As discussed earlier in section IV.A.2, we are proposing to revise the regulations at § 410.59 and § 410.60 to replace a requirement to provide personal supervision and instead require direct supervision of physical therapist assistants and occupational therapy assistants when therapy services are provided by physical therapists or occupational therapists in private practice. This proposed policy change would provide beneficiaries access to medically necessary therapy services, under a physician-certified plan of care. We believe that this change would result in a 5 percent increase in therapy billing in therapy private practice settings with an estimated cost of $9 million for FY 2005. Projected costs for FY 2006 are $17 million while each subsequent year would only increase by $1 million each year, assuming the therapy caps are applied.
As discussed earlier in the preamble, we are proposing to revise the regulations at § 414.38 to eliminate the restrictive criteria for the payment of LOCM. This proposal will make payment for LOCM consistent across Medicare payment systems. By identifying contrast-enhanced procedures that most commonly use LOCM, the typical ranges of LOCM amounts used by modality, and the cost ranges for LOCM in the marketplace, we estimate program costs as shown in the following table:
We believe that the proposals with respect to ESRD-related services furnished to patients in observation settings and payment for outpatient ESRD-related services for partial month scenarios discussed earlier in section 1V. E. provide clarification of current policy surrounding these issues. We do not believe these proposals would have a significant impact on Medicare expenditures.
We are proposing to change the supervision requirements regarding who can supervise diagnostic psychological testing services. As previously discussed, having ancillary staff supervised by clinical psychologists would enable these practitioners with a higher level of expertise to oversee psychological testing and potentially relieve burdens on physicians and healthcare facilities.
Additionally, in rural areas, we anticipate that permitting psychologists to supervise diagnostic psychological testing services would reduce delays in testing, diagnosis, and treatment that could result from the unavailability of physicians to supervise the tests. We believe that this proposal will have little impact on Medicare expenditures.
As discussed in section IV.G, we are proposing to revise § 414.39 to clarify that NPPs can perform home health care plan oversight even though they cannot certify a patient for home health services and sign the plan of care. We do not expect that this proposal would have an impact on Medicare expenditures, since it is only clarifying that an NPP or a physician can provide care plan oversight for home health care.
The proposed changes with respect to assignment of Medicare claims are currently estimated to have no significant impact on Medicare expenditures. However, as stated earlier in this preamble at section IV.H, we believe the proposed changes will reduce the paperwork burden on beneficiaries and suppliers.
This proposed rule contains a range of policies, including proposals related to specific MMA provisions. The preamble provides descriptions of the statutory provisions that are addressed, identifies those policies when discretion has been exercised and presents rationale for our decisions and, when possible, alternatives that were considered.
The following is a discussion of additional points on the proposed changes required by section 302 of the MMA involving ordering items of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS).
In developing the proposed changes to implement section 302 of the MMA, we did consider establishing “the face-to-face requirement,” and “the order prior to delivery” requirement only for specific items of DMEPOS for which there has been an identified proliferation of use. However, we believe it is important that the physician or nonphysician practitioner determine the medical need for all items of DME. It is good clinical practice for beneficiaries to be seen by the physician for their medical condition and at that time the physician will decide whether an item of DME is appropriate. It is our intent to make Medicare more consistent with private payers in that beneficiaries be seen by their physician for their medical condition, who then makes a diagnosis and orders any supplies needed to address their needs. Since we expect beneficiaries to be seen by their doctor for a specific medical condition, we do not believe that this would place a burden on the physician, as it would be part of a necessary examination.
We also note that in establishing these proposed requirements we do make exceptions for items of continued need, such as, glucose test strips or support surfaces. Once the physician has initially established the need, we do not require additional visits or additional documentation.
There are a number of changes made in this proposed rule that would have an effect on beneficiaries. In general, we believe these changes will improve beneficiary access to services that are currently covered or will expand the Medicare benefit package to include new services. As explained in more detail below, the MMA or regulatory provisions may increase beneficiary liability in some cases. Any changes in aggregate beneficiary liability from a particular provision will be a function of the coinsurance (20 percent if applicable for the particular provision after the beneficiary has met the deductible) and the effect of the aggregate cost (savings) of the provision on the calculation of the Medicare Part B premium rate (generally 25 percent of the provision's cost or savings). Taking into account the MMA and regulatory provisions of this proposed rule, we estimate beneficiary savings in FY 2005 of $270 million. This figure could be less if we make further changes to Medicare's drug administration payments.
The MMA provisions that expand Medicare benefits include: section 611, adding a preventive office visit for newly eligible Medicare beneficiaries; section 612 providing coverage of cardiovascular screening blood tests; and section 613, providing coverage for diabetes screening tests for Medicare beneficiaries at risk for diabetes. While the preventive office visit for newly eligible Medicare beneficiaries is subject to deductible and coinsurance, we believe Medicare beneficiaries will continue to benefit from expanded coverage for this service. We believe many beneficiaries have supplemental insurance coverage or Medicaid that pays the Medicare deductible on their behalf and there will be no immediate additional out-of-pocket cost. Further, even if a beneficiary pays nearly all of the costs of this new benefit, the preventive office visit will substitute for another service a beneficiary may need to meet the annual deductible and the beneficiary will receive more covered benefits at little additional cost. There are no out-of-pocket costs to the beneficiary for the cardiovascular screening blood tests and diabetes screening tests.
Other proposals in this rule related to the MMA will also impact beneficiary liability, with the most significant related to indexing of the part B deductible (section 629 of the MMA) and the drug administration payment changes (sections 303 and 305 of the MMA). Indexing of the Part B deductible will result in an estimated cost to beneficiaries of $110 million in 2005. MMA provisions that improve administration of the 10 percent HPSA bonus and provide an additional 5 percent bonus payment to physicians in Medicare scarcity areas will have no impact on beneficiary liability because the bonus payments are applied to the amount Medicare pays the physician net of beneficiary liability. These provisions will also improve access for Medicare beneficiaries by increasing payments to physicians in areas that traditionally have had a low ratio of physicians to population.
The implementation of MMA provisions related to drugs and drug administration will reduce Medicare beneficiary liability for Medicare covered services. We estimate that implementation of sections 303 through 305 of the MMA will reduce Medicare
We do not believe that the drug and drug administration payment changes required by the MMA are intended to lessen beneficiary access to care. By reducing beneficiary liability, we believe it is likely that beneficiary access to care will be improved. As indicated earlier, without any further change in payment for drug administration, the MMA increased payment for drug administration by more than 105 percent from 2003 to 2005 while making payment for drugs at 6 percent more than their average sales price. Nevertheless, we acknowledge that there is a concern among physicians and others that the large changes in Medicare's payments may affect their ability or willingness to continue making drugs and related services available.
As indicated above, we are considering making further changes to Medicare payment for drug administration based on the results of CPT's review of this issue or in response to public comment. Further, we are gathering Medicare utilization for drugs and drug administration beginning in 2002 and plan to analyze shifts or changes in utilization patterns as the information becomes available to us once the payment changes required by the MMA go into effect. While we do not believe the payment changes for drugs and drug administration will result in access problems, we plan to continue studying this issue. We also note that the MMA requires the Medicare Payment Advisory Commission (MedPAC) to study related issues. Specifically, section 303(a)(5) of the MMA requires MedPAC to study items and services furnished by oncologists and drug administration services furnished by other specialists. Similarly, section 305(b) requires the General Accounting Office to study the adequacy of Medicare payments for inhalation therapy.
We are also undertaking several changes using our administrative authority that will affect Medicare beneficiaries. Our proposal to remove restrictions that limit Medicare payment for use of low osmolar contrast material to specific indications would update Medicare's payment policy to be consistent with the standard practice of medicine and will improve the quality of care for beneficiaries.
We believe early involvement of the physician in determining the medical necessity for items of DMEPOS will assist in improving the accuracy of Medicare program payments and the quality of care. In addition, it will also reduce out-of-pocket costs for unnecessary DMEPOS that may have otherwise been provided to Medicare beneficiaries.
In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.
Administrative practice and procedure, Health facilities, Health professions, Kidney diseases, Medical devices, Medicare, Reporting and recordkeeping requirements, Rural areas, X-rays
Health facilities, Health professions, Kidney diseases, Laboratories, Medicare, Reporting and recordkeeping requirements, Rural areas, X-rays
Kidney diseases, Medicare, Reporting and recordkeeping requirements
Administrative practice and procedure, Health facilities, Health professions, Kidney diseases, Medicare, Reporting and recordkeeping requirements
Health facilities, Hospice care, Medicare, Reporting and recordkeeping requirements
Emergency medical services, Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements
Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements
Grant programs-health, Health facilities, Medicare, Reporting and recordkeeping requirements, X-rays
For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services proposes to amend 42 CFR chapter IV as follows:
1. The authority citation for part 405 continues to read as follows:
Secs. 1102, 1861, 1862(a), 1871, 1874, 1881, and 1886(k) of the Social Security Act (42 U.S.C. 1302, 1395x, 1395y(a), 1395hh, 1395kk, 1395rr, and 1395ww(k)), and sec. 353 of the Public Health Service Act (42 U.S.C. 263a).
2. Section 405.207 is amended by revising paragraph (b) to read as follows:
(b)
(1) Covered services to treat a condition or complication that arises due to the use of a noncovered device or a noncovered device-related service; or
(2) Routine care services related to experimental/investigational (Category A) devices as defined in § 405.201(b); and furnished in conjunction with an FDA-approved clinical trial. The trial must meet criteria established through the national coverage determination process; and if the trial is initiated before January 1, 2010, the device must be determined as intended for use in the diagnosis, monitoring or treatment of an immediate life-threatening disease or condition.
(3) Routine care services related to a non-experimental/investigational (Category B) device defined in § 405.201(b) that is furnished in conjunction with an FDA-approved clinical trial.
3. Section 405.517 is amended by adding a new paragraph (a)(3) to read as follows:
(a)
(3)
4. The authority citation for part 410 continues to read as follows:
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
5. Section 410.10 is amended by adding new paragraph (y) to read as follows:
(y) Intravenous immune globulin administered in the home for the treatment of primary immune deficiency diseases.
6. Section 410.16 is added to read as follows:
(a)
(1) Review of the individual's comprehensive medical and social history.
(2) Review of the individual's potential (risk factors) for depression, including past experiences with depression or other mood disorders, based on the use of an appropriate screening instrument, which the physician or other qualified nonphysician practitioner may select unless the appropriate screening instrument is further defined through a national coverage determination.
(3) Review of the individual's functional ability, and level of safety, based on the use of an appropriate screening instrument, which the physician or other qualified nonphysician practitioner may select unless the appropriate screening instrument is defined through a national coverage determination.
(4) An examination to include measurement of the individual's height, weight, blood pressure, a visual acuity screen, and other factors as deemed appropriate, based on the individual's medical and social history, and current clinical standards.
(5) Performance and interpretation of an electrocardiogram.
(6) Education, counseling, and referral, as deemed appropriate by the physician or qualified nonphysician practitioner, based on the results of the review and evaluation services described in this section.
(7) Education, counseling, and referral, including a written plan provided to the individual for obtaining the appropriate screening and other preventive services for the individual that are covered as separate Medicare Part B benefits as described in section 1861(s)(10), section 1861(jj), section 1861(nn), section 1861(oo), section 1861(pp), section 1861(qq)(1), section 1861(rr), section 1861(uu), section 1861(vv), section 1861(xx)(1), and section 1861(yy) of the Social Security Act (the Act).
(1) Past medical and surgical history, including experiences with illnesses, hospital stays, operations, allergies, injuries and treatments.
(2) Current medications and supplements, including calcium and vitamins.
(3) Family history, including a review of medical events in the patient's family, including diseases that may be hereditary or place the individual at risk.
(1) Hearing impairment.
(2) Activities of daily living.
(3) Falls risk.
(4) Home safety.
(1) History of alcohol, tobacco, and illicit drug use.
(2) Work and travel history.
(3) Diet.
(4) Social activities.
(5) Physical activities.
(b)
(c)
7. A new § 410.17 is added to read as follows:
(a)
(1) A lipid panel consisting of a total cholesterol, HDL cholesterol, and triglyceride. The test is performed after a 12-hour fasting period.
(2) Other blood tests, previously recommended by the U.S. Preventive Services Task Force (USPSTF), as determined by the Secretary through a national coverage determination process.
(3) Other non-invasive tests, for indications that have a blood test recommended by the USPSTF, as determined by the Secretary through a national coverage determination process.
(b)
(c)
8. A new § 410.18 is added to read as follows:
(a)
(1) Impaired fasting glucose.
(2) Impaired glucose tolerance.
(b)
(c)
(1) Fasting plasma glucose test.
(2) Post-glucose challenges including, but not limited to, an oral glucose tolerance test with a glucose challenge of 75 grams of glucose for non-pregnant adults, a 2-hour post glucose challenge test alone.
(3) Other tests as determined by the Secretary through a national coverage determination.
(d)
(1) Diagnosed with pre-diabetes Medicare, two screening tests per calendar year.
(2) Previously tested who were not diagnosed with pre-diabetes, or who have never been tested before, one screening test per year.
(e)
(1) Hypertension.
(2) Dyslipidemia.
(3) Obesity, defined as a body mass index greater than or equal to 30 kg/m2.
(4) Prior identification of impaired fasting glucose or glucose intolerance.
(5) Any two of the following characteristics:
(i) Overweight, defined as body mass index greater than 25, but less than 30, kg/m2.
(ii) A family history of diabetes.
(iii) 65 years of age or older.
(iv) A history of birthing a baby weighing more than 9 pounds.
(f)
9. Section 410.26 is amended by revising paragraph (c) to read as follows:
(c)
(2) Physical therapy, occupational therapy and speech-language pathology services provided incident to a physician's professional services are subject to the provisions established in § 410.59(a)(3)(iii), § 410.60(a)(3)(iii), and § 410.62(a)(3)(ii).
10. Section 410.32 is amended by revising paragraph (b)(2)(iii) to read as follows:
(b) * * *
(2) * * *
(iii) Diagnostic psychological testing services when—
(A) Personally furnished by a clinical psychologist or an independently practicing psychologist as defined in program instructions; or
(B) Furnished under the general supervision of a physician or a clinical psychologist.
11. Section 410.36 is amended by—
A. Revising the section heading.
B. Adding to paragraph (a), the paragraph heading “Condition for coverage medical supplies, appliances, and devices.”
C. Revising paragraph (b).
D. Adding new paragraphs (c) and (d).
The additions and revisions read as follows:
(a)
(b)
(1) The medical supplies, appliances, and devices are ordered by a physician, physician assistant, clinical nurse specialist, or nurse practitioner as defined in the Act.
(2) The physician or prescribing practitioner—
(i) Conducts a face-to-face examination to determine the medical necessity for medical supplies, appliances, and devices.
(ii) Conducts the face-to-face examination only for the initial order and at the time of the prescription renewal for items of continued need, such as glucose testing supplies.
(iii) Is independent from the DME supplier and may not be an employee or contractor of the supplier.
(3) A written order is completed and signed before delivery of these medical supplies, appliances, and devices to the beneficiary.
(4) The physician's or prescribing practitioner's order is dated and signed within 30 days after the face-to-face examination and the beneficiary's medical record includes verification of the face-to-face examination.
(5) The physician or prescribing practitioner documents in the beneficiary's medical record the need for the medical supplies, appliances, and devices being ordered.
(6) CMS may determine other criteria, such as prescription renewal requirements, repairs, minor revisions and replacement, through contractor instructions.
(c)
(d)
12. Section 410.38 is amended by—
A. Revising paragraph (g).
B. Adding paragraphs (h) and (i).
The revision and additions read as follows:
(g)
(2) The physician or prescribing practitioner must—
(i) Conduct a face-to-face examination to determine the medical necessity of each item of durable medical equipment.
(ii) Conduct the face-to-face examination for the initial order and at the time of the prescription renewal for items of continued need, such as infusion pumps or hospital beds.
(iii) Be independent from the DME supplier and cannot be an employee or contractor of the supplier.
(3) A written order must be completed and signed before delivery of any
(4) The physician's or prescribing practitioner's order must be dated and signed within 30 days after the face-to-face examination and the beneficiary's medical record must include verification of the face-to-face examination.
(5) The physician or prescribing practitioner must document in the beneficiary's medical record the need for the durable medical equipment being ordered.
(6) CMS may determine other additional payment criteria, such as prescription renewal requirements, repairs, minor revisions and replacement, through contractor instructions.
(h)
(i)
13. Section 410.59 is amended by—
A. Revising paragraph (a) introductory text and paragraph (a)(3)(ii).
B. Adding new paragraph (a)(3)(iii).
C. Revising paragraph (b) heading.
C. Revising paragraph (c)(2).
D. Adding new paragraph (e)(1)(iii).
The additions and revisions read as follows:
(a)
(3) * * *
(ii) By, or under the direct supervision of, an occupational therapist in private practice as described in paragraph (c) of this section; or
(iii) By, or incident to the service of, a physician, physician assistant, clinical nurse specialist, or nurse practitioner when those professionals may perform occupational therapy services within the scope of their State practice. When an occupational therapy service is provided incident to the service of a physician, physician assistant, clinical nurse specialist, or nurse practitioner, the service and the person who furnishes the service must meet the standards and conditions that apply to occupational therapy and occupational therapists, except that a license to practice occupational therapy in the State is not required.
(b)
(c)
(2)
(e)
(1) * * *
(iii) The limitation is not applied for services furnished from December 8, 2003 through December 31, 2005.
14. Section 410.60 is amended by—
A. Revising paragraph (a) introductory text.
B. Revising paragraph (a)(3)(ii).
C. Adding new paragraph (a)(3)(iii).
D. Revising paragraph (b) heading.
E. Revising paragraph (c)(2).
F. Adding new paragraph (e)(1)(iii).
The additions and revisions read as follows:
(a)
(3) * * *
(ii) By or under the direct supervision of a physical therapist in private practice as described in paragraph (c) of this section; or
(iii) By, or incident to, the service of a physician, physician assistant, clinical nurse specialist, or nurse practitioner when those professionals may perform physical therapy services within the scope of their State practice. When a physical therapy service is provided incident to the service of a physician, physician's assistant, clinical nurse specialist, or nurse practitioner, the service and person who furnishes the service must meet the standards and conditions that apply to physical therapy and physical therapists, except that a license to practice physical therapy in the State is not required.
(b)
(c) Special provisions for services furnished by physical therapists in private practice. * * *
(2)
(e)
(1) * * *
(iii) The limitation is not applied for services furnished from December 8, 2003 through December 31, 2005.
15. Section 410.62 is amended by—
A. Revising paragraph (a) introductory text and (a)(2)(i), (a)(2)(iii) and (a)(3).
B. Revising paragraphs (b) and (c).
The revisions read as follows:
(a)
(2) * * *
(i) Is established by a physician or, effective January 1, 1982, by either a physician or the speech-language pathologist who provides the services to the particular individual;
(ii) * * *
(iii) Meets the requirements of § 410.61.
(3) They are furnished—
(i) By a provider as defined in § 489.2 of this chapter, or by others under arrangements with, and under the supervision of, a provider; or
(ii) By, or incident to, the service of a physician, physician assistant, clinical
(b)
(c)
16. Section 410.63 is amended by—
A. Revising paragraph (b) section heading.
B. Adding a new paragraph (c).
The revision and addition reads as follows:
(b)
(c)
17. Section 410.78 is amended by—
A. Revising paragraph (a)(4).
B. Revising paragraph (b) introductory text.
The revisions read as follows:
(a) * * *
(4)
(b)
18. Section 410.160 is amended by revising paragraph (f) to read as follows:
(f)
(2) For 2005, the deductible is $110.
(3) From 1991 through 2004, the deductible was $100.
(4) From 1982 through 1990, the deductible was $75.
(5) From 1973 through 1981, the deductible was $60.
(6) From 1966 through 1972, the deductible was $50.
19. The authority citation for part 411 continues to read as follows:
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
20. Section 411.15 is amended by—
A. Revising paragraph (a)(1).
B. Adding paragraph (k)(11).
The revision and addition read as follows:
(a) * * *
(1) Examinations performed for a purpose other than treatment or diagnosis of a specific illness, symptoms, complaint, or injury, except for screening mammography, colorectal cancer screening tests, screening pelvic exams, prostate cancer screening tests, glaucoma screening exams, or initial preventive physical examinations that meet the criteria specified in paragraphs (k)(6) through (k)(11) of this section.
(k) * * *
(11) In the case of initial preventive physical examinations, with the goal of health promotion and disease prevention, subject to the conditions and limitations specified in § 410.16 of this chapter.
21. Section 411.404 is amended by revising paragraph (b) to read as follows:
(b)
22. The authority citation for part 414 continues to read as follows:
Secs. 1102, 1871, and 1881(b)(1) of the Social Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(1)).
23. Section 414.38 is removed.
24. Section 414.39 is amended by—
A. Revising paragraph (a).
B. Adding paragraph (c).
The revision and addition read as follows:
(a)
(c)
(i) The physician and NPP are part of the same group practice;
(ii) If the NPP is a nurse practitioner or clinical nurse specialist, the physician signing the plan of care also has a collaborative agreement with the NPP;
(iii) If the NPP is a physician assistant, the physician signing the plan of care is also the physician who provides general supervision of physician assistant services for the practice; or
(iv) The physician signing the plan of care provides regular ongoing care under the same plan of care as does the NPP billing for care plan oversight.
(2) Payment may be made for care plan oversight services furnished by an NPP when:
(i) The NPP providing the care plan oversight has seen and examined the patient;
(ii) The NPP providing care plan oversight is not functioning as a consultant whose participation is limited to a single medical condition rather than multi-disciplinary coordination of care; or
(iii) The NPP providing care plan oversight integrates his or her care with that of the physician who signed the plan of care.
25. Section 414.65 is amended by revising paragraph (a)(1) to read as follows:
(a) * * *
(1) The Medicare payment amount for office or other outpatient visits, consultation, individual psychotherapy, psychiatric diagnostic interview examination, monthly end stage renal disease (ESRD) related evaluation and management services and pharmacologic management furnished via an interactive telecommunications system is equal to the current fee schedule amount applicable for the service of the physician or practitioner.
26. Section 414.66 is added to read as follows:
(a)
(b) Physicians' services furnished to a beneficiary in a Physician Scarcity Area (PSA) for primary or specialist care are eligible for a 5 percent incentive payment.
(c) Primary care physicians furnishing services in primary care PSAs are entitled to an additional 5 percent incentive payment above the amount paid under the physician fee schedule for their professional services furnished on or after January 1, 2005 and before January 1, 2008.
(d) Physicians (other than dentists, podiatrists, optometrists, chiropractors, and those identified in paragraph (a) of this section) furnishing services in specialist care PSAs are entitled to an additional 5 percent payment above the amount paid under the physician fee schedule for their professional services furnished on or after January 1, 2005 and before January 1, 2008.
27. Section 414.67 is added to read as follows:
(a) Physicians' services furnished to a beneficiary in a geographic-based Health Professional Shortage Area (HPSA) are eligible for a 10 percent incentive payment.
(b) Physicians furnishing services in a geographic-based primary medical care HPSA are entitled to a 10 percent incentive payment above the amount paid for their professional services under the physician fee schedule.
(c) Psychiatrists furnishing services in a mental health HPSA are entitled to a 10 percent incentive payment above the amount paid for their professional services under the physician fee schedule. (The only physicians eligible to receive the 10 percent incentive payment in mental health HPSAs that do not overlap with primary care HPSAs are psychiatrists.)
28. Part 414 is amended by adding a new subpart K to read as follows:
(a) This subpart implements section 1842(o) of the Social Security Act by specifying the methodology for determining the payment allowance limit for drugs and biologicals covered under Medicare Part B that are not paid on a cost or prospective payment system basis.
(b) Examples of drugs that are subject to the requirements specified in this subpart are:
(1) Drugs furnished incident to a physician's service; durable medical equipment (DME) drugs.
(2) Separately billable drugs at independent dialysis facilities not under the ESRD composite rate.
(3) Statutorily covered drugs, for example—
(i) Influenza
(ii) Pneumococcal and hepatitis vaccines.
(iii) Antigens.
(iv) Hemophilia blood clotting factor.
(v) Immunosuppressive drugs.
(vi) Certain oral anti-cancer drugs.
As used in this subpart, unless the context indicates otherwise—
(a)
(1) The actual charge on the claim for program benefits; or
(2) 106 percent of the average sales price, subject to the applicable limitations specified in paragraph (d) of this section or subject to the exceptions described in paragraph (e) of this section.
(b)
(2)
(i) Computing the sum of the products (for each National Drug Code assigned to the drug products) of the manufacturer's average sales price and the total number of units sold; and
(ii) Dividing that sum by the sum of the total number of units sold for all NDCs assigned to the drug products.
(c)
(2)
(i) The sum of the products (for each National Drug Code assigned to the drug product) of the manufacturer's average sales price and the total number of units sold; and
(ii) Dividing that sum by the sum of the total number of units sold for all NDCs assigned to the drug product.
(d)
(2)
(3)
(e)
(2)
(3)
(4)
(f) Except as otherwise specified (see paragraph (e)(2)of this section) for infusion drugs, the payment limits are updated quarterly.
(g) The payment limit is computed without regard to any special packaging, labeling, or identifiers on the dosage form or product or package.
(h) The payment amount is subject to applicable deductible and coinsurance.
29. The authority citation for part 418 continues to read as follows:
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
30. Section 418.205 is added to read as follows:
(a)
(b)
(1)
(ii) Has not made a hospice election.
(iii) Has not previously received hospice pre-election evaluation and consultation services specified under this section.
(2)
(ii) Counseling regarding hospice and other care options; and
(iii) May include advising the individual regarding advanced care planning.
(3)
(ii) The services cannot be furnished by other hospice personnel, such as but not limited to nurse practitioners, nurses, or social workers, physicians under contractual arrangements with the hospice or by the beneficiary's physician, if that physician is not an employee of the hospice.
(iii) If the beneficiary's physician is also the medical director or a physician employee of the hospice, the attending physician is not required to request or provide this service because that physician already possesses the expertise necessary to furnish end-of-life evaluation and management, and counseling services.
(4)
(ii) The request or referral must be in writing, and the hospice medical director or physician employee is expected to provide a written note on the patient's medical record.
(iii) The hospice agency employing the physician providing these services is required to maintain a written record of the services rendered.
(iv) If the services are initiated by the beneficiary, the hospice agency is required to maintain a record of the services and that communication between the hospice medical director or physician and the beneficiary's physician occurs, with the beneficiary's permission, to the extent necessary to ensure continuity of care.
31. Section 418.304 is amended by adding paragraph (d) to read as follows.
(d)
32. The authority citation for part 424 continues to read as follows:
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
33. Section 424.55 is amended by adding new paragraph (c) to read as follows:
(c)
34. Section 424.71 is amended as follows:
A. The definition of “Health care delivery system or system” is removed.
B. The definition of the term “Entity” is added in alphabetical order.
The addition reads as follows:
35. Section 424.80 is amended by—
A. Revising paragraph (b)(2).
B. Removing paragraph (b)(3).
C. Redesignating paragraphs (b)(4) through (6) as paragraphs (b) (3) through (5), respectively.
D. Revising paragraph (c).
E. Adding a new paragraph (d).
The revisions and addition read as follows:
(b) * * *
(1) * * *
(2)
(c)
(d)
(2)
36. The authority citation for part 484 continues to read as follows:
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395(hh).
37. In § 484.4 in the definition of physical therapy assistant the term “physical therapy assistant” is removed and the term “physical therapist assistant” is added in its place wherever it appears.
38. The authority citation for part 486 continues to read as follows:
Sections 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
39. Part 486 subpart D, consisting of § 486.150 through § 486.163, is removed and reserved.
These addenda will not appear in the Code of Federal Regulations.
The addenda on the following pages provide various data pertaining to the Medicare fee schedule for physicians' services furnished in 2005. Addendum B contains the RVUs for work, non-facility practice expense, facility practice expense, and malpractice expense, and other information for all services included in the physician fee schedule.
In previous years, we have listed many services in Addendum B that are not paid under the physician fee schedule. To avoid publishing as many pages of codes for these services, we are not including clinical laboratory codes and most alpha-numeric codes (Healthcare Common Procedure Coding System (HCPCS) codes not included in CPT) in Addendum B.
This addendum contains the following information for each CPT code and alphanumeric HCPCS code, except for alphanumeric codes beginning with B (enteral and parenteral therapy), E (durable medical equipment), K (temporary codes for nonphysicians' services or items), or L (orthotics), and codes for anesthesiology.
1.
2.
Modifier -53 is shown for a discontinued procedure. There will be RVUs for the code (CPT code 45378) with this modifier.
3.
A = Active code. These codes are separately payable under the fee schedule if covered. There will be RVUs for codes with this status. The presence of an “A” indicator does not mean that Medicare has made a national decision regarding the coverage of the service. Carriers remain responsible for coverage decisions in the absence of a national Medicare policy.
B = Bundled code. Payment for covered services is always bundled into payment for other services not specified. If RVUs are shown, they are not used for Medicare payment. If these services are covered, payment for them is subsumed by the payment for the services to which they are incident. (An example is a telephone call from a hospital nurse regarding care of a patient.)
C = Carrier-priced code. Carriers will establish RVUs and payment amounts for these services, generally on a case-by-case basis following review of documentation, such as an operative report.
D = Deleted code. These codes are deleted effective with the beginning of the calendar year.
E = Excluded from physician fee schedule by regulation. These codes are for items or services that we chose to exclude from the physician fee schedule payment by regulation. No RVUs are shown, and no payment may be made under the physician fee schedule for these codes. Payment for them, if they are covered, continues under reasonable charge or other payment procedures.
F = Deleted/discontinued codes. Code not subject to a 90-day grace period.
G = Code not valid for Medicare purposes. Medicare does not recognize codes assigned this status. Medicare uses another code for reporting of, and payment for, these services.
H = Deleted modifier. Either the TC or PC component shown for the code has been deleted, and the deleted component is shown in the data base with the H status indicator. (Code subject to a 90-day grace period.)
I = Not valid for Medicare purposes. Medicare uses another code for the reporting of, and the payment for these services. (Code NOT subject to a 90-day grace period.)
N = Noncovered service. These codes are noncovered services. Medicare payment may not be made for these codes. If RVUs are shown, they are not used for Medicare payment.
P = Bundled or excluded code. There are no RVUs for these services. No separate payment should be made for them under the physician fee schedule.
R = Restricted coverage. Special coverage instructions apply. If the service is covered and no RVUs are shown, it is carrier-priced.
T = Injections. There are RVUs for these services, but they are only paid if there are no other services payable under the physician fee schedule billed on the same date by the same provider. If any other services payable under the physician fee schedule are billed on the same date by the same provider, these services are bundled into the service(s) for which payment is made.
X = Exclusion by law. These codes represent an item or service that is not within the definition of “physicians’ services” for physician fee schedule payment purposes. No RVUs are shown for these codes, and no payment may be made under the physician fee schedule. (Examples are ambulance services and clinical diagnostic laboratory services.)
4.
5.
6.
7.
8.
9.
10.
11.
MMM = The code describes a service furnished in uncomplicated maternity cases including antepartum care, delivery, and postpartum care. The usual global surgical concept does not apply.
XXX = The global concept does not apply.
YYY = The global period is to be set by the carrier (for example, unlisted surgery codes).
ZZZ = Code related to another service that is always included in the global period of the other service. (
Fish and Wildlife Service, Interior; National Marine Fisheries Service, National Oceanic and Atmospheric Administration, Commerce.
Final rule.
This final rule, developed by the U.S. Department of the Interior, Fish and Wildlife Service (FWS) and the U.S. Department of Commerce, National Oceanic and Atmospheric Administration, National Marine Fisheries Service (NOAA Fisheries) (referred to jointly as “Services” and individually as “Service”), after coordination with the Environmental Protection Agency (EPA) and the U.S. Department of Agriculture (USDA), codifies joint counterpart regulations for consultation under section 7 of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
This rule is effective September 7, 2004.
The complete file for this rule is available for inspection, by appointment, during normal business hours at the Division of Consultation, Habitat Conservation Planning, Recovery and State Grants, U.S. Fish and Wildlife Service, 4401 North Fairfax Drive, Room 420, Arlington, Virginia 22203.
Patrick Leonard, Chief, Division of Consultation, Habitat Conservation Planning, Recovery and State Grants, at the above address (Telephone 703/358-2171, Facsimile 703/358-1735) or Jim Lecky, Acting Senior Advisor for Intergovernmental Programs, NOAA Fisheries, 1315 East-West Highway, Silver Spring, MD 20910 (301/713-2239; facsimile 301/713-1940).
Through this final joint rulemaking, the FWS and NOAA adopt additional regulations to enhance the efficiency and effectiveness of the consultation process under section 7 of the ESA and to provide alternatives to the way EPA now consults with the Services under the ESA on regulatory actions under FIFRA involving pesticides. This Notice of Final Rulemaking, developed with assistance from EPA and the USDA, complements the Services' other consultation regulations in 50 CFR part 402. A rule providing an alternative consultation process for a specific Federal agency is called a “counterpart regulation.” See 50 CFR 402.04. The purpose of this rule is to improve interagency cooperation for regulatory actions under FIFRA involving pesticides, and provide optional, alternative approaches to consultation on pesticide actions that better integrate the consultation process under section 7 of the ESA with the processes for pesticide regulatory actions taken by EPA under FIFRA. By doing so, the Services expect the administration of the ESA and FIFRA will better protect threatened and endangered species and critical habitat with minimal disruption of the nation's access to products licensed under FIFRA that are necessary for the production of food and fiber and for health and disease protection. Additional supplementary information, including many of the documents mentioned in this Notice, is available on the Internet at
Congress enacted the ESA to establish a program for conservation of endangered and threatened species and the ecosystems on which they depend. 16 U.S.C. 1531(b). Section 7 of the ESA, 16 U.S.C. 1536, imposes obligations upon all Federal agencies to protect listed species or designated critical habitat. Section 7(a)(2) of the ESA, 16 U.S.C. 1536(a)(2) directs all Federal agencies, in consultation with and with the assistance of the Secretaries of the Interior and Commerce (delegated to the respective Services), to insure that any action authorized, funded, or carried out by such agency is not likely to jeopardize the continued existence of any listed species or result in the destruction or adverse modification of habitat of such species that has been designated as critical (“critical habitat”). 16 U.S.C. 1536(a)(2). In meeting this requirement, each agency is required to use the “best scientific and commercial data available.” 16 U.S.C. 1536(a)(2). The FWS and NOAA Fisheries are jointly responsible for administering the ESA.
The Services adopted joint consultation regulations set forth at 50 CFR part 402 (subparts A and B). These regulatory provisions require action agencies to consult with the Services on any Federal action that “may affect” a listed species or critical habitat. Consultation may be concluded “informally” if the action agency determines that the Federal action under consideration is “not likely to adversely affect” (NLAA) a listed species or critical habitat and the Service gives written concurrence. 50 CFR 402.13(a)(1). Such informal consultation fulfills the action agency's section 7 consultation obligation. 50 CFR 402.14(b)(1). Formal consultation, however, may always be pursued and is required if the action is likely to adversely affect a listed species or critical habitat or if the Service does not concur with an action agency's NLAA determination. During formal consultation, the action agency and Service examine the effects of the proposed action and the Service determines whether the proposed Federal action is likely to jeopardize the continued existence of any listed species or result in the destruction or adverse modification of critical habitat and whether incidental take of listed species is anticipated. 50 CFR 402.14(h), 402.14(i).
Under subparts A and B, the consultation process reviews a variety of
At the conclusion of formal consultation, the Service will issue a biological opinion that details the effects of the action on the listed species or critical habitat, and states whether the action is likely to jeopardize the continued existence of a listed species or result in the destruction or adverse modification of critical habitat. If the Service finds an agency action is likely to cause any such effect, the biological opinion must also include reasonable and prudent alternatives, if any are available, that would avoid the effect. Where jeopardy or adverse modification of critical habitat is not likely to occur, but take of listed species is expected, the Service issues an incidental take statement that specifies reasonable and prudent measures and terms and conditions necessary to minimize incidental take. 16 U.S.C. 1536(b)(4). When the terms and conditions of the incidental take statement are followed, all incidental takings that occur are not subject to any prohibition against take that may otherwise apply. 16 U.S.C. 1538(a)(1); 1533(d). Following consultation, the action agency is responsible for implementing protections, if necessary, through its available authority.
Regulations at 50 CFR 402.04 provide that “the consultation procedures may be superseded for a particular Federal agency by joint counterpart regulations among that agency, the Fish and Wildlife Service, and the National Marine Fisheries Service.” The Services recognized that in certain instances, the section 7 consultation process can be improved by procedures that differ from the standard consultation process. The purpose of counterpart regulations therefore is to provide an approach that “allow[s] individual Federal agencies to “fine tune” the general consultation framework to reflect their particular program responsibilities and obligations.” 51 FR 19937 (June 3, 1986). At the same time, the preamble to the 1986 regulations for implementing section 7 of the ESA states that “such counterpart regulations must retain the overall degree of protection afforded listed species required by the [ESA] and these regulations. Changes in the general consultation process must be designed to enhance its efficiency without elimination of ultimate Federal agency responsibility for compliance with section 7.” Id. (quoting the preamble justification for the predecessor regulation).
FIFRA is the primary statute under which EPA regulates the use of pesticides in the United States. 7 U.S.C. 136
FIFRA requires a person seeking to register a pesticide to demonstrate that the proposed product meets the statutory standard. The proponent of use bears the burden of demonstrating that a pesticide meets this statutory standard. EPA may approve the unconditional registration of a pesticide product only if the agency determines, among other things, that use of the pesticide would not cause “unreasonable adverse effects on the environment.” FIFRA section 3(c)(5). The statute defines “unreasonable adverse effects on the environment” to include “any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide * * *.” FIFRA section 2(bb). EPA has a broad duty under FIFRA to avoid unreasonable adverse effects on the environment generally, which includes consideration of effects to all species, whether or not federally protected.
When EPA registers a pesticide, it approves among other things a specific set of labeling for the product which contains directions for and restrictions on use of the product. Labeling includes any written or graphic material attached to the product container,
While most regulatory decisions allowing entry of new pesticide products into the marketplace are made by EPA in its FIFRA section 3 registration program, there are three other programs that can authorize the limited use of new pesticides. Under section 18 of FIFRA, EPA may allow the use of an unregistered pesticide product by a State or Federal agency when necessary to address an emergency situation. Under EPA's regulations, a petition for an exemption must establish that “emergency conditions—defined as “an urgent, non-routine situation that requires the use of a pesticide * * *''—exist and that no effective, currently registered pesticide or non-pesticidal pest control method is available. 40 CFR 166.4(d). The emergency exemption regulations provide that EPA will not approve a request unless EPA
EPA may issue a Notice of Intent to Cancel the registration of a pesticide if it appears at any time that the pesticide “when used in accordance with widespread and commonly recognized practice, generally causes unreasonable adverse effects on the environment.” FIFRA section 6(b). The registrant of a pesticide is required to submit to EPA additional factual information regarding unreasonable adverse effects. FIFRA section 6(a)(2); 40 CFR part 159. The decisions whether to approve a pesticide's entry into the marketplace and whether to retain a pesticide on the market are based on the most recent scientific information and the same standard: whether use of pesticide does not cause “unreasonable adverse effects on the environment.” FIFRA also contains provisions allowing EPA to “suspend” the registration and use of a pesticide, prior to the completion of a cancellation process, if use of the pesticide poses an “imminent hazard.” FIFRA section 6(c). FIFRA defines an “imminent hazard” as “a situation which exists when the continued use of a pesticide during the time required for [a] cancellation proceeding would be likely to result in unreasonable adverse effects on the environment or will involve unreasonable hazard to the survival of a species declared endangered or threatened under [the Endangered Species Act].” FIFRA section 2(1).
EPA's evaluation of such environmental risks follows the principles contained in its Guidelines for Ecological Risk Assessment. (EPA 1998). In 1986, EPA developed detailed guidance for the review and analysis of potential environmental risks from use of pesticide products. See Standard Evaluation Procedures (SEP) for Ecological Risk Assessment (EPA 1986). Since 1986, EPA has made many additions and refinements to the basic approach outlined in the SEP. All of EPA's risk assessment methods have included methodology for an assessment of potential risks to listed species.
EPA's approach to assessing risks of pesticides and framework for making regulatory decisions benefits from the advice of several advisory committees chartered under the Federal Advisory Committee Act (FACA). EPA routinely obtains independent, external, expert scientific peer review of its risk assessment methodologies from the FIFRA Scientific Advisory Panel (SAP). Authorized under FIFRA section 25(d), the SAP is chartered under FACA and consists of seven permanent members appointed by the EPA Administrator and additional ad hoc members who are selected to serve on panels addressing specific scientific issues to which they can contribute their expertise. The SAP provides EPA with recommendations and evaluations of data, models, and methodologies used in EPA's overall risk assessment processes that occur during registration and reregistration. Further information is available at:
EPA also works with stakeholders in the regulated community and environmental and public health advocacy groups through two other FACA-chartered groups: the Pesticide Program Dialogue Committee (PPDC) and the Committee to Advise on Reassessment and Transition (CARAT). For further information see:
EPA requires both new and existing pesticides to be supported by extensive information about the potential ecological risks of the pesticide product. Data requirements appear in EPA regulations at 40 CFR part 158. Laboratory studies conducted to generate data for EPA are subject to Good Laboratory Practice requirements that are designed to ensure that the results are reliable and of high quality. See 40 CFR part 160. EPA's scientists carefully review all data submissions and independently evaluate the potential risks of each pesticide. In situations raising novel or challenging scientific issues, EPA generally seeks outside peer review of its scientific assessments.
EPA requires extensive toxicity and environmental fate data and uses this information, together with field reports of adverse effects on wildlife caused by pesticides and other relevant information, to evaluate the potential hazards to non-target species, including listed species, of a pesticide intended for outdoor use. To assess potential hazard to non-target species, EPA requires a basic set of laboratory toxicity studies on an active ingredient using multiple surrogate species of birds, fish, aquatic invertebrates, non-target insects, and plants. In situations where additional, scientifically valid toxicity data related to effects on wildlife and aquatic organisms are available, EPA will consider them in establishing the toxicity endpoint for risk assessment. EPA conducts risk assessments using the toxicity endpoint from the most sensitive species tested. EPA also requires data from a series of laboratory and field studies of the environmental fate of both the active ingredients in a pesticide product and typical formulations containing the active ingredient. These studies provide data on both the parent active ingredient, as well as its environmental degradates.
EPA combines these data, along with information about how the pesticide product is intended to be used, to develop an estimate of the potential concentrations of residues of the active ingredient and significant environmental degradates in the environment (the Estimated Environmental Concentration or EEC). When estimating EEC, EPA makes conservative assumptions designed not to understate potential exposure in order to avoid the potential for underestimating risk.
When assessing risks to listed species and critical habitat, EPA evaluates data and risks in a tiered fashion. EPA compares its toxicity assessment of an active ingredient with the EEC. As part of a conservative initial risk screening, if this comparison demonstrates that the EEC is well below the amount of active ingredient that would be expected to cause harm to particular species or critical habitats, EPA concludes that the use of pesticide products containing that active ingredient would have “no effect” on those listed species or critical habitats. Most of EPA's focus is on the potential risks from exposure to the active ingredient and its significant environmental degradates. EPA also reviews the available information on the other ingredients in pesticide products and on the formulations themselves, to assess the potential for increased risk. If the conservative initial screening assessment indicates that a use of a pesticide may potentially affect a listed species or critical habitat, EPA conducts a more refined assessment looking at species-specific information and information about pesticide use in the area to determine whether, for example, there is spatial and temporal overlap of the pesticide use and species' habitat, such that adverse effects would appear likely.
If the initial comparison and subsequent refined assessments indicate that EPA's best estimate of the EEC for the active ingredient and/or significant environmental degradates could have toxic effects on a listed species or critical habitat, then EPA may require the pesticide applicant or registrant to supply additional laboratory and/or field data in order to refine the risk assessment, seek changes in the allowable use of the pesticide product that are sufficient to mitigate any potential risk, or request initiation of consultation with the Services. Higher tier toxicity data may include studies on the effects of a pesticide on other wildlife species and plants or studies of longer durations of exposure. The Agency may occasionally require higher tier studies to be conducted in the field under simulated or actual use conditions. EPA may also require additional information to improve its estimate of potential exposure. Possible risk mitigation measures include changes in the manner or timing of pesticide applications, the rate or frequency of applications, or geographical restrictions on use.
Between May and December 2003 inter-agency scientific teams from both Services and EPA carefully reviewed EPA's ecological risk assessment methodology, including earlier drafts of the Overview Document and the materials referenced therein. Based on this review, the Services have determined that the approach used by EPA will produce effects determinations that reliably assess the effects of pesticides on listed species and critical habitat pursuant to section 7 of the ESA and implementing regulations. The approach used by EPA addresses, where applicable, the informational and analytical requirements set forth at 50 CFR 402.14(c), relies upon the best scientific and commercial data available; and analyzes the best scientific and commercial data available by using sound, scientifically accepted practices for evaluating ecological effects. Additionally, the Services have concluded that the approach used by EPA should produce effects determinations that appropriately identify actions that are not likely to adversely effect listed species, and that are consistent with those that otherwise would be made by the Services. This approach also will produce all information necessary to initiate formal consultation where appropriate. Letter from S. Williams and W. Hogarth to Susan Hazen (January 2004).
In 1988, Congress addressed the relationship between ESA and EPA's pesticide labeling program in section 1010 of Public Law 100-478 (October 7, 1988), which required EPA to conduct a study, and to provide Congress with a report of the results, on ways to implement EPA's endangered species pesticide labeling program in a manner that both complies with ESA and allows people to continue production of agricultural food and fiber commodities. This law provided a clear sense that Congress desires that EPA should fulfill its obligation to conserve listed species, while at the same time considering the needs of agriculture and other pesticide users. Accordingly, EPA and the Services have coordinated with USDA in developing these counterpart regulations to ensure that the consultation process is efficient and timely while remaining as protective as the existing regulations.
In addition to EPA's strong scientific data bases and its expertise in the field of ecological risk assessment, EPA's decisions have characteristics that are rarely found in other section 7 consultations. Pesticide products typically are employed for multiple uses, and can potentially be used in many different parts of the country in different times of year. Thus, an ESA consultation on a pesticide registration must consider many different pesticide use patterns and determine whether wildlife species in many different locations throughout the country may be affected by such use. This broad scope of intended use of the product under review contrasts with the narrower geographical scope of most actions by Federal agencies that undergo section 7 consultation.
In addition, the number of annual pesticide decisions made by EPA was also a factor potentially affecting how best to improve the section 7 consultation process. In a typical year, EPA will make hundreds of significant decisions regarding pesticide registration. For example, in fiscal year (FY) 2003, EPA registered 31 new pesticide active ingredients; approved the addition of 334 new uses of previously registered active ingredients on over 1,500 different crops; and completed more than 6,500 more minor registration actions. EPA also completed re-registration assessments on 28 previously registered active ingredients, and processed nearly 500 emergency exemption requests in FY 2003. Numbers of actions in most of these categories have risen each year since FY 2000. The number of requests by EPA to initiate consultation on pesticide actions is expected to increase substantially in future years. The large number of consultations and their complexity is expected to require a significant level of resources, requiring careful use of resources by both EPA and the Services to effectively address issues of high biological priority and high priority to users in the most efficient manner possible. This rule is intended to make the consultation process more efficient because some FIFRA actions could be conducted pursuant to the alternative consultation procedures outlined in this rule.
These factors provided strong reasons for the Services to establish a counterpart rule for EPA FIFRA actions. New, streamlined procedures promise to be more efficient for both EPA and the Services, and potentially more protective of listed species, because they will allow EPA and the Services to focus more resources on those actions most likely to pose risk to listed species. The single greatest opportunity for efficiency in the consultation process is for the Services to take greater advantage of the extensive analysis produced by EPA in its ecological risk assessments of pesticides. Relying more heavily on the EPA's scientific work product, while at the same time assuring EPA's analysis meets the high scientific standards required by the ESA, will reduce the amount of work required from the Services in each consultation and therefore accelerate completion of consultations.
Further, those streamlined procedures are expected to enable EPA to more quickly implement any risk mitigation measures identified as necessary to protect species and critical habitat. Moreover, many of the applications submitted for registration of pesticide products containing new active ingredients involve pesticide formulations that have been developed to have less impact than the currently registered products with which they would compete. Thus, any improvements in the efficiency and effectiveness of the ESA review process that would allow EPA to make decisions more quickly, and therefore allow such new products in the market sooner, should generally benefit listed species, as well as more broadly provide benefits for human health and the environment. Finally, given the importance of maintaining the availability of pesticides for production of food and fiber, disease prevention and other purposes that are essential to the health and well-being of the American people, EPA and the Services believe that improved integration of the FIFRA registration/reregistration and section 7(a)(2) consultation processes under new counterpart regulations will be achieved in a way that avoids unnecessary burdens on pesticide users with no sacrifice to the protection of listed species.
These counterpart regulations establish new methods of interagency coordination between EPA and the Services and create two new, optional, alternative approaches for EPA to fulfill its obligations to ensure that its actions under FIFRA are not likely to jeopardize the continued existence of listed species or destroy or adversely modify critical habitat. The rule offers an alternative approach when EPA determines that a FIFRA action is not likely to cause adverse effects on listed species or critical habitat, and an alternative approach to formal consultations. EPA could also elect to follow any of the existing procedures for early (§ 402.11), informal (§ 402.13), or formal consultation (§ 402.14) described in subpart B of part 402 for these actions.
This counterpart rule establishes three additional methods (§§ 402.42(b), 402.43 and 402.44) of achieving the interagency cooperation that is the fundamental tenet of the section 7 consultation process. First, under § 402.43 EPA could request the Service to provide available information (or references thereto) describing the applicable environmental baseline for each species or habitat that EPA determines may be affected by a FIFRA action, and the Service would provide such information within 30 days of the request. This informational exchange would give EPA early and effective access to the Service's extensive biological database.
Second, under § 402.44 EPA may request the Service to designate a suitably-trained Service Representative (more than one Service employee may jointly serve in this capacity) to participate with EPA in the development of an “effects determination” for one or more of those species or habitats. The Service Representative will participate in all relevant discussions with the EPA team (in most cases in person), have access to all documentation and information used to prepare the effects determination (upon acceptance of the same confidentiality limitations applicable to EPA personnel), and have appropriate office and staff support to work effectively as part of the EPA team. The Service Representative will be expected to keep the Service informed at all times as to the progress and scope of the effects determination, and the Service may engage in additional coordination
Third, under § 402.42(b), EPA and the Services would establish new procedures for regular and timely exchanges of scientific information to achieve accurate and informed decision-making.
The section 7 regulations in subpart B require an action agency to complete formal consultation with the Service on any proposed action that may affect a listed species or critical habitat, unless following either a biological assessment or informal consultation with the Service, the action agency makes a determination that the proposed action is not likely to adversely affect any listed species or critical habitat and obtains written concurrence from the Service for the NLAA determination. The alternative process contained in § 402.45 of these counterpart regulations will allow the Service to provide training, oversight, and monitoring to EPA through an alternative consultation agreement that enables EPA to make an NLAA determination for a FIFRA action without formal consultation or written concurrence from the Service. The Services recently adopted a similar approach for certain Federal actions implementing the National Fire Plan. 68 FR 68254 (December 8, 2003).
The new approach to interagency coordination between EPA and the Services is intended to be a flexible, adaptable scheme that will continually evolve and improve over time as scientific knowledge expands. For this reason, although the regulation will require the Service and EPA to have in effect an alternative consultation agreement before EPA can utilize the procedures of § 402.45, the alternative consultation agreement itself is not part of this rule, and the Services have concluded that the alternative consultation agreement will not constitute a rule subject to the notice and comment provisions of the Administrative Procedure Act, 5 U.S.C. 553. As articulated in proposed § 402.45(b), the required content of the alternative consultation agreement includes provisions and procedures to guide the Services and EPA in implementing this subsection. The alternative consultation agreement does not create or mandate standards for effects determinations; nor does it limit EPA's or the Services' discretion in developing and applying scientific methodologies. The alternative consultation agreement will be expected to undergo continuous modification and improvement. EPA and the Service will also be able to mutually agree to depart from the terms of the alternative consultation agreement in a particular case. Further, the alternative consultation agreement will not create any substantive or procedural rights or benefits that could be enforced by third parties against either the Services or EPA.
The Services believe that EPA's expertise in ecological risk assessments of pesticides, together with the safeguards built into the alternative consultation agreement, make case-by-case discussions and written concurrences in EPA's NLAA determinations unnecessary for FIFRA actions. The Services have carefully reviewed EPA's assessment methodologies and believe that when EPA follows its established approach to ecological risk assessment for pesticides EPA will correctly make determinations as to when a pesticide is or is not likely to adversely affect listed species or critical habitat. Requiring the Services to concur on a case by case basis on every NLAA determination made by EPA would unjustifiably divert much of the Services' consultation resources away from projects in greater need of consultation. The counterpart regulations will increase the Services' capability to focus on Federal actions requiring formal consultation by eliminating the requirement to provide written concurrence for actions within the scope of the counterpart regulations. EPA and the Services are committed to implementing this authority in a manner that will be equally as protective of listed species and critical habitat as the current procedures that require written concurrence from the Service.
These counterpart regulations provide an additional tool for accelerating EPA's ESA compliance activities, while providing equal or greater protection of listed species and critical habitat. Under current procedures, EPA already must complete and document a full ESA analysis to reach an NLAA determination. The counterpart regulations permit a FIFRA action to proceed following EPA's NLAA determination without an overlapping review by the Service, where the Service has provided specific training and oversight to achieve comparability between EPA's determination and the outcome of an overlapping review by the Service.
The approach outlined in these counterpart regulations is consistent with subpart B because it leaves the standards for making jeopardy and NLAA determinations unchanged. Further, when EPA operates under these counterpart regulations it will retain full responsibility for compliance with section 7 of the ESA.
Under this rule, EPA will enter into an alternative consultation agreement with either FWS, NOAA Fisheries or both. The alternative consultation agreement will include: (1) A description of the actions that EPA and the Service have taken to document the approach EPA uses to make determinations regarding the effects of its actions on listed species or critical habitat and to evaluate that approach for consistency with the ESA and applicable implementing regulations; (2) a description of the program for developing and maintaining the skills necessary within EPA to make NLAA determinations, including a jointly developed training program based on the needs of EPA; (3) provisions for incorporating new information and newly listed species or critical habitat into EPA's effects analysis on FIFRA actions; (4) processes that EPA and the Service will use to incorporate scientific advances into EPA's effects determinations; (5) a description of a mutually agreed upon program for periodic program evaluations; and (6) provisions for EPA to maintain a list of FIFRA actions for which EPA has made NLAA determinations. By following the procedures in these counterpart regulations, including the establishment of the alternative consultation agreement, EPA will fulfill its ESA section 7 consultation responsibility for actions covered under these regulations.
The purpose of the jointly developed training program between EPA and the Service is to ensure that EPA consistently interprets and applies the provisions of the ESA and the regulations (50 CFR part 402) relevant to these counterpart regulations with the expectation that EPA will reach the same conclusions as the Service. It is expected that the training program will rely upon the ESA Consultation Handbook as much as possible.
The Service will use monitoring and periodic program reviews to evaluate EPA's performance under the alternative consultation agreement at the end of the first year of implementation and then at intervals specified under the alternative consultation agreement. The Service will evaluate whether the implementation of this regulation by EPA continues to be consistent with the best scientific and commercial data
Upon completion of an alternative consultation agreement, EPA and the Service will implement the training program outlined in the alternative consultation agreement. EPA will have full responsibility for the adequacy of its NLAA determinations since there would be no reviewable final agency action by the Service when EPA makes a NLAA determination for a FIFRA action.
The Services and EPA developed a draft of an alternative consultation agreement that addresses the topics identified in proposed § 402.45. This draft alternative consultation agreement is part of the administrative record of this rule, and was made available for the public to read to obtain a better understanding of how the Services anticipate the requirements of § 402.45 would be satisfied.
The counterpart regulations establish a new formal consultation process (§ 402.46) that will meet all statutory requirements and closely follow the procedural steps specified in the current subpart B process. The new process will combine the central concepts and procedures of the subpart B consultation process with innovations stemming from EPA's expertise in assessing the ecological effects of pesticide products.
The process relies on an effects determination that will be prepared by EPA according to analytical methodologies that the Services have reviewed and endorsed. The effects determination may be prepared, upon EPA's request, with the assistance of a Service Representative. While the contents of an effects determination will depend on the nature of the action, an effects determination submitted under § 402.46 or § 402.47 will contain the information described in § 402.14(c)(1)-(6) and a summary of the information on which the determination is based, detailing how the FIFRA action affects the listed species or critical habitat. EPA could also include three additional sections in an effects determination: (1) A conclusion whether or not the FIFRA action is likely to jeopardize the continued existence of any listed species or result in the destruction or adverse modification of critical habitat and a description of any reasonable and prudent alternatives that may be available; (2) a description of the impact of any anticipated incidental taking of such listed species resulting from the FIFRA action, reasonable and prudent measures considered necessary or appropriate to minimize such impact, and terms and conditions necessary to implement such measures; and (3) a summary of any information or recommendations from an applicant. An effects determination with the required information and the additional discretionary sections would contain the information currently provided by the Service in a biological opinion. All effects determinations will be based on the best scientific and commercial data available.
Once EPA has prepared an effects determination for the species and habitats that may be affected, it may initiate formal consultation on a FIFRA action under this section by delivering to the Service a written request for consultation. The written request will be accompanied by an effects determination as defined in § 402.40(b) and a list or summary of all references and data relied upon in the determination. The Service will be able on request to review any or all of the references and data relied upon in the determination as if it was in the Service's files. The time for conclusion of the consultation under section 7(b)(1) of the Act will run from the date the Service receives the written request from EPA. Any subsequent interchanges between the Service and EPA regarding the information submitted by EPA, including interchanges about the completeness of EPA's effects determination, will occur during consultation, and will not delay the initiation of consultation or extend the time for conclusion of the consultation unless EPA withdraws the request for consultation.
If EPA has prepared the effects determination without a designated Service Representative, the Service retains the discretion to determine within 45 days that additional available information would provide a better information base for the effects determination and may so notify EPA. After such a notification, EPA may revise the effects determination and resubmit it to the Service. The timing and form of EPA's resubmission are within its discretion, but the time limitations in section 7(b)(1) continue to apply. A request for additional information does not represent a finding by the Service that the effects determination was not based on the best scientific and commercial data available. Further, any requested additional information must actually be available to EPA during the specified consultation period. Where a designated Service Representative has participated in the development of the effects determination, the Service will rely upon its representative to identify all desired available information during the preparation of the determination, and this intermediate Service review during consultation is not needed. However, EPA at all times retains its duty to use the best scientific and commercial data available for its effects determinations, and the Services retain their duty to use the best scientific and commercial data available during consultation. Once an effects determination has been resubmitted following an additional information determination, the Service will proceed to conclude the consultation without further requests to EPA for additional information, although the Service may consider additional information at any time during the consultation process. If EPA advises the Service it will not resubmit a revised effects determination to the Service after the Service requests additional information, its initiation of consultation on the effects determination will be deemed withdrawn.
Within the later of 90 days after the Service receives EPA's written request for consultation or 45 days after the Service receives an effects determination resubmitted following an additional information determination by the Service, the Service will take one of three actions: (1) If the Service finds that the effects determination contains all required information and satisfies the requirements of section 7(b)(4) of the Act, and the Service concludes that the FIFRA action that is the subject of the consultation complies with section 7(a)(2) of the Act, the Service will issue a written statement adopting the effects determination; or (2) it may provide EPA a draft written statement modifying the effects determination and as modified adopting the effects determination; or (3) it may provide EPA a draft jeopardy biological opinion along with any reasonable and prudent alternatives if available. Providing these draft documents to EPA is consistent with current agency practice under other consultation procedures in Part 402. The deadlines for Service action are subject to section 7(b)(1) of the Act.
If the Service provides either the draft statement modifying the effects
Where consultation on a FIFRA action will be unusually complex due to factors such as the geographic area or number of species that may be affected by the action, a special provision (§ 402.47) allows EPA, after conferring with the Service, to address the effects of the action through successive effects determinations addressing groupings or categories of species or habitats as established by EPA. This provision is needed because for some widely-used pesticides, delaying the initiation of consultation until adequate information is available for every species or habitat that may be affected by the pesticide may result in denying some of the most vulnerable species the benefits of the section 7 consultation process for as much as several years. Further, allowing geographic or other functional groupings of species lets EPA and the Service conduct related biological inquiries together in an efficient, coordinated manner. EPA will use this provision after conferring with the Services, and EPA and the Services intend to collaboratively identify priorities where use of this provision will most effectively address these biological goals. When successive effects determinations are prepared, EPA may initiate consultation based upon each such effects determination using the procedures in § 402.46(a). The procedure in § 402.46(b) and (c) will apply to the consultation. The written statement or opinion provided by the Service under § 402.46(c) will constitute a partial biological opinion as to the species or habitats that are the subject of the consultation. The partial biological opinion would describe the provisions relating to incidental take of such species for inclusion in an incidental take statement at the conclusion of consultation, giving users of pesticide products such as farmers and forest managers, nursery operators, and other pesticide users prompt and reliable guidance for minimizing incidental take of the species. EPA will also retain authority to use such a partial biological opinion, along with other available information, in making a finding under section 7(d) of the Act as to whether the FIFRA action constitutes an irreversible and irretrievable commitment of resources which has the effect of foreclosing the formulation or implementation of any reasonable and prudent alternative as to those species and habitats. After conclusion of all consultation on the FIFRA action, the previously-issued partial biological opinions will then collectively constitute the opinion of the Secretary and the incidental take statement, reasonable and prudent measures, and terms and conditions under section 7(b) of the Act unless a partial biological opinion were to be modified by the Service using the procedures in § 402.46(c). For pesticide products currently in use, this process will provide prompt guidance for substantial protection for vulnerable species without unduly disrupting longstanding patterns of pesticide use in agriculture, public health vector control or other important pesticide use patterns throughout the country that are vital to the health and welfare of the American people.
The Services emphasize that § 402.47 is not intended as an authorization for EPA to take actions, such as registration of pesticides containing new active ingredients or registration of new uses, without complying with the requirements of section 7(a)(2) of the Act. Rather, for certain complex FIFRA actions the provision strengthens EPA's and the Services' ability to establish the most effective sequence for completing EPA's consultation obligations through a series of focused consultations on specific species or habitats. EPA will not satisfy its procedural obligations under section 7(a)(2) of the ESA until all necessary consultations are completed. Likewise, a Service's issuance of a partial biological opinion following each such focused consultation will not represent the opinion of the Secretary or an incidental take statement under section 7(b) of the ESA until all required consultation is concluded on listed species and habitats.
The Services expect this provision may be used for FIFRA actions in a variety of circumstances. For example, after reviewing an action, EPA might identify differing levels of risk for different species, and might conclude that it would be prudent to seek Service advice on the impacts of concern through formal consultation while EPA continued to analyze the lesser risk concerns. In addition, if EPA needs to update completed consultations on pesticides by addressing impacts on more than one newly listed species, EPA might find it more efficient and effective to consider each species separately, even though a particular pesticide might impact more than one of the newly listed species. Nonetheless, EPA has advised the Services that EPA does not intend to register any new use or active ingredient until completion of consultation under section 7(a)(2) for all species affected by that action. However, like any action agency, EPA retains statutory authority to use appropriate information to make section 7(d) determinations under the ESA. In sum, the Services believe that it is advisable for the consultation process on these and other complex FIFRA actions to have flexibility, so that EPA and the Services can most efficiently and effectively protect listed species and habitats. EPA will only use the provision after conferring with the Service, which should further insure the continued effective and appropriate use of this authority.
This counterpart rule makes clear that the emergency consultation provisions in existing Service regulations are available to EPA for consultation on actions under FIFRA section 18 by providing that EPA could conduct consultation on actions involving requests for emergency exemptions under FIFRA section 18 under section 402.05 or another available consultation procedure. As provided in § 402.05, any required formal consultation on such an action will have to be initiated as soon as practicable after the emergency is under control. For the purposes of the consultation required in § 402.05(b), the definition of formal consultation in § 402.02 will include the procedures in § 402.46 in addition to those in subpart B.
The Services believe that EPA's statutory and regulatory standard for an “emergency” under FIFRA section 18 is generally comparable to the intended scope of emergency in § 402.05 and that, therefore, the overwhelming majority of FIFRA emergency exemption actions could properly be considered
The Services' 1998 Joint Consultation Handbook (page 8-1) contains a passage suggesting that emergency actions under FIFRA may not usually qualify as emergencies “unless there is a significant unexpected human health risk.” While a significant unexpected human health risk will permit an emergency consultation under § 402.05, the quoted passage should not be read to mean that the emergency provisions in § 402.05 are available for FIFRA section 18 actions only where an unexpected human health risk is present. Such a narrow reading of the quoted passage is inconsistent with other statements in the Handbook and with past Service practice in comparable circumstances. The plain language of § 402.05 is not so limited, and can be read to encompass the kind of emergency situations that FIFRA section 18 contemplates even if no significant unexpected human health risk is present. The Services believe the use of § 402.05 by EPA for FIFRA section 18 actions under this rule will therefore be consistent with practices currently permitted under subpart B.
The counterpart rule contains other provisions to ensure full compliance with ESA requirements. After a consultation under this subpart has been concluded, EPA shall reinitiate consultation as required by § 402.16 as soon as practicable after a circumstance requiring reinitiation occurs, and may employ the procedures in this subpart or subpart B in any reinitiated consultation. EPA must comply with § 402.15 for all FIFRA actions subject to consultation under this subpart. EPA must prepare a biological assessment for FIFRA actions that constitute “major construction activities” to the extent required by § 402.12. The typical regulatory actions EPA takes under FIFRA (
On January 30, 2004, the Services proposed the rule that would establish joint counterpart regulations for consultation under section 7 of the ESA to streamline consultation on proposed actions under FIFRA. The comment period was to close on March 30, 2004 but was extended to April 16, 2004. The Services received more than 125,000 comments on the proposed rule from a large variety of entities, including States, agricultural entities, trade associations, industry, conservation groups, coalitions, and private individuals. The overwhelming majority of comments received were part of letter-writing and e-mail campaigns expressing, in a ratio of approximately 1:2, general support for or opposition to the proposal. The Services considered all of the information and recommendations received from all interested parties on the proposed regulations during the public comment period and appreciated the comments received on the proposed rule. The Services received numerous comments on the ACA, the Overview Document and other materials included in the rulemaking record that are neither part of the proposed counterpart regulations nor incorporated by reference into the regulations. Since these documents are not part of the regulations, the Services have only responded to them to the extent that the comments on these documents relate to the proposal to adopt the counterpart regulations.
The following is a summary of the comments received on the proposed counterpart regulations, and the Services' responses.
As stated in the 1986 regulations, § 402.01, “Section 7(b) of the Act requires the Secretary, after the conclusion of early or formal consultation, to issue a written statement setting forth the Secretary's opinion detailing how the agency action affects listed species or critical habitat.” However, neither informal consultation nor NLAA concurrence is specified in the ESA, and the ESA does not prescribe requirements directing how the Services should consult with federal agencies on NLAA actions. The Services have exercised their discretion through rulemaking to establish an alternate procedure for actions that are NLAA. The general informal consultation procedure in subpart B, with an individualized concurrence letter from the Services, reflects an exercise of the Services' discretion. Federal agencies and the Services have effectively employed this alternative to formal consultation several hundred thousand times over the past two decades for a myriad of diverse agency actions, and use of this alternative has been upheld in many court decisions. The counterpart regulations rely upon the fundamental structure in the subpart B regulations that created an informal consultative process for actions that are not likely to adversely affect listed species or designated critical habitat, and required formal consultation for other actions to ensure that 7(a)(2) requirements are met.
The counterpart regulations represent an alternative form of informal consultation for NLAA actions subject to § 402.45, creating a new, carefully-structured training, monitoring and oversight relationship between the Services and EPA as an alternative for the individual project-based concurrence system that was created in the subpart B regulatory framework. The counterpart regulations create a system where EPA uses a risk assessment methodology approved by the Services, engages in regular exchanges of scientific information with the Services, and its staff is trained and supervised to perform NLAA determinations just as the Services would in a concurrence letter, with less delay and equal protection for listed species and critical habitat.
The Services believe that through implementation of the ACA, and the provisions of § 402.45 for periodic review, oversight, and termination of the ACA by the Services if necessary, EPA is insuring, in consultation with and with the assistance of the Secretary, that FIFRA actions are not likely to jeopardize the continued existence of any listed species or result in the destruction or adverse modification of critical habitat. For these reasons, the Services believe that the counterpart regulations comply with the ESA.
As reflected in the record of this rulemaking, the Services have concluded that the approach to ecological risk assessment described in EPA's Overview Document is consistent with the ESA, and that this approach will produce effects determinations that reliably assess the effects of pesticides on listed species and critical habitat pursuant to section 7 of the ESA and implementing regulations (
In any case when EPA determines that a FIFRA action may affect a listed species or critical habitat, EPA is required to follow either the provisions of these counterpart regulations, or the provisions of the existing subpart B regulations. Further, the counterpart regulations continue to require formal consultation, in the manner provided in the regulations, for FIFRA actions that are likely to adversely affect a listed species or critical habitat. Therefore, the counterpart regulations do not change the threshold for consultation, as one commenter believes.
The Services note that the court decision cited by a commenter involved consultation under subpart B where a concurrence letter from the Service is required to conclude informal consultation; the case does not interpret the ESA as creating a statutory duty for an action agency to obtain a concurrence letter from the Service on NLAA actions.
Finally, the Services note that under subpart B, neither informal nor formal consultation is required if a proposed agency action will have no effect on a listed species that is present within the action area, whether or not the “no effect” finding results from mitigation measures adopted by the action agency. Under subpart B, the Services do not review an action agency's finding that a proposed action will have no effect on listed species or critical habitat. The counterpart regulations carry forward the same provisions for “no effect” actions and are consistent with the requirements of section 7 of the ESA and the subpart B regulations.
A series of general comments stated the Services should not adopt the proposed rule because it is based on EPA's flawed approach to ecological risk assessment and EPA lacks expertise in key areas of ecological risk assessment.
More specifically, in the Services' expert judgment, the approach used by EPA is rigorous; it is carefully described in the “Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs, U.S. Environmental Protection Agency—Endangered and Threatened Species Effects Determinations” January 23, 2004 (Overview Document) and the 81 support documents cited therein. In addition, EPA's risk assessments for individual chemicals are thoroughly documented, with the result that it is possible to identify the methodology used in each case.
The Services have also concluded that “the approach used by OPP should produce effects determinations * * * that are consistent with those that otherwise would be made by the Services.” Letter of January 26, 2004. This conclusion rests on the breadth of types of data that EPA will review and the manner in which EPA will analyze the data. EPA routinely requires a pesticide company to submit a substantial body of data in support of an application for registration. EPA will supplement this required database with information obtained through a systematic search of the open literature on the ecotoxicity of environmental substances. As recounted in detail in the Letter of January 26, 2004, EPA will examine this body of information for all of the types of potential impacts that an agency is required to consider under the ESA. Reliance on these sources of information is consistent with and should fulfill the statutory mandate to “use the best scientific and commercial information available.”
The Services also disagree that EPA's approach to ecological risk assessment is inconsistent with current science. EPA's pesticide program routinely draws on the latest results from its Office of Research & Development (ORD) and other researchers in the fields of ecotoxicology and environmental fate assessment through participation in national and international professional, scientific conferences and symposia. EPA also works closely with the FIFRA Scientific Advisory Panel (SAP) to obtain expert, independent, external scientific peer review on every aspect of its approach to ecological risk assessment, as well as on specific pesticide assessments. See
More specifically, the assertion that EPA assumes no risk to listed species when EPA lacks data misconstrues EPA's approach in the absence of data. As explained in the Overview Document, EPA has identified a base set of information about a pesticide it considers sufficient to permit an evaluation of the potential risks posed by the pesticide, and has committed to supplement those data with information obtained from the public literature. The types of data required will vary depending on the use pattern of the product and chemical-specific characteristics of the pesticide. EPA requires these data to support the registration of a pesticide, and, unless the data are waived, EPA typically would not approve the use of a pesticide without the required data. If data beyond the base set are considered necessary, EPA will require the applicant to provide those data. The agency will use its best scientific judgments, on a case-by-case basis, and as discussed in detail in the Overview Document, EPA may employ assumptions to account for any uncertainty due to missing data, and many steps within EPA's approach use conservative assumptions.
The ESA does not require Federal agencies to eliminate all forms of uncertainty in assessing impacts to listed species or critical habitat, which would be a practical impossibility. Instead, the ESA requires that decisions be based on the best scientific and commercial data available. The Services agree that such decisions need to be made on a case-by-case basis, using best professional judgment that takes into account all of the available relevant information. The Services have discussed with EPA the need to document in a transparent manner how it addresses data gaps and how it employs assumptions to deal with the resulting uncertainty. The Services are satisfied that EPA's approach to this general subject, as described in the Overview Document, will result in appropriate assessments of the potential risks to listed species and critical habitat.
Experience to date comparing the results of these broader ECOTOX searches conducted according to the Overview Document with other search strategies suggests that ECOTOX is at least as successful, if not more so, at locating relevant scientific information. Moreover, contrary to the comment, these comparisons indicate that ECOTOX does not fail to identify a significant portion of the relevant literature.
Finally, the Services do not find persuasive the comment stating that EPA did not consider a relevant study from the public literature. Whether or not that is accurate, it does not undermine the Services' conclusion, in the future, that EPA will use an acceptable approach to assessing ecological risks of pesticides. The Services note that EPA has committed to explaining in its risk assessments any decisions not to use a study obtained from the open literature or other source. Thus, if EPA obtains a study published in a scientific journal but decides not to make it part of the risk assessment database, the decision will be fully documented, and both the Services and the public would be able to evaluate the adequacy of EPA's justification. The Services believe this process will ensure that EPA handles studies from the open literature appropriately.
Further, EPA has agreed to discuss in its risk assessments the uncertainties associated with use of surrogate species. EPA also committed to work with the Services to develop methods to increase the level of confidence in future assessments.
Finally, although not employed expressly to address uncertainties in relying on surrogate species, the Services note that throughout its risk assessment methodology EPA deliberately uses conservative assumptions that add in a measure of additional protections.
In response to the comment concerning EPA's willingness to consider sublethal effects from atrazine, the Services note that, contrary to the comment, EPA has conducted its own review and subsequently has obtained an independent, external peer review of data on atrazine and sexual development of frogs. See SAP meeting on June 17-20, 2003, at
The commenter also misunderstands the approach to assessing indirect effects. The commenter apparently assumes that the direct-effects screening assessment considers only listed species. A conclusion that no indirect effects on a listed species would occur is based on the fact that indirect effects may only occur when some species—listed or nonlisted—other than the listed species is directly affected. The direct-effects screening assessment considers the full range of plant and animal species. If no species on which a listed species depends is directly affected, then the listed species would not be indirectly affected.
Contrary to the comment, EPA has explained in the Overview Document its approach to the use of different thresholds for listed and non-listed species. The Services are satisfied that the approach EPA intends to use in the future will produce an appropriate assessment of potential indirect effects.
The Services recognize that more extensive information is typically available about pesticide active ingredients than inert ingredients, and therefore EPA has a more limited ability to assess the risks posed by these compounds to listed species. In light of these limitations, the Services have concluded that EPA's approach makes appropriate use of the best scientific and commercial information available to evaluate these types of substances.
The Services note that the meaning of the term, “cumulative effects,” under the ESA is very different from the way that term is used under the FFDCA. Under ESA, cumulative effects refers to the effects on listed species and critical habitat of future State and private activities reasonably certain to occur within the action area of the federal action subject to consultation. Under the FFDCA, EPA must consider the cumulative effects on humans that may result from exposure to the pesticide chemical and other substances sharing a common mechanism of toxicity. Thus, the two meanings are quite distinct, and the FFDCA use of the term should not be applied to assessments under the ESA.
EPA's Overview Document explains the scientific basis for regarding these LOCs as protective. In the case of the LOC of 0.1 for acute toxicity, this value means that for a pesticide with a typical toxicity profile (slope of the dose-response curve of 4.5) the estimated probability of mortality resulting from exposure to one tenth the value of the median lethal dose (LC50) is approximately 1/300,000. The Overview Document also contains estimates of the probability of mortality for the 0.05 LOC and for other values for the slope of the dose-response curve. The Services are satisfied both with this explanation and with the agency's conclusion that there would be no effect when the ratio of exposure to toxicity is at or below the established LOCs.
The Services conclude that EPA's approach to incorporation of exposure estimates for non-oral routes is consistent with the ESA, in that EPA uses the best scientific and commercial information available. Pending implementation of these proposals, following external peer-review by the FIFRA SAP, the data on dietary exposure remains the best available quantified information provided through existing models.
With regard to section 24(c) registrations, this comment notes that the States, rather than EPA, issue these registrations, and that, therefore, ESA consultation obligations should not extend to section 24(c) registrations. It was not the Services' intention to suggest that State action in issuing section 24(c) registrations should be subject to the ESA consultation requirements. The consultation
In § 402.40(g), we deleted the second sentence which read, “[t]he Service may designate more than one individual to serve jointly as a Service Representative.” The change is made to remove redundancy with the first sentence which states that the “
In § 402.45(c), we edited the penultimate sentence which read “[t]he Service Director retains discretion to terminate the alternative consultation agreement . . .” to read, “[t]he Service Director retains discretion to terminate or suspend the alternative consultation agreement . . .” The change is made to clarify the statement and make it consistent with the final sentence of the subsection which begins, “[t]ermination, suspension, or modification of an alternative consultation . . .”
Language in § 402.46(a) was changed from “[t]he written request shall be accompanied by an effects determination prepared in accordance with § 402.40(b)” to “[t]he written request shall be accompanied by an effects determination as defined in § 402.40(b).” This change is intended to clarify that the Services do not intend to prescribe how EPA would prepare the effects determinations.
In accordance with Executive Order 12866, this document is a significant rule because of the legal or policy issues it has raised; it was reviewed by the Office of Management and Budget (OMB) in accordance with the four criteria discussed below.
(a) This counterpart regulation will not have an annual economic effect of $100 million or more or adversely affect an economic sector, productivity, jobs, the environment, or other units of government.
(b) This counterpart regulation is not expected to create inconsistencies with other agencies' actions. FWS and NOAA Fisheries are responsible for carrying out the Act.
(c) This counterpart regulation is not expected to significantly affect entitlements, grants, user fees, loan programs, or the rights and obligations of their recipients.
(d) OMB has determined that this rule may raise novel legal or policy issues and, as a result, this rule has undergone OMB review.
Under the Regulatory Flexibility Act (5 U.S.C. 601
Pursuant to the Regulatory Flexibility Act, the Secretaries of the Interior and Commerce certify that this regulation will not have a significant economic impact on a substantial number of small entities. The purpose of the rule is to increase the efficiency of the ESA section 7 consultation process for those activities involving pesticide regulation conducted by EPA. The proposed changes are expected to lead to the same protections for listed species as the section 7 consultation regulations at 50 CFR part 402.
Regulations at 50 CFR 402.04 provide that “the consultation procedures may be superseded for a particular Federal agency by joint counterpart regulations among that agency, the Fish and Wildlife Service, and the National Marine Fisheries Service.” The preamble to the 1986 regulations for implementing section 7 states that “such counterpart regulations must retain the overall degree of protection afforded listed species required by the [ESA] and these regulations. Changes in the general consultation process must be designed to enhance its efficiency without elimination of ultimate Federal agency responsibility for compliance with section 7.” The rule will not have a significant economic impact on a substantial number of small entities for the following reasons.
(1) The rule will modify procedures for formal section 7 consultation and remove the requirement for EPA to conduct informal consultation with and obtain written concurrence from FWS or NOAA Fisheries on those FIFRA actions it determines are NLAA listed species or critical habitat.
(2) The new consultation procedures may affect registrants, who provide EPA with the data used to assess the level of environmental risk. It is estimated that approximately two-thirds of the 1,850 pesticide registrants are small businesses. Because this rule is expected to streamline the consultation process and would therefore potentially accelerate the registration process for new pesticide products and the re-registration process for existing pesticides, these businesses are expected to experience no effect or a small positive effect as a result of this rule.
(3) Agricultural producers, many of which are small businesses, may be indirectly affected by this rule. Because this rule is expected to streamline the consultation process and would therefore potentially accelerate the registration process for new pesticide products pesticides and the re-registration process for existing pesticides, agricultural producers may experience a small indirect benefit from this rule.
Therefore, the Secretaries of the Interior and Commerce certify that this action will not have a significant economic impact on a substantial number of small businesses, organizations, or governments pursuant to the RFA.
On May 18, 2001, the President issued an Executive Order (E.O. 13211) on regulations that significantly affect energy supply, distribution, and use. Executive Order 13211 requires agencies to prepare Statements of Energy Effects when undertaking certain actions. Although this rule is a significant action under Executive Order 12866, it is not expected to significantly affect energy supplies, distribution, or use. Therefore, this action is not a significant energy action and no Statement of Energy Effects is required.
In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501
(a) These counterpart regulations will not “significantly or uniquely” affect small governments. A Small Government Agency Plan is not required. We expect that these counterpart regulations will not result in any significant additional expenditures by entities that develop formalized conservation efforts.
(b) These counterpart regulations will not produce a Federal mandate on State, local, or tribal governments or the
In accordance with Executive Order 12630, these counterpart regulations do not have significant takings implications. These counterpart regulations pertain solely to ESA section 7 consultation coordination procedures, and the procedures have no impact on personal property rights.
In accordance with Executive Order 13132, these counterpart regulations do not have significant Federalism effects. A Federalism assessment is not required. In keeping with Department of the Interior and Commerce regulations under section 7 of the ESA, we coordinated development of these counterpart regulations with appropriate resource agencies throughout the United States.
In accordance with Executive Order 12988, this rule does not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of the Order. We promulgate these counterpart regulations consistent with section 7 of the ESA.
This rule will not impose any new requirements for collection of information that require approval by the OMB under the Paperwork Reduction Act (44 U.S.C. 3501
These counterpart regulations have been developed by FWS and NOAA Fisheries, along with EPA and USDA. The FWS and NOAA Fisheries are considered the lead Federal agencies for the preparation of this proposed rule, pursuant to 40 CFR 1501. We have analyzed these counterpart regulations in accordance with the criteria of the National Environmental Policy Act (NEPA), the Department of the Interior Manual (318 DM 2.2(g) and 6.3(D)), and National Oceanic and Atmospheric Administration (NOAA) Administrative Order 216-6 and have determined, after preparation of an environmental assessment, that the action does not have any significant effects. A Finding Of No Significant Impact has been prepared.
In accordance with the Secretarial Order 3206, “American Indian Tribal Rights, Federal-Tribal Trust Responsibilities, and the Endangered Species Act” (June 5, 1997); the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951); E.O. 13175; and the Department of the Interior's 512 DM 2, we understand that we must relate to recognized Federal Indian Tribes on a Government-to-Government basis. However, these counterpart regulations do not directly affect Tribal resources since only EPA regulatory actions are subject to the proposed provisions. The intent of these counterpart regulations is to streamline the consultation process; therefore, any indirect effect would be wholly beneficial.
Endangered and threatened species.
16 U.S.C. 1531
The definitions in § 402.02 are applicable to this subpart. In addition, the following definitions are applicable only to this subpart.
(a)
(b)
(1) A conclusion whether or not the FIFRA action is likely to jeopardize the continued existence of any listed species or result in the destruction or adverse modification of critical habitat and a description of any reasonable and prudent alternatives that may be available;
(2) A description of the impact of any anticipated incidental taking of such listed species resulting from the FIFRA action, reasonable and prudent measures considered necessary or appropriate to minimize such impact, and terms and conditions necessary to implement such measures; and
(3) A summary of any information or recommendations from an applicant. An effects determination shall be based on the best scientific and commercial data available.
(c)
(d)
(e)
(f)
(g)
The purpose of these counterpart regulations is to enhance the efficiency and effectiveness of the existing consultation process under section 7 of the Endangered Species Act (Act), 16 U.S.C. 1531
(a)
(1) Interagency exchanges of information under § 402.43 and advance coordination under § 402.44 are available for any FIFRA action.
(2) Alternative consultation under § 402.45 is available for a listed species or critical habitat if EPA determines the FIFRA action is not likely to adversely affect the listed species or critical habitat.
(3) Optional formal consultation under § 402.46 is available for any FIFRA action with respect to any listed species or critical habitat.
(4) The special procedures in § 402.47 are available for consultations on FIFRA actions that will be unusually complex due to factors such as the geographic area or number of species that may be affected by the action.
(5) EPA shall engage in consultation as to all listed species and critical habitat that may be affected by a FIFRA action, and may in its discretion employ more than one of the available consultation procedures for a FIFRA action that may affect more than one listed species or critical habitat.
(6) EPA shall engage in consultation on actions involving requests for emergency exemptions under section 18 of FIFRA that may affect listed species or critical habitat, and may choose to do so under § 402.05 or other provisions of this subpart or subpart B of this part. Any required formal consultation shall be initiated as soon as practicable after the emergency is under control. For the purposes of § 402.05(b) the definition of formal consultation in § 402.02 includes the procedures in § 402.46.
(7) EPA must prepare a biological assessment for a FIFRA action to the extent required by § 402.12.
(8) EPA must comply with § 402.15 for all FIFRA actions.
(9) After a consultation under this subpart has been concluded, EPA shall reinitiate consultation as required by § 402.16 as soon as practicable after a circumstance requiring reinitiation occurs, and may employ the procedures in this subpart or subpart B of this part in any reinitiated consultation.
(b)
EPA may convey to the Service a written request for a list of any listed species or critical habitat that may be present in any area that may be affected by a FIFRA action. Within 30 days of receipt of such a request the Service shall advise EPA in writing whether, based on the best scientific and commercial data available, any listed species or critical habitat may be present in any such area. EPA may thereafter request the Service to provide available information (or references thereto) describing the applicable environmental baseline for each species or habitat that EPA determines may be affected by a FIFRA action, and the Service shall provide such information within 30 days of the request.
(a)
(b)
(a)
(b)
(1)
(2)
(i)
(ii)
(iii)
(iv)
(v)
(vi)
(vii)
(3)
(4)
(c)
(a)
(b)
(c)
(i) If the Service finds that the effects determination contains the information required by § 402.40(b) and satisfies the requirements of section 7(b)(4) of the Act, and the Service concludes that the FIFRA action that is the subject of the consultation complies with section 7(a)(2) of the Act, the Service will issue a written statement adopting the effects determination; or
(ii) The Service will provide EPA a draft of a written statement modifying the effects determination, which shall meet the requirements of § 402.14(i), and as modified adopting the effects determination, and shall provide a detailed explanation of the scientific and commercial data and rationale supporting any modification it makes; or
(iii) The Service will provide EPA a draft of a biological opinion finding that the FIFRA action is likely to jeopardize the continued existence of a listed species or result in the destruction or adverse modification of critical habitat, and describing any reasonable and prudent alternatives if available.
(2) If the Service acts under paragraphs (c)(1)(ii) or (c)(1)(iii) of this section, EPA shall, on request from an applicant, provide the applicant a copy of the draft written statement or draft biological opinion received from the Service. The Service shall at the request of EPA or an applicant discuss with EPA and the applicant the Service's review and evaluation under this section, and the basis for its findings. EPA and any applicant may submit written comments to the Service within 30 days after EPA receives the draft written statement or opinion from the Service unless the Service, EPA and any applicant agree to an extended deadline consistent with section 7(b)(1) of the Act.
(3) The Service will issue a final written statement or final biological opinion within 45 days after EPA receives the draft statement or opinion from the Service unless the deadline is extended under section 7(b)(1) of the Act.
(d)
(e)
(a)
(b)
EPA may employ the procedures described in § 402.10 to confer on any species proposed for listing or any habitat proposed for designation as critical habitat. For the purposes of § 402.10(d), the procedures in § 402.46 are a permissible form of formal consultation.