Food and Nutrition Service
Food Safety and Inspection Service
Forest Service
Engineers Corps
Committee for Purchase From People Who Are Blind or Severely Disabled
Census Bureau
International Trade Administration
National Oceanic and Atmospheric Administration
Army Department
Engineers Corps
Energy Efficiency and Renewable Energy Office
Federal Energy Regulatory Commission
Western Area Power Administration
Agency for Toxic Substances and Disease Registry
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Food and Drug Administration
Health Resources and Services Administration
National Institutes of Health
Federal Emergency Management Agency
Fish and Wildlife Service
Land Management Bureau
National Park Service
Drug Enforcement Administration
Employment and Training Administration
Employment Standards Administration
Agency for Toxic Substances and Disease Registry
Federal Aviation Administration
Federal Highway Administration
Surface Transportation Board
Alcohol and Tobacco Tax and Trade Bureau
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.
To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions.
Merit Systems Protection Board.
Final rule.
The Merit Systems Protection Board (MSPB or Board) is amending Appendix II and Appendix III of this part to rename the Dallas Field Office as the Dallas Regional Office. This change is being made to eliminate an unnecessary layer of supervision and achieve parity with other regional offices in the supervision of the administrative judges and support staff. This change will better reflect the actual workload and size of the Board's Dallas office.
October 22, 2004.
Timothy L. Korb, Information Services, Merit Systems Protection Board, 1615 M Street, NW., Washington, DC 20419; (202) 653-7200; fax: (202) 653-7130; e-mail:
The Board is amending Appendix II and Appendix III of this part to rename the Dallas Field Office as the Dallas Regional Office. This change is being made to better reflect the actual status of the office. Specifically, the workload, at 821 case receipts in fiscal year 2003, was similar to that of the regional offices, and well in excess of that of the other field offices. In fact, this has been the trend in all fiscal years since 1999. Further, the staffing level of the office is comparable to that of the regional offices, and again, greater than that of the other field offices. This, too, has consistently been the case in recent years. Finally, the Dallas office, alone among the current field offices, was a Regional Office even after the Board created a field office structure, and lost that designation only as a result of the retirement of the Regional Director.
The Board is publishing this rule as a final rule pursuant to 5 CFR part 1201.
Administrative Practice and Procedure.
5 U.S.C. 1204 and 7701, unless otherwise noted.
Federal Aviation Administration (FAA), DOT.
Final special conditions; request for comments.
These special conditions are issued for Dassault-Breguet Model Falcon 10 airplanes modified by Flight Test Associates Incorporated, of Mojave, California. The modified airplanes will have novel and unusual design features when compared to the state of technology envisioned in the airworthiness standards for transport category airplanes. The modification incorporates the installation of Honeywell Model AM-250 Altimeters. The applicable airworthiness regulations do not contain adequate or appropriate safety 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 that provided by the existing airworthiness standards.
The effective date of these special conditions is October 22, 2004. Comments must be received on or before November 22, 2004.
Comments on these special conditions may be mailed in duplicate to: Federal Aviation Administration, Transport Airplane Directorate, Attn: Rules Docket (ANM-113), Docket No. NM292, 1601 Lind Avenue SW., Renton, Washington 98055-4056; or delivered in duplicate to the Transport Airplane Directorate at the above address. All comments must be marked: Docket No. NM292.
Greg Dunn, FAA, Airplane and Flight Crew Interface Branch, ANM-111, Transport Airplane Directorate, Aircraft Certification Service, 1601 Lind Avenue SW., Renton, Washington 98055-4056; telephone (425) 227-2799; facsimile (425) 227-1320.
The FAA has determined that notice and opportunity for prior public comment is impracticable, because these procedures would significantly delay certification of the airplane 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; however, the FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. The most helpful comments reference a specific portion of the special conditions,
We will file in the docket all comments we receive as well as a report summarizing each substantive public contact with FAA personnel concerning these special conditions. The docket is available for public inspection before and after the comment closing date. If you wish to review the docket in person, go to the address in the
We will consider all comments we receive on or before the closing date for comments. We will consider comments filed late, if it is possible to do so without incurring expense or delay. We may change these special conditions, based on the comments received.
If you want the FAA to acknowledge receipt of your comments on these special conditions, include with your comments a pre-addressed, stamped postcard on which the docket number appears. We will stamp the date on the postcard and mail it back to you.
On June 10, 2004, Flight Test Associates Incorporated, of Mojave, California, applied to the FAA, Los Angeles Aircraft Certification Office, for a supplemental type certificate (STC) to modify Dassault-Breguet Model Falcon 10 airplanes. The proposed modification incorporates the installation of digital Honeywell Model AM-250 Barometric Altimeters as primary altimeters. These digital altimeters would perform critical functions, that is functions whose failure would prevent the continued safe flight and landing of the airplane. The digital altimeters to be installed in these airplanes have the potential to be vulnerable to high-intensity radiated fields (HIRF) external to the airplane.
Under the provisions of 14 CFR 21.101, Flight Test Associates must show that the Model Falcon 10 airplanes, as changed, continue to meet the applicable provisions of the regulations incorporated by reference in Type Certificate No. A33EU or the applicable regulations in effect on the date of application for the change. The regulations incorporated by reference in the type certificate are commonly referred to as the “original type certification basis.”
The regulations incorporated by reference in Type Certificate No. A33EU include 14 CFR part 25, as amended by Amendments 25-1 through 25-20.
If the Administrator finds that the applicable airworthiness regulations (
In addition to the applicable airworthiness regulations and special conditions, the Model Falcon 10 airplanes must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirements of 14 CFR part 36.
Special conditions, as defined in 14 CFR 11.19, are issued in accordance with § 11.38 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 Flight Test Associates apply at a later date for a supplemental type certificate to modify any other model included on Type Certificate No. A33EU to incorporate the same or similar novel or unusual design feature, these special conditions would also apply to the other model under the provisions of § 21.101.
The Dassault-Breguet Model Falcon 10 airplanes modified by Flight Test Associates Incorporated will incorporate new dual primary altimeters that will perform critical functions. These systems may be vulnerable to HIRF external to the airplane. The current airworthiness standards of part 25 do not contain adequate or appropriate safety standards for the protection of this equipment from the adverse effects of HIRF. Accordingly, this system is considered to be a novel or unusual design feature.
There is no specific regulation that addresses protection requirements for electrical and electronic systems from HIRF. Increased power levels from ground-based radio transmitters and the growing use of sensitive avionics/electronics and electrical systems to command and control airplanes have made it necessary to provide adequate protection.
To ensure that a level of safety is achieved equivalent to that intended by the regulations incorporated by reference, special conditions are needed for the Dassault-Breguet Model Falcon 10 airplanes modified by Flight Test Associates Incorporated. These special conditions require that new primary altimeters that perform critical functions be designed and installed to preclude component damage and interruption of function due to both the direct and indirect effects of HIRF.
With the trend toward increased power levels from ground-based transmitters and the advent of space and satellite communications coupled with electronic command and control of the airplane, the immunity of critical digital avionics/electronics and electrical systems to HIRF must be established.
It is not possible to precisely define the HIRF to which the airplane will be exposed in service. There is also uncertainty concerning the effectiveness of airframe shielding for HIRF. Furthermore, coupling of electromagnetic energy to cockpit-installed equipment through the cockpit window apertures is undefined. Based on surveys and analysis of existing HIRF emitters, an adequate level of protection exists when compliance with the HIRF protection special condition is shown with either paragraph 1 or 2 below:
1. A minimum threat of 100 volts rms (root-mean-square) per meter electric field strength from 10 KHz to 18 GHz.
a. The threat must be applied to the system elements and their associated wiring harnesses without the benefit of airframe shielding.
b. Demonstration of this level of protection is established through system tests and analysis.
2. A threat external to the airframe of the field strengths identified in the table below for the frequency ranges indicated. Both peak and average field strength components from the table are to be demonstrated.
The threat levels identified above are the result of an FAA review of existing studies on the subject of HIRF, in light of the ongoing work of the Electromagnetic Effects Harmonization Working Group of the Aviation Rulemaking Advisory Committee.
As discussed above, these special conditions are applicable to Dassault-Breguet Model Falcon 10 airplanes modified by Flight Test Associates Incorporated. Should Flight Test Associates Incorporated apply at a later date for a supplemental type certificate to modify any other model included on Type Certificate No. A33EU to incorporate the same or similar novel or unusual design feature, these special conditions would apply to that model as well as under the provisions of 14 CFR 21.101.
This action affects only certain novel or unusual design features on Dassault-Breguet Model Falcon 10 airplanes modified by Flight Test Associates Incorporated. It is not a rule of general applicability and affects only the applicant which applied to the FAA for approval of these features on the airplane.
The substance of the special conditions for these airplanes has been subjected to the notice and comment procedure in several prior instances and has been derived without substantive change from those previously issued. 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, Reporting and record keeping requirements.
49 U.S.C. 106(g), 40113, 44701, 44702, 44704.
1.
2. For the purpose of these special conditions, the following definition applies:
Federal Aviation Administration (FAA), DOT.
Final rule; request for comments.
The FAA is superseding Airworthiness Directive (AD) 96-20-07, which applies to certain B-Series Combustion Heaters Models B1500, B2030, B3040, and B4050 that are installed on airplanes. AD 96-20-07 currently requires you to repetitively test (pressure decay) the combustion tube and overhaul any heater that does not pass any test. AD 96-20-07 also requires you to repetitively test the operation of the combustion air pressure switch and replace any combustion pressure switch that does not pass one of the tests. As a terminating action for the repetitive test requirements of AD 96-20-07, you could install a new ceramic-coated combustion tube and an improved design combustion air pressure switch. This AD is the result of reports that the new ceramic-coated combustion tubes are subject to the same distress as the non-ceramic coated combustion tubes. Consequently, this AD retains the repetitive testing requirements of AD 96-20-07, removes the terminating action for the combustion tube, and adds Models B2500, B3500, and B4500 to the applicability section. We are issuing this AD to prevent combustion by-products (carbon-monoxide exhaust) and fuel leakage from the combustion heaters caused by failure of the combustion heater system. This failure could result in fire or explosion in the airplane and possible carbon monoxide poisoning of the crew and passengers in the cabin.
This AD becomes effective on November 19, 2004.
On November 14, 1996 (61 FR 51357, October 2, 1996), the Director of the Federal Register approved the incorporation by reference of JanAero Devices Service Bulletin # A-103, dated September 1995.
We must receive any comments on this AD by December 20, 2004.
Use one of the following to submit comments on this AD:
•
•
•
•
•
To get the service information identified in this AD, contact Kelly Aerospace Power Systems, P.O. Box 273, Fort Deposit, Alabama 36032; telephone: (334) 227-8306; facsimile: (334) 227-8596; Internet:
To view the comments to this AD, go to
Kevin L. Brane, Aerospace Engineer,
• Repetitively inspecting (pressure decay test) the combustion tube of the heater;
• Overhauling the heater and replacing the combustion tube with a serviceable tube or replacing the heater assembly if the heater fails any of these tests;
• Repetitively testing the operation of the combustion air pressure switch; and
• Replacing the switch with one of the same design or with one of improved design, P/N 94E42, if the combustion air pressure switch fails any of these tests.
Replacing the heater assembly with a new or rebuilt heater assembly that incorporates a ceramic combustion tube terminates the repetitive inspection requirements.
Replacing the combustion air pressure switch with a P/N 94E42 switch terminates the repetitive operational test requirements.
As an alternative method of compliance to AD 96-20-07, you may disable the heater.
B-Series Combustion Heaters, Models B2500, B3500, and B4500 were exempt from AD 96-20-07 because they incorporated a ceramic-coated combustion tube and a new combustion air pressure switch, P/N 94E42.
You must do the actions in AD 96-20-07 following JanAero Devices Service Bulletin # A-103, dated September 1995.
Since the unsafe condition described previously is likely to exist or develop on other airplanes that have certain B-Series Combustion Heaters Models B1500, B2030, B2500, B3040, B3500, B4050, and B4500 installed, we are issuing this AD to prevent combustion by-products (carbon-monoxide exhaust) and fuel leakage from the combustion heaters caused by failure of the combustion heater system. This failure could result in fire or explosion in the airplane and possible carbon monoxide poisoning of the crew and passengers in the cabin.
In preparing this rule, we contacted type clubs and aircraft operators to get technical information and information on operational and economic impacts. We did not receive any information through these contacts. If received, we would have included a discussion of any information that may have influenced this action in the rulemaking docket.
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and
3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
We prepared a summary of the costs to comply with this AD and placed it in the AD Docket. You may get a copy of this summary by sending a request to us at the address listed under
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
49 U.S.C. 106(g), 40113, 44701.
(a) This AD becomes effective on November 19, 2004.
(b) This AD supersedes AD 96-20-07, Amendment 39-9773.
(c) This AD affects Kelly Aerospace Power Systems B-Series Combustion Heaters, Models B1500, B2030, B2500, B3040, B3500, B4050, and B4500, marked as meeting the standards of TSO-C20, that are installed on, but not limited to, the following aircraft (all serial numbers), and are certificated in any category:
B-Series Combustion Heaters Models B2500, B3500, and B4500 incorporate a new combustion air pressure switch, P/N 94E42. Airplanes that are equipped with P/N 94E42 do not need to conduct an operational test of the combustion air pressure switch. The part number is ink-stamped on the side of these combustion air pressure switches.
(d) This AD is the result of reports that the new ceramic-coated combustion tubes are subject to the same distress as the non-ceramic coated combustion tubes. We are issuing this AD to prevent combustion by-products (carbon-monoxide exhaust) and fuel leakage from the combustion heaters caused by failure of the combustion heater system. This failure could result in fire or explosion in the airplane and possible carbon monoxide poisoning of the crew and passengers in the cabin.
(e) For airplanes with an affected B-Series combustion heater that does not incorporate an extended-life ceramic-coated combustion tube, do the following:
You may use a heater hour meter to determine heater hours time-in-service (TIS). Also, you may divide aircraft hours TIS in half to calculate heater hours TIS.
(f) For airplanes with an affected B-Series combustion heater that does incorporate an extended-life ceramic-coated combustion tube, do the following:
(g) You may request a different method of compliance or a different compliance time for this AD by following the procedures in 14 CFR 39.19. Unless FAA authorizes otherwise, send your request to your principal inspector. The principal inspector may add comments and will send your request to the Manager, Atlanta ACO, FAA. For information on any already approved alternative methods of compliance, contact Kevin L. Brane, Aerospace Engineer, Atlanta Aircraft Certification Office, FAA, One Crown Center, 1985 Phoenix Boulevard, Suite 450, Atlanta, GA 30349; telephone: (770) 703-6063; facsimile: (770) 703-6097.
(h) You must do the actions required by this AD following the instructions in JanAero Devices Service Bulletin # A-103, dated September 1995.
(1) On November 14, 1996 (61 FR 51357, October 2, 1996), and in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, the Director of the Federal Register approved the incorporation by reference of JanAero Devices Service Bulletin # A-103, dated September 1995.
(2) You may get a copy from Kelly Aerospace Power Systems, PO Box 273, Fort Deposit, Alabama 36032; telephone: (334) 227-8306; facsimile: (334) 227-8596; Internet:
Federal Aviation Administration (FAA), DOT.
Final rule.
This amendment adopts miscellaneous amendments to the required IFR (instrument flight rules) altitudes and changeover points for certain Federal airways, jet routes, or direct routes for which a minimum or maximum en route authorized IFR altitude is prescribed. This regulatory action is needed because of changes occurring in the National Airspace System. These changes are designed to provide for the safe and efficient use of the navigable airspace under instrument conditions in the affected areas.
0901 UTC, November 25, 2004.
Donald P. Pate, Flight Procedure Standards Branch (AMCAFS-420), Flight Technologies and Programs Division, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd. Oklahoma City, OK. 73169 (Mail Address: PO Box 25082 Oklahoma City, OK. 73125) telephone: (405) 954-4164.
This amendment to part 95 of the Federal Aviation Regulations (14 CFR part 95) amends, suspends, or revokes IFR altitudes governing the operation of all aircraft in flight over a specified route or any portion of that route, as well as the changeover points (COPs) for Federal airways, jet routes, or direct routes as prescribed in part 95.
The specified IFR altitudes, when used in conjunction with the prescribed changeover points for those routes, ensure navigation aid coverage that is adequate for safe flight operations and free of frequency interference. The reasons and circumstances that create the need for this amendment involve matters of flight safety and operational efficiency in the National Airspace System, are related to published aeronautical charts that are essential to the user, and provide for the safe and efficient use of the navigable airspace. In addition, those various reasons or circumstances require making this amendment effective before the next scheduled charting and publication date of the flight information to assure its timely availability to the user. The effective date of this amendment reflects those considerations. In view of the close and immediate relationship between these regulatory changes and safety in air commerce, I find that notice and public procedure before adopting this amendment are impracticable and contrary to the public interest and that good cause exists for making the amendment effective in less than 30 days.
The FAA has determined that this regulation only involves an established
Airspace, Navigation (air).
49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44719, 44721.
Food and Drug Administration, HHS.
Final rule.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Phoenix Scientific, Inc. The supplemental ANADA provides for use of oxytetracycline hydrochloride soluble powder for skeletal marking of finfish fry and fingerlings by immersion.
This rule is effective October 22, 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:
Phoenix Scientific, Inc., 3915 South 48th Street Ter., St. Joseph, MO 64503, filed a supplement to ANADA 200-247 that provides for use of Oxytetracycline HCl Soluble Powder-343 for skeletal marking of finfish fry and fingerlings by immersion. The approval of this supplemental ANADA relied on publicly available safety and effectiveness data contained in Public Master File (PMF) 5667 which were compiled under National Research Support Project 7 (NRSP-7), a national agricultural research program for obtaining clearances for use of new drugs in minor animal species and for special uses. The supplemental ANADA is approved as of September 15, 2004, and the regulations are amended in 21 CFR 529.1660 to reflect the approval. The basis of approval is discussed in the freedom of information summary.
In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
FDA has determined under 21 CFR 25.33(d)(4) 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)
(2) Each gram of powder contains 753 mg oxytetracycline hydrochloride.
(b)
(1) No. 046573 for use of product described in paragraph (a)(1) of this section.
(2) No. 059130 for use of product described in paragraph (a)(2) of this section.
Federal Communications Commission.
Final rule, correction.
This document corrects an error in the dates and supplementary sections of a
Effective October 17, 2004.
Jennifer Schneider, Attorney, Telecommunications Access Policy Division, Wireline Competition Bureau, (202) 418-7400.
This summary contains a correction to the dates and supplementary sections of a
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Closure.
NMFS closes the commercial fishery for king mackerel in the exclusive economic zone (EEZ) in the western zone of the Gulf of Mexico. This closure is necessary to protect the Gulf king mackerel resource.
The closure is effective 12 noon, local time, October 20, 2004, through June 30, 2005.
Steve Branstetter, phone 727-570-5305, fax: 727-570-5583, e-mail:
The fishery for coastal migratory pelagic fish (king mackerel, Spanish mackerel, cero, cobia, little tunny, and, in the Gulf of Mexico only, dolphin and bluefish) is managed under the Fishery Management Plan for the Coastal Migratory Pelagic Resources of the Gulf of Mexico and South Atlantic (FMP). The FMP was prepared by the Gulf of Mexico and South Atlantic Fishery Management Councils (Councils) and is implemented under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.
Based on the Councils' recommended total allowable catch and the allocation ratios in the FMP, NMFS implemented a commercial quota for the Gulf of Mexico migratory group of king mackerel in the western zone of 1.01 million lb (0.46 million kg) (66 FR 17368, March 30, 2001).
Under 50 CFR 622.43(a), NMFS is required to close any segment of the king mackerel commercial fishery when its quota has been reached, or is projected to be reached, by filing a notification at the Office of the Federal Register. NMFS has determined that the commercial quota of 1.01 million lb (0.46 million kg) for Gulf group king mackerel in the western zone will be reached on October 19, 2004. Accordingly, the commercial fishery for Gulf group king mackerel in the western zone is closed effective 12 noon, local time, October 20, 2004, through June 30, 2005, the end of the fishing year. The boundary between the eastern and western zones is 87°31′06″ W. long., which is a line directly south from the Alabama/Florida boundary.
Except for a person aboard a charter vessel or headboat, during the closure, no person aboard a vessel for which a commercial permit for king mackerel has been issued may fish for Gulf group king mackerel in the EEZ in the closed zones or subzones. A person aboard a vessel that has a valid charter vessel/headboat permit for coastal migratory pelagic fish may continue to retain king mackerel in or from the closed zones or subzones under the bag and possession limits set forth in 50 CFR 622.39(c)(1)(ii) and (c)(2), provided the vessel is operating as a charter vessel or headboat. A charter vessel or headboat that also has a commercial king mackerel permit is considered to be operating as a charter vessel or headboat when it carries a passenger who pays a fee or when there are more than three persons aboard, including operator and crew.
During the closure, king mackerel from the closed zones or subzones taken in the EEZ, including those harvested under the bag and possession limits, may not be purchased or sold. This prohibition does not apply to trade in king mackerel from the closed zones or subzones that were harvested, landed ashore, and sold prior to the closure and were held in cold storage by a dealer or processor.
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B), as such prior notice and opportunity for public comment is unnecessary and contrary to the public interest. Such procedures would be unnecessary because the rule itself already has been subject to notice and comment, and all that remains is to notify the public of the closure. Allowing prior notice and opportunity for public comment is contrary to the public interest because of the need to immediately implement this action in order to protect the fishery since the capacity of the fishing fleet allows for rapid harvest of the quota. Prior notice and opportunity for public comment will require time and would potentially result in a harvest well in excess of the quota.
For the aforementioned reasons, the AA also finds good cause to waive the 30 day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).
This action is taken under 50 CFR 622.43(a) and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Tilefish commercial quota and trip limit adjustment.
NMFS announces that the Administrator, Northeast Region, NMFS (Regional Administrator) has determined that the quota for the tilefish Part-time permit category has been exceeded for fishing year (FY) 2004, warranting an adjustment of the Part-time permit category quota for FY 2005. Further, the Regional Administrator has determined that the tilefish Incidental permit category has exceeded the 5 percent of total allowable landings (TAL) allowed under the Fishery Management Plan for the Tilefish Fishery (FMP) and warrants a reduction in the annual trip limit for FY 2005. This action complies with the FMP and is intended to continue the rebuilding program in the FMP by taking into account previous overages of the tilefish quota.
Effective October 22, 2004, through October 31, 2005.
Brian R. Hooker, Fishery Policy Analyst, (978) 281-9220.
The regulations at 50 CFR 648.290(c) state that any overages of the quota for any tilefish limited access category that occur in a given fishing year will be subtracted from the quota for that category in the following fishing year. This same section also states that, if the tilefish harvest attributed to the open access Incidental permit category exceeds 5 percent of the total allowable landings (TAL) for a given fishing year, the trip limit for the Incidental category may be reduced the following year. In both of these instances, § 648.290(c) specifies that, if an adjustment is required, a notification of adjustment of the quota will be published in the
The tilefish quota of 360,098 lb (163,338 kg) for the limited access Part-time permit category (Category C) is being adjusted for FY 2005 (November 1, 2004 - October 31, 2005) through this action. Based upon vessel reports available as of October 13, 2004, FY 2004 tilefish landings for Category C were 217,037 lb (98,446 kg). Therefore, an overage of 16,264 lb (7,377 kg) must be deducted from the FY 2005 Category C quota, which results in an adjusted quota of 343,834 lb (155,960 kg). As a result of the decision in the Hadaja v. Evans lawsuit on May 15, 2003, the permitting and reporting requirements for the FMP were suspended for nearly a year. The decision rendered the quotas for the various limited access permit categories, and the 5 percent of TAL target quota for the open access permit category inoperative. These requirements were reinstated on May 31, 2004. During the period that the permitting and reporting requirements were vacated, it was impossible to attribute tilefish landings to a particular permit category. Consequently, projected landings (159,307 lb (72,260 kg)) were used for the period November 1, 2003 - May 31, 2004. Based on landings for each permit category for the same time period in FY 2002 and FY 2003, a Part-time category quota of 200,791 lb (91,077 kg) was established for the remainder of FY 2004 (June 1-October 31, 2004).
Landings of tilefish by the Incidental permit category in FY 2002 totaled 105,858 lb (48,016 kg) and landings in FY 2003 totaled 178,955 lb (81,173 kg). In both FY 2002 and FY 2003, the Incidental permit category landed over 95 percent of its catch between November and May, the same time period that the reporting requirements were vacated. Thus, the majority of the landings information for the Incidental permit category are not available for FY 2004. An analysis of FY 2002 and FY 2003 landings data determined that a trip limit of 133 lb (60 kg) for Incidental category vessels would be necessary in order to not exceed the 5 percent of TAL for FY 2005 (99,750 lb (45,246 kg)). Thus, this action reduces the trip limit for Incidental category vessels for FY 2005 to 133 lb (60 kg).
This action informs the public of overages of the FY 2004 Part-time permit category quota and adjusts the FY 2005 Part-time permit category quota to account for those overages. Additionally, this action informs the public that the Incidental permit category has previously exceeded 5 percent of the TAL and thus the trip limit for the Incidental category is adjusted to 133 lb (60 kg) for FY 2005.
The FY 2004 tilefish Part-time permit category quota, available FY 2004 tilefish Part-time permit category landings, and the resulting overage of the FY 2004 tilefish Part-time permit category quota are presented in Table 1. The resulting adjusted FY 2005 tilefish Part-time permit category commercial quota is presented in Table 2.
This action is required by 50 CFR part 648 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to adopt a new airworthiness directive (AD) for all Eagle Aircraft (Malaysia) Sdn. Bhd. Model Eagle 150B airplanes. This proposed AD would require you to inspect the port and starboard undercarriage attach bracket for unwelded areas and replace the attach bracket if unwelded areas are found. This proposed AD results from mandatory continuing airworthiness information (MCAI) issued by the airworthiness authority for Malaysia. We are issuing this proposed AD to detect and correct inadequate welding of the undercarriage, which could result in cracks. This failure could lead to loss of control of the airplane.
We must receive any comments on this proposed AD by November 29, 2004.
Use one of the following to submit comments on this proposed AD:
•
•
•
•
•
To get the service information identified in this proposed AD, contact Eagle Aircraft (Malaysia) Sdn. Bhd., PO Box 1028, Pejabat Pos Besar, Melanka, Malaysia, 75150; telephone: (606) 317-4105; facsimile: (606) 317-7213.
To view the comments to this proposed AD, go to
Karl Schletzbaum, Aerospace Engineer, Small Airplane Directorage, ACE-112, 901 Locust, Rm 301, Kansas City, Missouri 64106; telephone: (816) 329-4146; facsimile: (816) 329-4149.
Under this bilateral airworthiness agreement, the DCA has kept us informed of the situation described above.
Since the unsafe condition described previously is likely to exist or develop on other Eagle 150B airplanes of the same type design that are registered in the United States, we are proposing AD action to detect and correct inadequate welding of the undercarriage attach bracket, which could result in cracks. This failure could lead to loss of control of the airplane.
We estimate the following costs to accomplish any necessary replacements that would be required based on the results of this proposed inspection. We have no way of determining the number of airplanes that may need this replacement:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and
3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
We prepared a summary of the costs to comply with this proposed AD and placed it in the AD Docket. You may get a copy of this summary by sending a request to us at the address listed under
Air transportation, Aircraft, Aviation safety, Safety.
Accordingly, under the authority delegated to me by the Administrator, the Federal Aviation Administration 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) We must receive comments on this proposed airworthiness directive (AD) by November 29, 2004.
(b) None.
(c) This AD affects the following airplane models and serial numbers that are certificated in any category: Eagle Aircraft (Malaysia) Sdn. Bhd. Eagle 150B airplanes, serial numbers 016 through 044, M1001 through M1003, and M1005.
(d) This AD is the result of unwelded areas on the undercarriage attach bracket. The actions specified in this AD are intended to detect and correct inadequate welding of the undercarriage, which could result in cracks. This failure could lead to loss of control of the airplane.
(e) To address this problem, you must do the following:
(f) You may request a different method of compliance or a different compliance time for this AD by following the procedures in 14 CFR 39.19. Unless FAA authorizes otherwise, send your request to your principal inspector. The principal inspector may add comments and will send your request to the Manager, Standards Office, Small Airplane Directorate, FAA. For information on any already approved alternative methods of compliance, contact Karl Schletzbaum, Aerospace Engineer, Small Airplane Directorage, ACE-112, 901 Locust, Rm 301, Kansas City, Missouri, 64106; telephone: (816) 329-4146; facsimile: (816) 329-4149.
(g) DCA CAM AD 001-08-2004, dated August 12, 2004, and Eagle Aircraft Alert Service Bulletin SB 1123, dated August 8, 2004, also address the subject of this AD.
(h) To get copies of the documents referenced in this AD, contact Eagle Aircraft, PO Box 1028, Pejabat Pos Besar, Melaka, Malaysia, 75150; telephone: (606) 317-4105; facsimile: (606) 317-7213. To view the AD docket, go to the Docket Management Facility; U.S. Department of Transportation, 400 Seventh Street, SW., Nassif Building, Room PL-401, Washington, DC, or on the Internet at
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to revise AD 98-20-38, which applies to all Beech 200 series airplanes. AD 98-20-38 requires you to revise the FAA-approved Airplane Flight Manual (AFM) to specify procedures that would prohibit flight in severe icing conditions (as determined by certain visual cues), limit or prohibit the use of various flight control devices while in severe icing conditions, and provide the flight crew with recognition cues for and procedures for exiting from severe icing conditions. Part of the applicability of AD 98-20-38 includes the Raytheon Models B200 and B200C airplanes. AD 96-09-13 already requires AFM revisions on this subject for these airplane models. Consequently, FAA is revising AD 98-20-38 to remove the Models B200 and B200C from the applicability and add clarification that AD 96-09-13 affects these airplanes. We are issuing this proposed AD to minimize the potential hazards associated with operating these airplanes in severe icing conditions by providing more clearly defined procedures and limitations.
We must receive any comments on this proposed AD by December 7, 2004.
Use one of the following to submit comments on this proposed AD:
•
•
•
•
•
You may view the comments to this proposed AD in the AD docket on the Internet at
Mr. Paul Pellicano, Aerospace Engineer (Icing Specialist), Atlanta Aircraft Certification Office, FAA, One Crown Center, 1895 Phoenix Boulevard, Suite 450, Atlanta, Georgia 30349; telephone: (770) 703-6064: facsimile: (770) 703-6097.
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and
3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
We prepared a summary of the costs to comply with this proposed AD and placed it in the AD Docket. You may get a copy of this summary by sending a request to us at the address listed under
Air transportation, Aircraft, Aviation safety, Safety.
Accordingly, under the authority delegated to me by the Administrator, the Federal Aviation Administration 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 Airworthiness Directive (AD)
98-20-38, Amendment 39-10806 (63 FR 51805, September 29, 1998), and by adding a new AD to read as follows:
(a) We must receive comments on this proposed airworthiness directive (AD) by December 7, 2004.
(b) This AD revises AD 98-20-38, Amendment 39-10806.
(c) This AD affects the following airplane models, all serial numbers, that are certificated in any category:
The actions of AD 96-09-13 are required for the Beech Models B200 and B200C airplanes.
(d) The actions specified in this AD are intended to minimize the potential hazards associated with operating these airplanes in severe icing conditions by providing more clearly defined procedures and limitations.
(e) Within 30 days after November 4, 1998 (the effective date of AD 98-20-38), do the requirements of paragraphs (e)(1) and (e)(2) of this AD, unless already accomplished.
Operators should initiate action to notify and ensure that flight crewmembers are apprised of this change.
(1) Revise the FAA-approved Airplane Flight Manual (AFM) by incorporating the following into the Limitations Section of the AFM. This may be accomplished by inserting a copy of this AD in the AFM.
Severe icing may result from environmental conditions outside of those for which the airplane is certificated. Flight in freezing rain, freezing drizzle, or mixed icing conditions (supercooled liquid water and ice crystals) may result in ice build-up on protected surfaces exceeding the capability of the ice protection system, or may result in ice forming aft of the protected surfaces. This ice may not be shed using the ice protection systems, and may seriously degrade the performance and controllability of the airplane.
• During flight, severe icing conditions that exceed those for which the airplane is certificated shall be determined by the following visual cues. If one or more of these visual cues exists, immediately request priority handling from Air Traffic Control to facilitate a route or an altitude change to exit the icing conditions.
• Unusually extensive ice accumulation on the airframe and windshield in areas not normally observed to collect ice.
• Accumulation of ice on the upper surface of the wing, aft of the protected area.
• Accumulation of ice on the engine nacelles and propeller spinners farther aft than normally observed.
• Since the autopilot, when installed and operating, may mask tactile cues that indicate adverse changes in handling characteristics, use of the autopilot is prohibited when any of the visual cues specified above exist, or when unusual lateral trim requirements or autopilot trim warnings are encountered while the airplane is in icing conditions.
• All wing icing inspection lights must be operative prior to flight into known or forecast icing conditions at night. [
(2) Revise the FAA-approved AFM by incorporating the following into the Normal Procedures Section of the AFM. This may be accomplished by inserting a copy of this AD in the AFM.
• Visible rain at temperatures below 0 degrees Celsius ambient air temperature.
• Droplets that splash or splatter on impact at temperatures below 0 degrees Celsius ambient air temperature.
These procedures are applicable to all flight phases from takeoff to landing. Monitor the ambient air temperature. While severe icing may form at temperatures as cold as -18 degrees Celsius, increased vigilance is warranted at temperatures around freezing with visible moisture present. If the visual cues specified in the Limitations Section of the AFM for identifying severe icing conditions are observed, accomplish the following:
• Immediately request priority handling from Air Traffic Control to facilitate a route or an altitude change to exit the severe icing conditions in order to avoid extended exposure to flight conditions more severe than those for which the airplane has been certificated.
• Avoid abrupt and excessive maneuvering that may exacerbate control difficulties.
• Do not engage the autopilot.
• If the autopilot is engaged, hold the control wheel firmly and disengage the autopilot.
• If an unusual roll response or uncommanded roll control movement is observed, reduce the angle-of-attack.
• Do not extend flaps when holding in icing conditions. Operation with flaps extended can result in a reduced wing angle-of-attack, with the possibility of ice forming on the upper surface further aft on the wing than normal, possibly aft of the protected area.
• If the flaps are extended, do not retract them until the airframe is clear of ice.
• Report these weather conditions to Air Traffic Control.”
(f) As an alternative method of compliance to the actions required by paragraph (e)(2) of this AD, revise the Abnormal Procedures Section or Emergency Procedures Section of the AFM instead of the Normal Procedures section of the AFM. Insert the information presented in paragraph (e)(2) of this AD into the applicable AFM section.
(g) The owner/operator holding at least a private pilot certificate as authorized by section 43.7 of the Federal Aviation Regulations (14 CFR 43.7) may incorporate the AFM revisions required by this AD. Enter this information into the aircraft records showing compliance with this AD following section 43.9 of the Federal Aviation Regulations (14 CFR 43.9).
(h) You may request a different method of compliance or a different compliance time for this AD by following the procedures in 14 CFR 39.19. Unless FAA authorizes otherwise, send your request to your principal inspector. The principal inspector may add comments and will send your request to the Manager, Standards Office, Small Airplane Directorate, FAA. For information on any already approved alternative methods of compliance, contact Mr. Paul Pellicano, Aerospace Engineer (Icing Specialist), Atlanta Aircraft Certification Office, FAA, One Crown Center, 1895 Phoenix Boulevard, Suite 450, Atlanta, Georgia 30349; telephone: (770) 703-6064; facsimile: (770) 703-6097.
(i) You may view the AD docket at the Docket Management Facility; US Department of Transportation, 400 Seventh Street, SW., Nassif Building, Room PL-401, Washington, DC, or on the Internet at
Federal Highway Administration (FHWA), DOT.
Propsed rule; extension of comment period.
The FHWA is extending the comment period for a notice of proposed amendments (NPA) to the Manual on Uniform Traffic Control Devices (MUTCD); request for comments on maintaining traffic sign retroreflectivity, which was published on July 30, 2004, at 69 FR 45623. The original comment period is set to close on October 28, 2004. The extension is based on concern expressed by the National Committee on Uniform Traffic Control Devices, (NCUTCD) and the American Association of State Highway and Transportation Officials (AASHTO) that the October 28 closing date does not provide sufficient time for discussion of the issues in committee and a subsequent comprehensive response to the docket. The FHWA recognizes that others interested in commenting may have similar time constraints and agrees that the comment
Submit comments on or before February 1, 2005.
Mail or hand deliver comments to the U.S. Department of Transportation, Dockets Management Facility, Room PL-401, 400 Seventh Street, SW., Washington, DC 20590, or submit electronically at
Mr. Peter J. Hatzi, Office of Safety Design (HSA-10), (202) 366-8036, or Raymond Cuprill, Office of the Chief Counsel (202) 366-0791, Federal Highway Administration, 400 Seventh Street, SW., Washington, DC 20590-0001. Office hours are from 7:45 a.m. to 4:15 p.m., e.t., Monday through Friday, except Federal holidays.
Interested parties may submit or retrieve comments online through the Document Management System (DMS) at:
An electronic copy of this document may be downloaded using a computer, modem and suitable communications software from the Government Printing Office's Electronic Bulletin Board Service at (202) 512-1661. Internet users may reach the Office of the Federal Register's home page at
The FHWA has conducted extensive research on the minimum levels of sign retroreflectivity. This research led to the development of proposed minimum maintained levels of traffic sign retroreflectivity, and a complement of maintenance methods for implementing the levels. On July 30, 2004, the FHWA published in the
The existing MUTCD requires that traffic signs be illuminated or retroreflective. However, until recently, little information was available about the levels of retroreflectivity necessary to meet the needs of drivers and thereby define the useful life of signs. The NPA for maintaining traffic sign retroreflectivity is proposing guidance for evaluating and maintaining traffic sign retroreflectivity to address the needs of drivers. The methods proposed would allow agencies options for evaluating and managing their signs.
The NPA proposes a seven-year compliance period for regulatory, warning, and post mounted guide signs and a 10-year compliance period for overhead guide signs and street name signs.
The original comment period for the NPA closes on October 28, 2004. The NCUTCD and the AASHTO have expressed concern that this closing date does not provide sufficient time to review and discuss the proposed changes; and then, develop and submit complete responses to the docket. To allow time for these organizations and others to submit comprehensive comments, the closing date is changed from October 28, 2004, to February 1, 2005.
23 U.S.C. 101(a), 104, 105, 109(d), 114(a), 135, 217, 307, 315, and 402(a); sec. 406(a), Pub. L. 102-388, 106 Stat. 1520, 1564, 23 CFR 1.32 and 49 CFR 1.48(b).)
Office of Innovation and Improvement, Department of Education.
Notice of proposed rulemaking.
The Secretary issues these proposed regulations to administer the Credit Enhancement for Charter School Facilities program and its predecessor, the Charter School Facilities Financing Demonstration Grant program. Under this program, the Department provides competitive grants to entities that are non-profit or public or are consortia of these entities to demonstrate innovative credit enhancement strategies to assist charter schools in acquiring, constructing, and renovating facilities through loans, bonds, other debt instruments, or leases.
We must receive your comments on or before November 22, 2004.
Address all comments about these proposed regulations to Jim Houser, U.S. Department of Education, 400 Maryland Avenue, SW., Washington, DC 20202-6140. If you prefer to send comments through the Internet, use the following address:
If you want to comment on the information collection requirements, you must send your comments to the Office of Management and Budget at the address listed in the Paperwork Reduction Act section of this preamble. You may also send a copy of these comments to the Department representative named in this section.
Valarie Perkins or Jim Houser, U.S. Department of Education, 400 Maryland Avenue, SW., Washington, DC 20202-6140. Telephone: (202) 260-1924 or via Internet, at:
Individuals with disabilities may obtain this document in an alternative format (
We invite you to submit comments regarding these proposed regulations. To ensure that your comments have maximum effect in developing the final regulations, we urge you to identify clearly the specific section or sections of the proposed regulations that each of your comments addresses and to arrange your comments in the same order as the proposed regulations.
We also invite you to assist us in complying with the specific requirements of Executive Order 12866 and its overall requirement of reducing regulatory burden that might result from these proposed regulations. Please let us know of any further opportunities we should take to reduce potential costs or increase potential benefits while preserving the effective and efficient administration of the program.
During and after the comment period, you may inspect all public comments about these proposed regulations in room 4W258, 400 Maryland Avenue, SW., Washington, DC, 20202-6140, between the hours of 8:30 a.m. and 4 p.m., Eastern time, Monday through Friday of each week except Federal holidays.
On request, we will supply an appropriate aid, such as a reader or print magnifier, to an individual with a disability who needs assistance to review the comments or other documents in the public rulemaking record for these proposed regulations. If you want to schedule an appointment for this type of aid, please contact the person listed under
These proposed regulations would apply to both (a) the Credit Enhancement for Charter School Facilities program, which is authorized under title V, part B, subpart 2 of the Elementary and Secondary Education Act of 1965 (the Act), as amended by the No Child Left Behind Act of 2001 (Pub. L. 107-110, enacted January 8, 2002) and (b) its predecessor, the Charter School Facilities Financing Demonstration Grant program, as authorized by title X, part C, subpart 2 of the Act as part of the Department of Education Appropriations Act, 2001 as enacted by the Consolidated Appropriations Act, 2001. The purpose of this program is to assist charter schools in meeting their facilities needs. Under this program, funds are provided on a competitive basis to public and nonprofit entities, and consortia of these entities, to leverage other funds and help charter schools acquire school facilities through such means as purchase, lease, and donation. Grantees may also use grants to leverage other funds to help charter schools construct and renovate school facilities.
To help leverage funds for charter school facilities, grant recipients may, among other things: Guarantee and insure debt, including bonds, to finance charter school facilities; guarantee and insure leases for personal and real property; facilitate a charter school's facilities financing by identifying potential lending sources, encouraging private lending, and carrying out other, similar activities; and establish temporary charter school facilities that new charter schools may use until they can acquire a facility on their own.
Sections in these proposed regulations that govern the management of grants would apply to grants under both the Credit Enhancement for Charter School Facilities program and its predecessor, the Charter School Facilities Financing Demonstration Grant program. These two programs are virtually identical and grants made under them will operate for several years. Sections related to grantee selection would apply only to grant competitions conducted after fiscal year (FY) 2004.
The primary purpose of this regulation is to establish selection criteria for this complex program's discretionary grant competitions after FY 2004. Since we seek to award grants to high-quality applicants with high-quality plans to use their grant funds, these criteria essentially include assessments on the quality of the applicant and the quality of the applicant's plan. The criteria also assess how applicants propose to leverage private or public sector funding and increase the number and variety of charter schools assisted in meeting their facilities needs. The proposed selection criteria are similar to those we have used in the two previous competitions for this program. As noted above, this proposed regulation also includes a few provisions that govern the ongoing management of the grants already awarded in preceding fiscal years.
Under Executive Order 12866, we have assessed the potential costs and benefits of this regulatory action.
The potential costs associated with the proposed regulations are those resulting from statutory requirements and those we have determined to be necessary for administering this program effectively and efficiently. Elsewhere in this
In assessing the potential costs and benefits—both quantitative and qualitative—of this regulatory action, we have determined that the benefits would justify the costs.
We have also determined that this regulatory action would not unduly interfere with State, local, and tribal governments in the exercise of their governmental functions.
The Secretary believes that these regulations are necessary to clarify complex statutory provisions. As noted elsewhere, these proposed regulations add clarity where the statute is ambiguous or reorganize statutory material to facilitate a better understanding of the statute's requirements. Nearly all of the benefits and costs of these proposed regulations stem from the underlying legislation and not the regulations. The costs associated with these proposed regulations are not only minimal but are also justified in terms of the benefits that successful applicants for these discretionary grants will receive. For example, the statute requires an application and the types of information that would be collected through the proposed selection criteria should be readily available to applicants under this program.
Executive Order 12866 and the Presidential memorandum on “Plain Language in Government Writing” require each agency to write regulations that are easy to understand.
The Secretary invites comments on how to make these proposed regulations
○ Are the requirements in the proposed regulations clearly stated?
○ Do the proposed regulations contain technical terms or other wording that interferes with their clarity?
○ Does the format of the proposed regulations (grouping and order of sections, use of headings, paragraphing, etc.) aid or reduce their clarity?
○ Would the proposed regulations be easier to understand if we divided them into more (but shorter) sections? (A “section” is preceded by the symbol “§ ” and a numbered heading; for example, § 225.1
○ Could the description of the proposed regulations in the “Supplementary Information” section of this preamble be more helpful in making the proposed regulations easier to understand? If so, how?
○ What else could we do to make the proposed regulations easier to understand?
Send any comments that concern how the Department could make these proposed regulations easier to understand to the person listed in the
The Secretary certifies that these proposed regulations would not have a significant economic impact on a substantial number of small entities. The small entities that would be tangentially affected by these proposed regulations are small grantees and, tangentially, small charter schools that ultimately benefit from services provided by grantees. In addition, we do not believe that the regulations would have a significant economic impact on the limited number of small grantees and small charter schools affected because the proposed regulations would not impose excessive regulatory burdens on those entities or require unnecessary Federal supervision.
The proposed regulations would benefit both small and large entities in that they clarify confusing and complex statutory requirements. Also, since the statute requires Credit Enhancement for Charter School Facilities applicants to apply to the Department if they wish to receive discretionary funds, it would be difficult for the Department to award funds without the application information specified in the proposed regulations. The proposed regulations will ensure that applicants do not provide significant amounts of information that is already otherwise available to the Department.
The proposed regulations would impose minimal paperwork burden requirements for all applicants and minimal requirements with which grant recipients must comply. However, the Secretary specifically invites comments on the effects of the proposed regulations on small entities, and on whether there may be further opportunities to reduce any potential adverse impact or increase potential benefits resulting from these proposed regulations without impeding the effective and efficient administration of the Credit Enhancement for Charter School Facilities program.
Sections 225.11 and 225.12 contain information collection requirements. Under the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)), the Department of Education submitted a copy of this section to the Office of Management and Budget (OMB) for its review.
The Department will use the information collected through the selection criteria and competitive priority to determine whether to fund applicants. Since the statute requires applicants to apply for funds, the Department would not be able to award these funds without the application to collect the required information.
We estimate the annual reporting and recordkeeping burden for this collection of information to average 80 hours for each respondent for 30 applicants, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Thus, we estimate the total annual reporting and recordkeeping burden for this collection to be 2400 hours.
If you want to comment on the information collection requirements, please send your comments to the Office of Information and Regulatory Affairs, OMB, room 10235, New Executive Office Building, Washington, DC 20503; Attention: Desk Officer for U.S. Department of Education. You may also send a copy of these comments to the Department representative named in the
We consider your comments on this proposed collection of information in—
○ Deciding whether the proposed collection is necessary for the proper performance of our functions, including whether the information will have practical use;
○ Evaluating the accuracy of our estimate of the burden of the proposed collection, including the validity of our methodology and assumptions;
○ Enhancing the quality, usefulness, and clarity of the information we collect; and
○ Minimizing the burden on those who must respond. This includes exploring the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology;
OMB is required to make a decision concerning the collection of information contained in these proposed regulations between 30 and 60 days after publication of this document in the
The proposed regulations would benefit both small and large entities in that they clarify confusing and complex statutory requirements. However, the Secretary specifically invites comments on the effects of the proposed regulations on small entities, and on whether there may be further opportunities to reduce any potential adverse impact or increase potential benefits resulting from these proposed regulations without impeding the effective and efficient administration of the Credit Enhancement for Charter School Facilities program.
Commenters are requested to describe the nature of any effect and provide empirical data and other factual support for their views to the extent possible. These comments will be placed in the public comment file and considered in the preparation of the final regulations.
This program is subject to Executive Order 12372 and the regulations in 34 CFR part 79. One of the objectives of the Executive order is to foster an intergovernmental partnership and a strengthened federalism. The Executive order relies on processes developed by State and local governments for coordination and review of proposed Federal financial assistance.
This document provides early notification of our specific plans and actions for this program.
You may view this document, as well as all other Department of Education documents published in the
To use PDF you must have Adobe Acrobat Reader, which is available free at this site. If you have questions about using PDF, call the U.S. Government Printing Office (GPO), toll free, at 1-888-293-6498; or in the Washington, DC, area at (202) 512-1530.
You may also view this document in PDF at the following site:
The official version of this document is the document published in the
Charter Schools, Credit Enhancement, Education, Educational facilities, Elementary and secondary education, Grant programs—education, Report and recordkeeping requirements, Schools.
For the reasons discussed in the preamble, the Secretary proposes to amend title 34 of the Code of Federal Regulations by adding a new part 225 to read as follows:
20 U.S.C. 7223, unless otherwise noted.
(a) The Credit Enhancement for Charter School Facilities Program provides grants to eligible entities to assist charter schools in obtaining facilities.
(b) Grantees use these grants to do the following:
(1) Assist charter schools in obtaining loans, bonds, and other debt instruments for the purpose of obtaining facilities.
(2) Assist charter schools in obtaining leases of facilities.
(c) Grantees may demonstrate innovative credit enhancement initiatives while meeting the program purposes under paragraph (b) of this section.
(d) For the purposes of these regulations, the Credit Enhancement for Charter School Facilities Program includes grants made under the Charter School Facilities Financing Demonstration Grant Program.
The following are eligible to receive a grant under this part:
(a) A public entity, such as a State or local governmental entity;
(b) A private nonprofit entity; or
(c) A consortium of entities described in paragraphs (a) and (b) of this section.
The following regulations apply to the Credit Enhancement for Charter School Facilities Program:
(a) The Education Department General Administrative Regulations (EDGAR) as follows:
(1) 34 CFR part 74 (Administration of Grants and Agreements with Institutions of Higher Education, Hospitals, and other Non-Profit Organizations).
(2) 34 CFR part 75 (Direct Grant Programs).
(3) 34 CFR part 77 (Definitions that Apply to Department Regulations).
(4) 34 CFR part 79 (Intergovernmental Review of Department of Education Programs and Activities).
(5) 34 CFR part 80 (Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments).
(6) 34 CFR part 81 (General Educational Provisions Act—Enforcement).
(7) 34 CFR part 82 (New Restrictions on Lobbying).
(8) 34 CFR part 84 (Governmentwide Requirements for Drug-Free Workplace (Grants)).
(9) 34 CFR part 85 (Governmentwide Debarment and Suspension (Nonprocurement)).
(b) The regulations in this part 225.
(a)
(b)
(a) The Secretary evaluates an application on the basis of the criteria in § 225.11.
(b) The Secretary awards up to 100 points for these criteria.
(c) The maximum possible score for each criterion is indicated in parentheses.
The Secretary uses the following criteria to evaluate an application for a Credit Enhancement for Charter School Facilities grant:
(a)
(1) The extent to which the grant proposal would provide financing to
(2) The extent to which the project goals, objectives, and timeline are clearly specified, measurable, and appropriate for the purpose of the program;
(3) The extent to which the project implementation plan and activities, including the partnerships established, are likely to achieve measurable objectives that further the purposes of the program;
(4) The extent to which the project is likely to produce results that are replicable;
(5) The extent to which the project will use appropriate criteria for selecting charter schools for assistance and for determining the type and amount of assistance to be given;
(6) The extent to which the proposed activities will leverage the private or public sector funding and increase the number and variety of charter schools assisted in meeting their facilities needs absent the program;
(7) The extent to which the project will serve charter schools in States with strong charter laws, consistent with the criteria for such laws in section 5202(e)(3) of the Elementary and Secondary Education Act of 1965; and
(8) The extent to which the requested grant amount and the project costs are reasonable in relation to the objectives, design, and potential significance of the project.
(b)
(1) The extent to which the services to be provided by the project reflect the identified needs of the charter schools to be served;
(2) The extent to which charter schools and chartering agencies were involved in the design of, and demonstrate support for, the project;
(3) The extent to which the technical assistance and other services to be provided by the proposed grant project involve the use of cost-effective strategies for increasing charter schools' access to facilities financing, including the reasonableness of fees and lending terms; and
(4) The extent to which the services to be provided by the proposed grant project are focused on assisting charter schools with a likelihood of success and the greatest demonstrated need for assistance under the program.
(c)
(1) The amount and quality of experience of the applicant in carrying out the activities it proposes to undertake in its application, such as enhancing the credit on debt issuances, guaranteeing leases, and facilitating financing;
(2) The applicant's financial stability;
(3) The ability of the applicant to protect against unwarranted risk in its loan underwriting, portfolio monitoring, and financial management;
(4) The applicant's expertise in education to evaluate the likelihood of success of a charter school;
(5) The ability of the applicant to prevent conflicts of interest, including conflicts of interest by employees and members of the board of directors in a decision-making role;
(6) If the applicant has co-applicants (consortium members), partners or other grant project participants, the specific resources to be contributed by each co-applicant (consortium member), partner, or other grant project participant to the implementation and success of the grant project;
(7) For State governmental entities, the extent to which steps have been or will be taken to ensure charter schools within the State receive the funding needed to obtain adequate facilities; and
(8) For previous grantees under the charter school facilities programs, their performance in implementing these grants.
(d)
(1) The qualifications of project personnel, including relevant training and experience, of the project manager and other members of the project team, including consultants or subcontractors; and
(2) The staffing plan for the grant project.
(a) The Secretary may award up to 15 additional points under a competitive priority regarding the capacity of charter schools to offer public school choice in those communities with the greatest need for this choice based on—
(1) The extent to which the applicant would target services to geographic areas in which a large proportion or number of public schools have been identified for improvement, corrective action, or restructuring under Title I of the Elementary and Secondary Education Act of 1965, as amended by the No Child Left Behind Act of 2001;
(2) The extent to which the applicant would target services to geographic areas in which a large proportion of students perform below proficient on State academic assessments; and
(3) The extent to which the applicant would target services to communities with large proportions of students from low-income families.
(b) The Secretary may elect to—
(1) Use this competitive priority only in certain years; and
(2) Consider the points awarded under this priority only for proposals that exhibit sufficient quality to warrant funding under the selection criteria in § 225.11.
(a) A grantee may draw down funds after it has signed a performance agreement acceptable to the Department of Education and the grantee.
(b) A grantee may draw down and spend a limited amount of funds prior to reaching an acceptable performance agreement provided that the grantee requests to draw down and spend a specific amount of funds and the Department of Education approves the request in writing.
(a) Grantees must not use reserve account funds to—
(1) Directly pay for a charter school's construction, renovation, repair, or acquisition; or
(2) Provide a down payment on facilities in order to secure loans for charter schools. A grantee may, however, use funds to guarantee a loan for the portion of the loan that would otherwise have to be funded with a down payment.
(b) In the event of a default of payment by a charter school whose loan or lease is guaranteed by reserve account funds, a grantee may use these funds to cover defaulted payments that are referenced under paragraph (a)(1) of this section.
Federal Emergency Management Agency (FEMA), Emergency Preparedness and Response Directorate, Department of Homeland Security.
Proposed rule.
Technical information or comments are requested on the proposed Base (1% annual chance) Flood Elevations (BFEs) and proposed BFE modifications for the communities listed below. The BFEs are the basis for the floodplain management measures that the community is required either to adopt or to show evidence of being already in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).
The comment period is ninety (90) days following the second publication of this proposed rule in a newspaper of local circulation in each community.
The proposed BFEs for each community are available for inspection at the office of the Chief Executive Officer of each community. The respective addresses are listed in the table below.
Doug Bellomo, P.E., Hazard Identification Section, Emergency Preparedness and Response Directorate, FEMA, 500 C Street SW., Washington, DC 20472, (202) 646-2903.
FEMA proposes to make determinations of BFEs and modified BFEs for each community listed below, in accordance with Section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
These proposed base flood and modified BFEs, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own, or pursuant to policies established by other Federal, state or regional entities. These proposed elevations are used to meet the floodplain management requirements of the NFIP and are also used to calculate the appropriate flood insurance premium rates for new buildings built after these elevations are made final, and for the contents in these buildings.
Administrative practice and procedure, flood insurance, reporting and recordkeeping requirements.
Accordingly, 44 CFR Part 67 is proposed to be amended as follows:
1. The authority citation for Part 67 continues to read as follows:
42 U.S.C. 4001
2. The tables published under the authority of § 67.4 are proposed to be amended as follows:
Food and Nutrition Service, USDA.
Notice.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the intention of the Food and Nutrition Service to request an extension of a currently approved collection. This collection is the voluntary submission of data including nutrient data from the food service industry to update and expand the Child Nutrition Database in support of the School Meals Initiative for Healthy Children.
Comments on this notice must be received by December 21, 2004, to be assured of consideration.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (b) the accuracy of the Agency's estimate of the burden of the proposed collection of information including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. All responses to this notice will be summarized and included in the request for OMB approval and will become a matter of public record. Comments may be sent to: William Wagoner, Team Leader, Technical Assistance Section, Nutrition Promotion and Training Branch, Child Nutrition Division, room 632, Food and Nutrition Service, United States Department of Agriculture, 3101 Park Center Drive, Alexandria, VA 22302.
Requests for additional information or copies of the information collection instruments and instruction should be directed to William Wagoner at (703) 305-2609.
Food Safety and Inspection Service (FSIS), USDA.
Notice.
This notice announces that the U.S. Department of Agriculture (USDA) is soliciting nominations for membership on the National Advisory Committee on Microbiological Criteria for Foods (NACMCF). Nominations for membership are being sought from individuals with scientific expertise in the fields of epidemiology, food technology, microbiology (food, clinical, and predictive), risk assessment, infectious disease, biostatistics, and other related sciences. Persons from State and Federal governments, industry and academia are invited to submit nominations. Members who are not Federal government employees will be appointed to serve as non-compensated special government employees (SGEs). SGEs will be subject to appropriate conflict of interest statutes and standards of ethical conduct.
The nominee's typed resume or curriculum vitae must be received by November 22, 2004.
Nominations should be sent to Ms. Karen Thomas, Advisory Committee Specialist, USDA, Food Safety and Inspection Service, Room
Ms. Karen Thomas, Advisory Committee Specialist, at the above address or by telephone (202) 690-6620 or Fax (202) 690-6634.
The NACMCF was established in March 1988, in response to a recommendation in a 1985 report of the National Academy of Sciences Committee on Food Protection, Subcommittee on Microbiological Criteria, “An Evaluation of the Role of Microbiological Criteria for Foods.” The current charter for the NACMCF and other information about the Committee are available for viewing on the NACMCF homepage at
The Committee provides scientific advice and recommendations to the Secretary of Agriculture and the Secretary of Health and Human Services concerning the development of microbiological criteria by which the safety and wholesomeness of food can be assessed. For example, the Committee assists in the development of criteria for microorganisms that indicate whether food has been processed using good manufacturing practices.
Appointments to the Committee will be made by the Secretary of Agriculture after consultation with the Secretary of Health and Human Services to ensure that recommendations made by the Committee take into account the needs of the diverse groups served by the Department. Membership shall include, to the extent practicable, individuals with demonstrated ability to represent minorities, women, and persons with disabilities.
Given the complexity of issues, the full Committee expects to meet at least once yearly, and the meetings will be announced in the
Appointment to the Advisory Committee is a two-year term; renewable for a total of three consecutive terms. Members must be prepared to work outside of scheduled Committee and subcommittee meetings, and may be required to assist in document preparation. Committee members serve on a voluntary basis; however, travel reimbursement and per diem are available.
All nominees who are selected must submit a USDA Advisory Committee Membership Background Information form AD-755, available on-line at:
In particular to their appointment, SGEs must complete the Office of Government Ethics (OGE) 450 Confidential Financial Disclosure Report, as new entrants before rendering any advice, or prior to their first meeting. All members will be reviewed for conflict of interest pursuant to 18 U.S.C. 208 in relation to specific NACMCF work charges. Financial disclosure updates will be required of members before each meeting. Members must report any changes in financial holdings requiring additional disclosure. OGE 450 forms are available on-line at
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 both on-line through the FSIS Web page located at
FSIS also will make copies of this
Food Safety and Inspection Service, USDA.
Notice of Re-chartering of Committee.
This notice is announcing the re-chartering of the National Advisory Committee on Microbiological Criteria for Foods (NACMCF). The Committee has been renewed in cooperation with the Department of Health and Human Services (HHS). The establishment of the Committee was recommended by a 1985 report of the National Academy of Sciences Committee on Food Protection, Subcommittee on Microbiological Criteria, “An Evaluation of the Role of Microbiological Criteria for Foods.” The current charter for the NACMCF is available for viewing on the NACMCF homepage at
Karen Thomas, Advisory Committee Specialist, United States Department of Agriculture (USDA), Food Safety and Inspection Service, Room 333 Aerospace Center, 1400 Independence Avenue, SW., Washington, DC 20250-3700. Background materials are available for inspection on the Web at the above address or by contacting Ms. Thomas at (202) 690-6620.
The United States Department of Agriculture (USDA) is charged with the
In order to assist the Secretaries in carrying out their responsibilities under the FMIA, PPIA, EPIA, and FFDCA, the NACMCF has been re-chartered. The Committee will be charged with advising and providing recommendations to the Secretaries on the development of microbiological criteria by which the safety and wholesomeness of food can be assessed, including criteria for microorganisms that indicate whether foods have been adequately and appropriately processed.
Re-chartering of this Committee is necessary and in the public interest because of the need for external expert advice on the range of scientific and technical issues that must be addressed by the Federal sponsors in meeting their statutory responsibilities. The complexity of the issues to be addressed requires that the Committee meet at least twice per year.
Members will be appointed by the Secretary of USDA after consultation with the Secretary of HHS. Because of their interest in the matters to be addressed by this Committee, advice on membership appointments will be requested from the Department of Commerce's National Marine Fisheries Service, the Department of Defense's Veterinary Service Activity, and the Centers for Disease Control and Prevention.
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
Forest Service, USDA.
Notice of meeting.
The Lake Tahoe Basin Federal Advisory Committee will hold a meeting on October 28, 2004, at the North Tahoe Conference Center, 8318 North Lake Blvd., Kings Beach, CA 96143. This Committee, established by the Secretary of Agriculture on December 15, 1998 (64 FR 2876), is chartered to provide advice to the Secretary on implementing the terms of the Federal Interagency Partnership on the Lake Tahoe Region and other matters raised by the Secretary.
The meeting will be held October 28, 2004, beginning at 9 a.m. and ending at 4 p.m.
The meeting will be held at the North Tahoe Conference Center, 8318 North Lake Blvd., Kings Beach, CA 96143.
Maribeth Gustafson or Jeannie Stafford, Lake Tahoe Basin Management Unit, Forest Service, 35 College Drive, South Lake Tahoe, CA 96150, (530) 543-2642.
The committee will meet jointly with the Lake Tahoe Basin Executives Committee. Items to be covered on the agenda include: (1) Tahoe Working Group Report; (2) Federal Agency Southern Nevada Land Management Act Round 6 Project Proposals; and, (3) Public Comment. All Lake Tahoe Basin Federal Advisory Committee meetings are open to the public. Interested citizens are encouraged to attend at the above address. Issues may be brought to the attention of the Committee during the open public comment period at the meeting or by filing written statements with the secretary for the Committee before or after the meeting. Please refer any written comments to the Lake Tahoe Basin Management Unit at the contact address stated above.
Forest Service, USDA.
Notice of meeting.
Pursuant to the authorities in the Federal Advisory Committee Act (Public Law 92-463) and under the Secure Rural Schools and Community Self-Determination Act of 2000 (Public Law 106-393) the Caribou-Targhee National Forests' Eastern Idaho Resource Advisory Committee will meet Tuesday, November 30, 2004 in Idaho Falls for a business meeting. The meeting is open to the public.
The business meeting will be held on November 30, 2004 from 10 a.m. to 3 p.m.
The meeting location is the Caribou-Targhee National Forest Headquarters Office, 1405 Hollipark Drive, Idaho Falls, Idaho 83402.
Jerry Reese, Caribou-Targhee National Forest Supervisor and Designated Federal Officer, at (208) 524-7500.
The business meeting on November 30, 2004, begins at 10 a.m. at the Caribou-Targhee National Forest Headquarters Office, 1405 Hollipark Drive, Idaho Falls, Idaho. Agenda topics will include looking at funding for this upcoming year, briefed on project status from last years approved projects, and welcoming new members.
Committee for Purchase From People Who Are Blind or Severely Disabled.
Addition to Procurement List.
This action adds to the Procurement List a service to be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.
Committee for Purchase From People Who Are Blind or Severely Disabled, Jefferson Plaza 2, Suite 10800, 1421 Jefferson Davis Highway, Arlington, Virginia 22202-3259.
Sheryl D. Kennerly, (703) 603-7740.
On July 16, 2004, the Committee for Purchase From People Who Are Blind or Severely Disabled published notice (69 FR 42649) of proposed addition to the Procurement List. After consideration of the material presented to it concerning capability of qualified nonprofit agencies to provide the service and impact of the additions on the current or most recent contractors, the Committee has determined that the service listed below is suitable for procurement by the Federal Government under 41 U.S.C. 46-48c and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will furnish the service to the Government.
2. The action will result in authorizing small entities to furnish the service to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 46-48c) in connection with the service proposed for addition to the Procurement List.
Accordingly, the following service is added to the Procurement List:
This action does not affect current contracts awarded prior to the effective date of this addition or options that may be exercised under those contracts.
Committee for Purchase from People Who Are Blind or Severely Disabled.
Proposed addition to and deletions from Procurement List.
The Committee is proposing to add to the Procurement List a product to be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and to delete a product and services previously furnished by such agencies.
Committee for Purchase From People Who Are Blind or Severely Disabled, Jefferson Plaza 2, Suite 10800, 1421 Jefferson Davis Highway, Arlington, Virginia 22202-3259.
Sheryl D. Kennerly, (703) 603-7740.
This notice is published pursuant to 41 U.S.C. 47(a) (2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.
If the Committee approves the proposed addition, the entities of the Federal Government identified in this notice for each product will be required to procure the product listed below from nonprofit agencies employing persons who are blind or have other severe disabilities.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. If approved, the action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will furnish the product to the Government.
2. If approved, the action will result in authorizing small entities to furnish the products to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 46-48c) in connection with the product proposed for addition to the Procurement List. Comments on this certification are invited. Commenters should identify the statement(s) underlying the certification on which they are providing additional information.
The following product is proposed for addition to Procurement List for production by the nonprofit agencies listed:
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. If approved, the action may result in additional reporting, recordkeeping or other compliance requirements for small entities.
2. If approved, the action may result in authorizing small entities to furnish the product and services to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 46-48c) in connection with the product and services proposed for deletion from the Procurement List.
The following product and services are proposed for deletion from the Procurement List:
DOC 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 of 1995, Pub. L. 104-13.
Copies of the above information collection proposal can be obtained by writing Diana Hynek, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6625, 14th and Constitution, NW., Washington, DC 20230. E-mail:
Written comments and recommendations for the proposed information collection should be sent via e-mail to
The Department of Commerce (DOC) has submitted to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under 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, Office of the Chief Information Officer, 202-482-0266, Department of Commerce, Room 6625, 14th and Constitution Avenue, NW., Washington, DC 20230.
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, e-mail address,
Proposed collection; comment request.
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Pub. L. 104-13 (44 U.S.C. 3506(c)(2)(A)).
Written comments must be submitted on or before December 21, 2004.
Direct all written comments to Diana Hynek, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6625, 14th and Constitution Avenue, NW., Washington, DC 20230 (or via the Internet at
Requests for additional information or copies of the information collection instrument(s) and instructions should be directed to Nancy Piesto, U.S. Census Bureau, Room 2632-FOB 3, Washington, DC 20223-6500, at (301) 763-2747.
The Monthly Wholesale Trade Survey provides the only continuous measure of monthly sales, end-of-month inventories, method of inventory valuation, and inventories/sales ratios in the United States by selected kinds of business for merchant wholesalers. The Bureau of Economic Analysis (BEA) uses this information to improve the inventory valuation adjustments applied to estimates of the Gross Domestic Product (GDP). The Bureau of Labor
Estimates produced from the Monthly Wholesale Trade Survey are based on a probability sample and are published on the North American Industry Classification System (NAICS) basis. The sample design consists of small, medium, and large cases requested to report sales and inventories each month. The sample, consisting of about 4,000 wholesale businesses, is drawn from the Business Register, which contains all Employer Identification Numbers (EINs) and listed establishment locations. The sample is updated quarterly to reflect employer business “births” and “deaths”; adding new employer businesses identified in the Business and Professional Classification Survey and deleting firms and EINs when it is determined they are no longer active.
The Monthly Wholesale Trade Survey will continue to generate its monthly report form through a print-on demand system. This system allows us to tailor the survey instrument to a specific industry. For example, it will print an additional instruction for a particular NAICS code. This system also reduces the time and cost of preparing mailout packages that contain unique variable data, while improving the look and quality of the products being produced.
We collect this information by mail, fax, and telephone follow-up.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information on respondents, including through the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
Import Administration, International Trade Administration, Department of Commerce.
Notice of initiation of antidumping and countervailing duty administrative reviews.
The Department of Commerce (the Department) has received requests to conduct administrative reviews of various antidumping and countervailing duty orders and findings with September anniversary dates. In accordance with the Department's regulations, we are initiating those administrative reviews.
October 22, 2004.
Holly A. Kuga, Office of AD/CVD Enforcement, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW., Washington, DC 20230, telephone: (202) 482-4737.
The Department has received timely requests, in accordance with 19 CFR 351.213(b) (2002), for administrative reviews of various antidumping and countervailing duty orders and findings with September anniversary dates.
In accordance with sections 19 CFR 351.221(c)(1)(i), we are initiating administrative reviews of the following antidumping and countervailing duty orders and findings. We intend to issue the final results of these reviews not later than September 30, 2005.
None.
None.
During any administrative review covering all or part of a period falling between the first and second or third and fourth anniversary of the publication of an antidumping duty order under section 351.211 or a determination under section 351.218(f)(4) to continue an order or suspended investigation (after sunset review), the Secretary, if requested by a domestic interested party within 30 days of the date of publication of the notice of initiation of the review, will determine, consistent with
Interested parties must submit applications for disclosure under administrative protective orders in accordance with 19 CFR 351.305.
These initiations and this notice are in accordance with section 751(a) of the Tariff Act of 1930, as amended (19 U.S.C. 1675(a)) and 19 CFR 351.221(c)(1)(I).
Import Administration, International Trade Administration, Department of Commerce.
Notice of amended final results of antidumping duty administrative reviews.
On April 26, 2004, and May 4, 2004, the United States Court of Appeals for the Federal Circuit dismissed appeals and lifted the stay of proceedings against the United States Court of International Trade's affirmations of the Department of Commerce's final remand results affecting final assessment rates for the administrative reviews of the antidumping duty orders on antifriction bearings (other than tapered roller bearings) and parts thereof from Italy, Sweden, and the United Kingdom for the period of review May 1, 1995, through April 30, 1996, and from France, Germany, Italy, and Sweden for the period of review May 1, 1997, through April 30, 1998, respectively. The classes or kinds of merchandise covered by these reviews are ball bearings and parts thereof, cylindrical roller bearings and parts thereof, and spherical plain bearings and parts thereof. As there are now final and conclusive court decisions in these actions, we are amending our final results of reviews and we will instruct U.S. Customs and Border Protection to liquidate entries subject to these reviews.
October 22, 2004.
Yang Jin Chun or Richard Rimlinger, AD/CVD Operations, Office 5, Import Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW, Washington, DC 20230; telephone: (202) 482-5760 or (202) 482-4477, respectively.
On October 17, 1997, the Department of Commerce (the Department) published
In
As there are now final and conclusive court decisions with respect to companies affected by these remand orders directly, we are amending our final results of review for these companies and we will subsequently instruct U.S. Customs and Border Protection (CBP) to liquidate the relevant entries subject to these reviews.
In
On October 11, 2000, the Department filed its Remand Results with the CIT. On May 24, 2002, the U.S. Court of Appeals for the Federal Circuit (CAFC) remanded for further explanation the Department's use of different definitions of “foreign like product” in its normal value calculations; the CAFC affirmed the CIT's decision with respect to duty absorption. See
In
On August 23, 2000, the Department filed its Remand Results with the CIT. On November 17, 2000, the CIT affirmed the Department's Remand Results in their entirety. See
In
On October 20, 2000, the Department filed its Remand Results with the CIT. On February 23, 2001, the CIT in
In
The Department filed its Remand Results for
The CIT's remand affirmations in
The remands for
Accordingly, the Department will determine and CBP will assess appropriate antidumping duties on entries of the subject merchandise produced by the affected companies. Individual differences between U.S. price and foreign market value may vary from the percentages published. The Department has disclosed or will disclose assessment instructions to the parties in advance. The Department will issue assessment instructions to CBP within 15 days of publication of these amended final results of reviews.
The CIT remanded
We are issuing and publishing these determinations in accordance with sections 751(a)(1) and 777(i)(1) of the Tariff Act of 1930, as amended.
Import Administration, International Trade Administration, Department of Commerce.
On August 24, 2004, the United States Court of International Trade issued an amendment to its order, clarifying a June 29, 2004, decision regarding liquidation of entries of bulk aspirin from the People's Republic of China. Consistent with the decision of the United States Court of Appeals for the Federal Circuit in
Effective October 22, 2004.
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.
On June 29, 2004, the United States Court of International Trade (“CIT”) issued its decision to invalidate certain sets of liquidation instructions issued by the Department of Commerce (“the Department”) in the antidumping proceeding covering entries of bulk aspirin from the People's Republic of China (“PRC”).
Pursuant to
On August 24, 2004, the CIT issued an amendment to its order to clarify that entries of bulk aspirin that (1) were manufactured and exported to the United States by Jilin Henghe Pharmaceutical Co. Ltd. (“Jilin”) and imported by Jilin Pharmaceutical USA (“Jilin USA”); and (2) were entered, or withdrawn from warehouse, for consumption during the time period of July 1, 2002, through September 29, 2002, or entered pursuant to Customs number D09-0929517-8, shall be liquidated in accordance with the Court's decision in
In its decision in
This notice will serve to continue the suspension of liquidation pending a final decision by the Federal Circuit. The Department will instruct Customs and Border Protection to continue to
Import Administration, International Trade Administration, Department of Commerce.
The Department of Commerce is extending the time limit for the final results of the administrative review of the antidumping duty order on gray portland cement and clinker from Mexico until December 20, 2004. This extension applies to one manufacturer/exporter, CEMEX, S.A. de C.V., and its affiliate, GCC Cemento, S.A. de C.V. The period of review is August 1, 2002, through July 31, 2003.
Effective October 24, 2004.
Jeffrey Frank or Hermes Pinilla, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW., Washington, DC 20230; telephone: (202) 482-0090 and (202) 482-3477, respectively.
On September 30, 2003, the Department of Commerce (the Department) published in the
Section 751(a)(3)(A) of the Tariff Act of 1930, as amended (the Act), requires the Department to issue the final results of an antidumping duty administrative review within 120 days of the date on which the preliminary results are published. Currently, the due date for the final results is October 20, 2004. The Act also provides that the Department may extend the 120-day period to 180 days, if it determines that it is not practicable to complete the review within the foregoing time period.
This review involves complex factual and legal issues regarding sales of a new type of cement, and the Department needs additional time to consider the issue. For this reason, the Department has determined that it is not practicable to complete the final results within the time limit mandated by section 751(a)(3)(A) of the Act. Therefore, in accordance with that section, the Department is extending the time limit for completion of the final results by 60 days.
The final results of review are now due no later than December 20, 2004. This extension of the time limit is in accordance with section 751(a)(3)(A) of the Act.
Notice of application.
Export Trading Company Affairs, International Trade Administration, Department of Commerce, has received an application for an Export Trade Certificate of Review. This notice summarizes the conduct for which certification is sought and requests comments relevant to whether the Certificate should be issued.
Jeffrey Anspacher, Director, Export Trading Company Affairs, International Trade Administration, by telephone at (202) 482-5131 (this is not a toll-free number) or e-mail at
Title III of the Export Trading Company Act of 1982 (15 U.S.C. 4001-21) authorizes the Secretary of Commerce to issue Export Trade Certificates of Review. An Export Trade Certificate of Review protects the holder and the members identified in the Certificate from state and federal government antitrust actions and from private treble damage antitrust actions for the export conduct specified in the Certificate and carried out in compliance with its terms and conditions. Section 302(b)(1) of the Export Trading Company Act of 1982 and 15 CFR 325.6(a) require the Secretary to publish a notice in the
Interested parties may submit written comments relevant to the determination whether a Certificate should be issued. If the comments include any privileged or confidential business information, it must be marked clearly and a nonconfidential version of the comments (identified as such) should be included. Any comments not marked privileged or confidential business information will be deemed to be nonconfidential. An original and five (5) copies, plus two (2) copies of the nonconfidential version, should be submitted no later than 20 days after the date of this notice to: Export Trading Company Affairs, International Trade Administration, U.S. Department of Commerce, Room 1104H, Washington, DC 20230. Information submitted by any person is exempt from disclosure under the Freedom of Information Act (5 U.S.C. 552). However, nonconfidential versions of the comments will be made available to the applicant if necessary for determining whether or not to issue the Certificate. Comments should refer to this application as “Export Trade Certificate of Review, application number 04-00004.” A summary of the application follows.
AmRus Ventures, Inc. seeks a Certificate to cover the following specific Export Trade, Export Markets, and Export Trade Activities and Methods of Operations.
All products.
All services.
Technology Rights, including, but not limited to, patents, trademarks, copyrights and trade secrets that relate to Products and Services.
Export Trade Facilitation Services, including, but not limited to, professional services and assistance relating to: Government relations; state and federal export programs; foreign trade and business protocol; consulting; market research and analysis; collection of information on trade opportunities; marketing; negotiations; joint ventures; shipping and export management; export licensing; advertising; documentation and services related to compliance with customs requirements; insurance and financing; trade show exhibitions; organizational development; management and labor strategies; transfer of technology; transportation services; and the formation of shippers' associations.
The Export Markets include all parts of the world except the United States (the fifty states of the United States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, American Samoa, Guam, the Commonwealth of the Northern Mariana Islands, and the Trust Territory of the Pacific Islands).
AmRus Ventures, Inc. may:
1. Provide and/or arrange for the provision of Export Trade Facilitation Services;
2. Engage in promotion and marketing activities and collect information on trade opportunities in the Export Markets and distribute such information to clients;
3. Enter into exclusive and/or non-exclusive licensing and/or sales agreements with Suppliers for the export of Products, Services, and/or Technology Rights in the Export Markets;
4. Enter into exclusive or non-exclusive agreements with distributors and/or sales representatives in Export Markets;
5. Allocate export sales or divide the Export Markets among Suppliers for the sale and/or licensing of Products, Services, and/or Technology Rights;
6. Allocate export orders among Suppliers;
7. Establish the price of Products, Services, and/or Technology Rights for sale and/or licensing in the Export Markets;
8. Negotiate, enter into, and/or manage licensing agreements for the export of Technology Rights;
9. Enter into contracts for shipping; and
10. Exchange information on a one-to-one basis with individual Suppliers regarding inventories and near-term production schedules for the purpose of determining the availability of Products for export and coordinating export with distributors.
1. “Supplier” means a person who produces, provides, or sells Products, Service and/or Technology Rights.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Receipt of application.
Notice is hereby given that Dr. Colleen Reichmuth Kastak, Long Marine Laboratory, Institute of Marine Science, University of California at Santa Cruz, 100 Schaffer Road, Santa Cruz, CA 95060, has applied in due form for a permit to conduct research on captive pinnipeds.
Written, telefaxed, or e-mail comments must be received on or before November 22, 2004.
The application and related documents are available for review upon written request or by appointment in the following office(s):
Permits, Conservation and Education Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301)713-2289; fax (301)713-0376; and
Southwest Region, NMFS, 501 West Ocean Blvd., Suite 4200, Long Beach, CA 90802-4213; phone (562)980-4001; fax (562)980-4018.
Written comments or requests for a public hearing on this application should be mailed to the Chief, Permits, Conservation and Education Division, F/PR1, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910. Those individuals requesting a hearing should set forth the specific reasons why a hearing on this particular request would be appropriate.
Comments may also be submitted by facsimile at (301)713-0376, provided the facsimile is confirmed by hard copy submitted by mail and postmarked no later than the closing date of the comment period.
Comments may also be submitted by e-mail. The mailbox address for providing email comments is
Amy Sloan or Tammy Adams, (301)713-2289.
The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361
The proposed research involves a continuation of studies designed to evaluate hearing and visual sensitivity, memory, and learning capabilities of up to seven captive pinnipeds (three California sea lions,
Concurrent with the publication of this notice in the
Department of Defense, DoD.
Notice of Advisory Committee Meeting.
The Defense Business Board (DBB) will meet in open session on Wednesday, November 17, 2004, at the Pentagon, Washington, DC from 1000 until 1145. The mission of the DBB is to advise the Senior Executive Council (SEC) and the Secretary of Defense on effective strategies for implementation of best business practices of interest to the Department of Defense. At this meeting, the Board's Acquisition, Human Resources, and Financial Management related task groups will deliberate on their preliminary findings and recommendations related to tasks assigned earlier this year.
Wednesday, November 17, 2004, 1000 to 1145 hrs.
Members of the public who wish to attend the meeting must contact the Defense Business Board no later than Wednesday, November 10th for further information about admission as seating is limited. Additionally, those who wish to make oral comments or deliver written comments should also request to be scheduled, and submit a written text of the comments by Wednesday, November 10th to allow time for distribution to the Board members prior to the meeting. Individual oral comments will be limited to five minutes, with the total oral comment period not exceeding thirty minutes.
The DBB may be contacted at: Defense Business Board, 1100 Defense Pentagon, room 2E314, Washington, DC 20301-1100, via e-mail at
Deputy Chief of Staff, G-1 (DAPE-TT), DOD.
Notice.
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Department of the Army announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
Consideration will be given to all comments received by December 21, 2004.
Written comments and recommendations on the proposed information collection should be sent to the Department of the Army, U.S. Military Academy, Institutional Research & Analysis, Office of Policy, Planning & Analysis, ATTN: (Dr. William Burke), West Point, New York 10966-5000. Consideration will be given to all comments received within 60 days of the date of publication of this notice.
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the above address, or call Department of the Army Reports clearance officer at (703) 325-8433.
The information will be collected via seven surveys, each with content appropriate to graduates of engineering and engineering related courses of study at the U.S. Military Academy. The surveys will go to graduates currently serving as officers in the U.S. Army and to graduates not currently serving. Respondents will be allowed to choose between completing a mailed survey or an Internet-based survey.
Department of the Army, U.S. Army Corps of Engineers, DoD.
Notice; amendment.
The Fort Worth District, U.S. Army Corps of Engineers hereby announces its intent to modify the study area to be evaluated during the preparation of a Draft Environmental Impact Statement (DEIS) for the potential multipurpose projects for ecosystem restoration, flood damage reduction, and recreation development within and along the portion of the Trinity River located in Forth Worth, Tarrant County, TX, as published in the
A resolution by the United States Senate Committee on Environment and Public Works dated April 22, 1988, requested that the Board of Engineers review the report of the Chief of Engineers on the Trinity River and Tributaries, Texas, House Document No. 276, Eighty-Ninth Congress, and other pertinent reports, with a view to determining the advisability of modifying the recommendations contained therein, with particular reference to providing improvements in the interest of flood protection, environmental enhancement, water quality, recreation, and other allied purposes in the Upper Trinity River Basin with specific attention on the Dallas-Fort Worth Metroplex. An initial assessment based on the resolution guidance indicates a Federal interest in continuing with more detailed studies for these purposes and in accordance with the National Environmental Policy Act (NEPA), the public was informed in October 2002 of the intent to prepare a DEIS. The notice identified a study area that was bound by Interstate Highway 30 on the Clear Fork, Rockwood Park on the upstream end of the West Fork, Northeast 28th Street on Marine Creek, a tributary of the West Fork, and Riverside Drive on the downstream end of the West Fork.
A public scoping and project studies have progressed, it has been determined that the study area for consideration of project purposes should be expanded further upstream of Rockwood Park on the West Fork of the Trinity River to include the additional area between Rockwood Park and U. S. Highway 183 (approximately 793 acres). Studies of the expanded area will concentrate on identifying new plans to evaluate flood damage reduction potential and/or prevent future damages through establishing hydraulic and hydrologic mitigation through new and creative methodologies that reduce environmental impact and provide for improved aesthetic properties. Expansion of the study area also provides opportunities for ecosystem restoration, including increased connectivity of existing high resource value environmental and recreational opportunities between isolated natural resource bases along the study area.
Dr. Rebecca Griffith, CESWF-PER-P, U.S. Army Corps of Engineers, Fort Worth District, P.O. Box 17300, 819 Taylor Street, Fort Worth, TX 76102-0300, phone (817) 886-1820, fax (817) 886-6498.
No additional public meetings have been scheduled as a result of the decision to expand the study area, as public participation during the process was a factor in determining to expand the study area. However, all affected Federal, state, and local agencies, affected Indian tribes, and other interested private organizations and parties are hereby invited to provide scoping comments that should be considered during the remainder of the feasibility study. The public will be given the opportunity to review the DEIS during the 45-day public comment period. Prior to the close of the comment period, any person may make a written request for a public meeting, setting forth the particular reasons for the request. The District Engineer will then determine whether the issues raised are substantial and should be considered in his decision. If a public meeting is warranted, all known interested parties will be notified of the time, date, and location of such a meeting in the local news media. Release of the DEIS for public comment is scheduled for March 2005. The exact release date, once established, will be announced in the local news media.
Department of Education.
The Leader, Information Management Case Services Team, Regulatory Information Management Services, Office of the Chief Information Officer, invites comments on the proposed information collection requests as required by the Paperwork Reduction Act of 1995.
An emergency review has been requested in accordance with the Act (44 U.S.C. Chapter 3507(j)), since public harm is reasonably likely to result if normal clearance procedures are followed. Approval by the Office of Management and Budget (OMB) has been requested by November 10. A regular clearance process is also beginning. Interested persons are invited to submit comments on or before December 31, 2004.
Written comments regarding the emergency review should be addressed to the Office of Information and Regulatory Affairs, Attention: Carolyn Lovett, Desk Officer, Department of Education, Office of Management and Budget; 725 17th Street, NW., Room 10235, New Executive Office Building, Washington, DC 20503 or faxed to (202) 395-6974.
Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that the Director of OMB provide interested Federal agencies and the public an early opportunity to comment on information collection requests. The Office of Management and Budget (OMB) may amend or waive the requirement for public consultation to the extent that public participation in the approval process would defeat the purpose of the information collection, violate State or Federal law, or substantially interfere with any agency's ability to perform its statutory obligations. The Leader, Information Management Case Services Team, Information Management Services, Office of the Chief Information Officer, publishes this notice containing proposed information collection requests at the beginning of the Departmental review of the information collection. Each proposed information collection, grouped by office, contains the following: (1) Type of review requested,
The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on respondents, including through the use of information technology.
Requests for copies of the proposed information collection request may be accessed from
Comments regarding burden and/or the collection activity requirements, contact Kathy Axt at her e-mail address
Department of Education.
Notice of proposed information collection requests.
The Leader, Information Management Case Services Team, Regulatory Information Management Services, Office of the Chief Information Officer, invites comments on the proposed information collection requests as required by the Paperwork Reduction Act of 1995.
An emergency review has been requested in accordance with the Act (44 U.S.C. Chapter 3507 (j)), since public harm is reasonably likely to result if normal clearance procedures are followed. Approval by the Office of Management and Budget (OMB) has been requested by November 1, 2004. A regular clearance process is also beginning. Interested persons are invited to submit comments on or before December 21, 2004.
Written comments regarding the emergency review should be addressed to the Office of Information and Regulatory Affairs, Attention: Carolyn Lovett, Desk Officer, Department of Education, Office of Management and Budget; 725 17th Street, NW., Room 10235, New Executive Office Building, Washington, DC 20503 or faxed to (202) 395-6974.
Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that the Director of OMB provide interested Federal agencies and the public an early opportunity to comment on information collection requests. The Office of Management and Budget (OMB) may amend or waive the requirement for public consultation to the extent that public participation in the approval process would defeat the purpose of the information collection, violate State or Federal law, or substantially interfere with any agency's ability to perform its statutory obligations. The Leader, Information Management Case Services Team, Office of the Chief Information Officer, publishes this notice containing proposed information collection requests at the beginning of the Departmental review of the information collection. Each proposed information collection, grouped by office, contains the following: (1) Type of review requested,
The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on respondents, including through the use of information technology.
Requests for copies of the proposed information collection request may be accessed from
Comments regarding burden and/or the collection activity requirements, contact Kathy Axt at her e-mail address
Federal Student Aid, Department of Education.
Notice of interest rates for the Federal Family Education Loan Program for the period July 1, 2004 through June 30, 2005.
The Chief Operating Officer for Federal Student Aid announces the interest rates for loans made under the Federal Family Education Loan (FFEL) Program for the period July 1, 2004 through June 30, 2005.
Don Watson, U.S. Department of Education, room 114I2, UCP, 400 Maryland Avenue, SW., Washington, DC 20202-5400. Telephone: (202) 377-4008.
If you use a telecommunications device for the deaf (TDD), you may call the Federal Information Relay Service (FIRS) at 1-800-877-8339.
Individuals with disabilities may obtain this document in an alternative format (
Under title IV, part B of the Higher Education Act of 1965, as amended (HEA), 20 U.S.C.1071,
The formulas for determining the interest on variable rate FFEL Program loans are established in section 427A of the HEA (20 U.S.C. 1077a).
The interest rates on variable-rate loans are determined annually and apply to the following 12-month period beginning July 1 and ending June 30.
As described below, interest rate caps apply to most FFEL Program loans.
FFEL interest rate formulas use the bond equivalent rate of 91-day Treasury bills auctioned at the final auction held before June 1 of each year plus a statutorily established add-on to determine the variable interest rate for—
• FFEL fixed-rate Stafford loans first disbursed before October 1, 1992 that have been converted to variable-rate loans;
• All FFEL Subsidized and Unsubsidized Stafford Loans first disbursed on or after October 1, 1992;
• FFEL PLUS loans first disbursed on or after July 1, 1998; and
• FFEL Consolidation Loans for which the Consolidation Loan application was received by the lender on or after November 13, 1997 and before October 1, 1998.
The bond equivalent rate of the 91-day Treasury bills auctioned on May 24, 2004, which is used to calculate the interest rates for the one-year period beginning on July 1, 2004, is 1.066 percent, which is rounded to 1.07 percent.
For FFEL PLUS loans first disbursed before July 1, 1998, interest rates are calculated based on the weekly average of a 1-year constant maturity Treasury yield, as published by the Board of Governors of the Federal Reserve System, for the last calendar week ending on or before June 26.
The weekly average of the 1-year constant maturity Treasury yield for the last calendar week ending on or before June 26, 2004 is 2.16 percent.
1. Under section 427A(i)(7) of the HEA (20 U.S.C. 1077a (i)(7)) loans that were originally made with a fixed interest rate of eight percent with an increase to ten percent four years after commencement of the repayment period were converted to a variable interest rate that may not exceed 10 percent: The interest rate for these loans for the
2. Loans with fixed interest rates of seven percent, eight percent, nine percent, or eight percent with an increase to ten percent four years after commencement of the repayment period, that were subject to the provisions of section 427A(i)(3) of the HEA (20 U.S.C. 1077a(i)(3)) and were converted to variable-rate loans—the interest rate may not exceed seven percent, eight percent, nine percent, or ten percent, respectively: The interest rate for the period from July 1, 2004, through June 30, 2005, is 4.17 percent (1.07 percent plus 3.1 percent equals 4.17 percent).
1. FFEL Stafford loans made to “new” borrowers for which the first disbursement was made (a) on or after October 1, 1992, but before July 1, 1994, or (b) on or after July 1, 1994, for a period of enrollment ending before July 1, 1994 (
2. FFEL Stafford loans made to all borrowers, regardless of prior borrowing, for periods of enrollment that include or begin on or after July 1, 1994, for which the first disbursement was made on or after July 1, 1994, but before July 1, 1995—the interest rate may not exceed 8.25 percent: The interest rate for the period from July 1, 2004, through June 30, 2005, is 4.17 percent (1.07 percent plus 3.1 percent equals 4.17 percent).
3. FFEL Stafford loans made to all borrowers, regardless of prior borrowing, on or after July 1, 1995, but before July 1, 1998—the interest rate may not exceed 8.25 percent:
(a) During the in-school, grace, or deferment period: The interest rate for the period from July 1, 2004, through June 30, 2005, is 3.57 percent (1.07 percent plus 2.5 percent equals 3.57 percent); and
(b) During all other periods: The interest rate for the period from July 1, 2004, through June 30, 2005, is 4.17 percent (1.07 percent plus 3.1 percent equals 4.17 percent).
4. FFEL Stafford loans, first disbursed on or after July 1, 1998, but before July 1, 2005—the interest rate may not exceed 8.25 percent:
(a) During the in-school, grace, and deferment periods: The interest rate for the period from July 1, 2004, through June 30, 2005, is 2.77 percent (1.07 percent plus 1.7 percent equals 2.77 percent); and
(b) During all other periods: The interest rate for the period from July 1, 2004, through June 30, 2005, is 3.37 percent (1.07 percent plus 2.3 percent equals 3.37 percent).
1. Variable-rate FFEL PLUS and FFEL SLS loans first disbursed before October 1, 1992—the interest rate may not exceed 12 percent: The interest rate for the period from July 1, 2004, through June 30, 2005, is 5.41 percent (2.16 percent plus 3.25 percent equals 5.41 percent).
2. FFEL SLS loans first disbursed on or after October 1, 1992, for a period of enrollment beginning before July 1, 1994—the interest rate may not exceed 11 percent: The interest rate for the period from July 1, 2004, through June 30, 2005, is 5.26 percent (2.16 percent plus 3.1 percent equals 5.26 percent).
3. FFEL PLUS loans first disbursed on or after October 1, 1992, but before July 1, 1994—the interest rate may not exceed 10 percent: The interest rate for the period from July 1, 2004, through June 30, 2005, is 5.26 percent (2.16 percent plus 3.1 percent equals 5.26 percent).
4. FFEL PLUS loans first disbursed on or after July 1, 1994, but prior to July 1, 1998—the interest rate may not exceed 9 percent: The interest rate for the period from July 1, 2004, through June 30, 2005, is 5.26 percent (2.16 percent plus 3.1 percent equals 5.26 percent).
5. FFEL PLUS loans first disbursed on or after July 1, 1998, and before July 1, 2005—the interest rate may not exceed 9 percent: The interest rate for the period from July 1, 2004, through June 30, 2005, is 4.17 percent (1.07 percent plus 3.1 percent equals 4.17 percent).
1. FFEL Consolidation loans for which the consolidation loan was made by the lender before July 1, 1994—the interest rate is the weighted average of the interest rates on the loans consolidated, rounded to the nearest whole percent, but may not be less than 9 percent.
2. FFEL Consolidation loans for which the consolidation loan was made by the lender on or after July 1, 1994, and before November 13, 1997—the interest rate is the weighted average of the interest rates on the loans consolidated, rounded to the nearest whole percent.
3. FFEL Consolidation loans for which the consolidation loan application was received by the lender on or after November 13, 1997, and before October 1, 1998—the interest rate may not exceed 8.25 percent: The interest rate for the period from July 1, 2004, through June 30, 2005, is 4.17 percent (1.07 percent plus 3.1 percent equals 4.17 percent).
4. FFEL Consolidation loans for which the consolidation loan application was received by the lender on or after October 1, 1998, and before July 1, 2005—the interest rate may not exceed 8.25 percent: The interest rate is the weighted average of the interest rates on the loans consolidated, rounded to the nearest higher
5. If a portion of a Consolidation loan is attributable to a loan made under subpart I of part A of title VII of the Public Health Service Act, the maximum interest rate for that portion of a Consolidation loan is determined annually, for each 12-month period beginning on July 1 and ending on June 30. The interest rate equals the average of the bond equivalent rates of the 91-day Treasury bills auctioned for the quarter ending prior to July 1, plus 3 percent. For the quarter ending prior to July 1, 2003, the average 91-day Treasury bill rate was 1.119 percent (rounded to 1.12 percent). The maximum interest rate for the period from July 1, 2004, through June 30, 2005, is 4.12 percent, which is rounded (1.12 percent plus 3.0 percent equals 4.12 percent).
You may review this document, as well as all other documents of this Department published in the
To use PDF you must have Adobe Acrobat Reader, which is available free at this site. If you have questions about using PDF, call the U.S. Government Printing Office (GPO), toll free at 1-888-293-6498; or in the Washington, DC area at (202) 512-1530.
The official version of this document is the document published in the
Department of Education.
Correction.
On September 23, 2004, a notice inviting applications for new awards under the Office of Postsecondary Education; International Research and Studies Program was published in the
Mr. Jose L. Martinez, U.S. Department of Education, 1990 K Street, NW., Room 6010, Washington, DC 20006-8521. Telephone: (202) 502-7635 or by e-mail:
If you use a telecommunications device for the deaf (TDD), you may call the Federal Information Relay Service (FIRS) at 1-800-877-8339.
Individuals with disabilities may obtain this document in an alternative format (
To use PDF you must have Adobe Acrobat Reader, which is available free at this site. If you have questions about using PDF, call the U.S. Government Printing Office (GPO), toll free, at 1-888-293-6498; or in the Washington, DC, area at (202) 512-1530.
The official version of this document is the document published in the
Notice of meeting.
This notice provides the schedule and a summary of the agenda for an upcoming meeting of the National Board of the Fund for the Improvement of Postsecondary Education (Board). The notice also describes the functions of the Board. Notice of this meeting is required by section 10(a)(2) of the Federal Advisory Committee Act.
November 4, 2004, 12:30 to 4:30 p.m.
Renaissance Washington, DC Hotel, 999 Ninth Street, NW., Washington, DC 20001. Telephone: (202) 898-9000.
Donald Fischer, U.S. Department of Education, 1990 K Street, NW., Washington, DC 20006-8544; telephone (202) 502-7500; e-mail
The meeting site is accessible to individuals with disabilities. An individual with a disability who will need an auxiliary aid or service to participate in the meeting (
The National Board of the Fund for the Improvement of Postsecondary Education is established under section 742 of the Higher Education Act of 1965 (20 U.S.C. 1138a). The Board is authorized to advise the Director of the Fund and the Assistant Secretary for Postsecondary Education on (1) priorities for the improvement of postsecondary education, including recommendations for the improvement of postsecondary education and for the evaluation, dissemination, and adaptation of demonstrated improvements in postsecondary educational practice; and (2) the operation of the Fund, including advice on planning documents, guidelines, and procedures for grant competitions prepared by the Fund.
On Thursday, November 4, 2004, from 12:30 to 4:30 p.m., the Board will meet in open session. The proposed agenda for the meeting will include discussions of the Fund's programs and special initiatives. A special presentation will be made on a U.S.-Brazil Consortia Program project.
Records are kept of all Board proceedings and are available for public inspection at the office of the Fund for the Improvement of Postsecondary Education, 6th Floor, 1990 K Street, NW., Washington, DC 20006-8544 from the hours of 8 a.m. to 4:30 p.m.
Federal Student Aid, Department of Education.
Notice of interest rates for the William D. Ford Federal Direct Loan Program for the period July 1, 2004 through June 30, 2005.
The Chief Operating Officer for Federal Student Aid announces the interest rates for loans made under the William D. Ford Federal Direct Loan (Direct Loan) Program for the period July 1, 2004 through June 30, 2005.
Don Watson, U.S. Department of Education, room 114I2, UCP, 400 Maryland Avenue, SW., Washington, DC 20202-5400. Telephone: (202) 377-4008.
If you use a telecommunications device for the deaf (TDD), you may call the Federal Information Relay Service (FIRS) at 1-800-877-8339.
Individuals with disabilities may obtain this document in an alternative format (
Section 455(b) of the Higher Education Act of 1965, as amended (HEA), 20 U.S.C. 1087e(b), provides
The Direct Loan Program includes loans with variable interest rates and loans with fixed interest rates. Most loans made under the Direct Loan Program have variable interest rates that change each year. The variable interest rate formula that applies to a particular loan depends on the date of the first disbursement of the loan. The variable rates are determined annually and are effective for each 12-month period beginning July 1 of one-year and ending June 30 of the following year.
In the case of some Direct Consolidation Loans, the interest rate is determined by the date on which the Direct Consolidation Loan application was received. Direct Consolidation Loans for which the application was received on or after February 1, 1999 have a fixed interest rate based on the weighted average of the loans that are consolidated rounded up to the nearest higher
Pursuant to section 455(b) of the HEA, 20 U.S.C. § 1087e(b), the Direct Loan interest rate formulas use the bond equivalent rates of the 91-day Treasury bills at the final auction held before June 1 of each year plus a statutory add-on percentage to determine the variable interest rate for all Direct Subsidized Loans and Direct Unsubsidized Loans; Direct Consolidation Loans for which the application was received on or after July 1, 1998 and before February 1, 1999; and Direct PLUS Loans disbursed on or after July 1, 1998.
The bond equivalent rate of the 91-day Treasury bills auctioned on May 24, 2004, which is used to calculate the interest rates on these loans, is 1.066 percent, which is rounded to 1.07 percent.
In addition, pursuant to section 455(b) of the HEA, 20 U.S.C. 1087e(b), as amended by Public Law 106-554, the Consolidated Appropriations Act 2001, the interest rate for Direct PLUS Loans that were disbursed on or after July 1, 1994 and on or before July 1, 1998, is calculated based on the weekly average of a 1-year constant maturity Treasury yield, as published by the Board of Governors of the Federal Reserve System, for the last calendar week ending on or before June 26 plus a statutory add-on percentage.
The last calendar week ending on or before June 26 2004, began on June 20, 2004 and ended on June 26, 2004. On June 25, 2004, the Board of Governors of the Federal Reserve System published the 1-year constant maturity Treasury yield average as 2.16 percent.
Below is specific information on the calculation of the interest rates for the Direct Loan Program. This information is listed in order by the date a loan was first disbursed or by the date that the Consolidation Application was received.
In addition, a summary of the interest rates that are effective for the period July 1, 2004 through June 30, 2005, is included on charts at the end of this notice. These charts are organized by loan type. In each chart, the interest rates are arranged by the date a loan was first disbursed or by the date that the consolidation application was received.
The interest rate for Direct Subsidized Loans, Direct Unsubsidized Loans, and Direct Subsidized and Unsubsidized Consolidation Loans is the bond equivalent rate of the 91-day Treasury bills auctioned at the final auction held before June 1 plus 3.1 percent. These interest rates may not exceed 8.25 percent during any period. From July 1, 2004, to June 30, 2005, the interest rate for Direct Subsidized Loans, Direct Unsubsidized Loans and Direct Subsidized and Unsubsidized Consolidation Loans that were first disbursed on or after July 1, 1994, and before July 1, 1995, is 4.17 percent during all periods.
The interest rate for Direct PLUS Loans and Direct PLUS Consolidation Loans is the weekly average of a 1-year constant maturity Treasury yield, as published by the Board of Governors of the Federal Reserve System, for the last calendar week ending on or before June 26 plus 3.1 percent. These interest rates may not exceed 9.0 percent during any period. From July 1, 2004, to June 30, 2005, the interest rate for Direct PLUS Loans and Direct PLUS Consolidation Loans that were first disbursed on or after July 1, 1994 and before July 1, 1995, is 5.26 percent for all periods.
The interest rate for Direct Subsidized Loans, Direct Unsubsidized Loans, and Direct Subsidized and Unsubsidized Consolidation Loans is the bond equivalent rate of the 91-day Treasury bills auctioned at the final auction held before June 1 plus 3.1 percent. However, during in-school, grace, and deferment periods, the interest rate formula is the bond equivalent rate of the 91-day Treasury bills auctioned at the final auction held before June 1 plus 2.5 percent. These interest rates may not exceed 8.25 percent during any period. From July 1, 2004, to June 30, 2005, the interest rate for Direct Subsidized Loans, Direct Unsubsidized Loans and Direct Subsidized and Unsubsidized Consolidation Loans that were first disbursed on or after July 1, 1995, and before July 1, 1998, is 3.57 percent during in-school, grace, and deferment periods and 4.17 percent during all other periods.
The interest rate for Direct PLUS Loans and Direct PLUS Consolidation Loans is the weekly average of a 1-year constant maturity Treasury yield, as published by the Board of Governors of the Federal Reserve System, for the last calendar week ending on or before June 26 plus 3.1 percent. These interest rates may not exceed 9.0 percent during any period. From July 1, 2004, to June 30, 2005, the interest rate for Direct PLUS Loans and Direct PLUS Consolidation Loans that were first disbursed on or after July 1, 1995 and before July 1, 1998, is 5.26 percent during all periods.
The interest rate for Direct Subsidized Loans, Direct Unsubsidized Loans, and Direct Subsidized and Unsubsidized Consolidation Loans is the bond equivalent rate of the 91-day Treasury bills auctioned at the final auction held before June 1 plus 2.3 percent. However, during in-school, grace, and deferment periods, the interest rate formula is the bond equivalent rate of the 91-day Treasury bills auctioned at the final auction held before June 1 plus 1.7 percent. These interest rates may not exceed 8.25 percent during any period. From July 1, 2004, to June 30, 2005, the interest rate for Direct Subsidized Loans, Direct Unsubsidized Loans, and Direct Subsidized and Unsubsidized Consolidation Loans that were first disbursed on or after July 1, 1998 and before October 1, 1998, is 2.77 percent during in-school, grace, and deferment periods and 3.37 percent during all other periods.
The interest rate for Direct PLUS Loans and Direct PLUS Consolidation Loans is the bond equivalent rate of the 91-day Treasury bills auctioned at the final auction held before June 1 plus 3.1 percent. These interest rates may not exceed 9.0 percent during any period. From July 1, 2004, to June 30, 2005, the
The interest rate for Direct Subsidized Loans and Direct Unsubsidized Loans is the bond equivalent rate of the 91-day Treasury bills auctioned at the final auction held before June 1 plus 2.3 percent. However, during in-school, grace, and deferment periods, the interest rate formula is the bond equivalent rate of the 91-day Treasury bills plus 1.7 percent. These interest rates may not exceed 8.25 percent during any period. From July 1, 2004, to June 30, 2005, the interest rate for Direct Subsidized Loans and Direct Unsubsidized Loans that were disbursed after July 1, 1998, and before July 1, 2005, is 2.77 percent during in-school, grace, and deferment periods and 3.37 percent during all other periods.
The interest rate for Direct PLUS Loans is the bond equivalent rate of the 91-day Treasury bills auctioned at the final auction held before June 1 plus 3.1 percent. These interest rates may not exceed 9.0 percent during any period. From July 1, 2004, to June 30, 2005, the interest rate for Direct PLUS Loans that were disbursed after July 1, 1998, and before July 1, 2005, is 4.17 percent during all periods.
The interest rate for Direct Subsidized and Unsubsidized Consolidation Loans is the bond equivalent rate of the 91-day Treasury bills auctioned at the final auction held before June 1 plus 2.3 percent. However, during in-school, grace, and deferment periods, the interest rate formula is the bond equivalent rate of the 91-day Treasury bills auctioned at the final auction held before June 1 plus 1.7 percent. These interest rates may not exceed 8.25 percent during any period. From July 1, 2004, to June 30, 2005, the interest rate for Direct Subsidized Loans, Direct Unsubsidized Loans, and Direct Subsidized and Unsubsidized Consolidation Loans that were first disbursed on or after July 1, 1998 and before October 1, 1998, is 2.77 percent during in-school, grace, and deferment periods and 3.37 percent during all other periods.
The interest rate for Direct PLUS Consolidation Loans is the bond equivalent rate of the 91-day Treasury bills auctioned at the final auction held before June 1 plus 3.1 percent. These interest rates may not exceed 9.0 percent during any period. From July 1, 2004, to June 30, 2005, the interest rate for Direct PLUS Loans and Direct PLUS Consolidation Loans that were disbursed on or after July 1, 1998, and before October 1, 1998, is 4.17 percent during all periods.
The interest rate for Direct Consolidation Loans for which the application was received on or after October 1, 1998 and before February 1, 1999 is the bond equivalent rate of the 91-day Treasury bills auctioned at the final auction held before June 1 plus 2.3 percent. These interest rates may not exceed 8.25 percent during any period. From July 1, 2004, to June 30, 2005, the interest rate for Direct Consolidation Loans for which the application was received on or after October 1, 1998 and before February 1, 1999, is 3.37 percent during all periods.
The interest rate for Direct Consolidation Loans for which the application was received on or after February 1, 1999, and before July 1, 2005, is the lesser of 8.25 percent, or the weighted average of the loans consolidated, rounded to the nearest higher 1/8 of one percent.
You may review this document, as well as all other documents of this Department published in the
To use PDF you must have Adobe Acrobat Reader, which is available free at this site. If you have questions about using PDF, call the U.S. Government Printing Office (GPO), toll free at 1-888-293-6498; or in the Washington, DC area at (202) 512-1530.
The official version of this document is the document published in the
Department of Energy.
Notice of open meeting.
This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Savannah River. The Federal Advisory Committee Act (Pub. L. No. 92-463, 86 Stat. 770) requires that public notice of these meetings be announced in the
Monday, November 15, 2004 1 p.m.-5:15 p.m. Tuesday, November 16, 2004 8:30 a.m.-4 p.m.
Augusta Towers Hotel & Conference Center, 2651 Perimeter Parkway, Augusta, GA 30909.
Gerri Flemming, Closure Project Office, Department of Energy Savannah River Operations Office, P.O. Box A, Aiken, SC 29802; Phone: (803) 952-7886.
Department of Energy.
Notice of open meeting.
This notice announces a meeting of the State Energy Advisory Board (STEAB). The Federal Advisory Committee Act (Pub. L. 92-463; 86 Stat. 770), requires that public notice of these meetings be announced in the
November 18, 2004 from 8:30 a.m. to 5 p.m., and November 19, 2004 from 8:30 a.m. to 2 p.m.
Sandia National Laboratories, 1515 Eubank SE., Bldg. 957 Receiving, Mail Stop 1033, Albuquerque, NM 87123.
Gary Burch, Office of Technology Development (EE.20), Energy Efficiency and Renewable Energy (EERE), U.S. Department of Energy, Washington, DC 20585, Telephone 202/586-0081.
Purpose of the Board: To make recommendations to the Assistant Secretary for Energy Efficiency and Renewable Energy regarding goals and objectives, programmatic and administrative policies, and to otherwise carry out the Board's responsibilities as designated in the State Energy Efficiency Programs Improvement Act of 1990 (Pub. L. 101-440).
Tentative Agenda: Briefings on, and discussions of:
Take notice that on October 4, 2004, American Electric Power Service Corporation (AEP) submitted for filing an executed Service Agreement between American Electric Power Service Corporation and PJM Interconnection, L.L.C. AEP requests an effective date of September 30, 2004.
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, 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 “eFiling” link at
This filing is accessible on-line at
Take notice that on September 30, 2004, Westar Energy, Inc. and Kansas Gas and Electric Company, filed an amendment to their September 27, 2004 filing submitting their triennial market power report.
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, 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 and all parties to these proceedings.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Western Area Power Administration, DOE.
Notice of Informal Meeting and Comment Opportunity.
The Western Area Power Administration (Western) is revising its Open Access Transmission Service Tariff (Tariff). Western's existing Tariff was approved by the Federal Energy Regulatory Commission (Commission) on April 12, 2002. Western intends to update certain Tariff provisions, adopt the principal features of the Commission's Standard Large Generator Interconnection Procedures (LGIP) and Standard Large Generator Interconnection Agreement (LGIA) consistent with applicable law, and to make additional changes to further Western's mission and transmission marketing efforts. Publication of this
Western will accept comments on the revised Tariff until November 22, 2004. Western will present a detailed explanation of the revised Tariff at an informal public meeting to be held on November 8, 2004, 1 p.m. MST, Denver, CO. Western will accept oral and written comments at this meeting, and will also accept written comments at any time during the informal comment period.
The public meeting location is the Radisson Stapleton Plaza Hotel, 3333 Quebec Street, Denver, CO.
Send written comments to Corporate Communications, Western Area Power Administration, P.O. Box 281213, Lakewood, CO 80228-8213, e-mail
For substantive questions, contact Darrick C. Moe, Tariff Project Manager, Upper Great Plains Region, Western Area Power Administration, Watertown, SD at (605) 882-7501. For information on
Western is a Federal power marketing administration, charged with the responsibility of selling electricity generated by power plants operated by the Bureau of Reclamation, the Corps of Engineers, and the International Boundary and Water Commission. Created in 1977 under Section 302 of the Department of Energy Organization Act, Western markets and transmits Federal power resources from various multi-purpose hydroelectric projects to customers in 15 Central and Western States. Western has four Customer Service Regional Offices and the Colorado River Storage Project Management Center, each referred to in the revised Tariff as a Regional Office.
Western is not a public utility under Sections 205 and 206 of the Federal Power Act and is not specifically subject to the requirements of the LGIP and LGIA. Western is a transmitting utility subject to Section 211 of the Federal Power Act as amended by the Energy Policy Act of 1992.
On July 24, 2003, the Commission issued Order No. 2003 requiring all public utilities that own, control, or operate facilities used for transmitting electric energy in interstate commerce to have on file standard procedures and a standard agreement for interconnecting generating facilities capable of producing more than 20 megawatts of power to their transmission facilities. Order No. 2003 requires all public utilities to modify their open access transmission tariffs to incorporate the LGIP and LGIA and requires non-public utilities with a “safe harbor” Tariff to adopt the
The revised Tariff, a summary of changes Western intends to make to its existing Tariff, and information about the tariff process is posted on Western's Web site at
Environmental Protection Agency (EPA).
Notice.
In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Written comments, identified by the docket identification (ID) number OPPT-2004-0117, must be received on or before December 21, 2004.
Comments may be submitted electronically, by mail, or through hand delivery/courier. Follow the detailed instructions as provided in Unit I. of the
You may be potentially affected by this action if you are a manufacturer or importer of chemical substances, mixtures, or categories listed on the TSCA Inventory and regulated under TSCA section 8, who had reported to the initial effort to establish the TSCA Inventory in 1979, and who needs to make a correction to that submission. Potentially affected entities may include, but are not limited to:
• Chemical manufacturing (NAICS 325), e.g., Basic chemical manufacturing, resin, synthetic rubber, artificial and synthetic fibers and filaments manufacturing, paint, coating, and adhesive manufacturing, and other chemical product and preparation manufacturing.
• Petroleum refineries (NAICS 32411), e.g., Crude petroleum refineries, diesel fuels manufacturing, fuel oils manufacturing, oil refineries, petroleum distillation.
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under
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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
Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, 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. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket.
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, 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 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 public 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 ID number 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. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I.D. Do not use EPA Dockets or e-mail to submit CBI or information protected by statute.
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Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e-mail. 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 public docket and EPA's electronic public docket. If you submit the copy that does
You may find the following suggestions helpful for preparing your comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used that support your views.
4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Offer alternative ways to improve the collection activity.
7. Make sure to submit your comments by the deadline in this notice.
8. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and
Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically solicits comments and information to enable it to:
1. Evaluate whether the proposed collections of information are 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 Agency's estimates of the burdens of the proposed collections of information.
3. Enhance the quality, utility, and clarity of the information to be collected.
4. Minimize the burden of the collections of information on those who are to respond, including through the use of appropriate automated or electronic collection technologies or other forms of information technology, e.g., permitting electronic submission of responses.
EPA is seeking comments on the following ICR:
However, from time to time, EPA or respondents discover that substances have been incorrectly described by reporting companies. Reported substances have been unintentionally misidentified as a result of simple typographical errors, the misidentification of substances, or the lack of sufficient technical or analytical capabilities to characterize fully the exact chemical substances. EPA has developed guidelines (45 FR 50544, July 29, 1980) under which incorrectly described substances listed in the Inventory can be corrected. The correction mechanism ensures the accuracy of the Inventory without imposing an unreasonable burden on the chemical industry. Without the Inventory correction mechanism, a company that submitted incorrect information would have to file a premanufacture notification (PMN) under TSCA section 5 to place the correct chemical substance on the Inventory whenever the previously reported substance is found to be misidentified. This would impose a much greater burden on both EPA and the submitter than the existing correction mechanism.
Responses to the collection of information are voluntary. Respondents may claim all or part of a notice confidential. EPA will disclose information that is covered by a claim of confidentiality only to the extent permitted by, and in accordance with, the procedures in TSCA section 14 and 40 CFR part 2.
Under PRA, “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. For this collection it 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.
The ICR provides a detailed explanation of this estimate, which is only briefly summarized in this notice. The annual public burden for this collection of information is estimated to average 2.0 hours per response. The following is a summary of the estimates taken from the ICR:
This request reflects a decrease of 180 hours (from 200 hours to 20 hours) in the total estimated respondent burden from that currently in the OMB
EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.12. EPA will issue another
Environmental protection, Reporting and recordkeeping requirements.
Availability of EPA comments prepared pursuant to the Environmental Review Process (ERP), under Section 309 of the Clean Air Act and Section 102(2)(c) of the National Environmental Policy Act, as amended. Requests for copies of EPA comments can be directed to the Office of Federal Activities at (202) 564-7167. An explanation of the ratings assigned to draft environmental impact statements (EISs) was published in FR dated April 2, 2004 (69 FR 17403).
ERP No. D-AFS-H65021-MO Rating LO, East Fredericktown Project, Shortleaf Pine Restoration, Forest Health Improvement, Treat Affected Stands and Recover Valuable Timber Products, Mark Twain National Forest, Potosi/Fredericktown Ranger District, Bollinger, Madison, St. Francois, and Ste. Genevieve Counties, MO.
ERP No. D-AFS-J65416-WY Rating EC2, Bighorn National Forest Revised Land and Resource Management Plan, Implementation, Big Horn Mountain Range, Bighorn National Forest, Johnson, Sheridan, Bighorn and Washakie Counties, WY.
ERP No. D-AFS-L65467-ID Rating EC2, Red Pines Project, Proposes to Implement Fuel Reduction Activities and Improve the Range of Watershed Activities, Nez Perce National Forest, Red River Ranger District, Idaho County, ID.
ERP No. F-AFS-L65388-WA Crystal Mountain Master Development Plan, To Provide Winter and Summer Recreational Use, Special-Use-Permit, Mt. Baker-Snoqualmie National Forest, Silver Creek Watershed, Pierce County, WA.
ERP No. F-BLM-J65387-CO Silverton Outdoor Learning and Recreation Center, Authorization for Long-Term Use of 1,300 acres for Backcountry-type Skiing, Summer Recreation and Educational Activities, Amendment of the San Juan/San Miguel Resource Management Plan, San Juan County, CO.
ERP No. F-COE-E32180-FL Miami Harbor Navigation Improvements Project to Study the Feasibility of Widening and Deepening Portions of the Port, Miami-Dade County, FL.
Environmental Protection Agency (EPA).
Notice; extension of comment period.
EPA issued a notice in the
Comments, identified by docket identification (ID) number OPP-2004-0205, must be received on or before December 6, 2004.
Comments may be submitted electronically, by mail, or through hand delivery/courier. Follow the detailed instructions as provided in Unit I. of the
Mary Frances Lowe, Field and External Affairs Division (7506C), Office of Pesticide Programs, Environmental
The Agency included in the August 25, 2004
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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
To submit comments, or access the official public docket, please follow the detailed instructions as provided in Unit I. of the
This document extends the public comment period established in the
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136-136y, provides this authority.
Environmental protection, Labeling, Occupational safety and health, Pesticides and pests, Reporting and recordkeeping requirements.
Notice of a partially open meeting of the Board of Directors of the Export-Import Bank of the United States.
Tuesday, October 26, 2004 at 9:30 a.m. The meeting will be held at Ex-Im Bank in Room 1143, 811 Vermont Avenue, NW., Washington, DC 20571.
Shipping Finance Program.
The meeting will be open to public participation for Item No. 1 only.
For further information, contact: Office of the Secretary, 811 Vermont Avenue, NW., Washington, DC 20571 (Tele. No. 202-565-3957).
Farm Credit Administration.
Notice is hereby given, pursuant to the Government in the Sunshine Act (5 U.S.C. 552b(e)(3)), that the November 10, 2004 regular meeting of the Farm Credit Administration Board (Board) has been rescheduled. The regular meeting of the Board will be held November 18, 2004 starting at 9 a.m. An agenda for this meeting will be published at a later date.
Jeanette C. Brinkley, Secretary to the Farm Credit Administration Board, (703) 883-4009, TTY (703) 883-4056.
Farm Credit Administration, 1501 Farm Credit Drive, McLean, Virginia 22102-5090.
Federal Communications Commission.
Notice.
The Enforcement Bureau (“Bureau”) gives notice of Mr. John Dotson's suspension from the schools and libraries universal service support mechanism. In addition, the Bureau gives notice that debarment proceedings are commencing against him. Mr. Dotson, or any person who has an existing contract with or intends to contract with him to provide or receive services in matters arising out of activities associated with or related to the schools and libraries support, may respond by filing an opposition request, supported by documentation.
Opposition requests must be received by November 22, 2004. However, an opposition request by the party to be suspended must be received 30 days from the receipt of suspension letter or November 22, 2004, whichever comes first. The Bureau will decide any opposition request for reversal or modification of suspension or debarment within 90 days of its receipt of such requests.
Diana Lee, Federal Communications Commission, Enforcement Bureau, Investigations and Hearings Division, Room 4-A265, 445 12th Street, SW., Washington, DC 20554. Diana Lee may be contacted by phone at 202-418-1420 or e-mail at
The Bureau has suspension and debarment authority under 47 CFR 54.521 and 47 CFR 0.111(a)(14). Suspension will help to ensure that the party to be suspended cannot continue to benefit from the schools and libraries mechanism pending resolution of the debarment process. Attached is the suspension letter,
The suspension letter follows:
Dear Mr. Dotson: The Federal Communications Commission (“FCC” or “Commission”) has received notice of your conviction on or about May 17, 2004 pursuant to 18 U.S.C. § 371 for conspiracy to defraud the United States.
Pursuant to section 54.521(a)(4) of the Commission's rules,
Suspension is immediate pending the Bureau's final debarment determination. You may contest this suspension or the scope of this suspension by filing arguments in opposition to the suspension, with any relevant documentation. Your request must be received within 30 days after you receive this letter or after notice is published in the
Commission rules establish procedures to prevent persons who have “defrauded the government or engaged in similar acts through activities associated with or related to the schools and libraries support mechanism” from receiving the benefits associated with that program.
You may contest debarment or the scope of the proposed debarment by filing arguments and any relevant documentation within 30 calendar days of the earlier of the receipt of this letter or of publication in the
If and when your debarment becomes effective, you will be prohibited from participating in activities associated with or related to the schools and libraries support mechanism for at least three years from the date of debarment.
Please direct any responses to the following address: Diana Lee, Esq., Federal Communications Commission, Enforcement Bureau, Investigations and Hearings Division, Room 4-A265, 445 12th Street, S.W., Washington, D.C. 20554.
If you submit your response via hand-delivery or non-United States Postal Service delivery (
If you have any questions, please contact Ms. Lee via mail, by telephone at (202) 418-1420 or by e-mail at
Sincerely yours,
Thursday, October 28, 2004 at 10 a.m.
999 E Street, NW., Washington, DC (Ninth Floor).
This meeting will be open to the public.
Correction and Approval of Minutes.
Draft Advisory Opinion 2004-38: George Nethercutt and the Nethercutt for Senate Committee by counsel, Stephen M. Hoersting and Tim McKeever.
Draft Advisory Opinion 2004-39: Washington State Republican Party by Chris Vance, Chairman (Tentative).
Explanation and justification for the Political Committee rulemaking.
Routine administrative matters.
Agency for Toxic Substances and Disease Registry (ATSDR), Department of Health and Human Services (HHS).
Notice of availability.
The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), Section 104(i)(3) [42 U.S.C. 9604(i)(3)] directs the Administrator of ATSDR to prepare toxicological profiles of priority hazardous substances and to revise and publish each updated toxicological profile as necessary. This notice announces the availability of the 18th set of toxicological profiles, which consists of one new draft and five updated drafts, prepared by ATSDR for review and comment.
In order to be considered, comments on these draft toxicological profiles must be received on or before February 23, 2005. Comments received after the close of the public comment period will be considered at the discretion of ATSDR based upon what is deemed to be in the best interest of the general public.
Requests for printed copies of the draft toxicological profiles should be sent to the attention of Ms. Yulandia Jordan, Division of Toxicology, Agency for Toxic Substances and Disease Registry, Mailstop E-29, 1600 Clifton Road, NE., Atlanta, Georgia 30333. Electronic access to these documents is also available at the ATSDR Web site:
Comments regarding the draft toxicological profiles should be sent to the attention of Ms. Nickolette Roney, Division of Toxicology, Agency for Toxic Substances and Disease Registry, Mailstop F-32, 1600 Clifton Road, NE., Atlanta, Georgia 30333.
Requests for printed copies of the draft toxicological profiles must be in writing, and must specifically identify the hazardous substance(s) profile(s) that you wish to receive. ATSDR reserves the right to provide only one copy of each profile requested, free of charge. In case of extended distribution delays, requestors will be notified.
Written comments and other data submitted in response to this notice and the draft toxicological profiles should bear the docket control number ATSDR-205. Send one copy of all comments and three copies of all supporting documents to Ms. Roney at the above stated address by the end of the comment period. Because all public comments regarding ATSDR toxicological profiles are available for public inspection, no confidential business information or other confidential information should be submitted in response to this notice.
Ms. Yulandia Jordon, Division of Toxicology, Agency for Toxic Substances and Disease Registry, Mailstop E-29, 1600 Clifton Road, NE., Atlanta, Georgia 30333, telephone 1-(888) 422-8737 or (404) 498-0261.
The Superfund Amendments and Reauthorization Act (SARA) (Pub. L. 99-499) amends the Comprehensive Environmental Response, Compensation, and Liability Act
Section 104(i)(3) of CERCLA [42 U.S.C. 9604(i)(3)] outlines the content of these profiles. Each profile will include an examination, summary and interpretation of available toxicological information and epidemiologic evaluations. This information and these data are to be used to identify the levels of significant human exposure for the substance and the associated health effects. The profiles must also include a determination of whether adequate information on the health effects of each substance is available or in the process of development. When adequate information is not available, ATSDR, in cooperation with the National Toxicology Program (NTP), is required to assure the initiation of research to determine these health effects.
Although key studies for each of the substances were considered during the profile development process, this
The following draft toxicological profiles will be made available to the public on or about October 18, 2004.
All profiles issued as “Drafts for Public Comment” represent ATSDR's best efforts to provide important toxicological information on priority hazardous substances. We are seeking public comments and additional information that may be used to supplement these profiles. ATSDR remains committed to providing a public comment period for these documents as a means to best serve public health and our clients.
Agency for Toxic Substances and Disease Registry (ATSDR), Department of Health and Human Services (HHS).
Notice of availability.
This notice announces the availability of one update and four new final toxicological profiles, completing the 2nd set developed for the Department of Energy, prepared by ATSDR.
Ms. Yulandia Jordon, Office of Communication, Agency for Toxic Substances and Disease Registry, Mailstop E-29, 1600 Clifton Road, NE., Atlanta, Georgia 30333, telephone 1-888-422-8737 or (404)498-0261.
These toxicological profiles were developed by ATSDR for hazardous substances at Department of Energy (DOE) waste sites under Section 104(i)(3) and (5) of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA or Superfund). This public law directed ATSDR to prepare toxicological profiles for hazardous substances that are most commonly found at facilities on the CERCLA National Priorities List (NPL) and that pose the most significant potential threat to human health, as determined by ATSDR and the EPA. The current ATSDR priority list of hazardous substances at DOE NPL sites was announced in the
Notices (66 FR 53610) and (66 FR 41243) announcing the availability of the draft toxicological profiles for public
This notice announces the availability of one update and four new final toxicological profiles, comprising the 2nd set developed for the Department of Energy, prepared by ATSDR. The following toxicological profiles are now available through the U.S. Department of Commerce, National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, Virginia 22161, telephone 1-800-553-6847. There is a charge for these profiles as determined by NTIS.
Measurable outcomes of the program will be in alignment with one of the following performance goal(s) for the National Center on Birth Defects and Developmental Disabilities (NCBDDD): (1) Prevent birth defects and developmental disabilities (2) improve the health and quality of life of Americans with disabilities.
This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be reviewed. For the definition of research, please see the CDC web site at the following Internet address:
Activities: Awardee activities for this program are as follows:
• Develop and/or maintain an international birth defects database that includes data from developed and developing countries from different areas of the world.
• Promote and operate an international collaboration and data clearinghouse among international partners and birth defect registries that enables international collaborative birth defect surveillance, epidemiologic assessment, and capacity building.
• Using such international partners and the international birth defects database, evaluate, compare and confirm patterns and trends of birth defects occurrences.
• Obtain, compile, and publish birth defect surveillance data from areas in the developed and developing world to assess the impact of birth defects.
• In collaboration with international partners, conduct secondary data analyses in order to evaluate potential birth defect risk factors and identify areas in need of epidemiologic assessments.
• Disseminate the birth defect surveillance data to member programs, partners such as national and international organizations, the World Health Organization, other health agencies, and other interested parties.
• Evaluate the changes in the occurrence of selected adverse reproductive outcomes likely to be prevented by folic acid (
• Promote or develop tools and guidelines to assist the development of birth defects surveillance activities in both developed and developing countries.
In a cooperative agreement, CDC staff is substantially involved in the program activities, above and beyond routine grant monitoring.
CDC Activities for this program are as follows:
• Assist, if requested, in designing, developing, and evaluating methodologies and approaches used for population-based birth defects surveillance.
• Assist, if requested, in analyzing surveillance data related to birth defects.
• Assist, if requested, in providing scientific consultation and assistance in the study of birth defects and in the approaches to study design, methodology, and implementation in the conduct of secondary data analyses.
• Assist, if requested, in the definition and format of the birth defect surveillance reports.
• Assist, if requested in developing tools and guidelines for birth defect surveillance.
Throughout the project period, CDC's commitment to continuation of awards will be conditioned on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the Federal Government.
• Applications may be submitted by private nonprofit organizations.
Matching funds are not required for this program.
CDC will accept and review applications with budgets greater than the ceiling of the award range.
Special Requirements: If your application is incomplete or non-responsive to the special requirements listed in this section, it will not be entered into the review process. You will be notified that your application did not meet submission requirements.
• Late applications will be considered non-responsive. See section “IV.3. Submission Dates and Times” for more information on deadlines.
• Note: Title 2 of the United States Code Section 1611 states that an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan.
To apply for this funding opportunity use application form PHS 5161. Application forms and instructions are available on the CDC web site, at the following Internet address:
If you do not have access to the Internet, or if you have difficulty accessing the forms on-line, you may contact the CDC Procurement and Grants Office Technical Information Management Section (PGO-TIM) staff at: 770-488-2700. Application forms can be mailed to you.
• Maximum number of pages: 25 if your narrative exceeds the page limit, only the first pages which are within the page limit will be reviewed.
• Font size: 12 point unreduced.
• Double spaced.
• Paper size: 8.5 by 11 inches.
• Page margin size: One inch.
• Printed only on one side of page.
• Held together only by rubber bands or metal clips; not bound in any other way.
Your narrative should address activities to be conducted over the entire project period, and must include the following items in the order listed:
• Objectives.
• Methods.
• Evaluation.
• Organizational and Program Personnel Capability.
• Program Plan.
• Budget and Justification (Not included in page limitation).
Additional information may be included in the application appendices. The appendices will not be counted toward the narrative page limit. This additional information includes:
Curriculum Vitaes.
Organizational Charts.
Letters of Support.
You 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
For more information, see the CDC web site at:
Additional requirements that may require you to submit additional documentation with your application are listed in section “VI.2. Administrative and National Policy Requirements.”
This announcement is the definitive guide on LOI and application content, submission address, and deadline. It supersedes information provided in the application instructions. If your submission does not meet the deadline above, it will not be eligible for review, and will be discarded. You will be notified that you did not meet the submission requirements.
CDC will not notify you upon receipt of your submission. If you have a question about the receipt of your LOI or application, first contact your courier. If you still have a question, contact the PGO-TIM staff at: 770-488-2700. Before calling, please wait two to three days after the submission deadline. This will allow time for submissions to be processed and logged.
Executive Order 12372 does not apply to this program.
Restrictions as found in 45 CFR Parts 74 and 92 and OMB Circular 1-122, which must be taken into account while writing your budget, are as follows:
• Funds may not be used for research.
• Reimbursement of pre-award costs is not allowed.
• Funds may be spent for reasonable program purposes, including personnel, travel, supplies, and services.
• The costs that are generally allowable in grants to domestic organizations are allowable to foreign institutions and international organizations, with the following exception: With the exception of the American University, Beirut and the World Health Organization, Indirect Costs will not be paid (either directly or through sub-award) to organizations located outside the territorial limits of the United States or to international organizations regardless of their location.
• The applicant may contract with other organizations under this program; however the applicant must perform a substantial portion of the activities (including program management and operations, and delivery of prevention services for which funds are required.)
• All requests for funds contained in the budget, shall be stated in U.S. dollars. Once an award is made, CDC will not compensate foreign grantees for currency exchange fluctuations through the issuance of supplemental awards.
• You must obtain annual audit of these CDC funds (program-specific audit) by a U.S.-based audit firm with international branches and current licensure/authority in-country, and in accordance with International Accounting Standards or equivalent standard(s) approved in writing by CDC.
• A fiscal Recipient Capability Assessment may be required, prior to or post award, in order to review the applicant's business management and fiscal capabilities regarding the handling of U.S. Federal funds.
Guidance for completing your budget can be found on the CDC Web site, at the following Internet address:
Application Submission Address: Submit the original and two hard copies of your application by mail or express delivery service to: Technical Information Management—RFA#05006, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.
Applications may not be submitted electronically at this time.
Applicants are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the cooperative agreement. Measures of effectiveness must relate to the performance goals stated in the “Purpose” section of this announcement. Measures must be objective and quantitative, and must measure the intended outcome. These measures of effectiveness must be submitted with the application and will be an element of evaluation.
Your application will be evaluated against the following criteria:
Are the proposed objectives specific, measurable, and time-phased?
Are the proposed methods feasible? To what extent are the proposed methods likely to lead to the accomplishment of the proposed objectives?
Does the evaluation plan enable the applicant to determine the success of its activities and the benefits provided?
Do the staff members have the experience, skills, and ability to develop and improve birth defects surveillance data to develop prevention programs and improve access to health services or early intervention programs? Are the staff roles clearly defined?
Is the plan adequate to carry out the proposed objectives? Does the applicant have a clear, concise understanding of the program requirements, objectives and purpose of the cooperative agreement?
Also, does the applicant meet the CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research?
This includes:
a. The proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation.
b. The proposed justification when representation is limited or absent.
c. A statement as to whether the design of the study is adequate to measure differences when warranted.
d. A statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community(ies) and recognition of mutual benefits.
Applications will be reviewed for completeness by the Procurement and Grants Office (PGO) staff, and for responsiveness by NCBDDD. Incomplete applications and applications that are non-responsive to the eligibility criteria will not advance through the review process. Applicants will be notified that their application did not meet submission requirements.
An objective review panel will evaluate complete and responsive applications according to the criteria listed in the “V.1. Criteria” section above.
Applications will be funded in order by score and rank determined by the review panel.
CDC will provide justification for any decision to fund out of rank order.
April 1, 2005.
Successful applicants will receive a Notice of Grant Award (NGA) from the CDC Procurement and Grants Office. The NGA shall be the only binding, authorizing document between the recipient and CDC. The NGA will be signed by an authorized Grants Management Officer, and mailed to the recipient fiscal officer identified in the application.
Unsuccessful applicants will receive notification of the results of the application review by mail.
45 CFR Parts 74 and 92.
For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address:
The following additional requirements apply to this project:
• AR-10 Smoke-Free Workplace Requirements.
• AR-11 Healthy People 2010.
• AR-12 Lobbying Restrictions.
• AR-14 Accounting System Requirements.
• AR-15 Proof of Non-Profit Status.
• AR-25 Release and Sharing of Data.
Additional information on these requirements can be found on the CDC web site at the following Internet
You must provide CDC with an original, plus two hard copies of the following reports:
1. Interim progress report, due no less than 90 days before the end of the budget period. The progress report will serve as your non-competing continuation application, and must contain the following elements:
a. Current Budget Period Activities Objectives.
b. Current Budget Period Financial Progress.
c. New Budget Period Program Proposed Activity Objectives.
d. Budget.
e. Measures of Effectiveness.
f. Additional Requested Information.
2. Financial status report and annual progress report, no more than 90 days after the end of the budget period.
3. Final financial and performance reports, no more than 90 days after the end of the project period.
These reports must be mailed to the Grants Management or Contract Specialist listed in the “Agency Contacts” section of this announcement.
We encourage inquiries concerning this announcement. For general questions, contact: Technical Information Management Section, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: (770) 488-2700.
For program technical assistance, contact: J. David Erickson, Project Officer, CDC, NCBDDD, 1600 Clifton Road, NE (E86), Atlanta, GA 30333, Telephone: (404) 498-3825, E-mail:
For financial, grants management, or budget assistance, contact: Steward Nichols, Contract Specialist, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: (770) 488-2788, E-mail:
This and other CDC funding opportunity announcements can be found on the CDC web site, Internet address:
Information on the National Center on Birth Defects and Developmental Disabilities may be found on
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) and the Health Resources and Services Administration (HRSA) announce the following committee meeting.
Agenda items are subject to change as priorities dictate.
Paulette Ford-Knights, Public Health Analyst, National Center for HIV, STD, and TB Prevention, 1600 Clifton Road, NE., Mailstop E-07, Atlanta, Georgia 30333. Telephone 404/639-8008, fax 404/639-3125, e-mail
The Director, Management Analysis and Services Office, has been delegated the authority to sign
The Community and Tribal Subcommittee of the Board of Scientific Counselors (BSC), Centers for Disease Control and Prevention (CDC), National Center for Environmental Health (NCEH)/Agency for Toxic Substances and Disease Registry (ATSDR): Teleconference.
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), NCEH/ATSDR announces the following subcommittee meeting:
Agenda items are subject to change.
This conference call is scheduled to begin at 3 p.m. eastern standard time. To participate in the teleconference, please dial 1 (877) 315-6535 and enter conference code 383520.
Sandra Malcom, Committee Management Specialist, Office of Science, NCEH/ATSDR, M/S E-28, 1600 Clifton Road, NE., Atlanta, Georgia 30333, telephone 404/498-0003.
The Director, Management Analysis and Services Office, has been delegated the authority to sign
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) announces the following meeting:
The Director, Management Analysis and Services Office, has been delegated the authority to sign
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, 5 U.S.C. Appendix 2, section 10(a) (Pub. L. 92-463), this notice announces a meeting of the Advisory Panel on Medicare Education (the Panel) on November 30, 2004. The Panel advises and makes recommendations to the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning the Medicare program. This meeting is open to the public.
The meeting is scheduled for November 30, 2004 from 9 a.m. to 4 p.m., e.s.t.
The meeting will be held at the Wyndham Washington Hotel, 1400 M Street, NW., Washington, DC 20005, (202) 429-1700.
Lynne Johnson, Health Insurance Specialist, Division of Partnership Development, Center for Beneficiary Choices, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, mail stop S2-23-05, Baltimore, MD 21244-1850, (410) 786-0090. Please refer to the CMS Advisory Committees' Information Line (1-877-449-5659 toll free)/(410-786-9379 local) or the Internet (
Press inquiries are handled through the CMS Press Office at (202) 690-6145.
Section 222 of the Public Health Service Act (42 U.S.C. 217a), as amended, grants to the Secretary of the Department of Health and Human Services (the Secretary) the authority to establish an advisory panel if the Secretary finds the panel necessary and in the public interest. The Secretary signed the charter establishing the Advisory Panel on Medicare Education (the Panel) on January 21, 1999 and approved the renewal of the charter on January 21, 2003. The Panel advises and makes recommendations to the Secretary and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Medicare program.
The goals of the Panel are as follows:
• To develop and implement a national Medicare education program that describes the options for selecting a health plan under Medicare.
• To enhance the Federal government's effectiveness in informing the Medicare consumer, including the appropriate use of public-private partnerships.
• To expand outreach to vulnerable and underserved communities, including racial and ethnic minorities, in the context of a national Medicare education program.
• To assemble an information base of best practices for helping consumers evaluate health plan options and build a community infrastructure for information, counseling, and assistance.
The current members of the Panel are: Dr. Drew E. Altman, President and Chief Executive Officer, Henry J. Kaiser Family Foundation; James L. Bildner, Chairman and Chief Executive Officer, New Horizons Partners, LLC; Dr. Jane Delgado, Chief Executive Officer, National Alliance For Hispanic Health; Clayton Fong, President and Chief Executive Officer, National Asian Pacific Center on Aging; Thomas Hall, Chairman and Chief Executive Officer, Cardio-Kinetics, Inc.; Bobby Jindal; David Knutson, Director, Health System Studies, Park Nicollet Institute for Research and Education; Donald J. Lott, Executive Director, Indian Family Health Clinic; Dr. Frank I. Luntz, President and Chief Executive Officer, Luntz Research Companies; Jeffrey McWaters, Chairman and Chief Executive Officer, AMERIGROUP Corporation; Katherine Metzger, Director, Medicare and Medicaid Programs, Fallon Community Health Plan; David Null, Financial Advisor, Merrill Lynch; Dr. Marlon Priest, Professor of Emergency Medicine, University of Alabama at Birmingham; Susan O. Raetzman, Associate Director, Public Policy Institute, AARP; and Catherine Valenti, Chairperson and Chief Executive Officer, Caring Voice Coalition.
The agenda for the November 30, 2004 meeting will include the following:
• Recap of the previous (September 9, 2004) meeting.
• Centers for Medicare & Medicaid Services Update.
• Medicare Modernization Act: Outreach and Education.
• Public Comment.
• Listening Session with CMS Leadership.
• Next Steps.
Individuals or organizations that wish to make a 5-minute oral presentation on an agenda topic must submit a written copy of the oral presentation to Lynne Johnson, Health Insurance Specialist, Division of Partnership Development, Center for Beneficiary Choices, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Mail stop S2-23-05, Baltimore, MD 21244-1850 or by email at
Sec. 222 of the Public Health Service Act (42 U.S.C. 217a) and sec. 10(a) of Pub. L. 92-463 (5 U.S.C. App. 2, sec. 10(a) and 41 CFR 102-3).
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice of meeting.
In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces a meeting of the Practicing Physicians Advisory Council (the Council). The Council will be meeting to discuss certain proposed changes in regulations and carrier manual instructions related to physicians' services, as identified by the Secretary of the Department of Health and Human Services (the Secretary). This meeting is open to the public.
The meeting is scheduled for Monday, November 22, 2004, from 8:30 a.m. until 5 p.m. e.s.t.
The meeting will be held in Room 505A, 5th floor, in the Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201.
Persons wishing to attend this meeting must contact John Lanigan, the Designated Federal Official (DFO), by e-mail at
Kenneth Simon, M.D., Executive Director, Practicing Physicians Advisory Council, 7500 Security Blvd., Mail Stop C4-10-07, Baltimore, MD 21244-1850, telephone (410) 786-2312, or e-mail
The Secretary of the Department of Health and Human Services (the Secretary) is mandated by section 1868 (a) of the Social Security Act (the Act) to appoint a Practicing Physicians Advisory Council (the Council) based on nominations submitted by medical organizations representing physicians. The Council meets quarterly to discuss certain proposed changes in regulations and carrier manual instructions related to physicians' services, as identified by the Secretary. To the extent feasible and consistent with statutory deadlines, the consultation must occur before publication of the proposed changes. The Council submits an annual report on its recommendations to the Secretary and the Administrator of the Centers for Medicare & Medicaid Services not later than December 31 of each year.
The Council consists of 15 physicians, each of whom must have submitted at least 250 claims for physicians' services under Medicare in the previous year. Members of the Council include both participating and nonparticipating physicians, and physicians practicing in rural and underserved urban areas. At least 11 members of the Council must be physicians as described in section 1861(r)(1) of the Act; that is, State-licensed doctors of medicine or osteopathy. The remaining 4 members may include dentists, podiatrists, optometrists and chiropractors. Members serve for overlapping 4-year terms; terms of more than 2 years are contingent upon the renewal of the Council by appropriate action prior to its termination. Section 1868(a) of the Act provides that nominations to the Secretary for Council membership must be made by medical organizations representing physicians.
The Council held its first meeting on May 11, 1992. The current members are—Jose Azocar, M.D.; James Bergeron, M.D.; Ronald Castellanos, M.D.; Rebecca Gaughan, M.D.; Peter Grimm, D.O.; Carlos R. Hamilton, M.D.; Dennis K. Iglar, M.D.; Joe Johnson, D.C.; Christopher Leggett, M.D.; Barbara McAneny, M.D.; Geraldine O'Shea, D.O.; Laura B. Powers, M.D.; Michael T. Rapp, M.D. (Chairperson); Anthony Senagore, M.D.; and Robert L. Urata, M.D.
The meeting will commence with a status report and our response to recommendations made by the Council at the August 30, 2004 meeting and prior meeting recommendations. Additionally, an update will be provided on the Physicians Regulatory Issues Team and Part “D” Benefits.
In accordance with the Council charter we are requesting assistance with the following agenda topics:
• Physician Fee Schedule Final Rule;
• Outpatient Final Rule;
• Medicare Coverage Process;
• Medicare Preventive Benefits & Welcome to Medicare Exam Visit; and
• Quality Initiative Projects: Doctor Office Quality—Information Technology Project (DOQ-IT).
For additional information and clarification on these topics, contact the Executive Director, listed under the
The number of oral presentations may be limited by the time available. A written copy of the presenter's oral remarks must be submitted to John Lanigan, Designated Federal Official, by e-mail at
The meeting is open to the public, but attendance is limited to the space available.
(Section 1868 of the Social Security Act (42 U.S.C. 1395ee) and section 10(a) of Pub. L. 92-463 (5 U.S.C. App. 2, section 10(a)).
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice.
This notice announces a town hall meeting. The purpose of the meeting is to solicit the opinions of individual Medicare providers and suppliers to educate CMS on how we can better serve Medicare providers and suppliers. Providers, physicians, home health agencies, industry billing staff representatives, and other Medicare billers are invited to attend this meeting. We will consider facts and opinions provided by individuals during this meeting. The information gathered will be used as feedback on CMS provider and supplier communication activities and related topics. The meeting is open to the public, but attendance is limited to space available.
The meeting is scheduled for Tuesday, November 16, 2004, from 2 p.m. until 3 p.m. e.s.t.
The meeting will be held in the auditorium at the Centers for Medicare and Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244.
Robin Magwood, (410) 786-1999. You may also send e-mail inquiries about this meeting to
On November 16, 2004, we will convene a town hall meeting to solicit the opinions of individual Medicare providers and suppliers on how CMS can better serve Medicare providers and suppliers through communication education materials and other means. This meeting will provide the Agency with a venue that allows Agency managers an opportunity to interact with individual Medicare providers and suppliers and obtain their opinions on various topics. We will have follow-up meetings to solicit additional opinions and clarify any issues that may arise during the November 16, 2004 meeting.
At the November 16th meeting, we will explain CMS's design for gathering individual provider and supplier information, and then ask for opinions on how CMS can better serve the Medicare provider and supplier community. An on-line registration is available for interested individuals who wish to participate in the meeting in person or by teleconference. The on-line registration will capture contact information and practice characteristics, such as names, email addresses, and provider and supplier types.
Individuals may participate in the public meeting by teleconference. The dial-in number is 877-357-7851, and you should reference conference identification number 1040512. Physicians and other interested parties may speak or ask questions during the question and answer period facilitated by the moderator. Parties may also submit written comments to the point of contact named in this
Section 1811 and 1831 of the Social Security Act (42 U.S.C. 1395c and 1395j).
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Clinical Pharmacology Subcommittee of the Advisory Committee for Pharmaceutical Science. This meeting was announced in the
Hilda Scharen, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville MD 20857, 301-827-7001, FAX: 301-827-6776, e-mail:
In the
This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Food and Drug Administration, HHS.
Notice.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Jan Johannessen at least 7 days in advance of the meeting.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Public Law 92-463), notice is hereby given of the following meeting:
Anyone interested in obtaining a roster of members, minutes of the meeting, or other relevant information should write or contact Ms. Elaine G. Cohen, M.S., R.N., Executive Secretary, National Advisory Council on Nurse Education and Practice, Parklawn Building, Room 9-35, 5600 Fishers Lane, Rockville, Maryland 20857, telephone (301) 443-1405.
National Institutes of Health, Public Health Service, DHHS.
Notice.
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: (301) 496-7057; fax: (301) 402-0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.
The invention describes a class of compounds that inhibit HIV RNase H and the methods of using these compounds for the treatment of HIV infections. More specifically, these compounds are vinylogous urea derivative containing substituted thiophene core structures and these compounds were part of the 100,000 member library of compounds purchased by NCI from ChemBridge. The selectivity of the antiviral activity was demonstrated in their selective inhibition of HIV-1 and HIV-2 Rnase H enzymes 1 in the CEM cell line of CD4+ lymphoblast cells. Five members of this class of compounds were able to block the cytopathic effect of the virus at concentrations that did not inhibit cell growth. Thus, these compounds may be used in the development of therapeutics for the treatment of retroviral infections, such as AIDS. In addition, these compounds described in this invention may also have particular value when used in combination treatments with other antiviral therapies directed at other viral targets, such as protease and integrase.
The invention describes the anti-HIV properties of cyclophilin-18, a protein expressed by the protozoan parasite Toxoplasma gondii. The protein was found to bind to the chemokine receptor CCR5 which is also a co-receptor for the HIV virus. Both the native and recombinant molecules display inhibitory activity in HIV-1 fusion (syncitia formation) and infectivity assays with human T cells and macrophages. Thus, Toxoplasma gondii cyclophilin-18 or modified versions of the molecule may be used in the development of treatment for AIDS. In particular, the protein described in this invention may have particular value when used as a microbicide for blocking initial HIV infection. More details of this invention can be found in Golding et al., “Inhibition of HIV-1 Infection by a CCR5 Binding Cyclophilin from Toxoplasma gondii”, Blood 1 Nov 2003 102(9): 3280-3286.
This application describes the methods for treating or preventing an HIV infection by the administration of an Egr 1 activator called Resveratrol (3, 5, 4”-trihydroxystilbene) and its derivatives. It has been known that HIV, once it infects a cell, integrates into the cellular genome and can (1) rapidly undergo lytic infection, or (2) lay dormant for a period of time (latent infection). The existence of latent infected cells poses a great challenge to HIV therapy because (1) there are no good existing means that can separate the latent infected cells from the uninfected cells; (2) even when antiretroviral drugs are able to completely suppress detectable HIV replication, these latent infected cells will remain and HIV can subsequently complete the viral replication cycle to produce more virus. Since Resveratrol and its derivatives can activate lytic replication from latent infected cells via its effects on Erk1/2 signaling, Resveratrol and its derivatives may lead to therapies in which Resveratrol and/or its derivatives is given together with highly active antiretroviral therapy in an
This application describes the methods for treating or preventing an HIV infection by the administration of proteosome inhibitors and their derivatives. It has been known that HIV, once it infects a cell, integrates into the cellular genome and can (1) rapidly undergo lytic infection, or (2) lay dormant for a period of time (latent infection). The existence of latent infected cells poses a great challenge to HIV therapy because (1) there are no good existing means that can separate the latent infected cells from the uninfected cells; (2) even when antiretroviral drugs are able to completely suppress detectable HIV replication, these latent infected cells will remain and HIV can subsequently complete the viral replication cycle to produce more virus. Since proteosome inhibitors can activate lytic replication from latent infected cells, proteosome inhibitors may lead to therapies in which proteosome inhibitors are given together with highly active antiretroviral therapy in an effort to decrease or eliminate the reservoir of latent infected cells with hope of perhaps eventually curing a patient of HIV infection.
This application describes the methods for treating or preventing an HIV infection by the administration of abl-kinase inhibitor called imatinib and its derivatives. It has been known that HIV, once it infects a cell, integrates into the cellular genome and can (1) rapidly undergo lytic infection, or (2) lay dormant for a period of time (latent infection). The existence of latent infected cells poses a great challenge to HIV therapy because (1) there are no good existing means that can separate the latent infected cells from the uninfected cells; (2) even when antiretroviral drugs are able to completely suppress detectable HIV replication, these latent infected cells will remain and HIV can subsequently complete the viral replication cycle to produce more virus. Since imatinib and its derivatives can activate lytic replication from latent infected cells by activating NF-kB, imatinib and its derivatives may lead to therapies in which imatinib and/or its derivatives is given together with highly active antiretroviral therapy in an effort to decrease or eliminate the reservoir of latent infected cells with hope of perhaps eventually curing a patient of HIV infection.
This application describes the methods for treating or preventing an HIV infection by the administration of farnesyl transferase inhibitors such as FTI277, L-744832, BMS214662, R115777 and SCH66336. It has been known that HIV, once it infects a cell, integrates into the cellular genome and can (1) rapidly undergo lytic infection, or (2) lay dormant for a period of time (latent infection). The existence of latent infected cells poses a great challenge to HIV therapy because (1) there are no good existing means that can separate the latent infected cells from the uninfected cells; (2) even when antiretroviral drugs are able to completely suppress detectable HIV replication, these latent infected cells will remain and HIV can subsequently complete the viral replication cycle to produce more virus. Since farnesyl transferase inhibitors can activate lytic replication from latent infected cells by modulating membrane-bound Ras-Rho levels, farnesyl transferase inhibitors may lead to therapies in which farnesyl transferase inhibitor is given together with highly active antiretroviral therapy in an effort to decrease or eliminate the reservoir of latent infected cells with hope of perhaps eventually curing a patient of HIV infection.
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 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 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 meetings.
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.
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.
Notice is hereby given of the cancellation of the National Institute of Allergy and Infectious Diseases Special Emphasis Panel, October 26, 2004, 1 p.m. to October 26, 2004, 4 p.m., National Institutes of Health, Rockledge 6700, 6700B Rockledge Drive, Bethesda, MD 20817 which was published in the
The meeting is cancelled due to the withdrawal of the application to be reviewed.
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 meetings.
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.
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 of 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.
Notice is hereby given of a change in the meeting of the Board of Scientific Counselors, National Library of Medicine, October 14, 2004, 9 a.m. to October 14, 2004, 5 p.m., National Library of Medicine, Building 38, 2nd Floor, Board Room, 8600 Rockville Pike, Bethesda, MD 20892 which was published in the
The meeting will be held on October 19, 2004, which is changed from the previous date of October 14, 2004. The meeting is partially Closed to the public.
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 meetings.
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 timining 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.
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.
Notice.
The National Institutes of Health (NIH) is requesting public comment on the following Written Request issued by the Food and Drug Administration (FDA) for off-patent drugs as defined in the Best Pharmaceuticals for Children Act (BPCA). The Written Request was referred to the NIH by the FDA as
Comments are requested within 45 days of publication of this notice.
Submit comments to: Anne Zajicek, M.D., Pharm.D., National Institute of Child Health and Human Development (NICHD), 6100 Executive Boulevard, Suite 4B-09, Bethesda, MD 20892-7510, telephone 301-435-6865 (not a toll-free number), e-mail <
Anne Zajicek, M.D., Pharm.D., National Institute of Child Health and Human Development (NICHD), 6100 Executive Boulevard, Suite 4B-09, Bethesda, MD 20892-7510, telephone 301-435-6865 (not a toll-free number), e-mail <
The NIH is providing notice of Written Requests issued by the FDA, and is requesting public comment. On January 4, 2002, President Bush signed into law the Best Pharmaceuticals for Children Act (BPCA). The BPCA mandates that NIH, in consultation with the FDA and experts in pediatric research, shall develop, prioritize, and publish an annual list of certain approved drugs for which pediatric studies are needed. In response to this list, the FDA then issues a Written Request to holders of the New Drug Application (NDA) or abbreviated New Drug Application (aNDA) to request that pediatric studies be performed to provide needed safety and efficacy information for pediatric labeling. If the Written Request is declined by the NDA/aNDA holder(s), the Written Request is referred to NIH, specifically the NICHD. A Request for Proposal (RFP) is then issued based on the Written Request and proposals are reviewed by a peer-review process for contract award. To assure that the most appropriate pediatric studies are delineated in the RFP, public comment on the Written Request for the use of oral azithromycin to treat Chlamydia trachomatis pneumonia in infants less than four months of age, and to prevent Chlamydia trachomatis conjunctivitis and pneumonia in at-risk infants less than two weeks of age, is hereby requested by the NIH.
Dear Contact: Reference is made to your New Drug Application 50-710 for Zithromax® (azithromycin) for Oral Suspension. To obtain needed pediatric information on the use of oral azithromycin, the Food and Drug Administration (FDA) is hereby making a formal Written Request, pursuant to Section 505A of the Federal Food, Drug, and Cosmetic Act, that you submit information from studies in pediatric patients described below.
Recommended treatment by the American Academy of Pediatrics (AAP) Committee on Infectious Diseases in 2003 for CT conjunctivitis and pneumonia includes a 14-day course of orally administered erythromycin, given in four divided doses daily.
The incidence of IHPS in infants treated with erythromycin during the first two weeks of life ranges from 27 to 32 cases per 1000 live births.
Azithromycin is labeled for use in infants six months of age and older. Off-label use of azithromycin in infants younger than six months of age occurs. However, no published controlled studies of azithromycin treatment for chlamydial pneumonia during the first six months of life were located in the English literature (1990-2003). In vitro, minimal inhibitory and minimal bactericidal concentrations of azithromycin have been reported to be similar to those of erythromycin against CT in vitro.
Differences between azithromycin and erythromycin metabolism may provide dosing regimen advantages of azithromycin for the infant. Based on a longer half-life, azithromycin would need to be given less frequently than erythromycin.
1. Oral azithromycin for the treatment of CT pneumonia in infant patients less than four months of age.
2. Oral azithromycin for the prevention of CT conjunctivitis and pneumonia in at-risk infants less than two weeks of age.
1. Single Dose Pharmacokinetics (PK) Study: Will characterize single dose oral azithromycin pharmacokinetics, safety and tolerability in patients with CT pneumonia or conjunctivitis at one or more potentially clinically relevant doses. The initial dose of azithromycin in this study will be guided by extrapolation from data of azithromycin use in older infants, published literature and current medical practice. PK information from patients with pneumonia will guide the starting dose for Study 2. PK information from patients with conjunctivitis will help to guide the starting dose(s) used in Studies 3 and 4.
2. Efficacy, Safety and PK Study:
a. Will determine oral azithromycin efficacy for the treatment of chlamydial pneumonia in comparison to oral erythromycin.
b. Will characterize the safety profile of oral azithromycin in the treatment of CT pneumonia.
c. To characterize oral azithromycin multiple-dose pharmacokinetics in patients with CT pneumonia.
3. Single dose PK Study: Will characterize single-dose oral azithromycin PK, safety and tolerability in infants less than two weeks of age born to mothers with untreated or inadequately treated genital tract infection at one or more clinically relevant doses. Initial dose will be guided by results of Studies 1 and 2.
4. Efficacy, Safety and PK Study:
a. Will determine oral azithromycin efficacy, in comparison to placebo, for the
b. Observe the incidence of IHPS following oral azithromycin use in infants less than two weeks of age, compared with placebo.
c. Determine individual incidence rates of CT conjunctivitis and pneumonia following azithromycin use or placebo, in infants less than two weeks of age, who were born to mothers with untreated or inadequately treated CT genital tract infection.
d. Characterize a safety profile for oral azithromycin.
e. Characterize azithromycin multiple-dose pharmacokinetics in infants less than two weeks of age.
Study 1 will be submitted to and assessed by the FDA in a timely manner, prior to proceeding with Study 2. Study 2 will be submitted to and assessed by the FDA prior to proceeding with Studies 3 and 4. In particular, the adverse event profile observed in Studies 1 and 2 will play a primary role in deciding whether to proceed. The pharmacokinetic data from Studies 1 and 2 will guide dosing in Studies 3 and 4. Results from the single dose pharmacokinetic studies of azithromycin (Studies 1 and 3) will be used in planning Studies 2 and 4, respectively.
Studies 1 and 2: Patients will be less than four months of age at study entry.
Studies 3 and 4: Patients will be less than two weeks of age at study entry.
Studies 1, 2, 3, and 4: Studies that assess pharmacokinetics will utilize sparse sampling and a population PK approach to minimize blood loss to individual patients. Sparse blood samples should be obtained at defined intervals to avoid collection of samples at fixed times. Bioanalytical methods to determine azithromycin concentrations must be capable of using small blood volumes to minimize blood loss.
Study 2: This study will be multicenter, prospective, randomized, double-blind, parallel-arm, and active-controlled, to assess oral azithromycin non-inferiority to oral erythromycin for the treatment of CT pneumonia with or without conjunctivitis. The protocol will specify the criteria for the diagnosis of CT pneumonia as well as criteria for pneumonia cure. Multiple-dose pharmacokinetics will be assessed in a subset of patients. Rationale for study duration will be provided in the protocol, taking into account that CT pneumonia may occur in patients through three months of age, with or without prior history of CT conjunctivitis.
Study 4: This study will be a multicenter, prospective, randomized, double-blind, parallel-arm and placebo-controlled. The study will evaluate oral azithromycin effectiveness in the prevention of CT conjunctivitis and pneumonia in comparison to placebo. The protocol will specify criteria for the diagnoses of CT conjunctivitis and pneumonia. Criteria for the definition of IHPS will be specified in the protocol. Multiple-dose pharmacokinetics will be assessed in a subset of patients in Study 4.
Study 2: A sufficient number of patients should be enrolled to have at least 80% power to demonstrate non-inferiority of azithromycin to erythromycin for the treatment CT pneumonia using a two-sided 95% confidence interval and a pre-specified non-inferiority margin that has been justified and agreed upon by the FDA. The size of the margin should take into account historical evidence of the treatment effect of erythromycin relative to placebo for the treatment of CT pneumonia. Natural history studies show a spontaneous cure rate of 27.2% (three of 11 patients) with a corresponding 95% confidence interval (6.0%, 61%).
Study 4: There are two co-primary endpoints and the number of patients enrolled should fulfill both of the following: (a) A sufficient number of patients should be enrolled to have at least 80% power to demonstrate superiority of azithromycin to placebo for prevention of CT conjunctivitis and pneumonia, using an alpha level=0.05. (b) A sufficient number of patients should be enrolled to have at least 80% power to demonstrate the non-inferiority of azithromycin to placebo in the incidence of IHPS using a two-sided 95% confidence interval and a pre-specified non-inferiority margin that has been justified and agreed upon by the FDA. Based on these requirements for the IHPS endpoint, a sample size of approximately 290 evaluable patients per arm would provide at least 80% power to demonstrate the non-inferiority of azithromycin to placebo in the incidence of IHPS for up to a four-fold increase in the IHPS rate for the azithromycin group relative to placebo. The estimated placebo IHPS incidence rate is 0.19%, and the non-inferiority margin is 3%.
Consideration should be given to the fact that IHPS occurs predominantly in males, and is more frequent in Caucasian and Hispanic/Latino infants than African-American and Asian infants. Investigators are strongly encouraged to enrich the study population with respect to the risk of IHPS, while at the same time assuring adequate gender, ethnic and racial distribution to allow for labeling of azithromycin for all population groups.
The protocols for these studies will be discussed with the FDA and agreed upon prior to study initiation. All measurement estimates used in sample size calculation will be specified and justified in the protocol.
Study 4: The protocol will specify oral azithromycin effectiveness, compared with placebo, for the prevention of CT conjunctivitis and pneumonia as one of the co-primary endpoints. Criteria for diagnoses of CT conjunctivitis and pneumonia will be provided in the protocol, including clinical and bacteriologic measures. Incidence of IHPS will be evaluated as the second co-primary endpoint element. Criteria for the diagnosis of IHPS will be provided in the protocol. Secondary endpoints will include comparison of individual rates of CT conjunctivitis and pneumonia in relation to oral azithromycin or placebo administration.
1. It is unknown whether azithromycin has an adverse events profile similar to or different than that reported for erythromycin, with respect to infantile hypertrophic pyloric stenosis.
2. Colonization and infection with other bacterial (including macrolide-resistant organisms) and non-bacterial organisms (
3. Macrolides have been associated with hearing loss at high doses. The potential for hearing loss with azithromycin treatment in this population will be assessed.
• Dosage Form: approved age appropriate oral formulations of azithromycin and erythromycin Route of Administration: oral
• Regimen: To be determined
Selection of doses for azithromycin in Study 1 will be guided by extrapolation of data from azithromycin use in older infants, published literature and/or current medical practice. Azithromycin doses chosen for Study 2 will be guided by the results of Study 1. For Studies 1 and 2, erythromycin dose will be based on current medical practice. Selection of azithromycin doses for Study 3 will be guided by the results of Studies 1 and 2. Azithromycin doses for Study 4 will be guided by the results of the first three studies.
Please submit protocols for the above studies to an investigational new drug application (IND) and clearly mark your submission “PEDIATRIC PROTOCOL SUBMITTED IN RESPONSE TO WRITTEN REQUEST” in large font, bolded type at the beginning of the cover letter of the submission. Please notify us as soon as possible if you wish to enter into a written agreement by submitting a proposed written agreement. Clearly mark your submission “PROPOSED WRITTEN AGREEMENT FOR PEDIATRIC STUDIES” in large font, bolded type at the beginning of the cover letter of the submission.
Reports of the studies should be submitted as a new drug application (NDA) or as a supplement to an approved NDA with the proposed labeling changes you believe would be warranted based on the data derived from these studies. When submitting the reports, please clearly mark your submission “SUBMISSION OF PEDIATRIC STUDY REPORTS—COMPLETE RESPONSE TO WRITTEN REQUEST” in large font, bolded type at the beginning of the cover letter of the submission and include a copy of this letter.
If you wish to discuss any amendments to this Written Request, please submit proposed changes and the reasons for the proposed changes to your application. Submissions of proposed changes to this request should be clearly marked “PROPOSED CHANGES IN WRITTEN REQUEST FOR PEDIATRIC STUDIES” in large font, bolded type at the beginning of the cover letter of the submission. You will be notified in writing if any changes to this Written Request are agreed upon by the Agency.
We hope you will fulfill this pediatric study request. We look forward to working with you on this matter in order to develop additional pediatric information that may produce health benefits in the pediatric population.
Federal Emergency Management Agency, Emergency Preparedness and Response Directorate, Department of Homeland Security.
Notice.
This notice amends the notice of a major disaster for the State of Florida (FEMA-1545-DR), dated September 4, 2004, and related determinations.
October 8, 2004.
Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472, (202) 646-2705.
Notice is hereby given that the incident period for this disaster is closed effective October 8, 2004.
Federal Emergency Management Agency, Emergency Preparedness and Response Directorate, Department of Homeland Security.
Notice.
This notice amends the notice of a major disaster declaration for the State of Florida (FEMA-1561-DR), dated September 26, 2004, and related determinations.
October 14, 2004.
Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472, (202) 646-2705.
The notice of a major disaster declaration for the State of Florida is hereby amended to include the following areas among those areas determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of September 26, 2004:
Federal Emergency Management Agency, Emergency Preparedness and Response Directorate, Department of Homeland Security.
Notice.
This notice amends the notice of a major disaster declaration for the State of Florida (FEMA-1561-DR), dated September 26, 2004, and related determinations.
October 14, 2004.
Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472, (202) 646-2705.
The notice of a major disaster declaration for the State of Florida is hereby amended to include the following areas among those areas determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of September 26, 2004:
Brevard, Citrus, DeSoto, Glades, Hardee, Hendry, Hernando, Highlands, Indian River, Lake, Levy, Manatee, Marion, Martin, Okeechobee, Orange, Osceola, Palm Beach, Pasco, Polk, Seminole, St. Lucie, Sumter, and Volusia Counties for Public Assistance [Categories C-G] (already designated for Individual Assistance and Public Assistance [Categories A and B], including direct Federal assistance, at 100 percent Federal funding of the total eligible costs for a period of up to 72 hours.)
Federal Emergency Management Agency, Emergency Preparedness and Response Directorate, Department of Homeland Security.
Notice.
This notice amends the notice of a major disaster declaration for the State of Florida (FEMA-1561-DR), dated September 26, 2004, and related determinations.
October 14, 2004.
Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472, (202) 646-2705.
The notice of a major disaster declaration for the State of Florida is hereby amended to include the following areas among those areas determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of September 26, 2004:
Broward County for Public Assistance.
Alachua, Baker, Bradford, Clay, Columbia, Dixie, Duval, Flagler, Gilchrist, Hamilton, Jefferson, Lafayette, Madison, Nassau, St. Johns, Suwannee, Taylor, and Union Counties for Public Assistance (already designated for Individual Assistance.)
Federal Emergency Management Agency, Emergency Preparedness and Response Directorate, Department of Homeland Security.
Notice.
This notice amends the notice of a major disaster declaration for the State of Louisiana (FEMA-1548-DR), dated September 15, 2004, and related determinations.
October 14, 2004.
Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472, (202) 646-2705.
The notice of a major disaster declaration for the State of Louisiana is hereby amended to include the following area among those areas determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of September 15, 2004:
Plaquemines Parish for [Categories C-G] under the Public Assistance program (already designated for Individual Assistance and Public Assistance (Categories A and B) debris removal and emergency protective measures, including direct Federal assistance, at 100 percent Federal funding of the total eligible costs for a period of up to 72 hours.
Federal Emergency Management Agency, Emergency Preparedness and Response Directorate, Department of Homeland Security.
Notice.
This notice amends the notice of a major disaster for the State of New Jersey (FEMA-1563-DR), dated October 1, 2004, and related determinations.
October 1, 2004.
Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472, (202) 646-2705.
Notice is hereby given that the incident period for this disaster is closed effective October 1, 2004.
Federal Emergency Management Agency, Emergency Preparedness and Response Directorate, Department of Homeland Security.
Notice.
This notice amends the notice of a major disaster declaration for the State of New York (FEMA-1564-DR), dated October 1, 2004, and related determinations.
October 13, 2004.
Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472, (202) 646-2705.
The notice of a major disaster declaration for the State of New York is hereby amended to include the following areas among those areas determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of October 1, 2004:
Cattaraugus and Orleans Counties for Public Assistance.
Federal Emergency Management Agency, Emergency Preparedness and Response Directorate, Department of Homeland Security.
Notice.
This notice amends the notice of a major disaster for the State of South Carolina (FEMA-1566-DR), dated October 7, 2004, and related determinations.
October 11, 2004.
Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472, (202) 646-2705.
Notice is hereby given that the incident period for this disaster is closed effective October 11, 2004.
Office of the Secretary, HUD.
Notice of Delegation of Authority.
Effective October 1, 2004, the Secretary is delegating authority and responsibilities to the Assistant
October 1, 2004.
Eliot C. Horowitz, Senior Advisor to the Assistant Secretary for Housing—Federal Housing Commissioner, Office of Housing, Department of Housing and Urban Development, Room 9110, Washington, DC 20410-8000, telephone (202) 708-0614. (This is not a toll-free number.) Persons with hearing or speech impairment may call HUD's toll-free Federal Information Relay Service at (800) 877-8339.
OMHAR was established under the Multifamily Assisted Housing Reform and Affordability Act (Title V of Public Law 105-65, approved October 27, 1997), 42 U.S.C. 1437 (MAHRA). On January 10, 2002, the President signed the Mark-to-Market Extension Act of 2001 (Title VI of Public Law 107-116), amending various programmatic and administrative provisions of MAHRA. MAHRA provides the Department with tools enabling it to restructure the mortgage financing of eligible Secretary-held or HUD-insured projects that receive project-based assistance where necessary to extend their long-term viability. The restructuring program is referred to as the Mark-to-Market program as it is designed to make the rents charged by an insured, assisted project commensurate with prevailing rents in the locality. Recognizing that some projects with above market rents might be unable to maintain economic viability if their rents were brought down to market, the legislation allows HUD to restructure a project's mortgage financing, if necessary. This enables HUD to preserve low-income housing, while the federal government saves money by reducing rent subsidies.
Section 579 of MAHRA states that OMHAR and the position of the Director of OMHAR terminate on September 30, 2004. However, section 579 provides further that on and after October 1, 2004, (1) the Department will continue to engage in restructuring activities previously administered by OMHAR through September 30, 2006, and thereafter, with respect to projects and programs for which binding commitments have been entered into prior to October 1, 2006, and (2) OMHAR's pertinent authority and responsibilities are transferred to the Secretary.
Specifically, section 579 states that subtitle A of MAHRA (titled FHA Insured Multifamily Housing Mortgage and Housing Assistance Restructuring), except for section 524 (titled Renewal of Expiring Project-Based Section 8 Contracts) is repealed effective October 1, 2006. An exception to this repeal allows HUD to continue to apply the provisions of subtitle A “with respect to projects and programs for which binding commitments have been entered into under this Act before October 1, 2006.” Accordingly, although MAHRA terminates OMHAR at the end of September 30, 2004, HUD's authorization to restructure mortgages will continue for a period of at least two years beyond that date.
Effective October 1, 2004, the Secretary is delegating this authority and attendant responsibilities to the Assistant Secretary for Housing-Federal Housing Commissioner. The Assistant Secretary for Housing-Federal Housing Commissioner has been overseeing the operations of OMHAR since January of 2002, when a new section 578 (titled Oversight by Federal Housing Commissioner) was included among the amendments to MAHRA. This oversight authority terminates on September 30, 2004, the same date upon which OMHAR is terminated. Upon the termination of OMHAR, responsibility for the actual conduct of the mark-to-market program will rest with the Assistant Secretary for Housing-Federal Housing, who is authorized to redelegate this authority.
The Assistant Secretary for Housing-Federal Housing Commissioner is delegated the power and authority of the Secretary of HUD to carry out the provisions of MAHRA, 42 U.S.C. 1437f note, and to redelegate such authority.
This delegation supersedes and revokes all authority previously delegated to the Director of OMHAR.
Section 7(d) of the Department of Housing and Urban Development Act (42 U.S.C. 3535(d)).
Office of the Assistant Secretary for Community Planning and Development, HUD.
Notice.
This notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for possible use to assist the homeless.
October 22, 2004.
Kathy Burruss, Department of Housing and Urban Development, Room 7262, 451 Seventh Street, SW., Washington, DC 20410; telephone (202) 708-1234; TTY number for the hearing- and speech-impaired (202) 708-2565, (these telephone numbers are not toll-free), or call the toll-free Title V information line at 1-800-927-7588.
In accordance with the December 12, 1988, court order in
Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD.
Notice of revocation and redelegation of authority.
Published elsewhere in today's
Effective October 1, 2004.
Eliot C. Horowitz, Senior Advisor to the Assistant Secretary for Housing—Federal Housing Commissioner, Office of Housing, Department of Housing and Urban Development, Room 9110, Washington, DC 20410-8000, telephone (202) 708-0614. (This is not a toll-free number.) Persons with hearing or speech impairments may call HUD's toll-free Federal Information Relay Service at (800) 877-8339.
The Mark-to-Market program was established under the Multifamily Assisted Housing Reform and Affordability Act, Title V. of Public Law 105-65 (approved October 27, 1997), 42 U.S.C. 1437f note, as amended (MAHRA). Under the Mark-to-Market program, HUD is authorized to restructure the mortgage financing of projects, financed with HUD-insured or HUD-held mortgages and receiving project-based Section 8 assistance. As originally enacted, MAHRA provided for the establishment of the Office of Multifamily Housing Assistance Restructuring (OMHAR), for the purpose of administering the program. However, present amendments to MAHRA provide for the elimination of OMHAR as of September 30, 2004, and for the continuation of the Mark-to-Market program subsequent to that date.
Elsewhere in today's
Under this redelegation of authority, the Assistant Secretary is redelegating authority to administer the program to the General Deputy Assistant Secretary and to various officials within OAHP.
The Office of Affordable Housing Preservation is headed by a Deputy Assistant Secretary (DAS) and an Associate Deputy Assistant Secretary (ADAS). OAHP is headquartered in Washington, DC and has two field offices; one located in Washington, DC, the other in Chicago, IL. OAHP also has staff out-stationed in New York City.
Within this redelegation, the Assistant Secretary is redelegating authority to the General Deputy Assistant Secretary; the OAHP Deputy Assistant Secretary; the OAHP Associate Deputy Assistant Secretary; OAHP Directors; OAHP Deputy Directors; the Bonds and Appeals Manager, at headquarters; and the Rehabilitation Escrow Administration Division Manager, out-stationed in New York City.
Based upon the foregoing, the Assistant Secretary for Housing hereby redelegates authority as follows:
A. The Assistant Secretary for Housing redelegates to the General Deputy Assistant Secretary (GDAS) the following authority:
All authority necessary to carry out the provisions of the Mark-to-Market Program, 42 U.S.C. 1437f note, except for the authority to issue and/or waive regulations; and except for the authority to sue and be sued.
B. The Assistant Secretary for Housing redelegates to the OAHP Deputy Assistant Secretary (DAS) and to the OAHP Associate Deputy Assistant Secretary (Associate DAS), the following authority:
(1) To modify and sign any documents necessary to perform enumerated functions and to waive any directive issued by OAHP that is not mandated by a statute or regulation.
(2) To administer all provisions of MAHRA, including but not limited to the following:
(a) To make eligibility determinations under sections 512 and 516 of MAHRA;
(b) To enter into, modify and or extend agreements with participating administrative entities under section 513 of MAHRA;
(c) In connection with a restructuring transaction, to make rent and/or mortgage restructuring determinations under sections 514, 515, 517 and 524; and
(d) To terminate, modify or affirm any decision on appeal under MAHRA.
(3) In connection with a restructuring transaction, to modify the principal balance, payments, interest rate, and amortization period and other terms of existing FHA insured and HUD-held mortgages including any HUD or Secretary-held subordinate debt encumbering or otherwise related to a project; and to issue restructuring commitments and closing documents relating to such debt.
(4) To issue HUD forms 92264 and 92264A upon approval of a restructuring plan.
(5) In connection with a restructuring transaction, to approve transfers of physical assets.
(6) In connection with a restructuring transaction, to approve environmental assessment and compliance findings for related laws report, HUD form 4128.1.
(7) To issue a commitment to insure and endorse for insurance a mortgage note given to refinance a HUD-insured or HUD-held mortgage, pursuant to section 223(a)(7) of the National Housing Act (12 U.S.C. 1715n).
(8) For qualified nonprofits acquiring projects that are the subject of a restructuring transaction, to modify, assign or forgive debt created in the restructuring.
(9) To administer escrow accounts and modify the agreement established under the restructuring transaction, for the purpose of addressing immediate and near term rehabilitation needs of a project.
(10) To perform all source selection official duties, subject to laws, regulations, and HUD policies and procedures governing the procurement process.
(11) To administer grant programs, other than selecting a grantee as only the Assistant Secretary for Housing is authorized to function as the Grant Official for the Office of Housing.
C. The Assistant Secretary for Housing redelegates to each OAHP Director and OAHP Deputy Director, in the Field Offices and at Headquarters, the following authority:
(1) To modify and sign any documents necessary to perform enumerated functions and to waive any directive issued by OAHP that is not mandated by a statute or regulation.
(2) To administer the following provisions of MAHRA:
(a) To make eligibility determinations under sections 512 and 516 of MAHRA;
(b) In connection with a restructuring transaction, to make rent and/or mortgage restructuring determinations under sections 514, 515, 517 and 524; and
(c) To reject or hear and decide any appeal made to the Production Office under 24 CFR 401.645 or other permissible procedure.
(3) In connection with a restructuring transaction, to modify the principal balance, payments, interest rate, and amortization period and other terms of existing FHA insured and HUD-held
(4) To issue HUD forms 92264 and 92264A upon approval of a restructuring plan.
(5) In connection with a restructuring transaction, to approve transfers of physical assets.
(6) In connection with a restructuring transaction, to approve environmental assessment and compliance findings for related laws report, HUD form 4128.1.
(7) To issue a commitment to insure and endorse for insurance a mortgage note given to refinance a HUD-insured or HUD-held mortgage, pursuant to section 223(a)(7) of the National Housing Act (12 U.S.C. 1715n).
(8) For qualified nonprofits acquiring projects that are the subject of a restructuring transaction, to modify, assign or forgive debt created in the restructuring.
D. The Assistant Secretary for Housing redelegates to the Rehabilitation Escrow Administration Manager, the following authority:
(1) To modify and sign any documents necessary to perform enumerated functions related to the rehabilitation needs of a project that was the subject of a restructuring transaction, and to waive any directive issued by OAHP that is not mandated by a statute or regulation.
(2) To administer escrow accounts and modify the agreement established under the restructuring transaction, for the purpose of addressing immediate and near term rehabilitation needs of a project.
E. The Assistant Secretary for Housing redelegates to the Bonds and Appeals Manager, the following authority:
(1) To modify and sign any documents necessary to perform enumerated functions related to appeals under MAHRA and/or the regulations promulgated under MAHRA.
(2) To reject or hear and decide any appeal under MAHRA and/or the regulations promulgated under MAHRA except for 24 CFR 401.645
The authority redelegated herein does not include the authority to issue or to waive HUD regulations. The authority redelegated herein also does not include the authority to sue or be sued.
The authority redelegated herein may not be further redelegated.
Section 7(d), Department of Housing and Urban Development Act (42 U.S.C. 3535(d)).
Fish and Wildlife Service, Interior.
Notice of availability.
The Family Crisis Center (Applicant) has applied for an incidental take permit (TE-094076-0) pursuant to section 10(a) of the Endangered Species Act (Act). The requested permit would authorize incidental take of the endangered Houston toad. The proposed take would occur as a result of the construction and operation of a retail thrift store on a 1.38-acre property located on State Highway 71 in the Tahitian Village Subdivision, Bastrop County, Texas.
To ensure consideration, written comments must be received on or before December 21, 2004.
Persons wishing to review the application may obtain a copy by writing to the Regional Director, U.S. Fish and Wildlife Service, P.O. Box 1306, Room 4102, Albuquerque, New Mexico 87103. Persons wishing to review the Environmental Assessment/Habitat Conservation Plan (EA/HCP) may obtain a copy by contacting Clayton Napier, U.S. Fish and Wildlife Service, 10711 Burnet Road, Suite 200, Austin, Texas 78758 (512/490-0057). Documents will be available for public inspection by written request, by appointment only, during normal business hours (8 to 4:30) at the U.S. Fish and Wildlife Service Office, Austin, Texas. Written data or comments concerning the application and EA/HCP should be submitted to the Supervisor, U.S. Fish and Wildlife Service, Austin, Texas, at the above address. Please refer to permit number TE-094076-0 when submitting comments.
Clayton Napier at U.S. Fish and Wildlife Service, 10711 Burnet Road, Suite 200, Austin, Texas 78758.
Section 9 of the Act prohibits the “taking” of endangered species such as the Houston toad. However, the Fish and Wildlife Service (Service), under limited circumstances, may issue permits to take endangered wildlife species incidental to, and not the purpose of, otherwise lawful activities. Regulations governing permits for endangered species are at 50 CFR 17.22.
The Service has prepared the EA/HCP for the incidental take application. A determination of jeopardy or non-jeopardy to the species and a decision pursuant to the National Environmental Policy Act (NEPA) will not be made until at least 60 days from the date of publication of this notice. This notice is provided pursuant to section 10(c) of the Act and NEPA regulations (40 CFR 1506.6).
Pursuant to the June 10, 2004, order in
Bureau of Land Management (BLM), Lakeview District.
The Southeast Oregon Resource Advisory Council (SEORAC) will hold a meeting for all members from 8 a.m. to 5 p.m. Standard Time (ST), Thursday, November 18, 2004 and 8 a.m. to noon (ST) on Friday, November 19, 2004 at the Holiday Inn, 1249 Tapadera Ave, Ontario, Oregon 97914. Members of the public may attend the meeting in person at the Holiday Inn Lewis and Clark Meeting Rooms. The meeting topics that may be discussed by the Council include a discussion of issues within Southeast Oregon related to: Welcome new members, Role and Responsibilities of RAC members; 2005 Calendar Dates; RAC charter changes. Update on Steens/Andrews RMP. Vale District weed presentation. Archeological presentation. Discussion of the subcommittee priorities and roles, meeting of subcommittees; Lakeview RMP, Timber Salvage, Wild Horses, North Lake Recreation Plan. Federal Officials' update and other issues that may come before the Council.
Friday, November 19, 2004 the SEORAC will have a field trip to the Owyhee River.
Information to be distributed to the Council members is requested in written format 10 days prior to the Council meeting. Public comment is scheduled for 9:15 a.m. (ST) on Thursday, November 18, 2004.
Additional information concerning the SEORAC meeting may be obtained from Pam Talbott, Contact Representative, Lakeview Interagency Office, 1301 South G Street, Lakeview, OR 97630 (541) 947-6107, or
Bureau of Land Management.
Notice of Extension of Comment Period for the Draft Resource Management Plan Amendment and Draft Environmental Impact Statement (Draft RMP/Draft EIS) for the Clear Creek Management Area, Hollister Field Office, California.
The Bureau of Land Management (BLM) announces an extension of the comment period on the Draft RMP/Draft EIS for the Clear Creek Management Area. The Original Notice of Availability issued July 19, 2004 (69FR43011) provided for a comment period to end on October 15, 2004. BLM is extending the comment period to November 15, 2004 to allow agencies and the public additional time to provide comments on the Draft RMP/Draft EIS.
Comments on the Draft RMP/Draft EIS must be received no later than November 15, 2004 at the address listed below.
Written comments should be sent to CCMA RMP Team, Bureau of Land Management, Hollister Field Office, 20 Hamilton Court, Hollister, CA 95023. Comments may also be sent by e-mail to
George E. Hill, Assistant Field Manager, at the above address, telephone number (831) 630-5036, or e-mail;
Bureau of Land Management, Interior.
Public land order.
This order withdraws 94.21 acres of public land from surface entry and mining, for a period of 10 years, for the Bureau of Land Management to protect public health and safety, as well as the reclamation efforts of land affected by previous milling operations at the Bullion Monarch Mill Site.
October 22, 2004.
Dennis J. Samuelson, BLM Nevada State Office, PO Box 12000, Reno, Nevada 89520, 775-861-6532.
By virtue of the authority vested in the Secretary of the Interior by Section 204 of the Federal Land Policy and Management Act of 1976, 43 U.S.C. 1714 (2000), it is ordered as follows:
1. Subject to valid existing rights, the following described public land is hereby withdrawn from settlement, sale, location, or entry under the general land laws, including the United States mining laws (30 U.S.C. Ch. 2 (2000)), but not from leasing under the mineral leasing laws, for the Bureau of Land Management to protect public health and safety, as well as the reclamation efforts of land affected by previous milling operations at the Bullion Monarch Mill Site:
The area described contains 94.21 acres in Nye County.
2. The withdrawal made by this order does not alter the applicability of those public land laws governing the use of the land under lease, license, or permit, or governing the disposal of their mineral or vegetative resources other than under the mining laws.
3. This withdrawal will expire 10 years from the effective date of this order unless, as a result of a review conducted before the expiration date pursuant to section 204(f) of the Federal Land Policy and Management Act of 1976, 43 U.S.C. 1714(f) (2000), the Secretary determines that the withdrawal shall be extended.
Bureau of Land Management, Interior.
Notice.
The Department of the Interior, Central Utah Project Completion Act Office, proposes to withdraw, for a term of 20 years, approximately 6,450 acres of National Forest System lands to protect the Utah Lake and the Diamond Fork Systems. This notice segregates the lands for up to 2 years from location and entry under the United States mining laws. The lands will remain open to all other uses which may by law be made of National Forest System lands. This notice also announces a public meeting.
Comments should be received on or before January 20, 2005. A public meeting is scheduled for December 1, 2004.
Comments should be sent to the Program Director, Central Utah Project (CUP) Completion Act Office, 302 East 1860 South, Provo, Utah 84606-7317.
Reed Murray, CUP Completion Act Office, 801-379-1237.
The Department of the Interior, Central Utah Project Completion Act Office, has filed an application to withdraw, pursuant to section 204 of the Federal Land Policy and Management Act of 1976, 43 U.S.C. 1714, the following described National Forest System lands from location and entry under the United States mining laws, for a period of 20 years, subject to valid existing rights:
The areas described aggregate approximately 6,450 acres in Utah County.
The purpose of the proposed withdrawal is to protect the Federal investment in the proposed Utah Lake and the Diamond Fork Systems, Bonneville Unit of the Central Utah Project.
Discretionary land use authorizations may be allowed during the segregative period, but only with the approval of an authorized office of the Forest Service and with the concurrence of an authorized officer of the Department of the Interior.
The use of a right-of-way or an interagency agreement is not considered to be a desirable or acceptable alternative.
There are no other sites where the systems could be economically constructed.
No water rights will be needed to fulfill the purpose of the requested withdrawal.
All persons who wish to submit comments, suggestions, or objections in connection with the proposed withdrawal may present their views in writing, by the date specified above, to the Program Director, CUP Completion Act Office.
Comments, including names and street addresses of respondents, will be available for public review at the CUP Completion Act Office, 302 East 1860 South, Provo, Utah 84606-7317, during regular business hours, 7:30 a.m. to 4:30 p.m., Monday through Friday, except holidays. Individual respondents may request confidentiality. If you wish to withhold your name or address from public review or from disclosure under the Freedom of Information Act, you must state this prominently at the beginning of your comments. Such requests will be honored to the extent allowed by law. All submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, will be made available for public inspection in their entirety.
Notice is hereby given that a public meeting will be held to provide an opportunity for public comment regarding the proposed withdrawal. The meeting will be held at 7 p.m. on Wednesday, December 1, 2004, at the CUP Completion Act Office, 302 East 1860 South, Provo, Utah.
The application will be processed in accordance with the regulations set forth in 43 CFR 2300.
For a period of 2 years from October 22, 2004, in accordance with 43 CFR 2310.2(a), the lands will be segregated from location and entry under the United States mining laws, unless the application is denied or canceled or the withdrawal is approved prior to that date.
National Park Service, Department of the Interior.
Notice of Intent to prepare an environmental assessment for the Fire Management Plan at Bandelier National Monument.
In a Notice of Intent published August 6, 2003 (68 FR 46661), the National Park Service (NPS) announced its intent to prepare an EIS for the Fire Management Plan at Bandelier National Monument (Bandelier). The NPS has since determined that an environmental assessment (EA), rather than an EIS, is the appropriate environmental documentation for the Fire Management Plan.
The NPS had begun working on the EIS following publication of the Notice of Intent. However, internal discussions and meetings, and comments from public scoping sessions held in the New Mexico cities of Santa Fe, Los Alamos, and Albuquerque in August of 2003 resulted in substantial changes to the fire management plan alternatives proposed under the EIS. Based on these
Through the EA process, Bandelier will revise and update the Fire Management Plan to include the following goals: (1) Provide the means for staff and the public to preserve, protect, understand, and enjoy the natural and cultural resources of Bandelier National Monument through an integrated program where management activities support naturally functioning ecosystems consistent with cultural resource preservation needs. (2) Educate, inform, consult, collaborate, and maintain cooperative fire planning with other land agencies, landowners, and local communities. (3) Achieve ecologically sustainable vegetative conditions across broad vegetation communities by restoring a natural range of variability and bio-diversity. (4) Identify and mitigate hazards related to the Wildland-Urban Interface (WUI) through coordination and collaboration with neighboring agencies and landowners over time and across boundaries.
The following fire management objectives support these goals: (1) Protect life, property, and Bandelier's natural and cultural resources from the effects of unwanted fire. (2) Prevent or mitigate impacts due to fire suppression activities. (3) Institute and maintain a comprehensive Fire Information and Education Program. (4) Restore and maintain fire-dependent ecosystems with the appropriate use of fire. (5) Use prescribed fire to meet fire and resource management goals and objectives. (6) Allow natural fires to function in fire dependent ecosystems. The new Fire Management Plan will emphasize the importance of mitigating measures to reduce effects in the Wildland/Urban Interface and maintaining a comprehensive Fire Information and Education Program.
Jim Whittington, Fire Information Officer, HCR 1, Box 1, Suite 15, Los Alamos, NM 87544. Telephone (505) 672-3861 x512.
National Park Service.
Notice of Availability of the Final General Management Plan/Wilderness Study/Final Environmental Impact Statement, Pictured Rocks National Lakeshore.
Pursuant to the National Environmental Policy Act of 1969, 42 U.S.C. 4321
The draft general management plan/wilderness study/environmental impact statement was on public review from August 29, 2003 through November 23, 2003. Public hearings were held on the draft wilderness study on August 26 at Munising, Michigan, and on August 27 at Grand Marais, Michigan. Responses to substantive public comments are addressed in the final general management plan/wilderness study/environmental impact statement. The NPS will execute a record of decision (ROD) no sooner than 30 days following publication of the Environmental Protection Agency's notice of availability of the final environmental impact statement in the
Copiers of the final general management plan/wilderness study/environmental impact statement are available upon request by writing Karen Gustin, Superintendent, Pictured Rocks National Lakeshore, P.O. Box 40, Munising, Michigan 49862-0040, by phone 906-387-2607, or by e-mail message at
Karen Gustin, Superintendent, Pictured Rocks National Lakeshore, or by calling 906-387-2607.
The final general management plan/wilderness study/environmental impact statement combines two planning elements and an environmental analysis that covers both the plan and the wilderness study. The general management plan (GMP) provides a framework for making decisions about and managing the national lakeshore's resources and visitor use for the next 15 years. The wilderness study explores options for wilderness designation in the national lakeshore from no wilderness to 26 percent of the park. The environmental impact statement (EIS) includes information and analysis on the potential effect of the alternatives explored in the final general management plan/wilderness study both within the national lakeshore boundaries as well as regionally. Five alternatives are examined that address wilderness as well as other visitor use and resource issues. The NPS preferred alternative would expand visitor services on the west and east ends of the park, recommend upgrading of county Road H-58, and propose the Beaver Basin (16% of the lakeshore) be designated as wilderness.
Based on the findings of the wilderness study, a formal wilderness proposal will be submitted to the Director of the NPS for approval and subsequent consideration by the Department of the Interior, President, and Congress.
Project sizes may range from 0.5 to 1,000 acres, and will occur in all vegetation types. Up to 2,200 acres could be treated in each year of implementation. To facilitate these operations, the park's fire operations cache will be centrally located at the Oak Bottom area.
An additional component of the Draft and Final EIS was the amending of the 2001 General Management Plan (GMP), to allow for future consideration of replacing or modernizing the existing park administrative center within the park. Under the selected alternative, the park's GMP is amended to allow the park to consider construction a new administrative building at the existing park headquarters site on Kennedy Memorial Drive (subsequent environmental compliance, with opportunity for public involvement, would be necessary to address this option within a full range of alternatives).
The selected plan was determined to be the “environmentally preferred” alternative. Since the Fire Management Plan/Final Environmental Impact Statement is programmatic in nature, project- or site-specific mitigations may need to be developed and implemented to ensure resource protection efforts reduce or avoid adverse effects. During the fire management planning phase, subject matter experts will review evaluate existing databases and maps, and, if necessary, conduct additional surveys to field verify natural or cultural resource conditions. Additional consultation with the U.S. Fish and Wildlife Service, the California State Historic Preservation Officer, the Redding Rancheria, and others may be required and will be documented in the project planning phase.
This selected plan and three alternatives were identified and analyzed in the Draft and Final EIS. In addition to the selected alternative, the environmental analysis addressed: Alternative/No Action (the current fire management program); Alternative II Prescribed Fire Dominated (the fire program would have focused on the intentional use of fire through the application of prescribed fire to meet ecological restoration and maintenance objectives, and to reduce hazardous fuels throughout the park); and Alternative III Suppression Dominated (all natural and human-ignited wildland fires would have been suppressed). The full spectrum of foreseeable environmental consequences was assessed, and appropriate mitigation measures identified for each alternative.
Interested parties desiring to review the Record of Decision may obtain a complete copy by contacting the Superintendent, Whiskeytown National Recreation Area, P.O. Box 188, Whiskeytown, CA 96095 (530) 242-3400.
Department of the Interior, National Park Service.
Notice of meeting.
Notice is hereby given in accordance with the Federal Advisory Committee Act that a meeting of the Committee for the Preservation of the White House will be held at the White House at 11 a.m. on Wednesday, November 17, 2004.
November 17, 2004.
Executive Secretary, Committee for the Preservation of the White House, 1100 Ohio Drive, SW., Washington, DC 20242. (202) 619-6344.
It is expected that the meeting agenda will include policies, goals, and long range plans. The meeting will be open, but subject to appointment and security clearance requirements. Clearance information, which includes full name, date of birth and social security number, must be received by November 10, 2004. Due to the present mail delays being experienced, clearance information should be faxed to (202) 619-6353 in order to assure receipt by deadline. Inquiries may be made by calling the Committee for the Preservation of the White House between 9 a.m. and 4 p.m. weekdays at (202) 619-6344. Written comments may be sent to the Executive Secretary, Committee for the Preservation of the White House, 1100 Ohio Drive, SW., Washington, DC 20242.
Notice is hereby given in accordance with the Federal Advisory Committee Act that a meeting of the Gates of the Arctic National Park Subsistence Resource Commissions will be held at Fairbanks, Alaska. The purpose of the meeting will be to continue work on currently authorized and proposed National Park Service subsistence hunting program recommendations including other related subsistence management issues. The meeting will be open to the public. Any person may file with the Commission a written statement concerning the matters to be discussed.
The Subsistence Resource Commission is authorized under Title VIII, Section 808, of the Alaska National Interest Lands Conservation Act, Pub. L. 96-487, and operates in accordance with the provisions of the Federal Advisory Committee Act.
The meeting times are, 1. Tuesday, November 9, 2004, from 9 a.m. to approximately 5 p.m. 2. Wednesday,
Locations and dates may need to be changed based on weather or local circumstances. Notice of this meeting will be published in local newspapers and announced on local radio stations prior to the meeting dates. The agenda for the meeting is as follows:
Draft minutes of the meeting will be available for public inspection approximately six weeks after the meeting from the Superintendent, Gates of the Arctic National Park and Preserve, 201 First Ave., Fairbanks, Alaska, 99701.
Dave Mills, Superintendent, at (907) 457-5752 or Fred Andersen, Subsistence Manager, at (907) 455-0621.
Notice is hereby given that on October 18, 2004, a proposed Settlement Agreement in
During negotiations regarding this bankruptcy case, the United States asserted that it has certain claims against the estates of two debtors, Federal-Mogul Corporation and Federal-Mogul Ignition Corporation. The proposed Settlement Agreement would resolve the claims of the United States, and certain state and local governments, against various debtors for the recovery of response costs, incurred at 14 sites, under Section 104(a) of the Comprehensive Environmental Response, Compensation and Liability Act, as amended, 42 U.S.C. 9604(a), and analogous state statutes. In addition, the proposed Settlement Agreement would permit governmental entities and other settlers to resolve in due course any alleged liabilities of debtors at 58 listed “Additional Sites” or any other Additional Site (
Under the proposed settlement, the United States will receive, on behalf of the United States Environmental Protection Agency, allowed secured claims for response costs respecting four Sites totaling $213,080.46. In addition, the United States will receive allowed general unsecured claims relating to two Sites (one of which is among the four Sites with respect to which the United States also has a secured claim) totaling $1,451,201.
The Department of Justice will receive for a period of thirty (30) days from the date of this publication comments relating to the proposed Settlement Agreement. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, P.O. Box 7611, U.S. Department of Justice, Washington, DC 20044-7611, and should refer to
The proposed Settlement Agreement may be examined at the Office of the United States Attorney, District of Delaware, 1007 N. Orange Street, Suite 700, Wilmington, Delaware 19801, and at the Region III Office of the Environmental Protection Agency, 1650 Arch St., Philadelphia, Pennsylvania 19103. During the public comment period, the Stipulation and Agreement may also be examined on the following Department of Justice Web site,
On May 6, 2004, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration (DEA), issued an Order to Show Cause to Absolute Distributing, Inc. (Absolute) proposing to deny its May 12, 2003, application for DEA Certificate of Registration as a distributor of list I chemicals. The Order to Show Cause alleged that granting Absolute's application would be inconsistent with the public interest, as that term is used in 21 U.S.C. 823(h) and 824(a). The order also notified Absolute that should no request for a hearing be filed within 30 days, its hearing right would be deemed waived.
According to the DEA investigative file, the Order to Show Cause was sent by certified mail to Absolute at its proposed registered location at 2005 S. 300 W., Suite C, Salt Lake City, Utah, 84115. It was received on May 10, 2004, and DEA has not received a request for a hearing or any other reply from Absolute or anyone purporting to represent the company in this matter.
Therefore, the Deputy Administrator of DEA, finding that (1) thirty days have passed since delivery of the Order to Show Cause, and (2) no request for a
List I chemicals are those that may be used in the manufacture of a controlled substance in violation of the Controlled Substances Act. 21 U.S.C. 802(34); 21 CFR 1310.02(a). Pseudoephedrine and ephedrine are list I chemicals commonly used to illegally manufacture methamphetamine, a Schedule II controlled substance. As noted in previous DEA final orders, methamphetamine is an extremely potent central nervous system stimulant, and its abuse is a persistent and growing problem in the United States.
The Deputy Administrator's review of the investigative file reveals that an application dated May 12, 2003, was submitted by Mr. David T. Milton, seeking registration to distribute ephedrine, a list I chemical product. Subsequently, Mr. Milton, the President of Absolute, asked that the application be changed to reflect the company's name as registrant.
In connection with the pending application, an on-site pre-registration investigation was conducted on August 18, 2003. Mr. Milton advised investigators that he had been solicited by Premium Oil Company (Premium) to obtain a DEA registration so that Absolute could provide ephedrine to Premium's convenience stores and gas stations, which are located throughout the State of Utah. Premium had also provided Absolute with office and storage space for ephedrine products so that Premium could have easy access to its distributor.
Premium had previously been obtaining its list I chemical products from Spencer Distributing. However, on May 22, 2003, that company surrendered its DEA registration. Mr. Milton was aware that Premium considered ephedrine products to be good sources of income, “better than fuel,” and the company needed Absolute to replace Spencer Distributing as its supplier.
Mr. Milton provided investigators only a generalized list of potential customers, which included almost every gas station and their associated convenience stores in the State of Utah. He could not provide a confirmed list of customers who would purchase the listed chemical products from the company. While he also intended to distribute sundry items if he obtained a DEA registration, Mr. Milton estimated that 30% of Absolute's sales would be ephedrine products.
He intended to primarily distribute 50 and 60 count bottles of list I chemical products. This form of packaging and quantities are preferred by individuals illicitly manufacturing methamphetamine. Further, one of Absolute's intended suppliers had already received two warning letters from DEA that its list I chemical products had been discovered in various illicit settings consistent with clandestine methamphetamine manufacturing.
Neither Mr. Milton nor his brother, the company's Vice-President, had any experience in handling or distributing listed chemical products. On May 1, 2003, diversion investigators had met with Mr. Milton. Among other items, they provided a copy of the DEA Chemical Handler's Manual and a notice regarding combination ephedrine and pseudoephrine products. The investigators explained how ephedrine and pseudoephedrine are used as immediate precursors for making methamphetamine and discussed the history and problems of methamphetamine in Utah.
On August 18, 2003, long after this meeting, investigators were arranging for the pre-registration inspection. At that time they asked Mr. Milton what he knew about the list I chemical products he was seeking to distribute. He replied that he knew nothing about list I chemicals and, while he had been told by investigators the product was used to manufacture methamphetamine, he had no personal proof of that fact.
On April 18, 2001, state investigators made an undercover purchase of Two-Way Max Brand Ephedrine 25 mg. tablets (60 tablets per bottle for a total of 480 dosage units) from a Premium owned gas station/convenience store in West Jordan, Utah. The total amount of ephedrine was 12 grams, which at the time was the threshold amount an individual could legally possess in Utah. The conversion included the topic of using ephedrine to manufacture methamphetamine and the employee suggested the undercover agents return daily to buy eight bottles of ephedrine so they could obtain what they needed. As discussed above Absolute intended to supply its list I chemical products to convenience stores and service stations owned by Premium.
Pursuant to 21 U.S.C. 823(h), the Deputy Administrator may deny an application for Certificate of Registration if she determines that granting the registration would be inconsistent with the public interest. Section 823(h) requires that the following factors be considered in determining the public interest:
(1) Maintenance of effective controls against diversion of listed chemicals into other than legitimate channels;
(2) Compliance with applicable Federal, State and local law;
(3) Any prior conviction record under Federal or State laws relating to controlled substances or to chemicals controlled under Federal or State law;
(4) Any past experience of the applicant in the manufacture and distribution of chemicals; and
(5) Such other factors as are relevant to and consistent with the public health and safety.
As with the public interest analysis for practitioners and pharmacies pursuant to subsection (f) of section 823, these factors are to be considered in the disjunctive; the Deputy Administrator may rely on any one or a combination of factors and may give each factor the weight she deems appropriate in determining whether a registration should be revoked or an application for registration denied.
The Deputy Administrator finds factors four and five relevant to the pending application for registration.
With regard to factor four, the applicant's past experience in the distribution of chemicals, the Deputy Administrator finds this factor relevant based on Mr. Milton's lack of knowledge regarding the laws and regulations governing handling of list I chemical products. In prior DEA decisions, this lack of experience in handling list I chemical products has been a factor in denying pending applications for registration.
With regard to factor five, other factors relevant to and consistent with the public safety, the Deputy Administrator finds this factor weighs heavily against granting the application. Unlawful methamphetamine use is a growing public health and safety concern throughout the United States and in the State of Utah and ephedrine and pseudoephedrine are precursor products needed to manufacture methamphetamine. Operators of illicit methamphetamine laboratories regularly
While there are no specific prohibitions under the Controlled Substances Act regarding the sale of listed chemical products to these entities, DEA has nevertheless found these establishments serve as sources for the diversion of large amounts of listed chemical products.
The Deputy Administrator has previously found that many considerations weighed heavily against registering a distributor of list I chemicals because, “[v]irtually all of the Respondent's customers, consisting of gas stations and convenience stores, are considered part of the grey market, in which large amounts of listed chemicals are diverted to the illicit manufacture of amphetamine and methamphetamine.” Xtreme Enterprises, Inc., supra, 67 FR at 76,197. As in Xtreme Enterprises, Inc., Mr. Milton's lack of a criminal record and stated intent to comply with the law and regulations are far outweighed by his lack of experience and the company's intent to sell ephedrine exclusively to the gray market.
Additionally, the Deputy Administrator is troubled by Mr. Milton's comments suggesting he still questioned whether list I chemical products are being diverted for illicit manufacturing, even after being specifically educated by DEA investigators to the contrary. His professed personal ignorance of the methamphetamine manufacturing problem in Utah suggests he is motivated by financial gain and would be unable or unwilling to comply with the responsibilities of a DEA registrant.
Based on the foregoing, the Deputy Administrator concludes that granting the pending application would be inconsistent with the public interest.
Accordingly, the Deputy Administrator of the Drug Enforcement Administration, pursuant to the authority vested in her by 21 U.S.C. 823 and 824 and 28 CFR 0.100(b) and 0.104, hereby orders the pending application for DEA Certificate of Registration, previously submitted by Absolute Distributing, Inc., be, and it hereby is, denied. This order is effective November 22, 2004.
On April 9, 2004, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration (DEA), issued an Order to show Cause to Roland F. Chalifoux, Jr., D.O. (Respondent) notifying him of an opportunity to show cause as to why DEA should not revoke his DEA Certificate of Registration, BC1457818, under 21 U.S.C. 824(a)(3), and deny his pending application for renewal of that registration pursuant to 21 U.S.C. 823(f). Specifically, the Order to Show Cause alleged in relevant part that on July 19, 2002, the Texas State Board of Medical Examiners (Medical Board) temporarily suspended Respondent's Texas medical license; that on March 20, 2003, the Texas Department of Public Safety (Department) revoked Respondent's state controlled substances registration; and that as a result, Respondent is not authorized to handle controlled substances in Texas, the state in which he maintains his DEA registration.
By letter dated May 7, 2004, the Respondent, through his legal counsel, timely requested a hearing in this matter. As part of his hearing request, the Respondent asserted that he “* * * has a license to practice medicine in Texas [and no] action has been taken to date that has deprived him of the license.” On May 24, 2004, the presiding Administrative Law Judge Mary Ellen Bittner (Judge Bittner) issued to counsel for DEA as well as the Respondent an Order for Prehearing Statements.
In lieu of filing a Prehearing Statement, counsel for DEA filed Government's Motion for Summary Disposition and Motion to Stay the Filing of Prehearing Statements on May 25, 2004. In its motion, the Government recited the primary allegations raised in the Order to Show Cause regarding the July 2002 Temporary Suspension Order of the Medical Board suspending the Respondent's medical license and the Department's March 30, 2003 revocation of the Respondent's Texas state controlled substance registration. In support of its motions, the Government attached copies of the aforementioned Temporary Suspension Order of the Medical Board as well as the revocation notice of the Department. Accordingly, the Government argued that a motion for summary disposition is appropriate in this matter and Respondent's DEA Certicate of Registration should be revoked.
On June 15, 2004, counsel for the Respondent filed a Response to Motion for Summary Disposition. In his reply brief, the Respondent argued in relevant part that because he currently has licenses to practice in jurisdictions outside of Texas, and since the DEA registration may be utilized in any jurisdiction where a practitioner has a license, the DEA matter is “premature.” The Respondent further argued that the Department's revocation notice does not evidence a final action. The Respondent's reply however did not address whether he is currently authorized to handle controlled substances under Texas state law.
On June 28, 2004, Judge Bittner issued her Opinion and Recommended Decision of the Administrative Law Judge (Opinion and Recommended Decision). As part of her recommended ruling, Judge Bittner granted the Government's Motion for Summary Disposition and found that the Respondent lacked authorization to handle controlled substances in Texas, the jurisdiction in which he is registered with DEA. In granting the Government's motion, Judge Bittner also recommended that the Respondent's DEA registration be revoked. No exceptions were filed by either party to Judge Bittner's Opinion and Recommended Decision, and on August 10, 2004, the record of these proceedings was transmitted to the Office of the DEA Deputy Administrator.
The Deputy Administrator has considered the record in its entirety and pursuant to 21 CFR 1316.67, hereby issues her final order based upon findings of fact and conclusions of law as hereinafter set forth. The Deputy Administrator adopts, in full, the Opinion and Recommended Decision of the Administrative Law Judge.
The Deputy Administrator finds that the Respondent currently possesses DEA Certificate of Registration BC1457818, and is registered to handle controlled substances at a location in Arlington, Texas, as well as a second medical practice location in South Lake, Texas. As outlined above, the Respondent is currently without authorization to handle controlled substances in Texas based upon the suspension of his medical license, and
DEA does not have statutory authority under the Controlled Substances Act to issue or maintain a registration if the applicant or registrant is without state authority to handle controlled substances in the state in which he conducts business.
Here, it is clear that the Respondent's state controlled substance license has been revoked and there is no information before the Deputy Administrator which points to the Department's revocation order having been rescinded. As a result, the Respondent is not licensed to handle controlled substances in Texas, where he is registered with DEA, and therefore, he is not entitled to maintain that registration.
In further support of his continued registration with DEA, Respondent argues that consideration should be given to his state licensure to practice medicine in jurisdictions other than Texas. However, as noted in Judge Bittner's Opinion and Recommended Decision, DEA regulations require a separate registration “for each principal place of business or professional practice * * * where controlled substances are manufactured, distributed, imported, exported, or dispensed by a person.” Therefore, the Respondent's assertions regarding his licensure status in jurisdictions outside of Texas are ultimately irrelevant since his DEA Certificate of Registration is for a Texas address, and he is currently not authorized to handle controlled substances in that state.
Accordingly, the Deputy Administrator of the Drug Enforcement Administration, pursuant to the authority vested in her by 21 U.S.C. 823 and 824 and 28 CFR 0.100(b) and 0.104, hereby orders that DEA Certificate of Registration, BC1457818, issued to Roland F. Chalifoux, Jr., D.O., be, and it hereby is, revoked. The Deputy Administrator further orders that any pending applications for renewal or modification of such registration be, and they hereby are, denied. This order is effective November 22, 2004.
On February 6, 2002, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration (DEA), issued an Order to Show Cause to Imran I. Chaudry, M.D. (Respondent) at two separate addresses in Monroe, Louisiana. The Order to Show Cause notified Respondent of an opportunity to show cause as to why DEA should not revoke his DEA Certificate of Registration, BC4775233, and deny any pending applications for modification or renewal of that registration, pursuant to 21 U.S.C. 824(a)(4) and 823(f), for reason that Respondent's continued registration was inconsistent with the public interest.
Specifically, the Order to Show Cause alleged that in March of 2001, Respondent, (1) had been abusing the controlled substances cocaine and methamphetamine, an (2) in April of 2001, Respondent offered to purchase, and in fact purchased, approximately 14 grams of methamphetamine, for which he was arrested and charged with Possession of Methamphetamine with Intent to Distribute, and Conspiracy to Distribute Methamphetamine.
By letter dated March 5, 2002, Respondent through his legal counsel requested a hearing on the issues raised by the Order to Show Cause. Following pre-hearing procedures, a hearing was held on December 4, 2002, in Monroe, Louisiana. While both parties called witnesses to testify at the hearing, Respondent elected not to testify in his behalf. Both parties also introduced documentary evidence. After the hearing, both parties submitted written proposed findings of fact, conclusions of law, and argument.
On June 13, 2003, Administrative Law Judge Gail A. Randall (Judge Randall) issued her Recommended Rulings, Findings of Fact, Conclusions of Law and Decision (Opinion and Recommended Ruling) in which she concluded that grounds existed to revoke Respondent's DEA registration, but recommended that Respondent's then-pending applications for renewal and change of registered address be granted, subject to certain conditions. On June 19, 2003, the Government filed exceptions to Judge Randall's Opinion and Recommended Ruling and on July 2, 2003, Respondent filed a response to the Government's exceptions. On August 6, 2003, Judge Randall transmitted the record of these proceedings to the Administrator of DEA.
The Deputy Administrator has considered the record in it entirety, and pursuant to 21 CFR 1316.67, hereby issues her final order based upon findings of fact and conclusions of law as hereinafter set forth. As set forth below, the Deputy Administrator adopts in part, the recommended findings of fact and conclusions of law of the Administrative Law Judge. The Deputy Administrator does not adopt the Administrative Law Judge's recommendation that Respondent's applications for renewal of registration and change of registered address be granted.
The record before the Deputy Administrator shows that as of the date of the hearing, Respondent's license to practice medicine in Louisiana was in good standing and that he possessed a then-current Louisiana narcotics license. Respondent practices medicine in the vicinity of Monroe, Louisiana as a cardiologist. In the rural area where Respondent's practice is located, the ratio of physicians to patients is approximately 1 to 2,000 to 2,500. Respondent is the only cardiologist in that community. Evidence was also presented during the hearing that, although twenty-five percent of Louisiana's citizens reside in rural areas of the state, only six percent of Louisiana's practicing primary care physicians practice medicine in rural areas.
On August 19, 1998, DEA issued Certificate of Registration BC4775233 to Respondent and that certificate expired on August 31, 2001. Nevertheless, by application dated September 4, 2001, Respondent attempted to renew the registration and modify it to reflect a new address. A Government witness testified that because Respondent submitted a renewal application, he was authorized to prescribe controlled substances within the course of legitimate medical practice on a day-to-day basis until conclusion of these proceedings. However, since he was no
Around March 2001, law enforcement officers from Ouachita Parish in Louisiana received information from a source that Respondent was abusing cocaine and methamphetamine, both Schedule II controlled substances. In response, on April 24, 2001, local law enforcement personnel used a cooperating individual to engage Respondent in a controlled sale of fourteen grams of methamphetamine for $850.00. Prior to their meeting, Respondent and the cooperating individual had a series of monitored phone calls during which Respondent indicated the methamphetamine was not just for personal use, but would be shared with another physician. He requested the methamphetamine be packaged in three separate containers; two containing two grams each and a third with ten grams.
As officers watched, Respondent, who was alone, met the cooperating individual in a parking lot. While seated in adjoining vehicles, Respondent received the drugs, packaged as requested, through the open window of his car. Respondent was then immediately arrested for possession of methamphetamine with intent to distribute and conspiracy to distribute methamphetamine.
During a videotaped post-arrest interview (admitted into evidence as a Government exhibit in this proceeding), Respondent admitted purchasing and using methamphetamine three or four times during the preceding six months. He told officers the methamphetamine he was buying when arrested was for himself and another physician. He admitted obtaining methamphetamine for that same colleague on one prior occasion. Respondent claimed he was not addicted to illegal substances and that he never used drugs at any time while working.
No charges were filed against Respondent's colleague and Respondent was ultimately charged in state court with possession of methamphetamine. As of the date of the hearing before Judge Randall, a motion to suppress Respondent's post-arrest statement was then pending and no trial date had yet been set. There is no evidence in the record that Respondent was ever subsequently tried or convicted of any charges related to this incident.
After his arrest, Respondent entered the Palmetto Addiction Recovery Center (“Palmetto Center”) in Rayville, Louisiana. The Palmetto Center is approved for evaluation and treatment of substance abuse patients by the Louisiana State Board of Medical Examiners (Board). Respondent was evaluated for chemical abuse or dependency at the request of the Board.
Following the Palmetto Center evaluation, Respondent was referred to the Physician's Health Program (“PHP”). The PHP is a professional group that monitors physicians with a prior history of substance abuse. It has had a Memorandum of Understanding with the Board since 1984 and has been accepted by the Board for monitoring the evaluation and treatment of impaired physicians since August 2001. Respondent entered into a monitoring contract with PHP from October 2001 through October 2002 for the purposes of determining whether or not he had developed a chemical dependency.
During this contract period, Respondent was required to abstain from consuming any mood altering substances unless prescribed by a physician, after consultation with PHP. Respondent was randomly drug tested twice a month for the presence of over thirty-five different drugs, including methamphetamine and completed each of his ramdom drug screenings in a timely manner without missing a test. The results were all negative.
PHP also required that Respondent work with a psychiatrist on a regular basis, as well as with a licensed clinical social worker and work-site monitor. The work-site monitor saw Respondent on a daily basis and reported to PHP on Respondent's overall progress in the program, including his interaction with patients, staff and “timeliness in responding to calls, timeliness in doing charts” and his overall professionalism. The record in this proceeding shows Respondent never missed a session with these clinicians.
PHP's medical director testified for Respondent as an expert in addiction medicine. He testified to receiving reports every two months from the monitor and that reports on Respondent's overall interaction with staff and patients were found, among other things, to be “exemplary.” The director also received very favorable progress notes from the psychiatrist and the clinical social worker and neither reported any evidence of clinical disorders in Respondent. Specifically, there were no reports of any indications of substance abuse or addictive behavior from their professionals monitoring Respondent's conduct.
Respondent attended continuing medical education courses as part of his contract with PHP. Specifically, he completed a review course sponsored by the American Society of Addiction Medicine. In addition to successfully completing his one-year monitoring contract, Respondent completed his exit interview with PHP personnel and voluntarily remained in communication with PHP.
Pursuant to 21 U.S.C. 823(f) and 824(a)(4), the Deputy Administrator may revoke a DEA Certificate of Registration and deny any pending applications for renewal of such registration, if she determines that the continued registration would be inconsistent with the public interest. Section 823(f) requires that the following factors be considered in determining the public interest:
(1) The recommendation of the appropriate state licensing board or professional disciplinary authority.
(2) The applicant's experience in dispensing or conducting research with respect to controlled substances.
(3) The applicant's conviction record under federal or state laws relating to the manufacture, distribution, or dispensing of controlled substances.
(4) Compliance with applicable state, federal, or local laws relating to controlled substances.
(5) Such other conduct which may threaten the public health or safety.
These factors are to be considered in the disjunctive; the Deputy Administrator may rely on any one or a combination of factors and may give each factor the weight she deems appropriate in determining whether a registration should be revoked or an application for registration denied.
As to factor one, the recommendation of the appropriate state licensing board or professional disciplinary authority, the Deputy Administrator finds that the Louisiana State Board of Medical Examiners has not made a recommendation in this matter. However, it has not taken adverse action against Respondent's medical or narcotic licenses and he is fully licensed as a physician in Louisiana with controlled substance handling privileges in that state, despite the Board's awareness of the then-pending criminal proceedings. While this may weigh in favor of continuing his registration with DEA, “inasmuch as State licensure is a necessary but not sufficient condition for a DEA registration * * * this factor is not dispositive.”
With regard to factors two and four, Respondent's experience in handling controlled substances and his compliance with applicable controlled substance laws, the record contains no
Of particular concern to the Deputy Administrator is Respondent's admission that he previously distributed methamphetamine to a fellow local physician and the evidence showing a portion of the methamphetamine he was buying when arrested was intended for distribution to that same medical colleague. Respondent's purchase, use and distribution of methamphetamine violated Louisiana and federal law and factors two and four weigh in favor of a finding that his continued registration with DEA would be inconsistent with the public interest.
Factor three, the applicant's conviction record under federal or state laws relating to the manufacture, distribution, or dispensing of controlled substances, is not relevant for consideration, as there is no evidence Respondent was ever convicted of any crime related to controlled substances.
With respect to factor five, other conduct that may threaten the public health and safety, Respondent's unlawful purchase and use of methamphetamine on prior occasions and his distribution of the controlled substance to another physician are also relevant under factor five and weigh in favor of a finding that continued registration would be inconsistent with the public interest.
As noted above, Respondent did not testify at the hearing. The Deputy Administrator may draw a negative inference from Respondent's failure to testify during the administrative hearing.
The Deputy Administrator agrees with the Government and Judge Randall that Respondent's choice in not testifying left the record silent as to possible remorse following his unlawful purchase and use of controlled substances. The Deputy Administrator also shares Judge Randall's concern about the lack of reassurances on the part of Respondent that he will not again engage in unlawful conduct with respect to controlled substances.
The Deputy Administrator agrees with Judge Randall that the Government met its prima facie burden for revoking Respondent's DEA Certificate of Registration and deny his pending requests for renewal and modification. Specifically, the Deputy Administrator agrees with Judge Randall that, “Although not linked with his medical practices per se, the Respondent unlawfully handled methamphetamine by purchasing it for his personal use and the use of others without appropriate medical justification. Such total disregard for the law governing controlled substances can not be tolerated in a physician who has been entrusted to use his professional discretion in treating patients with these same substances.”
However, as Judge Randall notes in her Opinion and Recommended Ruling, the governing statute is discretionary.
Judge Randall concluded a lesser sanction than total revocation of respondent's DEA Certificate of Registration was warranted, based primarily on Respondent's efforts since 2001 to demonstrate continued avoidance of substance abuse and, secondarily, on his community's need for a cardiology specialist, coupled with the absence of any evidence that Respondent mishandled controlled substances in the course of his medical practice. Judge Randall recommended that the Deputy Administrator grant Respondent's application to renew his DEA Certificate of Registration and modify it to the requested new address, with the conditions that he continue participating in the PHP program for the duration of his registration period and that the results of continuing random drug tests be provided the local DEA office.
The Deputy Administrator acknowledges Respondent's positive efforts to tackle his problems. He entered himself into the Palmetto Addiction Recovery Center and was subsequently referred to PHP, where he completed an intensive one-year monitoring program for impaired physicians. It appears Respondent was compliant with all phases of the program, including submission to random urine screens designed to detect the presence of illicit drugs and alcohol. Respondent was deemed to not have a chemical dependency.
The initial findings of the Palmetto Center and Respondent's compliance with the physician monitoring program were corroborated at the hearing by the PHP medical director's testimony on Respondent's behalf. There is no evidence of any misuse of controlled substances by Respondent since his April 2001 arrest, nor is there evidence of any disciplinary action being brought against Respondent by the Louisiana State Medical Board with respect to his handling of controlled substances. However, it is also recognized that these rehabilitative steps were taken while Respondent was under the threat of state prosecution and would have been motivated, at least in part, by the impact they might have on then-pending criminal proceedings, as well as his ability to remain licensed to practice medicine.
As noted above, the Government filed exceptions to Judge Randall's Opinion and Recommended Ruling and Respondent filed a response in opposition to the Government's exceptions.
The Government took exception to Judge Randall's finding that Respondent was the only cardiologist in Rayville, Louisiana; that Judge Randall made ancillary findings regarding physician populations generally in Louisiana; and, that Judge Randall neglected to note that one of the maps in a Respondent's exhibit showed that nearly every parish in Louisiana was classified as “medically underserved.”
There was no evidence presented in this matter that anyone other than Respondent was a licensed cardiologist practicing in Rayville, a town of approximately 4,000 people, which was the parish seat. While there was evidence that six physicians, including Respondent, practiced in the area, there was no evidence that any of them, other than Respondent, were trained, licensed or otherwise possessed credentials to practice cardiology.
The Deputy Administrator is also not persuaded by the Government's argument regarding the physician population in Louisiana, or its argument regarding the appropriate weight to be accorded evidence of maps purportedly demonstrating medically underserved parishes in Louisiana.
The Deputy Administrator finds that, regardless of any demographic showing as to what proportion of Louisiana's population is medically underserved;
The Government also took exception to Judge Randall's finding regarding the veracity of the random drug tests administered Respondent, especially as they relate to the detection of methamphetamine. The Government argued in part, that “[f]rom the factual findings, it would be possible that Respondent could have taken methamphetamine many times in the month, and yet evaded detection.” The Government further argues that the 24 to 36 hour metabolism rate for methamphetamine, in effect, creates an adequate window for a person to avoid detection when administered a drug test.
The Deputy Administrator is reluctant to apply the Government's arguments to these facts. While it is acknowledged it is “possible” Respondent could have taken methamphetamine and avoided detection, to accept the premise that he continued abusing would require assumptions about his conduct that are not supported by the record.
The primary aim of a “random” drug test is to create a level of unpredictability as to when the test will be administered. The unpredictable nature of such a test theoretically creates a disincentive for the continued use of drugs on the part of the individual being monitored. Against this backdrop, it is important to point out there is no evidence in the record raising any question as to the efficacy of the PHP drug testing program. Without such evidence, and in light of evidence of Respondent's negative drug tests, the Deputy Administrator concludes that the random nature of the PHP-administered tests served as an effective deterrent to Respondent's further drug use.
The Government also argued it would be unreasonable to reach the conclusion testified to by the PHP medical director that “a single use of illegal drugs or even three illegal uses in a one-year period” does not constitute evidence of chemical abuse. This argument is not particularly compelling.
The Deputy Administrator agrees with Respondent that the term “abuse,” as being used by the witness, was referring to the diagnosis of chemical abuse under the DSM-4, which requires certain criteria which, in the witness's opinion, were not present in Respondent's case. While the Deputy Administrator agrees with the Government that a single or multiple uses of illegal drugs can be deemed “abuse” in non-diagnostic terminology, Judge Randall's findings on this point were primarily credibility findings as to the expert's assessment of Respondent's lack of chemical dependency.
The Deputy Administrator considers Respondent's illicit purchase and use of methamphetamine particularly serious acts of misconduct. As the record demonstrates, Respondent was not chemically dependent. This infers that it was neither addiction nor dependency that motivated his “street” purchases of methamphetamine. Instead, he exercised unhindered judgment to illegally obtain and use what he as a physician, well knew to be an insidiously dangerous controlled substance and did so, according to his post-arrest interview, to enhance his sex life. This motivation to violate the law and risk his reputation and livelihood evidences a particularly cavalier and irresponsible attitude toward his responsibilities as a DEA registrant.
There is no evidence in the record that Respondent used illicit drugs while actually engaged in the practice of medicine. However, as a cardiologist, it is inferred that it was possible that he might be subject to being called on unexpectedly to treat patients experiencing serious heart problems on an emergent basis. If this had occurred while Respondent was under the influence of methamphetamine, his patients would either have been placed at risk by Respondent's impairment or, if he declined to treat them because of his drug use, they would not have been able to be seen immediately by another cardiology specialist, as Respondent was the only one in the rural area. These potential risks should have been apparent to Respondent when he elected to use methamphetamine and raise significant questions as to his judgment and ability to use sound professional discretion in treating patients with controlled substances.
Of particular concern to the Deputy Administrator is the finding that Respondent admitted previously purchasing methamhetamine and illicitly distributing it to another individual. This criminal conduct is made even more egregious because the recipient was a fellow physician. The evidence also shows that a portion of the methamphetamine Respondent was purchasing when arrested was destined for distribution to that medical colleague. Thus, in an area already undeserved by medical professionals, Respondent not only placed himself at risk, but, by distributing methamphetamine to another physician, added to the threat posed to his rural community by potentially impaired physicians.
Since his arrest, Respondent's professional practice has continued without blemish and he has avoided illicit drugs. These are commendable and indicate potential for future registration. On the other hand, Respondent's calculated abandonment of his responsibilities and willingness to risk serious criminal and professional sanctions do not auger well for continued registration being in the public interest. As observed by the Seventh Circuit Court of Appeal, “[a]n agency rationally may conclude that past performance is the best projector of future performance.”
Based on the foregoing, at this time, the Deputy Administrator does not have sufficient confidence that Respondent can successfully fulfill the responsibilities of a registrant.
Accordingly, the Deputy Administrator of the Drug Enforcement Administration, pursuant to the authority vested in her by 21 U.S.C. 823 and 28 CFR 0.100(b), and 0.104, hereby orders that DEA Certificate of Registration BC4775233, previously issued to Imran I. Chaudry, M.D., be and it hereby is revoked. His pending application for renewal of that registration and his request to modify said registration to reflect a new requested address, are hereby denied. This order is effective November 22, 2004.
On February 20, 2004, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration (DEA), issued an Order to Show Cause to Juan Pillot-Costas, M.D. (Respondent) of Ponce, Puerto Rico, notifying him of an opportunity to show cause as to why DEA should not revoke his DEA Certificate of Registration BP3441475, as a practitioner, under 21 U.S.C. 824(a)(5) and deny any pending applications for renewal or modification of that
By letter dated March 18, 2004, Respondent, through legal counsel, requested a hearing. On April 20, 2004, Administrative Law Judge Gail A. Randall (Judge Randall) issued an Order for Prehearing Statements, requiring the Government and Respondent to file prehearing statements by May 12 and June 2, 2004, respectively. The Government filed a timely prehearing statement, however, Respondent failed to file his prehearing statement by the deadline.
On June 29, 2004, Judge Randall issued a
Therefore, the Deputy Administrator finds that Respondent, having requested a hearing but having failed to participate in the matter after being apprised of the consequences, is deemed to have waived his hearing right.
The Deputy Administrator finds that Respondent currently possesses DEA Certificate of Registration BP3441475. The Deputy Administrator further finds that as a result of Respondent's fraudulent activities, pursuant to his guilty plea, he was convicted in the United States District Court, District of Puerto Rico of one count of conspiring to solicit and receive kickbacks in relation to Medicare referrals for durable medical equipment, in violation of 18 U.S.C. 371, in addition to one count of providing false declarations before the grand jury, in violation of 18 U.S.C. 1623.
As a result of Respondent's conviction of the Medicare related count, on March 31, 2003, he was notified by the Department of Health and Human Services of his five-year mandatory exclusion from participation in the Medicare program pursuant to 42 U.S.C. 1320a-7(a). Exclusion from Medicare is an independent ground for revoking a DEA registration. 21 U.S.C. 824(a)(5);
Accordingly, the Deputy Administrator of the Drug Enforcement Administration, pursuant to the authority vested in her by 21 U.S.C. 823 and 824 and 28 CFR 0.100(b) and 0.104, hereby orders that DEA Certificate of Registration BP3441475, issued to Juan Pillot-Costas, M.D., be, and it hereby is, revoked. The Deputy Administrator further orders that any pending applications for renewal of such registration be, and they hereby are, denied. This order is effective November 22, 2004.
On January 5, 2004, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration (DEA), issued an Order to Show Cause to John A. Cronk, M.D. (Dr. Cronk),
1. On May 21, 2003, in the Criminal District of Dallas County Texas, pursuant to a plea agreement, Dr. Cronk entered a plea of guilty to unlawfully possessing methamphetamine, a third degree felony under Texas state law. Dr. Cronk was placed on unsupervised probation for a period of five years, ordered to enroll in an inpatient drug treatment at a treatment center in Atlanta, Georgia and to pay a $1500 fine. The court directed that further proceedings be deferred in the case without entering an adjudication of guilt. The conviction was premised on Dr. Cronk's arrest for possession of methamphetamine which took place at the Dallas/Fort Worth Airport on November 28, 2002.
2. During April 2003, DEA diversion investigators received information from former and current employees of Dr. Cronk's medical office that he failed to maintain accountability of controlled substances or maintained a controlled substance log book for an extensive period. The employees further divulged that they suspected Dr. Cronk of abusing drugs during office hours and had also found on his office desk a vial containing a substance later tested and identified by a field test as methamphetamine. This test was conducted by a long-term patient of Dr. Cronk, who was also a former law enforcement officer. When confronted by that patient, Dr. Cronk admitted methamphetamine use.
3. On May 7, 2003, at the request of DEA investigators, officers of the Northeast Area Interdiction Task Force (NADITF) recovered three bags of trash from Dr. Cronk's residence in Heath, Texas. Among the items recovered were a syringe with a brown liquid substance later determined to be methamphetamine, an attached needle, and discarded pieces of mail bearing Dr. Cronk's name and address.
4. A state search warrant obtained to search Dr. Cronk's residence was then executed by NADITF officers and DEA investigators on May 9, 2003. Recovered in that search were several vials containing residual amounts of methamphetamine; forty-five tabs of methadone; two vials of testosterone; ninety-five tabs of alprazolam; thirty-six tabs of Ambien; eight tabs of Vicoprofen; six bottles of Lortab elixir; five bottles of Histex; six tabs of ecstasy; several marijuana cigarette butts; $9,911.00 in cash; and, over 200 blood collection vials which had been converted to methemphetamine pipes, along with other drug paraphernalia.
5. On May 15, 2003, DEA investigators arrived at Dr. Cronk's office in Quinlan, Texas (which was also Dr. Cronk's DEA registered location) to conduct an audit of controlled substances. Dr. Cronk was not present during, but his office manager nevertheless signed a DEA
6. Among the records provided was Dr. Cronk's controlled substance log, with the last entry in the log dated August 15, 2002. Dr. Cronk also produced an assortment of box tops, sample boxes, and other assorted pieces of paper and notes, including post-its, which he claimed were records of what had been dispensed to patients. Several of those boxes had multiple entries on them.
7. In the estimation of DEA investigators, Dr. Cronk's records were inaccurate, incomplete or irretrievable, thus making it impossible for them to conduct an audit of controlled substances. Dr. Cronk admitted his records were not in compliance with DEA requirements, that he was unaware of the requirement to conduct inventories of all controlled substances on hand every two years, and that he had not accomplished such inventories.
The Order to Show Cause was sent by certified mail to Dr. Cronk at his registered location in Quinlan, Texas and was accepted on his behalf on January 15, 2004. Despite subsequent written and verbal contacts by Dr. Cronk's office to the DEA Dallas Field Division, the agency's Office of Chief Counsel, as well as DEA Office of the Administrative Law Judges, there is no record of any request for a hearing having been received on behalf of Dr. Cronk.
Therefore, the Deputy Administrator of DEA, finding that (1) thirty days having passed since the delivery of the Order to Show Cause to the registrant's address of record, and (2) no request for hearing having been received, concludes that Dr. Cronk is deemed to have waived his hearing right.
The Deputy Administrator finds that Dr. Cronk is currently registered with DEA as a practitioner. According to information received subsequent to the issuance of the aforementioned Order to Show Cause, on March 15, 2004, Dr. Cronk entered into an Agreed Order with the Texas State Board of Medical Examiners (Board). As recited in the Order to Show Cause, the Board similarly found that on May 21, 2003, Dr. Cronk “* * * pled guilty to charges of possession of the controlled substance methamphetamine, a third degree felony. Conditions of [Dr. Cronk's plea] agreement included entrance to drug treatment * * *, probation for 5 years, fine of $1,300 and random drug screens.” The Board cited additional concerns regarding Dr. Cronk's “* * * unprofessional conduct, disciplinary action by [his] peers, and non-therapeutic prescribing.”
Accordingly, Dr. Cronk and the Board agreed,
There is no evidence before the Deputy Administrator that Dr. Cronk has satisfied the conditions of the Board for reinstatement of his medical license, or that the Board suspension order has been stayed or lifted. In light of the suspension of his authorization to practice medicine in Texas, the Deputy Administrator also finds it reasonable to infer that Dr. Cronk is also without authorization to handled controlled substances in that state. As a result, Dr. Cronk is not entitled to maintain a DEA registration in Texas.
Pursuant to 21 U.S.C. 824(a), the Deputy Administrator may revoke a DEA Certificate of Registration is she finds that the registrant has had his state license revoked or suspended and is no longer authorized to dispense controlled substances or has committed such acts as would render his registration contrary to the public interest as determined by factors listed in 21 U.S.C. 823(f).
DEA does not have statutory authority under the Controlled Substance Act to issue or maintain a registration if the applicant or registrant is without state authority to handle controlled substances in the state in which he conducts business.
Here, it is clear that Dr. Cronk's Texas medical license has been suspended and by inference, he is currently not authorized under Texas law to handle controlled substances in his medical practice. Therefore, he is not entitled to a DEA registration in that state. As a result of a finding that Dr. Cronk lacks state authorization to handle controlled substances, the Deputy Administrator concludes that it is unnecessary to address further whether his DEA registration should be revoked based upon the public interest grounds asserted in the Order to Show Cause.
Accordingly, the Deputy Administrator of the Drug Enforcement Administration, pursuant to the authority vested in her by 21 U.S.C. 823 and 824 and 28 CFR 0.100(b) and 0.104, hereby orders that DEA Certificate of Registration, BC2204131, issued to John A. Cronk, D.O., be, and it hereby is, revoked. The Deputy Administrator further orders that any pending applications for renewal or modification of such registration be, and they hereby are, denied. This order is effective November 22, 2004.
On September 27, 2002, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration (DEA), issued an Order to Show Cause to Express Wholesale (Respondent) proposing to deny its application for a DEA Certificate of Registration as a distributor of list I chemicals. The Order to Show Cause alleged in relevant part that granting the
Respondent, through counsel, requested a hearing on the issues raised by the Order to Show Cause and the matter was docketed before Administrative Law Judge Gail A. Randall. Following prehearing procedures, a hearing was held in Oklahoma City, Oklahoma on October 21-22, 2003. At the hearing both parties called witnesses to testify and introduced documentary evidence. Subsequently both parties filed Proposed Findings of Fact, Conclusions of Law, and Argument.
On May 18, 2004, Judge Randall issued her Recommended Findings of Fact, Conclusions of Law, and Decision of the Administrative Law Judge (Opinion and Recommended Ruling), recommending that Respondent's application for a Certificate of Registration as a distributor of listed chemical products be denied. Neither party filed exceptions to the Opinion and Recommended Ruling and on June 24, 2004, Judge Randall transmitted the record of these proceedings to the Deputy Administrator.
The Deputy Administrator has considered the record in its entirety and pursuant to 21 CFR 1316.67, hereby issues her final order based upon findings of fact and conclusions of law hereinafter set forth. The Deputy Administrator adopts, in full, the Opinion and Recommended Ruling of the Administrative Law Judge. Her adoption is in no manner diminished by any recitation of facts, issues and conclusions herein, or any failure to mention a matter of fact or law.
By application dated August 23, 2001, Mr. Terry H. Kim, owner of Express Wholesale, located at 1913 Dyer Drive, Moore, Oklahoma, submitted an application for a DEA Certificate of Registration as a distributor of list I chemicals, seeking authority to distribute pseudoephedrine and phenylpropanolamine.
List I chemicals are those that may be used in the manufacture of a controlled substance in violation of the Controlled Substances Act. 21 U.S.C. 802(34); 21 CFR 1310.02(a). Pseudoephedrine and ephedrine are list I chemicals commonly used to illegally manufacture methamphetamine, a Schedule II controlled substance. At the time that Respondent submitted its application for DEA registration, phenylpropanolamine, also a list I chemical, was a legitimately manufactured and distributed product used to provide relief of the symptoms resulting from irritation of the sinus, nasal and upper respiratory tract tissues, and is also used for weight control. Phenylpropanolamine is also a precursor chemical used in the illicit manufacture of methamphetamine and amphetamine. As noted in previous DEA final orders, methamphetamine is an extremely potent central nervous system stimulant, and its abuse is a persistent and growing problem in the United States.
On February 5, 2002, a DEA diversion investigator conducted a pre-registration inspection at Respondent's proposed registered location. It was situated in the residential duplex where Mr. Kim lives. He indicated he would store the listed chemical products in one-half of the unit's two-car garage, which did not have an internal secure storage container.
During the visit, the investigator provided Mr. Kim with a copy of DEA regulations and reference materials commonly referred to as the “Red Sheet” and the “Green Sheet.” These documents direct an applicant's attention to matters involving the diversion of ephedrine, pseudoephedrine and phenylpropanolamine to the illicit production of amphetamine and methamphetamine. The investigator additionally explained the meaning of both notices to Mr. Kim and asked if he had any questions about the notices.
When asked what products he intended to sell, Mr. Kim mentioned only Max Brand Pseudo 60 (“Max Brand”) and indicated that Max Brand would make up 30% of Respondent's overall business. He then asked the investigator if that was “too much.” After the on-site visit, Mr. Kim called the investigator several times inquiring as to the status of the application and stated he was losing business and customers because he could not provide them with the Max Brand product.
Mr. Kim also provided a customer list during the inspection and the investigator recognized many of the intended customers through her work on an unrelated criminal investigation during which she had visited 50 to 75 convenience stores in Oklahoma City, Oklahoma and Dallas, Texas. After being apprised the investigator was having problems confirming customers on his list, about a month later, Mr. Kim sent a supplemental list, which was shorter and had some different customers.
The investigator again recognized some of the store names as being involved with on-going criminal investigations. Several of the prospective customers were also on lists provided by other distributors with pending applications or were customers of current registrants. A significant portion of Respondent's prospective customers were convenience stores and gas stations.
During a brief follow-up visit on February 20, 2002, the investigator confirmed that Mr. Kim had now installed a wooden, padlocked storage container in the garage. The investigator concluded this would afford adequate physical security for storage of the list I chemical products.
Respondent's business consists primarily of supplying general merchandise to convenience stores and gas stations. When he began the registration application process, Mr. Kim was not aware that pseudoephedrine was used to manufacture methamphetamine. While Mr. Kim indicated he was aware of, and willing to abide by all requirements levied upon a DEA registrant, his testimony at the hearing reflected uncertainty as to his actual understanding of those requirements.
Mr. Kim did agree to exclude Max Brand from the product list if the application was granted. He also furnished 48 signed “form letter” type statements from owners or representatives of retail outlets in the Oklahoma City area, indicating they supported Respondent's DEA registration and would use its products only for legitimate purposes.
Methamphetamine use is a growing problem in the State of Oklahoma and pseudophedrine and ephedrine are combined with other products to manufacture methamphetamine. Convenience stores have been the primary source for the pseudoephedrine and ephedrine used in the illicit manufacturing of methamphetamine in the Oklahoma City area and some of these convenience stores are supplied through different wholesale distributors.
Max Brand Pseudo 60 is the precursor product predominantly encountered and seized at clandestine methamphetamine laboratories. Convenience stores are also the primary source for the purchase of the Max Brand products, which are the preferred brand for use by illicit methamphetamine producers and users. Large, nationally recognized chains such as Wal-Mart and Eckerd do not usually carry Max Brand products. While the record is unclear as to quantity and strength of products, in
By declaration, the Government presented an expert witness in the area of statistical analysis of convenience stores and their sale of pseudoephedrine. Mr. Jonathan Robbin, a consultant in marketing information systems and databases, presented his evidence on behalf of the government as an expert in statistical analysis and quantitative marketing research. With respect to the expert analysis by Mr. Robbin, the Deputy Administrator adopts the following findings of fact, as set forth in Judge Randall's Opinion and Recommended Ruling.
Using the 1997 United States Economic Census of Retail Trade, Mr. Robbin tabulated data indicating that “over 97% of all sales of non-prescription drug products,” including non-prescription cough, cold and nasal congestion remedies, occur in drug stores and pharmacies, supermarkets, large discount merchandisers, mail-order houses and through electronic shopping. He characterized these five retail industries as “the traditional marketplace where such goods are purchases by ordinary customers.”
Analyzing national sales data specific to over-the-counter, non-prescription drugs containing pseudoephedrine, Mr. Robbin characterized convenience stores as a “nontraditional market” for the sale of such products. His research and analysis show “that a very small percentage of the sales of such goods occur in convenience stores—only about 2.6% of the HABC [Health and Beauty Care] category of merchandise or 0.05% of total in-store (non-gasoline) sales.” He concluded that “[c]onvenience stores, therefore, definitely constitute a ‘non-traditional’ market for the sale of over-the-counter, non-prescription drug pseudoephedrine products.”
He explained that this information supports DEA's conclusion that pseudoephedrine products distributed to this nontraditional market greatly exceeded the normal demand for such products at such retail outlets. He agreed that such excessive sales could be purchases of listed chemical products that were diverted to illicit uses.
With respect to Oklahoma wholesale pseudoephedrine sales of several distributors and over 300 of their retail customers, all of which were convenience stores, a July 2002 analysis by Mr. Robbin led to the conclusion “that without evidence of the existence of immense numbers of legitimate customers, it was likely that the massive inventories of pseudoephedrine products purchased by these Oklahoma stores were being turned to illegal uses.”
In connection with Respondent's prospective customer list, Mr. Robbin also analyzed data accumulated from prior DEA cases regarding wholesale sales of pseudoephedrine products to convenience store retailers in Oklahoma. He found that more than two-thirds of Respondent's proposed customers had previously acquired “excessive amounts of listed chemical products from one or more sources.” He further opined that a large number of the stores from Respondent's list were not “in the normal or traditional range of expectation in regard to the stocking and presumed sale of pseudoephedrine (Hcl) tablets.”
Four of the stores show an index of actual purchase rates of pseudoephedrine tablets in excess of 100% over the expected purchase rate. One store purchased a quantity valued at 208.9% over the expected legitimate purchase rate for such products. Given the small size of most convenience stores and the normal purchases of legitimate customers, Mr. Robbin concluded that “[s]uch values are not possible in the normal commerce of these goods * * *”
He also concluded that the data pertaining to Respondent's proposed customer list indicates Respondent “will predominantly serve retailers who already acquire excessive amounts of product from multiple sources” and that Mr. Robbin's analysis clearly showed Respondent would not be selling listed chemical products to the traditional market for such over-the-counter drug products.
Pursuant to 21 U.S.C. 823(h), the Deputy Administrator may deny an application for a Certificate of Registration if she determines that granting the registration would be inconsistent with the public interest as determined under that section. Section 823(h) requires the following factors be considered in determining the public interest:
(1) Maintenance of effective controls against diversion of listed chemicals into other than legitimate channels;
(2) Compliance with applicable Federal, state, and local law;
(3) Any prior conviction record under Federal or State laws relating to controlled substances or to chemicals controlled under Federal or State law;
(4) Any past experience in the manufacture and distribution of chemicals; and
(5) Such other factors as are relevant to and consistent with the public health and safety.
As with the public interest analysis for practitioners and pharmacies pursuant to subsection (f) of section 823, these factors are to be considered in the disjunctive; the Deputy Administrator may rely on any one or combination of factors, and may give each factor the weight she deems appropriate in determining whether a registration should be revoked or an application for registration denied.
The Deputy Administrator finds factors one, four and five relevant to Respondent's pending registration application.
As to factor one, maintenance by the applicant of effective controls against diversion, the Deputy Administrator agrees with Judge Randall that the physical security of the proposed storage arrangement was adequate. However, DEA has previously held that registrants have a responsibility to maintain controls against diversion, beyond the confines of the mere physical security afforded the product.
Judge Randall found the record devoid of any indication that Mr. Kim had contemplated any measures by which he could ensure that potential customers would not acquire excessive listed chemical products that would ultimately be diverted. Lacking any business practices or systems that would act as a detection system, she concluded “Respondent would be unable to effectively monitor suspicious purchase orders to alert him to the need to inquire as to the possibility of a proposed illicit distribution of the listed chemical product, or to alert him to the need to report such illicit distribution to the DEA.”
The evidence also failed to demonstrate that Mr. Kim grasped the need for monitoring the packaging of the listed chemical product he planned to distribute. The Deputy Administrator agrees with Judge Randall that “DEA has legitimate concerns if a distributor elects to sell such bottles of listed chemical product, versus if a distributor elects to sell such product marketed in small quantity, blister packs.”
Accordingly, particularly given Respondent's lack of a plan for a business monitoring system, factor one weights against registration
As to factors two and three, there is no evidence that Mr. Kim has any criminal record or evidence that he violated any laws, which weighs in favor of granting the application.
With regard to factor four, the applicant's past experience in the distribution of chemicals, the Deputy Administrator agrees with Judge Randall that the record demonstrates Mr. Kim lacks experience and knowledge in the distribution of listed chemical products. While he has offered assurances that he now knows the risks involved in handling listed chemical products, the absence of an adequate business plan to minimize the risk to the general public is significant.
In prior DEA decisions, this lack of experience in handling list I chemical products has been a factor in denying pending applications for DEA registration.
With regard to factor five, other factors relevant to and consistent with the public safety, the Deputy Administrator finds this factor weighs heavily against granting the application. Unlawful methamphetamine use is a growing public health and safety concern throughout the United States and specifically in the State of Oklahoma. Pseudoephedrine and ephedrine are the precursor products used to manufacture methamphetamine and users predominantly have acquired the precursor products needed to manufacture the drug from convenience stores and gas stations.
The Deputy Administrator specifically concurs with Judge Randall's finding that Max Brand is the product preferred by illicit methamphetamine manufacturers and users. Also, while Mr. Kim made a belated gesture in agreeing to eliminate Max Brand from his product list, it is only one of multiple precursor products used to manufacture the drug and the same public interest factors apply to other brands as well. As recognized by Judge Randall, “merely declining to sell the Max Brand product is not enough to outweight the other public interest concerns that must be taken into consideration here.”
While Mr. Kim has not been involved in the manufacturing of methamphetamine, the majority of his proposed customers operate convenience stores and gas stations. As noted by Judge Randall, the Deputy Administrator has previously found that many considerations weighed heavily against registering a distributor of list I chemicals because, “[v]irtually all of the respondent's customers, consisting of gas station and convenience stores, are considered part of the grey market, in which large amounts of listed chemicals are diverted to the illicit manufacture of amphetamine and methamphetamine.” Extreme Enterprises, Inc., supra, 67 FR at 76,197. As in Xtreme Enterprises, Inc., Mr. Kim's lack of a criminal record, compliance with the law and a willingness to upgrade physical security are far outweighed by his lack of experience and his intent to sell ephedrine almost exclusively in the gray market. Id.
The Deputy Administrator additionally takes notice that after the hearing on this matter concluded, Oklahoma enacted House Bill 2176, titled the “Oklahoma Methamphetamine Reduction Act of 2004.” Under this statute, which was signed on and made effective as of April 6, 2004, among its provisions, the sale of pseudoephedrine tables is now restricted to licensed pharmacies. Accordingly, Respondent's proposed base of Oklahoma customers in no longer legally viable.
Among the listed chemical products Respondent intends to distribute is phenylpropanolamine. As did Judge Randall, the Deputy Administrator also finds factor five relevant to the request to distribute phenylpropanolamine and apparent lack of safety associated with the use of that product. DEA has previously determined that an applicant's request to distribute phenylpropanolamine constitutes a ground under factor five for denial of an application for registration.
Based on the foregoing, the Deputy Administrator concludes that granting the pending application of Respondent would be inconsistent with the public interest. As discussed by Judge Randall, DEA is justified in registering only those applicants who grasp the severity of the problem and understand and can implement controls to stop diversion of listed chemical products. Notwithstanding the loss of his customer base as a result of state legislative action, the record here falls woefully short of establishing that Mr. Kim has the requisite level of understanding, ability or willingness to establish and maintain business controls and procedures adequate to prevent diversion of listed chemical products.
Accordingly, the Deputy Administrator of the Drug Enforcement Administration, pursuant to the authority vested in her by 21 U.S.C. 823 and 28 CFR 0.100(b) and 0.104, hereby orders that the pending application for a DEA Certificate of Registration, previously submitted by Express Wholesale be, and it hereby is, denied. This order effective November 22, 2004.
On August 11, 2003, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration (DEA), issued an Order to Show Cause to J & S Distributors (J & S) proposing to deny its application, executed on August 30, 2000, for DEA Certificate of registration as a distributor of List I chemicals. The Order to Show Cause alleged in relevant part that granting the application of J & S would be inconsistent with the public interest as that term is used in 21 U.S.C. 823(h) and 824(a). The Order to Show Cause also notified J & S that should not request for a hearing be filed within 30 days, its hearing right would be deemed waived.
According to the DEA investigative file, the Order to Show Cause was sent by certified mail to J & S Distributors at its proposed registered location in Louisville, Kentucky. The return receipt indicated the Order to Show Cause was received on August 18, 2003, by Jeffrey D. Guernsey, president and owner of J & S. DEA has not received a request for hearing or any other reply from J & S or anyone purporting to represent the company in this matter.
Therefore, the Deputy Administrator of DEA, finding that (1) thirty days having passed since receipt of the Order to Show Cause, and (2) no request for hearing having been received, concludes that J & S has waived its hearing right.
List I chemicals are those that may be used in the manufacture of a controlled substance in violation of the Controlled Substances Act. 21 U.S.C. 802(34); 21 CFR 1310.02(a). Pseudoephedrine and ephedrine are List I chemicals commonly used to illegally manufacture methamphetamine, a Schedule II controlled substance. At the time that J & S Distributors submitted its application for DEA registration, phenylpropanolamine, also a List I chemical, was a legitimately manufactured and distributed product used to provide relief of the symptoms resulting from irritation of the sinus, nasal and upper respiratory tract tissues, and is also used in the illicit manufacture of methamphetamine and amphetamine. As noted in previous DEA final orders, Methamphetamine is an extremely potent central nervous system stimulant, and its abuse is a persistent and growing problem in the United States.
The Deputy Administrator's review of the investigative file reveals that on August 30, 2000, J & S submitted an application for DEA registration as a distributor of the List I chemicals epheedrine, pseudoephedrine and phenylpropanolamine. The application was submitted on behalf of J & S by Jeffrey Guernsey. There is no information before the Deputy Administrator that J & S had sought to modify its pending application with respect to any of the listed chemical products it proposes to distribute. Upon receipt of the application, the DEA Louisville District Office initiated a pre-registration investigation of J & S in September of 2000.
According to the investigative file, during DEA's initial pre-registration inspection of J & S, the firm had no office or warehouse to conduct its business, and therefore, DEA was unable to immediately accomplish an inspection. However, DEA investigators conducted a second on-site pre-registration inspection of J & S on April 2, 2001, when the firm subsequently secured office and storage space in the vicinity of Louisville.
DEA's investigation revealed that J & S is a sole proprietorship operated by Jeffrey Guernsey, along with this father David Guernsey. The company is a wholesale distributor of key chains, pens, ceramics, lighters and commemorative items. Mr. Guernsey provided DEA with a product list of predominantly novelty items. A few ephedra based non-drug products were on the list. However, no health and beauty aids or non-regulated cough and cold products were included in their product list.
According to the DEA investigative file, Jeffrey Guernsey provided DEA investigators with a “customer master list” indicating he had 270 customers in about twenty states. Mr. Guernsey indicated he would acquire product directly from three manufacturers and further proposed to ship listed chemicals to those on his customer list by parcel service or truck shipment.
DEA investigators contacted several purported customers of J & S, who indicated they did do business with the company. However, none of these customers expressed any intention of purchasing listed chemical products from J & S.
DEA's subsequent review of the company's “customer master file list” revealed those entities were predominantly distributors or wholesalers located in other states. Of the customers listed, several did not have DEA registrations to handle List I chemical products, four had their DEA registrations revoked or suspended, another four were the subject of pending DEA registration actions, and another ten were known to DEA to be already receiving similar listed chemical products form multiple wholesale distributors. None of these wholesalers had any known retail customers other than convenience stores or gas stations.
In support of J & S' pending application for registration, on March 30, 2001, Jeffrey Guernsey sent DEA a “Letter of Compliance” along with a copy of the company's “return policy on List I Chemicals.” The letter was signed by Jeffrey Guernsey as President and David L Guernsey, who listed himself as “Consultant.” The letter outlined the experience of certain members of the Guernsey family in handling listed chemical products. However, Jeffrey Guernsey did not provide information as to any experience he personally had with List I products.
Pursuant to 21 U.S.C. 823(h), the Deputy Administrator may deny an application for Certificate of Registration if she determines that granting the registration would be inconsistent with the public interest as determined under that section. Section 823(h) requires the following factors be considered in determining the public interest:
(1) Maintenance of effective controls against diversion of listed chemicals into other than legitimate channels;
(2) Compliance with applicable Federal, State, and local law;
(3) Any prior conviction record under Federal or State laws relating to controlled substances or to chemicals controlled under Federal or State law;
(4) Any past experience in the manufacture and distribution of chemicals; and
(5) Such other factors as are relevant to and consistent with the public health and safety.
As with the public interest analysis for practitioners and pharmacies pursuant to subsection (f) of section 823, these factors are to be considered in the disjunctive; the Deputy Administrator may rely on any one or combination of factors, and may give each factor the weight she deems appropriate in determining whether a registration should be revoked or an application for registration denied.
The Deputy Administrator finds factors four and five relevant to J & S' pending registration application.
With respect to factor four, the applicant's past experience in the distribution of chemicals, the Deputy Administrator finds this factor relevant to Jeffrey Guernsey's apparent lack of experience in the handling of List I chemical products. The DEA investigative files shows that J & S is a retailer of general merchandise. While Jeffrey Guernsey provided information to DEA about members of his family who had experience in the handling of listed chemicals, it is unclear what role, if any, these family members would have in J & S' overall operation. Jeffrey Guernsey, J & S' sole proprietor and president, appears to be company's primary operator and he has not demonstrated that he possesses any previous experience handling listed chemical products. In prior DEA decisions, lack of experience in handling List I chemicals was a factor in determinations to deny applications for DEA registration.
With respect to factor five, other factors relevant to and consistent with the public safety, the Deputy Administrator finds this factor relevant to J & S' proposal to distribute listed chemical products to customers who have engaged in questionable business practices. As noted above, several of J & S' proposed customers have had DEA registrations revoked or suspended, or are already receiving listed chemical
As noted above, there is no evidence in the investigative file that J & S has sought to modify its pending application with regard to the listed chemical products it seeks to distribute. Among the listed chemical products the firm intends to distribute is phenylpropanolamine. Accordingly, the Deputy Administrator also finds factor five relevant to J & S' request to distribute phenylpropanolamine and the apparent lack of safety associated with the use that product. DEA has previously determined that an applicant's request to distribute phenylpropanolamine constitutes a ground under factor five for denial of an application for registration.
Accordingly, the Deputy Administrator of the Drug Enforcement Administration, pursuant to the authority vested in her by 21 U.S.C. 823 and 28 CFR 0.100(b) and 0.104, hereby orders that the pending application for DEA Certificate of Registration, previously submitted by J & S Distributors be, and it hereby is, denied. This order is effective November 22, 2004.
On March 2, 2004, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration (DEA), issued an Order to Show Cause to Sarfraz Mirza, M.D. (Respondent) of Melbourne, FL, notifying him of an opportunity to show cause as to why DEA should not revoke his DEA Certificate of Registration, AM8413813, as a practitioner, pursuant to 21 U.S.C. 824(a)(3) and deny any pending applications for renewal of that registration pursuant to 21 U.S.C. 823(f). As a basis for revocation, the Order to Show Cause alleged that the Florida Department of Health had ordered an immediate suspension of Respondent's license to practice medicine in Florida and accordingly, he was not authorized to handle controlled substances in the state in which he is registered.
On May 17, 2004, through counsel, Respondent timely requested a hearing in this matter. On May 25, 2004, Administrative Law Judge Mary Ellen Bittner (Judge Bittner) issued the Government, as well as Respondent, an Order for Prehearing Statements.
In lieu of filing a prehearing statement, the Government filed Government's Request for Stay of Proceedings and Motion for Summary Disposition. The Government argued Respondent was without authorization to handle controlled substances in the State of Florida, and as a result, further proceedings in the matter were not required. Attached to the Government's motion was a copy of the State of Florida, Department of Health's Order of Emergency Suspension of License, indefinitely suspending Respondent's license to practice medicine in Florida, effective as of July 29, 2003.
On June 4, 2003, Judge Bittner issued a Memorandum to Counsel, staying the filing of prehearing statements and giving Respondent an opportunity to respond to the Government's motion. Respondent failed to file a response to the motion.
On August 10, 2004, Judge Bittner issued her Opinion and Recommended Decision of the Administrative Law Judge (Opinion and Recommended Decision). As part of her recommended ruling, Judge Bittner granted the Government's Motion for Summary Disposition, finding the Respondent lacked authorization to handle controlled substances in Florida, the jurisdiction in which he is registered. Judge Bittner recommended that Respondent's DEA registration be revoked and any pending applications for renewal or modification of that registration be denied. No exceptions were filed by either party to Judge Bittner's Opinion and Recommended Decision and on September 15, 2004, the record of these proceedings was transmitted to the Office of the DEA Deputy Administrator.
The Deputy Administrator has considered the record in its entirety and pursuant to 21 CFR 1316.67, hereby issues her final order based upon findings of fact and conclusions of law as hereinafter set forth. The Deputy Administrator adopts, in full, the Opinion and Recommended Decision of the Administrative Law Judge.
The Deputy Administrator finds that Respondent holds DEA Certificate of Registration, AM8413813. The Deputy Administrator further finds that, effective as of July 29, 2003, the State of Florida, Department of Health issued its Order of Emergency Suspension of License, suspending Respondent's authority to practice as a physician in the State of Florida. There is no evidence in the record indicating that this suspension has been lifted, stayed or that Respondent's license has been reinstated. As a result, he is not currently authorized to prescribe, dispense, administer, or otherwise handle controlled substances in the State of Florida, his place of DEA registration.
DEA does not have statutory authority under the Controlled Substances Act to issue or maintain a registration if the applicant or registrant is without state authority to handle controlled substances in the state in which he conducts business. See 21 U.S.C. 802(21), 823(f) and 924(a)(3). This prerequisite has been consistently upheld. See Karen Joe Smiley, M.D., 68 FR 48,944 (2003); Dominick A. Ricci, M.D., 58 FR 51,104 (1993); Bobby Watts, M.D., 53 FR 11,919 (1988). Revocation is also appropriate when a state license has been suspended, but with a possibility of future reactivation. See Anne Lazar Thorn, M.D., 62 FR 12,847 (1997).
Here, it is clear Respondent currently lacks authority to handle controlled substances in Florida, the state in which he is registered with DEA as a practitioner. Therrefore, DEA does not have authority to maintain Respondent's DEA Certificate of Registration for his Florida practice or to grant any pending applications for renewal or modification of that registration.
Accordingly, the Deputy Administrator of the Drug Enforcement Administration, pursuant to the authority vested in her by 21 U.S.C. 823 and 824 and 28 CFR 0.100(b) and 0.104, hereby orders that DEA Certificate of Registration, AM8413813, issued to Safraz Mirza, M.D., be, and it hereby is, revoked. The Deputy Administrator further orders that any pending applications for renewal or modification of such registration be, and they hereby are, denied. This order is effective November 22, 2004.
On March 15, 2004, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration (DEA), issued an Order to Show Cause to Richard Daniel Price, M.D. (Dr. Price) of Birmingham, Alabama, notifying him of an opportunity to show cause as to why DEA should not revoke his DEA Certificate of Registration, BP4769949, as a practitioner, pursuant to 21 U.S.C. 824(a)(3) and deny any pending applications for renewal of that registration pursuant to 21 U.S.C. 823(f). As a basis for revocation, the Order to Show Cause alleged that Dr. Price's license to practice medicine in Alabama had been revoked and accordingly, he was not authorized to handle controlled substances in Alabama, the state in which he is registered.
On May 3, 2004, Dr. Price, acting
On May 13, 2004, Judge Bittner issued an Order and Notice providing Dr. Price an opportunity to respond to the Government's motion. Dr. Price did not file a response. On June 28, 2004, Judge Bittner issued her Opinion and Recommended Decision of the Administrative Law Judge (Opinion and Recommended Decision). As part of her recommended ruling, Judge Bittner granted the Government's Motion for Summary Judgment, finding Dr. Price lacked authorization to handle controlled substances in Alabama, the jurisdiction in which he is registered. Judge Bittner recommended that Dr. Price's DEA registration be revoked and any pending applications for renewal or modification of that registration be denied. No exceptions were filed by either party to the Opinion and Recommended Decision and on August 10, 2004, the record of these proceedings was transmitted to the Office of the DEA Deputy Administrator.
The Deputy Administrator has considered the record in its entirety and pursuant to 21 CFR 1316.67, hereby issues her final order based upon findings of fact and conclusions of law as hereinafter set forth. The Deputy Administrator adopts, in full, the Opinion and Recommended Decision of the Administrative Law Judge.
The Deputy Administrator finds that Dr. Price holds DEA Certificate of Registration, BP4769949, which expires on March 31, 2005. The Deputy Administrator further finds that, effective as of March 31, 2003, the Medical Licensure Commission of Alabama revoked Dr. Price's Alabama medical license based on his conviction of a felony, a violation of Alabama Code 34-24-360(5) (1997). There is no evidence in the record indicating that the Commission's order has been stayed or rescinded or that Dr. Price's license has been reinstated. Therefore, the Deputy Administrator finds that Dr. Price is currently not licensed to practice medicine in Alabama and, as a result, it is reasonable to infer that he is also without authorization to handle controlled substances in that state.
DEA does not have statutory authority under the Controlled Substances Act to issue or maintain a registration if the applicant or registrant is without state authority to handle controlled substances in the state in which he conducts business.
Here, it is clear that Dr. Price is not currently authorized to handle controlled substances in Alabama, where he is registered with DEA. Therefore, he is not entitled to maintain that registration. Accordingly, the Deputy Administrator of the Drug Enforcement Administration, pursuant to the authority vested in her by 21 U.S.C. 823 and 824 and 28 CFR 0.100(b) and 0.104, hereby orders that DEA Certificate of Registration, BP4769949, issued to Richard Daniel Price, M.D., be, and it hereby is, revoked. The Deputy Administrator further orders that any pending applications for renewal or modification or such registration be, and they hereby are, denied. This order is effective November 22, 2004.
On August 11, 2003, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration (DEA), issued an Order to Show Cause to Ivan D. Garcia-Ramirez, M.D. (Respondent), proposing to evoke his DEA Certificate of Registration, BG2485173, pursuant to 21 U.S.C. 824(a)(2) and 824(a)(4). The Order to Show Cause alleged that Respondent had been convicted of a felony related to controlled substances and that his continued registration would be inconsistent with the public interest.
By letter dated September 10, 2003, Respondent, through his counsel, requested a hearing and on September 30, 2003, Presiding Administrative Law Judge Mary Ellen Bittner (Judge Bittner) issued the Government, as well as Respondent, an Order for Prehearing Statements.
On October 2, 2003, the Government timely filed its prehearing statement. However, Respondent failed to file a prehearing statement and on December 5, 2003, Judge Bittner issued an Order Terminating Proceedings, noting Respondent's lack of response was
Therefore, the Deputy Administrator finds as follows: (1) Respondent requested a hearing; (2) he was directed to file a prehearing statement and cautioned that failure to comply with that order could be considered a waiver of hearing and an implied withdrawal of his request for hearing; and (3) Respondent failed to submit a prehearing statement. The Deputy Administrator therefore concludes Respondent is deemed to have waived his hearing right and, after considering material from the investigative file in this matter, now enters her final order without a hearing, pursuant to 21 CFR 1301.43(d) and (e) and 1301.46.
Respondent is currently registered with DEA as a practitioner under Certificate of Registration number BG2485173, at a registered location in Mayaguez, Puerto Rico. That registration expires on September 30, 2005.
According to information in the investigative file, in November 2001, Special Agents from the DEA San Juan Field Office received information that the Sea Brave, a Puerto Rico registered vessel owned by Respondent, may have been used in the trafficking of controlled substances in St. Maarten, Netherlands Antilles. The same information was communicated to Dutch Customs, which placed a lookout for Respondent's vessel.
On June 16, 2002, the Dutch Coast Guard observed the Sea Brave outside the St. Maarten harbor channel. Dutch authorities instructed the vessel return to the marina, inside St. Maarten territorial waters,where it was boarded by Dutch authorities. At the time of boarding, Respondent was on board, along with two others. Upon search of the vessel by Dutch Customs officers, 549 grams of heroin were recovered from a hidden compartment in the cabin area and all individuals on board were arrested and taken to the St. Maarten Police Station.
When questioned the next day, Respondent admitted being told by an individual that at least nine kilograms of cocaine and six kilograms of heroin had been placed on board the Sea Brave. Further he admitted seeing an individual place two boxes and eighty pellets of suspected heroin inside a hidden compartment, behind a television set on board the vessel. Upon receipt of this information, Dutch Customs went back on board the Sea Brave, which had been docked overnight at a nearby pier. However, it was discovered that someone had apparently already boarded the vessel and removed the television from its wall unit. A hidden compartment behind the television was empty.
After negotiations between the United States Department of Justice and the Dutch Government, it was concluded prosecutions would take place in the United States District Court, District of Puerto Rico and Respondent and his cohorts were indicted on charges of conspiring to import more than one kilogram of heroin, a Schedule I Narcotic Controlled Substance, and more than five kilograms of cocaine, a Schedule II Narcotic Controlled Substance, in violation of 21 U.S.C. 952, 960 and 963. Respondent entered pleas of not guilty and was detained pending trial at the Metropolitan Detention Center in Guaynabo, Puerto Rico. On September 19, 2002, Respondent plead guilty to one felony count of 21 U.S.C. 952(a), Possession With Intent To Import Heroin. On May 16, 2003, he was sentenced to 20 months incarceration and 60 months supervised release.
Pursuant to 21 U.S.C. 823(f) and 824(a)(4), the Deputy Administrator may revoke a DEA Certification of Registration and deny any pending applications for renewal of such registration, if she determines that continued registration would be inconsistent with the public interest. Section 823(f) requires that the following factors be considered in determining the public interest:
(1) The recommendation of the appropriate state licensing board or professional disciplinary authority.
(2) The applicant's experience in dispensing, or conducting research with respect to controlled substances.
(3) The applicant's conviction record under federal or state laws relating to the manufacture, distribution, or dispensing of controlled substances.
(4) Compliance with applicable State, Federal, or local laws relating to controlled substances.
(5) Such other conduct which may threaten the public health or safety.
These factors are to be considered in the disjunctive; the Deputy Administrator may rely on any one or a combination of factors and may give each factor the weight she deems appropriate in determining whether a registration should be revoked or an application for registration denied.
It is undisputed that Respondent was convicted of Possession With Intent to Import Heroin. Since Respondent's felony conviction related to controlled substances, grounds exist to revoke his DEA registration under 21 U.S.C. 824(a)(2).
Next, the Deputy Administrator considers whether Respondent's continued registration would be inconsistent with the public interest. In this case, the Deputy Administrator finds factors three, four and five relevant in determining whether continuing Respondent's registration would be inconsistent with the public interest.
As to factor one, the recommendation of the appropriate state licensing board or professional disciplinary authority, there is no evidence in the investigative file of action being taken against any professional license of Respondent. With respect to factor two, his experience in dispensing, or conducting research with respect to controlled substances, there is no information in the investigative file relative to Respondent's lawful handling of controlled substances in his professional practice.
With regard to factors three, four and five, the Deputy Administrator finds that Respondent, by his own admission, used his vessel to knowingly transport cocaine and heroin and attempted to conceal the drugs in a hidden compartment. He was then arrested and convicted of Possession With Intent to Import Heroin. The egregious nature of Respondent's conduct bears directly upon his fitness to possess a DEA registration and, applying the above factors, leads to the obvious conclusion that Respondent's continued registration would be inconsistent with the public interest.
Accordingly, the Deputy Administrator of the Drug Enforcement Administration, pursuant to the authority vested in her by 21 U.S.C. 823 and 824 and 28 CFR 0.100(b) and 0.104, hereby orders that DEA Certificate of Registration, BG2485173, previously issued to Ivan D. Garcia-Ramirez, be, and it hereby is, revoked. This order is effective November 22, 2004.
On October 10, 2003, the then-Acting Deputy Administrator of the Drug Enforcement Administration (DEA),
The Order to Show Cause and Immediate Suspension of Registration alleged in relevant part, that Respondent, owned and operated by Vincent Chhabra, Sabrina Faruqui and Carleta Carolina, dispensed over 19,300,000 various controlled substances through orders of customers who had accessed an Internet Web site set up by Respondent. Customers of Respondent would complete a questionnaire set up on the Web site, which solicited information about the customer, including the type of medication desired. After the customer's credit card was processed, the questionnaire was forwarded to one of several “staff” physicians who then issued prescriptions for the controlled substances being ordered. The prescriptions were then sent electronically to Respondent, which then dispensed the controlled substances to customers through the mail. The “staff” physicians, as well as Respondent's customers, were located in various states throughout the United States and the physicians had no interaction with customers before prescribing the controlled substances.
The Order to Show Cause and Immediate Suspension of Registration also alleged that on April 21, 2001, DEA issued a policy statement,
The Order to Show Cause and Immediate Suspension of Registration further referenced correspondence during November 2002 and February 2003 between the United States Department of Justice and the then-attorney of Vincent Chhabar. In those letters, Mr. Chhabra's attorney was reminded that his client had been notified of the foregoing DEA policy and requested to shut down its Internet pharmacy operation.
The Order to Show Cause and Immediate Suspension of Registration further referenced an order of emergency suspension issued by the Florida Department of Health (the Department) against Respondent on May 30, 2002, as well as administrative complaints issued by the Department's Pharmacy Board against Respondent and one of its pharmacists. While both actions stemmed from allegations that Respondent operated an Internet pharmacy, the Order to Show Cause and Immediate Suspension of Registration referenced the Pharmacy Board's March 31, 2003, assessment of a $48,000 fine as the only sanction.
The Order to Show Cause and Immediate Suspension of Registration further alleged that on seven separated occasions during September and October 2003, DEA diversion investigators and agents from the United States Food and Drug Administration conducted a series of undercover operations with the objective of obtaining controlled substances from Respondent through its Internet operation. The operation resulted in law enforcement officers receiving quantities of Bontril (a Schedule III controlled substance) and phentermine (a Schedule IV controlled substance) from Respondent after filling out Internet questionnaires with fictitious names and fictitious weights. The law enforcement officers had no contact with the prescribing physicians, who issued prescriptions from locations in Florida, Missouri and Pennsylvania. However, there were no allegations in the Order to Show Cause and Immediate Suspension of Registration addressing the status of Respondent's authorization to handle controlled substances in the State of Florida.
By letter dated November 3, 2003, Respondent, through counsel, requested a hearing in this matter. The request included various arguments challenging the basis for the Order to Show Cause and Immediate Suspension of Registration. On November 10, 2003, Presiding Administrative Law Judge Mary Ellen Bittner (Judge Bittner) issued an Order for Prehearing Statements.
On November 21, 2003, in lieu of a prehearing statement, counsel for DEA filed Government's Motion for Summary Judgment and Motion to Stay the Filing of Prehearing Statements. In support of its motions, the Government referenced a letter dated November 20, 2003, in which Respondent's counsel had notified the Florida Board of Pharmacy of the following: “Without the ability to dispense controlled substance[s], a crucial element of operating a pharmacy, [Respondent] can no longer remain viable, and must relinquish its pharmacy permit.” According to the Government, the letter indicated Respondent no longer had a pharmacy license in the State of Florida and, as a result, further proceedings in the matter were not required. Attached to the Government's motion was the aforementioned letter from Respondent's counsel to the Florida Board of Pharmacy.
In response to the Government's motion, Respondent argued in relevant part, that the Order to Show Cause and Immediate Suspension of Registration had not alleged that it did not have a current state pharmacy license. Respondent further argued that its lack of such a license now rendered these proceedings “legally moot” and that the Administrative Law Judge should deny the Government's Motion for Summary Disposition and issue an order dismissing the case as moot.
On December 17, 2003, Judge Bittner issued her Opinion and Recommended Decision of the Administrative Law Judge (Opinion and Recommended Decision). As part of her recommended ruling, Judge Bittner rejected Respondent's contentions concerning the Government's failure to initially allege lack of state authority, holding the relevant question was Respondent's status to handle controlled substances at the time of the Opinion and Recommended Decision, not at what stage of the proceedings that status may have changed. She further noted Respondent had never surrendered its DEA Certificate of Registration and that the surrender of its state pharmacy license did not render this proceeding moot.
Judge Bittner granted the Government's Motion for Summary Disposition, finding Respondent lacked authorization to handle controlled
The Deputy Administrator has considered the record in its entirety and pursuant to 21 CFR 1316.67, hereby issues her final order based upon the findings of fact and conclusions of law as hereinafter set forth. The Deputy Administrator adopts, in full, the Opinion and Recommenced Decision of the Administrative Law Judge.
The Deputy Administrator finds that Respondent currently possesses DEA Certificate of Registration RB7139238 and is registered to handle controlled substances in Florida as a retail pharmacy. The Deputy Administrator's review of the November 20, 2003, letter from Respondent's counsel to the Florida Board of Pharmacy reveals that after receiving the order of immediate suspension of its DEA registration, Respondent surrendered its pharmacy permit to the Board of Pharmacy. It appears from this action that Respondent surrendered its authority to handle controlled substances in Florida and, as a result, lacks a necessary prerequisite for DEA registration. There is no evidence before the Deputy Administrator that Respondent's pharmacy permit has been returned or reinstated or that Respondent is currently licensed in Florida as a retail pharmacy. Accordingly, it is reasonable to infer that Respondent is without authorization to handle controlled substances in that state.
DEA does not have statutory authority under the Controlled Substances Act to issue or maintain a registration if the applicant or registrant is without state authority to handle controlled substances in the state in which he conducts business.
Here, Respondent is currently not licensed to handle controlled substances in Florida, the state where it maintains its registration with DEA. Therefore, Respondent is not entitled to maintain that registration. Because Respondent is not entitled to a DEA registration in Florida due to its lack of state authorization to handle controlled substances, the Deputy Administrator concludes it is unnecessary to address whether Respondent's registration should be revoked based upon the public interest grounds asserted in the Order to Show Cause and Immediate Suspension of Registration.
Accordingly, the Deputy Administrator of the Drug Enforcement Administration, pursuant to the authority vested in her by 21 U.S.C. 823 and 824 and 28 CFR 0.100(b) and 0.104, hereby orders that DEA Certificate of Registration, BR7139238, issued to RX Network of South Florida, LLC, be, and it hereby is, revoked. The Deputy Administrator further orders that any pending applications for renewal or modification of such registration be, and they hereby are, denied. This order is effective November 22, 2004.
On March 2, 2004, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration (DEA), issued an Order to Show Cause to Daniel Ortiz-Vargas, M.D. (Respondent) of Yauco, Puerto Rico, notifying him of an opportunity to show cause as to why DEA should not revoke his DEA Certificate of Registration BO6085395, as practitioner, under 21 U.S.C. 824(a)(5) and deny any pending applications for renewal or modification of that registration. As a basis for revocation, the Order to Show Cause alleged that Respondent had been mandatorily excluded from participating in federal health programs pursuant to 42 U.S.C. 1320-7(a).
By letter dated March 28, 2004, Respondent, through legal counsel, requested a hearing. On April 20, 2004, Administrative Law Judge Gail A. Randall (Judge Randall) issued an Order for Prehearing Statements, requiring the Government and Respondent to file prehearing statements by May 11 and June 1, 2004, respectively. The Government filed a timely prehearing statement, however, Respondent failed to file his prehearing statement by the deadline.
On June 29, 2004, Judge Randall issued a
Therefore, the Deputy Administrator finds that Respondent, having requested a hearing but having failed to participate in the matter after being apprised of the consequences, is deemed to have waived his hearing right.
The Deputy Administrator finds that Respondent currently possesses DEA Certificate of Registration BO6085395. The Deputy Administrator further finds that as a result of Respondent's fraudulent activities, pursuant to his guilty plea, he was convicted in the United States District Court, District of Puerto Rico of one count of conspiring to solicit and receive kickbacks in relation to Medicare referrals for durable medical equipment, in violation of 18 U.S.C. 371. On September 17, 2002, he was sentenced to three years probation.
As a result of Respondent's conviction, on January 31, 2003, he was notified by the Department of Health and Human Services of his five-year mandatory exclusion from participation in the Medicare program pursuant to 42 U.S.C. 1320a-7(a). Exclusion from Medicare is an independent ground for revoking a DEA registration. 21 U.S.C. 824(a)(5);
Accordingly, the Deputy Administrator of the Drug Enforcement Administration, pursuant to the authority vested in her by 21 U.S.C. 823 and 824 and 28 CFR 0.100(b) and 0.104, hereby orders that DEA Certificate of Registration BO6085395, issued to Daniel Ortiz-Vargas, M.D., be, and it hereby is, revoked. The Deputy Administrator further orders that any pending applications for renewal of such registration be, and they hereby are, denied. This order is effective November 22, 2004.
On October 30, 2003, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration (DEA), issued an Order to Show Cause to Serge V. Verne, D.D.S. (Dr. Verne) at his registered location in San Diego, California, with a second copy sent to a location in Rancho Santa Fe, California. Dr. Verne was notified of an opportunity to show cause as to why DEA should not revoke his DEA Certificate of Registration, BV2328830, under 21 U.S.C. 824(a), and deny any pending applications for renewal or modification of that registration. Specifically, the Order to Show Cause alleged that Dr. Verne was without state license to handle controlled substances in the State of California. The Order to Show Cause also notified Dr. Verne that should no request for a hearing be filed within 30 days, his hearing right would be deemed waived.
As alluded to above, copies of the Order to Show Cause were sent by certified mail to Dr. Verne at two separate locations. According to the investigative file, the copy sent to the San Diego location was returned to DEA unclaimed, however, the second show cause order sent to the Rancho Santa Fe location was accepted on Dr. Verne's behalf on November 19, 2003. DEA has not received a request for hearing or any other reply from Dr. Verne or anyone purporting to represent him in this matter.
Therefore, the Deputy Administrator, finding that (1) 30 days have passed since the receipt of the Order to Show Cause, and (2) no request for a hearing having been received, concludes that Dr. Verne is deemed to have waived his hearing right. After considering material from the investigative file in this matter, the Deputy Administrator now enters her final order without a hearing pursuant to 21 CFR 1301.43(d) and (e) and 1301.46.
The Deputy Administrator finds that Dr. Verne is currently registered with DEA as a practitioner authorized to handle controlled substances in Schedules II through V. According to information in the investigative file, effective May 8, 2003, the Dental Board of California (Dental Board) ordered the revocation of Dr. Verne's license to practice dentistry in that state. The Dental Board's action was based in part upon findings that Dr. Verne provided false and misleading information regarding his continuing education, and his use of fraud in the procurement of his dental license and general anesthesia permit. There is no evidence before the Deputy Administrator to rebut findings that Dr. Verne's California dental license has been revoked and has not been reinstated. Therefore, the Deputy Administrator finds that since Dr. Verne is not currently authorized to practice dentistry in California, it is reasonable to infer that he is not authorized to handle controlled substances in that state.
DEA does not have statutory authority under the Controlled Substances Act to issue or maintain a registration if the applicant or registrant is without state authority to handle controlled substances in the state in which he conducts business.
Here, it is clear that Dr. Verne is not licensed to handle controlled substances in California, where he is registered with DEA. Therefore, he is not entitled to maintain that registration.
Accordingly, the Deputy Administrator of the Drug Enforcement Administration, pursuant to the authority vested in her by 21 U.S.C. 823 and 824 and 28 CFR 0.100(b) and 0.104, hereby orders that DEA Certificate of Registration, BV2328830, issued to Serge V. Verne, D.D.S., be, and it hereby is, revoked. The Deputy Administrator further orders that any pending applications for renewal or modification of the aforementioned registration be, and hereby are, denied. This order is effective November 22, 2004.
Petitions have been filed with the Secretary of Labor under Section 221(a) of the Trade Act of 1974 (“the Act”) and are identified in the Appendix to this notice. Upon receipt of these petitions, the Director of the Division of Trade Adjustment Assistance, Employment and Training Administration, has instituted investigations pursuant to Section 221(a) of the Act.
The purpose of each of the investigations is to determine whether the workers are eligible to apply for adjustment assistance under Title II, Chapter 2, of the Act. The investigations will further relate, as appropriate, to the determination of the date on which total or partial separations began or threatened to begin and the subdivision of the firm involved.
The petitioners or any other persons showing a substantial interest in the subject matter of the investigations may request a public hearing, provided such request is filed in writing with the Director, Division of Trade Adjustment Assistance, at the address shown below, not later than November 1, 2004.
Interested persons are invited to submit written comments regarding the subject matter of the investigations to the Director, Division of Trade Adjustment Assistance, at the address shown below, not later than November 1, 2004.
The petitions filed in this case are available for inspection at the Office of the Director, Division of Trade Adjustment Assistance, Employment and Training Administration, U.S. Department of Labor, Room C-5311, 200 Constitution Avenue, NW., Washington, DC 20210.
General wage determination decisions of the Secretary of Labor are issued in accordance with applicable law and are based on the information obtained by the Department of Labor from its study of local wage conditions and data made available from other sources. They specify the basic hourly wage rates and fringe benefits which are determined to be prevailing for the described classes of laborers and mechanics employed on construction projects of a similar character and in the localities specified therein.
The determinations in these decisions of prevailing rates and fringe benefits have been made in accordance with 29 CFR Part 1, by authority of the Secretary of Labor pursuant to the provisions of the Davis-Bacon Act of March 3, 1931, as amended (46 Stat. 1494, as amended, 40 U.S.C. 276(a) and of other Federal statutes referred to in 29 CFR Part 1, Appendix, as well as such additional statutes as may from time to time be enacted containing provisions for the payment of wages determined to be prevailing by the Secretary of Labor in accordance with the Davis-Bacon Act. The prevailing rates and fringe benefits determined in these decisions shall, in accordance with the provisions of the foregoing statutes, constitute the minimum wages payable on Federal and federally assisted construction projects to laborers and mechanics of the specified classes engaged on contract work of the character and in the localities described therein.
Good cause is hereby found for not utilizing notice and public comment procedure thereon prior to the issuance of these determinations as prescribed in 5 U.S.C. 553 and not providing for delay in the effective date as prescribed in that section, because the necessity to issue current construction industry wage determinations frequently and in large volume causes procedures to be impractical and contrary to the public interest.
General wage determination decisions, and modifications and supersedes decisions thereto, contain no expiration dates and are effective from their date of notice in the
Any person, organization, or governmental agency having an interest in the rates determined as prevailing is encouraged to submit wage rate and fringe benefit information for consideration by the Department. Further information and self-explanatory forms for the purpose of submitting this data may be obtained by writing to the U.S. Department of Labor, Employment Standards Administration, Wage and Hour Division, Division of Wage Determinations, 200 Constitution Avenue, NW., Room S-3014, Washington, DC 20210.
The number of the decisions listed to the Government Printing Office document entitled “General Wage Determinations Issued Under the Davis-Bacon and related Acts” being modified are listed by Volume and State. Dates of publication in the
General wage determinations issued under the Davis-Bacon and related Acts, including those noted above, may be found in the Government Printing Office (GPO) document entitled “General Wage determinations Issued Under the Davis-Bacon And Related Acts”. This publication is available at each of the 50 Regional Government Depository Libraries and many of the 1,400 Government Depository Libraries across the country.
General wage determinations issued under the Davis-Bacon and related Acts are available electronically at no cost on the Government Printing Office site at
Hard-copy subscriptions may be purchased from: Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402, (202) 512-1800.
When ordering hard-copy subscription(s), be sure to specify the State(s) of interest, since subscriptions may be ordered for any or all of the six separate Volumes, arranged by State. Subscriptions include an annual edition (issued in January or February) which includes all current general wage determinations for the States covered by each volume. Throughout the remainder of the year, regular weekly updates will be distributed to subscribers.
The Connecticut Yankee Atomic Power Company (CYAPCO) is the licensee and holder of Facility Operating License No. DPR-61 issued for Haddam Neck Plant (HNP), located in East Hampton, Connecticut. The HNP is a permanently shutdown nuclear reactor facility. Beginning in 2003, the amount of radioactive waste shipped from the site significantly increased. The majority of the radioactive waste generated by the site is related to HNP decommissioning activities. Inherent to the decommissioning process, large volumes of slightly contaminated concrete rubble and debris are generated that require shipment for disposal in offsite low-level radioactive waste burial sites. Due primarily to the volume of radioactive waste, CYAPCO has encountered an increase in the number of routine shipments that take longer than 20 days from transfer to the shipper to receipt acknowledgment from the burial site. Each shipment with receipt notifications greater than 20 days requires a special investigation and report to the Nuclear Regulatory Commission (NRC) which the licensee believes to be burdensome and unnecessary to meet the intent of the regulation.
In a letter to the Commission dated June 1, 2004, CYAPCO requested an exemption from the requirements in 10 CFR part 20, Appendix G, Section III.E, to investigate and file a report to the NRC if shipments of low-level radioactive waste are not acknowledged by the intended recipient within 20 days after transfer to the shipper. This exemption would extend the time period that can elapse during shipments of low-level radioactive waste before CYAPCO is required to investigate and file a report to the NRC from 20 days to
The proposed action would grant an exemption to extend the 20-day investigation and reporting requirements for shipments of low-level radioactive waste to 35 days. Beginning in 2003, CYAPCO has made over 40 shipments of low-level radioactive waste as part of the decommissioning efforts at the facility. MHF Logistical Solutions is the rail broker company used by CYAPCO to perform these shipments. MHF Logistical Solutions has a tracking system that monitors the progress of the shipments from their originating point at HNP to their final destination at Envirocare of Utah, Inc. The shipments are made by either truck or combination truck/rail and, according to CYAPCO, the transportation time alone takes over 21 days on average, with one shipment taking 25 days.
In addition, administrative procedures at Envirocare and mail delivery can add up to 4 additional days. Based on historical data and estimates of the remaining waste at HNP, CYAPCO could have to perform over 400 investigations and reports to the NRC during the next 3 years if the 20-day notification criteria is maintained. The licensee affirms that the low-level radioactive waste shipments will always be tracked throughout transportation until they arrive at their intended destination. CYAPCO believes that the need to investigate, trace, and report to the NRC on the shipment of low-level radioactive waste packages not reaching their destination within 20 days does not serve the underlying purpose of the rule and is not necessary. As a result, CYAPCO states that granting this exemption will not result in an undue hazard to life or property.
Pursuant to 10 CFR 20.2301, the Commission may, upon application by a licensee or upon its own initiative, grant an exemption from the requirements of regulations in 10 CFR part 20 if it determines the exemption is authorized by law and would not result in undue hazard to life or property. There are no provisions in the Atomic Energy Act (or in any other Federal statute) that impose a requirement to investigate and report on low-level radioactive waste shipments that have not been acknowledged by the recipient within 20 days of transfer. Therefore, the Commission concludes that there is no statutory prohibition on the issuance of the requested exemption and the Commission is authorized to grant the exemption by law.
The Commission acknowledges that based on the statistical analysis of low-level radioactive waste shipments from the HNP site, the need to investigate and report on shipments that take longer than 20 days could result in an excessive administrative burden on the licensee. The Commission asserts that the underlying purpose of the rule is to investigate a late shipment that may be lost, misdirected, or diverted. Because of the oversight and monitoring of radioactive waste shipments throughout the entire journey from HNP to the disposal site, it is unlikely that a shipment could be lost, misdirected, or diverted without the knowledge of the carrier or CYAPCO. Furthermore, by extending the elapsed time for receipt acknowledgment to 35 days before requiring investigations and reporting, a reasonable upper limit on shipment duration (based on historical analysis) is still maintained if a breakdown of normal tracking systems were to occur. Consequently, the Commission finds that there is no hazard to life or property by extending the investigation and reporting time for low-level radioactive waste shipments from 20 days to 35 days for truck, combination truck/rail, or potential future combination barge/rail shipments. Therefore, the Commission concludes that the underlying purpose of 10 CFR part 20, Appendix G, Section III.E will be met.
Accordingly, the Commission has determined that, pursuant to 10 CFR 20.2301, the exemption requested by CYAPCO in its January 26, 2004, letter is authorized by law and will not result in undue hazards to life or property. Therefore, the Commission hereby grants CYAPCO an exemption to extend the 20-day investigation and reporting requirements for shipments of low-level radioactive waste, as required by 10 CFR part 20, Appendix G, Section III.E, to 35 days.
Pursuant to 10 CFR 51.31, the Commission has determined that the granting of this exemption will not have a significant effect on the quality of the human environment as documented in
This exemption is effective upon issuance.
For the Nuclear Regulatory Commission.
The ACRS Subcommittee on Planning and Procedures will hold a meeting on November 3, 2004, Room T-2B1, 11545 Rockville Pike, Rockville, Maryland.
The entire meeting will be open to public attendance, with the exception of a portion that may be closed pursuant to 5 U.S.C. 552b(c) (2) and (6) to discuss organizational and personnel matters that relate solely to the internal personnel rules and practices of the ACRS, and information the release of which would constitute a clearly unwarranted invasion of personal privacy.
The agenda for the subject meeting shall be as follows:
The Subcommittee will discuss proposed ACRS activities and related matters. The Subcommittee will gather information, analyze relevant issues and facts, and formulate proposed positions and actions, as appropriate, for deliberation by the full Committee.
Members of the public desiring to provide oral statements and/or written comments should notify the Designated Federal Official, Mr. Sam Duraiswamy (telephone: 301-415-7364) between 7:30 a.m. and 4:15 p.m. (ET) five days prior to the meeting, if possible, so that appropriate arrangements can be made. Electronic recordings will be permitted only during those portions of the meeting that are open to the public.
Further information regarding this meeting can be obtained by contacting the Designated Federal Official between 7:30 a.m. and 4:15 p.m. (ET). Persons planning to attend this meeting are urged to contact the above named individual at least two working days prior to the meeting to be advised of any potential changes in the agenda.
Office of Personnel Management.
Notice.
In accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, May 22, 1995), this notice announces that the Office of Personnel Management (OPM) has submitted to the Office of Management and Budget (OMB) a request for review of a revised information collection. RI 94-7, Death Benefit Payment Rollover Election for the Federal Employees Retirement System (FERS), provides FERS surviving spouses and former spouses with the means to elect payment of FERS rollover-eligible benefits directly or to an Individual Retirement Arrangement.
Approximately 2,000 RI 94-7 forms will be completed annually. The form takes approximately 60 minutes to complete. The annual burden is 2,000 hours.
For copies of this proposal, contact Mary Beth Smith-Toomey on (202) 606-8358, FAX (202) 418-3251 or via e-mail to
Comments on this proposal should be received within 30 calendar days from the date of this publication.
Send or deliver comments to—
and
Cyrus S. Benson, Team Leader, Publications Team, Support Group, (202) 606-0623.
Office of Personnel Management.
Notice.
In accordance with the Paperwork Reduction Act of 1995 (Public Law 104-13, May 22, 1995), this notice announces that the Office of Personnel Management (OPM) has submitted to the Office of Management and Budget (OMB) a request for review of a revised information collection. SF 2808, Designation of Beneficiary: Civil Service Retirement System (CSRS), is used by persons covered by CSRS to designate a beneficiary to receive the lump sum payment due from the Civil Service Retirement and Disability Fund in the event of their death.
Approximately 2,000 forms will be completed annually. The form takes approximately 15 minutes to complete. The annual burden is estimated at 500 hours.
For copies of this proposal, contact Mary Beth Smith-Toomey on (202) 606-8358, Fax (202) 418-3251 or via E-mail to
Comments on this proposal should be received within 30 calendar days from the date of this publication.
Send or deliver comments to—Pamela S. Israel, Chief Operations Support Group, Retirement Services Program, U.S. Office of Personnel Management, 1900 E Street, NW., Room 3349, Washington, DC 20415; and Joseph F. Lackey, OPM Desk Officer, Office of Information and Regulatory Affairs, Office of Management & Budget, New Executive Office Building, NW., Room 10235, Washington, DC 20503.
For Information Regarding Administrative Coordination—Contact: Cyrus S. Benson, Team Leader, Publications Team, Support Group, (202) 606-0623.
Office of Personnel Management.
Notice.
In accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, May 22, 1995), this notice announces that the Office of Personnel Management (OPM) intends to submit to the Office of Management and Budget (OMB) a revised information collection of the optional form called
The
OPM proposes to eliminate the optional form
OPM intends to reconstruct the resume builder in the USAJOBS Web site to be in line with the data elements collected in the revised
The
The USAJOBS Web site is the Federal Government's official one-stop source for Federal jobs and employment information. USAJOBS is operated by OPM and provides job vacancy information, employment fact sheets, and job applications/forms and on-line resume development. Job seekers may create a “My USAJOBS” account where they can create up to five resumes, or convert and store an existing one. These resumes are stored in one location where they can be updated, saved, or sent at any time.
Comments are particularly invited on: whether this information is necessary for the proper performance of functions of the Office of Personnel Management, and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; and ways in which we can further minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.
We estimate 245,000 applications will be completed annually using the
We estimate 3,510,600 applications will be completed annually using the resume builder in the USAJOBS Web site. The public reporting burden for the collection of the data will vary from 20 to 240 minutes, with an average of 40 minutes per response, including time for reviewing instructions, searching existing data sources, gathering data, and completing and reviewing the information. The annual estimated burden is 9,800 hours.
For copies of this proposal, contact Mary Beth Smith-Toomey on (202) 606-8358, FAX (202) 418-3251 or via E-mail to
Comments on this proposal should be received within 60 calendar days from the date of this publication.
Send or deliver comments to—U.S. Office of Personnel Management, USAJOBS, ATTN: Mariana Pardo, U.S. Office of Personnel Management, 1900 E Street, NW., Room 2469, Washington, DC 20415.
Office of Personnel Management.
Notice.
This gives notice of OPM decisions granting authority to make appointments under Schedules A, B and C in the excepted service as required by 5 CFR 6.6 and 213.103.
Mr. Art Walker, Center for Leadership and Executive Resources Policy, Division for Strategic Human Resources Policy, (202) 606-1506.
Appearing in the listing below are the individual authorities established under a Schedule B authority that was approved in August 3, 2004, and Schedule C's between September 1, 2004, and September 30, 2004. Future notices will be published on the fourth Tuesday of each month, or as soon as possible thereafter. A consolidated listing of all authorities as of June 30 is published each year.
No Schedule A appointments were approved for September 2004.
Temporary positions of professional Research Scientists, GS-15 or below, in the Agricultural Research Service, Economic Research Service, and the Forest Service, when such positions are established in support the Research Associateship Program and are filled by person having a doctoral degree in an appropriate field of study for research activities of mutual interest to appointees and the agency. Appointments are limited to proposals approved by the appropriate Administrator. Appointments may be made for initial periods not to exceed 2 years and may be extended for up to 2 additional years. Extension beyond 4 years, up to a maximum of 2 additional years, may be granted, but only in very rare and unusual circumstances, as determined by the Human Resources Officer for the Research, Education, and Economics Mission Area, or the Human Resources Officer, Forest Service. Effective August 3, 2004.
The following Schedule C appointments were approved for September 2004:
QQGS60010 Public Affairs Specialist to the Associate Director, Public Affairs. Effective September 2, 2004.
QQGS60009 Legal Analyst to the General Counsel. Effective September 14, 2004.
QQGS00028 White House Liaison and Intergovernmental Affairs Specialist to the Chief of Staff. Effective September 20, 2004.
DSGS60790 Special Assistant to the Assistant Secretary for Economical
DSGS60792 Legislative Management Officer to the Assistant Secretary for Legislative and Intergovernmental Affairs. Effective September 7, 2004.
DSGS60793 Chief, Voluntary Visitors Division to the Assistant Secretary for Education and Cultural Affairs. Effective September 7, 2004.
DSGS60794 Special Assistant to the Assistant Secretary for Public Affairs. Effective September 7, 2004.
DSGS60786 Senior Advisor to the Coordinator. Effective September 7, 2004.
DSGS60795 Member, Policy Planning Staff to the Director, Policy Planning Staff. Effective September 7, 2004.
DSGS60789 Senior Advisor to the Under Secretary for Public Diplomacy and Public Affairs. Effective September 14, 2004.
DSGS60785 Foreign Affairs Officer to the Assistant Secretary for International Organizational Affairs. Effective September 17, 2004.
DSGS60796 Program Analyst to the Assistant Secretary for Education and Cultural Affairs. Effective September 28, 2004.
DYGS00444 Special Assistant to the Deputy Assistant Secretary (Public Liaison, Strategic Planning and Business Development). Effective September 14, 2004.
DYGS00445 Senior Advisor to the Secretary (Scheduling) to the Chief of Staff. Effective September 23, 2004.
DDGS16834 Staff Assistant to the Principal Deputy Under Secretary of Defense for Policy. Effective September 17, 2004.
DDGS16839 Supervisory Public Affairs Specialist to the Deputy Assistant Secretary of Defense (Internal Communications). Effective September 23, 2004.
DDGS16838 Defense Fellow to the Special Assistant to the Secretary of Defense for White House Liaison. Effective September 24, 2004.
DDGS16836 Defense Fellow to the Special Assistant to the Secretary of Defense for White House Liaison. Effective September 29, 2004.
DWGS60051 Special Assistant to the Assistant Secretary of the Army (Research, Development and Acquisition). Effective September 10, 2004.
DWGS00083 Personal and Confidential Assistant to the Principal Deputy Assistant Secretary of the Army (Acquisition, Logistics and Technology) and Director for Iraq Reconstruction and Program Management. Effective September 29, 2004.
DNGS00064 Confidential Assistant to the Assistant Secretary of Navy (Installations and Environment). Effective September 17, 2004.
DJGS00237 Press Assistant to the Director, Office of Public Affairs. Effective September 24, 2004.
DMGS00264 Executive Assistant to the Chief of Staff. Effective September 7, 2004.
DMGS00269 Special Assistant to the Under Secretary for Science and Technology. Effective September 07, 2004.
DMGS00259 Counter Narcotics Liaison to the Counter Narcotics Officer. Effective September 08, 2004.
DCGS00676 Senior Advisor to the Assistant Secretary for Manufacturing and Services. Effective September 24, 2004.
DCGS00651 Public Affairs Specialist to the Director of Public Affairs. Effective September 29, 2004.
DLGS60126 Special Assistant to the Deputy Assistant Secretary for Labor Management Programs. Effective September 23, 2004.
DHGS60527 Confidential Assistant (Scheduling) to the Director of Scheduling. Effective September 23, 2004.
DBGS00360 Deputy Secretary's Regional Representative to the Deputy Assistant Secretary for Regional Services. Effective September 21, 2004.
DBGS00359 Confidential Assistant to the Deputy Assistant Secretary for Enforcement. Effective September 22, 2004.
DBGS00358 Special Assistant to the Deputy Assistant Secretary for Enforcement. Effective September 28, 2004.
DBGS00362 Deputy Secretary's Regional Representative to the Deputy Assistant Secretary for Regional Services. Effective September 30, 2004.
EPGS04022 Senior Advisor to the Deputy Assistant Administrator for Water. Effective September 14, 2004.
EPGS60018 Great Lakes Special Assistant to the Administrator. Effective September 23, 2004.
JCGS60078 Trial Clerk to the Chief Judge. Effective September 20, 2004.
DVGS60032 Director, Center for Faith Based Community Initiatives to the Assistant Secretary for Public and Intergovernmental Affairs. Effective September 14, 2004.
DEGS00430 Confidential Assistant to the Deputy Administrator for Defense Nuclear Nonproliferation. Effective September 16, 2004.
DEGS00427 Policy Advisor to the Assistant Secretary for Environment, Safety and Health. Effective September 28, 2004.
SZGS00013 Special Assistant to the Commissioner (Advance and Liaison) to the Commissioner. Effective September 23, 2004.
DUGS00170 Staff Assistant to the Assistant Secretary for Public and Indian Housing. Effective September 23, 2004.
5 U.S.C. 3301 and 3302; E.O. 10577, 3 CFR 1954-1958 Comp., P.218.
On October 8, 2004, Devon Energy Corporation, a Delaware corporation (“Issuer”) filed an application with the Securities and Exchange Commission (“Commission”), pursuant to Section 12(d) of the Securities Exchange Act of 1934 (“Act”)
The Board of Directors (“Board”) of the Issuer unanimously approved a resolution on September 27, 2004 to withdraw the Issuer's Security from listing on the Amex and to list on the New York Stock Exchange, Inc. (“NYSE”). The Board states that following reasons factored into its decision to withdraw the Issuer's Security from the Exchange: (i) To avoid the direct and indirect costs of, and the division of the market resulting from, dual listing on the Amex and the NYSE; and (ii) it was in the best interest of the Issuer to withdraw its Security from the Amex and list on the NYSE. The Issuer states that the Security ceased trading on the Amex at the close of business on October 11, 2004 and commence trading on the NYSE on October 12, 2004.
The Issuer stated in its application that it has complied with all the applicable laws in effect in Delaware, in which it is incorporated, and with the Amex's rules governing an issuer's voluntary withdrawal of a security from listing and registration.
The Issuer's application relates solely to the Security's withdrawal from listing on the Amex and from registration under Section 12(b) of the Act,
Any interested person may, on or before November 12, 2004, comment on the facts bearing upon whether the application has been made in accordance with the rules of the Amex, and what terms, if any, should be imposed by the Commission for the protection of investors. All comment letters may be submitted by either of the following methods:
• 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 1-32318. This file number should be included on the subject line if e-mail is used. To help us 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 (
The Commission, based on the information submitted to it, will issue an order granting the application after the date mentioned above, unless the Commission determines to order a hearing on the matter.
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
On July 26, 2004, the National Association of Securities Dealers, Inc. (“NASD”), through its subsidiary, The Nasdaq Stock Market, Inc. (“Nasdaq”), filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Commission finds that the proposed rule change, as amended, is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities association.
Specifically, the Commission believes that Nasdaq's dissemination of multiple levels of firm quotes/orders in exchange-listed securities should increase the market information available to market participants. The Commission believes the proposed fee is reasonable in that Nasdaq represents that the $6 monthly fee is based on anticipated message traffic through its new data feed, OpenView, in relation to the message traffic amounts and prices
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 is proposing to amend PCX Rule 6.37 to allow quotation spreads for options that trade on the Exchange's electronic trading platform, PCX Plus, to be $5 regardless of the price of the bid. The text of the proposed rule change appears below. Additions are underlined.
RULE 6.37. (a)-No Change.
(b) No Change.
(1) Bidding and/or offering so as to create differences of no more than:
(A) .25 between the bid and the offer for each option contract for which the bid is less than $2,
(B) no more than .40 where the bid is $2 or more but does not exceed $5,
(C) no more than .50 where the bid is more than $5 but does not exceed $10,
(D) no more than .80 where the bid is more than $10 but does not exceed $20, and
(E) no more than $1 when the last bid is $20.10 or more, provided that the Exchange may establish differences other than the above for one or more series or classes of options.
(F) The two Trading Officials or the Exchange may, with respect to options trading with a bid price less than $2, establish bid-ask differentials that are no more than $0.50 wide (“double-width”) when the primary market for the underlying security: (a) Reports a trade outside of its disseminated quote (including any Liquidity Quote); or (b) disseminates an inverted quote. The imposition of double-width relief must automatically terminate when the condition that necessitated the double-width relief (
(2)-(5)—No Change.
(c)-(h)—No Change.
Commentary .01-.09—No Change.
In its filing with the Commission, the self-regulatory organization 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. The self-regulatory organization 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 substantially relax the quotation spread requirements on options designated by the Exchange that trade on the Exchange's electronic trading platform, PCX Plus. Currently, the PCX's rules contain maximum quotation spread requirements that vary from $.25 to $1, depending on the price of the option. Each PCX market maker independently is subject to these requirements. According to the PCX, while the primary purpose of the spread requirements is to help maintain narrow spreads, the spread requirements also result in individual market makers sometimes quoting at prices that they believe are unnecessarily narrow, potentially exposing them to greater risk if markets move quickly. The PCX believes that, due to the market making system in PCX Plus, the quotation spread requirements may not be necessary to ensure tight and competitive quotations on the PCX.
In this regard, the PCX states that the market structure in PCX Plus creates strong incentives for competing market makers and other market participants to disseminate competitive prices. In PCX Plus, each market maker quotes independently and customers and professional traders can enter limit orders on the PCX's book. The PCX automatically collects this trading interest, calculates the PCX best bid and offer (“BBO”), and disseminates the BBO to the investing public. Furthermore, the PCX allocates trading interest on PCX Plus based upon the price and size of the interest. Under the PCX's trading algorithm, the PCX allocates volume to trading interest at the best price. The larger the size of a person's quote or order at the best price, the more trading interest that person
Accordingly, the PCX proposes to expand the allowable spreads for options designated by the Exchange that trade on the Exchange's electronic trading platform, PCX Plus. The $5 quote width shall only apply to options trading on PCX Plus and only following the opening rotation in each security.
The Exchange believes that the proposed rule change is consistent with Section 6(b) 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 on the proposed rule change were neither solicited nor received.
The proposed rule change has been designated by the PCX as a “non-controversial” rule change pursuant to Section 19(b)(3)(A) of the Act
The Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest.
At any time within 60 days of the filing of the proposed rule change, the Commission may summarily abrogate the rule change if it appears to the Commission that the action is necessary or appropriate in the public interest, for the protection of investors, or would otherwise further the purposes 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-PCX-2004-89. 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”)
PCX proposes to amend its rules pertaining to trade nullification and price adjustment procedures. Additions are italicized. Deletions are bracketed.
[(1) Mutual Agreement: The determination as to whether an Auto-Ex trade was executed at an erroneous price may be made by mutual agreement of the affected parties to a particular transaction. A trade may be nullified or adjusted on the terms that all parties to a particular transaction agree. In the absence of mutual agreement by the parties, a particular trade may only be nullified or adjusted when the transaction results from an Obvious Error as provided in this Rule.
(2) Obvious Error Subject to Trade Nullification or Price Adjustment: Absent mutual agreement as provided in Rule 6.87(g)(1), parties to a trade may have a trade nullified or its price adjusted if: (i) any such party makes a documented request within the time specified in Rule 6.87(g)(3); and (ii) one of the conditions below is met:
A. The trade resulted from a verifiable disruption or malfunction of an Exchange execution, dissemination, or communication system that caused a quote/order to trade in excess of its disseminated size (
B. The trade resulted from a verifiable disruption or malfunction of an Exchange dissemination or communication system that prevented a member from updating or canceling a quote/order for which the OTP Holder is responsible where there is Exchange documentation providing that the OTP Holder sought to update or cancel the quote/order; or
C. The trade resulted from an erroneous print disseminated by the underlying market which is later cancelled or corrected by the underlying
D. The trade resulted from an erroneous quote in the Primary Market (as defined in Rule 6.1(b)(27)) for the underlying security that has a width of at least $1.00 and that width is at least five times greater than the average quote width for such underlying security during the time period encompassing two minutes before and after the dissemination of such quote. For the purposes of this rule, the average quote width shall be determined by adding the quote widths of each separate quote during the four minute time period referenced above (excluding the quote in question) and dividing by the number of quotes during such time period (excluding the quote in question); or
E. The execution price of the trade is higher or lower than the mid-point of the Best Bid and Offer (among all of the exchanges other than the PCX) by an amount equal to at least the bid/ask spread provided in Rule 6.37(b)(1). The bid/ask spread set forth in Rule 6.37(b)(1) will also apply to LEAPS and options subject to unusual market conditions. In the event the bid/ask spread in the underlying is greater than the bid/ask spread set forth in Rule 6.37(b)(1), the Exchange will apply the bid/ask spread differential set forth in Rule 6.37(b)(3).
F. The trade resulted in an execution price in a series quoted no bid and at least one strike price below (for calls) or above (for puts) in the same class were quoted no bid at the time of the erroneous execution.
G. The trade is automatically executed at a price where the OTP Holder sells $0.10 or more below parity. Parity describes an option contract's total premium when that premium is equal to its intrinsic value. Parity for calls is measured by reference to the offer price of the underlying security in the Primary Market at the time of the transaction minus the strike price for the call. Parity for puts is measured by reference to the strike price for the put minus the bid price of the underlying security in the Primary Market at the time of the transaction.
(3) Obvious Error Procedure. Two Trading Officials will administer the application of this Rule as follows:
A. Notification. If an OTP Holder believes that it participated in a transaction that was the result of an Obvious Error, it must notify two Trading Officials within five (5) minutes of the execution. If an Order Entry Firm representing a public customer believes an order it executed on the Exchange was the result of an Obvious Error, it must notify the Exchange within twenty (20) minutes of the execution. Absent unusual circumstances, two Trading Officials will not grant relief under this Rule unless notification is made within the prescribed time periods.
B. Adjust or Nullify. Two Trading Officials will determine whether the execution is subject to a trade nullification or price adjustment. If two Trading Officials determine that one of the conditions of Rule 6.87(g)(2) has been met and that the complaining party has timely documented a request for relief, then a trade will be adjusted or nullified as follows:
(1) Where each party to the transaction is a Market Maker on the Exchange, or the trade involves a limit order that may be adjusted to its limit, the Exchange will adjust the execution price of the transaction within ten (10) minutes of two Trading Officials making such determination. In such case, the adjusted price will be the last bid (offer) price, just prior to the trade, from the exchange providing the highest total contract volume in the option for the previous sixty (60) days with respect to an erroneous bid (offer) entered on the Exchange. If there is no quote for comparison purposes, then the adjusted price of an option will be determined by two Trading Officials; or
(2) Where at least one party to the transaction is not a Market Maker on the Exchange or where the trade does not involve a limit order that may be adjusted to its limit, the Exchange will nullify the transaction within ten (10) minutes of two Trading Officials making such determination.
(3) Upon taking final action, the two Trading Officials will promptly notify both parties to the trade.]
[.01 In no case will the two Trading Officials involved in an obvious error determination include a person related to a party to the trade in question.]
.01 [02] All determinations made by the [two Trading Officials] Exchange under subsection [(g)(2)] (g)(3) will be rendered without prejudice as to the rights of the parties to the transaction to submit a dispute to arbitration.
Rule 10.14(a). General Provisions. This Rule provides the procedure for persons aggrieved by any of the following actions taken by the Exchange to apply for an opportunity to be heard and to have the action reviewed. These actions are:
(1)-(4)—No change.
(5) actions taken pursuant to Rules 6.37, 6.82(f), [and] 6.82(g),
(6)—No change.
In its filing with the Commission, the Exchange included statements
In 2003, the Commission approved a proposal by the Exchange to adopt PCX Rule 6.87(g), which delineated (1) the circumstances under which an error would be subject to a trade adjustment or nullification, and (2) the procedures that the Exchange would follow in order to effect such adjustments and nullifications.
Currently, Exchange Rule 6.87(g) provides that, absent mutual agreement, parties to a trade may have a trade nullified or its price adjusted if: (1) The trade resulted from a verifiable disruption or malfunction of an Exchange system that caused trades in excess of the disseminated size; (2) the trade resulted from a verifiable disruption or malfunction of an Exchange system that prevented an OTP Holder or OTP Firm from updating or canceling a quote/order for which the OTP Holder or OTP Firm is responsible; (3) the trade resulted from an erroneous print disseminated by the underlying market which is later cancelled or corrected by the underlying market; (4) the trade resulted from an erroneous quote in the Primary Market for the underlying security (under specified conditions); (5) the execution price of the trade is higher or lower than the mid-point of the best bid and offer by an amount equal to at least the bid/ask spread; (6) the trade resulted in an execution price in a series quoted no bid and at least one strike price below (for calls) or above (for puts) in the same class were quoted no bid at the time of the erroneous execution; or (7) the trade is automatically executed at a price where the market maker sells $0.10 or more below parity.
As proposed, the amended PCX Rule 6.87(g) would provide that the Exchange
For purposes of PCX Rule 6.87(g), the theoretical price of an option would be the last bid price with respect to an erroneous sell transaction and the last offer price with respect to an erroneous buy transaction, just prior to the trade, disseminated by the competing options exchange that has the most liquidity in that option (“Theoretical Price”). If there are no quotes for comparison purposes, the Theoretical Price would be determined by designated personnel of the Exchange.
The Exchange also proposes to modify the procedure it uses to adjust or nullify an execution that occurred as a result of an obvious error. The Exchange proposes that the administration and application of the obvious error procedure be handled by the Exchange itself, rather than by two trading officials. The Exchange also seeks to modify its adjust or nullify rules to eliminate most of the nuances between PCX Rule 6.87(g) and ISE Rule 720. Specifically, the Exchange's current rules provide that the execution price of a trade would be adjusted if the transaction is between market makers or if it involves a limit order that may be adjusted to its limit. In such case, the trade would be adjusted to the last bid or offer from the exchange providing the highest total contract volume in the option for the previous 60 days with respect to the erroneous bid or offer entered on the Exchange. The Exchange's current rules also provide that where a party to a transaction is not a market maker on the Exchange or where the trade involves a limit order that may be adjusted to its limit, the Exchange would nullify the transaction.
The Exchange proposes to adopt the following procedure instead:
The Exchange further seeks to renumber its Commentary provisions to
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
The Exchange does not believe that the proposed rule change will impose any significant burden on competition.
Written comments were neither solicited nor received with respect to the proposed rule change.
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. Furthermore, the Exchange provided the Commission with written notice of its intent to file the proposed rule change, along with a brief description and text of the proposed rule change, at least five business days prior to the date of filing of the proposed rule change. Consequently, the proposed rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
The PCX has requested that the Commission waive the 30-day operative delay. The Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest. The Commission believes that waiver of the 30-day operative delay would enable the Exchange to implement the proposal as quickly as possible. In addition, the Commission notes that the proposal to amend the PCX obvious error rule is substantially identical to ISE Rule 720. Thus, the Commission does not believe that the proposed rule change raises any new regulatory issues.
At any time within 60 days of the filing of this proposed rule change, the Commission may summarily abrogate such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes 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-PCX-2004-87. 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.
In accordance with a notice received from the Department of Homeland Security—Federal Emergency Management Agency—effective October 8, 2004, the above numbered declaration is hereby amended to establish the incident period for this disaster as beginning September 3, 2004, and continuing through October 8, 2004.
All other information remains the same,
In accordance with a notice received from the Department of Homeland Security—Federal Emergency Management Agency—effective September 27, 2004, the above numbered declaration is hereby amended to establish the incident period for this disaster as beginning September 14, 2004, and continuing through September 27, 2004.
All other information remains the same,
In accordance with a notice received from the Department of Homeland Security—Federal Emergency Management Agency—effective October 1, 2004, the above numbered declaration is hereby amended to establish the incident period for this disaster as beginning September 18, 2004, and continuing through October 1, 2004.
All other information remains the same,
In accordance with a notice received from the Department of Homeland Security—Federal Emergency Management Agency—effective October 11, 2004, the above numbered declaration is hereby amended to establish the incident period for this disaster as beginning September 6, 2004, and continuing through October 11, 2004.
All other information remains the same,
Cocke and Rhea Counties and the contiguous counties of Bledsoe, Cumberland, Greene, Hamblin, Hamilton, Jefferson, Meigs, Roane, and Sevier in the State of Tennessee; and Haywood, Madison, and Swain Counties, North Carolina constitute a disaster area as a result of heavy rains associated with Hurricane Ivan on September 16-20, 2004. Applications for loans for physical damage as a result of this disaster may be filed until the close of business on December 14, 2004 and for economic injury until the close of business on July 15, 2005 at the address listed below or other locally announced locations: U.S. Small Business Administration, Disaster Area 2 Office, One Baltimore Place, Suite 300, Atlanta, GA 30308.
The interest rates are:
The number assigned to this disaster for physical damage is 364008 for Tennessee and 364108 for North Carolina. The number assigned to this disaster for economic injury damage is 9AF200 for Tennessee and 9AF300 for North Carolina.
In accordance with a notice received from the Department of Homeland Security—Federal Emergency Management Agency, effective October 13, 2004, the above numbered declaration is hereby amended to reopen the filing period for this disaster. The new deadline for filing applications for physical damage is November 8, 2004.
In addition, this amendment hereby establishes the incident period as beginning May 7, 2004 and continuing through July 3, 2004.
All other information remains the same,
Based upon a review of the Administrative Record assembled in this matter, and in consultation with the Attorney General and the Secretary of the Treasury, the Secretary of State has concluded that there is a sufficient factual basis to find that the relevant circumstances described in section 219 of the Immigration and Nationality Act, as amended (8 U.S.C. 1189, hereinafter “INA”), exist with respect to Jemaah Islamiyah.
Therefore, effective October 22, 2004, the Secretary of State hereby redesignates that organization as a foreign terrorist organization pursuant to section 219(a) of the INA.
Department of State.
Notice.
Pursuant to Section 654(c) of the Foreign Assistance Act of 1961, as amended, notice is hereby given that the Deputy Secretary of State has made a determination pursuant to section 620H of the Foreign Assistance Act, and Section 543 of the Foreign Operations, Export Financing and Related Programs Appropriations, Division D, of the Consolidated Appropriations Resolution, 2004 (Pub. L. 108-199) and similar provisions in previous year Foreign Operations, Export Financing, and Related Programs Appropriations Acts, and Executive Order 12163, as amended. The Deputy Secretary of State has concluded that publication of the determination would be harmful to the national security of the United States.
Department of State.
Notice.
The United States Government has determined that the Bulgarian entities Beta JSC and KAS Engineering Consortium/BMG-M OOD transferred certain military equipment to a state sponsor of terrorism. Further notice is hereby given that it is the policy of the United States Government to deny all U.S. Government assistance to Beta JSC and KAS Engineering Consortium/BMG-M OOD for a period of one year, and that U.S. Government Procurement from these entities and new licenses for the import and export of defense articles and services insuring these entities will be banned for a period of one year and that U.S. government procurement from these entities and new licenses for the import and export of defense articles and services involving these entities will be banned for a period of one year.
The date of publication of this notice in the
On general issues: Ronald S. Parson, Office of Export Controls and Conventional Arms Nonproliferation Policy, Bureau of Nonproliferation, Department of State (202-647-0397).
On September 21, 2004 the United States Government determined that the entities Beta JSC and KAS Engineering Consortium/BMG-M OOD transferred certain military equipment to a state sponsor of terrorism. As a matter of policy, United States Government assistance will be denied to Beta JSC and KAS Engineering Consortium/BMG-M OOD for one year. The appropriate officials have been directed to implement additional measures against Beta JSC and KAS Engineering Consortium/BMG-M OOD, consisting of denial of U.S. Government procurement for one year and denial of new licenses and other approvals for exports and imports of defense articles and services for one year.
Federal Aviation Administration (FAA), DOT.
Notice.
In compliance with the Paperwork Reduction of 1995 (44 U.S.C. 3501
Comments must be submitted on or before November 22, 2004. A comment to OMB is most effective if OMB receives it within 30 days of publication.
Judy Street on (202) 267-9895.
1.
2.
Send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW., Washington, DC 20503, Attention FAA Desk Officer.
Comments are invited on: Whether the proposed collection of information is necessary for the proper performance of the functions of the Department, including whether the information will have practical utility: the accuracy of the Department's estimates of the burden of the proposed information collection; ways to enhance the quality, utility and clarity of the information to be collected; and ways to minimize the burden of the collection of information on respondents, including the use of automated collection technique or other forms of information technology.
Federal Aviation Administration (FAA), DOT.
Notice.
In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
Comments must be received on or before December 21, 2004.
Comments may be mailed or delivered to the FAA at the following address: Ms. Judy Street, Room 613, Federal Aviation Administration, Standards and Information Division, APF-100, 800 Independence Ave., SW., Washington, DC 20591.
Ms. Judy Street at the above address or on (202) 267-9895.
In accordance with the Paperwork Reduction Act of 1995, 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. Therefore, the FAA solicits comments on the following collection of information in order to evaluate the necessity of the collection, the accuracy of the agency's estimate of the burden, the quality, utility, and clarity of the information to be collected, and possible ways to minimize the burden of the collection in preparation for submission to renew the clearance of the following information collection.
1. 2120-XXXX, National Assessment of General Aviation Single Engine Land Pilots. The Civil Aerospace Medical Institute (CAMI) will collect the information on behalf of the Federal Aviation Administration's (FAA) Flight Standards (AFS) organization. Newly certified general aviation (GA) Airplane Single-Engine Land (ASEL) pilots within the United States will receive an anonymous and voluntary survey to complete and return by mail. The information collected will be used to assess pilots' experiences during the certification process. CAMI will be responsible for the logistical details associated with mailing out surveys and collecting and processing the responses. The current estimated annual reporting burden is 6,250 hours.
Federal Aviation Administration (FAA), Associate Administrator for Commercial Space Transportation (AST) prepared the Draft Supplemental EA.
Notice of availability and request for comment.
In accordance with National Environmental Policy Act (NEPA) regulations, the FAA is initiating a public review and comment period for a Draft Supplemental EA. In February 2004, the FAA released a Final Environmental Assessment for the East Kern Airport District Launch Site Operator License for the Mojave Airport, which analyzed the environmental impacts of operating a launch site at the Mojave Airport in Mojave, California. The February 2004 EA was prepared to support an application from EKAD to operate a licensed launch facility at the Mojave Airport. Two types of launch vehicles were included in the analysis as typical vehicles that would operate from the Mojave Airport. The first vehicle type, referred to in the EA as Concept A, includes air-drop designs where two vehicles, an airplane and a launch vehicle are mated together, and the airplane carries the launch vehicle to a predetermined altitude where the launch vehicle is dropped and its rocket engines ignite. The second vehicle type referred to in the EA as Concept B includes horizontally launched vehicles, which use rocket power to takeoff from a standard aviation runway.
The FAA issued a launch license to Scaled Composites, Limited Liability Corporation (LLC) on April 7, 2004 for launches of the SpaceShipOne vehicle, which is similar to Concept A launch vehicles described and analyzed in the February 2004 EA. The February 2004 EA considered the environmental impacts of launching up to six (6) Concept A launch vehicles from the Mojave Airport in 2004. To ensure that Scaled Composites and other potential Concept A vehicle operators would have maximum flexibility in using the Mojave Airport to support their launch programs, the Draft Supplemental EA considers the environmental impacts of
The public comment period for the NEPA process begins with the publication of this notice and request for comment in the Federal Register. To ensure that all comments can be addressed in the Final Supplemental EA, comments must be received by the FAA no later than November 24, 2004.
Copies of the Draft Supplemental EA will be made available at the following libraries:
• Edwards Air Force Base Library
• Kern County Library (Boron, California City, Mojave, and Tehachapi Branches)
• Kern River Valley Library (Lake Isabella and Rosamond Branches)
• Palmdale City Library
A downloadable electronic version of the Draft Supplemental EA is available on the FAA Internet site
Written and oral comments regarding the Draft Supplemental EA should be submitted to, Mr. Doug Graham, FAA Environmental Specialist, Mojave Airport Supplemental EA, c/o ICF Consulting, 9300 Lee Highway, Fairfax, VA 22031; e-mail
At this time, SpaceShipOne is the only operational Concept A vehicle that can launch from the Mojave Airport. Scaled Composites has notified EKAD that they may need to conduct up to 10 launches in 2004. The proposed action in the Draft Supplemental EA is for the FAA to license up to four (4) additional launches of Concept A vehicles from the Mojave Airport in 2004. There are no Concept B launches proposed in 2004. This would bring the maximum total number of launches of Concept A vehicles to 10 for 2004. Neither Scaled Composites, nor any other potential Concept A vehicle operator has identified a need to conduct more than six (6) launches per year in the years 2005 to 2008. Because there is no reasonably foreseeable need to conduct more than six (6) launches per year in 2005 to 2008, no additional launches are considered in subsequent years and the number of launches would remain as described in the February 2004 EA.
No construction activities are proposed as part of this proposed action. Existing infrastructure, including hangars and runways, would be used to support launch and landing operations at the airport.
Concept A launch operators would coordinate with the Mojave Airport and air traffic control towers in accordance with existing protocols prior to conducting launches and landings at the Mojave Airport.
Under the no action alternative, the FAA would not increase the number of licensed launches of Concept A vehicles. As analyzed in the February 2004 EA, six (6) total launches of Concept A vehicles could occur from the Mojave Airport in 2004; however, the four (4) additional proposed launches would not occur.
Potential impacts of the proposed action and no action alternative were analyzed in the Draft Supplemental EA. Potential environmental impacts of successful launches include impacts to air quality, airspace, biological resources, cultural resources, health and safety, hazardous materials and hazardous waste, geology and soils, land use, noise, socioeconomics and environmental justice, transportation, visual and aesthetic resources, and water resources. The impacts of the no action alternative would be the same as those described in the February 2004 EA.
Potential cumulative impacts of proposed action are also addressed in the Draft Supplemental EA.
Federal Aviation Administration (FAA), dot.
Notice of RTCA Special Committee 186 meeting.
The FAA is issuing this notice to advise the public of a meeting of RTCA Special Committee 186: Automatic Dependent Surveillance—Broadcast (ADS-B).
The meeting will be held November 1-5, 2004 starting at 9 a.m. (unless stated otherwise).
The meeting will be held at RTCA, Inc., 1828 L Street, NW., Suite 805, Washington, DC 20036.
RTCA Secretariat, 1828 L Street, NW., Suite 805, Washington, DC 20036; telephone (202) 833-9339; fax (202) 833-9434; Web site
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., Appendix 2), notice is hereby given for a Special Committee 186 meeting.
• November 4-5:
• Opening Plenary Session (Chairman's Introductory Remarks, Review of Meeting Agenda, Review/Approval of Previous Meeting Summary).
• SC-186 Activity Reports.
• WG-1, Operations & Implementation.
• WG-2, Traffic Information Service—Broadcast (TIS-B).
• WG-3, 1090 MHz Minimum Operational Performance Standard (MOPS).
• WG-4, Application Technical Requirements.
• WG-5, Universal Access Transceiver (UAT) MOPS.
• WG-6, Automatic Dependent Surveillance-Broadcast (ADS-B) Minimum Aviation System Performance Standards (MASPS).
• Requirement Focus Group.
• EUROCAE WG-51 Activity Report.
• Discussion of Working Group Structure.
• Discussion of inter-committee coordination & discussion of future changes to DO-242A.
• Vehicle Tracking System AC SF-21.
• New Business.
• Review/Approval Revised DO-286, Minimum Aviation System Performance Standards (MASPS) for Traffic Information Service—Broadcast (TIS-B), RTCA Paper No. 159-04/SC186-223.
• Closing Plenary Session (Date, Place and Time of Next Meeting, Other Business, Review Actions Items/Work Program, Adjourn).
Attendance is open to the interested public but limited to space availability. With the approval of the chairmen, members of the public may present oral statements at the meeting. Persons wishing to present statements or obtain information should contact the person listed in the
Federal Aviation Administration (FAA), DOT.
Monthly Notice of PFC Approvals and Disapprovals. In September 2004, there were three applications approved. This notice also includes information on two applications, approved in August 2004, inadvertently left off the August 2004 notice. Additionally, 15 approved amendments to previously approved applications are listed.
The FAA publishes a monthly notice, as appropriate, of PFC approvals and disapprovals under the provisions of the Aviation Safety and Capacity Expansion Act of 1990 (Title IX of the Omnibus Budget Reconciliation Act of 1990) (Pub. L. 101-508) and Part 158 of the Federal Aviation Regulations (14 CFR part 158). This notice is published pursuant to paragraph d of § 158.29.
Tracie D. Kleine, Atlanta Airports District Office, (404) 305-7148.
Lorna Sandridge, Central Region Airports Division, (816) 329-2641.
Christopher Schaffer, Denver Airports District Office, (303) 342-1258.
G. Thomas Wade, Southwest Region Airports Division, (817) 222-5613.
Roderick T. Nicholson, Jackson Airports District Office, (601) 664-9884.
Southwestern Railroad Company, Inc. (SWRR), a Class III rail carrier, has filed a verified notice of exemption under 49 CFR 1150.41
Because SWRR's projected annual revenues will exceed $5 million, SWRR certified to the Board on August 4, 2004, that, on July 29, 2004, it had posted the required 60-day notice of intent to undertake the proposed transaction at the workplace of the employees on the affected line and that, on August 4, 2004, it had served a copy of the notice of intent on the national offices of all labor unions with employees on the rail line.
SWRR states that it intended to consummate the transaction on or after the October 3, 2004 effective date of the exemption (60 days after its certification to the Board under 49 CFR 1150.42(e)).
If the notice contains false or misleading information, the exemption is void
An original and 10 copies of all pleadings, referring to STB Finance Docket No. 34533, must be filed with the Surface Transportation Board, 1925
Board decisions and notices are available on our Web site at
By the Board, David M. Konschnik, Director, Office of Proceedings.
The Burlington Northern and Santa Fe Railway Company (BNSF) has filed a notice of exemption under 49 CFR 1152 Subpart F—
BNSF has certified that: (1) No local traffic has moved over the line for at least 2 years; (2) there is no overhead traffic to be rerouted; (3) no formal complaint filed by a user of rail service on the line (or by a State or local government entity acting on behalf of such user) regarding cessation of service over the line either is pending with the Board or with any U.S. District Court or has been decided in favor of complainant within the 2-year period; and (4) the requirements at 49 CFR 1105.7 (environmental report), 49 CFR 1105.8 (historic report), 49 CFR 1105.11 (transmittal letter), 49 CFR 1105.12 (newspaper publication), and 49 CFR 1152.50(d)(1) (notice to governmental agencies) have been met.
As a condition to this exemption, any employees adversely affected by the abandonment shall be protected under
Provided no formal expression of intent to file an offer of financial assistance (OFA) has been received, this exemption will become effective November 23, 2004, unless stayed pending reconsideration. Petitions to stay that do not involve environmental issues,
A copy of any petition filed with the Board should be sent to applicant's representative: Michael Smith, Freeborn & Peters, 311 S. Wacker Dr., Suite 3000, Chicago, IL 60606-6677.
If the verified notice contains false or misleading information, the exemption is void
BNSF has filed an environmental report which addresses the abandonment's effects, if any, on the environment and historic resources. SEA will issue an environmental assessment (EA) by October 29, 2004. Interested persons may obtain a copy of the EA by writing to SEA (Room 500, Surface Transportation Board, Washington, DC 20423-0001) or by calling SEA, at (202) 565-1539. [Assistance for the hearing impaired is available through the Federal Information Relay Service (FIRS) at 1-800-877-8339.] Comments on environmental and historic preservation matters must be filed within 15 days after the EA becomes available to the public.
Environmental, historic preservation, public use, or trail use/rail banking conditions will be imposed, where appropriate, in a subsequent decision.
Pursuant to the provisions of 49 CFR 1152.29(e)(2), BNSF shall file a notice of consummation with the Board to signify that it has exercised the authority granted and fully abandoned the line. If consummation has not been effected by BNSF's filing of a notice of consummation by October 22, 2005, and there are no legal or regulatory barriers to consummation, the authority to abandon will automatically expire.
Board decisions and notices are available on our Web site at
By the Board, David M. Konschnik, Director, Office of Proceedings.
The Soo Line Railroad Company (Soo Line) has filed a notice of exemption under 49 CFR 1152 Subpart F—
Soo Line has certified that: (1) No local traffic has moved over the line for at least 2 years; (2) all overhead traffic can be and has been rerouted over other lines; (3) no formal complaint filed by a user of rail service on the line (or by a state or local government entity acting on behalf of such user) regarding cessation of service over the line either is pending with the Board or with any U.S. District Court or has been decided in favor of complainant within the 2-year period; and (4) the requirements at 49 CFR 1105.7 (environmental reports), 49 CFR 1105.8 (historic reports), 49 CFR 1105.11 (transmittal letter), 49 CFR 1105.12 (newspaper publication), and 49 CFR 1152.50(d)(1) (notice to governmental agencies) have been met.
As a condition to this exemption, any employee adversely affected by the abandonment shall be protected under
Provided no formal expression of intent to file an offer of financial assistance (OFA) has been received, this
Soo Line states that the line is the stub end of a grain branch line leased to Northern Plains Railroad, Inc. (NPRR).
A copy of any petition filed with the Board should be sent to Soo Line's representative: Annie Littlefield, Leonard, Street and Deinard Professional Association, 150 South Fifth Street, Suite 2300, Minneapolis, MN 55402.
If the verified notice contains false or misleading information, the exemption is void
Soo Line has filed an environmental report which addresses the abandonment's effects, if any, on the environment and historic resources. SEA will issue an environmental assessment (EA) by October 29, 2004. Interested persons may obtain a copy of the EA by writing to SEA (Room 500, Surface Transportation Board, Washington, DC 20423-0001) or by calling SEA, at (202) 565-1539. [Assistance for the hearing impaired is available through the Federal Information Relay Service (FIRS) at 1-800-877-8339.] Comments on environmental and historic preservation matters must be filed within 15 days after the EA becomes available to the public.
Environmental, historic preservation, public use, or trail use/rail banking conditions will be imposed, where appropriate, in a subsequent decision.
Pursuant to the provisions of 49 CFR 1152.29(e)(2), Soo Line shall file a notice of consummation with the Board to signify that it has exercised the authority granted and fully abandoned the line. If consummation has not been effected by Soo Line's filing of a notice of consummation by October 22, 2005, and there are no legal or regulatory barriers to consummation, the authority to abandon will automatically expire.
Board decisions and notices are available on our Web site at
By the Board, David M. Konschnik, Director, Office of Proceedings.
Alcohol and Tobacco Tax and Trade Bureau (TTB), Treasury.
Notice and request for comments.
The Department of the Treasury and its Alcohol and Tobacco Tax and Trade Bureau, as part of their continuing effort to reduce paperwork and respondent burden, invite the public and other Federal agencies to comment on proposed and continuing information collections, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
We must receive your written comments on or before December 21, 2004.
You may send comments to Sandra Turner, Alcohol and Tobacco Tax and Trade Bureau, at any of these addresses:
• P.O. Box 14412, Washington, DC 20044-4412;
• 202-927-8525 (facsimile); or
•
Please reference the information collection's title, form or recordkeeping requirement number, and OMB number (if any) in your comment. If you submit your comment via facsimile, send no more than five 8.5 x 11 inch pages in order to ensure electronic access to our equipment.
To obtain additional information, copies of the information collection and its instructions, or copies of any comments received, contact Sandra Turner, Alcohol and Tobacco Tax and Trade Bureau, P.O. Box 14412, Washington, DC 20044-4412; or telephone 202-927-8210.
Comments submitted in response to this notice will be included or summarized in our request for Office of Management and Budget (OMB) approval of this information collection.
We invite comments on: (a) Whether this information collection is necessary for the proper performance of the agency's functions, including whether the information has practical utility; (b) the accuracy of the agency's estimate of the information collection's burden; (c) ways to enhance the quality, utility, and clarity of the information collected; (d) ways to minimize the information collection's burden on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide the requested information.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning an existing final regulation, REG-104072-97 (TD 8853), Recharacterizing Financing Arrangements Involving Fast-Pay Stock (§ 1.7701(l)-3).
Written comments should be received on or before December 21, 2004 to be assured of consideration.
Direct all written comments to Joe Durbala, Internal Revenue Service, room 6516, 1111 Constitution Avenue, NW., Washington, DC 20224.
Requests for additional information or copies of the regulation should be directed to Allan Hopkins, at (202) 622-6665, or at Internal Revenue Service, room 6516, 1111 Constitution Avenue, NW., Washington, DC 20224, or through the Internet, at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number.
Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13(44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning an existing final regulation, REG-209830-96 (TD 8779), Estate and Gift Tax Marital Deduction.
Written comments should be received on or before December 21, 2004 to be assured of consideration.
Direct all written comments to Paul Finger, Internal Revenue Service, room 6516, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of the regulation should be directed to Allan Hopkins, at (202) 622-6665, or at Internal Revenue Service, room 6516, 1111 Constitution Avenue NW., Washington, DC 20224, or through the Internet, at
The estimated reporting burden in this regulation is reflected in the burden of Form 843, Claim for Refund and Request for Abatement, and Forms 706 and 706-NA, United States Estate (and Generation-Skipping Transfer) Tax Return.
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13(44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning an existing final regulation, PS-268-82 (TD 8696), Definitions Under Subchapter S of the Internal Revenue Code (Section 1.1377-1).
Written comments should be received on or before December 21, 2004 to be assured of consideration.
Direct all written comments to Paul Finger, Internal Revenue Service, room 6516, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of the regulation should be directed to Allan Hopkins, at (202) 622-6665, or at Internal Revenue Service, room 6516, 1111 Constitution Avenue NW., Washington, DC 20224, or through the Internet, at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent
Written comments should be received on or before December 21, 2004 to be assured of consideration.
Direct all written comments to Paul Finger, Internal Revenue Service, room 6516, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of the regulation should be directed to Allan Hopkins, at (202) 622-6665, or at Internal Revenue Service, room 6516, 1111 Constitution Avenue NW., Washington, DC 20224, or through the Internet, at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Centers for Medicare & Medicaid Services (CMS), HHS.
Final rule.
This final rule sets forth an update to the 60-day national episode rates and the national per-visit amounts under the Medicare prospective payment system for home health agencies. As part of this final rule, we are also rebasing and revising the home health market basket to ensure it continues to adequately reflect the price changes of efficiently providing home health services. In addition, we are revising the fixed dollar loss ratio, which is used in the calculation of outlier payments. This final rule will be the first update of the home health prospective payment system (HH PPS) rates on a calendar year update cycle. HH PPS was moved to a calendar year update cycle as a result of the provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003.
These regulations are effective on January 1, 2005.
Randy Throndset, (410) 786-0131. Debra Gillespie, (410) 786-4631. Mary Lee Seifert (Market Basket), (410) 786-0030. Mollie Knight (Market Basket), (410) 786-7948.
This
The Balanced Budget Act of 1997 (BBA), (Pub. L. 105-33), enacted on August 5, 1997, significantly changed the way Medicare pays for Medicare home health services. Until the implementation of a home health prospective payment system (HH PPS) on October 1, 2000, home health agencies (HHAs) received payment under a cost-based reimbursement system. Section 4603 of the BBA governed the development of the HH PPS.
Section 4603(a) of the BBA provides the authority for the development of a PPS for all Medicare-covered home health services provided under a plan of care that were paid on a reasonable cost basis by adding section 1895, entitled “Prospective Payment For Home Health Services,” to the Social Security Act (the Act).
Section 1895(b)(1) of the Act requires the Secretary to establish a PPS for all costs of home health services paid under Medicare.
Section 1895(b)(3)(A) of the Act requires that (1) the computation of a standard prospective payment amount include all costs of home health services covered and paid for on a reasonable cost basis and be initially based on the most recent audited cost report data available to the Secretary, and (2) the prospective payment amounts be standardized to eliminate the effects of case-mix and wage levels among HHAs.
Section 1895(b)(3)(B) of the Act addresses the annual update to the standard prospective payment amounts by the home health applicable increase percentage as specified in the statute.
Section 1895(b)(4) of the Act governs the payment computation. Sections 1895(b)(4)(A)(i) and (b)(4)(A)(ii) of the Act require the standard prospective payment amount to be adjusted for case-mix and geographic differences in wage levels. Section 1895(b)(4)(B) of the Act requires the establishment of an appropriate case-mix adjustment factor that explains a significant amount of the variation in cost among different units of services. Similarly, section 1895(b)(4)(C) of the Act requires the establishment of wage adjustment factors that reflect the relative level of wages and wage-related costs applicable to the furnishing of home health services in a geographic area compared to the national average applicable level. These wage-adjustment factors may be the factors used by the Secretary for the different area wage levels for purposes of section 1886(d)(3)(E) of the Act.
Section 1895(b)(5) of the Act gives the Secretary the option to grant additions or adjustments to the payment amount otherwise made in the case of outliers because of unusual variations in the type or amount of medically necessary care. Total outlier payments in a given fiscal year cannot exceed 5 percent of total payments projected or estimated.
On July 3, 2000, we published a final rule (65 FR 41128) in the
As required by section 1895(b)(3)(B) of the Act, we have historically updated the HH PPS rates annually in a separate
Generally, Medicare makes payment under the HH PPS on the basis of a national standardized 60-day episode payment, adjusted for case mix and wage index. For episodes with four or fewer visits, Medicare pays on the basis of a national per-visit amount by discipline, referred to as a low utilization payment adjustment (LUPA). Medicare also adjusts the 60-day episode payment for certain intervening events that give rise to a partial episode payment adjustment (PEP adjustment) or a significant change in condition adjustment (SCIC). For certain cases that exceed a specific cost threshold, an outlier adjustment may also be
On December 8, 2003, the Congress enacted the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 (Pub. L. 108-173). This new legislation affects our update to HH payment rates. Specifically, section 421 of MMA requires, for home health services furnished in a rural area (as defined in section 1886(d)(2)(D) of the Act), with respect to episodes or visits ending on or after April 1, 2004 and before April 1, 2005, that the Secretary increase the payment amount that otherwise would have been made under section 1895 of the Act for the services by 5 percent.
The statute waives budget neutrality for the purposes of this increase as it specifically states that the Secretary will not reduce the standard prospective payment amount (or amounts) under section 1895 of the Act applicable to home health services furnished during a period to offset the increase in payments resulting in the application of this section of the statute.
Section 701 of the MMA changes the yearly update cycle of the HH PPS rates from that of a fiscal year to a calendar year update cycle for 2004 and any subsequent year. Generally, section 701(a) of the MMA changes the references in the statute to refer to the calendar year for 2004 and any subsequent year. The changes result in updates to the HH PPS rates described as “fiscal year” updates for 2002 and 2003 and as calendar “year” updates for 2004 and any subsequent year (section 1895(b)(3)(B)(i) of the Act). In light of these provisions, we will not be updating the HH PPS rates on October 1, 2004 as HH PPS will now be updated on a calendar year update cycle.
In addition to changing the update cycle for HH PPS rates, section 701 of the MMA makes adjustments to the home health applicable increase percentage for 2004, 2005, and 2006. Specifically, section 701(a)(2)(D) of the MMA leaves unchanged the home health market basket increase for the last calendar year quarter of 2003 and the first calendar year quarter of 2004 (section 1895(b)(3)(B)(ii)(II) of the Act). Furthermore, section 701(b)(4) of the MMA sets the home health applicable percentage increase for the last 3 quarters of 2004 as the home health market basket (3.1 percent) minus 0.8 percentage points (section 1895(b)(3)(B)(ii)(III) of the Act). We implemented this provision through Pub. 100-20, One Time Notification, Transmittal 59, issued February 20, 2004. Section 701(b)(4) of the MMA also provides that updates for CY 2005 and CY 2006 will equal the applicable home health market basket percentage increase minus 0.8 percentage points. Lastly, section 701(b)(3) of the MMA revises the statute to provide that HH PPS rates for CY 2007 and any subsequent year will be updated by that year's home health market basket percentage increase (section 1895(b)(3)(B)(ii)(IV) of the Act).
Section 902 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) amended section 1871(a) of the Act and requires the Secretary, in consultation with the Director of the Office of Management and Budget, to establish and publish timelines for the publication of Medicare final regulations based on the previous publication of a Medicare proposed or interim final regulation. Section 902 of the MMA also states that the timelines for these regulations may vary but shall not exceed 3 years after publication of the preceding proposed or interim final regulation except under exceptional circumstances.
This final rule finalizes provisions set forth in proposed rule published in the
On June 2, 2004, we published a proposed rule in the
Medicare HH PPS has been effective since October 1, 2000. As set forth in the final rule published July 3, 2000 in the
As required by section 1895(b)(3)(B) of the Act, we have updated the HH PPS rates annually in a separate
(g) For 2007 and subsequent calendar years, the unadjusted national rate is equal to the rate for the previous calendar year increased by the applicable home health market basket index amount.
We also proposed to add new paragraphs (d), (e), and (f) to read as follows:
(d) For the last calendar quarter of 2003 and the first calendar quarter of 2004, the unadjusted national prospective 60-day episode payment rate is equal to the rate from the previous fiscal year (FY 2003) increased by the applicable home health market basket index amount.
(e) For the last 3 calendar quarters of 2004, the unadjusted national prospective 60-day episode payment rate is equal to the rate from the previous fiscal year (FY 2003) increased by the applicable home health market basket minus 0.8 percentage points.
(f) For each of calendar years 2005 and 2006, the unadjusted national prospective 60-day episode payment rate is equal to the rate from the previous calendar year, increased by the applicable home health market basket minus 0.8 percentage points.
We also proposed to rebase and revise the home health market basket. As proposed, the labor related portion of the rebased and revised home health market basket would be 76.775 percent, and the non-labor portion would be 23.225 percent. We added the wage-adjusted portion to the non-labor portion yielding the case-mix and wage-adjusted 60-day episode rate subject to applicable adjustments.
For CY 2005, we proposed to use again the design and case-mix methodology described in section III.G of the HH PPS July 3, 2000 final rule (65 FR 41192 through 41203). For CY 2005, we proposed to base the wage index adjustment to the labor portion of the PPS rates on the most recent pre-floor and pre-reclassified hospital wage index that does not apply the core-based statistical area (CBSA) policy. As discussed in the July 3, 2000 HH PPS final rule, for episodes with four or fewer visits, Medicare pays the national per-visit amount by discipline, referred to as a LUPA. We update the national per-visit amounts by discipline annually by the applicable home health market basket percentage. We adjust the national per-visit amount by the appropriate wage index based on the site of service for the beneficiary as set forth in § 484.230. We proposed to adjust the labor portion of the updated national per-visit amounts by discipline used to calculate the LUPA by the most recent pre-floor and pre-reclassified hospital wage index that does not apply the CBSA policy.
Medicare pays the 60-day case-mix and wage-adjusted episode payment on a split percentage payment approach. The split percentage payment approach includes an initial percentage payment and a final percentage payment as set forth in § 484.205(b)(1) and (b)(2). We may base the initial percentage payment on the submission of a request for anticipated payment and the final percentage payment on the submission of the claim for the episode, as discussed in § 409.43. The claim for the episode that the HHA submits for the final percentage payment determines the total payment amount for the episode and whether we make an applicable adjustment to the 60-day case-mix and wage-adjusted episode payment. The end date of the 60-day episode as reported on the claim determines the rate level at which Medicare will pay the claim for the fiscal period.
We may also adjust the 60-day case-mix and wage-adjusted episode payment based on the information submitted on the claim to reflect the following:
• A low utilization payment provided on a per-visit basis as set forth in § 484.205(c) and § 484.230.
• A partial episode payment adjustment as set forth in § 484.205(d) and § 484.235.
• A significant change in condition adjustment as set forth in § 484.205(e) and § 484.237.
• An outlier payment as set forth in § 484.205(f) and § 484.240.
The proposed rule reflected the updated CY 2005 rates that would be effective January 1, 2005.
We also proposed to rebase and revise the home health market basket to ensure it continues to adequately reflect the price changes of efficiently providing home health services. In addition to rebasing the base year cost structure from FY 1993 to FY 2000, we also proposed to revise the market basket by modifying several categories in the market basket cost structure. The major revision to the proposed market basket was the combining of the Administrative and General and Other Expenses cost categories. [See 69 FR 31251 for a more complete explanation of the market basket cost structure]
Section 1895(b)(3)(B) of the Act, as amended by section 701 of the MMA, requires for CY 2005 that the standard prospective payment amounts be increased by a factor equal to the applicable home health market basket increase minus 0.8 percentage points. We proposed to amend the regulations in § 484.225 to reflect this requirement.
•
In calculating the annual update for the CY 2005 60-day episode rates, we proposed to first look at the CY 2004 rates as a starting point. The CY 2004 national 60-day episode rate, as modified by section 701 of the MMA and implemented through Pub. 100-20 One Time Notification, Transmittal 59 issued February 20, 2004 is $2,213.37.
In order to calculate the CY 2005 national 60-day episode rate, we proposed to multiply the CY 2004 national 60-day episode rate ($2,213.37) by the applicable home health market basket update, at the time of publication of the proposed rule, of 3.3 percent for CY 2005 minus 0.8 percentage points.
We proposed to increase the CY 2004 60-day episode payment rate by the proposed home health market basket increase (3.3 percent) minus 0.8 percentage points ($2,213.37 × 2.5 percent) to yield the proposed updated CY 2005 national 60-day episode rate ($2,268.70).
•
The policies governing the LUPAs and outlier calculations set forth in the July 3, 2000 HH PPS final rule will continue during CY 2005. In calculating the annual update for the CY 2005 national per-visit amounts we use to pay LUPAs and to compute the imputed costs in outlier calculations, we proposed to look again at the CY 2004 rates as a starting point. We then proposed to multiply those amounts by the proposed home health market basket increase minus 0.8 percentage points for CY 2005 to yield the updated per-visit amounts for each home health discipline for CY 2005. For details as to the specific LUPA rates that we proposed for CY 2005, see the proposed rule (69 FR 31256) published on June 2, 2004.
Outlier payments are payments made in addition to regular 60-day case-mix and wage-adjusted episode payments for episodes that incur unusually large costs due to patient home health care needs. Outlier payments are made for episodes whose estimated cost exceeds a threshold amount. The episode's estimated cost is the sum of the national wage-adjusted per-visit payment amounts for all visits delivered during the episode. The outlier threshold for each case-mix group, PEP adjustment, or total SCIC adjustment is defined as the 60-day episode payment amount, PEP adjustment, or total SCIC adjustment for that group plus a fixed dollar loss amount. Both components of the outlier threshold are wage-adjusted.
The wage-adjusted fixed dollar loss amount (FDL) represents the amount of loss that an agency must bear before an episode becomes eligible for outlier payments. The FDL is computed by multiplying the wage-adjusted 60-day episode payment amount by the fixed dollar loss ratio, which is a proportion expressed in terms of the national standardized episode payment amount. The outlier payment is defined to be a proportion of the wage-adjusted estimated costs beyond the wage-adjusted threshold. The proportion of additional costs paid as outlier payments is referred to as the loss-sharing ratio.
Section 1895(b)(5) of the Act requires that estimated total outlier payments are no more than 5 percent of total estimated HH PPS payments. In response to the concerns about potential
For a given level of outlier payments, there is a trade-off between the values selected for the fixed dollar loss ratio and the loss-sharing ratio. A high fixed dollar loss ratio reduces the number of episodes that can receive outlier payments, but makes it possible to select a higher loss-sharing ratio and, therefore, increase outlier payments for outlier episodes. Alternatively, a lower fixed dollar loss ratio means that more episodes can qualify for outlier payments, but outlier payments per episode must be lower. As a result of public comments on the October 28, 1999 proposed rule, in our July 2000 final rule, we made the decision to attempt to cover a relatively high proportion of the costs of outlier cases for the most expensive episodes that would qualify for outlier payments within the 5 percent constraint.
We chose a value of 0.80 for the loss-sharing ratio, which is relatively high, but which preserves incentives for agencies to attempt to provide care efficiently for outlier cases. It is also consistent with the loss-sharing ratios used in other Medicare PPS outlier policies. Having made this decision, we estimated the value of the fixed dollar loss ratio that would yield estimated total outlier payments that were projected to be no more than 5 percent of total home health PPS payments. The resulting value for the fixed dollar loss ratio was 1.13.
Analysis of 100 percent of CY 2001 home health claims data reflected that outlier episodes represented approximately 3 percent of total episodes and 3 percent of total HH PPS payments. We proposed to make no change in the projected 5 percent target for outlier expenditures as a percent of total HH PPS payments. In addition, we proposed no change to the loss-sharing ratio of 0.80. Further, section 1895(b)(3)(C) of the Act requires that the episode payment amounts be adjusted to effectively pay for outlier payments within the same level of estimated total spending. We proposed no change to the adjustment to the episode payment amounts for outlier payments. We proposed to change only the fixed dollar loss ratio, and in turn, the fixed dollar loss amount.
For the proposed rule, we performed data analysis on CY 2001 HH PPS analytic data to update the fixed dollar loss ratio to enable the total estimated outlier payments to be 5 percent of total HH PPS payments. That analysis indicated that a fixed dollar loss ratio of 0.72 was consistent with the existing loss-sharing ratio of 0.80 and a target percentage of estimated outlier payments of the projected 5 percent. Consequently, we proposed to update the fixed dollar loss ratio from the current ratio of 1.13 to the fixed dollar loss ratio of 0.72. It was estimated that a fixed dollar loss ratio of 0.72 would allow approximately 6.5 percent of episodes to qualify for outlier payments. The estimated 6.5 percent outlier episodes is greater than the 3.0 percent of episodes that currently qualify for outlier payments, and is about the same as the 6.8 percent for outlier episodes that we estimated in our July 2000 final rule.
We believe that our proposed fixed dollar loss ratio of 0.72 preserved a reasonable degree of cost sharing, while allowing a greater number of episodes to qualify for outlier payments. In our proposed rule, we indicated our plan to update our estimate of the fixed dollar loss ratio using the most current, complete year of HH PPS data available.
Section 421 of the MMA requires, for home health services furnished in a rural area with respect to episodes and visits ending on or after April 1, 2004 and before April 1, 2005, that we increase by 5 percent the payment amount that otherwise would be made for these services. The statute waives budget neutrality related to this provision. By statute, the 5 percent rural add-on applies to home health services furnished in a rural area (as defined in section 1886(d)(2)(D) of the Act) for episodes and visits ending on or after April 1, 2004 and before April 1, 2005. Therefore, the 5 percent rural add-on ends after the first quarter of CY 2005 for episodes and visits ending before April 1, 2005. After the rural add-on is determined, the applicable case-mix and wage index adjustment is then subsequently applied for the provision of home health services where the site of service is the non-Metropolitan Statistical Area (MSA) of the beneficiary. Similarly, the applicable wage index adjustment is subsequently applied to the LUPA per visit amounts adjusted for the provision of home health services where the site of service for the beneficiary is a non-MSA area. We implemented this provision for CY 2004 on April 1, 2004 through Pub. 100-20 One Time Notification, Transmittal 59 issued February 20, 2004. For further details as to the specific rates for HH PPS payments to beneficiaries in rural areas, see the proposed rule (69 FR 31259) published on June 2, 2004.
Sections 1895(b)(4)(A)(ii) and (b)(4)(C) of the Act require the Secretary to establish area wage adjustment factors that reflect the relative level of wages and wage-related costs applicable to the furnishing of home health services and to provide appropriate adjustments to the episode payment amounts under HH PPS to account for area wage differences. We applied the appropriate wage index value to the labor portion of the HH PPS rates based on the geographic area in which the beneficiary received home health services. We determined each HHA's labor market area based on definitions of Metropolitan Statistical Areas (MSAs) issued by the Office of Management and Budget (OMB). We recognize that on June 6, 2003, the Office of Management and Budget (OMB) issued OMB Bulletin No. 03-04, announcing revised definitions of Metropolitan Statistical Areas, and new definitions of Micropolitan Statistical Areas, and Combined Statistical Areas. A copy of the Bulletin may be obtained at the following Internet address:
On May 18, 2004, we published a proposed rule entitled “Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and FY 2005 Rates” (69 FR 28195), which discusses some of the issues associated with using these new definitions and proposes to use these new definitions for the Inpatient Hospital PPS for FY 2005. We indicated that we believed it would be appropriate to wait until the public comments on that proposed rule had been submitted and analyzed before we considered proposing any new labor market definitions in the home health context.
As discussed previously and set forth in the July 3, 2000 final rule, the statute provides that the wage adjustment factors may be the factors used by the Secretary for purposes of section 1886(d)(3)(E) of the Act for hospital wage adjustment factors. Again, as discussed in the July 3, 2000 final rule,
Under previous fiscal year updates, the most recent pre-floor and pre-reclassified hospital wage index available at the time of publication of the HH PPS fiscal year update was that of the previous year. Beginning with the CY 2005 update to home health payment rates, the most recent pre-floor and pre-reclassified hospital wage index available at the time of publication will be that of the current year. Consequently, for our proposed CY 2005 update to the home health payment rates, we proposed to continue to use the most recent pre-floor and pre-reclassified hospital wage index available at the time of publication. We recognized that this change to a calendar year update cycle results in using the current year's wage index values. We also note that for HH PPS rates addressed in the proposed rule, we inadvertently published the 2004 pre-floor and pre-reclassified hospital wage index. Consequently, we published a correction notice in the
We received approximately 25 timely comments on the Home Health Prospective Payment System Rate Update for Calendar Year 2005 proposed rule (CMS-1265-P), published on June 2, 2004 (69 FR 31248). We have also received approximately 6 additional timely comments on the Home Health Prospective Payment System Rate Update for FY 2004 Notice (CMS-1473-NC), published on July 2, 2003 (68 FR 39764). We received comments from HHAs and other health care providers, national industry associations, suppliers and practitioners, State associations, health care consulting firms, and private citizens. The comments centered on issues such as the wage index used to update rates, home health market basket analysis, metropolitan statistical areas as they relate to the wage index, reduction in the fixed dollar loss ratio for outlier episodes, home health resource group (HHRG) payment inadequacies, responsibility of and payment for supplies in the home health episode, cost reporting requirements, and finally refinements to the HH PPS in the areas of: Case mix, LUPAs, RAPs, SCICs, PEPs, outliers, supplies, and OASIS items (that is, M0175). We have considered all comments received during the 60-day public comment period on the June 2, 2004 proposed rule, as well as from the July 2, 2003 notice. Our responses to the comments from both
As noted in the proposed rule published in the
We intend to address the aspects of the HH PPS that are subject to administrative revision when we initiate a refinement regulation. We believe it is prudent to avoid piecemeal revisions addressing one provision or another in isolation. Also, we believe it is common with new payment systems for providers to go through a period of adaptation. The adaptation process influences the data we use to study refinements, and those data lag by a year or more. We believe it is appropriate to base recommendations on data that reflect the end point of the provider adaptation process. Our study results will be more effective and provide a better basis for policy proposals when the data used in the studies reflect the end point of the adaptation period. Furthermore, we believe the best approach would be one that allows for analyzing interrelationships among payment features on the system in general. Moreover, it is more efficient to make numerous changes at the same time. Past experience with changes in systems and data collection for providers has shown that providers believe it is more burdensome when frequent changes are made to a payment system.
Many of the factors used to set prospective payment amounts for a given year are based on estimates. These factors include not only the outlier threshold, but also the market basket rate of increases used to establish the update factor to the HH PPS rates. We do not believe that the Congress intended that the standardized amounts for a given year should be adjusted (upward or downward) to reflect any difference between projected and actual outlier payments for a past year.
Under the policy we have maintained since the inception of the HH PPS, we do not make retroactive adjustments to reconcile differences between the percentage of outlier payments projected before a given year and the “actual” outlier payments for that year.
For the convenience of the public, we have recently published in the HH PPS rate updates, a comparison of wage index values from the current year to the upcoming year, as an illustration of the changes in the wage index from year to year. We are publishing a comparison table as part of this rule in Addendum C.
For specifics regarding the information on the hospital wage data used in computing the hospital wage index, please refer to the August 11, 2004 IPPS final rule (69 FR 48915).
As for the HIPAA compliance and quality assurance activities, the HH market basket will only reflect these costs since they impact the rate of change in prices. For example, if there are overall increases in wage levels due to staffing changes associated with HIPAA compliance and/or quality assurance activities, these price changes may be reflected in the price proxies. However, costs associated with purchasing new equipment or hiring more staff for HIPAA compliance and/or quality assurance activities will only be reflected in the base year weights when the index is rebased to reflect a year in which these costs were present.
We also believe the blending of the price proxies accurately captures the growth of nursing wage costs. We continued to use a 50/50 split of ECI for Professional Specialty & Technical Workers and Civilian Hospital Workers for both wages and benefits in order to reflect the competition between HHAs and hospitals for registered nurses, while still capturing the overall wage trends for professional and technical workers. We explained the need for this process as there is no specific wage or benefit measure for HHAs that holds skill mix constant. The increase in the Skilled Nursing & Therapist & Other Professional/Technical wages cost weight from the 1993-based (45.758 of the total wage cost category or 29.389 percent of the total index) to the proposed 2000-based HH market basket (53.816 percent of the wage cost category or 35.393 percent of the total index) is a reflection of the increase in skilled nursing, therapist, and other professional/technical wage costs relative to other market basket costs. The blended home health wage proxy, composed of ECIs which keep the skill mix constant, increased 35 percent from 1995 through 2003, while the Average Hourly Earnings for Nonsupervisory Home Health Workers grew by 24 percent.
The market basket is an important component of the PPS system, but it is also important to review total provider reimbursement and costs when assessing the adequacy of Medicare payments. In April 2004, MedPAC reported that the Medicare margin for home health providers was 16.8 percent in 2004, and recommended that no update be provided for 2005. The MMA, however, requires the market basket update minus 0.8 percent, which results in a 2.3 percent increase for 2005, which this final rule implements.
The Medicare cost reports provide actual cost share data for home health agencies serving Medicare patients. We believe that home health agencies understand the value we place upon accurate cost report data, and have provided us with reliable cost data, which aid our rebasing and revising of the home health market basket.
As noted previously, we received 6 comments on the 2004 update notice for HH PPS. A summary of those comments and our responses are noted below.
This final rule incorporates the provisions of the regulations text of the proposed rule [69 FR 31248]. We have adopted the proposed changes from the above captioned proposed rule with regards to the rebasing and revising of the home health market basket, differing only in that through the use of updated data, the final CY 2005 market basket increase is 3.1 percent, as compared to 3.3 percent in the proposed rule. Consequently, we will update the national 60-day episode rate and the per-visit payment amounts per discipline for CY 2005 for LUPAs by the final determined market basket percentage of 3.1 percent minus 0.8 percentage points for an update to the HH PPS rates of 2.3 percent. In addition, we will update, by 5 percent, the 60-day episode payment amounts and the LUPA, per-visit payment amounts for services furnished in a rural area with respect to episodes and visits ending on or after April 1, 2004 and before April 1, 2005. We have also updated the fixed dollar loss (FDL) ratio, used in the determination of outlier payments, from the proposed ratio of 0.72 in the proposed rule to 0.70, using the most recent available HH PPS data. Finally, this final rule includes the most recent version of the pre-floor and pre-reclassified hospital wage index, that does not apply the CBSA policy, used by the HH PPS.
Section 1895(b)(3)(B) of the Act, as amended by the MMA, requires the standard prospective payment amounts to be paid on a calendar year basis for 2004 and any subsequent year. Previous market basket updates were calculated on a fiscal year basis. Table 1 shows that the forecasted rate of growth for CY 2005, beginning January 1, 2005, for the rebased and revised home health market basket is 3.1 percent, while the forecasted rate of growth for the current 1993-based home health market basket is also 3.1 percent. This final update for CY 2005 is based on the Global Insight, Inc 2004, 3rd quarter forecast with historical data through 2004, 2nd quarter. The proposed CY 2005 update was based on a forecast with historical data through 2003, 3rd quarter. As previously mentioned, we rebase the home health market basket periodically so the cost category weights continue to reflect changes in the mix of goods and services that HHAs purchase in furnishing home health care.
Table 2 shows the percent changes for CY 2005 based on the 2004, 3rd quarter forecast for each cost category in the home health market basket.
Section 1895(b)(3)(B) of the Act, as amended by section 701 of the MMA, requires for CY 2005 that the standard prospective payment amounts be increased by a factor equal to the applicable home health market basket increase minus 0.8 percentage points. As previously noted, we are amending the regulations in § 484.225 to reflect this requirement.
To calculate the CY 2005 national 60-day episode rate, we multiply the CY 2004 (as of April 1, 2004) national 60-day episode rate ($2,213.37) by the applicable home health market basket update of 3.1 percent for CY 2005 minus 0.8 percentage points.
We increase the CY 2004 60-day episode payment rate by the proposed home health market basket increase (3.1 percent) minus 0.8 percentage points ($2,213.37 × 2.3 percent) to yield the updated CY 2005 national 60-day episode rate ($2,264.28) (see Table 4 below).
As discussed previously in this final rule, the policies governing the LUPAs and outlier calculations set forth in the July 3, 2000 HH PPS final rule will continue during CY 2005. In calculating the annual update for the CY 2005 national per-visit amounts we use to pay LUPAs and to compute the imputed costs in outlier calculations, we look again at the CY 2004 (as of April 1, 2004) rates as a starting point. We then multiply those amounts by the home health market basket increase minus 0.8 percentage points for CY 2005 to yield the updated per-visit amounts for each home health discipline for CY 2005. (
For the rule, we performed analysis of CY 2001 home health claims data. The results of that analysis reflected that outlier episodes represented approximately 3 percent of total episodes and 3 percent of total HH PPS payments. For this final rule, we have performed the same analysis on CY 2002 and CY 2003 home health claims data and have found the number of outlier episodes and payments to continue to hold at approximately 3 percent of total episodes and total HH PPS payments, respectively.
In the rule, we also performed data analysis on CY 2001 HH PPS analytic data to update the fixed dollar loss (FDL) ratio to enable the total estimated outlier payments to be a projected 5 percent of total HH PPS payments. The results of that analysis indicated that a fixed dollar loss ratio of 0.72 was consistent with the existing loss-sharing ratio of 0.80 and a projected target percentage of estimated outlier payments of 5 percent. For this final rule, we have performed the same analysis on CY 2003 HH PPS analytic data to update the fixed dollar loss ratio. The results of this analysis indicate that a fixed dollar loss ratio of 0.70 is consistent with the existing loss-sharing ratio of 0.80 and a projected target percentage of estimated outlier payments of 5 percent. Consequently, we are updating the fixed dollar loss ratio from the current ratio of 1.13 to the fixed dollar loss ratio of 0.70. Our analysis shows that reducing the fixed dollar loss ratio from 1.13 to 0.70 will allow approximately 5.9 percent of episodes to qualify for outlier payments. The estimated 5.9 percent outlier episodes are greater than the 3.0 percent of episodes that currently qualify for outlier payments.
Expressed in terms of a fixed dollar loss amount, the fixed dollar loss ratio of 0.70 implies that providers would absorb approximately $1,585 of their costs (before wage adjustment), in addition to their loss-sharing portion of the estimated cost in excess of the outlier threshold. This fixed dollar loss amount of approximately $1,585 is computed by multiplying the standard 60-day episode payment amount ($2,264.28) by the fixed dollar loss ratio (0.70). Using the current fixed dollar loss ratio (1.13), the fixed dollar loss amount would be approximately $2,558 ($2,264.28 × 1.13).
We believe that a fixed dollar loss ratio of 0.70 preserves a reasonable degree of cost sharing, while allowing a greater number of episodes to qualify for outlier payments.
The following analytical Tables 6-a through 6-d, derived from analysis of CY 2003 HH PPS claims data, characterize outlier episodes, and estimate how different types of providers and providers in different parts of the country will do under an outlier scenario that employs a fixed dollar loss ratio of 0.70 as compared to the current fixed dollar loss ratio of 1.13.
The new FDL of 0.70 will increase outlier payments to all types of home health providers in all areas of the country. Generally speaking, it has been estimated that, under a scenario where the FDL is equal to 0.70, for home health providers whose outlier payments are historically a lesser percentage of their total HH PPS payments, their outlier payments will increase at a greater rate than will outlier payments for home health providers whose outlier payments are historically of a greater percentage of their total HH PPS payments.
For example, non-profit home health agencies were estimated to receive outlier payments equal to approximately 1.9 percent of their total HH PPS payments under the current scenario where the FDL = 1.13. Under the same scenario, for-profit home health agencies were estimated to receive outlier payments equal to approximately 5.1 percent of their total HH PPS payments. While a scenario where the FDL = 0.70 increases the percentage of outlier payments to total HH PPS payments, the overall increase in outlier payments to non-profit home health agencies increases by an estimated 77.6 percent while the outlier payments for for-profit home health agencies increase by approximately 33.8 percent.
Similarly, while outlier payments to both provider-based and free-standing home health agencies will increase under a scenario where FDL = 0.70, outlier payments to provider-based home health agencies are estimated to increase by approximately 97.3 percent, while payments to free-standing home health agencies are estimated to increase
As discussed in the proposed rule, section 421 of the MMA requires, for home health services furnished in a rural area with respect to episodes and visits ending on or after April 1, 2004 and before April 1, 2005, that we increase by 5 percent the payment amount that otherwise would be made for the services.
The CY 2005 5 percent rural add-on to the 60-day episode standardized payment and the per-visit LUPA payments, as required by section 421 of the MMA, is noted in tables 7 and 8 below.
Sections 1895(b)(4)(A)(ii) and (b)(4)(C) of the Act require the Secretary to establish area wage adjustment factors that reflect the relative level of wages and wage-related costs applicable to the furnishing of home health services and to provide appropriate adjustments to the episode payment amounts under HH PPS to account for area wage differences. We have consistently used the most recent pre-floor and pre-reclassified hospital wage index available in determining HH PPS updates.
In our June 2, 2004 proposed rule (69 FR 31260), we proposed to continue to use the most recent pre-floor and pre-reclassified hospital wage index available at the time of the final rule. At the time of publication of the proposed rule, only preliminary versions of the wage index used by HH PPS were available. We indicated in the proposed rule that we would incorporate updated wage data for the wage index to be used in the final rule for the CY 2005 HH PPS update. Subsequent to the proposed rule, we published a correction notice on July 30, 2004 (69 FR 45640) in which we indicated that in our publishing of the proposed rule, we inadvertently published the 2004 pre-floor and pre-reclassified wage index tables instead of the intended 2005 pre-floor and pre-reclassified wage index tables. As part of that correction notice, we published the appropriate 2005 pre-floor and pre-reclassified wage index tables.
Since the publication of the correction notice, we have determined that there exists some labeling and other technical errors in the proposed wage index.
We note a labeling error in the wage index tables used in the HH PPS. That labeling error is the listing of Stanly County, NC as one of the areas under MSA 1520 when, in fact, we consider Stanly County, NC to be a rural area in North Carolina. Stanly County wage data have always been correctly treated as rural in the actual creation of the home health wage index values, and it has only been the listing of Stanly County under MSA 1520 that was in error. Consequently, the wage index table in this final rule correctly removes Stanly County from the list of areas that fall under the MSA 1520 wage index. As this is strictly a labeling correction that does not affect the actual computation of the wage index values, home health providers in Stanly County, NC will continue to fall under, and use, the wage index for rural North Carolina.
In addition, we have determined that Sharon Hospital of Litchfield County, Connecticut was inadvertently designated to the rural Connecticut area in our July 30, 2004 correction notice (69 FR 45640). Consequently, the updated CY 2005 pre-floor and pre-reclassified hospital wage index published in this final rule correctly designates Sharon Hospital to the
See Addenda A and B of this final rule, respectively, for the rural and urban hospital wage indexes. Furthermore, we have added an Addendum C that shows a side-by-side comparison of the FY 2003 pre-floor and pre-reclassified hospital wage index and the CY 2005 pre-floor and pre-reclassified hospital wage index, that does not apply the CBSA policy, for CY 2005 HH PPS.
This document does not impose information collection and record-keeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
We have examined the impacts 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 responsibility of duties) directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). The update set forth in this final rule would apply to Medicare payments under HH PPS in CY 2005. Accordingly, the following analysis describes the impact in CY 2005 only. We estimate that there will be an additional $250 million in CY 2005 expenditures attributable to the CY 2005 market basket (3.1 percent), minus 0.8 percentage points, an estimated increase of 2.3 percent.
Section 421 of the MMA provides for a 5 percent increase in home health payments to rural providers for episodes and visits ending after April 1, 2004 and before April 1, 2005. This increase is not subject to budget neutrality. Consequently, this increase in payments to rural providers will result in an estimated increase in expenditures of $50 million in CY 2004 and $60 million in CY 2005.
Section 701 of the MMA includes a provision that changes the update cycle for HH PPS, and thus the home health market basket update, from a fiscal year basis to that of a calendar year basis in 2004. This results in a projected reduction in expenditures of approximately $90 million in FY 2005.
The RFA requires agencies to analyze options for regulatory relief of small businesses. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and government agencies. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $6 million to $29 million or less annually (for details, see the Small Business Administration's regulation that set forth size standards for health care industries at 65 FR 69432). For purposes of the RFA, approximately 75 percent of HHAs are considered small businesses according to the Small Business Administration's size standards with total revenues of $11.5 million or less in 1 year. Individuals and States are not included in the definition of a small entity. As stated above, this final rule updates all of the HHAs for CY 2005 as required by statute. This rule will have a significant positive effect upon small entities.
In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area (MSA) and has fewer than 100 beds. We have determined that this final rule would not have a significant economic impact on the operations of a substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule that may result in expenditure in any 1 year by State, local, or tribal governments, in the aggregate, or by the private sector, of $110 million. We believe that this final rule would not mandate expenditures in that amount.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. We have reviewed this rule under the threshold criteria of Executive Order 13132, Federalism. We have determined that this final rule would not have substantial direct effects on the rights, roles, and responsibilities of States.
In accordance with the requirements of section 1895(b)(3) of the Act, we publish an update for each subsequent fiscal year that will provide an update to the payment rates. Section 1895(b)(3)(B) of the Act, as amended by section 701 of the MMA, requires us, for CY 2005, to increase the prospective payment amounts by the applicable home health market basket increase minus 0.8 percentage points. We estimate that with a home health market basket of 3.1 percent minus 0.8 percentage points, the increase for CY 2005 is 2.3 percent.
This final rule provides a percentage update to all Medicare HHAs. Therefore, we have not furnished any impact tables. We increased the payment to each Medicare HHA equally by the home health market basket update for CY 2005, minus 0.8 percentage points, as required by statute. There is no differential impact among provider types. The impact is in the aggregate. We can show the impact that the CY 2005 wage index would have on providers. Addendum C shows a side-by-side comparison of the FY 2003 pre-floor and pre-reclassified hospital wage index and the CY 2005 pre-floor and pre-reclassified hospital wage index, that does not apply the CBSA policy, for the CY 2005 HH PPS update final rule. We estimate that there would be an additional $250 million in CY 2005 expenditures attributable to the CY 2005 market basket (3.1 percent), minus 0.8 percentage points, resulting in a 2.3 percent increase. Thus, the anticipated expenditures outlined in this final rule
The applicable home health market basket (minus 0.8 percentage points) increase of 2.3 percent for CY 2005 applies to all Medicare-participating HHAs. We do not believe there is a differential impact due to the aggregate nature of the update.
We believe that this rule would have a positive effect on providers of Medicare home health services by increasing their rate of Medicare payments. We do not anticipate specific effects on other providers. This final rule reflects the statutorily required annual update to the HH PPS rates. We do not believe there is a differential impact due to the consistent and aggregate nature of the update.
This final rule reflects an annual update to the HH PPS rates as required by statute. We believe that the statute provides no latitude for alternatives other than the approach set forth in this final rule reflecting the CY 2005 annual update to the HH PPS rates. Other than the positive effect of the market basket increase, this final rule would not have a significant economic impact nor would it impose an additional burden on small entities. When a regulation or notice imposes additional burden on small entities, we are required under the RFA to examine alternatives for reducing burden.
This final rule rebases and revises the home health market basket by moving the base year from FY 1993 to FY 2000 to reflect the latest available, thorough data on the structure of HHA costs. We periodically rebase and revise market baskets for multiple types of health care providers, generally on a 5-year cycle. We continue to believe that by rebasing and revising the home health market basket periodically, cost category weights will better reflect changes in the mix of goods and services that HHAs purchase in furnishing home health care. The alternative to not rebase and revise the market basket would be to delay the inevitable task of rebasing and revising the home health market basket to some later date. For this final rule, the forecasted rate of growth for CY 2005 for both the rebased and revised home health market basket and the current 1993-based home health market basket is 3.1 percent (see Table 1 of this rule). Future updates will be better served by using a more up-to-date cost structure, as is accomplished in the revised and rebased home health market basket.
Section 1895(b)(5) of the Act states that the total amount of payments for outliers, under HH PPS, may not exceed 5 percent of the total payments projected or estimated to be made for a given fiscal year or year. As discussed in section IV, “Provisions of the Final Regulations”, we are reducing the fixed dollar loss ratio used in the formula to determine outlier cases in HH PPS, from that of 1.13 to 0.70. Analysis indicates that a fixed dollar loss ratio of 0.70 is consistent with the existing loss-sharing ratio of 0.80 and our target percentage of estimated outlier payments of 5 percent of total home health payments. Other alternatives considered in the updating of the formula for determining outlier cases included updating/changing the loss-sharing ratio from that of 0.80 as well as changing the outlier payment target of to less than 5 percent of total home health payments. We believe that a value of 0.80 for the loss-sharing ratio is appropriate in that it preserves incentives for agencies to provide care efficiently for outlier cases. Similarly, we continue to believe that the total outlier payment target of 5 percent of total home health payments appropriately targets the most costly cases under HH PPS.
We have examined the economic impact of this final rule on small entities and have determined that the economic impact is positive, significant, and that all HHAs would be affected. To the extent that small rural hospitals are affiliated with HHAs, the impact on these facilities would also be positive. Finally, we have determined that the economic effects described above are largely the result of the specific statutory provisions, which this final rule serves to announce.
In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.
Health facilities, Health professions, Medicare, Reporting and record-keeping requirements.
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395(hh)) unless otherwise indicated.
The revisions and additions read as follows:
(d) For the last calendar quarter of 2003 and the first calendar quarter of 2004, the unadjusted national prospective 60-day episode payment rate is equal to the rate from the previous fiscal year (FY 2003) increased by the applicable home health market basket index amount.
(e) For the last the 3 calendar quarters of 2004, the unadjusted national
(f) For each calendar year of 2005 and 2006, the unadjusted national prospective 60-day episode payment rate is equal to the rate from the previous calendar year, increased by the applicable home health market basket minus 0.8 percentage points.
(g) For 2007 and subsequent calendar years, the unadjusted national rate is equal to the rate for the previous calendar year increased by the applicable home health market basket index amount.
The following addenda will not be published in the Code of Federal Regulations.
Office of the Assistant Secretary for Public and Indian Housing, HUD.
Final rule.
This final rule removes barriers to the participation of religious (also referred to as “faith-based”) organizations in HUD regulations implementing the Indian HOME Program, the Indian Community Development Block Grant Program, the Indian Housing Block Grant Program, the Title VI Loan Guarantee Assistance Program, and the Section 184 Loan Guarantees for Indian Housing Program. These changes are consistent with revisions of program regulations undertaken on a department-wide basis. In general, no group of applicants competing for HUD funds or seeking to participate in HUD programs should be subject to greater or fewer requirements than other organizations solely because of their religious character or affiliation or absence of religious character or affiliation. This final rule follows publication of a June 21, 2004, proposed rule and takes into consideration the one public comment received on the proposed rule. After careful consideration of the issues raised by the commenter, HUD has decided to adopt the June 21, 2004, proposed rule without change.
Effective Date: November 22, 2004.
Ryan Streeter, Director, Center for Faith-Based and Community Initiatives, Department of Housing and Urban Development, Room 10184, 451 Seventh Street, SW., Washington, DC 20410-0001, telephone: (202) 708-2404 (this is not a toll-free number). For program specific information, contact Deborah Lalancette, Director, Office of Grants Management, Office of Native American Programs, Office of Public and Indian Housing, Department of Housing and Urban Development, Suite 3390, 1919 Broadway, Denver, CO 80202, telephone: (303) 675-1600, extension 3325 (this is not a toll-free number). Individuals with speech or hearing impairments may access these telephone numbers through TTY by calling the toll-free Federal Information Relay Service at 800-877-8339.
On June 21, 2004 (69 FR 34544), HUD published a proposed rule for public comment that removes barriers to the participation of religious (also referred to as “faith-based”) organizations in HUD regulations for its Native American programs. The proposed rule was published as part of HUD's implementation of the Administration's Faith-Based and Community Initiative. President Bush has directed executive branch agencies, including HUD, to ensure that federal policy and programs are fully open to faith-based and community organizations in a manner consistent with the Constitution. The Administration believes that all eligible organizations, including faith-based organizations, should be able to participate in federal programs and activities and compete, where required, for federal financial assistance on an equal footing.
Consistent with President's Executive Order 13198, “Agency Responsibilities With Respect to Faith-Based and Community Initiatives,” issued January 31, 2001 (66 FR 8497), HUD undertook a comprehensive review of its program requirements and regulations, particularly those that would be expected to attract interest and participation by nonprofit organizations. As a result of that comprehensive review, HUD identified regulations that imposed or appeared to impose barriers to the participation of faith-based organizations in eight programs administered by the Office of Community Planning and Development. On January 6, 2003 (68 FR 648), HUD published a proposed rule to eliminate these barriers and to ensure that these HUD programs were open to all qualified organizations, regardless of their religious character. After a period of public comment, HUD finalized this rule on September 30, 2003 (68 FR 56396).
On March 3, 2004 (69 FR 10126), HUD published a second proposed rule to amend its general program requirements at 24 CFR part 5 and extend the equal participation protections to HUD programs and activities not covered by the September 30, 2003, final rule. The March 3, 2004, proposed rule was followed by a final rule published on July 9, 2004 (69 FR 41712), which adopted the proposed rule without change. Neither the September 30, 2003, nor the July 9, 2004, final rules, however, applied to HUD's Native American programs. HUD's Native American programs were excluded from these earlier rules so that HUD could first consult with Indian tribal governments in accordance with Executive Order 13175, “Consultation and Coordination With Indian Tribal Governments,” issued on November 6, 2000.
Executive Order 13175 requires federal departments and agencies, to the greatest extent practicable and permitted by law, to consult with tribal governments prior to taking actions that have substantial direct effects on federally recognized tribal governments. Accordingly, prior to publication of the June 21, 2004, proposed rule, HUD provided Indian tribes and Alaska Native Villages with the opportunity to comment on the substance of the proposed regulatory changes that would extend the equal participation protections to the Indian HOME Program at 24 CFR part 954; the Indian Housing Block Grant Program (IHBG) at 24 CFR part 1000; the Title VI Loan Guarantee Assistance (Title VI Loan Guarantee) program at subpart E of 24 CFR part 1000; the Indian Community Development Block Grant Program (ICDBG) at 24 CFR part 1003; and the Section 184 Loan Guarantees for Indian Housing Program (Section 184) at 24 CFR part 1005.
This final rule follows publication of the June 21, 2004, proposed rule and takes into consideration the one public comment received on the proposed rule. After careful consideration of the public comment, HUD has decided to adopt the proposed rule without change. Section IV of this preamble contains a discussion of the one public comment and HUD's responses to the significant issues raised by the commenter.
Of the programs listed above, only the Indian HOME and ICDBG program regulations have sections that specifically address the participation of faith-based organizations. Although the Indian HOME Program was terminated by section 505 of the Native American Housing Assistance and Self-Determination Act of 1996 (25 U.S.C. 4101
The regulations for the IHBG, Title VI Loan Guarantee, and Section 184 programs do not have sections that specifically address the participation of faith-based organizations. Such organizations could participate in those programs as subrecipients or contractors, as appropriate. This final rule makes the equal participation protections at 24 CFR part 5 established by the July 9, 2004, final rule apply to these Native American programs, as well as to the other HUD programs and activities not covered by the September 30, 2003, final rule. These provisions were originally not made applicable to the IHBG, Title VI Loan Guarantee, and Section 184 programs so that HUD could consult with the affected tribes. Now that consultation has been completed, these provisions of part 5 apply.
The specific policies and requirements that are codified by this final rule, consistent with the September 30, 2003, and July 9, 2004, final rules are as follows:
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As used in this final rule, the term “direct HUD funds” refers to direct funding within the meaning of the Establishment Clause of the First Amendment. For example, direct HUD funding may mean that the government or an intermediate organization with similar duties as a governmental entity under a particular HUD program selects an organization and purchases the needed services straight from the organization (
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The public comment period on the June 21, 2004, proposed rule closed on August 20, 2004. HUD received one public comment, which came from a civil rights organization. This section of the preamble presents a summary of the significant issues raised by the public commenter and HUD's responses to these issues.
In addition, the Supreme Court's “pervasively sectarian” doctrine—which held that there are certain religious institutions in which religion is so pervasive that no government aid may be provided to them, because their performance of even “secular” tasks will be infused with religious purpose—no longer enjoys the support of a majority of the Court. Four Justices expressly abandoned it in
As more fully discussed in the responses to the issues below, HUD believes that the policies and procedures contained in this final rule are fully within the bounds of constitutional church-state guidelines and consistent with recent Supreme Court decisions concerning the Establishment Clause.
HUD believes that, under current precedent, faith-based organizations that receive HUD funds as the result of the genuine and independent choice of a beneficiary (for example, where the entity administering HUD funds established a voucher, coupon, certificate, or similar funding mechanism) are permitted to offer assistance that integrates religion and social services and requires participation in all aspects of their programs. The religious freedom of beneficiaries in an indirect funding program is protected by the guarantee of genuine and independent private choice. A beneficiary has the right to select any eligible provider, and no beneficiary may be required to receive services from a provider to which the beneficiary has a religious objection. In other words, vouchers for services
Furthermore, HUD declines to require that religious organizations provide a notice to a beneficiary or potential beneficiary that participation in religious activities was entirely on a voluntary basis. However, grantees are encouraged to take steps to ensure that clients and prospective clients have a clear understanding of the services offered by their organization by explaining the services offered, including any inherently religious activities, as well as the individual's right not to participate in any such activities, while still accepting or receiving services. The requirement that participation be voluntary, however, is sufficient to address concerns about the religious freedom of program beneficiaries.
HUD also does not agree that preventing the use of direct HUD capital-improvement funds for inherently religious activities would necessarily fail or, in the process, excessively entangle the government in the affairs of recipients or subrecipients that are religious organizations. Because inherently religious activities are non-HUD activities, HUD need not distinguish between program participants' religious and nonreligious non-HUD activities; the same mechanism by which HUD polices the line between ineligible and eligible activities will serve to exclude inherently religious activities from funding. This system of monitoring is more than sufficient to address the commenter's concerns, and the amount of oversight of religious organizations necessary to accomplish these purposes is no greater than that involved in other publicly funded programs that the Supreme Court has sustained.
HUD believes that the prorated funding of improvements to a structure that has a mixed use—both religious and nonreligious— is not itself a violation of the Constitution. In a neutral program in which the government directly funds the capital improvements of institutions that administer federal social welfare programs, the government need only put in place safeguards to ensure that public money is not used to finance inherently religious activities. Therefore, the final rule's prohibition on the funding of capital improvements for sanctuaries, chapels, or any other rooms that a HUD-funded religious congregation uses as its principal place of worship simply provides extra assurance that HUD-funded capital improvements will not be used to support inherently religious activities, and HUD's rule is well within the bounds of the Constitution.
In accordance with Executive Order 13175 (entitled “Consultation and Coordination With Indian Tribal Governments”), issued on November 6, 2000, HUD has consulted with representatives of tribal governments concerning the subject of this rule. HUD, through a letter dated February 23, 2004, provided Indian tribes and Alaska Native Villages the opportunity to comment on the substance of the regulatory changes during the development of the June 21, 2004, proposed rule. HUD considered their comments on the proposed changes in the preparation of the June 21, 2004, proposed rule for publication. Additionally, the June 21, 2004, proposed rule provided Indian tribes with an additional opportunity to comment on the proposed regulatory changes.
The Office of Management and Budget (OMB) reviewed this rule under Executive Order 12866 (entitled “Regulatory Planning and Review”). OMB determined that this rule is a “significant regulatory action” as defined in section 3(f) of the Order (although not an economically significant regulatory action under the Order). Any changes made to the rule as a result of that review are identified in the docket file, which is available for public inspection in the Regulations Division, Room 10276, 451 Seventh Street, SW., Washington, DC 20410-0500.
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1531-1538) establishes requirements for federal agencies to assess the effects of their regulatory actions on state, local, and tribal governments, and the private sector. This rule does not impose any federal mandate on any state, local, or tribal governments or the private sector within the meaning of UMRA.
This final rule sets forth nondiscrimination standards. Accordingly, under 24 CFR 50.19(c)(3), this final rule is categorically excluded from environmental review under the National Environmental Policy Act of 1969 (42 U.S.C. 4332).
The Secretary, in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)) has reviewed and approved this rule and in so doing certifies that this rule will not have a significant economic impact on a substantial number of small entities. The final rule will not impose new costs, or modify existing costs, applicable to HUD grantees. Rather, the purpose of the final rule is to ensure the equal participation of faith-based organizations (irrespective of size) in HUD's programs.
The Catalog of Federal Domestic Assistance numbers for the programs affected by this rule are: Indian Home Program—14.239; ICDBG—14.862;
Administrative practice and procedure, Grant programs—housing and community development, Grant programs—Indians, Indians, Low and moderate income housing, Manufactured homes, Rent subsidies, Reporting and recordkeeping requirements.
Alaska, Community development block grants, Grant programs—housing and community development, Indians, Reporting and recordkeeping requirements.
42 U.S.C. 3535(d) and 12701-12839.
(a) Religious organizations are eligible, on the same basis as any other organization, to participate in the Indian HOME program. Neither the federal government nor a tribal government nor any other entity that administers any program or activity under this part shall discriminate against an organization on the basis of the organization's religious character or affiliation.
(b) Organizations that receive direct HUD funds under the Indian HOME program may not engage in inherently religious activities, such as worship, religious instruction, or proselytization, as part of the program or services funded under this part. If an organization conducts such inherently religious activities, the inherently religious activities must be offered separately, in time or location, from the programs, activities, or services supported by direct HUD funds under this part, and participation must be voluntary for the beneficiaries of the programs, activities, or services provided.
(c) A religious organization that participates in the Indian HOME program will retain its independence from federal, state, local, and tribal governments, and may continue to carry out its mission, including the definition, practice, and expression of its religious beliefs, provided that it does not engage in any inherently religious activities, such as worship, religious instruction, or proselytization, as part of the programs or services funded under a program or activity pursuant to this part. Among other things, religious organizations may use space in their facilities to provide services under the Indian HOME program without removing religious art, icons, scriptures, or other religious symbols. In addition, a religious organization participating in the Indian HOME program retains its authority over its internal governance, and it may retain religious terms in its organization's name, select its board members on a religious basis, and include religious references in its organization's mission statements and other governing documents.
(d) A religious organization's exemption from the federal prohibition on employment discrimination on the basis of religion, set forth in section 702(a) of the Civil Rights Act of 1964 (42 U.S.C. 2000e-1), is not forfeited when the organization participates in a HUD program. Some HUD programs, however, contain independent statutory provisions that impose certain nondiscrimination requirements on all grantees. Accordingly, grantees should consult with the appropriate HUD program office to determine the scope of applicable requirements.
(e) An organization that receives direct funds under the Indian HOME program shall not, in providing program assistance, discriminate against a program beneficiary or prospective program beneficiary on the basis of religion or religious belief.
(f) Indian HOME funds may not be used for the acquisition, construction, or rehabilitation of structures to the extent that those structures are used for inherently religious activities. Indian HOME funds may be used for the acquisition, construction, or rehabilitation of structures only to the extent that those structures are used for conducting eligible activities under this part. Where a structure is used for both eligible and inherently religious activities, Indian HOME funds may not exceed the cost of those portions of the acquisition, construction, or rehabilitation that are attributable to eligible activities in accordance with the cost accounting requirements applicable to Indian HOME funds in this part. Sanctuaries, chapels, or other rooms that an Indian HOME-funded religious congregation uses as its principal place of worship, however, are ineligible for Indian HOME-funded improvements. Disposition of real property after the term of the grant, or any change in use of the property during the term of the grant, is subject to governmentwide regulations governing real property disposition (
(g) If a tribal government voluntarily contributes its own funds to supplement federally funded activities, the tribal government has the option to segregate the federal funds or commingle them. However, if the funds are commingled, this section applies to all of the commingled funds. Further, if a state or local government is required to contribute matching funds to supplement a federally funded activity, the matching funds are considered commingled with the federal assistance and therefore subject to the requirements of this section. Some HUD programs requirements govern any project or activity assisted under those programs. Accordingly, grantees should consult with the appropriate HUD program office to determine the scope of applicable requirements
42 U.S.C. 3535(d) and 5301
(a) Religious organizations are eligible, on the same basis as any other eligible organization, to participate in the ICDBG program. Neither the federal government nor a tribal government nor any other entity that administers any program or activity under this part shall discriminate against an organization on the basis of the organization's religious character or affiliation.
(b) Organizations that receive direct HUD funds under the ICDBG program may not engage in inherently religious activities, such as worship, religious instruction, or proselytization, as part of the programs or services funded under this part. If an organization conducts such inherently religious activities, the inherently religious activities must be offered separately, in time or location, from the programs, activities or services supported by direct HUD funds under this part, and participation must be voluntary for the beneficiaries of the programs, activities, or services provided.
(c) A religious organization that participates in the ICDBG program will retain its independence from federal, state, local, and tribal governments, and may continue to carry out its mission,
(d) A religious organization's exemption from the federal prohibition on employment discrimination on the basis of religion, set forth in section 702(a) of the Civil Rights Act of 1964 (42 U.S.C. 2000e-1), is not forfeited when the organization participates in a HUD program. Some HUD programs, however, contain independent statutory provisions that impose certain nondiscrimination requirements on all grantees. Accordingly, grantees should consult with the appropriate HUD program office to determine the scope of applicable requirements.
(e) An organization that receives direct funds under the ICDBG program shall not, in providing program assistance, discriminate against a program beneficiary or prospective program beneficiary on the basis of religion or religious belief.
(f) ICDBG funds may not be used for the acquisition, construction, or rehabilitation of structures to the extent that those structures are used for inherently religious activities. ICDBG funds may be used for the acquisition, construction, or rehabilitation of structures only to the extent that those structures are used for conducting eligible activities under this part. Where a structure is used for both eligible and inherently religious activities, ICDBG funds may not exceed the cost of those portions of the acquisition, construction, or rehabilitation that are attributable to eligible activities in accordance with the cost accounting requirements applicable to ICDBG funds in this part. Sanctuaries, chapels, or other rooms that an ICDBG-funded religious congregation uses as its principal place of worship, however, are ineligible for ICDBG-funded improvements. Disposition of real property after the term of the grant, or any change in use of the property during the term of the grant, is subject to governmentwide regulations governing real property disposition (
(g) If a tribal government voluntarily contributes its own funds to supplement federally funded activities, the tribal government has the option to segregate the federal funds or commingle them. However, if the funds are commingled, this section applies to all of the commingled funds. Further, if a state or local government is required to contribute matching funds to supplement a federally funded activity, the matching funds are considered commingled with the federal assistance and therefore subject to the requirements of this section. Some HUD programs requirements govern any project or activity assisted under those programs. Accordingly, grantees should consult with the appropriate HUD program office to determine the scope of applicable requirements.
Office of the Secretary, HUD.
Final rule.
This final rule updates HUD's regulations that govern equal employment opportunity to make HUD's requirements for equal employment opportunity plans consistent with a recently issued Equal Employment Opportunity Commission (EEOC) management directive.
Linda Bradford-Washington, Acting Director, Office of Departmental Equal Employment Opportunity, Department of Housing and Urban Development, 451 Seventh Street, SW., Washington, DC 20410, telephone (202) 708-3362 (this is not a toll-free number). Hearing-or speech-impaired individuals may access this number through TTY by calling the toll-free Federal Information Relay Service at (800) 877-8339.
HUD's regulations governing the Department's equal employment opportunity (EEO) policies, procedures, and programs are located at 24 CFR part 7. This final rule revises and updates the Department's current EEO regulations that concern equal employment opportunity plans. This regulatory change will make HUD's EEO provisions at 24 CFR part 7 consistent with the recently issued EEOC governmentwide management directive (MD-715, effective October 1, 2003). This final rule also makes conforming changes to part 7 to remove obsolete terms.
Title VII of the Civil Rights Act of 1964 (42 U.S.C. 2000e-17) and the Rehabilitation Act of 1973 (29 U.S.C. 791
This final rule revises 24 CFR part 7 to make HUD's EEO policies consistent with MD-715. The new directive no longer requires federal agencies to submit data, accomplishment reports, or plans concerning the under-representation of women and minorities. Accordingly, HUD is removing from 24 CFR 7.4, any reference to such requirement. In addition, the directive no longer uses the terms “affirmative employment” or “AE” in reference to the plans that federal agencies are required to submit to EEOC. Therefore, this final rule removes all references to “affirmative employment” and “AE.”
HUD's regulations at 24 CFR 10.1 state that notice and public procedure may be omitted with respect to statements of policy, interpretative rules, rules governing the Department's organization or its own internal practices or procedures. This rule is limited to updating the Department's internal procedures as described in the regulations at 24 CFR part 7, to reflect current practices.
The Secretary, in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed and approved this final rule and in so doing has certified that this rule will not have a significant economic impact on a substantial number of small entities. This rule makes changes to regulations that affect only the Department's own internal procedures and will not have any effect on small entities.
In accordance with 24 CFR 50.19(c)(1) of the Department's regulations, this rule does not direct, provide for assistance or loan and mortgage insurance for, or otherwise govern or regulate, real property acquisition, disposition, leasing, rehabilitation, alteration, demolition, or new construction, or establish, revise, or provide for standards for construction or construction materials, manufactured housing, or occupancy. Therefore, this final rule is categorically excluded from the requirements of the National Environmental Policy Act (42 U.S.C. 4321
Because this rule is limited to internal agency practices and procedures, this rule does not impose unfunded mandates within the meaning of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) or have federalism implications within the meaning of Executive Order 13132 (Federalism).
Administrative practice and procedure, Equal employment opportunity, Organization and functions (Government agencies).
29 U.S.C. 206(d), 633a, 791 and 794; 42 U.S.C. 2000e note, 2000e-16, 42 U.S.C. 3535(d); E.O. 11478 of Aug. 8, 1969; 34 FR 19285, Aug. 12, 1969; E.O. 10577, 3 CFR 1954-1958; E.O. 11222, 3 CFR 1964-1965.
The Department's equal employment opportunity policy conforms with the policies expressed in Title VII of the Civil Rights Act of 1964 (42 U.S.C. 2000d-2000d-4); the Civil Rights Act of 1991 (Pub. L. 102-166, approved November 21, 1991); Executive Order 11478 of 1969 (34 FR 12985, 3 CFR 1966-1970 Comp., p. 803); the Age Discrimination in Employment Act of 1967 (ADEA) (29 U.S.C. 621
The Secretary, each Assistant Secretary, the General Counsel, the Inspector General, the President of the Government National Mortgage Association, the Chief Financial Officer, the Director of Healthy Homes and Lead Hazard Control, the Director of the Office of Departmental Operations and Coordination, and other HUD officials who may be determined by the Secretary for purposes of this part to be comparable to an Assistant Secretary, shall establish, maintain, and carry out a plan of equal employment opportunity to promote equal opportunity in every aspect of employment policy and practice. Each plan must be consistent with 29 CFR part 1614 and EEOC Management Directive 715. A copy of the EEOC Management Directive 715 is available at
(a) Advising the Secretary with respect to the preparation of plans, procedures, regulations, reports, and other matters pertaining to the government's equal employment opportunity policy and the Department's EEO/ADR programs;
(b) Developing and maintaining plans, procedures, and regulations necessary to carry out the Department's EEO programs;
(c) Evaluating, at least annually, the sufficiency of each organizational unit's EEO/ADR program and providing reports thereon to the Secretary with recommendations as to any improvement or correction needed, including remedial or disciplinary action with respect to managerial or supervisory employees who have failed in their responsibility;
(e) Making changes in programs and procedures designed to eliminate discriminatory practices and improve the Department's EEO/ADR programs;
(a) Advising the Director of EEO on matters affecting the implementation of the Department's EEO/ADR policies and programs in the organizational unit;
(b) Developing and maintaining a program of equal employment opportunity for the organizational unit and ensuring that the program is carried out in an exemplary manner;
(c) Publicizing to all employees of the organizational unit the name and address of the Director of EEO, the EEO Officer(s), and the EEO Counselor(s), the EEO Discrimination Complaint Manager(s), the Diversity Program Manager, ADR Officials, and the EEO complaint procedures;
(g) Designating a senior-level manager in Headquarters responsible for providing advice and guidance to managers and supervisors in removing barriers to EEO/ADR and in implementing all of their EEO responsibilities; and reviewing recruitment and personnel actions taken by managers and supervisors to ensure the achievement of EEO standards;
(j) Ensuring the successful operation of the EEO/ADR Program by requiring management's support;
(a) Provide leadership in developing and maintaining personnel management policies, programs, automated systems, and procedures that will promote and ensure equal opportunity in the recruitment, selection, placement, training, awards, recognition, and promotion of employees, including an applicant flow tracking system to track information reflecting characteristics of the pool of individuals applying for an employment opportunity.
(g) Designate a senior-level Disability Program Manager to promote EEO/ADR for persons with disabilities; to assure the accessibility of all HUD facilities and programs; and to manage the resources for providing reasonable accommodation;
(i) Provide and coordinate mandatory supervisors' and managers' EEO/ADR training;
(e) Ensure that new employee orientation programs contain appropriate references to the Department's EEO/ADR policies, procedures, and programs and accomplishment of EEO standards under the Department's Performance Accountability and Communications System (PACS), or other Departmental performance appraisal system;
(g) In coordination with the HUD official charged with training responsibilities, develop an ongoing training program for supervisors and managers to ensure understanding of the Departmental EEO/ADR programs, policies, and other requirements that foster effective teamwork and high morale;
(h) * * *
(4) EEOC's regulations and policy guidance concerning EEO and ADR;
(i) In coordination with the HUD official charged with training responsibilities, the Office of General Counsel, the Office of Administration, and the Director of EEO, the Department may enter into agreements to have EEO/ADR mandatory annual supervisory and management training provided by other federal agencies or other resources;
(l) Track applicant flow data that reflects characteristics of the pool of individuals applying for an employment opportunity and promptly take or recommend appropriate action to overcome any impediment to achieving the standards of the EEO/ADR programs and accomplishing the EEO standards under the applicable HUD performance appraisal system;
(a) Removing barriers to EEO and ensuring that EEO standards are accomplished in their areas of responsibility;
(b) Evaluating and documenting subordinate managers and supervisors on their performance of EEO/ADR responsibilities;
(f) Being proactive in addressing EEO/ADR issues, and maintaining work environments that encourage and support complaint avoidance through sound management and personnel practices;
(a) Being informed as to the Department's EEO/ADR programs;
(d) Providing assistance to supervisors and managers in carrying out their responsibilities in the EEO/ADR programs; and
(a) The Department shall establish a system to collect and maintain accurate employment information on the race, national origin, sex, and disability of all its employees and applicants in accordance with 29 CFR 1614.601 through 29 CFR 1614.602, and the Department shall report to the EEOC on employment by race, national origin, sex, and disability, in the form and at such times as the EEOC may require.