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Agricultural Marketing Service, USDA.
Final rule.
The Department of Agriculture (USDA) is adopting, as a final rule, without change, an interim final rule that removed the Dancy and Robinson varieties of tangerines from the regulated varieties of Florida citrus prescribed under the marketing order covering oranges, grapefruit, tangerines, and tangelos grown in Florida (order). The order is administered locally by the Citrus Administrative Committee (committee). This rule also continues in effect the removal of a section of the rules and regulations dealing with handling procedures for Dancy and Robinson tangerines. Production of these varieties has declined and is expected to continue to decline. Removing these varieties will not have a significant impact on the tangerine market.
December 2, 2002.
William G. Pimental, Southeast Marketing Field Office, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, 799 Overlook Drive, Suite A, Winter Haven, Florida 33884-1671; telephone: (863) 324-3375, Fax: (863) 325-8793; or George Kelhart, Technical Advisor, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237; telephone: (202) 720-2491, Fax: (202) 720-8938.
Small businesses may request information on complying with this regulation by contacting Jay Guerber, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237; telephone: (202) 720-2491, Fax: (202) 720-8938, or E-mail:
This rule is issued under Marketing Agreement No. 84 and Marketing Order No. 905, both as amended (7 CFR part 905), regulating the handling of oranges, grapefruit, tangerines, and tangelos grown in Florida, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”
USDA is issuing this rule in conformance with Executive Order 12866.
This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is not intended to have retroactive effect. This rule will not preempt any State or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule.
The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.
The order provides for the establishment of grade and size requirements for Florida citrus, with the concurrence of USDA. These grade and size requirements are designed to provide fresh markets with citrus fruit of acceptable quality and size. This helps create buyer confidence and contributes to stable marketing conditions. This is in the interest of growers, handlers, and consumers, and is designed to increase returns to Florida citrus growers.
This rule continues in effect the removal of Dancy and Robinson tangerines from the regulated varieties of Florida citrus fruit prescribed under the marketing order covering oranges, grapefruit, tangerines, and tangelos grown in Florida. Production of these varieties has declined, and it is expected that production will continue to decline. Removing these varieties from the minimum grade and size requirements will not have a significant impact on the overall quality of tangerines. This action was unanimously recommended by the committee at its meeting on May 22, 2002.
Section 905.52 of the order, in part, authorizes the committee to recommend minimum grade and size regulations to USDA. Section 905.306 of the order's rules and regulations specifies the regulation period and the minimum grade and size requirements for different varieties of fresh Florida citrus. Such requirements for domestic shipments are specified in § 905.306 in Table I of paragraph (a), and for export shipments in Table II of paragraph (b).
This rule continues to modify § 905.306 by deleting Dancy tangerines and Robinson tangerines from the list of entries in Table I of paragraph (a), and in Table II of paragraph (b). In its deliberations, the committee realized that Dancy tangerines and Robinson tangerines no longer significantly impact the citrus market. During the 2001-02 season, total shipments of Dancy tangerines were 12,798 cartons. Florida Department of Agriculture statistics show that in 2000-01, 23,000 cartons were shipped. This is down from 94,000 cartons shipped during the 1997-98 season. During 2001-02, only 124,249 cartons of Robinson tangerines were shipped. Florida Department of Agriculture statistics show that in 2000-01, 165,000 cartons were shipped. This is down from 262,000 cartons shipped in 1997-98. Production of these varieties has declined as newer varieties
Section 905.152 sets forth procedures for determining handlers' permitted quantities of Dancy and Robinson tangerine varieties when a portion of the 210 size of these varieties was restricted. Because Dancy and Robinson tangerines no longer have to meet size requirements, § 905.152 is unnecessary and the removal of this section is continued.
Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA), the Agricultural Marketing Service (AMS) has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.
The purpose of the RFA is to fit regulatory actions to the scale of business subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf. Thus, both statutes have small entity orientation and compatibility.
There are approximately 11,000 producers of Florida citrus in the production area and approximately 75 tangerine handlers subject to regulation under the marketing order. Small agricultural producers are defined by the Small Business Administration (13 CFR 121.201) as those having annual receipts less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $5,000,000.
Based on industry and committee data, the average annual F.O.B. price for fresh early Florida tangerines during the 2000-01 season was around $10.00 per
Approximately 20 percent of all handlers handled 77 percent of Florida tangerine shipments. Using tangerine shipments and the average F.O.B. prices, it can be determined that the majority of Florida tangerine handlers could be considered small businesses under SBA's definition. In addition, the majority of Florida citrus growers may be classified as small entities.
This rule continues in effect the removal of Dancy and Robinson tangerines from the varieties of citrus regulated under the order. These varieties are no longer required to meet the minimum grade and size requirements. Production of these varieties has declined and it is expected that production will continue to decline. Removing these varieties from the list of regulated varieties will not have a significant impact on the tangerine market.
Section 905.52 of the order, in part, authorizes the committee to recommend minimum grade and size regulations to the USDA. Section 905.306 of the order's rules and regulations specifies the regulation period and the minimum grade and size requirements for different varieties of fresh Florida citrus. This rule continues in effect modifications to § 905.306 of the rules and regulations concerning covered varieties and minimum grade and size requirements, respectively. This rule also continues to remove § 905.152.
This rule is expected to have a positive impact on affected entities because these varieties are being removed from the handling requirements. Because this rule continues to relax the handling requirements by removing two varieties from the list of varieties regulated, handlers will be able to market these varieties free from the order's requirements. There are no additional costs imposed on growers and handlers with this rule.
Only a total of approximately 137,000 cartons of these tangerines were shipped during the 2001-02 season. Florida Department of Agriculture statistics show that in 2000-01, a total of 188,000 cartons of these varieties were shipped. This is down from a total of 356,000 cartons of Dancy and Robinson tangerines shipped during the 1997-98 season. Shipments of these varieties accounted for less than 3 percent of the overall 5.2 million cartons of early Florida tangerines shipped during the 2001-02 season. Production of these varieties has declined as newer varieties have been developed and planted. The decline in production of these varieties is expected to continue. Most producers have already discontinued growing these varieties and handlers find it easier to sell the newer varieties that have been developed. The benefits derived from this change are expected to benefit both large and small entities equally.
One alternative discussed was to make no change to the order's handling regulations. The committee saw this alternative as being of no benefit to the industry because of the declining production and minimal market share of these varieties. The committee believes these varieties have no significant impact on the tangerine market and agreed that action should be taken to remove these varieties from the handling regulations, so this alternative was rejected.
Another alternative was to also remove the Ambersweet variety from the regulations. However, the committee determined that annual shipments of this variety are at a level that impacts the market and, therefore, this alternative was rejected.
This rule will not impose any additional reporting or recordkeeping requirements on either small or large Florida tangerine handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies. In addition, as noted in the initial regulatory flexibility analysis, USDA has not identified any relevant Federal rules that duplicate, overlap or conflict with this rule.
Further, the committee's meeting was widely publicized throughout the citrus industry and all interested persons were invited to attend the meeting and participate in the committee's deliberations. Like all committee meetings, the May 22, 2002, meeting was a public meeting and all entities, both large and small, were able to express their views on this issue.
An interim final rule concerning this action was published in the
A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at:
After consideration of all relevant material presented, including the committee's recommendation, and other information, it is found that finalizing the interim final rule, without change, as published in the
Grapefruit, Marketing agreements, Oranges, Reporting and recordkeeping requirements, Tangelos, Tangerines.
Agricultural Marketing Service, USDA.
Final rule.
This rule removes the reference to Norgold variety potatoes from the handling regulation issued under the marketing order for Idaho-Eastern Oregon potatoes. The Norgold variety was specifically referenced to establish less restrictive maturity requirements for early season shipments. However, Norgold variety potatoes are no longer produced in the production area covered under the marketing order and the less restrictive requirements are not needed. As required under section 608e of the Agricultural Marketing Agreement Act of 1937, the maturity requirements for potato imports are changed accordingly.
This final rule becomes effective December 2, 2002.
Robert Curry, Northwest Marketing Field Office, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, 1220 SW Third Avenue, suite 385, Portland, Oregon 97204; telephone: (503) 326-2724, Fax: (503) 326-7440; or George Kelhart, Technical Advisor, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, room 2525-S, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237; telephone: (202) 720-2491, Fax: (202) 720-5698.
Small businesses may request information on complying with this regulation by contacting Jay Guerber, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, room 2525-S, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237; telephone: (202) 720-2491, Fax: (202) 720-5698, or e-mail:
This final rule is issued under Marketing Agreement No. 98 and Marketing Order No. 945, both as amended (7 CFR part 945), regulating the handling of Irish potatoes grown in certain designated counties in Idaho, and Malheur County, Oregon, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”
This rule also is issued under section 608e of the Act, which provides that whenever certain specified commodities, including potatoes, are regulated under a Federal marketing order, imports of these commodities into the United States are prohibited unless they meet the same or comparable grade, size, quality, or maturity requirements as those in effect for the domestically produced commodities.
The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Order 12866.
This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This action is not intended to have retroactive effect. This rule will not preempt any State or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule.
The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.
There are no administrative procedures which must be exhausted prior to any judicial challenge to the provisions of import regulations issued under section 608e of the Act.
Sections 945.51 and 945.52 of the order provide authority for the establishment and modification of regulations applicable to the handling of potatoes. Section 945.341 establishes minimum maturity and pack requirements for potatoes handled subject to the order. Requirements in effect prior to this final rule provided, in part, that all potatoes packed in cartons were to be inspected and certified as meeting U.S. No. 1 grade or better. All varieties were to meet the maturity requirement of slightly skinned (except the Norgold variety from August 1-15, and the White Rose and red skinned varieties from August 1-December 31 were allowed to be moderately skinned). During other periods of the year, the White Rose and red skinned varieties are not subject to maturity requirements. Size is to be conspicuously marked on all cartons (except when used as a master container). The grade requirements are based on the U.S. Standards for Grades of Potatoes (7 CFR 51.1540-51.1566), and the size must be marked consistent with section 51.1545 of these standards.
The Idaho-Eastern Oregon Potato Committee (Committee), the agency responsible for local administration of the order, met on November 9, 1999, and unanimously recommended the removal of reference to Norgold variety potatoes from the handling regulations.
Prior to this final rule, the Norgold variety of potatoes was specifically referenced in the handling regulations so a less restrictive maturity requirement (moderately skinned) could be applied during a 15-day period (August 1-August 15) at the beginning of each shipping season. This rule removes the reference to Norgold potatoes as a separate variety from the minimum maturity requirements of the handling regulations. As required under section 608e of the Act, the maturity requirements for potato imports are changed accordingly. This rule also removes outdated language and makes other conforming changes to the handling and import regulations. The Committee recommended this change in the regulations because Norgold variety
Production of this long type variety was discontinued due in part to the Norgold variety's inherent propensity to have lighter, thinner skin early in the season compared to the varieties produced today. Newer replacement varieties are less prone to early season maturity problems, which enables the industry to maintain a consistent maturity level throughout the entire shipping season.
In addition, buyers are accustomed to long type potatoes having a higher maturity level than this minimum requirement allowed. To meet buyer expectations, all varieties of long type potatoes currently produced are required to be of a higher maturity level (slightly skinned) throughout the marketing year. The degree of skinning or maturity is differentiated by the amount of loss of the outer surface or skin layer. “Slightly skinned” means that up to 10 percent of the potatoes in any inspected lot can have one-fourth of the outer skin missing, while “moderately skinned” potatoes can have one-half of the skin missing.
This change will not have any economic impact upon producers or handlers, as it simply updates the handling regulations to recognize that the Norgold variety is no longer being produced within the production area.
As mentioned earlier, section 608e of the Act requires that when certain domestically produced commodities, including Irish potatoes, are regulated under a Federal marketing order, imports of that commodity must meet the same or comparable grade, size, quality, or maturity requirements. Section 608e also provides that whenever two or more marketing orders regulating the same commodity produced in different areas of the United States are concurrently in effect, a determination must be made as to which of the areas produces the commodity in most direct competition with the imported commodity. Imports must then meet the minimum requirements established for that particular area.
Grade, size, quality, and maturity regulations have been issued regularly under the order since it was established. The import regulation in § 980.1 specifies that import requirements for long type potatoes be based on those in effect for potatoes grown in certain designated counties in Idaho, and Malheur County, Oregon, during each month of the marketing year. This rule removes reference to Norgold variety potatoes from the maturity requirements of the handling regulation.
While no changes are required in the language of § 980.1, any potential imports of long type potatoes, including the Norgold variety, during the period from August 1-15 will be required to meet the modified maturity requirement of “slightly skinned.”
This rule is not expected to have any economic impact upon importers. Nearly all potato imports come from Canada, and representatives of USDA's Market News Service have indicated that their contacts in Canada have reported that Norgold variety potatoes are no longer commercially produced in Canada.
This rule also removes § 945.130 of the rules and regulations which is obsolete, and revises and updates language in § 980.1, Import regulations; Irish potatoes. Sections 945.22 and 945.23 of the order, regarding committee membership districts within the production area and redistricting and committee reapportionment, were amended on June 5, 1995 (60 FR 29724), and § 945.130 is no longer needed. In addition, this rule removes references in the potato import regulation to the terminated marketing orders for Red River Valley and Maine potatoes, removes outdated language regarding import regulations in effect during 1970 and 1971, updates the list and addresses of inspection offices for imports, and updates the references in the import regulation to government agencies.
Pursuant to the requirements set forth in the Regulatory Flexibility Act (RFA), the Agricultural Marketing Service (AMS) has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.
The purpose of the RFA is to fit regulatory actions to the scale of business subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf. Thus, both statutes have small entity orientation and compatibility. Import regulations issued under the Act are based on those established under Federal marketing orders.
There are approximately 63 handlers of Idaho-Eastern Oregon potatoes subject to regulation under the order and about 1,600 potato producers in the regulated area. There are approximately 161 importers of potatoes. Small agricultural service firms, which include potato handlers and importers, are defined by the Small Business Administration (13 CFR 121.201) as those having annual receipts of less than $5,000,000, and small agricultural producers are defined as those whose annual receipts are less than $750,000. A majority of these handlers, importers, and producers may be classified as small entities.
This rule removes the reference to Norgold variety potatoes from the maturity requirements in the handling regulation. The Norgold variety was specifically referenced to establish less restrictive maturity requirements for early season shipments. However, Norgold variety potatoes are no longer produced in the production area covered under the marketing order. As required under section 608e of the Act, the maturity requirements for potato imports are also changed.
The Committee met on November 9, 1999, and unanimously recommended the removal of the reference to Norgold variety potatoes from the handling regulations.
Prior to this final rule, the Norgold variety of potatoes was specifically referenced in the handling regulations so a less restrictive maturity requirement (moderately skinned) could be applied during a 15-day period (August 1-15) at the beginning of each shipping season. This final rule removes the reference to Norgold potatoes as a separate variety from the minimum maturity requirements of the handling regulations. As earlier stated, the Committee recommended this change in the regulations because Norgold variety potatoes are no longer produced in the production area. In addition, buyers have become accustomed to long type potatoes (such as Norgold variety potatoes) having a higher maturity level than this minimum requirement allowed. To meet buyer expectations, all varieties of long type potatoes currently produced are required to be of a higher maturity level (slightly skinned) throughout the marketing year. “Slightly skinned” means that up to 10 percent of the potatoes in any inspected lot can have one-fourth of the outer skin missing, while “moderately skinned” potatoes can have one-half of the skin missing. This change will not have any economic impact upon producers or handlers, as it simply updates the handling regulations to recognize that the Norgold variety is no longer being produced within the production area.
As mentioned earlier, section 608e of the Act requires that when certain domestically produced commodities, including Irish potatoes, are regulated under a Federal marketing order, imports of that commodity must meet
This rule is not expected to have an economic impact upon importers as there are currently no potato imports during the period of August 1-15. In addition, representatives of the USDA Market News Service have indicated that their contacts in Canada have reported that Norgold variety potatoes are no longer commercially produced in Canada. Nearly all potato imports come from Canada, but there are no shipments until the latter part of September.
The removal of the references to Norgold variety potatoes is not expected to impose any additional costs on handlers, importers, or producers.
As an alternative to this rule, the Committee discussed leaving the handling regulations unchanged. The Committee rejected this idea because it would have left outdated language in the rules and regulations.
This rule does not impose any additional reporting or recordkeeping requirements on either small or large potato handlers and importers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sectors. USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this final rule.
Further, the Committee's meeting was widely publicized throughout the potato industry, and all interested persons were invited to attend the meeting and participate in Committee deliberations. Like all Committee meetings, the November 9, 1999, meeting was a public meeting and all entities, both large and small, were able to express their views on this issue.
A proposed rule concerning this action was published in the
A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at the following Web site:
After consideration of all relevant matter presented, including the information and recommendation submitted by the Committee and other available information, it is hereby found that this rule, as hereinafter set forth, will tend to effectuate the declared policy of the Act.
In accordance with section 608e of the Act, the United States Trade Representative has concurred with the issuance of this rule.
Marketing agreements, Potatoes, Reporting and recordkeeping requirements.
Food grades and standards, Imports, Marketing agreements, Onions, Potatoes, Tomatoes.
7 U.S.C. 601-674.
(a) * * *
(1) * * *
(i) Grade, size, quality, and maturity regulations have been issued from time to time pursuant to the following marketing orders: No. 945 (part 945 of this chapter), No. 948 (part 948 of this chapter), No. 947 (part 947 of this chapter), No. 946 (part 946 of this chapter), and No. 953 (part 953 of this chapter).
(2) * * *
(ii) Imports of all other round type potatoes during the period June 5 through July 31 are in most direct competition with the marketing of the same type of potatoes produced in the Southeastern States covered by Order No. 953 (part 953 of this chapter); and during the period of August 1 through June 4 of the following year they are in most direct competition with all other round type potatoes produced in Area No. 3, Colorado (Northern Colorado) covered by Marketing Order No. 948, as amended (part 948 of this chapter).
(b) * * *
(2) During the period June 5 through July 31 of each marketing year, the grade, size, quality, and maturity requirements of Marketing Order No. 953 (part 953 of this chapter) applicable to potatoes of the round type shall be the respective grade, size, quality, and maturity requirements for imports of other round type potatoes; and during the period August 1 through the following June 4 of each year the grade, size, quality, and maturity requirements of Area No. 3, Colorado (Northern Colorado) covered by Marketing Order No. 948, as amended (part 948 of this chapter) shall be the respective grade, size, quality, and maturity requirements for imports of all other round type potatoes.
(e)
(f)
(g) * * *
(1) * * *
(ii) Since inspectors may not be stationed in the immediate vicinity of a port, or point of entry, an importer of uninspected and uncertified Irish potatoes should make advance arrangements for inspection. Each importer should give at least the specified advance notice to one of the following applicable inspection offices prior to the time the Irish potatoes will be imported.
(i)
(2)
Immigration and Naturalization Service, Justice.
Final rule: Corrections.
The Department of Justice published in the
November 1, 2002.
Elizabeth N. Lee or Suzy Nguyen, Assistant Directors, Residence and Status Branch, Office of Adjudications, Immigration and Naturalization Service, 425 I Street NW., Room 3040, Washington, DC 20536, telephone (202) 514-3228.
As published in the
Animal and Plant Health Inspection Service, USDA.
Affirmation of interim rule as final rule.
We are adopting as a final rule, without change, an interim rule that amended the regulations by adding Israel to the list of regions where bovine spongiform encephalopathy exists because the disease had been detected in a native-born animal in that region. The effect of the interim rule was a restriction on the importation of ruminants, meat, meat products, and certain other products of ruminants that had been in Israel. The interim rule was necessary to help prevent the introduction of bovine spongiform encephalopathy into the United States.
The interim rule became effective on June 4, 2002.
Dr. Gary Colgrove, Chief Staff Veterinarian, Sanitary Trade Issues Team, National Center for Import and Export, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231; (301) 734-4356.
The regulations in 9 CFR parts 93, 94, 95, and 96 (referred to below as the regulations) govern the importation of certain animals, birds, poultry, meat, other animal products and byproducts, hay, and straw into the United States in order to prevent the introduction of various animal diseases, including bovine spongiform encephalopathy (BSE).
In an interim rule effective June 4, 2002, and published in the
Comments on the interim rule were required to be received on or before September 16, 2002. We did not receive any comments. Therefore, for the reasons given in the interim rule, we are adopting the interim rule as a final rule.
This action also affirms the information contained in the interim rule concerning Executive Orders 12866 and 12988 and the Paperwork Reduction Act.
Further, for this action, the Office of Management and Budget has waived its review under Executive Order 12866.
This action affirms an interim rule that amended the regulations by adding Israel to the list of regions where BSE exists. The effect of the interim rule was a restriction on the importation of ruminants, meat, meat products, and certain other products of ruminants that had been in Israel. The interim rule was necessary to help prevent the introduction of BSE into the United States.
The following analysis addresses the economic effects of the interim rule on small entities, as required by the Regulatory Flexibility Act.
The interim rule's restrictions on the importation of ruminants and ruminant products and byproducts from Israel are not expected to have a significant impact on a substantial number of small entities due to the fact that the restricted items are either not imported from Israel or are imported in very small amounts. There are three categories of imports that may be affected, but Israel's share of U.S. imports is small in each case.
The first category of affected imported commodities is “Meat and edible meat offal, salted in brine, dried or smoked; edible flours and meals of meat or meat offal.” Average total yearly imports of these products by the United States over the 3-year period 1999-2001 were valued at $24.6 million. Imports from Israel in 1999 were valued at $26,000. No imports of these products from Israel were reported for 2000 or 2001.
The second category of affected commodities is “Preparations of a kind used in animal feeding.” Average total yearly imports of these products, 1999-2001, were valued at $93.5 million. Imports from Israel had an average yearly value over this period of about $76,000.
The final category of affected commodities is “Other prepared or preserved meat, meat offal or blood.” Average yearly imports of these products, 1999-2001, were valued at $101.2 million. Imports from Israel had an average yearly value over this period of about $2.7 million.
It is apparent that Israel is a minor supplier to the United States of the ruminant products and byproducts affected by the BSE-related restrictions resulting from the interim rule. Therefore, we do not expect that the interim rule's restrictions on ruminants and ruminant products and byproducts from Israel will substantially affect any U.S. importers, large or small, of those commodities.
Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action will not have a significant economic impact on a substantial number of small entities.
Animal diseases, Imports, Livestock, Meat and meat products, Milk, Poultry and poultry products, Reporting and recordkeeping requirements.
7 U.S.C. 450, 7711-7714, 7751, 7754, 8303, 8306, 8308, 8310, 8311, and 8315; 21 U.S.C 136 and 136a; 31 U.S.C. 9701; 42 U.S.C. 4331 and 4332; 7 CFR 2.22, 2.80, and 371.4.
Office of Federal Housing Enterprise Oversight, HUD.
Final rule.
The Office of Federal Housing Enterprise Oversight (OFHEO) is adopting technical amendments to Appendix A to Subpart B of 12 CFR part 1750 Risk-Based Capital. The amendments are intended to enhance the accuracy of the calculation of the
November 1, 2002.
Jeannine Schroeder, Manager of Operations, Office of Risk Analysis and Model Development, telephone (202) 414-8881 or Jamie Schwing, Associate General Counsel, telephone (202) 414-3787 (not toll free numbers), Office of Federal Housing Enterprise Oversight, Fourth Floor, 1700 G Street, NW., Washington, DC 20552. The telephone number for the Telecommunications Device for the Deaf is (800) 877-8339.
OFHEO published a final regulation setting forth a risk-based capital stress test on September 13, 2001, 12 CFR part 1750 (the Rule), which formed the basis for determining the risk-based capital requirement for the federally sponsored housing enterprises—Federal National Mortgage Association (Fannie Mae) and Federal Home Loan Mortgage Corporation (Freddie Mac) (collectively, the Enterprises).
On September 12, 2002, OFHEO published a notice of proposed rulemaking (NPRM), 67 FR 57760, which proposed twelve technical and corrective amendments to the Rule. One commenter, Freddie Mac, expressed concern regarding the appropriate effective date for a proposed technical amendment that corrected a table that utilized original loan-to-value ratios rather than amortized original loan-to-value ratios (amendment number eight in the list of 12 amendments in the preamble of the NPRM). Freddie Mac also requested a delay in the effective date for two amendments relating to the implementation of Financial Accounting Standard 133 (FAS 133) in the Rule (amendments numbered 11 and 12 in the list of 12 amendments in the preamble of the NPRM).
(1) Provisions relating to new activities are updated to cross-reference the Prompt Supervisory Response and Corrective Action regulation, 12 CFR part 1777, in paragraph 3.11.3[c] and to correct a typographical error in paragraph 3.11.2[a];
(2) Out-of-date third party sources of information related to interest rate indexes (
(3) Credit Ratings in Table 3-30 are updated to include certain credit ratings used in the marketplace that were not listed in the original table. Specifically, Moody's assigns an additional rating from VMIG1 through VMIG3 to quantify the risks of the demand feature of variable-rate demand obligations and Standard & Poor's rates short term issuances as SP-1+, SP-1, SP-2, and SP-3;
(4) Paragraph 3.6.3.4.3.1 [a] 3. a. on single family default and prepayment explanatory variables is replaced in full, including equations, to correct the parenthetical (q= −7, −6,...0, 1,...40);
(5) Table 3-35, in which the explanatory variable categories for Relative Spread (RS
(6) The equation related to mortgage credit enhancement procedures at paragraph 3.6.3.6.4.3 is corrected to reflect the fact that in extreme circumstances (
(7) A typographical error in the equation in 3.7.3.1[g]2. for calculating haircuts for mortgage backed securities is corrected by changing a specified addition sign (+) to a multiplication sign (×); and
(8) Table 3-68 is revised to reflect that the Table relates to long caps and floors.
In order to make these eight adjustments applicable to the first fully enforceable risk-based capital calculation for each Enterprise, OFHEO has determined that the amendments shall be effective immediately and shall apply to any data submissions from the Enterprises received after the effective date. Waiver of the normal 30-day delay in effective date is in the public interest because these changes rectify errors in the code and in the language of the rule that could mislead the public if left unamended. In some cases they simply reflect changes that have already been implemented in the computer software used to implement the stress test and are necessary for the stress test to be operational. Moreover, both Enterprises have participated in data and software validation processes with OFHEO for the past year and have been aware of the pendency of these technical changes, which have no material impact on capital requirements, for many months.
This document contains amendments to the Rule, which was designated a major rule by the Office of Management and Budget (OMB). The amendments address provisions of the Rule that are out-of-date, incorrect or contain typographical errors. OFHEO has determined that the amendments to the Rule are not economically significant for purposes of Executive Order 12866. Further, they implement technical changes and do not involve novel policy issues. Therefore, these amendments are not a “significant rule” under Executive Order 12866.
These amendments do not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. 3501
The Regulatory Flexibility Act (5 U.S.C. 601
Capital classification, Mortgages, Risk-based capital.
12 U.S.C. 4513, 4514, 4611, 4612, 4614, 4615, 4618.
The revisions and additions read as follows:
[c] * * *
[b] The process for determining Interest Rates is as follows: first, identify the values for the necessary Interest Rates at time zero; second, project the ten-year CMT for each month of the Stress Period as specified in the 1992 Act; third, project the 1-month Treasury yield, the 3-month, 6-month, 1-, 2-, 3-, 5-, 20-year, and 30-year CMTs; fourth, project non-treasury Interest Rates, including the Federal Agency Cost of Funds Index; and fifth, project the Enterprises Cost of Funds Index, which provides borrowing rates for the Enterprises during the Stress Period, by increasing the Agency Cost of Funds Index by 10 basis points for the last 108 months of the Stress Test. Guidance in determining interest rates is available under OFHEO Guideline No. 402, “Risk Based Capital Process for Capturing and Utilizing Interest Rates Files,” which is available on OFHEO's Web site,
[a] * * *
[a] * * *
[a] * * *
[g] * * *
[e] * * *
[c] OFHEO will provide the Enterprise with its estimate of the capital treatment as soon as possible after receiving notice of the New Activity. In any event, the Enterprise will be notified of the capital treatment in accordance with the notice of proposed capital classification provided for in § 1777.21 of this chapter.
Federal Aviation Administration, DOT.
Final rule.
This amendment adopts a new airworthiness directive (AD) that applies to certain MORAVAN a.s. (Moravan) Models Z-143L and Z-242L airplanes. This AD requires you to modify the engine secondary vent line. This AD is the result of mandatory continuing airworthiness information (MCAI) issued by the airworthiness authority for the Czech Republic. The actions specified by this AD are intended to prevent the engine crankcase ventilation lines from freezing during flight in cold weather (winter) conditions, which could result in oil leaking from the engine. Such a condition could lead to engine failure.
This AD becomes effective on December 13, 2002.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in the regulations as of December 13, 2002.
You may get the service information referenced in this AD from Moravan, Inc., 765 81 Otrokovice, Czech Republic; telephone: +420 67 767 3940; facsimile: +420 67 792 2103. You may view this information at the Federal Aviation Administration (FAA), Central Region, Office of the Regional Counsel, Attention: Rules Docket No. 99-CE-71-AD, 901 Locust, Room 506, Kansas City, Missouri 64106; or at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC.
Doug Rudolph, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4059; facsimile: (816) 329-4090.
The Civil Aviation Authority (CAA), which is the airworthiness authority for the Czech Republic, notified FAA that an unsafe condition may exist on certain Moravan Models Z-143L and Z-242L airplanes. The CAA reports that during a production delivery flight of a Model Z-242L airplane, smoke accumulated in the cockpit of the airplane, and engine oil pressure dropped significantly. As a result of this situation, the pilot was forced to make an emergency landing.
Investigation analysis revealed that the engine crankcase ventilation lines became frozen while flying in low ambient air temperature (winter) conditions. When the engine crankcase ventilation lines freeze, the front crankcase seal ring slips out, which allows oil to leak from the engine.
This condition, if not corrected, could result in the engine crankcase ventilation lines freezing during flight in cold weather (winter) conditions. Such a condition could lead to engine failure.
We issued a proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an AD that would apply to certain Moravan Models Z-143L and Z-242L airplanes. This proposal was published in the
The FAA encouraged interested persons to participate in the making of this amendment. We did not receive any comments on the proposed rule or on our determination of the cost to the public.
After careful review of all available information related to the subject presented above, we have determined that air safety and the public interest require the adoption of the rule as proposed except for minor editorial corrections. We have determined that these minor corrections:
We estimate that this AD affects 39 airplanes in the U.S. registry.
We estimate the following costs to accomplish the modification:
The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.
For the reasons discussed above, I certify that this action (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A copy of the final evaluation prepared for this action is contained in the Rules Docket. A copy of it may be obtained by contacting the Rules Docket at the location provided under the caption
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
49 U.S.C. 106(g), 40113, 44701.
(a)
(b)
(c)
(d)
(e)
(1) Your alternative method of compliance provides an equivalent level of safety; and
(2) The Manager, Small Airplane Directorate, approves your alternative. Submit your request through an FAA Principal Maintenance Inspector, who may add comments and then send it to the Manager, Small Airplane Directorate.
This AD applies to each airplane identified in paragraph (a) of this AD, regardless of whether it has been modified, altered, or repaired in the area subject to the requirements of this AD. For airplanes that have been modified, altered, or repaired so that the performance of the requirements of this AD is affected, the owner/operator must request approval for an alternative method of compliance in accordance with paragraph (e) of this AD. The request should include an assessment of the effect of the modification, alteration, or repair on the unsafe condition addressed by this AD; and, if you have not eliminated the unsafe condition, specific actions you propose to address it.
(f)
(g)
(h)
The subject of this AD is addressed in Czech Republic AD Number CAA-AD-042/1999, August 18, 1999.
(i)
Federal Aviation Administration, DOT.
Final rule.
This amendment adopts a new airworthiness directive (AD) that applies to certain PILATUS Aircraft Ltd. (Pilatus) Model PC-7 airplanes. This AD requires you to repetitively inspect the main landing gear front attachment brackets for cracks, and, if cracks are found, install improved-design brackets. Installing the improved-design brackets terminates the required inspections. This AD is the result of mandatory continuing airworthiness information (MCAI) issued by the airworthiness authority for Switzerland. The actions specified by this AD are intended to detect and correct cracks in the main landing gear front attachment brackets,
This AD becomes effective on December 20, 2002.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in the regulations as of December 20, 2002.
You may get the service information referenced in this AD from Pilatus Aircraft Ltd., Customer Liaison Manager, CH-6371 Stans, Switzerland; telephone: +41 41 619 63 19; facsimile: +41 41 619 6224; or from Pilatus Business Aircraft Ltd., Product Support Department, 11755 Airport Way, Broomfield, Colorado 80021; telephone: (303) 465-9099; facsimile: (303) 465-6040. You may view this information at the Federal Aviation Administration (FAA), Central Region, Office of the Regional Counsel,
Doug Rudolph, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4059; facsimile: (816) 329-4090.
The Federal Office for Civil Aviation (FOCA), which is the airworthiness authority for Switzerland, recently notified FAA that an unsafe condition may exist on certain Pilatus Model PC-7 airplanes. The FOCA reports that an operator of a similar aircraft type design, which uses identical main landing gear support brackets, reported a single crack in one bracket. A fleet inspection of the operator's aircraft revealed stress corrosion cracking in more than 20 aircraft.
Cracks in the main landing gear front attachment brackets could result in failure of the brackets. Such failure could lead to the main landing gear leg detaching from the wing main spar.
We issued a proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an AD that would apply to certain Pilatus Model PC-7 airplanes. This proposal was published in the
The FAA encouraged interested persons to participate in the making of this amendment. We did not receive any comments on the proposed rule or on our determination of the cost to the public.
After careful review of all available information related to the subject presented above, we have determined that air safety and the public interest require the adoption of the rule as proposed except for minor editorial corrections. We have determined that these minor corrections:
We estimate that this AD affects 14 airplanes in the U.S. registry.
We estimate the following costs to accomplish the inspection:
The FAA has no method of determining the number of repetitive inspections each owner/operator would incur over the life of each of the affected airplanes so the cost impact is based on the initial inspection.
We estimate the following costs to accomplish any necessary replacements that would be required based on the results of the inspection. We have no way of determining the number of airplanes that may need such replacement:
The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.
For the reasons discussed above, I certify that this action (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A copy of the final evaluation prepared for this action is contained in the Rules Docket. A copy
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
49 U.S.C. 106(g), 40113, 44701.
(a)
(b)
(c)
(d)
If you find cracks on one side only, you are only required to replace the damaged side with the new improved-design bracket and continue the repetitive inspections required by paragraph (d)(2) of this AD. Repetitive inspections are still required on any installed bracket with either P/N 111.34.07.105 or P/N 111.34.07.106.
(e)
(1) Your alternative method of compliance provides an equivalent level of safety; and
(2) The Standards Office Manager, Small Airplane Directorate, approves your alternative. Submit your request through an FAA Principal Maintenance Inspector, who may add comments and then send it to the Standards Office Manager.
This AD applies to each airplane identified in paragraph (a) of this AD, regardless of whether it has been modified, altered, or repaired in the area subject to the requirements of this AD. For airplanes that have been modified, altered, or repaired so that the performance of the requirements of this AD is affected, the owner/operator must request approval for an alternative method of compliance in accordance with paragraph (e) of this AD. The request should include an assessment of the effect of the modification, alteration, or repair on the unsafe condition addressed by this AD; and, if you have not eliminated the unsafe condition, specific actions you propose to address it.
(f)
(g)
(h)
The subject of this AD is addressed in Swiss AD HB 2002-270, dated June 24, 2002.
(i)
Federal Aviation Administration, DOT.
Final rule.
This amendment adopts a new airworthiness directive (AD) that applies to all Pilatus Britten-Norman Limited (Pilatus Britten-Norman) BN-2, BN-2A, BN-2B, BN-2T, and BN2A MK. III series airplanes. This AD requires you to repetitively inspect the bottom corner of the engine mount bracket for cracks and replace any cracked bracket with a new one. This AD is the result of mandatory continuing airworthiness information (MCAI) issued by the airworthiness authority for the United Kingdom. The actions specified by this AD are intended to detect and correct cracks in the engine mount bracket. Such a condition could cause the engine mount assembly to fail, which could result in the engine separating from the airplane and lead to loss of control of the airplane.
This AD becomes effective on December 20, 2002.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in the regulations as of December 20, 2002.
You may get the service information referenced in this AD from B-N Group Limited, Bembridge, Isle of Wight, United Kingdom PO35 5PR; telephone: +44 (0) 1983 872511; facsimile: +44 (0) 1983 873246. You may view this information at the Federal Aviation Administration (FAA), Central Region, Office of the Regional Counsel, Attention: Rules Docket No. 2002-CE-21-AD, 901 Locust, Room 506, Kansas City, Missouri 64106; or at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC.
Doug Rudolph, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4059; facsimile: (816) 329-4090.
The Civil Aviation Authority (CAA), which is the airworthiness authority for the United Kingdom, recently notified FAA that an unsafe condition may exist on all Pilatus Britten-Norman BN-2, BN-2A, BN-2B, BN-2T, and BN2A MK. III series airplanes. The CAA reports two occurrences of extensive cracks being found on the bottom corner of the engine mount bracket between the attachment flange and the main bracket. The cracks were found during regular scheduled maintenance.
The manufacturer has determined that this condition is a result of the reinforcing doubler being too close to the flange.
This condition, if not detected and corrected, could result in failure of the engine mount. Such failure could result in the engine separating from the airplane and lead to loss of control of the airplane.
We issued a proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an AD that would apply to all Pilatus Britten-Norman BN-2, BN-2A, BN-2B, BN-2T, and BN2A MK. III series airplanes. This proposal was published in the
The CAA AD and the service information allow continued flight if cracks are found in the engine mount bracket that do not exceed certain limits. The applicable service bulletin specifies replacement of the engine mount bracket only if cracks are found exceeding this limit, as does CAA AD 005-11-2001. This AD does not allow continued flight if any crack is found. FAA policy is to disallow airplane operation when known cracks exist in primary structure, unless the ability to sustain ultimate load with these cracks is proven. The engine mount bracket is considered primary structure, and the FAA has not received any analysis to prove that ultimate load can be sustained with cracks in this area.
The FAA has determined that long-term continued operational safety will be better assured by design changes that remove the source of the problem rather than by performing repetitive inspections. With this in mind, we will continue to work with Pilatus Britten-Norman in collecting information to determine whether a future design change may be necessary.
The FAA encouraged interested persons to participate in the making of this amendment. We did not receive any
After careful review of all available information related to the subject presented above, we have determined that air safety and the public interest require the adoption of the rule as proposed except for minor editorial corrections. We have determined that these minor corrections:
We estimate that this AD affects 126 airplanes in the U.S. registry.
We estimate the following costs to accomplish the inspection for BN-2, BN-2A, BN-2B, and BN2A MK. III series airplanes:
We estimate the following costs to accomplish the inspection for BN-2T series airplanes:
We estimate the following costs to accomplish any necessary replacements for BN-2, BN-2A, BN-2B, and BN-2T series airplanes that will be required based on the results of the inspection. We have no way of determining the number of airplanes that may need such replacement:
We estimate the following costs to accomplish any necessary replacements for BN2A MK. III series airplanes that will be required based on the results of the inspection. We have no way of determining the number of airplanes that may need such replacement:
The compliance time of this AD is “within the next 500 hours time-in-service (TIS) or within the next 24 calendar months after the effective date of this AD, whichever occurs first.”
We have established the compliance time of this AD in both hours TIS and calendar time. The unsafe condition is dependent upon repetitive airplane operation. However, the recommended maintenance program specifies other actions in this area at intervals not to exceed 2 years. Therefore, the compliance time will ensure that high-time airplanes are inspected within a certain amount of hours TIS and the lower time airplanes would be inspected at the next maintenance event in the affected area. We have determined that this compliance time:
The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.
For the reasons discussed above, I certify that this action (1) is not a significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A copy of the final
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
49 U.S.C. 106(g), 40113, 44701.
(a)
BN-2, BN-2A, BN-2A-2, BN-2A-3, BN-2A-6, BN-2A-8, BN-2A-9, BN-2A-20, BN-2A-21, BN-2A-26, BN-2A-27, BN-2B-20, BN-2B-21, BN-2B-26, BN-2B-27, BN-2T, BN-2T-4R, BN2A MK. III, BN2A MK. III-2, BN2A MK. III-3
(b)
(c)
(d)
(e)
(1) Your alternative method of compliance provides an equivalent level of safety; and
(2) The Standards Office Manager, Small Airplane Directorate, approves your alternative. Submit your request through an FAA Principal Maintenance Inspector, who may add comments and then send it to the Standards Office Manager.
This AD applies to each airplane identified in paragraph (a) of this AD, regardless of whether it has been modified, altered, or repaired in the area subject to the requirements of this AD. For airplanes that have been modified, altered, or repaired so that the performance of the requirements of this AD is affected, the owner/operator must request approval for an alternative method of compliance in accordance with paragraph (e) of this AD. The request should include an assessment of the effect of the modification, alteration, or repair on the unsafe condition addressed by this AD; and, if you have not eliminated the unsafe condition, specific actions you propose to address it.
(f)
(g)
(h)
The subject of this AD is addressed in the United Kingdom CAA-AD Number 005-11-2001, not dated.
(i)
Federal Aviation Administration, DOT.
Final rule.
This amendment adopts a new airworthiness directive (AD) that applies to certain Stemme GmbH & Co. KG (Stemme) Model S10-VT sailplanes. This AD requires you to modify the engine compartment fuel and oil system and firewall. This AD is the result of mandatory continuing airworthiness information (MCAI) issued by the airworthiness authority for Germany. The actions specified by this AD are intended to reduce the potential for a fire to ignite in the engine compartment and increase the containment of an engine fire in the engine compartment. A fire in the engine compartment could lead to loss of control of the sailplane.
This AD becomes effective on December 20, 2002.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in the regulations as of December 20, 2002.
You may get the service information referenced in this AD from Stemme GmbH & Co. KG, Gustav-Meyer-Allee 25, D-13355 Berlin, Germany; telephone: 49.33.41.31.11.70; facsimile: 49.33.41.31.11.73. You may view this information at the Federal Aviation Administration (FAA), Central Region, Office of the Regional Counsel, Attention: Rules Docket No. 2002-CE-29-AD, 901 Locust, Room 506, Kansas City, Missouri 64106; or at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC.
Mike Kiesov, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4144; facsimile: (816) 329-4090.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
49 U.S.C. 106(g), 40113, 44701.
(a)
(b)
(c)
(d)
(e)
(1) Your alternative method of compliance provides an equivalent level of safety; and
(2) The Manager, Standards Office, Small Airplane Directorate, approves your alternative. Submit your request through an FAA Principal Maintenance Inspector, who may add comments and then send it to the Manager, Standards Office.
This AD applies to each sailplane identified in paragraph (a) of this AD, regardless of whether it has been modified, altered, or repaired in the area subject to the requirements of this AD. For sailplanes that have been modified, altered, or repaired so that the performance of the requirements of this AD is affected, the owner/operator must request approval for an alternative method of compliance in accordance with paragraph (e) of this AD. The request should include an assessment of the effect of the modification, alteration, or repair on the unsafe condition addressed by this AD; and, if you have not eliminated the unsafe condition, specific actions you propose to address it.
(f)
(g)
(h)
The subject of this AD is addressed in German AD 2002-156, dated June 13, 2002.
(i)
Federal Aviation Administration, DOT.
Final rule; request for comments.
This amendment adopts a new airworthiness directive (AD) that is applicable to Honeywell International, Inc., (formerly AlliedSignal, Inc. and Textron Lycoming) LF507 and ALF502R series turbofan engines with combustion chamber liner assembly part number (P/N) 2-131-520-03 installed. This action requires initial and repetitive borescope inspections of the combustion chamber liner assembly to determine if the combustion liner assembly condition is acceptable for continued operation, requires the removal from service of certain serial number (SN) combustion chamber liner assemblies, and provides an optional terminating action to the
Effective November 18, 2002. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of November 18, 2002.
Comments for inclusion in the Rules Docket must be received on or before December 31, 2002.
Submit comments in triplicate to the Federal Aviation Administration (FAA), New England Region, Office of the Regional Counsel,
The service information referenced in this AD may be obtained from Honeywell International, Inc. (formerly AlliedSignal, Inc. and Textron Lycoming),
Robert Baitoo, Aerospace Engineer, Los Angeles Aircraft Certification Office (LAACO), FAA, Transport Airplane Directorate, 3960 Paramount Blvd., Lakewood, CA 90712-4137; telephone (562) 627-5245; fax (562) 627-5210.
The FAA has received three reports of combustion liner assemblies that have been found with burned and missing material. One combustion chamber liner assembly that burned through was found at routine maintenance, one manifested itself as a low thrust condition, and one resulted in an engine in-flight shutdown. Some combustion liner assemblies may have inferior baffle attachment welds. To date, there have been no in-flight engine fires due to separation of the combustor dome baffle from the combustion chamber liner assembly. However, the FAA has determined that LF507 and ALF502R series turbofan engines with combustion chamber liner assembly part number (P/N) 2-131-520-03 installed could experience burn through due to separation of the combustor dome baffle and the flow of hot combustor gases on oil and fuel lines. This condition, if not corrected, could result in engine fire, in-flight shutdown, and damage to the airplane.
The FAA has reviewed and approved the technical contents of Honeywell International, Inc., (formerly AlliedSignal, Inc. and Textron Lycoming) alert service bulletin (ASB).
• ALF/LF A72-1076, Revision 1, dated August 30, 2002. That ASB describes initial and repetitive borescope inspection procedures of the combustion chamber liner assembly part number (P/N) 2-131-520-03. That ASB also lists combustion chamber liner assembly SN's that require removal within 250 cycles from date of receipt of that service bulletin revision (Revision 1).
Since an unsafe condition has been identified that is likely to exist or develop on other Honeywell International, Inc., (formerly AlliedSignal, Inc. and Textron Lycoming) LF507 and ALF502R series turbofan engines of the same type design, this AD is being issued to prevent separation of the combustor dome baffle from the combustion chamber liner assembly and the flow of hot combustor gases on oil and fuel lines which could result in an engine fire, an in-flight shutdown, and damage to the airplane. The actions are required to be done in accordance with the alert service bulletin described previously.
Since a situation exists that requires the immediate adoption of this regulation, it is found that notice and opportunity for prior public comment hereon are impracticable, and that good cause exists for making this amendment effective in less than 30 days.
Although this action is in the form of a final rule that involves requirements affecting flight safety and, thus, was not preceded by notice and an opportunity for public comment, comments are invited on this rule. Interested persons are invited to comment on this rule by submitting such written data, views, or arguments as they may desire. Communications should identify the Rules Docket number and be submitted in triplicate to the address specified under the caption
Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the rule that might suggest a need to modify the rule. All comments submitted will be available, both before and after the closing date for comments, in the Rules Docket for examination by interested persons. A report that summarizes each FAA-public contact concerned with the substance of this AD will be filed in the Rules Docket.
Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this action must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2002-NE-21-AD.” The postcard will be date stamped and returned to the commenter.
This final rule does not have federalism implications, as defined in Executive Order 13132, because it would not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the FAA has not consulted with state authorities prior to publication of this final rule.
The FAA has determined that this regulation is an emergency regulation that must be issued immediately to correct an unsafe condition in aircraft, and is not a “significant regulatory action” under Executive Order 12866. It has been determined further that this action involves an emergency regulation
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
49 U.S.C. 106(g), 40113, 44701.
This AD applies to each engine identified in the preceding applicability provision, regardless of whether it has been modified, altered, or repaired in the area subject to the requirements of this AD. For engines that have been modified, altered, or repaired so that the performance of the requirements of this AD is affected, the owner/operator must request approval for an alternative method of compliance in accordance with paragraph (e) of this AD. The request should include an assessment of the effect of the modification, alteration, or repair on the unsafe condition addressed by this AD; and, if the unsafe condition has not been eliminated, the request should include specific proposed actions to address it.
To prevent separation of the combustor dome baffle from the combustion chamber liner assembly and the flow of hot combustor gases on oil and fuel lines which could result in an engine fire, an in-flight shutdown, and damage to the airplane, do the following:
(a) Within 250 cycles-in-service (CIS) after the effective date of this AD, remove from service engines that have combustion chamber liner assemblies, P/N 2-131-520-03, listed by serial number (SN) in Table 1 of this AD. Replace that SN combustion chamber liner assembly with a serviceable part. Table 1 follows:
(b) On engines that have combustion chamber liner assemblies with more than 2,000 CIS on the effective date of this AD, perform an initial borescope inspection of combustion chamber liner assembly P/N 2-131-520-03 within 500 CIS after the effective date of this AD in accordance with paragraphs 2(A)(1) through 2(A)(8) of the Accomplishment Instructions of Honeywell alert service bulletin (ASB) ALF/LF A72-1076, Revision 1, dated August 30, 2002.
(c) Thereafter, at each successive 500 CIS, perform a borescope inspection of combustion chamber liner assembly P/N 2-131-520-03 in accordance with paragraphs 2(A)(1) through 2(A)(8) of the Accomplishment Instructions of Honeywell ASB ALF/LF A72-1076, Revision 1, dated August 30, 2002.
(d) Replacement of combustion chamber liner assembly, P/N 2-131-520-03, with the new improved durability combustion chamber liner assembly, P/N 2-131-520-04, constitutes terminating action to the borescope inspection requirements of paragraph (c) of this AD. Information regarding the replacement of combustion chamber liner assembly P/N 2-131-520-03 with P/N 2-131-520-04 can be found in Honeywell service bulletin ALF/LF 72-1078, dated June 28, 2002.
(e) An alternative method of compliance or adjustment of the compliance time that provides an acceptable level of safety may be used if approved by the Manager, Los Angeles Aircraft Certification Office (LAACO). Operators must submit their requests through an appropriate FAA Principal Maintenance Inspector, who may add comments and then send it to the Manager, LAACO.
Information concerning the existence of approved alternative methods of compliance with this airworthiness directive, if any, may be obtained from the LAACO.
(f) Special flight permits may be issued in accordance with §§ 21.197 and 21.199 of the Federal Aviation Regulations (14 CFR 21.197 and 21.199) to operate the airplane to a location where the requirements of this AD can be done.
(g) The initial and repetitive borescope inspections of combustion chamber liner assembly, PN 2-131-520-03, must be done in accordance with the Honeywell International, Inc. ASB ALF/LF A72-1076, Revision 1, dated August 30, 2002. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from Honeywell International, Inc. (formerly AlliedSignal, Inc. and Textron Lycoming),
(h) This amendment becomes effective on November 18, 2002.
Consumer Product Safety Commission.
Final rule.
The Commission is amending its child-resistant packaging requirements to exempt hormone replacement therapy (“HRT”) products containing one or more progestogen or estrogen substances. Current exemptions cover some HRT products, but not others. This rule would uniformly exempt from child resistant packaging requirements all HRT products that rely solely on the activity of one or more progestogen or estrogen substances.
The rule is effective November 1, 2002, and applies to products packaged on or after that date.
Geri Smith, Office of Compliance and Enforcement, Consumer Product Safety Commission, Washington, DC 20207; telephone (301) 504-0608 ext. 1160.
The Poison Prevention Packaging Act of 1970 (“PPPA”), 15 U.S.C. 1471-1476, authorizes the Commission to issue standards for the special packaging of household substances, such as drugs, when (1) Child resistant packaging is necessary to protect children from serious personal injury or illness due to the substance and (2) the special packaging is technically feasible, practicable, and appropriate for the substance. Accordingly, a Commission rule requires that oral prescription drugs be in child resistant (”CR”) packaging. 16 CFR 1700.14(a)(10).
The Commission's regulations allow exemptions from this requirement for substances that have low acute toxicity. 16 CFR 1702.1(b) and 1702.7. Current regulations provide four PPPA exemptions for sex hormones: (1) Oral contraceptives in mnemonic packages containing one or more progestogen or estrogen substances; (2) conjugated estrogen tablets in mnemonic packages; (3) norethindrone acetate tablets in mnemonic packaging; and (4) medroxyprogesterone acetate tablets. 16 CFR 1700.14(a)(10)(iv), (xvii), (xviii) and (xix). Some HRT products fall within these exemptions, but because of the way these exemptions are written, other HRT products currently require CR packaging.
On February 19, 2002, the Commission published a notice of proposed rulemaking (“NPR”) proposing to exempt from the special packaging requirements HRT products containing one or more progestogen or estrogen substances. 67 FR 7319. This rule will make the exemption of HRT products more uniform by exempting all HRT products that rely solely on the activity of one or more progestogen or estrogen substances.
HRT is used to replace the estrogen and progesterone that normally decline following menopause (the cessation of menstruation). Women may experience a range of menopausal symptoms. Additionally, menopause accelerates bone depletion that commonly occurs with aging, leading to osteoporosis.
HRT has been used to relieve a number of menopausal symptoms and help to prevent osteoporosis. HRT consists of using estrogen alone or various combinations of estrogens and progestins, similar to oral contraceptives. Some are natural hormones (
Recently, studies have raised questions about the health effects of HRT. A Women's Health Initiative study indicated that women treated for about 5 years with a combination of estrogen and progestin had an increased risk of breast cancer, heart disease, stroke and blood clots compared to placebo. While this study suggests that HRT may not be indicated for long term use, it did not examine different doses, different estrogen or progestins or alternative formulations. It is likely that physicians may consider prescribing short term hormone therapy for menopausal symptoms after evaluating the risks and benefits for individual patients. Because the acute toxicity of HRT is low and its use is likely to continue even with the questions raised about its long term use, the Commission believes that a rule uniformly exempting HRT products from CR packaging requirements is appropriate.
Human toxic doses for estrogens or progestins have not been defined. Exposure summaries in the Poisindex® for estrogens, progestins, and oral contraceptives state that acute toxicity is unlikely following overdosage. Gastrointestinal effects (
The medical literature provides little information concerning acute overdosage of progestins or estrogens. One case mentioned in the NPR showed that a single dose of 160 mg estradiol valerate (80 tablets/2 mg each), ingested by a 19-year-old woman in a suicide attempt, produced little toxicity. The woman slept easily during the night of the ingestion and the next evening presented in the emergency clinic in generally good condition with nausea and a headache.
For the NPR, the staff reviewed poisoning data from the American Association of Poison Control Centers (“AAPCC”) Toxic Exposure Surveillance System (“TESS”) showing acute exposures in children less than five years old to estrogens, progestins, and oral contraceptives from 1993 to 1998. There were no deaths and most of the exposures were non-toxic.
For this final rule, the staff reviewed available AAPCC data since the NPR was published, and found no major outcomes or deaths in any of the hormone categories in 1999 and 2000 (the most recent data available).
The Commission received one comment in response to the NPR. It came from Berlex Laboratories, which wrote that it currently markets estrogen replacement therapy, long-acting contraception, and oral contraception products and plans to market an oral HRT product in the near future. Berlex states that the proposed exemption is “beneficial in terms of cost and efficiency” and provides “drug producers greater flexibility in meeting the needs of the HRT patient population.”
With this rule, the Commission issues an exemption from the child-resistant packaging requirements generally applicable to oral prescription drugs. Thus, the rule imposes no new requirements, but lifts requirements currently in existence for some HRT products (some HRT products are already exempt from CR packaging requirements). Under these circumstances the Commission believes it is appropriate for the rule to become effective on the date it is published in the
As discussed in the NPR, the Commission preliminarily concluded that the proposed amendment exempting HRT products from special packaging requirements would not have a significant impact on a substantial number of small businesses or other small entities. This conclusion was based on the fact that the exemption would actually increase the packaging options for manufacturers because it would allow them to package the affected HRT products in non-CR packages. Thus, the exemption is not likely to have a significant impact on a substantial number of companies, regardless of size.
In the NPR, the Commission also discussed possible impact on the environment as required by the National
According to Executive Order 12988 (February 5, 1996), agencies must state in clear language the preemptive effect, if any, of new regulations.
The PPPA provides that, generally, when a special packaging standard issued under the PPPA is in effect, “no State or political subdivision thereof shall have any authority either to establish or continue in effect, with respect to such household substance, any standard for special packaging (and any exemption therefrom and requirement related thereto) which is not identical to the [PPPA] standard.” 15 U.S.C. 1476(a). A State or local standard may be excepted from this preemptive effect if (1) the State or local standard provides a higher degree of protection from the risk of injury or illness than the PPPA standard; and (2) the State or political subdivision applies to the Commission for an exemption from the PPPA's preemption clause and the Commission grants the exemption through a process specified at 16 CFR part 1061. 15 U.S.C. 1476(c)(1). In addition, the Federal government, or a State or local government, may establish and continue in effect a non-identical special packaging requirement that provides a higher degree of protection than the PPPA requirement for a household substance for the Federal, State or local government's own use. 15 U.S.C. 1476(b).
Accordingly, with the exceptions noted above, the rule exempting HRT products from special packaging requirements would preempt non-identical state or local special packaging standards for those products.
The Commission has also evaluated the rule in light of the principles stated in Executive Order 13132 concerning federalism, even though that Order does not apply to independent regulatory agencies such as CPSC. The Commission does not expect that the rule will have any substantial direct effects on the States, the relationship between the national government and the States, or the distribution of power and responsibilities among various levels of government.
Consumer protection, Drugs, Infants and children, Packaging and containers, Poison prevention, Toxic substances.
Pub. L. 91-601, secs. 1-9, 84 Stat. 1670-74, 15 U.S.C. 1471-76. Secs 1700.1 and 1700.14 also issued under Pub. L. 92-573, sec. 30(a), 88 Stat. 1231. 15 U.S.C. 2079(a).
(a)
(10)
(xxi) Hormone Replacement Therapy Products that rely solely upon the activity of one or more progestogen or estrogen substances.
1. Briefing memorandum from Jacqueline Ferrante, Ph.D., Directorate for Health Sciences, to the Commission, “Final Rule to Exempt Hormone Replacement Therapy Products from the Special Packaging Requirements of the Poison Prevention Packaging Act,” October 9, 2002.
2. Memorandum from Robert Franklin, Directorate for Economic Analysis, to Jacqueline Ferrante, Ph.D., Project Manager, “Small Business and Environmental Considerations Related to Exempting HRT Products from PPPA Requirements,” September 9, 2002.
Coast Guard, DOT.
Notice of temporary deviation from regulations.
The Commander, First Coast Guard District, has issued a temporary deviation from the drawbridge operation regulations for the Kernwood Bridge, mile 1.0, across the Danvers River in Massachusetts. This temporary deviation will allow the bridge to remain in the closed position from 7 a.m. on November 12, 2002 through 8 p.m. on November 14, 2002. This temporary deviation is necessary to facilitate structural repairs at the bridge.
This deviation is effective from November 12, 2002 through November 14, 2002.
John McDonald, Project Officer, First Coast Guard District, at (617) 223-8364.
The Kernwood Bridge has a vertical clearance in the closed position of 8 feet at mean high water and 17 feet at mean low water. The existing regulations are listed at 33 CFR 117.595.
The bridge owner, Massachusetts Highway Department, requested a temporary deviation from the drawbridge operating regulations to facilitate structural maintenance, replacement of the pinion bearing and support frame, at the bridge. The bridge must remain closed during these repairs. The bridge opening records indicate this bridge has received few requests to open during the requested closure time during past years.
This deviation from the drawbridge operation regulations will allow the bridge to remain in the closed position from 7 a.m. on November 12, 2002 through 8 p.m. on November 14, 2002.
This deviation from the drawbridge operation regulations is authorized
Coast Guard, DOT.
Temporary final rule.
The Coast Guard is establishing a temporary final rule governing the operation of the Route 82 Bridge, at mile 16.8, across the Connecticut River at East Haddam, Connecticut. This temporary final rule allows the bridge to operate on fixed opening schedule from November 1, 2002 through October 31, 2003. This action is necessary to facilitate major rehabilitation of the bridge.
This temporary final rule is effective from November 1, 2002 through October 31, 2003.
Material received from the public, as well as documents indicated in this preamble as being available in the docket, are part of docket (CGD01-02-100) and are available for inspection or copying at the First Coast Guard District, Bridge Branch Office, 408 Atlantic Avenue, Boston, Massachusetts 02110, 6:30 a.m. to 3 p.m., Monday through Friday, except Federal holidays.
Mr. Joseph Schmied, Project Officer, First Coast Guard District, (212) 668-7165.
On September 10, 2002, we published a notice of proposed rulemaking (NPRM) entitled Drawbridge Operation Regulations; Connecticut River, Connecticut, in the
Pursuant to 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this final rule effective in less than 30 days after publication in the
The Route 82 Bridge has a vertical clearance of 22 feet at mean high water, and 25 feet at mean low water in the closed position. The existing drawbridge operating regulations listed at 33 CFR 117.205(c), require the bridge to open on signal at all times; except that, from May 15 to October 31, 9 a.m. to 9 p.m., the bridge is required to open for recreational vessels on the hour and half hour only. The bridge is required to open on signal at all times for commercial vessels.
The Route 82 Bridge was scheduled for major repairs in the summer of 2001, but due to a funding shortfall the work was delayed. Subsequent to that, the bridge has continued to deteriorate. Funding has now been made available and the necessary repairs should be performed with due speed to assure safe reliable continued operation of the bridge.
The bridge owner, Connecticut Department of Transportation, has requested a temporary final rule to allow the bridge to open for recreational and commercial vessels at specific times; however, commercial vessels may obtain unscheduled openings at any time provided they give a twenty-four hour notice with a two-hour confirmation to the bridge tender.
The bridge owner has also requested one seven day bridge closure, two eight-hour closures and one twenty-four hour bridge closure required to facilitate the bridge repairs. The exact dates for the above closures are not known at this time. The Coast Guard plans to publish the exact times and dates in the Local Notice to Mariners at least thirty-days in advance of the anticipated occurrence to assist mariners in their planning.
The operating schedule that would be in effect at the Route 82 Bridge from November 1, 2002 through October 31, 2003, is as follows:
From November 1 through July 6, the draw shall open on signal at 5:30 a.m., 1:30 p.m., and 8 p.m., daily.
From July 7 through October 31 the draw shall open on signal Monday through Thursday at 6:30 a.m., 1:30 p.m., and 8 p.m., with one additional opening on Friday at 11:30 p.m., three additional openings on Saturday at 9:30 a.m., 4 p.m., and 11:30 p.m., two additional openings on Sunday at 9:30 a.m. and 4 p.m.
The draw shall open on signal at any time for Commercial vessels provided a twenty-four hour notice with a two-hour confirmation is given to the drawtender at the bridge.
The Coast Guard and the bridge owner have successfully coordinated the above temporary operating schedule with the mariners. The Coast Guard believes this temporary final rule is reasonable as a result of the above information.
We received no comments in response to the notice of proposed rulemaking.
The effective dates of this temporary final rule have been changed to be effective from November 1, 2002 through October 31, 2003. The notice of proposed rulemaking listed the effective dates as October 15, 2002 through April 30, 2004.
We changed the effective dates of this temporary final rule because the new dates depict the actual time period that the operating schedule of the bridge will be changed.
This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3), of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Transportation (DOT) (44 FR 11040; February 26, 1979).
This conclusion is based on the fact that vessel traffic will not be prevented from transiting the bridge as a result of this temporary final rule.
Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations less than 50,000.
The Coast Guard certifies under 5 U.S.C. 605(b), that this rule will not have a significant economic impact on a substantial number of small entities.
This conclusion is based on the fact that vessel traffic will not be prevented
This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
This rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not concern an environmental risk to health or risk to safety that may disproportionately affect children.
This final rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.
We have considered the environmental impact of this rule and concluded that under figure 2-1, paragraph (32)(e), of Commandant Instruction M16475.1D, this rule is categorically excluded from further environmental documentation because promulgation of changes to drawbridge regulations have been found to not have a significant effect on the environment. A “Categorical Exclusion Determination” is available in the docket for inspection or copying where indicated under
Bridges.
33 U.S.C. 499; 49 CFR 1.46; 33 CFR 1.05-1(g); section 117.255 also issued under the authority of Pub. L. 102-587, 106 Stat. 5039.
(d) The draw of the Route 82 Bridge, mile 16.8, shall operate as follows:
(1) From November 1 through July 6 the draw shall open on signal at 5:30 a.m., 1:30 p.m., and 8 p.m., daily.
(2) From July 7 through October 31, Monday through Thursday, the draw shall open on signal at 6:30 a.m., 1:30 p.m., and 8 p.m., with one additional opening on Friday at 11:30 p.m., three additional openings on Saturday at 9:30 a.m., 4 p.m., and 11:30 p.m., and two additional openings on Sunday at 9:30 a.m., and 4 p.m.
(3) The draw shall open on signal for commercial vessels at all times provided a twenty-four hour advance notice with a two-hour confirmation is given.
Department of Veterans Affairs.
Final rule.
This document affirms amendments to VA's medical regulations to extend CHAMPVA eligibility to persons age 65 and over who would have otherwise lost their CHAMPVA eligibility due to attainment of entitlement to hospital insurance benefits under Medicare Part A, implement coverage of physical examinations required in connection with school enrollment for beneficiaries through age 17, and reduce the catastrophic cap for CHAMPVA dependents and survivors (per family) from $7,500 to $3,000 for each calendar year. These amendments were made by an interim final rule and were necessary to implement provisions of the Floyd D. Spence National Defense Authorization Act for Fiscal Year 2001 and the Veterans' Survivor Benefits Improvements Act of 2001.
Susan Schmetzer, Chief, Policy & Compliance Division, VA Health Administration Center, P.O. Box 65020, Denver, CO 80206-9020, telephone (303) 331-7552.
An interim final rule amending VA's medical regulations to extend CHAMPVA eligibility to persons age 65 and over who would have otherwise lost their CHAMPVA eligibility due to attainment of entitlement to hospital insurance benefits under Medicare Part A, implement coverage of physical examinations required in connection with school enrollment for beneficiaries through age 17, and reduce the catastrophic cap for CHAMPVA dependents and survivors (per family) from $7,500 to $3,000 for each calendar year was published in the
We provided a 60-day comment period that ended April 1, 2002. No comments have been received. Based on the rationale set forth in the interim final rule, we now affirm as a final rule the changes made by the interim final rule.
The changes made by this final rule in large part reflect statutory changes. Moreover, we have found good cause to dispense with the notice-and-comment and delayed effective date provisions of the Administrative Procedure Act (5 U.S.C. 553). Compliance with such provisions would be impracticable, unnecessary, and contrary to the public interest. To avoid significant administrative confusion, it was in the public's interest to provide these benefits within approximately the same period as similar benefits were provided to DoD's TRICARE beneficiaries.
The Unfunded Mandates Reform Act requires at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before developing any rule that may result in an expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more in any given year. This rule would have no consequential effect on State, local, or tribal governments.
This final rule will not impose additional information collection requirements on the public under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3511).
The Secretary hereby certifies that this regulatory amendment will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act (RFA), 5 U.S.C. 601-612. Based on a more recent projection, the number of potential beneficiaries over age 65 has increased from 89,500 as estimated in the interim final rule to approximately 135,209 potential beneficiaries that will use the benefit of coverage secondary to Medicare. The interim final rule estimates of approximately 2,000 beneficiaries impacted by the inclusion of school-required physical examination benefit and approximately 2,500 families benefiting from the reduction of the catastrophic cap remain unchanged. Since these beneficiaries are widely geographically diverse, the health care provided to them would not have a significant impact on any small businesses. Therefore, pursuant to 5 U.S.C. 605(b), this amendment is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.
There are no Catalog of Federal Domestic Assistance program numbers for the programs affected by this document.
Administrative practice and procedure, Alcohol abuse, Alcoholism, Claims, Day care, Dental health, Drug abuse, Foreign relations, Government contracts, Grant programs-health, Grant programs-veterans, Health care, Health facilities, Health professions, Health records, Homeless, Medical and dental schools, Medical devices, Medical research, Mental health programs, Nursing homes, Philippines, Reporting and recordkeeping requirements, Scholarships and fellowships, Travel and transportation expenses, Veterans.
Environmental Protection Agency (EPA).
Direct final rule.
On September 26, 2001, the State of Washington requested EPA to redesignate the Yakima “not classified” carbon monoxide (CO) nonattainment area to attainment for the CO National Ambient Air Quality Standard (NAAQS) and submitted a CO maintenance plan for Yakima. In this action, EPA is approving the maintenance plan and redesignating the Yakima CO nonattainment area to attainment.
This direct final rule will be effective December 31, 2002, unless EPA receives adverse comments by December 2, 2002. If relevant adverse comments are received, EPA will publish a timely withdrawal of the direct final rule in the
Written comments may be mailed to: Steve Body, State and Tribal Programs Unit, Office of Air Quality, EPA Region 10, 1200 Sixth Avenue, Seattle, WA 98101.
Copies of the documents relevant to this action are available for public inspection during normal business hours at the United States Environmental Protection Agency, Region 10, Office of Air Quality, 1200 Sixth Avenue, Seattle WA.
Steve Body, State and Tribal Programs Unit, Office of Air Quality, EPA Region 10, 1200 Sixth Avenue, Seattle WA, Telephone number: (206) 553-0782.
EPA is redesignating the Yakima “not classified” CO nonattainment area from nonattainment to attainment and approving the maintenance plan that will keep the area in attainment for the next 10 years.
EPA originally designated the Yakima area as nonattainment for CO under the provisions of the 1977 Clean Air Act (CAA) Amendments (see 43 FR 8962, March 3, 1978). On November 15, 1990, the Clean Air Act Amendments of 1990 were enacted (Pub. L. 101-549, 104 Stat. 2399, codified at 42 U.S.C. 7401-7671q). Under section 107(d)(1)(C) of the CAA, the Yakima area was designated nonattainment for CO by operation of law because the area had been designated as nonattainment before November 15, 1990. The Yakima area is classified as an unclassified, or “not classified” CO nonattainment area.
Nonattainment areas can be redesignated to attainment after the area has measured air quality data showing it has attained the NAAQS and when certain planning requirements are met. Section 107(d)(3)(E) of the CAA provides the requirements for redesignation. These are:
(i) The Administrator determines that the area has attained the national ambient air quality standard;
(ii) The Administrator has fully approved the applicable implementation plan for the area under section 110(k) of the Act;
(iii) The Administrator determines that the improvement in air quality is due to permanent and enforceable reductions in emissions resulting from implementation of the applicable implementation plan, applicable Federal air pollution control regulations, and other permanent and enforceable reductions;
(iv) The Administrator has fully approved a maintenance plan for the area as meeting the requirements of CAA section 175A; and,
(v) The State containing the area has met all requirements applicable to the area under section 110 and part D of the CAA.
Before an area can be redesignated to attainment, all applicable State Implementation Plan (SIP) elements must be fully approved.
The CAA requires States to follow certain procedural requirements for submitting SIP revisions to EPA. Section 110(a)(2) of the CAA requires that each SIP revision be adopted by the State after reasonable notice and public hearing. The State then submits the SIP revision to EPA for approval.
The Yakima Regional Clean Air Authority (YRCAA), which has regulatory authority for sources of air pollution in the Yakima CO nonattainment area, developed the CO maintenance plan. They released the draft maintenance plan for public review on August 21, 2000. On February 14, 2001, the Board of Directors for the YRCAA adopted the
EPA has reviewed the State's maintenance plan and redesignation request and is approving the maintenance plan and redesignating the area to attainment consistent with the requirements of CAA section 107(d)(3)(E). The following is a summary of EPAs evaluation and a description of how each requirement is met.
Section 107(d)(3)(E)(i) requires that the Administrator determine that the area has attained the applicable NAAQS. The primary NAAQS for CO is 9 parts per million (10 milligrams per cubic meter) for an 8-hour average, not to be exceeded more than once per year. CO in the ambient air is measured by a reference method based on 40 CFR part 50, Appendix C. EPA considers an area as attaining the CO NAAQS when all of the CO monitors in the area have one or less exceedance of the CO standard each calendar year over a two calendar year period. (See 40 CFR 50.8 and 40 CFR part 50, Appendix C.) EPA's interpretation of this requirement is that an area seeking redesignation to attainment must show attainment of the CO NAAQS for at least two consecutive calendar years (September 4, 1992, John Calcagni policy memorandum “Procedures for Processing Requests to Redesignate Areas to Attainment” (“Calcagni Memorandum”)). In addition, the area must continue to show attainment through the date that EPA promulgates redesignation to attainment.
Washington's CO redesignation request for the Yakima area is based on valid ambient air quality data. Ambient air quality monitoring data for calendar years 1988 through 2001 show a measured exceedance rate of the CO NAAQS of 1.0 or less per year at all monitoring sites. These data were collected and analyzed as required by EPA (see 40 CFR 50.8 and 40 CFR part 50, Appendix C) and have been stored in EPA's Aerometric Information and Retrieval System (AIRS). These data have met minimum quality assurance requirements and have been certified by the State as being valid before being included in AIRS. Further information on CO monitoring is presented in Section 2.3 and 2.4 of the Yakima maintenance plan. EPA has analyzed the ambient air quality data and determined that the Yakima area has not violated the CO standard since January 1988 and continues to attain through 2001.
Section 107(d)(3)(E)(v) requires that an area must meet all applicable requirements under section 110 and part D of the CAA. EPA interprets this requirement to mean the State must meet all requirements that applied to the area prior to, or at the time of, the submission of a complete redesignation request.
On May 31, 1972, EPA approved the original Washington SIP as meeting the requirements of section 110(a)(2) of the CAA (see 37 FR 10900). Although section 110 of the CAA was amended in 1990, the changes to the implementation plan requirements of section 110(a)(2) were not substantial. Thus, EPA has determined that the SIP revisions
The Yakima area was originally designated as nonattainment for CO on March 3, 1978 (see 43 FR 8962). On May 20, 1983, (48 FR 22716) EPA approved an extension of the attainment date to December 31, 1982. Washington's original CAA Part D plan for the Yakima CO nonattainment area was submitted and approved by EPA on June 5, 1980.
Prior to the 1990 CAA Amendments, EPA had begun development of its post-1987 policy for carbon monoxide; however, EPA did not finalize the post-1987 policy for CO because the Clean Air Act (CAA) was amended on November 15, 1990. Under section 107(d)(1)(C) of the CAA, the Yakima area was by operation of law designated nonattainment for CO because the area had been previously designated nonattainment before November 15, 1990. In the November 6, 1991,
Before the Yakima “not classified” CO nonattainment area may be redesignated to attainment, the State must have fulfilled the applicable requirements of part D. Under part D, an area's classification indicates the requirements to which it will be subject. Subpart 1 of part D sets forth the basic nonattainment requirements applicable to all nonattainment areas, whether classified or nonclassifiable.
The relevant Subpart 1 requirements are contained in sections 172(c) and 176. The April 16, 1992, General Preamble for the Implementation of Title I of the Clean Air Act Amendments of 1990 (see 57 FR 13498) (“General Preamble of April 16, 1992”) provides EPAs interpretation of the CAA requirements for not classified CO areas (see specifically 57 FR 13535). The General Preamble reads, “Although it seems clear that the CO-specific requirements of subpart 3 of part D do not apply to CO “not classified” areas, the 1990 CAAA are silent as to how the requirements of subpart 1 of part D, which contains general SIP planning requirements for all designated nonattainment areas, should be interpreted for such CO areas. Nevertheless, because these areas are designated nonattainment, some aspects of subpart 1 necessarily apply.”
Under section 172(b), the applicable section 172(c) requirements, as determined by the Administrator, were due no later than three years after an area was designated as nonattainment under section 107(d) of the amended CAA (see 56 FR 56694, November 6, 1991). In the case of the Yakima area, the due date was November 15, 1993. Since the Yakima CO redesignation request and maintenance plan were not submitted by Washington until September 26, 2001, the General Preamble of April 16, 1992, provides that the applicable requirements of CAA section 172 are: 172(c)(3) (emissions inventory), 172(c)(5)(new source review permitting program), and 172(c)(7)(the section 110(a)(2) air quality monitoring requirements)). See 57 FR 13535, April 16, 1992.
EPA has determined that the Part D requirements for Reasonably Available Control Measures (RACM), an attainment demonstration, reasonable further progress (RFP), and contingency measures (CAA section 172(c)(9)) are not applicable to “not classified” CO nonattainment areas. See 57 FR 13535, April 16, 1992. EPA has also interpreted the requirements of sections 172(c)(1) (reasonably available control measures—RACM), 172(c)(2) (reasonable further progress—RFP), 172(c)(6) (other measures), and 172(c)(9) (contingency measures) as being irrelevant to a redesignation request because they only have meaning for an area that is not attaining the standard. See the General Preamble of April 16, 1992, and the Calcagni Memorandum. Finally, the State has not sought to exercise the options that would trigger sections 172(c)(4) (identification of certain emissions increases) and 172(c)(8) (equivalent techniques). Thus, these provisions are also not relevant to this redesignation request.
Section 176 of the CAA contains requirements related to conformity. Although federal regulations (see 40 CFR 51.396) require that states adopt transportation conformity provisions in their SIPs for areas designated nonattainment or that are subject to a federally approved maintenance plan, EPA has decided that a transportation conformity SIP is not an applicable requirement for purposes of evaluating a redesignation request under section 107(d) of the CAA. This decision is reflected in the 1996 approval of the Boston carbon monoxide redesignation. (See 61 FR 2918, January 30, 1996.)
The remaining applicable requirements of CAA section 172 are discussed below.
Section 172(c)(3) of the CAA requires a comprehensive, accurate, current inventory of all actual emissions from all sources in the Yakima CO nonattainment area. The emission inventory requirement for “not classified” CO nonattainment areas is detailed in the General Preamble of April 16, 1992. EPA has determined that an emissions inventory is required by CAA section 172(c)(3) regardless of air quality levels. An emissions inventory must be included as a revision to the SIP and was due three years from the time of the area's designation. For “not classified” CO areas, this date is November 15, 1993. To address the section 172(c)(3) requirement for a “current” inventory, EPA interpreted “current” to mean calendar year 1990 (see 57 FR 13502, April 16, 1992).
On March 4, 1994, Washington submitted a 1992 emission inventory for the Yakima CO nonattainment area. EPA deferred action on that inventory pending submittal of a maintenance plan. A 1996 emission inventory was prepared by YRCAA but it was never submitted to EPA. A new 1999 emission inventory was prepared for the CO maintenance plan. EPA believes this 1999 inventory meets the emission inventory obligation. EPA has reviewed the emission inventory and determined it is current, accurate, and comprehensive at the time and it continues to represent emissions in the area that provide for attainment with a 1998-1999 design value of 5.1 ppm CO.
The CAA requires all nonattainment areas to meet several requirements regarding NSR. The State must have an approved NSR program that meets the requirements of section 172(c)(5) of the Act. The State of Washington has an approved NSR program (see 60 FR 28726, June 2, 1995) that is applicable in Yakima CO nonattainment area. The requirements of the Part D, NSR program will be replaced by the Prevention of Significant Deterioration (PSD) program upon the effective date of this redesignation. The Federal PSD regulations found at 40 CFR 52.21 are the PSD rules in effect in Washington.
According to the General Preamble of April 16, 1992, “not classified” CO nonattainment areas should meet the “applicable” air quality monitoring requirements of section 110(a)(2) of the CAA. The State of Washington has operated a CO monitor in the Yakima area since the early 1970's. EPA previously approved the SIP for monitoring on April 15, 1981 (46 FR 21994). This SIP revision does not change that monitoring provision and it remains approved and in effect.
Section 107(d)(3)(E)(ii) of the CAA states that for an area to be redesignated to attainment, it must be determined that the Administrator has fully approved the applicable implementation plan for the area under section 110(k).
Based on the approval into the SIP of provisions under the pre-1990 CAA, EPA's prior approval of a SIP revision required under the 1990 amendments to the CAA, and it's approval of the State's commitment to maintain an adequate monitoring network, EPA has determined that, as of the date of this action, Washington has a fully approved CO SIP under section 110(k) for the Yakima CO nonattainment area.
Section 107(d)(3)(E)(iii) of the CAA provides that for an area to be redesignated to attainment, the Administrator must determine that the improvement in air quality is due to permanent and enforceable reductions in emissions resulting from implementation of the applicable implementation plan, implementation of applicable Federal air pollutant control regulations, and other permanent and enforceable reductions.
The CO emissions reductions for the Yakima area were achieved through a number of control measures. The primary emission reductions are the result of the Federal Motor Vehicle Emission Standards and fleet turnover. These reductions will continue into the maintenance period for the Yakima area. In addition, there is a State requirement for commute trip reduction within the city of Yakima. The Yakima CO nonattainment area is a geographic area contained within the City boundary. This measure covers six employers in the nonattainment area and six additional employers within the City of Yakima, but outside the nonattainment area. And lastly there are three local measures that reduce CO emissions in the area: control of outdoor and agricultural burning, prohibition of installation of uncertified wood stoves, and wood stove curtailment program. While these local control measures are aimed at controlling particulate matter emissions, they concurrently reduce CO emissions especially during wintertime inversion conditions that are conducive to both PM and CO pollutant build-up. These local control measures have previously been approved by EPA in the PM-10 SIP for Yakima.
EPA has evaluated the various State and Federal control measures, and the 1999 emission inventory, and have concluded that the improvement in air quality in the Yakima nonattainment area has resulted from emission reductions that are permanent and enforceable.
Section 107(d)(3)(E)(iv) of the CAA provides that for an area to be redesignated to attainment, the Administrator must have fully approved a maintenance plan for the area meeting the requirements of section 175A of the CAA.
Section 175A of the CAA sets forth the elements of a maintenance plan for areas seeking redesignation from nonattainment to attainment. For areas such as Yakima that are utilizing EPA's limited maintenance plan approach, as detailed in the EPA guidance memorandum, “Limited Maintenance Plan Option for Nonclassifiable CO Nonattainment Areas” from Joseph Paisie, Group Leader, Integrated Policy and Strategies Group, Office of Air Quality and Planning Standards, dated October 6, 1995 (“Paisie Memorandum”), the maintenance plan demonstration requirement is considered to be satisfied for “not classified” areas if the monitoring data show the design value is at or below 7.65 ppm, or 85% of the level of the 8 hour CO NAAQS. The design value must be based on the 8 consecutive quarters of data. There is no requirement to project emissions or air quality over the maintenance period. EPA believes if the area begins the maintenance period at, or below, 85 percent of the level of the CO 8 hour NAAQS, the applicability of PSD requirements, the control measures already in the SIP, and Federal measures, should provide adequate assurance of maintenance over the initial 10-year maintenance period. In addition, the design value for the area must continue to be at or below 7.65 ppm until the time of final EPA action on the redesignation. The method for calculating the design value is presented in the June 18, 1990, EPA guidance memorandum entitled “Ozone and Carbon Monoxide Design Value Calculations”, from William G. Laxton, Director of the OAQPS Technical Support Division, to Regional Air Directors (hereafter referred to as the “Laxton Memorandum”.)
In the case of a “not classified” area applying for a limited maintenance plan, all the monitors must have a separate design value calculated and the highest design value must be at or below 7.65 ppm. Should the design value for the area exceed 7.65 ppm prior to final EPA action on the redesignation, then the area no longer qualifies for the limited maintenance plan and must instead submit a full maintenance plan as described in the Calcagni Memorandum.
Eight years after redesignation to attainment, the State must submit a revised maintenance plan that demonstrates continued maintenance of the CO NAAQS for an additional 10 years following the initial ten-year maintenance period. To address the possibility of future NAAQS violations, the maintenance plan must contain contingency measures, with a schedule for adoption and implementation, that are adequate to assure prompt correction of a violation. In this direct final rulemaking action, EPA is approving the limited maintenance plan for the Yakima nonattainment area because EPA has determined, as detailed below, that the State's maintenance plan submittal meets the requirements of section 175A of the CAA.
The analysis of the pertinent maintenance plan requirements follows:
The plan must contain an attainment year emissions inventory to identify the level of emissions in the area which is sufficient to attain the CO NAAQS. This inventory is to be consistent with EPA's most recent guidance on emissions inventories for nonattainment areas available at the time
As described in the October 6, 1995, limited maintenance plan guidance memorandum (Paisie Memorandum), the maintenance plan demonstration requirement is considered to be satisfied for “not classified” CO areas if the design value for the area is equal to, or less than 7.65 ppm. The CO design value for 1998-1999 period for the Yakima area is 5.1 ppm, which is below the limited maintenance plan requirement of 7.65 ppm. Therefore, the Yakima area has adequately demonstrated that it will maintain the CO NAAQS into the future.
Continued ambient monitoring of an area is required over the maintenance period. Sections 5.3 and 5.4 of the Yakima CO maintenance plan provide for continued ambient monitoring in the area.
Section 175A(d) of the CAA requires that a maintenance plan include contingency provisions. As discussed above, this requirement is not relevant to the redesignation request, but a contingency measure has been included in the plan. The plan contains a measure that requires the City of Yakima to change the timing of intersection stop lights in the downtown core to increase the speed of traffic on the heavily traveled streets. The change in speed is estimated to be from an average of 14 mph to 16 mph resulting in a 17% reduction in CO emissions. The City will adjust the stop light timing to achieve the reductions when CO levels reach 7.1 ppm and levels continue to increase.
Because Yakima submitted a limited maintenance plan, special conformity provisions apply. The transportation conformity rule (58 FR 62188; November 24, 1993) and the general conformity rule (58 FR 63214; November 30, 1993) apply to nonattainment areas and maintenance areas operating under maintenance plans. Under either rule, one means of demonstrating conformity of Federal actions is to indicate that expected emissions from planned actions are consistent with the emissions budget for the area. Emissions budgets in limited maintenance plan areas may be treated as essentially not constraining for the length of the initial maintenance period because there is no reason to expect that such an area will experience so much growth in that period that a violation of the CO NAAQS would result. In other words, emissions need not be capped for the maintenance period. Therefore, in areas with approved limited maintenance plans, Federal actions requiring conformity determination under the transportation conformity rule could be considered to satisfy the “budget test” required in sections 93.118, 93.119, and 93.120 of the rule. Similarly, in these areas, Federal actions subject to the general conformity rule could be considered to satisfy the “budget test” specified in section 93.158(a)(5)(i)(A) of the rule.”
EPA approves the maintenance plan and request to redesignate the Yakima CO nonattainment area to attainment.
EPA is publishing this action without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comments. However, in the proposed rules section of this
If EPA receives such comments, then EPA will publish a timely withdrawal of the direct final rule informing the public that the rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. The EPA will not institute a second comment period on this rule. Any parties interested in commenting on this rule should do so at this time. If no such comments are received, the public is advised that this rule will be effective on December 31, 2002 and no further action will be taken on the proposed rule.
Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.
In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 31, 2002. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Air pollution control, Carbon Monoxide, Intergovernmental relations, Reporting and recordkeeping requirements.
Air pollution control, National parks, Wilderness areas.
42 U.S.C. 7401
(a) Carbon Monoxide.
(1) Yakima.
(i) EPA approves as a revision to the Washington State Implementation Plan, the Yakima Carbon Monoxide maintenance plan submitted by the State on August 31, 2001.
(ii) [Reserved]
(2) Spokane. [Reserved]
(b) Lead. [Reserved]
(c) Nitrogen Dioxide. [Reserved]
(d) Ozone. [Reserved]
(e) Particulate Matter. [Reserved]
(f) Sulfur dioxide. [Reserved]
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes a tolerance for combined residues of thiamethoxam and its metabolite in or on corn forage, corn stover and popcorn, corn grain and sweet corn (kernal and cob with husk removed). Syngenta Crop Protection, Inc. requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA) , as amended by the Food Quality Protection Act of 1996 (FQPA).
This regulation is effective November 1, 2002. Objections and requests for hearings, identified by docket ID number OPP-2002-0298, must be received on or before December 31, 2002.
Written objections and hearing requests may be submitted electronically, by mail, or through hand delivery/courier. Follow the detailed instructions as provided in Unit VI. of the
Dani Daniel, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; telephone number: 703 305-5409; e-mail address: daniel.dani@epa.gov.
You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:
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 the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the 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 http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. 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. Once in the system, select “search,” then key in the appropriate docket ID number.
In the
The petition requested that 40 CFR 180.565 be amended by establishing tolerances for combined residues of the insecticide thiamethoxam, 3-[(2-chloro-5-thiazolyl)methyl] tetrahydro-5-methyl-
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of the FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....”
EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of
Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for a tolerance for combined residues of thiamethoxam and its metabolite on field corn forage at 0.10 parts per million (ppm), sweet corn forage at 0.10 ppm, popcorn forage at 0.10 ppm, field corn stover at 0.05 ppm, sweet corn stover at 0.05 ppm, field corn grain at 0.07 ppm popcorn grain at 0.02 ppm, and sweet corn (kernal and cob with husk removed) at 0.02 parts per million (ppm). EPA's assessment of exposures and risks associated with establishing the tolerance follows.
EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by thiamethoxam are discussed in Table 1 of this unit as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies reviewed.
The dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences.
For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factors (SF) is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA SF.
For non-dietary risk assessments (other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.
The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x 10
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Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide chemicals that have been measured in food. If EPA relies on such information, EPA must require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. Following the initial data submission, EPA is authorized to require similar data on a time frame it deems appropriate. As required by section 408(b)(2)(E) of the FFDCA, EPA will issue a data call-in for information relating to anticipated residues to be submitted no later than 5 years from the date of issuance of this tolerance.
Section 408(b)(2)(F) of the FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings: Condition 1, that the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and Condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408(b)(2)(F) of the FFDCA, EPA may require registrants to submit data on PCT.
The Agency used percent crop treated (PCT) information as follows in Table 3.
Since the May 23, 2001 Final Rule establishing tolerances for thiamethoxam, the Agency has updated the percent crop-treated value for apples. The registrant is voluntarily restricting use of thiamethoxam on apples to only three states, Michigan, New York and Pennsylvania. These three states account for 28% of the U.S. apple production (122,000 out of 430,200 bearing acres). After consultation with experts in the field, EPA believes that no more than 10% of the apple acreage in these states will be treated with thiamethoxam. Thus, using a percent crop-treated value of 5% for the U.S. apple acreage is expected to be an over-estimate of the acres which will actually be treated with thiamethoxam.
The Agency used 6% CT for field corn since this is the percent crop-treated value for the market leader. Sweet corn exposure estimates, which currently make up the bulk of the exposure for the cereal grains, assume 100% crop treated.
As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and regional populations.
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The Agency uses the Generic Estimated Environmental Concentration (GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS) to estimate pesticide concentrations in surface water and SCI-GROW, which predicts pesticide concentrations in groundwater. In general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS (a tier 2 model) for a screening-level assessment for surface water. The GENEEC model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. GENEEC incorporates a farm pond scenario, while PRZM/EXAMS incorporate an index reservoir environment in place of the previous pond scenario. The PRZM/EXAMS model includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin.
None of these models include consideration of the impact processing (mixing, dilution, or treatment) of raw
Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations (EECs) from these models to quantify drinking water exposure and risk as a %RfD or %PAD. Instead, drinking water levels of comparison (DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to thiamethoxam they are further discussed in the aggregate risk sections below.
Based on the PRZM/EXAMS and SCI-GROW models the estimated environmental concentrations (EECs) of thiamethoxam for acute exposures are estimated to be 11.4 parts per billion (ppb) for surface water and 1.94 ppb for ground water. The EECs for chronic exposures are estimated to be 0.77 ppb for surface water, and 1.94 ppb for ground water.
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Thiamethoxam is not registered for use on any sites that would result in residential exposure. Although such uses have been requested, they are not being assessed at this time.
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EPA does not have, at this time, available data to determine whether thiamethoxam has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, thiamethoxam does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that thiamethoxam has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).
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b. The significant decrease in alanine amino transferase levels in the companion animal studies and in the dog studies.
c. The mode of action of this chemical in insects (interferes with the nicotinic acetyl choline receptors of the insect's nervous system) thus a developmental neurotoxicity study is required.
d. The transient clinical signs of neurotoxicity in several studies across species.
e. The suggestive evidence of increased quantitative susceptibility in the rat reproduction study, the Agency is retaining the FQPA factor which is l0X.
To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against the model estimates of a pesticide's concentration in water (EECs). DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure (i.e., the PAD) is available for exposure through drinking water [e.g., allowable chronic water exposure (mg/kg/day) = cPAD - (average food + residential exposure)]. This allowable exposure through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by the EPA are used to calculate DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg (child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening-level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and groundwater are less than the calculated DWLOCs, EPA concludes with reasonable certainty that exposures to the pesticide in drinking water (when considered along with other sources of exposure for which EPA has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because EPA considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, EPA will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process.
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5. Aggregate cancer risk for U.S. population. The cancer aggregate dietary risk estimate was calculated, using the Agency's 6% estimated market share for treatment of field corn. The dietary cancer risk from residues in food is 0.9 x 10
The surface water EEC is 0.6 μg/L and the ground water EEC is 1.9 μg/L. Since the ground water value is greater than, the surface water value it will be used for comparison purposes and will protect for any concerns for surface water concentrations. The estimated chronic ground water value for thiamethoxam (1.9 μg/L) is essentially at the DWLOC
The Agency used a screening level model designed to estimate pesticide concentrations in shallow ground water. A number of factors lead EPA to believe that the actual lifetime exposure through drinking water will be less than the DWLOC
a. Thiamethoxam is systemic. EPA's Tier 1 ground water model assumes that all of the product that is applied to the crop is available for runoff. The registrant has submitted data to show that a percentage (15-25%) of the product is absorbed by the plant, resulting in that much less product available to leach into ground water. Although the registrant has submitted data on only 2 crops, beans and cucumbers, it is likely that the total amount of thiamethoxam that is available to leach into ground water is less than the amount EPA uses as an input into its model. Due to limited data on the amount absorbed, EPA is unable to quantify this.
b. Although the Agency model is based on aerobic soil half lives, EPA's risk assessment for cancer estimate is for lifetime exposure. Data indicate the anaerobic aquatic half life for thiamethoxam is shorter than the aerobic soil half life and longer than the aerobic aquatic half life. Although EPA is unable to predict with a high degree of certainty about what happens to thiamethoxam over time in ground water, this does provide some support for an expectation that concentrations in ground water will decline between annual applications.
c. Shallow ground water modeling is not the perfect model for representing all drinking water from ground water sources. It is likely to be an overestimate of most drinking water, which tends to originate from deeper sources. EPA's experience is that the model is reasonably accurate for shallow drinking water, but the Agency believes that it is less accurate for drinking water from deeper sources.
d. The Agency has established conditions of registration for the previous uses which include two prospective ground water studies and a retrospective monitoring study, so that the reasonable certainty of no harm finding will be sustained. Preliminary results have indicated no detections of thiamethoxam in ground water.
e. The cancer risk from the food uses alone is 0.9 x 10
Thus, EPA does not expect that the general population would be exposed to levels exceeding the DWLOC
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Adequate enforcement methodology High Performance Liquid Chromatography using ultra violet or mass spectrometry (HPLC/UV or MS) is available to enforce the tolerance expression. The method may be requested from: Calvin Furlow, PIRIB, IRSD (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: furlow.calvin@epa.gov.
There are no international residue limits for thiamethoxam.
Therefore, the tolerances are established for combined residues of thiamethoxam, 3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-
Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) of the FFDCA provides essentially the same process
You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2002-0298 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before December 31, 2002.
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Mail your written request to: Office of the Hearing Clerk (1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. You may also deliver your request to the Office of the Hearing Clerk in Rm.104, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (703) 603-0061.
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EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
3.
A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).
This final rule establishes a tolerance under section 408(d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled
The Congressional Review Act, 5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticide and pests, Reporting and recordkeeping requirements.
21 U.S.C. 321(q), 346(a) and 371.
(a) * * *
Research and Special Programs Administration (RSPA), DOT.
Final rule; response to appeals.
In this final rule, RSPA is making changes to a final rule published on July 12, 2002, in which RSPA amended the Hazardous Materials Regulations (HMR) to require shippers and carriers to retain a copy of each hazardous material shipping paper, or an electronic image thereof, for a period of 375 days after the date the hazardous material is accepted by a carrier. This final rule responds to five appeals of the July 12, 2002 final rule.
This final rule is effective on November 1, 2002. Voluntary compliance is authorized as of August 12, 2002.
Deborah Boothe of the Office of Hazardous Materials Standards, (202) 366-8553, Research and Special Programs Administration, U.S. Department of Transportation, 400 Seventh Street, SW., Washington, DC 20590.
On July 12, 2002, The Research and Special Programs Administration (RSPA, we) published a final rule under Docket HM-207B (67 FR 46123) amending the Hazardous Materials Regulations (HMR; 49 CFR parts 171-180) to require shippers and carriers to retain a copy of each hazardous material shipping paper, or an electronic image thereof, for a period of 375 days after the date the hazardous material is accepted by a carrier. The July 12, 2002 final rule incorporates into the HMR the requirements in the Federal hazardous material transportation law (Federal hazmat law) to require that, after a hazardous material “is no longer in transportation,” each offeror and carrier of a hazardous material must retain the shipping paper “or electronic image thereof for a period of 1 year to be accessible through their respective principal places of business.” 49 U.S.C. 5110(e), added by Public Law 103-311, Title I, section 115, 108 Stat. 1678 (Aug. 26, 1994). That section also provides that the offeror and carrier “shall, upon request, make the shipping paper available to a Federal, State, or local government agency at reasonable times and locations.”
The July 12, 2002 final rule requires each person who offers or transports a hazardous material in commerce to retain a copy of the shipping paper for 375 days after the date the shipment is accepted by the initial carrier. To facilitate enforcement of this requirement, the final rule requires each
We received five appeals of the July 12, 2002 final rule from the following industry associations involved in the transportation of hazardous materials: (1) American Trucking Associations (ATA), (2) Dangerous Goods Advisory Council (DGAC), (3) Truckload Carriers Association (TCA), (4) National Propane Gas Association (NPGA), and (5) International Vessel Operators Hazardous Materials Association (VOHMA). The appellants raise two major issues of concern, and they request clarification or revision of the final rule to provide for easier compliance. All the appellants expressed concern about the final rule requirement for shipping papers to be made “immediately” available, upon request, to an authorized official. In addition, VOHMA requests us to modify the final rule to permit a date on a bill of lading or waybill to be used as the shipment acceptance date for vessel shipments.
All appellants request that we remove the words “immediately available” in §§ 172.201(e), 174.24(b), 175.30(a)(2), 176.24(b), and 177.817(f), as modified in the July 12, 2002 final rule. Appellants argue that requiring a copy of a shipping paper, or an electronic image thereof, to be made immediately available upon request could be unreasonable and burdensome. Appellants note that we did not define the term “immediately”; thus, appellants expressed concern that enforcement personnel may be unreasonable in the way that they interpret the requirement. DGAC provides a definition for “immediately” as taken from the American Heritage Dictionary of the English Language. According to DGAC, the dictionary definition “states these words ‘* * * imply no delay whatever, as between request and response.’ * * * The word ‘immediately’ does not appear in 49 U.S.C. 5110(e) * * * In fact, its use appears to conflict with the congressional intent for Paragraph 5110(e) * * *” Appellants suggest that 48 hours is a reasonable time frame to provide an authorized official with requested documents for review and inspection. According to appellants, the final rule as written is different from the Federal Motor Carrier Safety Administrations's (FMCSA) definition of a “principal place of business” which allows motor carriers to make records available for inspection at its principal place of business within 48 hours (excluding weekends and holidays). Therefore, they contend that allowing 48 hours as a time frame would more closely resemble the FMCSA regulations in 49 CFR 390.5 concerning the definition of a “principal place of business.”
In response to the appeals, we are revising §§ 172.201(e), 174.24(b), 175.30(a)(2), 176.24(b), and 177.817(f) in this final rule by removing the word “immediately.” Persons subject to the shipping paper retention requirement must make copies available, upon request, “at reasonable times and locations.” This change aligns the language in the regulations with the statutory language establishing the shipping paper retention requirement in § 5110(d) of Federal hazmat law. Generally, we expect that the requested documents will be made available to an inspector some time on the day that he or she is at the inspection site. However, the words “at reasonable times and locations” also take into account the fact that, in some instances, the principal place of business may be in a different time zone. VOHMA notes that “some of the provisions of [the final rule] do not address international business considerations. For cargo originating at a terminal operated by the carrier in the Far East where the shipping documents are maintained in the carriers files as required by the IMDG code, there may be a delay of 12 or more hours due to time zones and international date lines.” VOHMA, therefore, asks us to amend the final rule language to account for differences in time zones.
We do not agree with appellants' suggestion to allow 48 hours for compliance with an authorized official's request for the shipping document copies. As we stated in the preamble to the July 12, 2002 final rule, electronic capabilities such as facsimile machines and email permit companies to transmit copies of shipping papers from shipping locations to a principal place of business very quickly. We also do not believe that appellants have any basis for their fears about unreasonable enforcement of this requirement.
The July 12, 2002 final rule permits rail carriers to use the date on the shipment waybill or bill of lading as the date of acceptance required to be included on shipping papers. VOHMA requests a similar provision for shipments by vessel: “The interlining of freight containers in the intermodal transportation system and similarity in booking and transfer practices should mean that the acceptability of the last modified version of the shipping paper should extend to the water mode as well. The date of the booking for a voyage corresponds to the date of booking for rail carriage and is currently captured in the electronic system.” As we stated in the preamble to the July 12, 2002 final rule, it was not our intention to require shippers and carriers to implement new systems for preparing and dating shipping documentation. Shipping paper retention requirements should be sufficiently flexible to accommodate current transportation practices concerning acceptance dates for shipments. We understand that air carrier systems for completing and transmitting shipping documentation are similar to those for rail and vessel shipments. Therefore, in this final rule, we are revising §§ 172.201, 175.30, and 176.24 to permit use of the date on a waybill, airbill, or bill of lading for the date of acceptance required on a shipping paper.
VOHMA notes that a shipping paper prepared in accordance with the International Maritime Organization's Dangerous Goods Code (IMDG Code) may be used for further transportation within the United States. VOHMA suggests that § 176.24 of the HMR should be modified to reflect the provisions of § 171.12 authorizing transportation of shipments prepared in accordance with the IMDG Code. We agree, and are making the suggested change in this final rule.
This final rule is not considered a significant regulatory action under Executive Order 12866 and was not reviewed by the Office of Management and Budget. This final rule is not considered significant under the regulatory policies and procedures of the Department of Transportation (44 FR 11034).
This final rule implements a statutory requirement that has been in effect since 1994. We do not anticipate any additional costs on offerors and carriers of hazardous materials. Therefore, preparation of a regulatory evaluation is not warranted.
This final rule has been analyzed in accordance with the principles and criteria contained in Executive Order 13132 (“Federalism”). Federal hazardous materials transportation law preempts any State, local, or Indian tribe requirement on the preparation, execution, and use of shipping documents related to hazardous materials that is not substantively the same as this final rule, 49 U.S.C. 5125(b)(1)(B), but this final rule does not have substantial direct effects on the States, the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government. The consultation and funding requirements of Executive Order 13132 do not apply.
Federal hazardous materials transportation law, 49 U.S.C. 5101-5127, contains an express preemption provision (49 U.S.C. 5125(b)) preempting state, local, and Indian tribe requirements that are not substantively the same as Federal requirements on certain subjects. These subjects are:
(1) The designation, description, and classification of hazardous materials;
(2) The packing, repacking, handling, labeling, marking, and placarding of hazardous materials;
(3) The preparation, execution, and use of shipping documents related to hazardous materials and requirements related to the number, contents, and placement of those documents;
(4) The written notification, recording, and reporting of the unintentional release in transportation of hazardous material; or
(5) The design, manufacture, fabrication, marking, maintenance, recondition, repair, or testing of a packaging or container represented, marked, certified, or sold as qualified for use in transporting hazardous material.
This final rule addresses item 3 above and preempts State, local, and Indian tribe requirements not meeting the “substantively the same as” standard. This final rule is necessary to assure that the HMR requirements for retention of shipping papers are consistent with Federal hazardous materials transportation law.
Federal hazardous materials transportation law provides at § 5125(b)(2) that, if DOT issues a regulation concerning any of these subjects, DOT must determine and publish in the
This final rule has been analyzed in accordance with the principles and criteria contained in Executive Order 13175 (“Consultation and Coordination with Indian Tribal Governments”). Because this final rule does not have tribal implications, does not impose substantial direct compliance costs, and is required by statute, the funding and consultation requirements of Executive Order 13175 do not apply.
The Regulatory Flexibility Act (5 U.S.C. 601
This final rule imposes no mandates and thus does not impose unfunded mandates under the Unfunded Mandates Reform Act of 1995.
Under the Paperwork Reduction Act of 1995, no person is required to respond to an information collection unless it displays a valid OMB control number. No new burdens are proposed under this final rule. RSPA has a current information collection approval under OMB No. 2137-0034, “Shipping Papers and Emergency Response Information” which includes the shipping paper retention requirement in the burden estimates.
A regulation identifier number (RIN) is assigned to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. The RIN number contained in the heading of this document can be used to cross-reference this action with the Unified Agenda.
This final rule does not affect packaging or hazard communication requirements for shipments of hazardous materials transported in commerce. We find that there are no significant environmental impacts associated with this final rule.
Hazardous materials transportation, Hazardous waste, Labeling, Markings, Packaging and containers, Reporting and recordkeeping requirements.
Hazardous materials transportation, Radioactive materials, Railroad safety.
Air Carriers, Hazardous materials transportation, Radioactive materials, Reporting and recordkeeping requirements.
Hazardous materials transportation, Maritime carriers, Radioactive materials, Reporting and recordkeeping requirements.
Hazardous materials transportation, Motor carriers, Radioactive materials, Reporting and recordkeeping requirements.
In consideration of the foregoing, we are amending 49 CFR Parts 172, 174, 175, 176, and 177, as follows:
49 U.S.C. 5101-5127; 49 CFR 1.53.
(e) Each person who provides a shipping paper must retain a copy of the shipping paper required by § 172.200(a), or an electronic image thereof, that is accessible at or through its principal place of business and must make the
49 U.S.C. 5101-5127; 49 CFR 1.53.
(b) Each person receiving a shipping paper required by this section must retain a copy or an electronic image thereof, that is accessible at or through its principal place of business and must make the shipping paper available, upon request, to an authorized official of a Federal, State, or local government agency at reasonable times and locations. For a hazardous waste, each shipping paper copy must be retained for three years after the material is accepted by the initial carrier. For all other hazardous materials, each shipping paper copy must be retained for 375 days after the material is accepted by the initial carrier. Each shipping paper copy must include the date of acceptance by the initial carrier. The date on the shipping paper may be the date a shipper notifies the rail carrier that a shipment is ready for transportation, as indicated on the waybill or bill of lading, as an alternative to the date the shipment is picked up, or accepted, by the carrier.
49 U.S.C. 5101-5127; 49 CFR 1.53.
(a) * * *
(1) * * *
(2) Described and certified on a shipping paper prepared in duplicate in accordance with part 172 of this subchapter or as authorized by § 171.11 of this subchapter. Each person receiving a shipping paper required by this section must retain a copy or an electronic image thereof, that is accessible at or through its principal place of business and must make the shipping paper available, upon request, to an authorized official of a federal, state, or local government agency at reasonable times and locations.
For a hazardous waste, each shipping paper copy must be retained for three years after the material is accepted by the initial carrier. For all other hazardous materials, each shipping paper copy must be retained for 375 days after the material is accepted by the carrier. Each shipping paper copy must include the date of acceptance by the carrier. The date on the shipping paper may be the date a shipper notifies the air carrier that a shipment is ready for transportation, as indicated on the airbill or bill of lading, as an alternative to the date the shipment is picked up or accepted by the carrier. Only an initial carrier must receive and retain a copy of the shipper's certification, as required by § 172.204 of this subchapter.
49 U.S.C. 5101-5127; 49 CFR 1.53.
(a) A person may not accept a hazardous material for transportation or transport a hazardous material by vessel unless that person has received a shipping paper prepared in accordance with part 172 of this subchapter, or as authorized by § 171.12 of this subchapter, unless the material is excepted from shipping paper requirements under this subchapter.
(b) Each person receiving a shipping paper required by this section must retain a copy or an electronic image thereof, that is accessible at or through its principal place of business and must make the shipping paper available, upon request, to an authorized official of a Federal, State, or local government agency at reasonable times and locations. For a hazardous waste, each shipping paper copy must be retained for three years after the material is accepted by the initial carrier. For all other hazardous materials, each shipping paper copy must be retained for 375 days after the material is accepted by the carrier. Each shipping paper copy must include the date of acceptance by the carrier. The date on the shipping paper may be the date a shipper presents a booking for carriage with the carrier as an alternative to the date the shipment is picked up, accepted, or loaded on the vessel by the carrier.
49 U.S.C. 5101-5127; 49 CFR 1.53.
(f)
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Closure.
NMFS is closing directed fishing for Pacific cod by vessels using trawl gear in the Bering Sea and Aleutian Islands management area (BSAI). This action is necessary to prevent exceeding the 2002 Pacific halibut bycatch allowance specified for the trawl Pacific cod fishery.
Effective 1200 hrs, Alaska local time (A.l.t.), October 29, 2002, until 2400 hrs, A.l.t., December 31, 2002.
Andrew Smoker, 907-586-7228.
NMFS manages the groundfish fishery in the BSAI exclusive economic zone according to the Fishery Management Plan for the Groundfish Fishery of the Bering Sea and Aleutian Islands Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.
The 2002 halibut bycatch allowance specified for the BSAI trawl Pacific cod fishery, which is defined at § 679.21(e)(3)(iv)(E), is 1,434 metric tons (67 FR 956, January 8, 2002).
In accordance with § 679.21(e)(7)(v), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2002 halibut bycatch allowance specified for the trawl Pacific cod fishery in the BSAI has been caught. Consequently, the Regional Administrator is closing directed fishing for Pacific cod by vessels using trawl gear in the BSAI.
Maximum retainable bycatch amounts may be found in the regulations at § 679.20(e) and (f).
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, finds that the need to immediately implement this action to avoid exceeding the halibut bycatch allowance for the trawl Pacific cod fishery constitutes 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). These procedures are unnecessary and contrary to the public interest because the need to implement these measures in a timely fashion to avoid exceeding the halibut bycatch allowance for the trawl Pacific cod fishery constitutes good cause to find that the effective date of this action cannot be delayed for 30 days. Accordingly, under 5 U.S.C. 553(d)(3), a delay in the effective date is hereby waived.
This action is required by 50 CFR 679.21 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
Agricultural Marketing Service, USDA.
Proposed rule.
The Agricultural Marketing Service (AMS) proposes to increase the hourly fees charged for voluntary Federal meat grading and certification services performed by the Meat Grading and Certification (MGC) Branch. The hourly fees would be adjusted by this action to reflect the increased cost of providing service and to ensure that the MGC Branch operates on a financially self-supporting basis.
Comments must be received on or before December 31, 2002.
Interested persons are invited to submit written comments to Larry R. Meadows, Chief; USDA, AMS, LS, MGC Branch, STOP 0248, Room 2628-S, 1400 Independence Avenue, SW., Washington, DC 20250-0248. Telephone number (202) 720-1246. Comments may also be submitted electronically to
All comments should reference docket number LS-02-06 and note the date and page number of this issue of the
Comments received may be inspected at the above address, between 8 a.m. and 4:30 p.m., e.s.t., Monday through Friday, except legal holidays.
Larry R. Meadows, Chief, MGC Branch, (202) 720-1246.
The Secretary of Agriculture is authorized by the Agricultural Marketing Act of 1946 (AMA), as amended (7 U.S.C. 1621,
AMS regularly reviews its user-fee-financed programs to determine if the fees are adequate. The most recent review determined that the existing fee schedule for the MGC Branch would not generate sufficient revenues to recover operating costs for current and near-term periods while maintaining an adequate reserve balance. The operating loss for fiscal year (FY) 2002 is projected to total $1.6 million. Without a fee increase, the operating loss for FY 2003 is projected to reach $2.9 million. These combined losses will deplete MGC Branch's operating reserve and place the MGC Branch in an unstable financial position that will adversely affect its ability to provide meat grading and certification services.
This proposal is necessary to offset decreased revenue hours and increased program operating expenses incurred since the last fee increase. The MGC Branch has lost revenue due to the implementation of more efficient audit-based and pilot certification programs and the continued consolidation within the livestock and meat industry. Audit-based and pilot certification programs employ fewer personnel and, therefore, generate fewer revenue hours as compared to traditional certification services.
MGC Branch operating expenses have increased due to (1) information system upgrades mandated by changes in information system technology; (2) congressionally mandated salary increases for all Federal Government employees in 2001, 2002, and 2003; (3) inflation of nonsalary operating costs; and (4) accumulated increases in continental United States (CONUS) per diem rates, mileage rates, and office maintenance costs. In the past 9 years, the MGC Branch has made efforts to control operating costs by closing 3 field offices, reducing mid-level supervisory staff by over 50 percent, and reducing the number of support staff by 38 percent. At the same time, the MGC Branch has utilized automated information management systems for data collection, retrieval, and dissemination, applicant billing, and disbursement of employee entitlements. The reduction in field offices, supervisory staff, and support personnel and the increased use of automated systems has enabled the MGC Branch to absorb a substantial portion of the operating costs and minimize hourly fee increases during these years.
Despite these cost reduction efforts and hourly fee increases in 1998 and 2000, the MGC Branch incurred a $657,000 operating loss in FY 2001. Furthermore, AMS projects that without an hourly fee increase, the MGC Branch will lose approximately $8.6 million from FY 2002 through FY 2004 and totally deplete program reserves to the point of deficit operations (
In view of these increased costs, AMS proposes to increase the hourly fees. The base hourly fee for commitment applicants would increase from $45 to $55. A commitment applicant is a user of meat grading and certification services who agrees to pay for five continuous 8 hour days, Monday through Friday between the hours of 6 a.m. and 6 p.m., excluding legal holidays. The base hourly fee for noncommitment applicants would increase from $52 to $64. A noncommitment applicant is a user of meat grading and certification services, who agrees to pay an hourly fee without committing to a certain number of service hours. The premium hourly fee would increase from $57 to $70. The premium hourly fee is charged to
This action has been determined to be not significant for purposes of Executive Order 12866, and has not been reviewed by the Office of Management and Budget.
Pursuant to the requirements set forth in the Regulatory Flexibility Act (5 U.S.C. 601,
AMS, through its MGC Branch, provides voluntary Federal meat grading and certification services to 450 businesses, including 152 livestock slaughterers, 79 facilities that process federally donated products, 74 meat processors, 46 livestock producers and feeders, 28 brokers, 26 organic certifying companies, 25 trade associations, 17 State and Federal entities, and 3 distributors. Seventy-two percent of these businesses qualify as small entities, a company that employs less than 500 employees. Small entities generate approximately 17 percent of the MGC Branch's revenues and are under no obligation to use voluntary Federal meat grading and certification services provided under the authority of the AMA.
Federal meat grading and certification services facilitate the orderly marketing of meat and meat products and enable consumers to obtain the quality of meat they desire. Grading services consist of the evaluation of carcass beef, lamb, pork, veal, and calf for compliance with the grades of the appropriate official U.S. Standard. The MGC Branch grades approximately 21.1 billion pounds of meat each year. Certification services consist of the evaluation of meat and meat products for compliance with specification and contractual requirements. Certification services are regularly used by meat purchasers to ensure that the quality and yields of the products they purchase comply with their stated requirements. The MGC Branch certifies approximately 18.1 billion pounds of meat and meat products each year.
This action would raise the hourly fees charged to users of Federal meat grading and certification services. AMS estimates that this action would provide the MGC Branch an additional $401,000 per month in FY 2003. Since small entities account for 17 percent of MGC Branch revenues, they would pay an average of $212 per month per applicant. This action and the projected increase in revenue hours would increase revenues by $4.8 million per year and replenish operating revenues for the projected losses of $2.6 million in FY 2002 and $2.3 million in FY 2003. Even with this action, the unit cost for MGC Branch service (revenue/total pounds graded and certified) would remain unchanged at approximately $0.0006 per pound.
This action is necessary to offset decreased revenue hours and increased program operating costs incurred since the last fee increase. The MGC Branch has lost revenue due to the implementation of more efficient audit-based and pilot certification programs and the continued consolidation within the livestock and meat industry. Audit-based and pilot certification programs employ fewer personnel and, therefore, generate fewer revenue hours as compared to traditional certification services.
MGC Branch operating expenses have increased due to (1) information system upgrades mandated by the information system technology; (2) congressionally mandated salary increases for all Federal Government employees in 2001, 2002, and 2003; (3) inflation of nonsalary operating costs; and (4) accumulated increases in continental United States (CONUS) per diem rates, mileage rates, and office maintenance costs. Since 1993, the MGC Branch has made efforts to control operating costs by closing 3 field offices, reducing mid-level supervisory staff by over 50 percent, and reducing the number of support staff by 38 percent. At the same time, the MGC Branch has utilized automated information management systems for data collection, retrieval, and dissemination, applicant billing, and disbursement of employee entitlements. The reduction in field offices, supervisory staff and support personnel and the increased use of automated systems has enabled the MGC Branch to absorb a substantial portion of the operating costs and minimize hourly fee increases over the past 9 years.
Despite these cost reduction efforts and hourly fee increases in 1998 and 2000, the MGC Branch incurred a $657,000 operating loss in FY 2001. Furthermore, AMS projects that without an hourly fee increase; the MGC Branch would lose approximately $8.6 million from FY 2002 through FY 2004 and totally deplete program reserves to the point of deficit operations.
In view of these increased costs, AMS proposes to increase the hourly fees for Federal meat grading and certification services. The base hourly fee for commitment applicants would increase from $45 to $55. A commitment applicant is a user of meat grading and certification services who agrees to pay for five continuous 8 hour days, Monday through Friday between the hours of 6 a.m. and 6 p.m., excluding legal holidays. The base hourly fee for noncommitment applicants would increase from $52 to $64. A noncommitment applicant is a user of meat grading and certification services, who agrees to pay an hourly fee without committing to a certain number of service hours. The premium hourly fee would increase from $57 to $70. The premium hourly fee is charged to applicants when meat grading and certification services (1) exceed 8 hours per day, (2) are performed before 6 a.m. and after 6 p.m. Monday through Friday, and (3) any time on Saturday or Sunday, except on legal holidays. The legal holiday fee would increase from $90 to $110 and is charged to applicants for meat grading and certification services provided on legal holidays.
This action has been reviewed under Executive Order 12988, Civil Justice Reform. This action is not intended to have retroactive effect and would not pre-empt any State or local laws, regulations, or policies, unless they present an irreconcilable conflict. There are no administrative procedures which must be exhausted prior to any judicial challenge to the provisions of this rule.
This action would not impose any additional reporting or recordkeeping requirements on users of Federal meat grading and certification services.
Food grades and standards, Food labeling, Meat and meat products.
For the reasons set forth in the preamble, it is proposed that 7 CFR part 54 be amended as follows:
1. The authority citation for 7 CFR part 54 continues to read as follows:
7 U.S.C. 1621-1627.
2. Section 54.27 is amended as follows:
a. In paragraph (a), remove “$52” and add “$64” in its place, remove “$57” and add “$70” in its place, remove “$90” and add “$110” in its place.
b. In paragraph (b), remove “$45” and add “$55” in its place, remove “$57” and add “$70” in its place, remove “$90” and add “$110” in its place.
Agricultural Marketing Service, USDA.
Reopening of the comment period.
Notice is hereby given that the comment period on the establishment of grade and inspection requirements for Walla Walla sweet onions is reopened.
Comments must be received by November 22, 2002.
Interested persons are invited to submit written comments concerning this proposal. Comments must be sent to the Docket Clerk, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20090-0237, Fax: (202) 720-8938, or e-mail:
George Kelhart, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20090-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938.
Small businesses may request information on compliance with this proposed regulation by contacting: Jay Guerber, Marketing Order Information Branch, Fruit and Vegetable Programs, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20090-0237; Telephone: (202) 720-2491, Fax: (202) 720-5698, or e-mail:
A proposed rule was published in the
One comment was received. After evaluating that comment, USDA determined that additional information could clarify certain aspects of the proposal and provide further guidance to USDA in making a final decision on the proposal. The commenter's primary objection with the proposal is that the June 10 date is too early. The commenter stated that inspections should be required on all sweet onions shipped prior to June 15, at the earliest, because, contrary to the proposal's premise, any earlier date would not prevent immature onions from being marketed.
The commenter noted that there were no shipments of Walla Walla sweet onions during the 2002 season prior to June 10, and that this indicates the proposal could be ineffective. Further analysis of the impact the proposed June 10 date would have on early-season immature onion shipments would be useful to the USDA in making a final determination on this matter.
Further, regarding the higher potential cost of inspections to the Committee if a later date were to be used rather than June 10, the commenter suggested some alternatives, including not requiring all sweet onions shipped prior to an established date to be inspected. These alternatives were not discussed by the Committee prior to its submission of the proposed rule and further information regarding such alternatives also would be useful to USDA in making a final determination on this matter.
Although providing an additional period of time for comments would delay the final decision on this proposal, it would not delay the decision so as to negatively affect its effectiveness for the 2003 marketing season. Therefore, before proceeding further on the recommendation to establish grade and inspection requirements, USDA is reopening the comment period to allow the Committee, as well as other interested persons, more time to review the proposed rule and to submit additional information. Accordingly, the period in which to file written comments is reopened until November 22, 2002. This notice is issued pursuant to the Agricultural Marketing Agreement Act of 1937.
7 U.S.C. 601-674.
Nuclear Regulatory Commission.
Proposed rule.
The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its fire protection requirements for nuclear power reactor licensees. The proposed rule would permit reactor licensees to voluntarily adopt a set of fire protection requirements contained in the National Fire Protection
Submit comments by January 15, 2003. Comments received after this date will be considered if it is practical to do so, but the Commission is only able to ensure consideration of comments received on or before this date.
Submit written comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemaking and Adjudications Staff. Written comments may also be hand-delivered to 11555 Rockville Pike, Rockville, Maryland, between 7:30 a.m. and 4:15 p.m. on Federal workdays.
Documents related to this rulemaking may be examined and copied for a fee at the NRC's Public Document Room (PDR), One White Flint North, 11555 Rockville Pike (first floor), Rockville, Maryland (NFPA standards and copyrighted NFPA 805 may only be examined in the PDR). Copies of NFPA 805 may be purchased from the NFPA Customer Service Department, 1 Batterymarch Park, P.O. Box 9101, Quincy, MA 02269-9101 and in PDF format through the NFPA Online Catalog (
The NRC maintains an Agencywide Documents Access and Management System (ADAMS), which provides text and image files of the agency's public documents. These documents may be accessed through the NRC's Public Electronic Reading Room on the Internet at
Leon E. Whitney, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington DC 20555-0001. Mr. Whitney can also be reached by telephone 301-415-3081, or via email at:
In 1971, the NRC promulgated General Design Criterion (GDC) 3, “Fire protection,” of Appendix A to 10 CFR part 50. Subsequently (largely as a result of the fire at Browns Ferry Nuclear Plant in 1975), the NRC developed specific guidance for implementing GDC 3, as provided in Branch Technical Position (BTP) Auxiliary Power Conversion Systems Branch (APCSB) 9.5-1, “Guidelines for Fire Protection for Nuclear Power Plants,” dated May 1, 1976, and Appendix A to BTP APCSB 9.5-1, “Guidelines for Fire Protection for Nuclear Power Plants Docketed Prior to July 1, 1976,” dated February 24, 1977. In the late 1970s, the NRC worked with licensees to establish configurations that meet this guidance, reaching closure on most issues. However, to resolve the remaining contested issues, the NRC published the final fire protection rule (10 CFR 50.48, “Fire Protection”) and Appendix R to 10 CFR part 50 on November 10, 1980 (45 FR 76602).
Light water reactor licensees are currently required to have fire protection programs that comply with 10 CFR 50.48 and Criterion 3 of Appendix A to 10 CFR part 50 (GDC 3). A fire protection program that satisfies Criterion 3 is required for all operating nuclear power plants by 10 CFR 50.48(a). Criterion 3—“Fire protection,” requires that structures, systems, and components (SSCs) important to safety shall be designed and located to minimize, consistent with other safety requirements, the probability and effects of fires and explosions. Further it requires that fire detection and fighting systems of appropriate capacity and capability be provided and designed to minimize the adverse effects of fires on SSCs important to safety. These fire protection requirements are deterministic.
As stated in 10 CFR 50.48(b)(1), with the exception of Sections III.G, III.J, and III.O of Appendix R, nuclear power plants that were licensed to operate before January 1, 1979, are exempt from the requirements of Appendix R to 10 CFR part 50, to the extent that features meeting the provisions of Appendix A to Branch Technical Position (BTP) APCSB 9.5-1 had been accepted by the NRC staff. These reactor plants otherwise must meet 10 CFR 50, Appendix R, as well as any requirements contained in plant specific fire protection license conditions and/or technical specifications. Nuclear power plants that were licensed to operate after January 1, 1979, must comply with 10 CFR 50.48(a) as well as any plant-specific fire protection license conditions and/or technical specifications. Their fire protection license conditions typically reference Safety Evaluation Reports (SERs) generated by the NRC as the product of initial licensing reviews against either Appendix A to BTP APCSB 9.5-1 and the criteria of certain sections of 10 CFR 50, Appendix R, or against NUREG 0800, the NRC's Standard Review Plan (SRP) for fire protection (which closely follows the structure of 10 CFR 50, Appendix R).
The NRC has issued approximately 900 exemptions from the technical requirements specified in Appendix R. These exemptions were granted to licensees that submitted a technical evaluation demonstrating that an alternative fire protection approach satisfied the underlying safety purpose of Appendix R. During the initial implementation period for “Pre-1979 Appendix R plants,” the NRC granted exemptions under the provisions of 10 CFR 50.48(c)(6), which has since been deleted. For exemptions requested by “Pre-1979” plants after the licensee's initial Appendix R implementation period, the NRC has conducted its reviews in accordance with the provisions specified in 10 CFR 50.12 “Specific exemptions.” “Post-1979” plants have also requested and, when deemed acceptable by the staff, received approval to deviate from their licensing requirements. The processing of exemption and deviation requests has placed a significant burden on the resources of the NRC and the nuclear industry.
Industry representatives and some members of the public have described the current deterministic fire protection requirements as “prescriptive” and an “unnecessary regulatory burden.” Beginning in the late 1990s, the Commission provided the NRC staff with guidance for identifying and
In SECY-00-0009 dated January 13, 2000, the NRC staff requested and received Commission approval for proceeding with a rulemaking to permit reactor licensees to adopt NFPA 805 as a voluntary alternative to existing fire protection requirements. On February 24, 2000, in a Staff Requirements Memorandum (SRM) titled “Rulemaking Plan, Reactor Fire Protection Risk-Informed, Performance-Based Rulemaking,” the Commission directed the staff to proceed with this rulemaking.
The NFPA Standards Council approved 2001 Edition of NFPA 805 as a performance-based American National Standard for light water nuclear power plants, effective February 9, 2001. The NRC cooperatively participated in the development of NFPA 805. The standard specifies the minimum fire protection requirements for existing light water nuclear power plants during all modes (“phases” in NFPA 805) of plant operation, including, shutdown, degraded conditions, and decommissioning.
The Nuclear Energy Institute (NEI) expressed support for the rulemaking in a letter dated September 13, 2001. The staff prepared a memorandum, dated October 9, 2001, informing the Commission that the staff had revised the rulemaking plan such that the staff would submit the proposed rule revision to the Commission by July 2002, and the final rule revision 12 months after the NRC published the proposed rule revision for public comment. Additionally, the staff informed the Commission that it was pursuing development of the implementation guidance to be endorsed by a regulatory guide. NEI is currently developing this guidance.
On December 20, 2001 (66 FR 65661), the NRC published in the
The comment period on the draft rule language ended on February 4, 2002. In response to the
An NRC staff member pointed out that the draft rule language inadvertently overlooked an entire class of licensees (i.e., the so-called “post January 1, 1979 licensees”). The NRC agrees with this comment and has corrected this oversight in the proposed rule by including this class of licensee.
The Nuclear Energy Institute (NEI) disagreed with a proposed NRC exception to NFPA 805 which would not endorse the italicized exception contained in Section 3.3.5.3 of NFPA 805. This italicized exception had the effect of permitting existing electrical cable which does not comply with a flame propagation test acceptable to the NRC to remain as is. Compliance with an electrical cable flame propagation test has been in NRC guidance since 1981 (NUREG 0800, the NRC's Standard Review Plan or SRP). The largest single contributor to combustible fire loading in most areas of a nuclear power plant is electrical cable insulation in open cable trays. This was demonstrated by the cable fire at Brown's Ferry in 1975. The electrical cable insulation safety hazard in nuclear power plants should be mitigated by successful completion of a cable insulation fire propagation test (or the application of a fire retardant coating or the installation of fixed, automatic fire suppression, as stated in the rule language). Therefore, the NRC cannot endorse the italicized exception contained in Section 3.3.5.3 of NFPA 805.
NEI submitted a number of other specific comments, which were endorsed as a group by the Tennessee Valley Authority (TVA), none of which resulted in the NRC choosing to make changes to the draft rule language. These comments regarded: (1) Appropriate radiological limits for fire suppression activities; (2) licensee freedom to establish secondary fire protected safe shutdown paths; (3) the standing of “docketed licensing-basis information” within Chapter 3 of NFPA 805; (4) the need for the NFPA 805 Section 3.5.4 seismic/Class 1E emergency power buses fire pump requirements; (5) the need for seismically designed fire hose station standpipes in lieu of a plan for manual fire capabilities following an earthquake (see Section 3.6.4 of the standard); (6) the degree of flexibility in the deterministic 3-hour fire area boundary rating requirement of Section 4.2.3.2 of NFPA 805; (7) the use of recovery actions within the deterministic approach of the standard.
An industry consultant commented that the NRC should endorse, as part of the rulemaking, NFPA 805, Appendix B, “Nuclear Safety Analysis,” and its post-fire safe shutdown circuit analysis methodology for use by licensees in meeting the standard. Appendix B is now endorsed as discussed in section II below.
Another comment from an industry consultant stated that the rule should permit licensees to adopt only those NFPA 805 requirements that relate to post-fire safe shutdown, without meeting NFPA 805 requirements related to combustible/ignition control, and detection and suppression. This comment did not result in the NRC choosing to make any changes to the draft rule language.
The NRC has conducted a review of the technical requirements contained in NFPA 805, related to nuclear safety and radiological release, and has concluded that NFPA 805, taken as a whole, provides an acceptable alternative for satisfying General Design Criterion 3 (GDC 3) of Appendix A to 10 CFR Part 50. The standard contains a number of changes to the character of fire protection features when compared to current fire protection requirements (
To determine that NFPA 805 contains the elements of an acceptable fire protection program, the NRC uses Regulatory Guide 1.189, “Fire Protection for Operating Nuclear Power Plants”. Section C, “Regulatory Position,” contains a description of the eight elements of an acceptable fire
1. The delineation of organization, staffing, and responsibilities.
Section 3.2.2 of the standard defines the management authorities and responsibilities and establishes the general policy for the fire protection program. This section adequately meets the intent of this element in RG 1.189.
2. A fire hazards analysis sufficient to perform safe shutdown functions and minimize radioactive material releases in the event of a fire.
Within the standard, nuclear safety goals and performance criteria are defined in Chapter 1. Section 2.4.2 defines the methodology for performing a nuclear safety capability assessment necessary to meet these goals and criteria. The criteria in the standard is adequate to meet the intent of this element of RG 1.189.
3. The limitation of damage to structures, systems, and components important to safety so that the capability to safely shut down the reactor is ensured.
Within the standard, Chapters 4 & 5 establish the methodologies to determine the fire protection elements needed to limit fire damage and protect structures, systems, and components important to safety. The criteria in the standard is adequate to meet the intent of this element of RG 1.189.
4. Evaluation of fire test reports and fire data to ensure they are appropriate and adequate for ensuring compliance with regulatory requirements.
Section 3.11.2 establishes fire test qualifications for fire barriers to be in accordance with NFPA 251, Standard Methods for Tests of Fire Endurance of Building Construction and Materials or E-119, Standard Test Methods for Fire Tests of Building Construction and Materials. These standards are adequate and meet the intent of this element in RG 1.189.
5. Evaluation of compensatory measures for interim use for adequacy and appropriate length of use.
The standard has an adequate definition of compensatory actions and requires procedures to be established to accomplish these compensatory actions and limit the duration, Sections 1.6.8 and 3.2.3(2) respectfully. The criteria in the standard is adequate to meet the intent of this element of RG 1.189.
6. Training and qualification of fire protection personnel appropriate for their level of responsibility.
Section 2.7.3.4 discusses the qualification of personnel who apply engineering analysis and numerical models. Section 3.4 discusses the training and qualifications of the fire brigade and those plant personnel who will respond to a fire. The criteria in the standard is adequate to meet the intent of this element of RG 1.189.
7. Quality assurance.
Throughout the standard and in particular, Section 2.7, discusses the requirements for program documentation, configuration control, and quality. The NRC considers the standard adequate to meet the quality assurance guidance in RG 1.189.
8. Control of fire protection program changes.
Chapter 2 discusses plant change evaluations and configuration control of design basis documents. These sections will assist in maintaining compliance with the fire protection regulatory requirements and are adequate to meet the change control guidance in RG 1.189.
For these reasons, the NRC believes that NFPA 805 adequately provides requirements to meet the elements of an acceptable fire protection program.
The overall approach of NFPA 805 is consistent with the key principles for evaluating licensing basis changes, as described in NRC Regulatory Guide (RG) 1.174. Namely, the proposed change is consistent with defense-in-depth philosophy, maintains sufficient safety margins, and when the proposed change results in an increase in core damage frequency (CDF) or risk, the increase is small and consistent with the intent of the Commission's Safety Goal Policy Statement. In Section 2.2.9 of the standard, objective criteria for plant change evaluations are set forth: “a risk-informed plant change evaluation shall be performed and the results used * * * to ensure that the public risk associated with fire-induced nuclear fuel damage accidents is low and that adequate defense-in-depth and safety margins are maintained. Therefore, the concepts and processes in NFPA 805 comprise a risk-informed, integrated, performance-based decision making process for evaluating plant changes related to fire protection systems and features. In accordance with 10 CFR 50.59(c)(4), because NFPA 805 contains its own change control process, reactor plant changes conducted under NFPA 805 therefore will not be subject to the requirements of 10 CFR 50.59.
As stated in Section 2.4.4 of NFPA 805, the Standard's general methodology requires that the plant change evaluation process must consist of an integrated assessment of the acceptability of change in risk, defense-in-depth, and safety margins. This approach requires engineering evaluations to assess the adequacy of the fire protection elements (
The NFPA 805 approach also includes requirements, Section 2.4.3, for the application of acceptable codes and standards to assess the calculated margin between designed and qualified fire protection features versus specified nuclear safety and radioactive release performance criteria, as well as provisions for evaluating acceptable change in risk in terms of small increases in Core Damage Frequency (CDF) and Large Early Release Frequency (LERF) based on risk acceptance guidelines, as presented in NRC Regulatory Guide 1.174.
Chapters 1 and 2 of NFPA 805 specify performance criteria, nuclear safety objectives, and radioactive release performance criteria; provide flexibility for the program, processes, and analytical approach; and ensure that a performance failure will not result in an immediate safety concern (through application of the fire protection defense-in-depth philosophy and the assurance of adequate safety margins). Potential performance failures are assessed in advance to ensure that the licensee is capable of detecting the performance failure, and that adequate time is available to take the needed corrective actions upon detection.
NFPA 805 achieves the risk principles of the Commission's PRA Policy Statement (60 FR 42622) in the following manner:
NFPA 805 Appendices B, C, and D providing methodologies for nuclear safety analysis (which includes post-fire safe shutdown circuit analysis), fire modeling, and PSA methods respectively, are state-of-the-art analytical approaches representing a consensus of members of a diverse national standards committee (the NFPA Technical Committee on Fire Protection for Nuclear Facilities).
The NFPA 805 deterministic approach (Section 4.2.3) was derived from existing NRC deterministic requirements.
In Section 4.2.4.1.5 of NFPA 805, the alternative NFPA performance-based approach includes the requirement that “the effectiveness of fire protection systems and features shall demonstrate that the circuits and components required to achieve the nuclear safety performance criteria are maintained free of fire damage.” Combined with the deterministic requirements of Section 3.3.1.2 (Control of Combustible Materials) and Section 3.3.1.3 (Control of Ignition Sources), Sections 3.4 (Industrial Fire Brigade), 3.5 (Water Supply), 3.6 (Standpipe and Hose Stations), 3.7 (Fire Extinguishers), 3.8 (Fire Alarm and Detection Systems), 3.9 (Automatic and Manual Water-based Fire Suppression Systems), 3.10 (Gaseous Fire Suppression Systems) and 3.11 (Passive Fire Protection Features), and the Nuclear Safety Goal, Objective and Performance Criteria of Chapter 1 of NFPA 805, NFPA strongly supports the NRC's traditional fire protection defense-in-depth and nuclear safety defense-in-depth philosophies.
The performance-based approach of NFPA 805 (Section 4.2.4) would utilize the concepts of: Damage threshold; minimum damage threshold; fire scenario for the fire area under consideration; and sufficient margin between the maximum expected fire scenario and the limiting fire scenario in the context of protection of required nuclear safety success paths. These performance-based approach concepts reduce the conservatisms associated with the current largely deterministic reactor plant fire protection requirements, license commitments and NRC staff practices.
Section 2.7.1.1 of NFPA 805 says: “The analyses performed to demonstrate compliance with this standard shall be documented for each nuclear power plant (NPP). The intent of the documentation is that the assumptions be clearly defined and that the results be easily understood, that results be clearly and consistently described, and that sufficient detail be provided to allow future review of the entire analyses. Documentation shall be maintained for the life of the plant and be organized carefully so that it can be checked for adequacy or accuracy either by an independent reviewer or by the AHJ [authority having jurisdiction].”
Section 2.7.2 of NFPA 805 addresses configuration control, and Section 2.7.3 addresses the quality of the calculational or numerical models, the appropriateness of their application, and the qualifications of the personnel who apply them.
Therefore, there would be a well-founded expectation that licensee NFPA 805 analyses would be readily available for review by the NRC or independent reviewers supporting licensee quality assurance activities.
As a voluntary regulation, the proposed rule does not represent a new generic requirement on nuclear power plant licensees, and could be considered to not be bound by PRA Policy Statement 4. However, the following two qualitative safety goals and two supporting quantitative objectives would be met by licensees meeting Section 1.3.1 of NFPA 805 (Nuclear Safety Goal) and Section 1.3.2 of NFPA 805 (Radioactive Release Goal), and their supporting NFPA 805 nuclear and radioactive release objectives and performance criteria.
The NRC's two qualitative safety goals are: (1) Individual members of the public should be provided a level of protection from the consequences of nuclear power plant operation such that individuals bear no significant additional risk to life and health, and (2) Societal risks to life and health from nuclear power plant operation should be comparable to or less than the risks of generating electricity by viable competing technologies and should not be a significant addition to other societal risks.
Two quantitative objectives are used in determining achievement of the above safety goals: (1) The risk to an average individual in the vicinity of a nuclear power plant of prompt facilities that might result from reactor accidents should not exceed one-tenth of one percent (0.1 percent) of the sum of prompt fatality risks resulting from other accidents to which members of the U.S. population are generally exposed, and (2) The risk to the population in the area near a nuclear power plant of cancer fatalities that might result from nuclear power plant operation should not exceed one-tenth of one percent (0.1 percent) of the sum of cancer fatality risks resulting from all other causes.
As an outgrowth of the Commission's PRA Policy Statement, the NRC has embarked upon an effort to risk-inform 10 CFR Part 50. In SECY-99-264 (later endorsed in a Staff Requirements Memorandum (SRM) dated February 3, 2000) the NRC staff informed the Commission that it would conduct its work applying the set of safety principles established in Regulatory Guide (RG) 1.174. The NRC staff stated that it expects that changes to requirements would be consistent with the defense-in-depth philosophy, would maintain sufficient safety margins, would be performance-based to the extent possible, and would result in safety improvements or only small increases in risk, and would reduce any unnecessary burden. The NRC staff also stated that their approach would also ensure that adequate protection continues to be maintained. These considerations are addressed individually below:
The NRC has considered the regulatory practicality of the proposed rule. The areas considered are as follows:
The proposed rule would add a new Paragraph (c) to 10 CFR 50.48. Paragraph (c) would permit reactor licensees to voluntarily adopt NFPA 805, with certain exceptions stated in the rule language, as an alternative set of fire protection requirements for the operation and/or decommissioning of light-water reactors. NFPA 805, when and if adopted by licensees, would constitute an acceptable means for operating reactors to comply with 10 CFR 50.48(a), and would be an alternative to meeting their existing fire protection requirements, and for decommissioning reactors would be an acceptable method for meeting 10 CFR 50.48(f).
Appendices B, C, and D of NFPA 805 constitute methodologies for conducting nuclear safety circuit analyses, nuclear power plant fire hazard modeling, and fire probabilistic safety assessments, respectively. At a number of locations within the standard appendices are referred to as “acceptable methods,” and at other locations within the standard the reader is directed to them for “considerations when performing analyses.” Although each of the three appendices begins with a disclaimer in the form “Appendix (letter B, C or D) is not a part of the requirements of this NFPA document but is included for informational purposes only,” the methodologies contained therein are nevertheless considered by the NRC to be “specified in NFPA 805” within the meaning of section (c)(4) of the proposed rule language, and therefore their use by licensees need not be
The Life Safety Goal and Plant Damage/Business Interruption Objectives of NFPA 805 are not within the regulatory charter of the NRC (see the Energy Reorganization Act of 1974) and, therefore, the NRC does not endorse them.
This paragraph does not accept the use of a high-pressure charging/injection pump coupled with the pressurizer PORVs as the sole fire protected shutdown path for maintaining reactor coolant inventory, pressure control, and decay heat removal capability (
This paragraph makes clear that licensees need not prepare uncertainty analyses when conducting deterministic analyses under Section 2.2.6 and Chapter 4 of NFPA 805.
In lieu of installing cables meeting flame propagation tests as required by Section 3.3.5.3 of the standard, a flame retardant coating may be applied to the electric cables, or alternatively an automatic fixed fire suppression system may be installed. Either alternative would establish an equivalent level of fire protection to that provided by the presence of flame propagation test compliant cables. The italicized exception to Section 3.3.5.3 is not endorsed.
Electrical flame propagation test compliance has been in NRC guidance since 1981 (NUREG 0800, the NRC's Standard Review Plan or SRP). The NRC is unaware of any licensees which are using electrical cable which does not comply with flame propagation tests where an alternate means of protection (
The italicized exception to Section 3.6.4 is not endorsed.
This paragraph would not allow a standpipe/hose station system in place of seismically qualified standpipes and hose stations unless previously approved in the licensing basis. Seismically qualified standpipes and hose stations have been in NRC guidance since 1976 (Appendix A to Branch Technical Position (BTP) APCSB 9.5-1. The NRC is unaware of any licensees using a non-seismically qualified standpipe/hose station system in place of a seismically qualified standpipe/hose station system. Accordingly, the NRC does not expect any licensee to be adversely affected by this proposed exception.
The use of the term “Authority Having Jurisdiction” (AHJ) within the standard, for the purposes of this rulemaking, means the U.S. Nuclear Regulatory Commission.
For purposes of transitioning to NFPA 805, the NRC expects that licensees will be able to treat existing reactor plant fire protection elements as “previously approved” for the purposes of the Chapter 3 delineation of fundamental program elements. This approach would normally be acceptable because licensees should either be in compliance with regulatory requirements or should have obtained approval from the NRC for exemptions or deviations from those requirements. Fire protection elements that have not been previously reviewed and approved would continue to be subject to normal NRC inspection and enforcement.
Section 50.48(c)(3)(i). A licensee may maintain a fire protection program that complies with NFPA 805 as an alternative to complying with paragraph (b) of this section for plants licensed to operate before January 1, 1979; or the fire protection license conditions for plants licensed to operate after January 1, 1979. The licensee shall submit a request to comply with NFPA 805 in the form of an application for license amendment under § 50.90. The application must identify any orders and license conditions that must be revised or superseded, and contain any necessary revisions to the plant's technical specifications and the bases thereof. The Director of the Office of Nuclear Reactor Regulation, or a designee of the Director, may approve the application if the Director or designee determines that the licensee has identified orders, license conditions, and the technical specifications that must be revised or superseded, and that any necessary revisions are adequate. Any approval by the Director or the designee of the Director shall be in the form of a license amendment approving the use of NFPA 805 together with any necessary revisions to the technical specifications.
This paragraph of the proposed rule language would allow licensees to adopt NFPA 805 as an acceptable means of meeting the fire protection program and GDC 3 requirements of 10 CFR 50.48(a). This section also describes the methods by which the licensees will submit their requests to adopt NFPA 805. If the NRC approves a licensee's request to use NFPA 805, the Director of NRR (or a designee of the Director) will issue a license amendment that: (1) removes superseded license conditions, and (2) includes a license condition imposing the use of NFPA 805. In addition, the NRC will issue an order revoking unnecessary and superseded exemptions and orders.
Licensees who are approved under paragraph (c)(3)(i) to use NFPA 805 are permitted to later return to compliance with paragraph (b) and their previous licensing basis. However, each licensee must comply with all applicable requirements, including submitting an application for a license amendment, and, as applicable, a request for exemption if the licensee wishes to reinstate a revoked exemption.
Section 50.48(c)(3)(ii). The licensee shall complete its implementation of the methodology in Chapter 2 of NFPA 805 (including all required evaluations and analyses) and, upon completion, modify the fire protection plan required by paragraph (a) of this section to reflect the licensee's decision to comply with NFPA 805, before changing its fire protection program or nuclear power plant as permitted by NFPA 805.
This section of the proposed rule language requires licensees to complete all of the NFPA 805 evaluations and analyses, and also modify their fire protection plan to indicate that they are adopting NFPA 805 as an alternative set of fire protection requirements. This is to ensure that the changeover to an NFPA 805 configuration is conducted in a complete, controlled, integrated, and organized manner. This also ensures that the NRC reactor oversight (inspection) process can effectively identify and monitor the changeover. This requirement of the proposed rule has the effect of precluding licensees from implementing NFPA 805 on a partial or selective basis (
50.48(c)(4) Alternative Methods and Analytical Approaches. A licensee may submit a request to use alternative methods and analytical approaches, including alternatives to the fundamental fire protection program
This section of the proposed rule language provides licensees with a mechanism to gain plant-specific NRC approval of alternative methods and analytical approaches to those specified in NFPA 805. It allows licensees maximum flexibility to identify and apply new methods of analysis that may be appropriately used within NFPA 805. This approval mechanism is broad enough to allow licensees to apply risk-informed, performance-based methods to establish the (deterministic) fundamental elements of a fire protection program and the minimum design requirements for fire protection systems and features.
Section 50.48(c)(4)(i). Satisfy the goals, performance objectives, and performance criteria specified in NFPA 805 related to nuclear safety and radiological release.
Section 50.48(c)(4)(ii). Maintain safety margins.
Section 50.48(c)(4)(iii). Maintain fire protection defense-in-depth (fire prevention, fire suppression, and post-fire safe shutdown capability).
50.48(f) Licensees that have submitted the certifications required under Section 50.82(a)(1) shall maintain a fire protection program to address the potential for fires that could cause the release or spread of radioactive materials (
This section describes how a licensee choosing to comply with NFPA 805 would conduct a plant-wide review in accordance with the NFPA 805 analytical process (under paragraphs (c)(3)(ii) of the proposed rule). The discussion first addresses the actions of licensees for operating light water reactors, and then addresses the actions of licensees for light water reactors that are undergoing decommissioning.
For a performance-based nuclear safety analysis, the licensee will perform the engineering analyses (
Section 2.7 of the standard has adequate requirements for the retention of licensee NFPA 805 analyses and evaluations so that NRC inspectors may effectively monitor the conduct and effect of licensee fire protection program changes.
B.
Licensees may voluntarily adopt the NFPA 805 standard, and any additional burden associated with adopting the standard will be at their discretion. The NRC anticipates that significant additional analysis, beyond that currently documented by licensees, may be elected by licensees that choose to adopt NFPA 805. The level of effort required for each plant will depend upon the degree to which risk-informed and performance-based approaches have already been adopted for the subject reactor plant (
The current fire protection requirements (10 CFR 50.48) were developed before the NRC or industry had the benefit of probabilistic risk assessments (PRAs) for fires, and before there was a significant body of operating experience. A revised fire protection rule could provide flexibility in achieving adequate fire protection. In addition, as discussed in SECY 96-134, “Options for Pursuing Regulatory Improvement in Fire Protection Regulations for Nuclear Power Plants,” dated June 21, 1996, a revised fire protection rule that would facilitate the use of alternative approaches may reduce the need for exemptions.
As well as seeking public comment on the proposed rule itself, the NRC is also seeking public comment regarding any other alternative consensus standards
The NRC is making the documents identified below available to interested persons through one or more of the following methods, as indicated.
In addition to the addresses previously provided (see
The Presidential memorandum entitled, “Plain Language in Government Writing,” dated June 1, 1998, directed that the Government must write in plain language. This memorandum was published in the
The National Technology Advancement and Transfer Act of 1995, Public Law 104-113, requires that Federal agencies use technical standards that are developed or adopted by voluntary consensus standards bodies, unless the use of such standards is inconsistent with applicable law or otherwise impractical. Under this proposed rule, the NRC would provide holders of operating licenses for nuclear power plants with the option to voluntarily adopt NFPA 805, as excepted, as an alternative set of fire protection requirements. The NRC is not aware of any consensus standard that could be adopted instead of NFPA 805, but will consider using an alternative standard if identified. If an alternative consensus standard is identified, the notifying submittal from the member of the public or industry should explain how it is comparable to, and how it could be used in addition to or instead of, NFPA 805 in the proposed rule.
The Commission has determined under the National Environmental Policy Act of 1969, as amended, and the Commission's regulations in Subpart A of 10 CFR part 51, that this proposed rule, if adopted, would not be a major Federal action significantly affecting the quality of the human environment and, therefore, an environmental impact statement is not required. The NRC determined that there would not be significant radiological or non-radiological impacts. Under NFPA 805, the environment would continue to be adequately protected because the methods used for fire detection, suppression, and mitigation are the same as those used under the existing fire protection requirements. Further there will be no change in the release of radiological or nonradiological effluents to the environment.
This determination is based on an evaluation of the goals, objectives and performance criteria in NFPA 805. These provide for defense-in-depth to control fires; control of plant reactivity, coolant inventory, and pressure; decay heat removal; vital auxiliaries; and process monitoring to minimize radioactive releases. The NRC has determined that the environmental impacts of the proposed action, the no-action alternative, and an alternative in which the NRC would develop its own risk-informed standard, were similar. Further, the NRC determined that the proposed action does not involve the use of any different resources than those considered in the current rule.
The general public should note that the NRC is seeking public participation. Comments on any aspect of the environmental assessment may be submitted to the NRC as indicated under either the
The NRC has sent a copy of the draft environmental assessment and this
This proposed rule contains information collection requirements that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The burden to the public for these information collections is estimated to average four hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the information collection. In addition, there is a one-time estimated burden of 20,000 to 65,000 hours for each licensee, who chooses to use NFPA 805, to complete the required one-time plant-wide re-analysis of the reactor's fire protection systems, equipment, features, and procedures. The U.S. Nuclear Regulatory Commission is seeking public comment on the potential impact of the information collections contained in the proposed rule and on the following issues:
1. Is the proposed information collection necessary for the proper performance of the functions of the NRC, including whether the information will have practical utility?
2. Is the estimate of burden accurate?
3. Is there a way to enhance the quality, utility, and clarity of the information to be collected?
4. How can the burden of the information collection be minimized, including the use of automated collection techniques?
Send comments on any aspect of these proposed information collections, including suggestions for reducing the burden, to the Records Management Branch (T-6 E6), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by Internet electronic mail at
Comments to OMB on the information collections or on the above issues should be submitted by December 2, 2002. Comments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given to comments received after this date.
The NRC may not conduct or sponsor, and a person is not required to respond to, a request for information or an information collection requirement unless the requesting document displays a currently valid OMB control number.
The Commission has prepared a draft regulatory analysis of this proposed regulation. The analysis examines the costs and benefits of the alternatives considered by the Commission. The draft regulatory analysis may be examined and/or copied for a fee at the NRC's Public Document Room, located at One White Flint North, Room 01-F15, 11555 Rockville Pike, Rockville, Maryland.
The Commission requests public comment on the draft regulatory analysis. Comments on the draft analysis may be submitted to the NRC as indicated in either the
As required by the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b), the Commission certifies that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities. This proposed rule would affect only the licensing and operation of nuclear power plants. The companies that own these plants do not fall within the definition of “small entities” found in the Regulatory Flexibility Act or within the size standards established by the NRC in 10 CFR 2.810.
The NRC has determined that a backfit analysis is not required for this proposed rule, because the rule does not involve any provisions that would impose backfits as defined in 10 CFR 50.109(a)(1). The proposed rule will establish voluntary alternative fire protection requirements for licensees with construction permits prior to January 1, 1979 (all existing LWR reactor plants). Licensees may adopt NFPA 805 as an alternative set of fire protection requirements by submitting a license amendment. However, current licensees may continue to comply with existing requirements. Any additional burden incurred by adopting NFPA 805 would be at the licensee's discretion. The proposed rule does not impose any new requirements, and therefore, does not constitute a backfit as defined in 10 CFR 50.109(a)(1).
Antitrust, Classified information, Criminal penalties, Fire protection, Intergovernmental relations, Nuclear power plants and reactors, Radiation protection, Reactor siting criteria, and Reporting and recordkeeping requirements.
For the reasons given in the preamble and under the authority of the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C. 553, the NRC is proposing to adopt the following amendments to 10 CFR Part 50:
Secs. 102, 103, 104, 105, 161, 182, 183, 186, 189, 68 Stat. 936, 938, 948, 953, 954, 955, 956, as amended, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2132, 2133, 2134, 2135, 2201, 2232, 2233, 2239, 2282); secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).
Section 50.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat. 2951, as amended by Pub. L. 102-486, sec. 2902, 106 Stat. 3123 (42 U.S.C. 5851). Section 50.10 also issued under secs. 101, 185, 68 Stat. 936, 955, as amended (42 U.S.C. 2131, 2235); sec. 102, Pub. L. 91-190, 83 Stat. 853 (42 U.S.C. 4332). Sections 50.13, 50.54(dd), and 50.103 also issued under sec. 108, 68 Stat. 939, as amended (42 U.S.C. 2138). Sections 50.23, 50.35, 50.55, and 50.56 also issued under sec. 185, 68 Stat. 955 (42 U.S.C. 2235). Sections 50.33a, 50.55a and Appendix Q also issued under sec. 102, Pub. L. 91-190, 83 Stat. 853 (42 U.S.C. 4332). Sections 50.34 and 50.54 also issued under Pub. L. 97-415, 96 Stat. 2073 (42 U.S.C. 2239). Section 50.78 also issued under sec. 122, 68 Stat. 939 (42 U.S.C. 2152). Sections 50.80-50.81 also issued under sec. 184, 68 Stat. 954, as amended (42 U.S.C. 2234). Appendix F also issued under sec. 187, 68 Stat. 955 (42 U.S.C. 2237).
2. In § 50.48, paragraph (c) is added and paragraph (f) is revised to read as follows:
(c) National Fire Protection Standard NFPA 805—(1) Approval of incorporation by reference. National Fire Protection Association (NFPA) Standard 805, “Performance-Based for Fire Protection for Light Water Reactor Electric Generating Plants, 2001 Edition” (NFPA 805), which is referenced in this section, was approved for incorporation by reference by the Director of the Federal Register. A notice of any changes made to the material incorporated by reference will
(2) Exceptions, modifications, and supplementation of NFPA 805. As used in this section, references to NFPA 805 are to the 2001 Edition, with the following exceptions, modifications, and supplementations:
(i) Life Safety Goal. The Life Safety Goal of Section 1.3.3 is not endorsed.
(ii) Plant Damage/Business Interruption Objectives. The Plant Damage/Business Interruption Objectives of Section 1.3.4 of NFPA 805 are not endorsed.
(iii) Use of feed-and-bleed. In demonstrating compliance with the performance criteria of Sections 1.5.1(b) and (c) of NFPA 805, a high pressure charging/injection pump coupled with the pressurizer power-operated relief valves (PORVs) as the sole fire-protected safe shutdown path for maintaining reactor coolant inventory, pressure control, and decay heat removal capability (
(iv) Uncertainty analysis. An uncertainty analysis performed in accordance with Section 2.7.3.5 is not required to support deterministic approach calculations.
(v) Existing cables. In lieu of installing cables meeting flame propagation tests as required by Section 3.3.5.3 of the standard, a flame retardant coating may be applied to the electric cables, or an automatic fixed fire suppression system may be installed to provide an equivalent level of protection. In addition, the italicized exception to Section 3.3.5.3 is not endorsed.
(vi) Water supply and distribution. The italicized exception to Section 3.6.4 is not endorsed.
(3) Compliance with NFPA 805. (i) A licensee may maintain a fire protection program that complies with NFPA 805 as an alternative to complying with paragraph (b) of this section for plants licensed to operate before January 1, 1979; or the fire protection license conditions for plants licensed to operate after January 1, 1979. The licensee shall submit a request to comply with NFPA 805 in the form of an application for license amendment under § 50.90. The application must identify any orders and license conditions that must be revised or superseded, and contain any necessary revisions to the plant's technical specifications and the bases thereof. The Director of the Office of Nuclear Reactor Regulation, or a designee of the Director, may approve the application if the Director or designee determines that the licensee has identified orders, license conditions, and the technical specifications that must be revised or superseded, and that any necessary revisions are adequate. Any approval by the Director or the designee of the Director shall be in the form of a license amendment approving the use of NFPA 805 together with any necessary revisions to the technical specifications.
(ii) The licensee shall complete its implementation of the methodology in Chapter 2 of NFPA 805 (including all required evaluations and analyses) and, upon completion, modify the fire protection plan required by paragraph (a) of this section to reflect the licensee's decision to comply with NFPA 805, before changing its fire protection program or nuclear power plant as permitted by NFPA 805.
(4) Alternative methods and analytical approaches. A licensee may submit a request to use alternative methods and analytical approaches, including fundamental fire protection program and minimum design requirements identified in Chapter 3 of NFPA 805, in lieu of those methods and approaches specified in NFPA 805. The request must be in the form of an application for license amendment under § 50.90. The Director of the Office of Nuclear Reactor Regulation, or designee of the Director, may approve the application if the Director or designee determines that the alternative methods and analytical approaches:
(i) Satisfy the goals, performance objectives, and performance criteria specified in NFPA 805 related to nuclear safety and radiological release.
(ii) Maintain safety margins.
(iii) Maintain fire protection defense-in-depth (fire prevention, fire suppression, and post-fire safe shutdown capability).
(f) Licensees that have submitted the certifications required under § 50.82(a)(1) shall maintain a fire protection program to address the potential for fires that could cause the release or spread of radioactive materials (
For the U.S. Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Petition for rulemaking; notice of receipt.
The Nuclear Regulatory Commission (NRC) is publishing for public comment a notice of receipt of a petition for rulemaking, dated September 4, 2002, which was filed with the Commission by Lawrence T. Christian, et al. The petition was docketed by the NRC on September 23, 2002, and has been assigned Docket No. PRM-50-79. The petition requests that the NRC amend its regulations regarding offsite emergency plans for nuclear power plants to insure that all day care centers and nursery schools in the vicinity of nuclear power facilities are properly protected in the event of a radiological emergency.
Submit comments by January 15, 2003. Comments received after this date will be considered if it is practical to do so, but assurance of consideration can only be given to comments received on or before this date.
Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings and Adjudications Staff.
Deliver comments to: 11555 Rockville Pike, Rockville, Maryland between 7:30 a.m. and 4:15 p.m. on Federal workdays.
For a copy of the petition, write to Michael T. Lesar, Chief, Rules and Directives Branch, Division of Administrative Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.
You may also provide comments via the NRC's interactive rulemaking website at
The petition and copies of comments received may be inspected, and copied for a fee, at the NRC Public Document Room, (first floor) 11555 Rockville Pike, Rockville, Maryland. These same documents may be accessed via the NRC's Agencywide Documents Access and Management System (ADAMS) on the Internet at
Michael T. Lesar, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Telephone: 301-415-7163 or Toll-free: 1-800-368-5642. E-mail:
The Nuclear Regulatory Commission received a petition for rulemaking dated September 4, 2002, submitted by Lawrence T. Christian, et al. (the petitioners). The petition was docketed by the NRC on September 23, 2002, and assigned Docket No. PRM-50-79.
Lawrence T. Christian submitted a letter and attachments stating the substance of the petition. Mr. Christian identified himself as a resident of the evacuation zone around the Three Mile Island Nuclear Power Station (TMI) and as the father of two preschool-aged children, including a four-year-old daughter who attends a nursery school within eyesight of TMI. Attached to the petition are pages bearing the signatures of over 3,000 public co-signers. Most of the co-petitioners indicated that they were residents of the State of Pennsylvania.
According to the petitioners, there are currently no Federally-mandated requirements specifically designed to protect daycare centers and nursery schools located in the evacuation zones around nuclear power stations. They believe that this regulatory deficiency puts preschool children at risk in the event of a nearby radiological accident and undermines FEMA requirements that offsite plans adequately protect the public health and safety.
The petition states that Mr. Christian became aware of this situation after he contacted several daycare centers and nursery schools in his York County, Pennsylvania, community, and learned that none of them has an adequate emergency evacuation plan in case of a radiological emergency at the nearby TMI plant. Mr. Christian conducted an informal survey of local daycare and nursery school directors, and learned that most of them do not know what to do in case of a radiological emergency. Mr. Christian found that most daycare and nursery school directors in his area:
1. Do not believe that they have been given adequate information or training to handle an evacuation of children in their care during a radiological emergency.
2. Do not have copies of radiological emergency evacuation plans for their localities.
3. Are frequently uncertain or mistaken as to how an evacuation of their own institution would proceed. Some directors assume that parents would pick up their own children; others assume that center or school staff would have to transport the children, but have no clear plan for executing a staff-run evacuation. Some mistakenly believe that York County would provide emergency bus service and relocation centers if an evacuation were necessary.
4. Do not know where children would or should be taken in the event of an emergency evacuation in response to a radiological accident.
5. Do not know whether the children in their charge would be transported in approved child-safety seats during an evacuation.
6. Assume that, if no organized mass transportation were provided for the children in their charge, daycare center and nursery school employees would be required to stay in the workplace until every child had been safely picked up by their parents.
7. Believe that the question of evacuation plans for their institutions needs to be addressed in a systematic way.
The petition states that Mr. Christian reported his findings to the York County Board of Commissioners and the York County Director of Emergency Management, expressing his alarm at this gap in emergency planning. Mr. Christian received responses from the York County Director of Emergency Management and the Executive Director of York County's Department of Emergency Services indicating that Pennsylvania State law did not require licensed daycare centers and nursery schools to plan for radiological emergencies, and that the county did not have the authority to mandate such planning. Mr. Christian was advised by York County emergency management officials to ask municipal government officers in his community for emergency planning assistance concerning local daycare and nursery schools.
According to the petition, municipal government officials advised Mr. Christian to have the director of his daughter's nursery school work with Exelon Corporation, which owns and operates TMI, to develop an evacuation plan for the school. The school director requested Exelon's assistance, but had received no response after 30 days. Moreover, the school director informed Mr. Christian that her institution did not have the resources to arrange for bus or van transportation for students in the event of an emergency, and that, should an accident occur at TMI, the school would have to request that parents pick up their children individually.
The petitioners note that Federal Emergency Management Agency (FEMA) regulations pertaining to Radiological Emergency Readiness Planning (RERP) mandate that emergency offsite plans protect the public health and safety, and they stress that preschool-aged children are members of the public covered by that mandate. The petitioners believe that voluntary, ad hoc emergency evacuation plans that rely on parents to enter an evacuation zone to pick up preschool students during a radiological emergency are inadequate to protect the health and safety of the children at risk. The petitioners claim that Federally-required RERPs already mandate that public and private elementary, middle, junior, and high schools located in evacuation zones around nuclear power plants be provided with designated relocation centers, designated emergency transportation, rosters of emergency bus drivers, and educational materials about radiological emergency procedures. These institutions are also required to undergo state of readiness checks and must be included in local radiological emergency preparedness exercises. The petitioners contend that because no corresponding standard measure of adequate protection currently exists for daycare centers and nursery schools in the vicinity of nuclear power facilities, Federal, state and county emergency plans do not properly take these preschool institutions into account.
The petitioners request that the NRC immediately establish a standard measure of adequate protection by creating new rules requiring that emergency planning for daycare centers and nursery schools located in evacuation zones be included in the offsite emergency plans of all NRC nuclear power facility licensees. The petitioners request that the NRC amend its regulations to insure that all children attending daycare centers and nursery schools within the evacuation zone are:
1. Assigned to designated relocation centers established safely outside the evacuation zone.
2. Provided with designated transportation to relocation centers in the event of an emergency evacuation.
3. Transported in approved child-safety seats that meet State and Federal laws as they pertain to the transportation of children and infants under 50 pounds in weight or 4′9″ in height.
The petitioners also request that the following be mandated by NRC regulations:
4. The creation and maintenance of working rosters of emergency bus drivers and back-up drivers for nursery school and daycare center evacuation vehicles, and the establishment of a system for notifying these individuals in the event of a radiological emergency. These rosters should be regularly checked and updated, with a designated back-up driver listed for each vehicle and route.
5. Notification of emergency management officials by individual preschools as to the details of each institution's radiological emergency plan.
6. Annual site inspections of daycare centers and nursery schools within the evacuation zone by emergency management officials.
7. Participation of daycare centers and nursery schools within the evacuation zone in radiological emergency preparedness exercises designed to determine each institution's state of readiness.
8. Creation of identification cards, school attendance lists, and fingerprint records for all children who are to be transported to a relocation center, to insure no child is left behind or is unable, due to age, to communicate his or her contact information to emergency workers.
9. Development by emergency management officials of educational materials for parents informing them what will happen to their children in case of a radiological emergency, and where their children can be picked up after an emergency evacuation.
10. Stocking of potassium iodide (KI) pills and appropriate educational materials at all daycare centers and nursery schools within the evacuation zone.
11. Radiological emergency preparedness training for all daycare center and nursery school employees within the evacuation zone.
12. Listing of designated relocation centers for daycare centers and nursery schools in area phone directories so that parents can quickly and easily find where their children will be sent in case of a radiological emergency.
13. Establishment of toll-free or 911-type telephone lines to provide information about radiological emergency plans and procedures for daycare centers and nursery schools within the evacuation zone.
14. Creation of written scripts for use by the local emergency public broadcast system that include information about evacuation plans and designated relocation centers for daycare centers and nursery schools.
In support of their request, the petitioners detail their reasons for asking the NRC to change its regulations to include the aforementioned protective measures aimed at securing the health and safety of preschoolers in evacuation zones surrounding nuclear power plants. The petitioners stated reasons for requesting that the NRC amend its rules to mandate these emergency planning measures are as follows:
The petitioners note that FEMA emergency planning regulations require that the health and safety of the general public be protected in the event of a radiological accident at a nuclear power plant. Preschoolers are part of the general population and their well-being must be provided for. The petitioners claim that the designation of emergency relocation centers for all elementary, middle school and high school students is already standard practice, and contend that the establishment of such centers for preschoolers is no less vital. Because the thyroid glands of young children are highly susceptible to damage by exposure to radiation, the petitioners stress that children attending daycare centers and nursery schools in the evacuation zone should be moved to safety as quickly and as efficiently as possible. If parents are forced to backtrack into the evacuation zone to fetch their preschool-aged children and carry them to safety one-by-one, frantic parents will clog evacuation routes. The petitioners conclude that radiological emergency plans should provide for the mass evacuation of children from daycare centers and nursery schools located in the evacuation zone to relocation centers situated at a safe distance from the nuclear power facility.
The petitioners note that most daycare centers and nursery schools currently have no access to public school buses or school bus drivers. If frantic parents must drive personal vehicles into the evacuation zone to pick up their children during a radiological emergency, evacuation routes will be clogged with private cars, the evacuation will be impeded, and the health and well-being of preschool children will not be adequately protected. Therefore, the petitioners conclude that the NRC should require that offsite emergency plans provide for designated busses or vans, manned by designated emergency drivers, to transport children from daycare centers and nursery schools located in the evacuation zone to designated relocation centers.
The petitioners note that newborns and infants cannot safely be placed on a standard bus seat and transported out of the evacuation zone. Unrestrained children could roll or fall off the seats and be injured or killed en route to designated relocation centers. Federal law requires all children under 50 lbs or under the height of 4′9″ to be placed in federally-approved child safety seats when riding in motor vehicles. The use of approved child-safety seats is the only safe and legal way to transport small children. The petitioners conclude that NRC regulations should require that infants and young children being evacuated during a radiological emergency be properly secured in approved child safety seats.
The petitioners maintain that these measures are necessary to insure that daycare centers and nursery schools properly comply with the requested regulations and implement the
The petitioners note that most children under the age of three do not know their parents' legal names, but will simply identify them as “Mommy” or “Daddy”. Preschool children are also typically unable to state their home address or phone number. Young children therefore have no effective means of communicating their parents' names or contact information to teachers, caregivers, or emergency workers. The petitioners conclude that identifying and tracking young children through the use of ID cards, school attendance lists, and fingerprinting is necessary to ensure that no preschool-aged child is left behind in a radiological emergency.
The petitioners contend that such materials are necessary in order to properly inform parents about procedures for evacuating their preschool-aged children from the danger zone in case of a radiological emergency.
The petitioners note that preschool-aged children are particularly susceptible to thyroid damage due to exposure to radiation. Since the ingestion of KI protects against this damage, the petitioners contend that KI should be stocked by daycare centers and nursery schools in the evacuation zone for distribution to the children their charge in case of radiological emergency. However, because parents may be unaware of a young child's allergy to iodine, the petitioners believe that daycare centers and nursery schools should prepare for possible future radiological emergencies by having parents sign release forms giving daycare and nursery school workers standing permission to administer KI to their children, in the proper children's dose, in case of radiological emergency.
The petitioners maintain that radiological emergency preparedness training is necessary to equip employees of daycare centers and nursery schools to properly respond in case of a radiological accident.
The petitioners claim that many parents are not acquainted with, or may not even have access to information about emergency procedures for evacuating their preschool-aged children from the danger zone following a radiological accident. Moreover, even if parents are well-informed, in the event of a radiological emergency, someone other than a parent (
The petitioners believe that, during an emergency, parents might panic if they cannot locate their children and do not have timely information about their movements in the event of an evacuation. The emergency broadcast system could be used to inform parents that their preschool-aged children have left their buildings and are en route to designated relocation centers. The petitioners contend that this will free parents to redirect their efforts toward escaping the danger zone themselves, rather than further exacerbating traffic problems by trying to move back into the evacuation zone to fetch their children from daycare centers or nursery schools. Finally, the petitioners say, the general public should have access to such information during a radiological emergency. The petitioners conclude that the public emergency broadcast system should prepare to disseminate information about the evacuation of daycare centers and nursery schools in the event of a radiological accident.
The petitioners also offer a statement in support of their request which focuses on the specialized evacuation needs of preschool-aged children. They note that very young children are more difficult to safely transport than school-aged children and would require more and different kinds of care from emergency workers. The petition makes the following points in this connection:
1. Most children under the age of three have no effective way of communicating their parents legal names, but identify them only as “Mommy” and “Daddy”.
2. Most children under the age of three cannot tell you their home address or phone number, and therefore have no effective means of communicating their contact information.
3. Infants and newborns are usually unable to walk, so they are completely dependent on others for their safe relocation during an emergency evacuation.
4. Infants and newborns have special dietary and sanitary needs.
5. Infants and newborns can be easily injured if not properly handled, due to the weakness in their young spines and necks.
6. Preschool children must be transported in approved child-safety seats when being evacuated. Young children cannot ride unsecured in bus seats, as they might fall off and be injured or killed.
7. Unlike public school teachers, nursery school teachers and daycare center employees have little or no emergency evacuation training.
8. Infants, newborns, toddlers, and preschoolers are physically and emotionally dependent on adults for their overall well-being. During an emergency, these needs are greatly amplified. Planning and training for, and providing proper supervision of the emergency evacuation of such young children is a therefore a necessity.
9. Very young children have an especially high susceptibility to damage and health risks caused by radiation exposure. Because they are especially vulnerable, children in daycare centers and nursery schools require special protection in a radiological emergency.
The petitioners maintain that without new NRC requirements concerning offsite emergency plans no standard measure of adequate protection will ever exist for daycare centers and nursery schools located within evacuation zones surrounding nuclear power facilities. The petitioners note that a FEMA fact sheet concerning emergency radiological planning states that Federal law mandates that “plans and preparedness must be determined
The petitioners contend that, if the NRC refuses to require the basic protections for preschoolers laid out in the petition, the agency will be perpetuating an improper implementation of FEMA regulations as they pertain to properly protecting the public in the event of a radiological emergency. The petitioners stress that the NRC's principal duty is to safeguard the public, and maintain that, barring the adoption of the provisions requested by the petitioners, the NRC will be guilty of negligence in the fulfillment of its duty.
For the Nuclear Regulatory Commission.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking.
This action proposes to establish Class E airspace at Crisfield Municipal Airport, Crisfield, MD. The development of a Standard Instrument Approach Procedure (SIAP) to serve flights operating into Crisfield Municipal Airport under Instrument Flight Rules (IFR) makes this action necessary. Controlled airspace extending upward from 700 feet Above Ground Level (AGL) is needed to contain aircraft executing the approach. The area would be depicted on aeronautical charts for pilot reference.
Comments must be received on or before December 2, 2002.
Send comments on the proposal in triplicate to: Manager, Airspace Branch, AEA-520, Docket No. 02-AEA-18, FAA Eastern Region, 1 Aviation Plaza, Jamaica, NY, 11434-4809.
The official docket may be examined in the Office of the Regional Counsel, AEA-7, FAA Eastern Region, 1 Aviation Plaza, Jamaica, NY, 11434-4809.
An informal docket may also be examined during normal business hours in the Airspace Branch, AEA-520, FAA Eastern Region, 1 Aviation Plaza, Jamaica, NY, 11434-4809.
Mr. Francis T. Jordan, Jr., Airspace Specialist, Airspace Branch, AEA-520 FAA Eastern Region, 1 Aviation Plaza, Jamaica, NY 11434-4809: telephone: (718) 553-4521.
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, economic, environmental, and energy-related aspects of the proposal. Communications should identify the airspace docket number and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Airspace Docket No. 02-AEA-18”. The postcard will be date/time stamped and returned to the commenter. All communications received on or before the closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this action may be changed in light of comments received. All comments submitted will be available for examination in the Rules Docket closing both before and after the closing date for comments. A report summarizing each substantive public contact with the FAA personnel concerned with this rulemaking will be filed in the docket.
Any person may obtain a copy of this Notice of Proposed Rulemaking (NPRM) by submitting a request to the Office of the Regional Counsel, AEA-7, FAA Eastern Region, 1 Aviation Plaza, Jamaica, NY, 11434-4809. Communications must identify the docket number of this NPRM. Persons interested in being placed on a mailing list for future NPRMs should also request a copy of Advisory Circular No. 11-2A, which describes the application procedure.
The FAA is considering an amendment to Part 71 of the Federal Aviation Regulations (14 CFR Part 71) to establish Class E airspace area at Crisfield, MD. The development of a SIAP to serve flights operating IFR into the airport makes this action necessary. Controlled airspace extending upward from 700 feet AGL is needed to accommodate the SIAP. Class E airspace designations for airspace areas extending upward from 700 feet or more above the surface of the earth are published in Paragraph 6005 of FAA Order 7400.9K, dated August 30, 2002, and effective September 16, 2002, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document would be published subsequently in the Order.
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this proposed regulation—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that would only affect air traffic procedures and air navigation, it is certified that this proposed rule would not have significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR Part 71 as follows:
1. The authority citation for 14 CFR Part 71 continues to read as follows:
49 U.S.C. 106(g), 40103, 40113, 40120; EO 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation Administration Order 7400.9K, Airspace Designations and Reporting Points, dated August 30, 2002 and effective September 16, 2002, is proposed to be amended as follows:
That airspace extending upward from 700 feet above the surface within a 6.0-mile radius of Crisfield Municipal Airport, Crisfield, MD.
Food and Drug Administration, HHS.
Proposed rule; withdrawal.
The Food and Drug Administration (FDA) is announcing the withdrawal of a proposed rule published in the
The proposed rule is withdrawn November 1, 2002.
J. Kenneth Borgerding, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041.
In the
The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) (the Hatch-Waxman Amendments) created section 505(j) of the act (21 U.S.C. 355(j)). The ANDA approval program established by section 505(j) of the act permits a generic version of a previously approved innovator drug to be approved without submission of a full new drug application (NDA). An ANDA references a previously approved drug product (the “listed drug”) and relies on the agency's prior finding of safety and effectiveness for that drug product.
Applicants seeking approval for an NDA must include in their NDA information about patents for the drug that is the subject of the NDA. FDA publishes this patent information as part of the agency's publication “Approved Drug Products with Therapeutic Equivalence Evaluations” (the Orange Book).
Under section 505(j)(2)(A)(vii) of the act, generic drug applicants must include in an ANDA a patent certification for each patent listed in the Orange Book for the listed drug. The applicant must certify to one of the following for each listed patent: (1) That no patent information on the listed drug has been submitted to FDA; (2) that such patent has expired; (3) the date on which such patent will expire; or (4) that such patent is invalid, unenforceable, or will not be infringed by the manufacture, use, or sale of the drug product for which the ANDA is submitted. These certifications are referred to as “paragraph I,” “paragraph II,” “paragraph III,” and “paragraph IV” certifications, respectively. The ANDA applicant must also provide notice of a paragraph IV certification to each owner of the patent that is the subject of the certification and to the holder of the approved NDA to which the ANDA refers.
Section 505(j)(5)(B)(iv) of the act provides an incentive for ANDA applicants to file paragraph IV certifications challenging patents that may be invalid, unenforceable, or not infringed by the drug product that is the subject of the ANDA. In certain circumstances, the first ANDA applicant with a paragraph IV certification is granted 180-day exclusivity. The 180-day exclusivity gives the first ANDA applicant protection from market competition by subsequent generic versions of the same drug product for a 180-day period from either the date the first ANDA applicant begins commercially marketing its drug product or from the date of a court decision holding the patent that is the subject of the paragraph IV certification invalid, unenforceable, or not infringed.
In 1994, FDA issued its final rule implementing the patent and marketing exclusivity provisions of the Hatch-Waxman Amendments. The requirements for 180-day exclusivity are contained in § 314.107(c)(1) (21 CFR 314.107(c)(1)).
In 1998, two appellate courts found that FDA's interpretation of section 505(j)(5)(B)(iv) of the act as expressed in § 314.107(c)(1) was not supported by the act (
Shortly after these decisions, the agency published a guidance for industry entitled “180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal
In the August 1999 proposed rule, the agency described a new approach to implementing the 180-day generic drug exclusivity consistent with the act. The August 1999 proposed rule addressed the issues resulting from the
Since publication of the August 1999 proposed rule, there has been extensive litigation of issues relating to ANDA approvals and 180-day exclusivity. Among these litigated issues was whether 180-day exclusivity would begin to run with the first district or other court decision finding the patent invalid, unenforceable, or not infringed or with a final court decision from which no appeal has been or can be taken.
FDA's interpretation of the words “the court” contained in section 505(j)(5)(B)(iii) of the act was initially challenged and reviewed by the court in
In another case decided after the proposed rule was published, the agency's interpretation of the phrase “a decision of a court” contained in section 505(j)(5)(B)(iv) of the act was successfully challenged in Mylan
In response to the litigation and in an effort to provide guidance to the pharmaceutical industry regarding the timing of approval of ANDAs following an unsuccessful patent infringement action by the NDA holder and the start of 180-day generic drug exclusivity, the agency issued a guidance for industry entitled “Court Decisions, ANDA Approvals, and 180-day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act” (March 2000) (the March 2000 guidance for industry). FDA announced that it would interpret the term “court” as found in section 505(j)(5)(B)(iii)(I) and (j)(5)(B)(iv) of the act to mean the first court that renders a decision finding the patent at issue invalid, unenforceable, or not infringed. FDA also announced that it would apply the new guidance policy prospectively. In the case of a district court decision, FDA may approve the ANDA as of the date the district court enters its decision. Also, for eligible applicants, 180-day exclusivity will begin to run on that date.
After the March 2000 guidance for industry was issued, the agency's interpretation of the meaning of “court decision” was again litigated in a consolidated case,
In the
The opinion of the United States Court of Appeals for the D.C. Circuit in
FDA received several comments on the August 1999 proposed rule. Comments were received from pharmaceutical companies, attorneys, trade associations, generic companies, the Federal Trade Commission, and chemical companies. The comments addressed a wide variety of issues described in the August 1999 proposed rule. Some comments favored and some opposed all or parts of the August 1999 proposed rule.
After careful consideration of the comments on the August 1999 proposed rule and the multiple court decisions affecting the agency's interpretation of the provisions of the act relating to 180-day exclusivity and ANDA approvals, FDA has concluded that it is appropriate to withdraw the August 1999 proposed rule at this time. The agency will continue to regulate directly from the statute and applicable FDA regulations to make 180-day exclusivity decisions on an issue-by-issue basis. The agency will also carefully evaluate possible options for future rulemaking addressing 180-day exclusivity and the timing of ANDA approvals.
Coast Guard, DOT.
Notice of proposed rulemaking.
The Coast Guard proposes to establish moving and fixed security zones around and under all cruise ships that are located in the Port of San Diego. These proposed security zones are needed for national security reasons to protect the public and ports from potential terrorist acts. Entry into these zones will be prohibited, unless specifically authorized by the Captain of the Port San Diego.
Comments and related material must reach the Coast Guard on or before November 29, 2002.
You may mail comments and related material to Coast Guard Marine Safety Office San Diego, 2716 North Harbor Drive, San Diego, California, 92101. The Port Operations Department maintains the public docket for this rulemaking. Comments and material received from the public, as well as documents indicated in this preamble as being available in the docket, will become part of this docket and will be available for inspection or copying at the Port Operations Department, 2716 North Harbor Drive, San Diego, California, 92101, between 8 a.m. and 4 p.m., Monday through Friday, except Federal holidays.
Lieutenant Commander Rick Sorrell, Chief, Port Operations Department, Marine Safety Office San Diego, (619) 683-6495.
We encourage you to participate in this rulemaking by submitting comments and related material. If you do so, please include your name and address, identify the docket number for this rulemaking (COTP San Diego 02-026), indicate the specific section of this document to which each comment applies, and give the reason for each comment. Please submit all comments and related material in an unbound format, no larger than 8
In our final rule, we will include a concise general statement of the comments received and identify any changes from the proposed rule based on the comments. If as we anticipate, we make the final rule effective less than 30 days after publication in the
We do not now plan to hold a public meeting. But you may submit a request for a meeting by writing to Marine Safety Office San Diego at the address under
Since the September 11, 2001, terrorist attacks on the World Trade Center in New York, the Pentagon in Arlington, Virginia, and Flight 93, the Federal Bureau of Investigation (FBI) has issued several warnings concerning the potential for additional terrorist attacks within the United States. In addition, the ongoing hostilities in Afghanistan and growing tensions in Iraq have made it prudent for U.S. ports to be on a higher state of alert because the Al Qaeda organization and other similar organizations have declared an ongoing intention to conduct armed attacks on U.S. interests worldwide.
In its effort to thwart terrorist activity, the Coast Guard has increased safety and security measures on U.S. ports and waterways. As part of the Diplomatic Security and Antiterrorism Act of 1986 (Pub. L. 99-399), Congress amended section 7 of the Ports and Waterways safety Act (PWSA), 33 U.S.C. 1226, to allow the Coast Guard to take actions, including the establishment of security and safety zones, to prevent or respond to acts of terrorism against individuals, vessels, or public or commercial structures. The Coast Guard also has authority to establish security zones pursuant to the Magnuson Act (50 U.S.C. 191
In this particular rulemaking, to address the aforementioned security concerns, and to take steps to prevent the catastrophic impact that a terrorist attack against a cruise ship would have on the public interest, the Coast Guard proposes to establish security zones around and under cruise ships entering, departing, or moored within the port of San Diego. These security zones will help the Coast Guard prevent vessels or persons from engaging in terrorist actions against cruise ships. The Coast Guard believes the establishment of security zones is prudent for cruise ships because they carry multiple passengers.
On November 4, 2001, we issued a rule under docket COTP San Diego 01-022 which was published in the
On June 12, 2002, a change in effective period temporary rule was issued, under docket COTP SD 02-013, and was published in the
Accordingly, this rulemaking proposes to make permanent the temporary security zones established on November 4, 2001, under docket COTP San Diego 01-022, 33 CFR 165.T11-030 published in the
The Coast Guard proposes to establish moving and fixed security zones around all cruise ships that are anchored, moored, or underway within the port of San Diego. These proposed security zones will take effect upon the entry of any cruise ship into the waters within the San Diego sea buoy and will remain into effect until the cruise ship passes the San Diego sea buoy on its departure
These security zones are needed for national security reasons to protect cruise ships, the public, transiting vessels, adjacent waterfront facilities, and the port from potential subversive acts, accidents, or other events of a similar nature. Entry into these zones will be prohibited unless specifically authorized by the Captain of the Port or his designated representative. Vessels already moored when these security zones take effect are not required to get underway to avoid either the moving or fixed zones unless specifically ordered to do so by the Captain of the Port or his designated representative.
This zone will be enforced by the official patrol, (Coast Guard commissioned, warrant or petty officers) onboard Coast Guard vessels and patrol craft. The official patrol may also be onboard patrol craft and resources of any government agency that has agreed to assist the Coast Guard in the performance of its duties. The Captain of the Port will enforce these zones and may request the use of resources and personnel of other government and private agencies to assist in the patrol and enforcement of the regulation. This regulation is proposed under the authority of 33 U.S.C. 1226 in addition to the authority contained in 33 U.S.C. 1231 and 50 U.S.C. 191.
Vessels or persons violating this section will be subject to the penalties set forth in 33 U.S.C. 1232. Pursuant to 33 U.S.C. 1232 and 33 CFR part 27, any violation of the security zone described herein, is punishable by civil penalties (not to exceed $27,500 per violation, where each day of a continuing violation is a separate violation), criminal penalties (imprisonment up to 6 years and a maximum fine of $250,000), and in rem liability against the offending vessel. Any person who violates this section, using a dangerous weapon, or who engages in conduct that causes bodily injury or fear of imminent bodily injury to any officer authorized to enforce this regulation, also faces imprisonment up to 12 years.
Vessels or persons violating this section are also subject to the penalties set forth in 50 U.S.C. 192: seizure and forfeiture of the vessel to the United States; a maximum criminal fine of $10,000; and imprisonment up to 10 years.
This proposed rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Transportation (DOT) (44 FR 11040, February 26, l979).
We expect the economic impact of this proposed rule to be so minimal that a full Regulatory Evaluation under paragraph 10e of the regulatory policies and procedures of DOT is unnecessary.
The effect of this regulation will not be significant due to the minimal time that vessels will be restricted from the area. Also, the zones will encompass only a small portion of the waterway. The Port of San Diego can accommodate only a few cruise ships moored at the same time. Most cruise ship calls at each location occur on only one day each week, and are generally less than 18 hours in duration. Furthermore, vessels will be able to pass safely around the zones, and vessels and people may be allowed to enter these zones on a case-by-case basis with permission of the Captain of the Port.
The sizes of the zones are the minimum necessary to provide adequate protection for the cruise ships, their crews and passengers, other vessels operating in the vicinity of the cruise ships and their crews, adjoining areas, and the public. The entities most likely to be affected are commercial vessels transiting the main ship channel en route the Port of San Diego and pleasure craft engaged in recreational activities and sightseeing. The security zones will prohibit any commercial vessels from meeting or overtaking a cruise ship in the main ship channels, effectively limiting the use of the channel. However, the moving security zones will only be effective during cruise ship transits, which will last for approximately 60 minutes. In addition, vessels are able to safely transit around the zones while a vessel is moored or at anchor in the Port of San Diego.
Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this proposed rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.
The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities. We expect this proposed rule may affect the following entities, some of which may be small entities: The owners and operators of private and commercial vessels intending to transit or anchor in these small portions near the cruise ships covered by these security zones, of the port of San Diego. The impact to these entities would not be significant since these zones are proposed to encompass only small portions of the waterway for limited period of times (while the cruise ships are transiting, moored). Delays, if any, are expected to be less than sixty minutes in duration. Small vessel traffic can pass safely around the area and vessels engaged in recreational activities, sightseeing and commercial fishing have ample space outside of the security zone to engage in these activities. When a cruise ship is at anchor, vessel traffic will have ample room to maneuver around the security zone. The outbound or inbound transit of a cruise ship will last about 60 minutes. Although this regulation prohibits simultaneous use of portions of the channel, this prohibition is of short duration. While a cruise ship is moored, commercial traffic and small recreational traffic will have an opportunity to coordinate movement through the security zone with the patrol commander.
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule so that they can better evaluate its effects on them and participate in the rulemaking. If the proposed rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact
This proposed rule would call for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this proposed rule under that Order and have determined that it does not have implications for federalism.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
This proposed rule would not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This proposed rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this proposed rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and would not create an environmental risk to health or risk to safety that might disproportionately affect children.
This proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. We invite your comments on how this proposed rule might impact tribal governments, even if that impact may not constitute a “tribal implication” under the Order.
We have analyzed this proposed rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.
We have considered the environmental impact of this proposed rule and concluded that, under figure 2-1, paragraph (34)(g), of Commandant Instruction M16475.lD, this rule is categorically excluded from further environmental documentation because we are proposing to establishing a security zone. A “Categorical Exclusion Determination” is available in the docket where indicated under
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 165 as follows:
1. The authority citation for part 165 continues to read as follows:
33 U.S.C. 1231; 50 U.S.C. 191, 33 CFR 1.05-1(g), 6.04-1, 6.04-6 and 160.5; 49 CFR 1.46.
2. Add § 165.1108 to read as follows:
(a)
(b)
(1) All waters, extending from the surface to the sea floor, within a 100 yard radius around any cruise ship that is anchored at a designated anchorage within the San Diego port area inside the sea buoys bounding the port of San Diego.
(2) The shore area and all waters, extending from the surface to the sea floor, within a 100 yard radius around any cruise ship that is moored at any berth within the San Diego port area inside the sea buoys bounding the Port of San Diego; and
(3) All waters, extending from the surface to the sea floor, within a 100 yard radius around any cruise ship that is underway on the waters inside the sea buoys bounding the Port of San Diego.
(c)
(2) Persons desiring to transit the area of the security zone may contact the Captain of the Port at telephone number (619) 683-6495 or on VHF-FM channel 16 (156.8 MHz) to seek permission to transit the area. If permission is granted, all persons and vessels must comply with the instructions of the Captain of the Port or his or her designated representative.
(d)
(e)
Environmental Protection Agency (EPA).
Proposed rule.
On September 26, 2001, the State of Washington submitted a request to redesignate the Yakima “not classified” carbon monoxide (CO) nonattainment area to attainment for the CO National Ambient Air Quality Standard (NAAQS). The State also submitted a CO maintenance plan for Yakima. In this action, EPA is proposing to approve the Yakima CO redesignation request and the maintenance plan. In the Final Rules Section of this
Comments on this proposed rule must be received in writing by December 2, 2002.
Copies of the documents relevant to this action are available for public inspection between 8 a.m. and 4 p.m., Monday through Friday at the following office: United States Environmental Protection Agency, Region 10, Office of Air Quality, 1200 Sixth Ave., Seattle WA 98101.
Steven K. Body, Office of Air Quality, EPA Region10, 1200 Sixth Ave. Seattle WA 98101. Telephone at (206) 553-0782.
For additional information see the direct final rule, of the same title, published in the rules section of this
Research and Special Programs Administration (RSPA), DOT.
Notice of proposed rulemaking; status.
In a notice of proposed rulemaking (NPRM) published on July 3, 2001, RSPA (we) proposed changes to RSPA's Hazardous Materials Incident Report (DOT Form F 5800.1). This notice is to inform the public that we have contracted with a professional form development contractor to provide recommendations for the layout of the form consistent with RSPA's goals outlined in the NPRM. Also, the contractor will provide a web-based form to fulfill RSPA's goal of electronic, internet-based reporting and will draft detailed instructions to assist in completing the forms. Members of the regulated community may be contacted to participate in focus groups to test the proposed form and subsequent alternative layouts developed by the contractor. The contract is expected to be completed by December 31, 2002.
For comments or questions concerning the contract discussed in this update, contact Ron DiGregorio at the Office of Hazardous Materials Planning and Analysis, telephone (202) 366-4484, Research and Special Programs Administration. For comments or questions concerning the NPRM or rulemaking, contact Michael Johnsen at the Office of Hazardous Materials Standards, telephone (202) 366-8553 or Kevin Coburn, at the Office of Hazardous Materials Planning & Analysis, telephone (202) 366-4555, Research and Special Programs Administration.
On July 3, 2001, RSPA (“we”) published an NPRM (66 FR 35155) proposing revisions to the incident reporting requirements of the Hazardous Materials Regulations and the hazardous materials incident report form, DOT Form F 5800.1. Our intent is to improve the clarity of the form to make it more user-friendly and to allow for electronic scanning of the form.
We included a proposed revision to DOT Form F 5800.1 in the NPRM that incorporated elements found in recent versions of the U.S. Census form and other government forms that are subjected to scanning for electronic data storage, retrieval and analysis. We received several comments concerning the layout of the form, which will be addressed in the final rule. However, we believe that the recommendations of a company well experienced in developing these types of forms could further improve the usefulness of the form. The contractor will consider incorporating recommendations on the format from commenters into its suggested layouts. RSPA will review the suggestions submitted by the contractor in addition to comments received in response to the NPRM, during the development of the revised form that will be part of the final rule.
It is important to note that the final content (
RSPA seeks to compile an accurate database of incidents meeting the criteria specified in § 171.16. A form that can be completed easily and accurately will assist us in compiling accurate data and reduce the information collection burden on the regulated community.
A comprehensive set of instructions for completing the form will answer questions a filer may have without requiring the filer to contact us directly. Clear and concise instructions will also improve the accuracy of the data submitted by providing examples and explanations for each of the questions posed on the form.
We believe that a web-based DOT Form F 5800.1 that can be completed online is essential to our efforts for reducing burden on members of the regulated community and obtaining accurate reporting data. It also assists us in meeting our obligations under the Government Paperwork Elimination Act to accept electronic documents for transactions conducted with the public and regulated communities. In addition to reducing paperwork and postage costs, the on-line version of the form will include logic patterns to minimize accidental errors and remove non-required questions, as the form will “respond” to the data entered into it. This will reduce the time required to complete the form.
RSPA retains final authority as to the format and content of the incident report form.
Fish and Wildlife Service, Interior.
Proposed rule; notice of availability of draft economic analysis; reopening of comment period.
We, the U.S. Fish and Wildlife Service (Service), announce the availability of the draft economic analysis for the proposed designation of critical habitat for
We will accept comments on both the draft economic analysis and the proposed critical habitat designation until December 2, 2002.
Written comments and information should be submitted to the Field Supervisor, Sacramento Fish and Wildlife Office, U.S. Fish and Wildlife Service, 2800 Cottage Way, Suite W-2605, Sacramento, CA 95825. For the electronic mail address, and further instructions on commenting, refer to Public Comments Solicited section of this notice.
Glen Tarr, at the address above (telephone 916/414-6600; facsimile 916/414-6710).
We listed both plants as endangered species under the Endangered Species Act of 1973, as amended (Act) (16 U.S.C. 1531
Critical habitat receives protection from destruction or adverse modification through required consultation under section 7 of the Act with regard to actions carried out, funded, or authorized by a Federal agency. Section 4(b)(2) of the Act requires that the Secretary of the Interior shall designate or revise critical habitat based upon the best scientific and commercial data available, after taking into consideration the economic impact of specifying any particular area as critical habitat.
The public comment period for the June 18, 2002, proposal originally closed on August 19, 2002. We have prepared a draft economic analysis on the effects of the proposed critical habitat designation, and are now announcing its availability for review. The draft analysis estimates the foreseeable economic impacts of the critical habitat designation on government agencies and private businesses and individuals. Reopening of the comment period will provide the public an opportunity to evaluate and comment on both the proposed rule and the draft economic analysis. Comments already submitted on the proposed designation of critical habitat for
The final economic analysis concerning the designation of critical habitat for
You may mail or hand-deliver written comments and information to the Field Supervisor, Sacramento Fish and Wildlife Office, U.S. Fish and Wildlife Service, 2800 Cottage Way, Suite W-2605, Sacramento, CA 95825. Hand deliveries must be made during normal business hours.
You may also send comments by electronic mail (e-mail) to:
Hand-delivered or mailed comments and information should be submitted to the Sacramento Fish and Wildlife Office, as found in the
We solicit comments or suggestions from the public, other concerned governmental agencies, tribes, the scientific community, industry, or any other interested parties concerning the proposal or the draft economic analysis. We particularly seek comments concerning:
(1) Plans or potential for development within the area proposed to be designated, notwithstanding the comments of the county employee contacted in preparing the economic analysis;
(2) Plans or potential for conversion of land within the area proposed to be designated to other types of agricultural uses, such as vineyards, which might require a permit under section 404 of the Clean Water Act, or other types of Federal permits;
(3) The likelihood of “stigma effects” and costs associated with the designation; and
(4) The likely effects and resulting costs arising from the California Environmental Quality Act and other State laws as a result of the designation.
Comments and materials received, as well as supporting documentation used in preparation of the proposal to designate critical habitat, will be available for inspection, by appointment, during normal business hours at our office listed in the
The primary author of this notice is Glen Tarr (
The authority for this action is the Endangered Species Act of 1973 (16 U.S.C. 1531
Agricultural Marketing Services, USDA.
Notice.
This Notice invites all States of the United States of America, its territories, the District of Columbia, and the Commonwealth of Puerto Rico (collectively hereinafter called States) to submit a Standard Form 424, Application for Federal Assistance, and to enter into a Cooperative Agreement with the Agricultural Marketing Service for the Allocation of National Organic Certification Cost-Share Funds. The Agricultural Marketing Service (AMS) has allocated $5.0 million for this organic certification cost-share program in Fiscal Year 2002. Funds will be available under this program to all interested States to assist organic producers or organic handlers certified to the National Organic Program. States interested in obtaining cost-share funds for their organic producers or organic handlers will have to submit an Application for Federal Assistance, and will have to enter into a cooperative agreement with AMS for the allocation of such funds.
Completed applications for federal assistance along with signed cooperative agreements must be received by December 31, 2002 in order to participate in the program.
Applications for federal assistance and cooperative agreements shall be requested from and submitted to: Robert Pooler, Marketing Specialist, National Organic Program, USDA/AMS/TMP/NOP, Room 4008-South, Ag Stop 0268, 1400 Independence Avenue, SW., Washington, DC 20250-0264; Telephone: (202) 720-3252; Fax: (202) 205-7808; E-mail:
Robert Pooler, Marketing Specialist, National Organic Program, USDA/AMS/TM/NOP, Room 4008-South, Ag Stop 0268, 1400 Independence Avenue, SW., Washington, DC 20250-0264; Telephone: (202) 720-3252; Fax: (202) 205-7808; E-mail:
This National Organic Certification Cost-Share Program is part of the Farm Security and Rural Investment Act of 2002 (Act) Public Law 107-171, 116 Stat. 134, 7 U.S.C. § 6523. Under this Act, USDA is authorized to provide certification cost share assistance to producers or handlers of organic agricultural products in all States. This National Organic Certification Cost-Share Program provides financial assistance to organic producers or organic handlers of agricultural products in obtaining certification under the National Organic Program authorized under the Organic Foods Production Act of 1990, as amended (7 U.S.C. 6501
Producers who participate in the Organic Certification Cost-Share Program authorized under Section 1524 of the Federal Crop Insurance Act, as amended, (7 U.S.C. 1501-1524) are not eligible to participate in the producer portion of the National Organic Certification Cost-Share Program.
Pub. L. No. 107-171-116 Stat. 134, 7 U.S.C. § 6523.
Food Safety and Inspection Service, USDA.
Notice of public meeting.
The National Advisory Committee on Meat and Poultry Inspection (NACMPI) will hold a public meeting on November 6-7, 2002, to review and discuss three issues: Education and Training of the Field Workforce to Achieve a Public Health Vision, Escherichia coli 0157:H7 Developments, and Procedures for Evaluating State Meat and Poultry Inspection Programs. Three subcommittees of the full committee will also meet on November 6, 2002, to work on the issues discussed during the full Committee session.
The full Committee will hold a public meeting on Wednesday, November 6, and Thursday, November 7, 2002 from 8:30 a.m. to 5 p.m. Subcommittees will hold open meetings on Wednesday, November 6, 2002 from 7 p.m. to 9 p.m. Note: FSIS was not able to publish notification of this public meeting in the
All Committee meetings will take place at the Holiday Inn Capitol at the Smithsonian, located at 550 C Street SW., Washington, DC 20024. The full committee meeting will be held in the “Columbia Ballroom” and Sub-Committee 1 will meet in break out room “Apollo (second floor),” subcommittee 2 will meet in the “Mercury” (second floor), and Subcommittee 3 will meet in the “Mars (first floor).” A meeting agenda is available on the Internet at
Charles L. Gioglio for technical information at (202) 205-0010 and Sonya L. West for meeting information at (202) 720-2561, FAX (202) 205-0157, or e-mail
On January 19, 2001, the Secretary of Agriculture renewed the charter for the NACMPI. The Committee provides advice and recommendations to the Secretary of Agriculture pertaining to the Federal and State meat and poultry inspection programs pursuant to sections 301(a)(4), 7(c), 24, 205, 301(a)(3), and 301(c) of the Federal Meat Inspection Act and sections 5(a)(3), 5(a)(4), 5(c), 8(b), and 11(e) of the Poultry Products Inspection Act. The Administrator of FSIS is the chairperson of the Committee. Membership of the Committee is drawn from representatives of consumer groups; producers, processors, and marketers from the meat and poultry industry; State government officials; and academia. The current members of the NACMPI are: Dr. Gladys Base, Spelman College; Nancy Donley, Safe Tables Our Priority; Sandra Eskin, American Association of Retired Persons; Dr. James Denton, University of Arkansas; Carol Tucker Foreman, Food Policy Institute, Consumer Federation of America; Michael Govro, Oregon Department of Agriculture; Martin Holmes, North American Meat Processors; Dr. Lee C. Jan, Texas Department of Health; Dr. Alice Johnson, National Food Processors Association; Collette Schultz Kaster, Premium Standard Farms; Dr. Daniel E. Lafontaine, South Carolina Meat Poultry Inspection Department; Dr. Irene Leech, Virginia Tech; Charles Link, Cargill Turkey Products; Dr. Catherine Logue, North Dakota State University; Dr. Dale Morse, New York Department of Health; John Neal, Courseys Smoked Meats, and Michael Mamminga, Iowa Department of Agriculture and Land Stewardship.
The Committee has three subcommittees to deliberate on specific issues and make recommendations to the whole Committee.
All interested parties are welcome to attend the meetings and to submit written comments and suggestions concerning issues the Committee will review and discuss.
Members of the public will be required to register before entering the meeting.
Public awareness of all segments of rulemaking and policy development is important. Consequently, in an effort to better ensure that minorities, women, and persons with disabilities are aware of this notice, FSIS will announce it and make copies of this
Forest Service, USDA.
Revised notice of intent to prepare an environmental impact statement.
The Cascade Ranger District of the Boise National Forest will prepare an environmental impact statement (EIS) for a resource management project in the Middle Fork of the Payette River drainage. The project involves 864 acres of timber stand treatment in the 15,881-acre project area, less than a mile of road construction, nearly 3 miles of road reconstruction, and less than a mile of road decommissioning. The entire project area is located within watersheds that drain directly into the Middle Fork of the Payette River or its tributaries. The project area is located 12 miles east of Cascade, Idaho, and about 100 miles north of Boise, Idaho.
Comments concerning the scope of the analysis should be postmarked within 30 days following publication of this announcement in the
Send written comments to Keith Dimmett, Cascade Ranger District, P.O. Box 696, Cascade, ID 83611.
Keith Dimmett, Project Leader, Cascade Ranger District at the address mentioned above or by calling (208)382-7430.
The NFMA planning for this project was initiated in the spring of 2001 with the Upper Middle Fork Payette River Ecosystem Analysis at the Watershed Scale (EAWS). A letter announcing plans to complete the EAWS and soliciting comments was mailed to interested individuals and/or groups in March of 2001.
A notice of intent to prepare an EIS for a similar project in the same location appeared on page 24097 of the
Roughly 70 percent of the project area occurs within one of two inventoried roadless areas (IRA's). A portion of the Peace Rock IRA occupies an estimated 8,947 acres, and a section of the Stony Meadows IRA another 2,357 acres of the project area. A large portion of the project area also occurs within Management Area 43 (Peace Rock). The Proposed Action does not include any management activities within either IRA or within Management Area 43. Instead, management activities associated with the Proposed Action have been confined to the roaded portion of the project area, consisting of roughly 4,302 acres. The Middle Fork Payette River originates within, and runs through the center of the project area. The Forest Plan discloses that that segment of the river from Railroad Pass to the Middle Fork Bridge on the #409 road is potentially eligible for inclusion in the National Wild and Scenic River system as a “wild” river. However, in June of 1991 the Forest Plan corrected to show that this segment of the river is potentially eligible as a “recreational” river.
Two primary objectives have been identified for the project: (1) Reduce current and future stand susceptibility to western spruce budworm, Douglas-fir beetle, and/or mountain pine beetle, and; (2) improve long-term stand growth to or near levels indicative of healthy, sustainable forests.
The Proposed Action would treat an estimated 864 acres in the 15,881 acre project area. Proposed activities would occur within a portion of the 67,637 acre Gold Fork/Clear Creek Management Area 53. An estimated 4.0 MMbf of timber would be harvested using ground-based (683 acres), skyline (24 acres), and helicopter (157 acres) yarding systems. The Proposed Action would employ a variety of silvicultural prescriptions including commercial thin (169 acres), improvement cut/sanitation (427 acres), seed cut shelterwood (92 acres), final removal shelterwood (141 acres), and clearcut with reserve trees (35 acres). The existing transportation system would be improved to facilitate log haul and reduce sedimentation with individual sections of 2.9 miles of road being reconstructed. An estimated 0.7 miles of specified road and 0.2 miles of temporary road would be constructed to facilitate harvest. In addition, 0.9 miles of the #409F road, currently closed year-round would be decommissioned.
One alternative to the Proposed Action, a No Action Alternative, has been discussed thus far. Other alternatives will likely be developed as issues are identified and information received.
Suzanne C. Rainville, Acting Forest Supervisor, Boise National Forest, 1249 South Vinnell Way, Boise, ID 83709.
The Boise National Forest Supervisor will decide the following. Should roads be built and timber harvested within the project area at this time, and if so; where within the project area, and how many miles of road should be built; and which stands should be treated and what silvicultural systems should be used? What design features and/or mitigation measures should be applied to the project? Should the decommissioning of existing roads be implemented at this time?
The agency invites written comments and suggestions on the scope of the analysis. In addition to this notice, a proposed action letter will be sent to interested government officials, agencies, groups, and individuals. No public meetings are currently planned.
Preliminary concerns with the Proposed Action include: (1) Potential impacts on sediment delivery to area streams; (2) potential impacts on bull trout, and; (3) potential impacts on the visual quality of the area.
This notice of intent initiates the scoping process which guides the development of the environmental impact statement. Specific written comments on the proposed action will be most helpful.
A draft environmental impact statement will be prepared for comment. The comment period on the draft environmental impact statement will be 45 days from the date the Environmental Protection Agency publishes the notice of availability in the
The Forest Service believes, at this early stage, it is important to give reviewers notice of several court rulings related to public participation in the environmental review process. First, reviewers of draft environmental impact statements must structure their participation in the environmental review of the proposal so that it is meaningful and alerts an agency to the reviewer's position and contentions.
To assist the Forest Service in identifying and considering issues and concerns on the proposed action, comments on the draft environmental impact statement should be as specific as possible. It is also helpful if comments refer to specific pages or chapters of the draft statement. Comments may also address the adequacy of the draft environmental impact statement or the merits of the alternatives formulated and discussed in the statement. Reviewers may wish to refer to the Council on Environmental Quality Regulations for implementing the procedural provisions of the National Environmental Policy Act at 40 CFR 1503.3 in addressing these points.
Comments received, including the names and addresses of those who comment, will be considered part of the public record on this proposal and will be available for public inspection.
Forest Service, USDA.
Notice of intent to prepare an environmental impact statement.
The USDA, Forest Service will prepare an environmental impact statement (EIS) on a proposal to assist the recovery of areas burned in 2002 by the Toolbox Complex Fires (includes Toolbox Fire, Silver Fire and small portion of Winter Fire). This will include proposals to salvage burned timber, implement re-forestation and implement projects to alleviate the potential for future damage to riparian and aquatic resources as a result of the Toolbox Complex Fires. The 48,000 acre project area is located on the Silver Lake Ranger District and is centered approximately 13 miles south of Silver Lake, Oregon, within the Silver Creek, Silver Lake and Summer Lake Watersheds.
Comments concerning the scope of the analysis must be received by December 2, 2002.
Send written comments to Carolyn Wisdom, District Ranger, Silver Lake Ranger District, PO Box 129, Silver Lake, OR 97638.
Rick Elston, Toolbox Fire Recovery Project Interdisciplinary Team Leader, Silver Lake Ranger District,
In July 2002 the Toolbox Complex Fires burned approximately 85,000 acres, of which 49,500 occur on the Fremont National Forest. The remainder of the fire includes approximately 8,000 acres of Bureau of Land Management Administered lands and 27,500 acres of private land. The 48,000 acre decision area for the Toolbox Fire Recovery Projects includes those portions of the Toolbox Complex Fires that occurred within the Silver Creek, Silver Lake and Summer Lake Watersheds on National Forest System lands.
Most of the proposed timber salvage units would be harvested using ground-based logging systems. Access for salvage would require reconstruction of about 9 miles of existing roads, primarily by adding surfacing, and construction of approximately 12 miles of new temporary roads and 14 miles of temporary roads located on old road locations. The temporary roads would be closed and obliterated after completion of project activities. Approximately 10 to 15% of the area to be salvaged would be harvested using helicopter based logging systems, including areas salvaged within Riparian Habitat Conservation Areas (RHCAs). All activities within RHCAs would be in accordance with Fremont National Forest Land and Resource Management Plan (LRMP) Standards and Guidelines, as amended by the Inland Native Fish Strategy (INFISH). Other connected actions in association with salvage include water barring and erosion control measures such as scattering of slash on skid trails and treatment of slash.
Planting of tree seedlings following site preparation would occur on approximately 28,500 acres, including areas that are salvage harvested and existing plantations or young stands in which fire damage occurred. Most or all seedlings would be ponderosa pine. Reduction of fuels, including those created by the fire, by salvage activity and by site preparation would occur throughout the project area. A variety of fuel treatment methods would be used, including removing marketable timber through salvage harvest, burning in place, piling and burning, yarding tops to landings to be burned, or lopping and scattering to speed decay. In order to meet desired fuels conditions some areas may be “pretreated” (by thinning very small diameter trees) and prescribed burned. In some instances this may require a Forest Plan amendment.
All proposed activities are responsive to the stated purpose and need for this project.
A full range of alternatives will be considered, including a “no-action” alternative in which none of the activities proposed above would be implemented. Based on the issues gathered through scoping, the action alternatives would differ in (1) The silvicultural and post-harvest treatments prescribed (2) the amount and location of harvest (3) the amount and location of fuels reduction activity. Tentative
Public participation will be sought at several points during the analysis, including listing of this project in the Fall 2002 and subsequent issues of the Fremont-Winema National Forest's Schedule of Proposed Activities; letters to agencies, organizations, and individuals who have previously indicated their interest in such activities; and a legal notice in the
Preliminary issues include: Snag and downed wood habitat; big game thermal cover; disturbance of cultural resources; potential noxious weed expansion; effects of proposed activities on soils exposed by the fire; effects of proposed activities on the recovery of water quality and resident fisheries resource; ability of proposed activities to contribute to restoration of historic vegetation composition, structures, and patterns; potential loss of commercial timber value; and economic viability of timber salvage.
Public comments about this proposal are requested in order to assist in properly scoping issues, determining how to best manage the resources, and fully analyzing environmental effects. Comments received to this notice, including names and addresses of those who comment, will be considered part of the public record on this proposed action and will be available for public inspection. Comments submitted anonymously will be accepted and considered; however, those who submit anonymous comments will not have standing to appeal the subsequent decision under 36 CFR parts 215 and 217. Additionally, pursuant to 7 CFR 1.27(d), any person may request the agency to withhold a submission from the public record by showing how the Freedom of Information Act (FOIA) permits such confidentiality. Persons requesting such confidentiality should be aware that, under FOIA, confidentiality may be granted in only very limited circumstances, such as to protect trade secrets. The Forest Service will inform the requester of the agency's decision regarding the request for confidentiality, and where the request is denied, the agency will return the submission and notify the requester that the comments may be resubmitted with or without name and address within a specified number of days.
The comment period on the draft environmental impact statement will be 45 days from the date the Environmental Protection Agency publishes the notice of availability in the
The Forest Service believes, at this early stage, it is important to give reviewers notice of several court rulings related to public participation in the environmental review process. First, reviewers of draft environmental impact statements must structure their participation in the environmental review of the proposal so that it is meaningful and alerts an agency to the reviewer's position and contentions.
To assist the Forest Service in identifying and considering issues and concerns on the proposed action, comments on the draft environmental impact statement should be as specific as possible. It is also helpful if comments refer to specific pages or chapters of the draft statement. Comments may also address the adequacy of the draft environmental impact statement or the merits of the alternatives formulated and discussed in the statement. Reviewers may wish to refer to the Council on Environmental Quality Regulations for implementing the procedural provisions of the National Environmental Policy Act at 40 CFR 1503.3 in addressing these points.
The Forest Service is the lead agency. The Responsible Official is the Forest Supervisor, Fremont National Forest, 1301 South “G” Street, Lakeview, Oregon 97630-9701. The Responsible Official will decide which, if any, of the proposed projects will be implemented. The Responsible Official may also decide on site-specific Forest Plan amendments regarding standards and guidelines for snag and coarse woody debris, as well as big game habitat, if warranted by the analysis of those components in light of recent science.
The Responsible Official will document the Toolbox Fire Recovery Project decision and reasons for the decision in the Record of Decision. That decision will be subject to Forest Service Appeal Regulations (36 CFR part 215).
Committee for Purchase From People Who Are Blind or Severely Disabled.
Additions to and deletions from Procurement List.
This action adds to the Procurement List services to be
December 1, 2002.
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 August 30, 2002, the Committee for Purchase From People Who Are Blind or Severely Disabled published notice (67 FR 55776) of proposed additions to the Procurement List. After consideration of the material presented to it concerning capability of qualified nonprofit agencies to provide the services and impact of the additions on the current or most recent contractors, the Committee has determined that the services listed below are suitable for procurement by the Federal Government under 41 U.S.C. 46-48c and 41 CFR 51-2.4. I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will furnish the services of the Government.
2. The action will result in authorizing small entities to furnish the services to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 46-48c) in connection with the services proposed for addition to the Procurement List.
Accordingly, the following services are added to the Procurement List:
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 products and service the Government.
2. The action will result in authorizing small entities to furnish the products and 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 products and service proposed for deletion to the Procurement List.
After consideration of the relevant matter presented, the committee has determined that the products and service listed below are no longer suitable for procurement by the Federal Government under 41 U.S.C. 46-48c and 41 CFR 51-2.4.
Accordingly, the following products and service are deleted from the Procurement List:
Committee for Purchase From People Who Are Blind or Severely Disabled.
Proposed additions to Procurement List.
The Committee is proposing to add to the Procurement List products and services 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.
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 possible impact of the proposed actions.
If the Committee approves the proposed additions, the entities of the Federal Government identified in the notice for each product or service will be required to procure the products and services 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 products and services to the Government.
2. If approved, the action will result in authorizing small entities to furnish the products 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 products and services 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 products and services are proposed for addition to Procurement List for production by the nonprofit agencies listed:
Office of Administration, Office of the Secretary, Department of Commerce.
Notice.
In accordance with the Privacy Act (5 U.S.C. 552a(e) (4) and (11)), the Department of Commerce is issuing notice of our intent to delete the system of records entitled “Agriculture Census Records for 1974 and 1978, Commerce/Census—1.” This system of records is no longer collected or maintained by the U.S. Census Bureau.
Comments may be mailed to Gerald W. Gates, Chief, Policy Office, U.S. Census Bureau, Washington, DC 20233.
This Privacy Act System of Records is being deleted because the records are no longer collected or maintained by the U.S. Census Bureau.
Office of Administration, Office of the Secretary, Department of Commerce.
Notice and request for comments.
In accordance with the Privacy Act (5 U.S.C. 552a(e)(4) and (11)), the Department of Commerce is issuing notice of our intent to amend the system of records entitled Commerce/Census-2, “Employee Productivity Measurement Records.” We invite public comment on the proposed change in this publication.
The amendments will become effective as proposed without further notice on December 2, 2002.
Comments may be mailed to Gerald W. Gates, Chief, Policy Office, U.S. Census Bureau, Washington, DC 20233.
The amendment updates administrative information concerning the locations of the system files, the categories of individuals covered by the system, the purpose of the system of records, and the disposal of the records in the system in addition to other minor administrative updates.
Accordingly, the Employee Productivity Measurement Records system notice originally published at 45 FR 82105, December 12, 1980, is amended by the addition of the following information updates.
Strike “and Bureau of the Census, Personal Census Service Branch, Pittsburg, Kansas 66762.” Before “1201” insert “National Processing Center,”. Strike the remainder of the paragraph after “Also at the following Census Regional Offices:” and insert “101 Marietta Street, NW., Suite 3200, Atlanta, Georgia 30303-2700; 2 Copley Place, Suite 301, P.O. Box 9108, Boston, Massachusetts 02117-9108; 901 Center Park Drive, Suite 106, Charlotte, North Carolina 28217-2935; 2255 Enterprise Drive, Suite 5501, Chicago, Illinois 60154; 6303 Harry Hines Boulevard, Suite 210, Dallas, Texas 75235-2569; 6900 West Jefferson Avenue, Suite 100,
Insert “Bureau” between “Census” and employees.”
After “percent performance,” insert “percent of time or standard (incentive coverage),''.
Add “The purpose of this system of records is to determine employee performance and work group productivity, to improve workforce performance, and to evaluate the cost effectiveness of the programs that the Bureau manages.”
(1) In the event that a system or records maintained by the Department to carry out its functions indicates a violation or potential violation of law or contract, whether civil, criminal or regulatory in nature, and whether arising by general statute or particular program statute or contract, or rule, regulation, or order issued pursuant thereto, or the necessity to protect an interest of the Department, the relevant records in the system of records may be referred to the appropriate agency, whether Federal, state, local or foreign, charged with the responsibility of investigating or prosecuting such violation or charged with enforcing or implementing the statute or contract, or rule, regulation or order issued pursuant thereto, or protecting the interest of the Department.
(2) A record from this system of records may be disclosed to a Federal, state or local agency maintaining civil, criminal or other relevant enforcement information or other pertinent information, such as current licenses, if necessary to obtain information relevant to a Department decision concerning the assignment, hiring or retention of an individual, the issuance of a security clearance, the letting of a contract, or the issuance of a license, grant or other benefit.
(3) A record from this system of records may be disclosed to a Federal, state, local or international agency, in response to its request, in connection with the assignment, hiring or retention of an individual, the issuance of a security clearance, the reporting of an investigation of an individual, the letting of a contract, or the issuance of a license, grant, or other benefit by the requesting agency, to the extent that the information is relevant and necessary to the requesting agency's decision on the matter.
(4) A record from this system of records may be disclosed in the course of presenting evidence to a court, magistrate or administrative tribunal, including disclosures to opposing counsel in the course of settlement negotiations.
(5) A record in this system of records may be disclosed to a Member of Congress submitting a request involving an individual when the individual has requested assistance from the Member with respect to the subject matter of the record.
(6) A record in this system of records may be disclosed to the Office of Management and Budget in connection with the review of private relief legislation as set forth in OMB Circular No. A-19 at any stage of the legislative coordination and clearance process as set forth in that Circular.
(7) A record in this system of records may be disclosed to the Department of Justice in connection with determining whether disclosure thereof is required by the Freedom of Information Act (5 U.S.C. 552).
(8) A record in this system of records may be disclosed to a contractor of the Department having need for the information in the performance of the contract, but not operating a system of records within the meaning of 5 U.S.C. 552a(m).
(9) A record in this system may be transferred to the Office of Personnel Management: for personnel research purposes; as a data source for management information; for the production of summary descriptive statistics and analytical studies in support of the function for which the records are collected and maintained; or for related manpower studies.
(10) A record from this system of records may be disclosed to the Administrator, General Services, or his designee, during an inspection of records conducted by GSA as part of that agency's responsibility to recommend improvements in records management practices and programs under authority of 44 U.S.C. 2904 and 2906. Such disclosure shall be made in accordance with the GSA regulations governing inspection of records for this purpose, and any other relevant (
After “paper copy” add: “and electronic records'.
Insert “s” at the end of the word “Tape”; insert “and” after “Tapes”; insert “and” before “sensitive”; insert “are” between “materials” and “held”.
Change “Records” to “records”, and insert before “records” the following: “In accordance with the General Records Schedule and Census Bureau records control schedules that are approved by the National Archives and Records Administration,”.
Delete “Administration.” Insert “Field Operations”.
Insert “Privacy Act” between “Department's” and “rules.”
* Indicates that there are no changes to that paragraph of the notice.
Office of Administration, Office of the Secretary, Department of Commerce.
Notice and request for comments.
In accordance with the Privacy Act (5 U.S.C. 552a(e)(4) and
The amendments will become effective as proposed without further notice on December 2, 2002.
Comments may be mailed to Gerald W. Gates, Chief, Policy Office, U.S. Census Bureau, Washington, DC 20233.
The amendment updates administrative information concerning the locations of the system files, the categories of individuals covered by the system, the categories of records in the system, the purpose of the system of records, and the disposal of the records in the system in addition to other minor administrative updates. Accordingly, the Individual and Household Statistical Surveys and Special Studies Records system notice originally published at 45 FR 82105, December 12,1980, is amended by the addition of the following information updates.
Insert after “20233;” “Bureau of the Census, Bowie Computer Center 1701, Melford Boulevard, Bowie, Maryland 20717”. Insert before “1201 East 10th Street” “National Processing Center,”.
Delete the sentence and insert the following information. “This system contains information on households and individuals designated for statistical sample surveys. It includes:
(1) Household respondents age 15 year old or over selected for participation in the Current Population Survey, a survey with monthly interviewing and monthly supplements.
(2) Household members 15 years old and over who participate in the Survey of Income and Program Participation, a survey with monthly interviewing.
(3) Household respondents 15 years old or older selected for participation in the Survey of Program Dynamics, a longitudinal survey conducted on a yearly basis.
(4) Household respondents age 16 years or over selected for participation in the American Housing Surveys, conducted on a yearly basis.
(5) All household members age 12 and over who participate in the National Crime Victimization Survey, a monthly survey with supplements that include the Police Public Contact Survey and the School Crime Supplement.
(6) Household respondents selected for participation in the National Survey of Fishing, Hunting, and Wildlife-Associated Recreation, a survey conducted every five years.
(7) Women selected for participation in the National Longitudinal Survey of Women, a longitudinal survey conducted every two years.
(8) College graduates in science and engineering selected for participation in the National Survey of College Graduates, conducted biennially.
(9) Household respondents selected for participation in the New York City Housing and Vacancy Survey, conducted triennially.
(11) Household respondents age 15 year or over selected for participation in the American Community Survey, a survey with monthly interviewing.
(12) Persons age 16 years old or over selected to provide information for the consumer unit for the Consumer Expenditure Survey, which includes a quarterly interview and a diary survey.
(13) Owners of nonfarm, privately owned residential properties selected to provide information on the characteristics of homeowner and rental properties for the Residential Finance Survey, conducted decennially.”
Add “The purpose of this system of records is to conduct research on the methodology associated with various aspects of surveys, such as data quality checks and review during post data collection processing because of an unusual inconsistency or other data problem. Special studies' data maintained by the Bureau of the Census are collected in order to conduct research on the methodology associated with various aspects of surveys (
Delete all citations. Add “13 U.S.C. 8, 141, and 182”.
Delete paragraph (1). Renumber “(2)” as “(1)” and “(3)” as “(2)''.
After “hard disk” insert “local area network, audio and video tape, CD-ROM, and DVD''.
Change “Unique” to “unique” and before “unique” insert “Name, address, Social Security number, and''.
At the end of the paragraph add “Computer systems processing sensitive information meet the basic security requirements for discretionary access control as defined by DOD 5200.28 STD, commonly referred to as C2-level security. This level of security controls through use of specific security features, access to information such that only properly authorized individuals, or processes operating on their behalf, will have access to read, write, create, or delete information.”
Strike “approved GSA Schedules” and insert “the General Records Schedule and Census Bureau records control schedules that are approved by the National Archives and Records Administration.”
Strike “Privacy Officer, Program and Policy Development Office,” and add “Associate Director for Demographic Programs and Associate Director for Methodology and Standards''.
Insert “system of” between “this” and “records” in the first sentence.
Office of Administration, Office of the Secretary, Department of Commerce.
Notice and request for comments.
In accordance with the Privacy Act (5 U.S.C. 552a(e) (4) and (11)), the Department of Commerce is issuing notice of our intent to amend the system of records entitled Commerce/Census-4, “Minority-Owned Business Enterprises Survey Records.” We invite public comment on the proposed change in this publication.
The amendments will become effective as proposed without further notice on December 2, 2002.
Comments may be mailed to Gerald W. Gates, Chief, Policy Office, U.S. Census Bureau, Washington, DC 20233.
The amendment updates administrative information concerning the locations of the system files, the categories of individuals covered by the system, the categories of records in the system, the purpose of the system of records, safeguards, and the disposal of the records in the system in addition to other minor administrative updates. Accordingly, the Minority-Owned Business Enterprises Survey Records system notice originally published at 45 FR 82105, December 12, 1980, is amended by the addition of the following information updates.
Add “Women-and” before Minority-Owned.
After the last zip code add: “Bureau of the Census, Bowie Computer Center, 17101 Melford Boulevard, Bowie, Maryland 20715; Bureau of the Census, National Processing Center, 1201 East 10th Street, Jeffersonville, Indiana 47132.”
Strike “Female and minority” and insert “Ethnicity, race, and gender of”.
After “race,” insert “ethnicity,” and after “geographic area,” insert “place of birth, and”. Strike “Name and social security number are deleted from partners and stockholders once other data are coded.” Strike “of minority business enterprises.”.
Add “The purpose of this system of records is to conduct research on the methodology associated with various aspects of surveys, such as data quality checks and review during post data collection processing because of an unusual inconsistency or other data problem.”
After “tape” add: “and CD-ROM.”
Delete “Filed” and insert “Retrieved”.
After the last sentence add: “Computer systems processing sensitive information meet the basic security requirements for discretionary access control as defined by DOD 5200.28 STD, commonly referred to as C2-level security. This level of security controls through use of specific security features, access to information such that only properly authorized individuals, or processes operating on their behalf, will have access to read, write, create, or delete information.”
Delete “unit's Records Control Schedule” and insert “Census Bureau's records schedule approved by the National Archives and Records Administration”.
Strike “Administration” and insert “Economic Programs”.
Insert “system of” between “this” and “record” in the first sentence and change “record” to “records”.
* Indicates that there are no changes to that paragraph of the notice.
Office of Administration, Office of the Secretary, Department of Commerce.
Notice and request for comments.
In accordance with the Privacy Act (5 U.S.C. 552a(e) (4) and (11)), the Department of Commerce is issuing notice of our intent to amend the system of records entitled Commerce/Census—6, “Population Census Personal Service Records for 1900 and All Subsequent Decennial Censuses.” We invite public comment on the proposed change in this publication.
The amendments will become effective as proposed without further notice on December 2, 2002.
Comments may be mailed to Gerald W. Gates, Chief, Policy Office, U.S. Census Bureau, Washington, DC 20233.
The amendment updates administrative information concerning the locations of the system files, the categories of individuals covered by the system, the categories of records in the system, the purpose of the system of records, retrievability, safeguards, and the disposal of the records in the system in addition to other minor administrative updates. Accordingly, the Population Census Records Personal Service Records for 1900 and All Subsequent Decennial Censuses system notice originally published at 45 FR 82105, December 12, 1980, is amended by the addition of the following information updates.
Delete “Personal Service” and change “1900” to “1910”.
Strike “Personal Census Services Branch, Pittsburg, Kansas 66762” and add “National Processing Center, 1201 East 10th Street, Jeffersonville, Indiana 47132.”
Strike “(1900-1970)” and add “(1910 and all subsequent decennial censuses)”.
After “head of household” strike “date of birth” and insert “age (at time of census) or month/year of birth (depending on census year),”. Before “education” insert “limited”.
Add “The 1910-1990 decennial census records are searched and official census transcripts of the results are provided to the named persons(s), their heirs, or legal representatives, upon receipt of a signed Application for Search of Census Records (Form BC-600). Census transcripts provide proof of age for Social Security or other retirement benefits. They can also be used in making passport applications, to prove relationship in settling estates, in limited genealogy research or to satisfy other situations where a birth certificate or other legal documentation is needed but not available.”
Change “15 CFR part 60” to “15 CFR part 50”.
Delete the entire sentence and add: “Some census records are indexed by the SOUNDEX system—a numerical coding of the surname. The majority of census records are arranged on a geographic basis where the address must be known to determine which roll of microfilm contains the name(s) for which a search is requested.”
After the last sentence add: “Details from confidential records can only be released to the named persons, their heirs, or legal representatives upon submission of a notarized transcript application. Individual records are confidential for 72 years (Title 44, U.S.C. 2108(b)).”
Add: “Records are stored at the Census Bureau's National Processing Center in Jeffersonville, Indiana, and also are provided to the National Archives and Records Administration for permanent retention. Records stored at the National Archives and Records Administration are not made public for 72 years.”
Strike “Administration” and insert “Economic Programs”.
Insert “system of” between “this” and “record” in the first sentence and change “record” to “records”.
* Indicates that there are no changes to that paragraph of the notice.
Office of Administration, Office of the Secretary, Department of Commerce.
Notice and request for comments.
In accordance with the Privacy Act (5 U.S.C. 552a(e) (4) and (11)), the Department of Commerce is issuing notice of our intent to amend the system of records entitled Commerce/Census 7, “Special Censuses of Population Conducted for State and Local Government.” We invite public comment on the proposed change in this publication.
The amendments will become effective as proposed without further notice on December 2, 2002.
Comments may be mailed to Gerald W. Gates, Chief, Policy Office, U.S. Census Bureau, Washington, DC 20233.
The amendment updates administrative information concerning the categories of individuals covered by the system, the authority for maintenance of the system, the purpose of the system of records, safeguards, the retention and disposal of the records in the system, and the system manager in addition to other minor administrative updates. Accordingly, the Special Censuses of Population Conducted for State and Local Government system notice originally published at 45 FR 82105, December 12, 1980, is amended by the addition of the following information updates.
Insert before “1210 East 10th Street,” “National Processing Center,”. Delete “47102” and insert “47132”.
Strike “requesting a census” and insert after “the” “geographical boundaries of local units of government requesting a special census during non-decennial years”.
Strike “8” and insert “196”. Add “These collections are conducted under procedures published at 15 CFR, Part 50”.
Add “The purpose of this system of records is to verify the accuracy and quality of data collection and processing.”
After the last sentence add: “Computer systems processing sensitive information meet the basic security requirements for discretionary access control as defined by DOD 5200.28 STD, commonly referred to as C2-level security. This level of security controls through use of specific security features, access to information such that only properly authorized individuals, or processes operating on their behalf, will have access to read, write, create, or delete information.”
Insert at the beginning “In accordance with the Census Bureau records control schedule approved by the National Archives and Records Administration,” change “Tapes” to “tapes” insert “are” after “tapes”. Strike “2” and insert “three”.
Strike “Administration” and insert “Field Operations”.
Insert “system of” between “this” and “record” in the first sentence and change “record” to “records”.
* Indicates that there are no changes to that paragraph of the notice.
Import Administration, International Trade Administration, Department of Commerce.
Notice of opportunity to request administrative review of antidumping or countervailing duty order, finding, or suspended investigation.
Each year during the anniversary month of the publication of an antidumping or countervailing duty order, finding, or suspension of investigation, an interested party, as defined in section 771(9) of the Tariff Act of 1930, as amended, may request, in accordance with § 351.213 (2002) of the Department of Commerce (the Department) Regulations, that the Department conduct an administrative review of that antidumping or countervailing duty order, finding, or suspended investigation.
In accordance with § 351.213(b) of the regulations, an interested party as defined by section 771(9) of the Act may request in writing that the Secretary conduct an administrative review. For both antidumping and countervailing duty reviews, the interested party must specify the individual producers or exporters covered by an antidumping finding or an antidumping or countervailing duty order or suspension agreement for which it is requesting a review, and the requesting party must state why it desires the Secretary to review those particular producers or exporters. If the interested party intends for the Secretary to review sales of merchandise by an exporter (or a producer if that producer also exports merchandise from other suppliers) which were produced in more than one country of origin and each country of origin is subject to a separate order, then the interested party must state specifically, on an order-by-order basis, which exporter(s) the request is intended to cover.
Six copies of the request should be submitted to the Assistant Secretary for Import Administration, International Trade Administration, Room 1870, U.S. Department of Commerce, 14th Street & Constitution Avenue, NW., Washington, DC 20230. The Department also asks parties to serve a copy of their requests to the Office of Antidumping/Countervailing Enforcement, Attention: Sheila Forbes, in room 3065 of the main Commerce Building. Further, in accordance with § 351.303(f)(1)(i) of the regulations, a copy of each request must be served on every party on the Department's service list.
The Department will publish in the
This notice is not required by statute but is published as a service to the international trading community.
Import Administration, International Trade Administration, U.S. Department of Commerce.
The Department of Commerce is extending the time limit of the preliminary results of the new shipper review of the antidumping duty order on freshwater crawfish tail meat from the People's Republic of China until no later than February 13, 2003. The period of review is September 1, 2001, through February 28, 2002. This extension is made pursuant to section 751(a)(2)(B)(iv) of the Tariff Act of 1930, as amended.
November 1, 2002.
Douglas Kirby or Thomas Gilgunn, AD/CVD Enforcement, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, N.W., Washington D.C. 20230; telephone: (202) 482-3782 or (202) 482-4236, respectively.
Unless otherwise indicated, all citations to the statute are references to the provisions of the Tariff Act of 1930, as amended (the Act). In addition, unless otherwise indicated, all citations to the Department's regulations are to the provisions codified at 19 CFR Part 351(2002).
Section 751(a)(2)(B)(iv) of the Act requires the Department to issue the preliminary results of a new shipper review within 180 days after the date on which the new shipper review was initiated, and final results of review within 90 days after the date on which the preliminary results were issued. However, if the Department determines the issues are extraordinarily complicated, section 751(a)(2)(B)(iv) of the Act allows the Department to extend the deadline for the preliminary results to up to 300 days after the date on which the new shipper review was initiated.
On March 29, 2002 the Department received a timely request from Weishan Zhenyu Foodstuff Co., Ltd. (Zhenyu), in accordance with section 751(a)(2)(B) of the Act and section 351.214(c) of the regulations, for a new shipper review of the antidumping duty order on freshwater crawfish tail meat from the People's Republic of China (“PRC”), which has a September anniversary date. On April 23, 2002 the Department initiated this new shipper review covering the period September 1, 2001, through February 28, 2002.
Pursuant to section 751(a)(2)(B)(iv) of the Act, the Department may extend the deadline for completion of the preliminary results of a new shipper review if it determines that the case is extraordinarily complicated. The Department has determined that this case is extraordinarily complicated, and the preliminary results of this new shipper review cannot be completed within the statutory time limit of 180 days. The Department finds that this new shipper review is extraordinarily complicated because of the issues that must be addressed. The Department is now analyzing the respondent's supplemental questionnaire response containing additional information concerning affiliation, date of sale, and factor value data. Given the issues in this case, the Department may find it necessary to request further information in this new shipper review. Therefore, in accordance with section 351.214(i)(2) of the regulations, the Department is extending the time limit for the completion of preliminary results for an additional 83 days. The preliminary results will now be due no later than February 13, 2003.
This notice is published pursuant to sections 751(a)(2)(B) and 777(i)(1) of the Act.
Import Administration, International Trade Administration, Department of Commerce.
The Department of Commerce is extending the time limit for the preliminary results of the administrative review of mechanical transfer presses (MTPs) from Japan until no later than February 28, 2003. The period of review is February 1, 2001 through January 31, 2002. This extension is made pursuant to section 751(a)(3)(A) of the Tariff Act of 1930, as amended (the Act).
November 1, 2002.
Jacqueline Arrowsmith, Office of AD/CVD Enforcement VII, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, N.W., Washington D.C. 20230; telephone: (202) 482-5255.
Unless otherwise indicated, all citations to the statute are references to the Act. In addition, unless otherwise indicated, all citations to the Department's regulations are to the regulations codified at 19 CFR Part 351 (2001).
On February 19, 2001, the Department of Commerce (the Department) received a timely request for administrative review of the antidumping duty order on MTPs from Japan from respondent Hitatchi Zosen Corporation (HZC), and its subsidiary Hitatchi Zosen Fukui Corporation d/b/a H&F Corporation (H&F).
Due to several complex issues involving normal value, it is not practicable to complete this review within the time limits mandated by section 751(a)(3)(A) of the Act. The Department is therefore extending the time period for issuing the preliminary results of this review by 120 days, from October 31, 2002, until no later than February 28, 2003, in accordance with section 751(a)(3)(A) of the Act. The final results continue to be due 120 days after the publication of the preliminary results. This notice is published pursuant to sections 751(a)(3)(A) and 777(i)(1) of the Act.
Import Administration, International Trade Administration, U.S. Department of Commerce.
The Department of Commerce is extending the time limit of the preliminary results of the administrative review of the antidumping duty order on natural bristle paint brushes from the People's Republic of China until no later than January 23, 2003. The period of review is February 1, 2001, through January 31, 2002. This extension is made pursuant to section 751(a)(2)(B)(iv) of the Tariff Act of 1930, as amended.
November 1, 2002.
Douglas Kirby or Sean Carey, AD/CVD Enforcement, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, N.W., Washington D.C. 20230; telephone: (202) 482-3782 or (202) 482-3964, respectively.
Unless otherwise indicated, all citations to the statute are references to the provisions of the Tariff Act of 1930, as amended (the Act). In addition, unless otherwise indicated, all citations to the Department's regulations are to the provisions codified at 19 CFR Part 351 (2002).
Section 351.213(h)(1) of the Department's regulations requires the Department to issue the preliminary results of an administrative review within 245 days after the last day of the anniversary month of the order or suspension agreement for which the administrative review was requested, and final results of review within 120 days after the date on which notice of the preliminary results was published in the Federal Register. However, if the Department determines that it is not practicable to complete the review within this time period, section 351.213(h)(2) of the Regulations allows the Department to extend the 245-day period to 365 days and may extend the 120-day period to 180 days.
On February 1, 2002, the Department published a notice of opportunity to request an administrative review of the antidumping duty order on natural bristle paint brushes and brush heads from the People's Republic of China (PRC) (67 FR 4945). On February 28, 2002, the Department received a timely request from petitioner for administrative reviews of Hunan Provincial Native Produce and Animal By-Products Import and Export Corporation (Hunan) and Hebei Founder Import and Export Company (Hebei). On March 27, 2002, the Department initiated an administrative review of the antidumping duty order on natural bristle paintbrushes and brush heads, for the period from February 1, 2001 through January 31, 2002, in order to determine whether merchandise imported into the United States is being sold at less than fair value with respect to these two companies.
On May 1, 2002 the Department issued antidumping questionnaires to Hebei and Hunan. In its reply to Section A of the questionnaire, Hebei stated that it had made no sales or shipments of subject merchandise to the United States during the POR. The Department also performed a U.S. Customs Service (Customs) query for entries of natural bristle paintbrushes and brush heads, classified under the Harmonized Tariff Schedule of the United States (HTSUS) item number 9603.40.40.40, from the PRC during the POR. We found no entries or shipments from Hebei during the POR. Thus, the Department rescinded the review with respect to Hebei.
Pursuant to section 751(a)(2)(B) of the Act, the Department may extend the deadline for completion of the preliminary results of an administrative review if it determines that it is not practicable to complete the review within the time specified in section 351.213(h)(2) of the Department's regulations. The Department has determined that the preliminary results of this administrative review cannot be completed within the statutory time limit of 245 days. The Department finds that it is not practicable to complete the preliminary results of this administrative review because there are a number of issues that must be addressed. For example, the Department has prepared a supplemental questionnaire requesting additional information on the respondent's questionnaire responses concerning affiliation and date of sale. Given the issues in this case, the Department may find it necessary to request even more information in this administrative
This notice is published pursuant to sections 751(a)(2)(B) and 777(i)(1) of the Act.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
2002 inseason orders.
NMFS publishes the Fraser River salmon inseason orders regulating salmon fisheries in U.S. waters. The orders were issued by the Fraser River Panel (Panel) of the Pacific Salmon Commission (Commission) and subsequently approved and issued by NMFS during the 2002 sockeye and pink salmon fisheries within the U.S. Fraser River Panel Area. These orders established fishing times, areas, and types of gear for U.S. treaty Indian and all-citizen fisheries during the period the Commission exercised jurisdiction over these fisheries. Due to the frequency with which inseason orders are issued, publication of individual orders is impracticable. The 2002 orders are therefore being published in this document to avoid fragmentation.
Each of the following inseason actions was effective upon announcement on telephone hotline numbers as specified at 50 CFR 300.97(b)(1); those dates and times are listed under
Comments will be accepted through November 18, 2002.
Comments may be mailed to D. Robert Lohn, Regional Administrator, Northwest Region, NMFS, 7600 Sand Point Way N.E., BIN C15700-Bldg. 1, Seattle, WA 98115-0070. Information relevant to this document is available for public review during business hours at the office of the Regional Administrator, Northwest Region, NMFS.
David Cantillon, 206-526-4140.
The treaty between the Government of the United States of America and the Government of Canada concerning Pacific Salmon was signed at Ottawa on January 28, 1985, and subsequently was given effect in the United States by the Pacific Salmon Treaty Act (Act) at 16 U.S.C. 3631-3644. Under authority of the Act, Federal regulations at 50 CFR part 300 subpart F provide a framework for implementation of certain regulations of the Commission and inseason orders of the Commission's Panel for U.S. sockeye and pink salmon fisheries in the Fraser River Panel Area.
The regulations close the Fraser River Panel Area (U.S.) to U.S. sockeye and pink salmon fishing unless opened by Panel regulation or by inseason regulations published by NMFS that give effect to Panel orders. During the fishing season, NMFS may issue regulations that establish fishing times and areas consistent with the Commission agreements and inseason orders of the Panel. Such orders must be consistent with domestic legal obligations. The Regional Administrator, Northwest Region, NMFS, issues the inseason orders. Official notification of these inseason actions of NMFS is provided by two telephone hotline numbers described at 50 CFR 300.97(b)(1). Inseason orders must be published in the
The following inseason orders were adopted by the Panel and issued for U.S. fisheries by NMFS during the 2002 fishing season. The times listed are local times, and the areas designated are Puget Sound Management and Catch Reporting Areas as defined in the Washington State Administrative Code at Chapter 220-22.
Areas 4B, 5 and 6C: Open for drift gillnets from 12 p.m. (noon) Sunday, July 21, 2002, to 12 p.m. (noon) Wednesday, July 24, 2002.
Areas 4B, 5 and 6C: Extended for drift gillnets from 12 p.m. (noon) Wednesday, July 24, 2002, to 12 p.m. (noon) Saturday, July 27, 2002.
Areas 4B, 5 and 6C: Open for drift gillnets from 4 p.m. Monday, July 29, 2002, to 12 p.m. (noon) Friday, August 2, 2002.
Areas 6, 7 and 7A: Open for net fishing from 4 a.m to 8 p.m. Wednesday, July 31, 2002.
Areas 7 and 7A: Purse Seines open from 9 a.m. to 3 p.m. on Friday, August 2, 2002.
Drift Gillnets open from 4 p.m. to 10 p.m. on Friday, August 2, 2002.
Areas 4B, 5 and 6C: Open for drift gillnets from 4 p.m. Friday, August 2 to 12 p.m. (noon) Monday, August 5, 2002.
Areas 6, 7 and 7A: Open for net fishing from 6 a.m to 11 p.m. Saturday, August 3, 2002.
Areas 7 and 7A Reef Net: Open for net fishing 5 a.m. Saturday, August 3, 2002, until 9 p.m. Saturday, August 3, 2002, and then again 5 a.m. Sunday, August 4, 2002, until 9 p.m. Sunday, August 4, 2002, and then again 5 a.m. Monday, August 5, 2002, until 9 p.m. Monday, August 5, 2002.
Areas 4B, 5 and 6C: Open for drift gill nets from 4 p.m. Tuesday, August 6, 2002 to 12 p.m. (noon) Friday, August 9, 2002.
Areas 7 and 7A Purse Seine: Open for purse seine in that portion of Area 7 and Area 7A south and east of a line from Iwersen's Dock on Point Roberts to Georgina Point Light at the entrance to Active Pass in British Columbia, from 2 p.m. Thursday, August 8, 2002 to 3 p.m Thursday, August 8, 2002.
Areas 7 and 7A Gill Net: Open for gill net in that portion of Area 7 and Area 7A south and east of a line from Iwersen's Dock on Point Roberts to Georgina Point Light at the entrance to Active Pass in British Columbia, from 4 p.m. Thursday, August 8, 2002 to 8 p.m. Thursday, August 8, 2002.
Areas 4B, 5 and 6C: Open for drift gill nets from 4 p.m. Friday, August 9, 2002 to 12 p.m. (noon) Tuesday, August 13, 2002.
Areas 6, 7 and 7A: Open for that portion of Area 6, Area 7 and Area 7A south and east of a line from Iwersen's Dock on Point Roberts to Georgina Point Light at the entrance to Active Pass in British Columbia for net fishing from 5 a.m. to 5 p.m. on Sunday, August 11, 2002.
Non-Treaty Gill Net: Open for that portion of Area 7 and Area 7A south and east of a line from Iwersen's Dock on Point Roberts to Georgina Point Light at the entrance to Active Pass in British Columbia for gill net from 4 p.m. to 8 p.m. on Monday, August 12, 2002.
Non-Treaty Reef Net: Open for that portion of Area 7 and Area 7A south and east of a line from Iwersen's Dock on Point Roberts to Georgina Point Light at the entrance to Active Pass in British Columbia for reef net from 5 a.m. to 9 p.m. on Saturday, August 10, 2002.
Areas 4B, 5 and 6C: Open for drift gill nets from 4 p.m. Friday, August 9, 2002, to 6 p.m. Monday, August 12, 2002.
Non-Treaty Gill Net: Open for that portion of Area 7 and Area 7A south and east of a line from Iwersen's Dock on Point Roberts to Georgina Point Light at the entrance to Active Pass in British Columbia for gill net from 4 p.m. to 8 p.m. on Monday, August 12, 2002.
Inseason Order 2002-08 supersedes all previous inseason orders implementing 2002 orders of the Fraser River Panel.
Non-Treaty Gill Net: Open for that portion of Areas 7 and 7A south and east of a line from Iweresen's Dock on Point Roberts to Georgina Point Light at the entrance to Active Pass in British Columbia as follows:
Area 7A: Open from 8 a.m. to 8 p.m. on Saturday, August 24, 2002, and from 8 a.m. to 8 p.m. on Sunday, August 25, 2002.
Areas 7 and 7A: Open from 8 a.m. to 8 p.m. on Monday, August 26, 2002.
The Assistant Administrator for Fisheries NOAA (AA), finds that good cause exists for the inseason orders to be issued without affording the public prior notice and opportunity for comment under 5 U.S.C. 553(b)(B) as such prior notice and opportunity for comment is impracticable and contrary to the public interest. Prior notice and opportunity for public comment is impracticable because NMFS has insufficient time to allow for prior notice and opportunity for pubic comment between the time the stock abundance information is available to determine how much fishing can be allowed and the time the fishery must open and close in order to harvest the appropriate amount of fish while they are available.
Moreover, such prior notice and opportunity for public comment is contrary to the public interest because not closing the fishery upon attainment of the quota would allow the quota to be exceeded and thus compromise the conservation and allocation objectives established preseason, and it does not allow fishers appropriately controlled access to the available fish at the time they are available.
The AA also finds good cause to waive the 30-day delay in the effective date, required under 5 U.S.C. 553(d)(3), of the inseason orders. A delay in the effective date of the inseason orders would not allow fishers appropriately controlled access to the available fish at that time they are available.
This review is authorized by 50 CFR 300.97, and is exempt from review under Executive Order 12866.
16 U.S.C. 3636(b).
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Issuance of permit amendment.
Notice is hereby given that the Alaska SeaLife Center, P.O. Box 1329, Seward, AK 99664 has been issued an amendment to scientific research Permit No. 881-1443-05.
The amendment 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;
Regional Administrator, Alaska Region, National Marine Fisheries Service, NOAA, P.O. Box 21668, Juneau, AK 99802-1668 (907/586-7221).
Amy Sloan or Ruth Johnson, (301)713-2289.
The requested amendment has been granted under the authority of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361
Issuance of this amendment, as required by the ESA was based on a finding that such permit (1) was applied for in good faith, (2) will not operate to the disadvantage of the endangered species which is the subject of this permit, and (3) is consistent with the purposes and policies set forth in section 2 of the ESA.
The amendment extends the expiration date of the permit from March 31, 2003, to March 31, 2004.
Friday, November 8, 2002, 10 a.m.
Room 420, East West Towers, 4330 East West Highway, Bethesda, Maryland.
Open to the public.
The staff will brief the Commission on Petition HP 99-1 requesting a ban of polyvinyl chloride (PVC) in all toys and other products intended for children five of age and under.
For a recorded message containing the latest agenda information, call (301) 504-0709.
Todd A. Stevenson, Office of the Secretary, 4330 East West Highway, Bethesda, MD 20207 (301) 504-0800.
Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).
Notice of request for public comments regarding an extension to an existing OMB clearance.
Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Federal Acquisition Regulation (FAR) Secretariat will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a currently approved information collection requirement concerning the Davis-Bacon Act price adjustment (actual method). The clearance currently expires on January 31, 2003.
Submit comments on or before December 31, 2002.
Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to the General Services Administration, FAR Secretariat (MVP), 1800 F Street, NW, Room 4035, Washington, DC 20405.
Linda Nelson, Acquisition Policy Division, GSA (202) 501-1900.
The clause at 52.222-32, Davis-Bacon Act-Price Adjustment (Actual Method), requires that a contractor must submit at the exercise of each option to extend the term of the contract, including a statement of the amount claimed for incorporation of the most current wage determination by the Department of Labor, and any relevant supporting data, including payroll records, that the contracting officer may reasonably require.
The contracting officer may include this clause in fixed-price solicitations and contracts, subject to the Davis-Bacon Act, that will contain option provisions to extend the term of the contract. Generally, this clause is only appropriate if contract requirements are predominantly services subject to the Service Contract Act and the construction requirements are substantial and segregable.
Department of the Army, DoD.
Notice.
Notice is given of the names of members of a Performance Review Board for the Department of the Army.
October 28, 2002.
Marilyn Ervin, U.S. Army Senior Executive Service Office, Assistant Secretary of the Army, Manpower & Reserve Affairs, 111 Army, Washington, DC 20310-0111.
Section 4314(c)(1) through (5) of Title 5, U.S.C., requires each agency to establish, in accordance with regulations, one or more Senior Executive Service performance review boards. The boards shall review and evaluate the initial appraisal of senior executives' performance by supervisors and make recommendations to the appointing authority or rating official relative to the performance of these executives.
The members of the Performance Review Board for the U.S. Army Communications-Electronics Command (CECOM), U.S. Army Materiel Command are:
1. BG Michael R. Mazzucchi, Program Executive Officer, Command, Control and Communications (Tactical).
2. Mr. Edward Bair, Program Executive Officer, Intelligence, Electronic Warfare and Sensors.
3. Mr. Edward Thomas, Director, CECOM Software Engineering Center, U.S. Army Communications-Electronics Command.
4. Mr. John Perrapato, Deputy Program Executive Officer, Command and Control Systems.
5. Mr. Edward Elgart, Director, CECOM Acquisition Center, U.S. Army Communications-Electronics Command.
1. Ms. L. Marlene Cruze, Director, Acquisition Center, U.S. Army Aviation and Missile Command.
2. Dr. Richard Amos, Acting Associated Director (Systems), Research, Development and Engineering Center, U.S. Army Aviation and Missile Command.
3. Mr. John Chapman, Executive Director of Integrated Materiel Management Center, U.S. Army Aviation and Missile Command.
4. Mr. Bill Reeves, Assistant to the Deputy Commanding General for Research, Development and Acquisition, U.S. Army Space and Missile Defense Command.
National Assessment Governing Board; Education.
Notice of open meeting and partially closed meetings.
This notice sets forth the schedule and proposed agenda of a forthcoming meeting of the National Assessment Governing Board. This notice also describes the functions of the Board. Notice of this meeting is required under Section 10(a)(2) of the Federal Advisory Committee Act. The document is intended to notify the general public of their opportunity to attend. Individuals who will need accommodations for a disability in order to attend the meeting (i.e. interpreting services, assistive listening devices, materials in alternative format) should notify Munira Mwalimu at 202-357-6938 or at
November 14-November 16, 2002.
Munira Mwalimu, Operations Officer, National Assessment Governing Board, 800 North Capitol Street, NW, Suite 825, Washington, DC, 20002-4233, Telephone: (202) 357-6938.
The National Assessment Governing Board is established under section 412 of the National Education Statistics Act of 1994 (Title IV of the Improving America's Schools Act of 1994, as amended by the No Child Left Behind Act of 2001 (Public Law 107-110).
The Board is established to formulate policy guidelines for the National Assessment of Educational Progress (NAEP). The Board's responsibilities include selecting subject areas to be assessed, developing assessment objectives, developing appropriate student achievement levels for each grade and subject tested, developing guidelines for reporting and disseminating results, and developing standards and procedures for interstate and national comparisons.
The Executive Committee will meet in partially closed session on November 14 from 6:30-7 p.m. to receive independent cost estimates on contract initiatives for NAEP. The meeting must be conducted in closed session because public disclosure of this information would likely have an adverse financial effect on the NAEP program. The discussion of this information would be likely to significantly impede implementation of a proposed agency action if conducted in open session. Such matters are protected by exemption 9(B) of 552b(c) of Title 5 U.S.C.
On November 15, 2002 the full board will convene in open session from 8:15 a.m.-10:15 a.m. The Board will approve the agenda and introduce new Board Members. Secretary Paige will administer the oath of office for new Board members and address the Board. The Board will then receive the Executive Director's report and a NAEP Update from the Deputy Commissioner of NCES, Gary Phillips. From 10:30 a.m. to 12:30 p.m., the Board's standing committees—the Assessment Development Committee, the Committee on Standards, Design, and Methodology, and the Reporting and Dissemination Committee will meet in open session.
The full Board will reconvene in open session on November 15, 2002 from 12:30 p.m.-1:30 p.m. to discuss the work of a proposed Commission to study 12th grade NAEP. From 1:30 p.m. to 2 p.m. the Board will receive an update on NAEP/NAGB reauthorization and on the new reading framework project. From 2:30 p.m. to 4 p.m. the full board will meet in closed session to review and discuss test items from the upcoming 2003 Main Reading Assessment. Disclosure of the specific test items for the NAEP Reading Assessment would significantly impede implementation of the NAEP program, and is therefore protected by exemption 9(B) of Section 552b(c) of Title 5 U.S.C.
On November 16, the full Board will meet in open session from 9 a.m. to 12 p.m. The Board will receive a briefing from the National Urban League on efforts to reduce achievement gaps. This presentation will be followed by Board actions on policies and Committee reports. The November 16, 2002 session of the Board meeting will adjourn at 12 noon.
Summaries of the activities of the closed session and related matters, which are informative to the public and consistent with the policy of section 5 U.S.C. 552b (c), will be available to the public within 14 days of the meeting. Records are kept of all Board proceedings and are available for public inspection at the U.S. Department of Education, National Assessment Governing Board, Suite #825, 800 North Capitol Street, NW, Washington, DC, from 9 a.m. to 5 p.m. Eastern Standard Time.
Department of Energy.
Notice and request for OMB review and comment.
The Department of Energy (DOE) has submitted the proposed collection of information described in this Notice to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). These forms will certify to DOE that respondents were advised of the requirements for occupying or continuing to occupy a Human Reliability Program (HRP) position. The HRP is a new program which merges the Personnel Security Assurance Program (PSAP) and the Personnel Assurance Program (PAP) into one DOE human reliability program. The HRP forms will be identical to the OMB approved PSAP forms, just changing the name of the program. In addition to the above, the DOE has requested approval of two new forms, the HRP Certification form and the HRP Alcohol Testing form. The HRP Certification form is used internally to assure that an individual in an HRP position has met all of the annual program requirements. The HRP Alcohol Testing form is identical to the Department of Transportation (DOT) alcohol testing form with the only change being the insertion of the HRP in place of the DOT.
Comments regarding this collection must be received on or before December 2, 2002. If you anticipate that you will be submitting comments, but find it difficult to do so within the time period allowed by this Notice, please advise the OMB Desk Officer of your intention to make a submission as soon as possible. The Desk Officer may be telephoned at (202) 395-7318. In addition, please notify the DOE contact listed in this Notice.
Address comments to the DOE Desk Officer, Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10102, 735 17th Street, NW., Washington, DC 20503. (Comments should also be addressed to Susan L. Frey, Director, Records Management Division [IM-11], Office of Records and Business Management, Office of the Chief Information Officer, U.S. Department of Energy, 1000 Independence Avenue, SW., Washington, DC 20585-1290.
Current—Refusal of Consent [for Personnel Security Assurance Program (PSAP)].
New—Refusal of Consent [for Human Reliability Program (HRP)].
Current—Authorization and Consent To Release Personnel Security Assurance Program (PSAP) Records in Connection with PSAP.
New—Authorization and Consent To Release Human Reliability Program (HRP) Records in Connection with HRP.
Current—Acknowledgment and Agreement To Participate in the Personnel Security Assurance Program (PSAP).
New—Acknowledgment and Agreement To Participate in the Human Reliability Program (HRP).
(2)
(3)
(4)
(5)
Paperwork Reduction Act of 1995, P.L. No. 104-13, U.S.C. section 3507(h)(1).
Department of Energy.
Notice inviting grant applications.
The Office of Biological and Environmental Research (OBER) of the Office of Science (SC), U.S. Department of Energy (DOE) and the Office of Biological and Physical Research (OBPR), National Aeronautics and Space Administration (NASA), hereby announce their interest in receiving grant applications for new research to develop a better scientific basis for understanding exposures and risks to humans from low dose and low fluence radiation. Topics of high priority include endogenous oxidative damage versus low dose radiation-induced damage, radio-adaptive responses, bystander effects, and individual genetic susceptibility to low dose radiation exposure. Research should employ genome-wide or proteome-wide high-throughput screening methods whenever possible, and priority will also be given to the use of three-dimensional biological models. Research should support the DOE/OBER Low Dose Radiation Research Program, and may include complementary research of direct interest to the NASA/OBPR Space Radiation Health Program of sufficient scientific merit to qualify for partial NASA support. Please review the
The Office of Biological and Environmental Research of the Office of Science, U.S. Department of Energy also announces its interest in receiving smaller applications for grants to support collaborative work between two or more laboratories, one or more of which should be funded to do low dose-related research. Please review the
In addition, we anticipate a separate request for modeling projects in the near future.
Preapplications (letters of intent), including information on collaborators, areas of research, and a one-page summary of the proposed research, should be submitted by December 6, 2002.
Formal applications submitted in response to this notice must be received by 4:30 p.m., E.S.T., Thursday, February 27, 2003, in order to be accepted for merit review and to permit timely consideration for award in Fiscal Year 2003.
Preapplications referencing Program Notice 03-07, should be sent to Ms. Joanne Corcoran by E-mail:
Formal applications in response to this solicitation are to be electronically submitted by an authorized institutional business official through DOE's Industry Interactive Procurement System (IIPS) at:
If you are unable to submit an application through IIPS please contact the Grants and Contracts Division, Office of Science at (301) 903-5212 in order to gain assistance for submission through IIPS or to receive special approval and instructions on how to submit printed applications.
Dr. Noelle Metting, telephone: (301) 903-8309, E-mail:
The DOE/OBER Low Dose Radiation Research Program has the challenge of conducting research that can be used to inform the development of future national radiation risk policy for the public and the workplace. For the present solicitation, DOE/OBER is chiefly concerned with very low doses of low Linear Energy Transfer (LET) radiation (electrons, x- and gamma-rays). The focus of research should be on doses of low LET radiation that are at or near current workplace exposure limits. In general, research in this program should focus on total radiation doses that are less than or equal to 10 rads. Some experiments will likely involve selected exposures to higher doses of radiation for comparisons with previous experiments or for determining the validity of extrapolation methods previously used to estimate the effects of low doses of radiation from observations made at high doses. This research program will be a success if the science it generates is useful to policy makers, standard setters, and the public. Successful applicants will be expected to effectively communicate research results through publication in peer-reviewed journals. They will also be encouraged to communicate with the wider community of concerned persons, so that current thinking and the public debate is better able to reflect sound science.
Research projects utilizing the systems biology or discovery science approach, including the tools of comparative genomics and proteomics are especially sought. Research projects that use experimental protocols or cell microenvironments that will lead to an understanding of radiobiological responses in intact human tissue are also strongly encouraged.
Not all research on the biological effects of low doses of radiation will be equally useful for the development of radiation risk policy, though the path from basic radiation biology research to radiation risk policy is admittedly not clear at this time. In the present context, the research considered to be most useful will focus on biological responses that are known to be induced at low doses of radiation, have the potential to directly impact (
Alternatively, a biological response of interest could meet all of the above criteria only at high doses but may actually be absent (as opposed to simply undetectable) at low doses of radiation. Since evidence is accumulating that the mechanisms of action are different after high versus low doses of radiation, such studies would help define these mechanisms. Defining the doses where these mechanisms shift is of critical importance.
Living organisms are subject to a daily plethora of environmental insults. Carcinogenesis in an individual occurs as a function of all the forces and phenomena that go into the production of that individual's phenotype. These include (but are not limited to) individual genotype, as well as current and historical aspects of diet, physical exercise, and exposures to chemicals and radiation. To understand all factors responsible for individual responses to radiation, we are also soliciting research on key factors that influence the extent of metabolic, endogenously produced oxidative damage and, concomitantly, affect susceptibility to low doses of radiation.
Because applications to study bystander effects are limited to three-dimensional biological models, investigators are also encouraged to propose novel bioimaging protocols for the purpose of
The DOE Low Dose Program is currently funding several projects to develop micro-irradiation devices capable of delivering low doses of low LET radiation to individual cells or to specific parts of individual cells. Investigators are encouraged to use these irradiators, as appropriate, through collaborative means, and funds are available to assist in the collaborative use of these or comparable tools. Information on the microbeam irradiators can be found at:
A new resource that is now available to all Low Dose Program investigators, but might be of particular interest to those proposing research in the area of genetic susceptibility, is a tissue repository containing cells from patients who developed second cancers following total body irradiation and hematopoietic stem cell transplantation (HSCT). Presently there are EBV-transformed cell lines from 25 individuals exposed to radiation who subsequently developed a skin tumor, and an equal number from exposed individuals that have not yet developed a second cancer. A much larger tissue resource will be available in the future. Please contact directly Dr. Jeffrey L. Schwartz, Associate Professor of Radiation Oncology, University of Washington, (206) 598-4091, E-mail:
The NASA/OBPR Space Radiation Health Program is charged with providing input for the determination of health risks to humans visiting the space radiation environment. NASA is especially interested in human exposure to low fluences of high-energy particulate ionizing radiation (protons and heavy ions). Applications whose principal focus is on low LET radiation are encouraged to include complementary research with high-energy particulate ionizing radiation that leverages progress, resources, and technology used for the low LET radiation research. Investigators with currently funded low dose projects may also apply for supplementary funding to address closely related research of interest to NASA.
The primary area of emphasis of the NASA/OBPR Space Radiation Health Program is the development of mechanistic insights into biological effects of space radiation that account for radiation risks. Applications are required to be hypothesis-driven and are expected to obtain their data in ground-based experimental radiobiology studies with protons and high-energy heavy ion beams in the energy range corresponding to space radiation. This is mainly a ground-based program using accelerator facilities to simulate space radiation. In addition to the research topics already described above this includes research on non-phenomenological predictors of late cell and tissue effects and the control and modification of radiation effect mechanisms
A short description of the current Space Radiation Health Strategic Program may be found at:
Scientists working in rapidly developing areas of biological sciences not necessarily associated with the study of radiation are particularly encouraged to consider the contributions that their field of study can make to Radiation Health. Applications are required to provide evidence for expertise in radiation, either by reference to the Principal Investigator's work or by inclusion of active collaborators expert in radiation research. Hypotheses should be substantiated by presentation of preliminary data wherever feasible, or by adequate references to the published literature. Experimental applications should include a clear discussion of the relevant aspects of the required radiation dosimetry and an estimate of the statistical power of the expected results.
Research applications to which NASA will assign high priority:
a. Studies that increase the confidence in the accuracy of extrapolating the probability of radiation-induced genetic
b. Determination of carcinogenic risks following irradiation by protons and HZE particles.
c. Determination if exposure to heavy ions at the level that would occur in deep space poses a risk to the integrity and function of the central nervous system.
d. Studies likely to result in the development of biological countermeasures in humans that could lead to prevention or intervention (including genetic or pharmacological agents) against effects of radiation damage in space.
Research that can lead to future space flight investigations will be welcome, and should take into account the impact of gender, age, nutrition, stress, genetic predisposition, or sensitivity to other factors of importance in managing space radiation risks.
NASA envisions that the selected applications will be structured and operated in a manner that supports the country's educational initiatives and goals (including historically black colleges and universities and other minority universities), and in particular the need to promote scientific and technical education at all levels. NASA envisions that the selected applications will support the goals for public awareness and outreach to the general public. The selected investigators are invited to participate in NASA-funded educational programs.
The applications represent an opportunity to enhance and broaden the public's understanding and appreciation of radiation effects, as specified in the DOE Low Dose Program emphasis on communication of research results and the OBPR Policy for Education and Public Outreach. Therefore, all investigators are strongly encouraged to promote general scientific literacy and public understanding of radiation induced health risk research through formal and/or informal education opportunities. If appropriate, applications should include a clear and concise description of the education and outreach activities proposed. Examples include such items as involvement of students in the research activities, technology transfer plans, public information programs that will inform the general public of the benefits being gained from the research, and/or plans for incorporation of scientific results obtained into educational curricula consistent with educational standards.
Where appropriate, the supported institution will be required to produce, in collaboration with NASA, a plan for communicating to the public the value and importance of their work.
The particles of interest to the Space Radiation Health Program are protons with energies between 20 and 1000 MeV, and nuclei of He, C, N, O, Ne, Si, Ar, Ca, Mn, and Fe, with energies between 50 and 3000 MeV/nucleon. Fluences of interest are of the order of 1-2 particles per cell; studies with higher fluences will need to be justified by compelling arguments, including an explanation of how the results can be applied in the low fluence regime. NASA has developed facilities for use of protons at Loma Linda University Medical School and high-energy heavy ion beams at the Brookhaven National Laboratory Alternating Gradient Synchrotron (AGS). A dedicated irradiation facility, using the Booster Synchrotron at Brookhaven, is under construction and is expected to be operational in 2003. Applications should not budget for the use of beams at these facilities, which is paid by NASA. NASA will cooperate with DOE to expand the range of technical resources available for experimentation and analysis of experimental results at Brookhaven.
The Low Dose Radiation Research Program also announces its interest in receiving applications for the purpose of supporting collaborative work between two or more laboratories, one or more of which should be funded to do low dose-related research. These small grants are primarily designed to support post-doctoral or graduate-student research that will enable laboratories with complementary expertise to develop and apply innovative new approaches to low dose research. Comparative studies between laboratories already using similar experimental approaches are also encouraged. At least one of the applicants must hold a grant focusing on low dose issues. All applicants must have at least 1 year (and preferably 2 years) of support remaining on their core grants at the time of award. Collaborative glue grants can be set up between laboratories funded by such diverse agencies as DOE, NIH/NCI, NASA, DOD, EPA, the European Union, Canada, France, and Japan, but in any case preference will be given to proposed research that is of interest to the DOE Low Dose Radiation Research Program. The proposed collaborative research should add a new dimension or approach to at least one of the studies it is linking. Applications for these small grants must follow the instructions in IIPS for electronic submission. Please note: the Project Description should not exceed five pages.
It is anticipated that up to $4 million will be available from DOE/OBER for new basic research awards during FY 2003, contingent upon the availability of funds. Multiple year funding of grant awards is expected, and is also contingent upon the availability of appropriated funds, progress of the research, and continuing program need. Up to ten 3-year Glue Grants may be awarded, each averaging $60,000 total costs per year. Up to $0.5M will be available from NASA for joint funding of new research in Fiscal Year 2003, also contingent upon the availability of funds. Funds will be available from DOE to assist in the collaborative use of certain microbeam irradiators. NASA provides beam time at the Brookhaven AGS and the Loma Linda proton accelerator; investigators will not be required to pay for the beam time. It is expected that most awards will be from 1 to 3 years and will range from $100,000 to $500,000 per year (total costs).
Applicants are encouraged to collaborate with researchers in other institutions, such as universities, industry, non-profit organizations, federal laboratories and Federally Funded Research and Development Centers (FFRDCs), including the DOE National Laboratories, where appropriate, and to incorporate cost sharing and/or consortia wherever feasible. Additional information on collaboration is available in the Application Guide for the Office of Science Financial Assistance Program that is available via the Internet at:
Applications will be subjected to scientific merit review (peer review) and will be evaluated against the following evaluation criteria listed in descending order of importance as codified at 10 CFR 605.10(d):
1. Scientific and/or Technical Merit of the Project.
2. Appropriateness of the Proposed Method or Approach.
3. Competency of Applicant's Personnel and Adequacy of Proposed Resources.
4. Reasonableness and Appropriateness of the Proposed Budget.
The evaluation will include program policy factors such as the relevance of
Information about the development and submission of applications, eligibility, limitations, evaluation, selection process, and other policies and procedures may be found in the Application Guide for the Office of Science Financial Assistance Program and 10 CFR part 605. Electronic access to the Guide and required forms is made available via the World Wide Web:
Adherence to type size and line spacing requirements is necessary for several reasons. No applicants should have the advantage of providing more text in their applications by using small type. Small type may also make it difficult for reviewers to read the application. Applications must have 1-inch margins at the top, bottom, and on each side. Type sizes must be 10 point or larger. Line spacing is at the discretion of the applicant but there must be no more than 6 lines per vertical inch of text. Pages should be standard 8
Applicants are asked to use the following ordered format:
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• Budget pages and budget explanation for each collaborative subproject, if any.
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The Office of Science, as part of its grant regulations, requires at 10 CFR 605.11(b) that a recipient receiving a grant to perform research involving recombinant DNA molecules and/or organisms and viruses containing recombinant DNA molecules shall comply with the National Institutes of Health “Guidelines for Research Involving Recombinant DNA Molecules”, which is available via the World Wide Web at:
DOE requirements for reporting, protection of human and animal subjects and related special matters can be found on the World Wide Web at:
The Catalog of Federal Domestic Assistance number for this program is 81.049, and the solicitation control number is ERFAP 10 CFR part 605.
Department of Energy.
Notice of open meeting.
This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Idaho National Engineering and Environmental Laboratory. The Federal Advisory Committee Act (Pub. L. No. 92-463, 86 Stat. 770) requires that public notice of these meetings be announced in the
Tuesday, November 19, 2002, 8 a.m.-6 p.m., Wednesday, November 20, 2002, 8 a.m.-5 p.m.
These times are subject to change as the meeting progresses. Please check with the meeting facilitator to confirm these times.
West Coast Downtown, 1800 Fairview Avenue, Boise, Idaho 83702,
Ms. Wendy Lowe, Idaho National Engineering and Environmental Laboratory (INEEL) Citizens' Advisory Board (CAB) Facilitator, Jason Associates Corporation, 545 Shoup Avenue, Suite 335B, Idaho Falls, ID 83402, Phone (208) 522-1662 or visit the Board's Internet Home page at
• Transition in INEEL's mission to Nuclear Energy
• Possible remedial actions to reduce risks associated with the buried waste at the Radioactive Waste Management Complex
• Performance Management Plan for Accelerating Cleanup and recent activities under the Environmental Management program
• Design for Stage II of the Pit 9 removal action
• Fiscal Year 2003 funding allocation for the INEEL cleanup program
• Final Idaho High-Level Waste and Facilities Disposition Environmental Impact Statement
• Consolidation of spent nuclear fuel into dry storage
• Remediation approach for the V Tanks in Waste Area Group I (Test Area North)
• The Draft Remedial Action Work Plan for the Sorting, Sizing and Staging Treatment Facility and the waste acceptance criteria for the INEEL Comprehensive Environmental Response, Compensation, and Liability Act Disposal Facility
• Status of the Waste Incidental to Reprocessing Determination if the lawsuit has been resolved
• Completion of the 3,100 Cubic Meter Project
• Status of Advanced Mixed Waste Treatment Project
• Values and priorities that should inform decisions related to decontamination and decommissioning of facilities at INEEL
• Possible changes in how the CAB issues press releases proposed by the Public Communications Committee
• Possible evaluation of presentations delivered to the CAB
The following filings have been made with the Commission. The filings are listed in ascending order within each docket classification.
Take notice that on October 4, 2002, the Cities of Anaheim, Azusa, Banning, and Riverside, California (Southern Cities) filed a Petition for Declaratory Order, Request for Expedited Procedures, and Request for Waiver of Filing Fee. Southern Cities seek a determination of the propriety of a withdrawal provision in the Transmission Control Agreement that will enable them to participate in the California ISO as Participating Transmission Owners.
Take notice that on October 4, 2002, LMB Funding, Limited Partnership (Petitioner) filed a Petition for Declaratory Order Disclaiming Jurisdiction and Request for Expedited Consideration. Petitioner is seeking a disclaimer of jurisdiction in connection with a lease financing involving a generating plant of approximately 600 MW to be located in Lower Mount Bethel Township, Northampton County, Pennsylvania.
Take notice that on October 7, 2002, in compliance with the Commission's September 5, 2002 “Order Conditionally Approving Uncontested Settlement,” 100 FERC ¶ 61,255 (2002), in the above-referenced dockets, Westar Generating, Inc. (Westar) submitted a new Order 614 designation for the Purchase Power Agreement between Westar and Western Resources, Inc. (Western), and changes to Section 3.2 of Article III of the Settlement Agreement as required by the Order in the above-referenced proceedings.
A copy of this filing was served on every participant to the proceedings.
Take notice that on October 7, 2002, Southwest Power Pool, Inc. (SPP) submitted for filing the compliance filing required by the Federal Energy Regulatory Commission's September 5, 2002 issued in the proceeding listed above. Southwest Power Pool, Inc., 100 FERC ¶ 61,248.
Take notice that on October 7, 2002, in compliance with the Commission's order in Docket Nos. ER02-2008-000 and ER02-2008-001 issued September 5, 2002, Duke Energy Corp., 100 FERC 61,251, Duke Energy Corporation, on behalf of Duke Electric Transmission, filed a revised Interconnection and Operating Agreement by and between Duke Electric Transmission and GenPower Anderson, LLC. The Interconnection and Operating Agreement was made effective as of September 9, 2002 by the Commission.
Take notice that on October 7, 2002, New England Power Pool and ISO New England Inc. tendered for filing with the Federal Energy Regulatory Commission (Commission) a Compliance Filing in response to the Commission's September 20, 2002 Order issued in the above proceedings. Copies of these materials were sent to the NEPOOL
Take notice that on October 8, 2002, Pinnacle West Capital Corporation (PWCC) tendered for filing a refund report for the time value of revenues received from Phelps Dodge Energy Services (PDES).
A copy of this filing has been served on PDES.
Take notice that on October 8, 2002, Westar Energy, Inc. (Westar Energy) filed an errata to its Notification of Change in Status and Petition for Acceptance of Revised Market Rate Schedules. The errata corrects the proposed tariff sheets to comply with Order No. 614.
Take notice that on October 8, 2002, El Paso Electric Company (EPE) tendered for filing eight umbrella service agreements for firm transmission service, two umbrella service agreements for non-firm transmission service, and seven service agreements and accompanying specification sheets for firm transmission service transactions of exactly one year (collectively, TSAs) between EPE and nine of its customers. The rates, terms, and conditions of the TSAs are those of EPE's Open Access Transmission Tariff (OATT). EPE seeks effective dates for the TSAs in accordance with their service commencement dates.
Take notice that on October 8, 2002, Los Esteros Critical Energy Facility, LLC (Los Esteros) tendered for filing, under section'205 of the Federal Power Act, a request for authorization to make wholesale sales of electric energy, capacity and ancillary services at market-based rates, to reassign transmission capacity, and to resell firm transmission rights. Los Esteros proposes to own and operate an approximately 180 megawatt simple cycle natural gas-fired generation facility located in Santa Clara County, California.
Take notice that on October 8, 2002, Blue Spruce Energy Center, LLC (the Applicant) tendered for filing, under section'205 of the Federal Power Act (FPA), a request for authorization to make wholesale sales of electric energy, capacity, replacement reserves, and ancillary services at market-based rates, to reassign transmission capacity, and to resell firm transmission rights. Applicant proposes to own and operate a 300 MW gas fired, simple cycle electric generating facility in Aurora, Colorado.
Take notice that on October 8, 2002, Wisconsin Electric Power Company (Wisconsin Electric) tendered for filing revisions to the Wisconsin Corporation Operating Companies (WEC Operating Companies) Joint Ancillary Services Tariff. (WEC Operating Companies FERC Electric Tariff, Original Volume No. 2) Wisconsin Electric respectfully requests an effective date October 15, 2002.
Take notice that on October 2, 2002, Edison Sault Electric Company (Edison Sault) filed an application pursuant to section 204 of the Federal Power Act seeking authorization to issue, over a two-year period, long-term and short-term debt to its parent company, Wisconsin Energy Corporation, and/or short term debt to other third-party lenders, with no more than $50 million outstanding at any one time. Edison Sault also requests a waiver of the Commission's competitive bidding and negotiated placement requirements at 18 CFR 34.2.
Any person desiring to intervene or to protest this filing should file with the Federal Energy Regulatory Commission, 888 First Street, NE, Washington, DC 20426, in accordance with rules 211 and 214 of the Commission's rules of practice and procedure (18 CFR 385.211 and 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a motion to intervene. All such motions or protests should be filed on or before the comment date, and, to the extent applicable, must be served on the applicant and on any other person designated on the official service list. This filing is available for review at the Commission or may be viewed on the Commission's Web site at
The following filings have been made with the Commission. The filings are listed in ascending order within each docket classification.
Take notice that on October 10, 2002, Creed Energy Center, LLC tendered for filing a revised rate schedule to correct an error in the name of the company.
Take notice that on October 10, 2002, RockGen Energy LLC (the Applicant) tendered for filing with the Federal Energy Regulatory Commission (Commission), under section'205 of the Federal Power Act, a compliance filing pursuant to the Commission's September 10, 2002 Order in the above-captioned proceeding.
Take notice that on October 10, 2002, Allegheny Energy Service Corporation on behalf of Monongahela Power Company, The Potomac Edison Company, and West Penn Power Company (Allegheny Power), filed an amendment to its Interconnection Agreement (Agreement) with Mill Run Windpower LLC as First Revised Sheet No. 12 to First Revised Service Agreement No. 345 under Allegheny Power's Open Access Transmission Tariff. The proposed effective date for First Revised Sheet No.12 to First Revised Service Agreement No. 345 is September 20, 2002.
Copies of the filing have been provided to the Public Utilities Commission of Ohio, the Pennsylvania Public Utility Commission, the Maryland Public Service Commission, the Virginia State Corporation Commission, and the West Virginia Public Service Commission.
Take notice that on October 4, 2002 NorthWestern Energy, L.L.C. (NWE) filed with the Federal Energy Regulatory Commission (Commission) pages of Exhibit No. NWE-3 that were inadvertently omitted from NWE's September 20, 2002 filing with the Commission. On October 7, 2002, NWE filed a few more pages to Exhibit No. NWE-3 that were inadvertently omitted from the October 4, 2002 filing.
Take notice that on October 10, 2002, CP Power Sales Eighteen, L.L.C. tendered for filing a Notice of Succession. Effective September 10, 2002, CP Power Sales Eighteen, L.L.C. changed its name to Midwest Generation Energy Services, LLC.
Take notice that on October 10, 2002, The United Illuminating Company (The United Illuminating Company) tendered for filing with the Federal Energy Regulatory Commission (Commission) an Interconnection Agreement between UI and Cross-Sound Cable Company, LLC , executed pursuant to UI's Open Access Transmission Tariff, FERC Electric Tariff, Original Volume No. 4, as amended.
Take notice that on October 10, 2002 Virginia Electric and Power Company (Dominion Virginia Power), tendered for filing revisions to its Amended and Restated Interconnection and Operating Agreement (I&O Agreement), First Revised Rate Schedule FERC No. 126, between Dominion Virginia Power and Old Dominion Electric Cooperative (Old Dominion). The revisions address generation reserves in Section 8.05(a), operating costs in Section 11.01, reserve capacity charges in Appendix I and the appropriate billing format in Appendix L.
Dominion Virginia Power respectfully requests that the Commission allow the revised I&O Agreement to become effective on January 1, 2001 and allow the revisions in Section 8.05(a) and Appendix I to become effective as of January 1, 2002.
Copies of the filing were served upon Old Dominion, the Virginia State Corporation Commission and the North Carolina Utilities Commission.
Take notice that on October 11, 2002, Duquesne Light Company (DLC) filed a Service Agreement for Retail Network Integration Transmission Service and a Network Operating Agreement for Retail Network Integration Transmission Service dated October 11, 2002 with Constellation NewEnergy, Inc. under DLC's Open Access Transmission Tariff (Tariff). The Service Agreement and Network Operating Agreement adds Constellation NewEnergy, Inc. as a customer under the Tariff. DLC requests an effective date of October 11, 2002 for the Service Agreement.
Any person desiring to intervene or to protest this filing should file with the Federal Energy Regulatory Commission, 888 First Street, NE, Washington, DC 20426, in accordance with rules 211 and 214 of the Commission's rules of practice and procedure (18 CFR 385.211 and 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a motion to intervene. All such motions or protests should be filed on or before the comment date, and, to the extent applicable, must be served on the applicant and on any other person designated on the official service list. This filing is available for review at the Commission or may be viewed on the Commission's web site at
Environmental Protection Agency (EPA).
Notice.
In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
Comments must be submitted on or before December 2, 2002.
Send comments, referencing EPA ICR Number 1131.07 and OMB Control Number 2060-0054, to the following addresses: Susan Auby, United States Environmental Protection Agency, Collection Strategies Division (Mail Code 2822T), 1200 Pennsylvania Avenue, NW., Washington, DC 20460-0001; and to the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB),
For a copy of the ICR, contact Susan Auby at EPA by phone at: (202) 566-1672, by E-Mail to:
Owners or operators of the affected facilities described must make initial notifications, conduct and report on a performance test, demonstrate and report on continuous monitor performance, maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility. Semiannual reports of excess emissions are required. These notifications, reports, and records are required, in general, for all sources subject to NSPS. The recordkeeping and reporting requirements specific to glass manufacturing plants are detailed in the CFR. This information is being collected to assure compliance with 40 CFR part 60, subpart CC.
Any owner or operator subject to the provisions of this part shall maintain a file of these measurements, and retain the file for at least two years following the date of such measurements, maintenance reports, and records. All reports are sent to the delegated State or local authority. In the event that there is no such delegated authority, the reports are sent directly to the EPA Regional Office.
In the Administrator's judgment, particulate matter emissions from glass manufacturing plants cause or contribute to air pollution that may reasonably be anticipated to endanger public health or welfare. Therefore, NSPS were promulgated for this source category at 40 CFR part 60, subpart CC.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15. The
Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the addresses listed above. Please refer to EPA ICR Number 1131.07 and OMB Control Number 2060-0054 in any correspondence.
Environmental Protection Agency (EPA).
Notice.
In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
Comments must be submitted on or before December 2, 2002.
Send comments, referencing EPA ICR No. 1867.02 and OMB Control No. 2060-0411, to the following addresses: Susan Auby, U.S. Environmental Protection Agency, Collection Strategies Division (Mail Code 2822T), 1200 Pennsylvania Avenue, NW., Washington, DC 20460-0001; and to Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503.
For a copy of the ICR contact Susan Auby at EPA by phone at (202) 566-1672, by E-Mail at
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15. The
Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the addresses listed above. Please refer to EPA ICR No. 1867.02 and OMB Control No. 2060-0411 in any correspondence.
Environmental Protection Agency (EPA).
Notice.
In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
Comments must be submitted on or before December 2, 2002.
Send comments, referencing EPA ICR No. 1820.03 and OMB Control No. 2040-0211, to the following addresses: Susan Auby, U.S. Environmental Protection Agency, Collection Strategies Division (Mail Code 2822T), 1200 Pennsylvania Avenue, NW, Washington, DC 20460-0001; and to Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, NW, Washington, DC 20503.
For a copy of the ICR contact Susan Auby at EPA by phone at (202) 566-1672, by E-Mail at
Permits were not required for small construction sites and regulated small MS4s during the first three years of the program. The data collection effort during this first three-year period was limited to the submittal and review of no exposure certifications and some preliminary Agency work in developing specific program elements. A significant increase in burden for this ICR is the product of that fact.
After general permits for small MS4s and small construction sites are issued in December of 2002, NPDES permitting authorities, including the Water Permits Division of the EPA Office of Wastewater Management, intend to use the data contained in storm water
It is expected that respondents will submit information in hard copy form. The information from them will be entered into a computer database and the original document will be filed. The information will be submitted by the respondents directly to each NPDES-authorized State or Territory, or to EPA in areas where EPA is the NPDES permitting authority. Plans are underway to allow electronic submission of much of the required information but these options are not included in the ICR. At the time those options become available, EPA will update this information collection to reflect a revised burden estimate.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15. The
Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the addresses listed above. Please refer to EPA ICR No. 1820.03 and OMB Control No. 2040-0211 in any correspondence.
Responsible Agency: Office of Federal Activities, General Information (202) 564-7167 or
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 12, 2002 (67 FR 17992).
Environmental Protection Agency.
Notice of availability of a final document.
The U.S. Environmental Protection Agency (EPA) is announcing the availability of a final document,
A limited number of copies of the
James Raub, National Center for Environmental Assessment/Research Triangle Park Office (MD-B-243-01), U.S. Environmental Protection Agency, Research Triangle Park, NC 27711; telephone: 919-541-4157; facsimile: 919-541-1818; e-mail:
The
Asthma is characterized by chronic airway inflammation, mucus secretion, airway remodeling, and reversible airway obstruction. The disease has a definite genetic component, and can be caused by a variety of factors. In susceptible individuals, the inflammation causes recurrent episodes of wheezing, breathlessness, chest tightness, and cough particularly at night and/or early morning. Airflow obstruction usually associated with these symptoms is partly reversible either spontaneously or with treatment. Inflammation also causes an increase in airway responsiveness to a variety of stimuli. Most types of asthma are linked to allergic responses to common aeroallergens present in the indoor and outdoor environment. Common allergens include: house-dust mites, cockroaches, animal secretions, pollens, and molds. Exacerbation of asthma may occur with subsequent re-exposure to allergens or by exposure to a number of nonspecific triggers such as respiratory viruses, tobacco smoke, or certain air pollutants.
EPA has prepared the
This
Environmental Protection Agency.
Notice; request for public comment.
In accordance with section 122(i) of the Comprehensive Environmental Response, Compensation, and Liability Act, as amended (“CERCLA”), 42 U.S.C. 9622(i), notice is hereby given of a proposed administrative settlement for recovery of past response costs concerning the Yonkelowitz Junkyard Site in Hoopeston, Vermilion County, Illinois with the following settling parties: Martin Young and the Martin Young Trust. The settlement requires Martin Young to pay $50,000 to the Hazardous Substance Superfund. Also, the settlement requires the Martin Young Trust to pay to the Hazardous Substance Superfund, within 60 days of receipt, all proceeds received from the sale, lease, transfer, mortgage, grant of, or conveyance of any interest, etc. in property located at the northwest corner of the intersection of First Avenue and Main Street, Hoopeston, Vermilion County, Illinois. The settlement includes a covenant not to sue the settling parties pursuant to section 107(a) of CERCLA, 42 U.S.C. 9607(a), with respect to past response costs. For thirty (30) days following the date of publication of this notice, the Agency will receive written comments relating to the settlement. The Agency will consider all comments received and may modify or withdraw its consent to the settlement if comments received disclose facts or considerations which indicate that the settlement is inappropriate, improper, or inadequate. The Agency's response to any comments received will be available for public inspection at the United States Environmental Protection Agency, Region 5, 77 West Jackson Blvd., Chicago, Illinois 60604-3590.
Comments must be submitted on or before December 2, 2002.
The proposed settlement is available for public inspection at the United States Environmental Protection Agency, Region 5, 77 West Jackson Blvd., Chicago, Illinois 60604-3590. A copy of the proposed settlement may be
Diana Embil, Associate Regional Counsel, United States Environmental Protection Agency, Region 5, 77 West Jackson Blvd. (C-14J), Chicago, Illinois 60604-3590, (312) 886-7889.
Environmental Protection Agency (“EPA”).
Notice.
EPA is providing notice of five proposed administrative penalty assessments for alleged violations of the Clean Water Act (“Act”). EPA is also providing notice of opportunity to comment on the proposed assessments.
EPA is authorized under section 309(g) of the Act, 33 U.S.C. 1319(g), to assess a civil penalty after providing the person subject to the penalty notice of the proposed penalty and the opportunity for a hearing, and after providing interested persons notice of the proposed penalty and a reasonable opportunity to comment on its issuance. Under section 309(g), any person who has violated the conditions of a National Pollutant Discharge Elimination System permit may be assessed a penalty in a “Class II” administrative penalty proceeding. Class II proceedings under section 309(g) are conducted in accordance with the “Consolidated Rules of Practice Governing the Administrative Assessment of Civil Penalties, Issuance of Compliance or Corrective Action Orders, and the Revocation, Termination or Suspension of Permits,” 40 CFR part 22 (“Consolidated Rules”), published at 64 FR 40138, 40177 (July 23, 1999).
On September 30, 2002, EPA commenced the following Class II proceedings for the assessment of penalties by filing with Danielle Carr, Regional Hearing Clerk, U.S. EPA, Region IX, 75 Hawthorne Street, San Francisco, California 94105, (415) 972-3871, the following Complaints:
In the Matter of Pick Your Part Auto Wrecking—Chula Vista, Docket No. CWA-9-2002-01; Pick Your Part Auto Wrecking—Help Yourself, Docket No. CWA-9-2002-07; Pick Your Part Auto Wrecking—Santa Paula, Docket No. CWA-9-2002-08; Pick Your Part Auto Wrecking—Sun Valley, Docket No. CWA-9-2002-09; Pick Your Part Auto Wrecking—Wilmington, Docket No. CWA-9-2002-10.
Each Complaint proposes a penalty of up to One Hundred Thirty Seven Thousand, Five Hundred Dollars ($137,500) for violations of NPDES Permit No. CAS000001 (issued by the California State Water Resources Control Board (Order No. 97-03-DWQ)) and sections 301(a) and 308(a) of the Act, 33 U.S.C. 1311(a), 1318(a), at Pick Your Part facilities in Chula Vista, Santa Paula, Sun Valley, and Wilmington, California.
The procedures by which the public may comment on a proposed Class II penalty or participate in a Class II penalty proceeding are set forth in the Consolidated Rules. The deadline for submitting public comment on a proposed Class II penalty is thirty (30) days after issuance of public notice. The Regional Administrator of EPA, Region 9, may issue an order upon default if the respondent in the proceeding fails to file a response within the time period specified in the Consolidated Rules.
Persons wishing to receive a copy of EPA's Consolidated Rules, review one or more of the Complaints, or other documents filed in these proceedings, comment upon the proposed assessments, or otherwise participate in the proceedings should contact Danielle Carr, Regional Hearing Clerk, U.S. EPA, Region IX, 75 Hawthorne Street, San Francisco, California 94105, (415) 972-3871. The administrative record for this proceeding is located in the EPA Regional Office identified above, and the file will be open for public inspection during normal business hours. All information submitted by Pick Your Part is available as part of the administrative record, subject to provisions of law restricting public disclosure of confidential information. In order to provide opportunity for public comment, EPA will issue no final order assessing a penalty in these proceedings prior to thirty (30) days after the date of publication of this notice.
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 14, 2002 regular meeting of the Farm Credit Administration Board (Board) will not be held. The FCA Board will hold a special meeting at 9 a.m. on Thursday, November 7, 2002. An agenda for this meeting will be published at a later date.
Jeanette C. Brinkley, Acting 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.
This document announces the procedures and minimum opening bids for the upcoming auction of construction permits for new AM broadcast stations (Auction No. 32) scheduled to begin December 10, 2002. This document is intended to familiarize prospective bidders with the procedures and minimum opening bids for this auction.
Auction No. 32 is scheduled to begin on December 10, 2002.
Auctions and Industry Analysis Division: Kenneth Burnley, Legal Branch, at (202) 418-0660; Linda Sanderson, or Roy Knowles, Auctions Operations Branch at (717) 338-2888. Media Contact: Meribeth McCarrick at (202) 418-0654. Audio Division: Lisa Scanlan or Edward DeLaHunt at (202) 418-2700.
This is a summary of the
1. By the
2. Auction No. 32 will include construction permits for three new AM broadcast stations. These construction permits are the subject of pending, mutually exclusive short-form applications (FCC Form 175) filed on or before February 1, 2000, and participation in this auction is limited to the applicants identified in Attachment A of the
3.
4. The Bureaus will not delay the auction for MX Group AM 38 as requested by the commenters. In the
5. As stated in the
6. Prospective bidders must familiarize themselves thoroughly with the Commission's rules relating to the AM broadcast service contained in title 47, part 73 of the Code of Federal Regulations. Prospective bidders must also be familiar with the rules relating to broadcast auctions and competitive bidding proceedings in title 47, part 1, subpart Q and part 73, subpart I of the Commission's rules. Prospective bidders must also be thoroughly familiar with the procedures, terms and conditions contained in the
7. The terms contained in the Commission's rules, relevant orders, and public notices are not negotiable. The Commission may amend or supplement the information contained in our public notices at any time, and will issue public notices to convey any new or supplemental information to bidders. It is the responsibility of all prospective bidders to remain current with all Commission rules and with all public notices pertaining to this auction. Copies of most Commission documents, including public notices, can be retrieved from the FCC Auctions Internet site at
8. Bidders are reminded that § 1.2105(c) of the Commission's rules prohibits competing applicants from communicating with each other during the auction about bids, bidding strategies, or settlements unless they have identified each other as parties with whom they have entered into agreements under § 1.2105(a)(2)(viii). For further details regarding the anti-collusion rule, refer to the
9. Bidders in Auction No. 32 are encouraged not to use the same individual acting as an authorized bidder for any other applicant. A violation of the anti-collusion rule could occur if an individual acts as the authorized bidder for two or more competing applicants, and conveys information concerning the substance of bids or bidding strategies between the bidders he/she is authorized to represent in the auction. A violation could similarly occur if the authorized bidders are different individuals employed by the same organization (
10. In addition, § 1.65 of the Commission's rules requires an applicant to
11. A summary listing of documents from the Commission and the Bureaus addressing the application of the anti-collusion rules may be found in Attachment D of the
12. Potential bidders are reminded that they are solely responsible for investigating and evaluating all technical and market place factors that may have a bearing on the value of the AM broadcast facilities in this auction. The FCC makes no representations or warranties about the use of this spectrum for particular services. Applicants should be aware that an FCC auction represents an opportunity to become an FCC permittee in the broadcast service, subject to certain conditions and regulations. An FCC auction does not constitute an endorsement by the FCC of any particular service, technology, or product, nor does an FCC construction permit or license constitute a guarantee of business success. Applicants should perform their individual due diligence before proceeding as they would with any new business venture.
13. Potential bidders are strongly encouraged to conduct their own research prior to Auction No. 32 in order to determine the existence of pending proceedings that might affect their decisions regarding participation in the auction. Participants in Auction No. 32 are strongly encouraged to continue to conduct due diligence examinations regarding pending proceedings and other legal developments with respect to the construction permits for which they may bid during the course of the auction. Bidders should be aware that certain applications (including those for modification), petitions for rulemaking, requests for special temporary authority (“STA”), waiver requests, petition to deny, petitions for reconsideration, and applications for review may be pending before the Commission and relate to particular applicants or the construction permits available in Auction No. 32. In addition, certain judicial proceedings that may relate to particular applicants or the construction permits available in Auction No. 32 may be commenced or may be pending or subject to further review. We note that resolution of these matters could have an impact on the availability of spectrum in Auction No. 32. Some of these matters (whether before the Commission or the courts) may not be resolved at the time of the auction. In the event that a final determination reached in a pending proceeding requires a winning bidder to surrender a construction permit(s) won in Auction No. 32, the Commission will return payments relating to such construction permit(s) to the payor of record. The Commission, however, will not pay interest on the returned payment(s) as it lacks the legal authority to do so.
14. Bidders are solely responsible for identifying associated risks and for investigating and evaluating the degree to which such matters may effect their ability to bid on, otherwise acquire, or make use of the construction permits available in Auction No. 32.
15. By submitting an FCC Form 175 application, applicants have certified under penalty of perjury that they are legally, technically, financially and otherwise qualified to hold a license, and not in default on any payment for Commission licenses or construction permits (including down payments) or delinquent on any non-tax debt owed to any Federal agency. Prospective bidders are reminded that submission of a false certification to the Commission is a serious matter that may result in severe penalties, including monetary forfeitures, license revocations, exclusion from participation in future auctions, and/or criminal prosecution.
16. As is the case with many business investment opportunities, some unscrupulous entrepreneurs may attempt to use Auction No. 32 to deceive and defraud unsuspecting investors. Common warning signals of fraud include the following:
• The first contact is a “cold call” from a telemarketer, or is made in response to an inquiry prompted by a radio or television infomercial.
• The offering materials used to invest in the venture appear to be targeted at IRA funds, for example by including all documents and papers needed for the transfer of funds maintained in IRA accounts.
• The amount of the minimum investment is less than $25,000.
• The sales representative makes verbal representations that: (a) The Internal Revenue Service (“IRS”), Federal Trade Commission (“FTC”), Securities and Exchange Commission (“SEC”), FCC, or other government agency has approved the investment; (b) the investment is not subject to state or federal securities laws; or (c) the investment will yield unrealistically high short-term profits. In addition, the offering materials often include copies of actual FCC releases, or quotes from FCC personnel, giving the appearance of
Information about deceptive telemarketing investment schemes is available from the FTC at (202) 326-2222 and from the SEC at (202) 942-7040. Complaints about specific deceptive telemarketing investment schemes should be directed to the FTC, the SEC, or the National Fraud Information Center at (800) 876-7060. Consumers who have concerns about specific proposals may also call the FCC Consumer Center at (888) CALL-FCC ((888) 225-5322).
17. Permittees must comply with the Commission's rules regarding the National Environmental Policy Act (NEPA). The construction of a broadcast antenna facility is a federal action and the permittee must comply with the Commission's NEPA rules for each such facility. The Commission's NEPA rules require, among other things, that the permittee consult with expert agencies having NEPA responsibilities, including the U.S. Fish and Wildlife Service, the State Historic Preservation Office, the Army Corp of Engineers and the Federal Emergency Management Agency (through the local authority with jurisdiction over floodplains). The permittee must prepare environmental assessments for facilities that may have a significant impact in or on wilderness areas, wildlife preserves, threatened or endangered species or designated critical habitats, historical or archaeological sites, Indian religious sites, floodplains, and surface features. The permittee must also prepare environmental assessments for facilities that include high intensity white lights in residential neighborhoods or excessive radio frequency emission.
18. Auction No. 32—will begin on Tuesday, December 10, 2002. The initial schedule for bidding will be announced by public notice at least one week before the start of the auction. Unless otherwise announced, bidding on all construction permits will be conducted on each business day until bidding has stopped on all construction permits.
19. Auction No. 32—New AM Broadcast Stations.
20. The bidding methodology for Auction No. 32 will be simultaneous multiple round bidding. The Commission will conduct this auction over the Internet. Telephonic bidding will also be available. As a contingency, the FCC Wide Area Network will be available as well. Qualified bidders are permitted to bid telephonically or electronically.
21. Listed are important dates associated with Auction No. 32:
22. Those wishing to participate in the auction must:
• Be listed on Attachment A of the
• Submit a sufficient upfront payment and an FCC Remittance Advice Form (FCC Form 159) by 6 p.m. ET, November 15, 2002.
• Comply with all provisions outlined in this public notice and applicable Commission rules.
23. The following is a list of general contact information relating to Auction No. 32.
24. As noted in the
25. A separate copy of the letter should be faxed to the attention of Kathryn Garland at (717) 338-2850. Questions about other changes should be directed to Kenneth Burnley of the Auctions and Industry Analysis Division at (202) 418-0660.
26. In addition, applicants should make these changes to their FCC Form 175 applications on-line after release of the public notice explaining the status of the applications.
27. Although applicants submitted their original FCC Form 175 applications by using a Taxpayer Identification Number (TIN), any review of and updates to these applications will require the use of an FCC Registration Number (FRN). On August 24, 2001, the
28. To obtain an FRN, an applicant must register their TIN using the CORES. To access CORES, point web browser to the FCC Auctions page at
29. A filing window for review and resubmission of FCC Form 175 applications will open after the future release of a public notice announcing the status of applications. This public notice announcing the status of applications will contain additional information for reviewing and accessing applications.
30.
31. As noted in the
32. Installment payment plans will not be available in Auction No. 32.
33. The FCC will process all timely submitted applications to determine which are acceptable for filing, and subsequently will issue a public notice identifying: (i) Those applications accepted for filing; (ii) those applications rejected; and (iii) those applications which have minor defects that may be corrected, and the deadline for filing such corrected applications.
34. As described more fully in the Commission's rules, after the short-form filing deadline, applicants may make only minor corrections to their FCC Form 175 applications. For example, permissible minor changes include deletion and addition of authorized bidders (to a maximum of three) and certain revision of exhibits. Applicants will not be permitted to make major modifications to their applications (
35. On November 6, 2002, the FCC will sponsor a free seminar for Auction No. 32 at the Federal Communications Commission, located at 445 12th Street, SW. (Room 4-B516), Washington, DC. The seminar will provide attendees with information about pre-auction procedures, conduct of the auction, FCC Automated Auction System, and the broadcast service and auction rules. The seminar will also provide an opportunity for prospective bidders to ask questions of FCC staff.
36. To register, complete the registration form included as Attachment B of the
37. In order to be eligible to bid in the auction, applicants must submit an upfront payment accompanied by an FCC Remittance Advice Form (FCC Form 159). After the FCC Form 175 becomes available electronically, filers will have access to an electronic version of the FCC Form 159 that can be printed and faxed to Mellon Bank in Pittsburgh, PA. All upfront payments must be received at Mellon Bank by 6 p.m. ET on November 15, 2002.
Please note that:
• All payments must be made in U.S. dollars.
• All payments must be made by wire transfer.
• Upfront payments for Auction No. 32 go to a lockbox number different from the ones used in previous FCC auctions, and different from the lockbox number to be used for post-auction payments.
• Failure to deliver the upfront payment by the November 15, 2002 deadline will result in dismissal of the application and disqualification from participation in the auction.
38. Wire transfer payments must be received by 6 p.m. ET on November 15, 2002. To avoid untimely payments, applicants should discuss arrangements (including bank closing schedules) with their banker several days before they plan to make the wire transfer, and allow sufficient time for the transfer to be initiated and completed before the deadline. Applicants will need the following information:
The BNF and Lockbox number are specific to the upfront payments for this auction; do not use BNF or Lockbox numbers from previous auctions.
39. Applicants must fax a completed FCC Form 159 (Revised 2/00) to Mellon Bank at (412) 209-6045 at least one hour before placing the order for the wire transfer (but on the same business day). On the cover sheet of the fax, write “Wire Transfer—Auction Payment for Auction Event No. 32.” Bidders should confirm receipt of their upfront payment at Mellon Bank by contacting their sending financial institution.
40. A completed FCC Remittance Advice Form (FCC Form 159, Revised 2/00) must be faxed to Mellon Bank in order to accompany each upfront payment. Proper completion of FCC Form 159 (Revised 2/00) is critical to ensuring correct credit of upfront payments. Detailed instructions for completion of FCC Form 159 are included in Attachment C of the
41. The Commission delegated to the Bureaus the authority and discretion to determine appropriate upfront payment(s) for each auction. In addition, in the
42. In the
43. Former defaulters should calculate their upfront payment for all construction permits by multiplying the number of bidding units they wish to purchase by 1.5. In order to calculate the number of bidding units to assign to former defaulters, the Commission will divide the upfront payment received by 1.5 and round the result up to the nearest bidding unit.
An applicant's actual bidding in any round will be limited by the bidding units reflected in its upfront payment, in conjunction with the selections made on the FCC Form 175.
44. The Commission will use wire transfers for all Auction No. 32 refunds. To ensure that refunds of upfront payments are processed in an expeditious manner, the Commission is requesting that all pertinent information as listed be supplied to the FCC. Applicants can provide the information electronically after the FCC Form 175 becomes available for review. Wire Transfer Instructions can also be manually faxed to the FCC, Financial Operations Center, Auctions Accounting Group, ATTN: Tim Dates or Gail Glasser, at (202) 418-2843 by November 15, 2002. All refunds will be returned to the payer of record as identified on the FCC Form 159 unless the payer submits written authorization instructing otherwise. For additional information, please call (202) 418-1995.
45. Approximately ten days before the auction, the FCC will issue a public notice announcing all qualified bidders for the auction. Qualified bidders are those applicants whose FCC Form 175 applications have been accepted for filing and have timely submitted upfront payments sufficient to make them eligible to bid on the construction permit for which they applied.
46. All qualified bidders are automatically registered for the auction. Registration materials will be distributed prior to the auction by two separate overnight mailings, one containing the confidential bidder identification number (BIN) required to place bids and the other containing the SecurID cards. These mailings will be sent only to the contact person at the contact address listed in the FCC Form 175.
47. Applicants that do not receive both registration mailings will not be able to submit bids. Therefore, any qualified applicant that has not received both mailings by noon on Tuesday, December 3, 2002, should contact the Auctions Hotline at 717-338-2888. Receipt of both registration mailings is critical to participating in the auction and each applicant is responsible for ensuring it has received all of the registration material.
48. Qualified bidders should note that lost bidder identification numbers or SecurID cards can be replaced only by appearing
49. The Commission will conduct this auction over the Internet. Telephonic bidding will also be available. As a contingency, the FCC Wide Area Network will be available as well. The telephone number through which the backup FCC Wide Area Network may be accessed will be announced in a later public notice. Qualified bidders are permitted to bid telephonically or electronically,
50. Please note that the SecurID cards can be recycled, and we encourage bidders to return the cards to the FCC. We will provide pre-addressed envelopes that bidders may use to return the cards once the auction is over.
51. All qualified bidders will be eligible to participate in a mock auction on Thursday, December 5, 2002. The mock auction will enable applicants to become familiar with the FCC Automated Auction System prior to the auction. Participation by all bidders is strongly recommended. Details will be announced by public notice.
52. The first round of bidding for Auction No. 32 will begin on Tuesday, December 10, 2002. The initial bidding schedule will be announced in the public notice listing the qualified bidders, which is released approximately 10 days before the start of the auction.
53. In the
54. In the
55. For Auction No. 32, we adopt our proposal. The amount of the upfront payment submitted by a bidder determines the maximum initial eligibility (in bidding units) for each bidder. Note again that each construction permit is assigned a specific number of bidding units equal to the upfront payment listed in Attachment A of the
56. In addition, we received no comments on our proposal for a single stage auction. Therefore, in order to ensure that the auction closes within a reasonable period of time, we adopt our proposal with the following activity requirements: a bidder must either, place a valid bid and/or be the standing high bidder during each round of the auction rather than wait until the end before participating. A bidder is required to be active on 100 percent of their bidding eligibility. Failure to maintain the requisite activity level will result in the use of an activity rule waiver, if any remain, or a reduction in the bidder's bidding eligibility, thus eliminating them from the auction.
57. In the
58. Based upon our experience in previous auctions, we adopt our proposal that each bidder be provided three activity rule waivers that may be used in any round during the course of the auction. Use of an activity rule waiver preserves the bidder's current bidding eligibility despite the bidder's activity in the current round being below the required minimum level. An activity rule waiver applies to an entire round of bidding. We are satisfied that our practice of providing three waivers over the course of the auction provides a sufficient number of waivers and flexibility to the bidders, while safeguarding the integrity of the auction.
59. The FCC Automated Auction System assumes that bidders with insufficient activity would prefer to use an activity rule waiver (if available) rather than lose bidding eligibility. Therefore, the system will automatically apply a waiver (known as an “automatic waiver”) at the end of any bidding period where a bidder's activity level is below the minimum required. If a bidder has no waivers remaining and does not satisfy the required activity level, the bidder's eligibility will be permanently reduced, eliminating them from the auction.
60. A bidder may proactively use an activity rule waiver as a means to keep the auction open without placing a bid. If a bidder submits a proactive waiver (using the proactive waiver function in the bidding system) during a bidding period in which no bids are submitted, the auction will remain open and the bidder's eligibility will be preserved. An automatic waiver invoked in a round in which there are no new valid bids will not keep the auction open. Note: Once a proactive waiver is placed during a round, that waiver cannot be unsubmitted.
61. For Auction No. 32, the Bureaus proposed to employ a simultaneous stopping rule. Under this rule, bidding will remain open on all construction permits until bidding stops on every construction permit. The auction will close for all construction permits when one round passes during which no bidder submits a new acceptable bid on any construction permit, or applies a proactive waiver. After the first such round, bidding closes simultaneously on all construction permits.
62. The Bureaus also proposed retaining discretion to implement a modified version of the simultaneous stopping rule. The modified version will close the auction for all construction permits after the first round in which no bidder submits a proactive waiver, or a new bid on any construction permit on which it is not the standing high bidder. Thus, absent any other bidding activity, a bidder placing a new bid on a construction permit for which it is the standing high bidder will not keep the auction open under this modified stopping rule.
63. The Bureaus further proposed retaining the discretion to keep the auction open even if no new acceptable bids or proactive waivers are submitted in a round. In this event, the effect will be the same as if a bidder had submitted a proactive waiver. Thus, the activity rule will apply as usual, and a bidder with insufficient activity will either lose bidding eligibility or use an activity rule waiver (if any remain).
64. In addition, the Bureaus proposed that they reserve the right to declare that the auction will end after a designated number of additional rounds (“special stopping rule”). If the Bureaus invoke this special stopping rule, it will accept bids in the final round(s) only for construction permits on which the high bid increased in at least one of the preceding specified number of rounds. The Bureaus proposed to exercise this
65. The Bureaus received no comments on these issues, therefore, we adopt all of the proposals concerning the auction stopping rules. Auction No. 32 will begin under the simultaneous stopping rule, and the Bureaus will retain the discretion to invoke the other versions of the stopping rule. The Bureaus believe that these stopping rules are most appropriate for Auction No. 32, because their experience in prior auctions demonstrates that the auction stopping rules balance the interests of administrative efficiency and maximum bidder participation.
66. In the
67. Because this approach has proven effective in resolving exigent circumstances in previous auctions, we adopt our proposed auction cancellation rules. By public notice or by announcement during the auction, the Bureaus may delay, suspend or cancel the auction in the event of natural disaster, technical obstacle, evidence of an auction security breach, unlawful bidding activity, administrative or weather necessity, or for any other reason that affects the fair and competitive conduct of competitive bidding. In such cases, the Bureaus, in their sole discretion, may elect to resume the auction starting from the beginning of the current round, resume the auction starting from some previous round, or cancel the auction in its entirety. Network interruption may cause the Bureaus to delay or suspend the auction. We emphasize that exercise of this authority is solely within the discretion of the Bureaus, and its use is not intended to be a substitute for situations in which bidders may wish to apply their activity rule waivers.
68. The initial bidding schedule will be announced in the public notice listing the qualified bidders, which is released approximately 10 days before the start of the auction. The round structure for each bidding round contains a single bidding round followed by the release of the round results. Multiple bidding rounds may be conducted in a given day. Details regarding round result formats and locations will also be included in the qualified bidders public notice referenced.
69. The Bureaus have the discretion to change the bidding schedule in order to foster an auction pace that reasonably balances speed with the bidders' need to study round results and adjust their bidding strategies. The Bureaus may increase or decrease the amount of time for the bidding rounds and review periods, or the number of rounds per day, depending upon the bidding activity level and other factors.
70.
71. In the
72. In the
73. In each round, each eligible bidder will be able to place a bid on the particular construction permit for which it applied in any of nine different amounts. The Auctions Bidding System interface will list the nine acceptable bid amounts for each construction permit.
74. For Auction No. 32, the Bureaus proposed to use a fixed 10 percent bid increment. This means that the minimum acceptable bid for a construction permit will be approximately 10 percent greater than the previous standing high bid received on the construction permit. The minimum acceptable bid amount will be calculated by multiplying the standing high bid times one plus the fixed percentage—
75. At the start of the auction and until a bid has been placed on a construction permit, the minimum acceptable bid for that construction permit will be equal to its minimum opening bid. Corresponding additional bid amounts will be calculated using bid increments defined as the difference between the minimum opening bid times one plus the percentage increment, rounded as described, and the minimum opening bid—
76. Once there is a standing high bid on the construction permit, the Auctions Bidding System will calculate a minimum acceptable bid for that construction permit for the following round, as described. The difference between the minimum acceptable bid and the standing high bid for each construction permit will define the bid increment—
77. The Bureaus retain the discretion to change the minimum acceptable bids and bid increments and the methodology for determining the minimum acceptable bids and bid increments if they determine circumstances so dictate. The Bureaus will do so by announcement in the FCC Automated Auction System. The Bureaus may also use its discretion to adjust the minimum bid increment without prior notice if circumstances warrant.
78. At the end of each round, the FCC Automated Auction System determines the standing high bid for each construction permit based on the gross dollar amounts of the bids received for each construction permit.
79. In the case of tied high bids, a random number generator will be used to determine the standing high bid. A random number will be assigned to each bid. The tie bid having the highest random number will become the standing high bid.
80. During a bidding round, a bidder may submit a bid, subject to its eligibility, as well as remove a bid placed in the same bidding round. Bidders also have the option of making multiple submissions in each bidding round. If a bidder submits multiple bids for a construction permit in the same round, the system takes the last bid entered as that bidder's bid for the round. Bidders should note that the bidding units associated with the construction permit for which the bidder has removed its bid do not count towards the bidder's activity at the close of the round.
81. Please note that all bidding will take place remotely either through the FCC Automated Auction System or by telephonic bidding. (Telephonic bid assistants are required to use a script when entering bids placed by telephone. Telephonic bidders are therefore reminded to allow sufficient time to bid by placing their calls well in advance of the close of a round. Normally, four to five minutes are necessary to complete a bid submission.) There will be no on-site bidding during Auction No. 32.
82. A bidder's ability to bid on a specific construction permit in the first round of the auction is determined by two factors: (i) The construction permit applied for on FCC Form 175 and (ii) the upfront payment amount deposited. The bid submission screens will allow bidders to submit bids on only the construction permit for which the bidder applied on its FCC Form 175.
83. The FCC Automated Auction System requires each bidder to be logged in during the bidding round using the bidder identification number provided in the registration materials, and the generated SecurID code. Bidders are strongly encouraged to print bid confirmations
84. In each round, eligible bidders will be able to place bids on a given construction permit in any of nine different amounts. For each construction permit, the FCC Automated Auction System interface will list the nine acceptable bid amounts in a drop-down box. Bidders may use the drop-down box to select from among the nine acceptable bid amounts. The FCC Automated Auction System also includes an import function that allows bidders to upload text files containing their bid information.
85. Until a bid has been placed on a construction permit, the minimum acceptable bid for that construction permit will be equal to its minimum opening bid. Once there is a standing high bid on a construction permit, the FCC Automated Auction System will calculate a minimum acceptable bid for that construction permit for the following round, as described in section IV.B.iii.
86. In the
87. Bid Removal Procedures. Before the close of a bidding round, a bidder has the option of removing any bids placed in that round. By using the “remove bid” function in the bidding system, a bidder may effectively “unsubmit” any bid placed within that round. Removing a bid will affect a bidder's activity for the round in which it is removed,
88. Bids placed during a round will not be published until the conclusion of that bidding period. After a round closes, the Bureaus will compile reports of all bids placed, current high bid, new minimum accepted bid, and bidder eligibility status (bidding eligibility and activity rule waivers), and post the reports for public access. Reports reflecting bidders' identities and bidder identification numbers for Auction No. 32 will be available before and during
89. The FCC will use auction announcements to announce items such as schedule changes. All FCC auction announcements will be available by clicking a link on the FCC Automated Auction System.
90. After bidding has ended, the Commission will issue a public notice declaring the auction closed, identifying the winning bidders and winning bids for each construction permit, and any down payments due.
91. Within ten business days after release of the auction closing notice, each winning bidder must submit sufficient funds (in addition to its upfront payment) to bring its total amount of money on deposit with the Government to 20 percent of its net winning bids (actual bids less any applicable bidding credit).
92. Within thirty days after release of the auction closing public notice, winning bidders must electronically submit a properly completed long-form application and required exhibits for the construction permit won through Auction No. 32. Winning bidders that are claiming new entrant status must include an exhibit demonstrating their eligibility for the bidding credit. Further filing instructions will be provided to the auction winners at the close of the auction.
93. Any high bidder that defaults or is disqualified after the close of the auction (
94. All applicants that submitted upfront payments but were not winning bidders for a construction permit in Auction No. 32 will be entitled to a refund of their upfront payment balance after the conclusion of the auction. All refunds will be returned to the payer of record, as identified on the FCC Form 159, unless the payer submits written authorization instructing otherwise.
95. Qualified bidders that have exhausted all of their activity rule waivers and have no remaining bidding eligibility must submit a written refund request. If you have completed the refund instructions electronically, then only a written request for the refund is necessary. If not, the request must also include wire transfer instructions, Taxpayer Identification Number (TIN) and FCC Registration Number (FRN). Send refund request to: Federal Communications Commission, Financial Operations Center, Auctions Accounting Group, Gail Glasser or Tim Dates, 445 12th Street, SW., Room 1-C863, Washington, DC 20554.
96. Bidders are encouraged to file their refund information electronically using the refund information portion of the FCC Form 175, but bidders can also fax their information to the Auctions Accounting Group at (202) 418-2843. Once the information has been approved, a refund will be sent to the party identified in the refund information.
Refund processing generally takes up to two weeks to complete. Bidders with questions about refunds should contact Gail Glasser at (202) 418-0578 or Tim Dates at (202) 418-0496.
The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board’s Regulation Y (12 CFR 225.41) to acquire a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the office of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than November 15, 2002.
Board of Governors of the Federal Reserve System, October 28, 2002.
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The application also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than November 25, 2002.
Board of Governors of the Federal Reserve System, October 28, 2002.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services.
Notice.
This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the Centers for Disease Control and Prevention (CDC), Technology Transfer Office, Department of Health and Human Services (DHHS), is contemplating the grant of a worldwide, limited field of use, exclusive license to practice the inventions embodied in the patent and patent applications referred to below to Johnson & Johnson Pharmaceutical Research & Development, L.L.C., having a place of business in Raritan, New Jersey. The patent rights in these inventions relate to the administration of folic acid in a contraceptive or hormonal replacement composition and have been assigned to Ortho-McNeil Pharmaceutical, Inc. (Raritan, New Jersey) and the government of the United States of America. The patent and patent applications to be licensed are:
The prospective exclusive license will be royalty-bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless, within 60 days from the date of this published Notice, CDC receives written evidence and argument that the grant of this license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.
Folic acid is a vitamin. It plays a crucial role in DNA synthesis, and in hematopoiesis (although the details of this role remain undefined). Folic acid is involved, for example, in single carbon transfers (such as those required for purine and pyrimidine metabolism), and in the re-methylation of homocysteine to methionine. Numerous disorders can result from insufficient intake of folic acid. Enhanced effects of risk factors for cervical dysplasia (
Requests for a copy of this patent, inquiries, comments, and other materials relating to the contemplated license should be directed to Andrew Watkins, Director, Technology Transfer Office, Centers for Disease Control and Prevention (CDC), 4770 Buford Highway, Mailstop K-79, Atlanta, GA 30341, telephone: (770) 488-8610; facsimile: (770) 488-8615. Applications for a license filed in response to this notice will be treated as objections to the grant of the contemplated license. Only written comments and/or applications for a license which are received by CDC within sixty days of this notice will be considered. Comments and objections submitted in response to this notice will not be made available for public inspection, and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. A signed Confidential Disclosure Agreement will be required to receive a copy of any pending patent application.
Centers for Medicare & Medicaid Services (CMS), HHS.
Final notice.
This final notice announces the approval of the American Osteopathic Association (AOA) for recognition as a national accreditation program for ambulatory surgical centers (ASCs) that request certification to participate in the Medicare or Medicaid programs. We have found that accreditation of ASCs by this organization will demonstrate that all Medicare ASC Conditions for Coverage are met or exceeded, and, thus, ASCs accredited by AOA will be granted deemed status to participate in the Medicare program.
This final notice is effective January 30, 2003.
Laura A. Weber, (410) 786-0227.
This
Under the Medicare program, eligible beneficiaries may receive covered services in an ambulatory surgical center (ASC) provided that the ASC meets certain requirements. Section 1832(a)(2)(F)(i) of the Social Security Act (the Act) includes requirements that an ASC have an agreement in effect with the Secretary and that it meet health, safety, and other standards specified by the Secretary in regulations. Requirements concerning supplier agreements are located in 42 CFR part 489, and those pertaining to the survey and certification of facilities are set forth in 42 CFR part 488.
In 42 CFR part 416, we specify the conditions that an ASC must meet in order to participate in the Medicare program, the scope of covered services, and the conditions for Medicare payment for facility services.
For an ASC to enter into an agreement, a State survey agency must first certify that the ASC complies with our conditions or requirements. Following that certification, the ASC is subject to routine monitoring by a State survey agency to ensure continuing compliance. As an alternative to surveys by State agencies, section 1865(b)(1) of the Act provides that, if the Secretary finds that, through accreditation by a national accreditation body, a provider entity demonstrates that all of our applicable conditions and requirements are met or exceeded, the Secretary will deem that the provider entity has met the applicable Medicare requirements.
In making our finding as to whether the accreditation organization demonstrates that all Medicare conditions or requirements are met or exceeded, we consider factors such as the organization's accreditation requirements, its survey procedures, its ability to provide adequate resources for conducting required surveys and supplying information for us in enforcement activities, its monitoring procedures for providers entities found to be out of compliance with conditions or requirements, and its ability to provide us with necessary data for validation.
It has been brought to our attention that some ASCs are under the mistaken impression that, once we have granted deeming authority to an accreditation organization, then ASCs must be accredited by such an organization to receive Medicare certification. Accreditation by an accreditation organization is voluntary, and we do not require that accreditation for Medicare certification.
The American Osteopathic Association (AOA) was the fourth accreditation organization to apply for deeming authority for ASCs. The three other accreditation organizations already granted deeming authority are the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO), the Accreditation Association of Ambulatory Health Care (AAAHC), and The American Association for the Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF).
The AOA is defined as a national accrediting body in section 1865(b)(1) of the Act, and was granted deeming authority by us for hospitals (65 FR 8727, published February 22, 2000). This was taken into consideration in the evaluation of this application for ASC deeming authority.
The AOA previously applied to us for deeming authority, which we announced in the
A national accrediting organization may request the Secretary to recognize its program as employing standards that meet or exceed Medicare's standards. The Secretary then examines the national accreditation organization's requirements to determine if they meet or exceed Medicare standards. If the Secretary recognizes an accreditation organization in this manner, any provider accredited by the national accrediting body's program that we have approved for that service will be “deemed” to meet the Medicare Conditions for Coverage.
The regulations specifying the Medicare Conditions for Coverage for ASCs are located in 42 CFR part 416. These conditions implement section 1832(a)(2)(F)(i) of the Act, which provides for Medicare Part B coverage of facility services furnished in connection with surgical procedures specified by the Secretary under section 1833(i)(1)(a) of the Act.
The proposed notice, published on May 24, 2002 (67 FR 36611), announced the application of AOA for deemed status for its accreditation program for ASCs. Under section 1865(b)(2) of the Act and our regulations in § 488.8 (Federal review of accreditation organizations), our review and evaluation of a national accreditation organization was conducted in accordance with, but not necessarily limited to, the following factors:
• The equivalency of an accreditation organization's requirements for an entity to our comparable requirements for that entity.
• The organization's survey process to determine the following:
—The composition of the survey team, surveyor qualifications, and the ability of the organization to provide continuing surveyor training.
—The comparability of its processes to those of State agencies, including survey frequency, and the ability to investigate and respond appropriately to complaints against accredited facilities.
—The organization's procedures for monitoring providers or suppliers found by the organization to be out of compliance with program requirements. These monitoring procedures are used only when the organization identifies noncompliance. If noncompliance is identified through validation reviews, the survey agency monitors corrections as specified in § 488.7(d).
—The ability of the organization to report deficiencies to the surveyed facilities and respond to the facility's plan of correction in a timely manner.
—The ability of the organization to provide us with electronic data in ASCII comparable code, and reports necessary for effective validation and assessment of the organization's survey process.
—The adequacy of staff and other resources, and its financial viability.
—The organization's ability to provide adequate funding for performing required surveys.
—The organization's policies with respect to whether surveys are announced or unannounced.
• The accreditation organization's agreement to provide us with a copy of the most current accreditation survey together with any other information
We did not receive any comments to the proposed notice published in the
We evaluated the AOA's standards and survey process to determine if facilities accredited by AOA met Medicare Conditions for Coverage. We did a standard-by-standard comparison of the applicable conditions or requirements to determine which of them met or exceeded Medicare requirements.
We compared the standards contained in the AOA's “Ambulatory Surgical Center (ASC) Manual” and its survey process in the “Ambulatory Surgical Center Surveyor Handbook” with the Medicare ASC Conditions for Coverage and our State and Regional Operations Manual. Our review and evaluation of AOA's deeming application, which were conducted as described in this notice, yielded the following clarifications:
• AOA provided an updated listing of its accredited ASC facilities.
• AOA adjusted language to refer consistently to the entities as ASCs as opposed to hospitals in its documents.
• AOA modified its standards to meet fully the requirements of the Medicare Conditions for Coverage.
• AOA modified its survey policy to ensure that ASC surveys are unannounced.
• AOA modified its requirements to indicate that any ASC seeking to participate in Medicare by virtue of an AOA accreditation must meet the “Accreditation with Medicare Certification,” which requires that all State licensure requirements are satisfied in addition to meeting all AOA standards.
• AOA adjusted its standards to require written confirmation of primary source verifications with regard to medical staff credentialing.
• AOA adjusted its standard to conform with all applicable requirements of each State Nurse Practice Act to specify what duties a registered nurse may be allowed to perform in the area of pharmaceutical services.
• AOA agrees to notify us of all accreditation decisions made.
Review of AOA's application raised issues concerning the comparability of the AOA's ASC accreditation standards with the Medicare Conditions for Coverage for ASCs. We requested that the AOA demonstrate compliance with the Medicare ASC Conditions for Coverage and submit supplemental information to clarify its policies and procedures. Upon our final review of this information, we have determined that the AOA's ASC accreditation program meets the Medicare Conditions for Coverage for ASCs.
Based on the review and observations described in this final notice, we have determined that AOA's requirements for ASCs meet or exceed our requirements. We reserve the right to observe an AOA ASC survey to determine the compliance of AOA surveyors to the policies and procedures, as there were none scheduled during the review of this application. In addition, the AOA must seek approval of all standards pertaining to the Life Safety Code (LSC) when we move to the LSC 2000 Edition, which we intend to implement in Spring 2003. We therefore recognize the AOA as a national accreditation organization for ASCs that request participation in the Medicare program, effective for a 6-year period beginning January 30, 2003.
This final notice does not impose any information collection and record keeping requirements subject to the Paperwork Reduction Act (PRA). Consequently, it does not need to be reviewed by the Office of Management and Budget (OMB) under the authority of the PRA. The requirements associated with granting and withdrawal of deeming authority to national accreditation organizations, codified in 42 CFR part 488, “Survey, Certification, and Enforcement Procedures,” are currently approved by OMB under OMB approval number 0938-0690.
We have examined the impact of this notice 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 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).
The RFA requires agencies to analyze options for regulatory relief for 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 in any 1 year (for details, see the Small Business Administration's publication that set forth size standards for health care industries at 65 FR 69432). Approximately 73 percent of ASCs are considered small businesses with total revenues of $8.5 million or less according to the Small Business Administration's data. For purposes of the RFA, States and individuals are not considered small entities.
Also, section 1102(b) of the Act requires the Secretary to prepare a regulatory impact analysis for any notice that may have a significant impact on the operations of a substantial number of small rural hospitals. Such an analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we consider a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area and has fewer than 100 beds.
This notice merely recognizes AOA as a national accreditation organization that has requested approval for deeming authority for ASCs that are participating in the Medicare program. Since these provider entities must be routinely monitored to determine compliance with Medicare requirements, we believe that this organization's accreditation program has the potential to reduce both the regulatory and administrative burdens associated with the Medicare program requirements.
This notice is not a major rule as defined in Title 5, United States Code, section 804(2) and is not an economically significant rule under Executive Order 12866.
Therefore, we have determined, and the Secretary certifies, that this final notice will not result in a significant impact on small entities and will not have an effect on the operations of small rural hospitals. Therefore, we are not preparing analyses for either the RFA or section 1102(b) of the Act.
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. This
In accordance with Executive Order 13132, this notice will not significantly affect the rights of States and will not significantly affect State authority.
In accordance with the provisions of Executive Order 12866, this notice was reviewed by the Office of Management and Budget.
Section 1865(b)(3)(A) of the Social Security Act (42 U.S.C. 1395bb(b)(3)(A)).
• What are the issues and challenges associated with operating the new welfare-to-work services and policy approaches being studied?
• How effective are the welfare-to-work programs under the project in increasing employment and earnings and in improving other measures?
• What are the net costs of the welfare-to-work programs, and do the programs' benefits outweigh the costs?
• What approaches should policymakers and program managers consider in designing strategies to improve the efficacy of welfare-to-work strategies for families in rural areas?
The evaluation employs a multi-pronged approach to answer the research questions. These approaches include: (1) An impact study, which will examine the differences between control and intervention groups with respect to factors such as employment rates, earnings, and welfare receipt; (2) a cost-benefit analysis, which will calculate estimates of net program cost-effectiveness; and (3) an in-depth process study, which will identify implementation issues and challenges, examine program costs, and provide details on how programs achieve observed results. The data collected during the conduct of this study will be used for the following purposes:
• To study rural welfare-to-work programs' effects on factors such as employment, earnings, educational attainment, family composition;
• To collect data on a wider range of outcome measures—such as job acquisition, retention, and advancement, job quality, educational attainment, and employment barriers—than is available through welfare or unemployment insurance records, in order to understand how individuals are being affected by the demonstration programs;
• To support research on the implementation of welfare-to-work programs across sites;
• To obtain program participation and service use information important to the evaluation's cost-benefit component; and
• To obtain contact information for a future follow-up survey that will be important to achieving high response rates for that survey.
Respondents of the process study data collection efforts (interviews, case studies, and focus groups) include State and local-level agency staff from welfare agencies and other organizations. These individuals include program directors and site managers, program line staff, workforce development staff, TANF agency staff, and community partners and employers. Approximately 105 staff members per site are expected to participate in semi-structured interviews, 21 in case conferences, and 108 in focus groups, across the three demonstration sites.
In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Administration Office of Information Services, 370 L'Enfant Promenade, SW., Washington,
The Department specifically requests comments 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 collection of information; (c) the quality, utility, and clarity of the information to be collected; and (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. Consideration will be given to comments and suggestions submitted within 60 days of this publication.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is postponing the meeting of the Women's Health Initiative Subcommittee of the Advisory Committee for Reproductive Health Drugs scheduled for November 12 and 13, 2002. The meeting was announced in the
Jayne E. Peterson, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7001, FAX 301-827-6776, or e-mail:
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled “Antiretroviral Drugs Using Plasma HIV RNA Measurements—Clinical Considerations for Accelerated and Traditional Approval.” This guidance is intended to assist sponsors in the clinical development of drugs for the treatment of human immunodeficiency virus (HIV) infection. Specifically, this guidance addresses the agency's current thinking regarding designs of clinical trials that use HIV ribonucleic acid (RNA) measurements to support accelerated and traditional approvals of antiretroviral drug products.
Submit written or electronic comments on agency guidances at any time.
Submit written requests for single copies of this guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the guidance to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to
Jeffrey S. Murray, Center for Drug Evaluation and Research (HFD-530), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-2330.
FDA is announcing the availability of a guidance for industry entitled “Antiretroviral Drugs Using Plasma HIV RNA Measurements—Clinical Considerations for Accelerated and Traditional Approval.” This guidance is intended to assist sponsors in the clinical development of drugs for the treatment of HIV infection. Specifically, this guidance addresses the agency's current thinking regarding designs of clinical trials that use HIV RNA measurements to support accelerated and traditional approvals of antiretroviral drug products. It is also intended to serve as a focus for continued discussions among the Division of Antiviral Drug Products (DAVDP), pharmaceutical sponsors, the academic community, and the public.
The draft version of this document, first issued in August 1999, was based on a DAVDP advisory committee meeting, convened in July 1997, to discuss the use of HIV RNA endpoints for traditional approval of antiretroviral drugs. This document has been updated to address public comments to the draft version and to include pertinent information from a DAVDP advisory committee meeting held in January 2001 that addressed issues relating to trial design in HIV-infected patients who have already been heavily treated for the disease. The guidance summarizes the rationale for using HIV RNA as a primary endpoint in clinical trials to support both accelerated and traditional approval. It describes the amount and type of safety and efficacy data recommended for new drug applications. The guidance also reviews pertinent clinical trial design issues including choice of control arms, study procedures, and statistical considerations. An appendix addresses the use of experimental HIV RNA assays in phase 3 studies.
This guidance does not address specific phase-1 and -2 development issues, development of alternate dosing regimens, or the use of HIV-1 resistance testing. These issues will be addressed in separate future guidance documents.
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on clinical considerations for accelerated and
Interested persons may, at any time, submit written or electronic comments on the guidance to the Dockets Management Branch (see
Persons with access to the Internet may obtain the document at either
Food and Drug Administration, HHS.
Notice; correction.
The Food and Drug Administration is correcting a notice that appeared in the
Joyce Strong, Office of Policy (HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7010.
In FR Doc. 02-25881, appearing on page 63108 in the
1. On page 63108, in the third column, at the end of the document, the phrase “Dated: October 1, 2022” is corrected to read “Dated: October 1, 2002”.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled “Immunotoxicology Evaluation of Investigational New Drugs.” This guidance provides recommendations for sponsors of investigational new drugs (INDs) on what parameters to routinely assess in toxicology studies to determine effects on immune function, when to conduct additional immunotoxicity studies, and when additional mechanistic information could better characterize a given effect on the immune system.
Submit written or electronic comments on agency guidances at any time.
Submit written requests for single copies of this guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the guidance to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See the
Kenneth L. Hastings, Center for Drug Evaluation and Research (HFD-590), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-2489.
FDA is announcing the availability of a guidance for industry entitled “Immunotoxicology Evaluation of Investigational New Drugs.” The human immune system is a complex set of cells and organs that can be adversely affected by drugs. Impairment of the immune system can result in increased susceptibility to infections and tumors, allergic responses to drugs, autoimmune reactions, or other forms of immune system disease. Immunotoxicology studies can be conducted in animals to determine the potential of an investigational drug to adversely affect the immune system. This guidance provides advice on: (1) When to conduct immunotoxicology studies, (2) what types of effects can be observed in standard nonclinical toxicology studies that would indicate that a drug has immunotoxic potential, and (3) what types of studies could be useful in determining the nature of the immunotoxicity. It is expected that this guidance will provide sponsors with useful information for proper assessment of the immunotoxic potential of drugs.
In the
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on immunotoxicology evaluation of INDs. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.
Interested persons may, at any time, submit written comments on the guidance to the Dockets Management
Persons with access to the Internet may obtain the document at either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.
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 pubic 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
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.
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 timing
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the Board of Scientific Counselors, National Institute of Mental Health. The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the National Institute of Mental Health, including consideration of personnel qualifications and performance, and the competence of individual investigators, 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 urgent need to meet timing limitations imposed by the intramural research review cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following 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.
Substance Abuse and Mental Health Services Administration, HHS.
Notice.
The Department of Health and Human Services notifies Federal agencies of the laboratories currently certified to meet standards of Subpart C of Mandatory Guidelines for Federal Workplace Drug Testing Programs (59 FR 29916, 29925). A notice listing all currently certified laboratories is published in the
If any laboratory has withdrawn from the National Laboratory Certification Program during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter.
This notice is also available on the internet at the following Web sites:
Mrs. Giselle Hersh or Dr. Walter Vogl, Division of Workplace Programs, 5600 Fishers Lane, Rockwall 2 Building, Room 815, Rockville, Maryland 20857; Tel.: (301) 443-6014, Fax: (301) 443-3031.
Mandatory Guidelines for Federal Workplace Drug Testing were developed in accordance with Executive Order 12564 and section 503 of Public Law 100-71. Subpart C of the Guidelines, “Certification of Laboratories Engaged in Urine Drug Testing for Federal Agencies,” sets strict standards which laboratories must meet in order to conduct urine drug testing for Federal
To maintain that certification a laboratory must participate in a quarterly performance testing program plus periodic, on-site inspections.
Laboratories which claim to be in the applicant stage of certification are not to be considered as meeting the minimum requirements expressed in the HHS Guidelines. A laboratory must have its letter of certification from SAMHSA, HHS (formerly: HHS/NIDA) which attests that it has met minimum standards.
In accordance with Subpart C of the Guidelines, the following laboratories meet the minimum standards set forth in the Guidelines:
The following laboratory voluntarily withdrew from the National Laboratory Certification Program, on October 28, 2002:
* The Standards Council of Canada (SCC) voted to end its Laboratory Accreditation Program for Substance Abuse (LAPSA) effective May 12, 1998. Laboratories certified through that program were accredited to conduct forensic urine drug testing as required by U.S. Department of Transportation (DOT) regulations. As of that date, the certification of those accredited Canadian laboratories will continue under DOT authority. The responsibility for conducting quarterly performance testing plus periodic on-site inspections of those LAPSA-accredited laboratories was transferred to the U.S. DHHS, with the DHHS' National Laboratory Certification Program (NLCP) contractor continuing to have an active role in the performance testing and laboratory inspection processes. Other Canadian laboratories wishing to be considered for the NLCP may apply directly to the NLCP contractor just as U.S. laboratories do.
Upon finding a Canadian laboratory to be qualified, the DHHS will recommend that DOT certify the laboratory (Federal Register, 16 July 1996) as meeting the minimum standards of the “Mandatory Guidelines for Workplace Drug Testing” (59 FR, 9 June 1994, Pages 29908-29931). After receiving the DOT certification, the laboratory will be included in the monthly list of DHHS certified laboratories and participate in the NLCP certification maintenance program.
Office of Policy Development and Research, HUD.
Notice.
The proposed information collection requirement described below will be submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Reports Liaison Officer, Office of Policy Development and Research, Department of Housing and Urban Development, 451 7th Street, Room 8228, SW., Washington, DC 20410.
Harold R. Holzman, Program Evaluation Division, Office of Policy Development and Research, Department of Housing and Urban Development, 451 7th Street, SW., Room 8140, Washington, DC 20410, telephone 202-708-3700, extension 5709. This is not a toll-free number. E-mail:
The Department will submit the proposed information collection to OMB for review, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended).
This notice is soliciting comments from members of the public and affected agencies concerning the proposed collection of information to: (1) Evaluate whether the proposed collection of information is necessary for the proper
This notice also provides the following information:
Accuracy of the results has been an issue in past versions of the AHS. Specifically, a substantial proportion of respondents misidentify their housing subsidy status in the survey. This threatens the accuracy of information that is reported to Congress, and it also can lead the Department to provide inadequate amounts of housing assistance to low-income families.
Some housing subsidy misidentifications in the AHS involve a ‘false positive’ pattern: individuals who do not receive a housing subsidy based on program records indicate that they do receive a subsidy in the AHS. The present investigation is an attempt to determine whether alternative survey questions would reduce the number of false positives in the AHS.
To identify false positives, it is necessary to first identify individuals who believe themselves in receipt of a housing subsidy, then use program records to determine whether they are actually receiving a subsidy. In the present study, screening interviews matched with program records will be used to identify individuals who fit the false positive pattern. Alternative questions designed to more effectively identify false positives will be tested in a second interview with a sample of such individuals.
Section 3506 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35, as amended.
Office of the Chief Information Officer, HUD.
Notice.
The proposed information collection requirement described below has been submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB approval number (2535-0106) and should be sent to: Lauren Wittenberg, OMB Desk Officer, Office of Management and Budget, Room 10235, New Executive Office Building, Washington, DC 20503; Fax number (202) 395-6974; E-mail
Wayne Eddins, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 Seventh Street, SW., Washington, DC 20410; e-mail
The Department has submitted the proposal for the collection of information, as described below, to OMB for review, as required by the Paperwork Reduction Act (44 U.S.C. Chapter 35). The Notice lists the following information: (1) The title of the information collection proposal; (2) The office of the agency to collect the information; (3) The OMB approval number, if applicable; (4) The description of the need for the information and its proposed use; (5) The agency form number, if applicable; (6) What members of the public will be affected by the proposal; (7) How frequently information submissions will be required; (8) An estimate of the total number of hours to prepare the information submission including number of respondents, frequency of response, and hours of response; (9) Whether the proposal is new, an extension, reinstatement, or revision of an information collection requirement; and (10) The name and telephone number of an agency official familiar with the proposal and of the OMB Desk Officer for the Department.
This Notice also lists the following information:
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. 35, as amended.
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.
November 1, 2002.
Mark Johnston, 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
Today's Notice is for the purpose of announcing that no additional properties have been determined suitable or unsuitable this week.
Fish and Wildlife Service, Department of the Interior.
Notice.
This Notice advises the public that Eastern North Carolina Natural Gas, has applied for a right-of-way permit for the installation of a twelve (12)-inch outer-diameter natural gas pipeline across 8.5 acres of Roanoke River National Wildlife Refuge in Bertie County, North Carolina, described as follows: A right-of-way with a total width of twenty (20) feet on, over, across, and through that part of the Roanoke River National Wildlife lying and being in Bertie County, North Carolina. The proposed route is within the existing Department of Transportation right-of-way.
The proposed pipeline will cross approximately 3.5 miles of refuge lands between Windsor and Williamston, North Carolina. Commencing at the Northern entrance to the refuge running along the highway to the Roanoke River.
The purpose of the notice is to inform the public that the United States Fish and Wildlife Service is currently considering the merits of approving this application.
Interested persons desiring to comment on this application should do so within thirty (30) days following the date of publication of this notice.
If you wish to comment, you may submit comments by any one of several methods. You may mail comments to Regional Director, U.S. Fish and Wildlife Service, 1875 Century Boulevard, Room 400, Atlanta, Georgia 30345. You may also comment via the Internet to
Roger Beckham, Chief, Realty Branch-East, at the above Atlanta, Georgia, address or call (404) 679-7204 or FAX (404) 679-7273.
Right-of-way applications are filed in accordance with section 28 of the Mineral Leasing Act of 1920 (41 Stat. 449:30 U.S.C. 185), as amended by Public Law 93-153. Additionally, 50 CFR 29.21-9f requires this Agency to publish Notices in the
Minerals Management Service (MMS), Interior.
Notice of an extension of a currently approved information collection (OMB Control Number 1010-0103).
To comply with the Paperwork Reduction Act (PRA) of 1995, we are inviting comments on a collection of information that we will submit to the Office of Management and Budget (OMB) for review and approval. The information collection request (ICR) is titled “30 CFR part 206, subpart E—Indian Gas (Form MMS-4411, Safety Net Report).”
Submit written comments on or before December 31, 2002.
Submit written comments to Sharron L. Gebhardt, Regulatory Specialist, Minerals Management Service, Minerals Revenue Management, PO Box 25165, MS 320B2, Denver, Colorado 80225. If you use an overnight courier service, our courier address is Building 85, Room A-614, Denver Federal Center, Denver, Colorado 80225. You may also email your comments to us at
Sharron L. Gebhardt, telephone (303) 231-3211, FAX (303) 231-3385 or email
On August 10, 1999, MMS published in the
Form MMS-4411 ensures Indian mineral lessors receive the maximum revenues from mineral resources on their land consistent with the Secretary's trust responsibility and lease terms. It permits lessees to comply with the regulatory requirements at the time that royalties are due.
The safety net calculation establishes the minimum value, for royalty purposes, of natural gas production from Indian leases. This reporting requirement will assist the Indian lessor in receiving all the royalties that are due and aid MMS in its compliance efforts. The safety net price is calculated using prices received for gas sold downstream of the first index pricing point. It will include only the lessee's or the lessee's affiliate's arm's-length sales price, and it will not require detailed calculations for the costs of transportation. By June 30 following any calendar year, the lessee calculates a safety net price for each month of the previous calendar year. Lessees must calculate the safety net prices for each index zone where the lessee has an Indian lease. The safety net price will capture the significantly higher values for sales occurring beyond the index point. The lessee will submit its safety net prices to MMS annually (by June 30) using Form MMS-4411.
We are also revising this ICR to include reporting requirements that were inadvertently overlooked when the final rule was published. See the chart below for these requirements and associated burden hours. These reporting requirements are rare and unusual circumstances where the standard valuation procedures set out in the Indian gas valuation rule are not appropriate.
MMS is requesting OMB's approval to continue to collect this information. Not collecting this information would limit the Secretary's ability to discharge his/her duties and may also result in loss of royalty payments to the Indian lessor due to royalties not being collected on prices received under higher priced long-term sales contracts. Proprietary information submitted is protected, and there are no questions of a sensitive nature included in this information collection.
We have also changed the title of this ICR from “Safety Net Report” to “30 CFR part 206, subpart E—Indian Gas (Form MMS-4411, Safety Net Report),” to clarify the regulatory language we are covering under 30 CFR part 206.
The following chart shows the breakdown of the burden hours by CFR section and paragraph:
The PRA also requires agencies to estimate the total annual reporting “non-hour cost” burden to respondents or record keepers resulting from the collection of information. We have not identified non-hour cost burdens for this information collection. If you have costs to generate, maintain, and disclose this information, you should comment and provide your total capital and startup cost components or annual operation, maintenance, and purchase of service components. You should describe the methods you use to estimate major cost factors, including system and technology acquisition, expected useful life of capital equipment, discount rate(s), and the period over which you incur costs. Capital and startup costs include, among other items, computers and software you purchase to prepare for collecting information; monitoring, sampling, testing equipment; and record storage facilities. Generally, your estimates should not include equipment or services purchased: (i) Before October 1, 1995; (ii) to comply with requirements not associated with the information collection; (iii) for reasons other than to provide information or keep records for the Government; or (iv) as part of customary and usual business or private practices.
We will summarize written responses to this notice and address them in our ICR submission for OMB approval, including appropriate adjustments to the estimated burden. We will provide a copy of the ICR to you without charge upon request and the ICR will also be posted on our Web site at
Notice is hereby given in accordance with the Federal Advisory Committee Act that a meeting of the Na Hoapili O Kaloko Honokohau, Kaloko-Honokohau National Historical Park Advisory Commission will be held at 9 a.m., November 16, 2002 at Kaloko-Honokohau National Historical Park headquarters, 73-4786 Kanalani St. Suite 14, Kailua-Kona, Hawaii.
The agenda will include Status on Park Brochure, Report on Alu Like Training Program, and FY2003 Budget Plans.
The meeting is open to the public. Minutes will be recorded for documentation and transcribed for dissemination. Minutes of the meeting will be available to the public after approval of the full Advisory Commission. Transcripts will be available after 30 days of the meeting.
For copies of the minutes, contact Kaloko-Honokohau National Historical Park at (808) 329-6881.
Nominations for the following properties being considered for listing in the National Register were received by the National Park Service before October 12, 2002. Pursuant to § 60.13 of 36 CFR Part 60 written comments concerning the significance of these properties under the National Register criteria for evaluation may be forwarded by the United States Postal Service, to the National Register Historic Places, National Park Service, 1849 C St. NW, NC400, Washington, DC 20240; by all other carriers, National Register of Historic Places, National Park Service,1201 Eye St. NW, 8th floor, Washington, DC 20005; or by fax, 202-343-1836. Written or faxed comments should be submitted by November 18, 2002.
A request for REMOVAL has been made for the following resources:
Department of Interior, National Park Service.
Notice of availability of Information Quality Guidelines.
The National Park Service is announcing the availability of Information Quality Guidelines in order to comply with the guidelines issued by the Office of Management and Budget in the
Persons interested in reviewing the final Information Quality Guidelines are encouraged to access the guidelines at website
The National Park Service disseminates a wide variety of information to the public, including organizational information, natural and cultural resource information, and budget information. Organizational information includes general descriptive information about the NPS and its component parks and offices. Examples include the parks' history, functions, and legislative authorities; organizational charts, the offices within the parks and their functions; the parks' strategic and performance plans and their budgetary information; and information pertaining to the parks' history, natural and cultural resources and administrative processes. This document is the basis for National Park Service policy to assure the quality of the information it disseminates.
On the basis of the record
The Commission instituted these investigations effective August 31, 2001, following receipt of petitions filed with the Commission and Commerce by counsel on behalf of Co-Steel Raritan, Inc., Perth Amboy, NJ; GS Industries, Inc., Charlotte, NC; Keystone Consolidated Industries, Inc., Dallas, TX; and North Star Steel Texas, Inc., Edina, MN. The final phase of the investigations was scheduled by the Commission following notification of preliminary determinations by Commerce that imports of carbon and certain alloy steel wire rod from Canada and Germany were being subsidized within the meaning of section 703(b) of the Act (19 U.S.C. 1671b(b))
The Commission transmitted its determinations in these investigations to the Secretary of Commerce on October 15, 2002. The views of the Commission are contained in USITC Publication 3546 (October 2002), entitled
By order of the Commission.
International Trade Commission.
November 14, 2002 at 10 a.m.
Room 101, 500 E Street SW., Washington, DC 20436, Telephone: (202) 205-2000.
Open to the public.
1.
2. Minutes.
3. Ratification List.
4. Inv. No. 731-TA-1020 (Preliminary) (Barium Carbonate from China)—briefing and vote. (The Commission is currently scheduled to transmit its determination to the Secretary of Commerce on November 14, 2002; Commissioners' opinions are currently scheduled to be transmitted to the Secretary of Commerce on or before November 21, 2002).
5.
In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carrier over to the agenda of the following meeting.
By order of the Commission.
In accordance with section 6 of the Voting Rights Act of 1965, as amended, 42 U.S.C. 1973d, I hereby certify that in my judgment the appointment of examiners is necessary to enforce the guarantees of the Fourteenth and Fifteenth Amendments of the Constitution of the United States in Titus County, Texas. This county is included within the scope of the determinations of the Attorney General and the Director of the Census made under section 4(b) of the Voting Rights Act of 1965 and published in the
Drug Enforcement Administration (DEA), Justice.
Notice of proposed year 2003 aggregate production quotas.
This notice proposes initial year 2003 aggregate production quotas for controlled substances in Schedules I and II of the Controlled Substances Act (CSA).
Comments or objections must be received on or before November 22, 2002.
Send comments or objections to the Deputy Administrator, Drug Enforcement Administration, Washington, DC 20537, Attn.: DEA Federal Register Representative (CCR).
Frank L. Sapienza, Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration,
Section 306 of the CSA (21 U.S.C. 826) requires that the Attorney General establish aggregate production quotas for each basic class of controlled substance listed in Schedules I and II. This responsibility has been delegated to the Administrator of the DEA by Section 0.100 of Title 28 of the Code of Federal Regulations. The Administrator, in turn, has redelegated this function to the Deputy Administrator, pursuant to § 0.104 of Title 28 of the Code of Federal Regulations.
The proposed year 2003 aggregate production quotas represent those quantities of controlled substances that may be produced in the United States in 2003 to provide adequate supplies of each substance for: The estimated medical, scientific, research, and industrial needs of the United States; lawful export requirements; and the establishment and maintenance of reserve stocks. These quotas do not include imports of controlled substances for use in industrial processes.
In determining the proposed year 2003 aggregate production quotas, the Deputy Administrator considered the following factors: Total actual 2001 and estimated 2002 and 2003 net disposals of each substance by all manufacturers; estimates of 2002 year-end inventories of each substance and of any substance manufactured from it and trends in accumulation of such inventories; product development requirements of both bulk and finished dosage form manufacturers; projected demand as indicated by procurement quota applications filed pursuant to Section 1303.12 of Title 21 of the Code of Federal Regulations; and other pertinent information.
Pursuant to Section 1303 of Title 21 of the Code of Federal Regulations, the Deputy Administrator of the DEA will, in early 2003, adjust aggregate production quotas and individual manufacturing quotas allocated for the year based upon 2002 year-end inventory and actual 2002 disposition data supplied by quota recipients for each basic class of Schedule I or II controlled substance.
Therefore, under the authority vested in the Attorney General by Section 306 of the CSA of 1970 (21 U.S.C. 826), and delegated to the Administrator of the DEA by § 0.100 of Title 28 of the Code of Federal Regulations, and redelegated to the Deputy Administrator pursuant to § 0.104 of Title 28 of the Code of Federal Regulations, the Deputy Administrator hereby proposes that the year 2003 aggregate production quotas for the following controlled substances, expressed in grams of anhydrous acid or base, be established as follows:
The Deputy Administrator further proposes that aggregate production quotas for all other Schedules I and II controlled substances included in §§ 1308.11 and 1308.12 of Title 21 of the Code of Federal Regulations be established at zero.
All interested persons are invited to submit their comments and objections in writing regarding this proposal. A person may object to or comment on the proposal relating to any of the above-mentioned substances without filing comments or objections regarding the others. If a person believes that one or more of these issues warrant a hearing, the individual should so state and summarize the reasons for this belief.
In the event that comments or objections to this proposal raise one or more issues which the Deputy Administrator finds warrant a hearing, the Deputy Administrator shall order a public hearing by notice in the
The Office of Management and Budget has determined that notices of aggregate production quotas are not subject to centralized review under Executive Order 12866.
This action does not preempt or modify any provision of state law; nor does it impose enforcement responsibilities on any state; nor does it diminish the power of any state to enforce its own laws. Accordingly, this action does not have federalism implications warranting the application of Executive Order 13132.
The Deputy Administrator hereby certifies that this action will have no significant impact upon small entities whose interests must be considered under the Regulatory Flexibility Act, 5 U.S.C. 601
This action meets the applicable standards set forth in Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.
This action will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.
This action is not a major rule as defined by Section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This action will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.
The Drug Enforcement Administration makes every effort to write clearly. If you have suggestions as to how to improve the clarity of this regulation, call or write Frank L. Sapienza, Chief, Drug and Chemical Evaluation Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Telephone: (202) 307-7183.
The Department of Labor (DOL) has submitted the following public information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. chapter 35). A copy of this ICR, with applicable supporting documentation, may be obtained by calling the Department of Labor. To obtain documentation contact Darrin King on 202-693-4129 or e-mail:
Comments should be sent to Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for ETA, Office of Management and Budget, Room 10235, Washington, DC 20503 (202-395-7316), within 30 days from the date of this publication in the
The OMB is particularly interested in comments which:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
The Department of Labor (DOL) has submitted the following public information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. chapter 35). A copy of each individual ICR, with applicable supporting documentation, may be obtained by calling the Department of Labor. To obtain documentation contact Marlene Howze at (202) 693-4158 or e-mail
Comments should be sent to Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for ESA, Office of Management and Budget, Room 10235, Washington, DC 20503 ((202) 395-7316), within 30 days from the date of this publication in the
The OMB is particularly interested in comments which:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
The Department of Labor (DOL) has submitted the following public information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork
Comments should be sent to Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for ESA, Office of Management and Budget, Room 10235, Washington, DC 20503 ((202) 395-7316), within 30 days from the date of this publication in the
The OMB is particularly interested in comments which:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
The Department of Labor (DOL) has submitted the following public information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35). A copy of each individual ICR, with applicable supporting documentation, may be obtained by calling the Department of Labor. To obtain documentation contact Marlene Howze at ((202) 693-4158) or e-mail
Comments should be sent to Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for PWBA, Office of Management and Budget, Room 10235, Washington, DC 20503 ((202) 395-7316), within 30 days from the date of this publication in the
The OMB is particularly interested in comments which:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Employment Standards Adminstration, Labor.
Notice.
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Employment Standards Administration is soliciting comments concerning the proposed collection: Work Experience and Career Exploration Programs (WECEP), Regulations, 29 CFR part 570.35a (Fair Labor Standards Act). A copy of the proposed information collection request can be obtained by contacting the office listed below in the addresses section of this Notice.
Written comments must be submitted to the office listed in the addresses section below on or before December 31, 2002.
Ms. Patricia A. Forkel, U.S. Department of Labor, 200 Constitution Ave., NW., Room S-3201, Washington, DC 20210, telephone (202) 693-0339, fax (202) 693-1451, e-mail
Section (3)(1) of the Fair Labor Standards Act (FLSA) establishes a minimum age of 16 for most nonagricultural employment, but allows the employment of 14 and 15 year olds in occupations other than manufacturing and mining if the Secretary of Labor determines such employment is confined to periods which will not interfere with their health and well-being. Subpart C of Regulations, 29 CFR Part 570, Child Labor Regulations, Orders and Statements of Interpretation, sets forth the employment standards for 14 and 15 year olds (Child Labor Reg. 3). Section 570.35a of these regulations permits employment of 14 and 15 year olds under conditions otherwise prohibited by Child Labor Reg. 3 pursuant to a school-supervised and school-administered Work Experience and Career Exploration Program (WECEP) which meets the stated requirements. In order to utilize the WECEP provisions of Child Labor Reg. 3, section 570.35 of the regulations require a State Educational Agency to file an application for approval of a State WECEP program as one not interfering with schooling or with the health and well-being of the minors involved and therefore not constituting oppressive child labor. Section 57.35a(b)(vi) of the regulations requires each student participating in a WECEP to execute a written training agreement signed by the teacher-coordinator, the employer, and the student and signed or otherwise consented to by the student's parent or guardian. This information collection is currently approved for use through February 28, 2003.
The Department of Labor is particularly interested in comments which:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.
State educational agencies are required to file applications for WECEP which provide exceptions to the child labor regulations issued under the FLSA. State educational agencies are also required to maintain certain records with respect to approved WECEP programs. The Department of Labor seeks the extension of the collection of information in order to carry out its responsibility to determine that regulatory tests for approval of the program have been met, and to document the validity of the WECEP program as one which is structured to provide training for the student. There is no change in the substance or method of collection since the last OMB approval.
Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they will also become a matter of public record.
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. 276a) 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 is 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 supersedeas 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 202010.
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.
Occupational Safety and Health Administration, Labor.
Request for comment.
The Occupational Safety and Health Administration (OSHA) requests comments concerning the proposed extension of information-collection requirements contained in the Temporary Labor Camps Standard (29 CFR 1910.142).
Comments must be submitted by the following dates:
The Supporting Statement for the Information Collection is available for downloading from OSHA's Web site at
Todd Owen, Directorate of Standards and Guidance, Occupational Safety and Health Administration, U.S. Department of Labor, Room N3631, 200 Constitution Avenue, NW., Washington, DC 20210, (202) 693-1941.
You may submit comments in response to this document by (1) hard copy, (2) FAX transmission (facsimile), or (3) electronically through the OSHA webpage. Please note that you cannot attach materials such as studies or journal articles to electronic comments. If you have additional materials, you must submit three copies of them to the OSHA Docket Office at the address above. The additional materials must clearly identify your electronic comments by name, date, subject and docket number so we can attach them to your comments. Because of security-related problems there may be a significant delay in the receipt of comments by regular mail. Please contact the OSHA Docket Office at (202) 693-2350 for information about security procedures concerning the delivery of materials by express delivery, hand delivery and message service.
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burdens, conducts a pre-clearance consultation program to provide the public with an opportunity to comment on proposed and continuing information collection requirements in accordance with the Paperwork Reduction Act of 1995 (PRA-95) (44 U.S.C. 3506(c)(2)(A)). OSHA will be requesting approval from the Office of Management and Budget (OMB) for certain information collection requirements contained in the Temporary Labor Camps Standard (29 CFR 1910.142). This notice initiates the process for OSHA to request OMB approval. The purpose of the Temporary Labor Camps Standards is to eliminate the incidence of communicable disease among temporary labor camp residents. The Standard requires camp superintendents to report immediately to the local health officer (1) the name and address of any individual in the camp known to have or suspected of having a communicable disease or suspected food poisoning, or (2) an unusual prevalence of any illness in which fever, diarrhea, sore throat, vomiting or jaundice is a prominent symptom.
OSHA has a particular interest in comments on the following issues:
• Whether the proposed collection of information is necessary for the proper performance of the Agency's functions, including whether the information will have practical utility;
• 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, especially the number of temporary labor camps in the United States; and
• The quality, utility, and clarity of the information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
OSHA proposes to extend OMB's approval of the collection of information requirements specified in 5 CFR
This document was prepared under the direction of John L. Henshaw, Assistant Secretary of Labor for Occupational Safety and Health, 200 Constitution Avenue, NW., Washington, DC 20210.
This action is taken pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3506(c)(2)(A)).
Facility Operating License No. NPF-86 authorizes the operation of Seabrook Station, Unit No. 1 (Seabrook Station or the facility), at steady-state power levels not in excess of 3,411 megawatts thermal. The facility is located in Seabrook Township, Rockingham County, New Hampshire, on the southeast coast of the State of New Hampshire. The license authorizes North Atlantic Energy Service Corporation (NAESCO) to possess, use, and operate the facility, and certain other entities discussed below to possess the facility.
Under cover of a letter dated May 17, 2002, NAESCO, on its own behalf and on the behalf of certain licensees owning interests in Seabrook Station—North Atlantic Energy Corporation (NAEC), The United Illuminating Company, Great Bay Power Corporation, New England Power Company, The Connecticut Light and Power Company, Canal Electric Company, Little Bay Power Corporation, and New Hampshire Electric Cooperative, Inc.—and FPL Energy Seabrook, LLC (FPLE Seabrook) jointly submitted an application requesting approval of the transfer of Facility Operating License No. NPF-86 for Seabrook Station, to the extent held by the foregoing licensees, to FPLE Seabrook. The applicants also requested approval of a conforming amendment to reflect the transfer. The application was supplemented by submittals dated June 28, July 1, July 24, August 29, and October 11, 2002 (collectively referred to as the “application” herein unless otherwise indicated).
FPLE Seabrook is an indirect, wholly owned subsidiary of FPL Energy, LLC (FPLE), which is a wholly owned subsidiary of FPL Group Capital Inc., which, in turn, is a wholly owned subsidiary of FPL Group Inc. (FPL Group). According to the application, the current licensees owning interests in the facility listed above will sell their ownership interests in Seabrook Station to FPLE Seabrook. In addition, NAESCO will transfer its operating authority under the license to FPLE Seabrook which will assume title to the acquired interests in the facility and operate and maintain Seabrook Station. While the transfer of operating authority and the ownership interests identified in the application is expected to occur at one time, it is possible that certain ownership interests proposed to be transferred will be transferred in a second phase, depending upon the timing of the receipt of other regulatory approvals. Current licensees which own interests in Seabrook Station but are not involved in this license transfer are Massachusetts Municipal Wholesale Electric Company, Taunton Municipal Lighting Plant, and Hudson Light and Power Department, all of which will remain licensees.
The conforming license amendment would remove from the license references to NAESCO and the licensees transferring their interests in the facility and add references to FPL Energy Seabrook, LLC, as a licensee, and make other administrative changes to reflect the proposed transfer.
The application requested approval of the subject transfer of the license and a conforming license amendment pursuant to 10 CFR 50.80 and 50.90. Notice of the requests for approval and an opportunity to request a hearing or submit written comments was published in the
Under 10 CFR 50.80, no license, or any right thereunder, shall be transferred, directly or indirectly, through transfer of control of the license, unless the Commission shall give its consent in writing. After reviewing the information submitted in the application and other information before the Commission, and relying upon the representations and agreements contained in the application, the Nuclear Regulatory Commission (NRC) staff has determined that FPLE Seabrook is qualified to be the holder of the license to the extent proposed in the application, and that the transfer of the license to FPLE Seabrook is otherwise consistent with applicable provisions of law, regulations, and orders issued by the Commission, subject to the conditions set forth below. The NRC staff has further found that the application for the proposed license amendment complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's rules and regulations set forth in 10 CFR Chapter I; the facility will operate in conformity with the application, the provisions of the Act, and the rules and regulations of the Commission; there is reasonable assurance that the activities authorized by the proposed license amendment can be conducted without endangering the health and safety of the public and that such activities will be conducted in compliance with the Commission's regulations; the issuance of the proposed license amendment will not be inimical to the common defense and security or the health and safety of the public; and the issuance of the proposed license amendment will be in accordance with 10 CFR part 51 of the Commission's regulations and all applicable requirements have been satisfied. The findings set forth above are supported by the staff's safety evaluation dated October 25, 2002.
Accordingly, pursuant to sections 161b, 161i, and 184 of the Atomic Energy Act of 1954, as amended, 42 U.S.C. 2201(b), 2201(i), and 2234; and 10 CFR 50.80,
(1) Before the transfer of operating authority and completion of the sale and transfer of any interest in Seabrook Station to FPLE Seabrook, FPLE Seabrook shall provide the Director of the Office of Nuclear Reactor Regulation satisfactory documentary evidence that FPLE Seabrook has obtained the appropriate amount of insurance required of licensees under 10 CFR part 140 of the Commission's regulations.
(2) On the closing date(s) of the transfer of any ownership interests in Seabrook Station covered by this Order, FPLE Seabrook shall obtain from each respective transferring owner all of the accumulated decommissioning trust funds for the facility, and ensure the deposit of such funds and additional funds, if necessary, into a decommissioning trust or trusts for Seabrook Station established by FPLE Seabrook, such that the amount of funds deposited meets or exceeds the amount required under 10 CFR 50.75 with respect to the interest in Seabrook Station FPLE Seabrook acquires on such dates(s).
(3) With respect to the decommissioning trust(s) established by FPLE Seabrook,
(i) The decommissioning trust agreement must be in a form acceptable to the NRC.
(ii) Investments in the securities or other obligations of FPL Group Inc. or its affiliates, successors, or assigns shall be prohibited. In addition, except for investments tied to market indexes or other non-nuclear-sector mutual funds, investments in any entity owning one or more nuclear power plants shall be prohibited.
(iii) The decommissioning trust agreement must provide that no disbursements or payments from the trust(s), other than for ordinary administrative expenses, shall be made by the trustee unless the trustee has first given the NRC 30 days prior written notice of payment. The decommissioning trust agreement shall further provide that no disbursements or payments from the trust(s) shall be made if the trustee receives prior written notice of objection from the Director of the Office of Nuclear Reactor Regulation.
(iv) The decommissioning trust agreement must provide that the agreement cannot be amended in any material respect without 30 days prior written notification to the Director of the Office of Nuclear Reactor Regulation.
(v) The appropriate section of the decommissioning trust agreement shall provide that the trustee, investment advisor, or anyone else directing the investments made in the trust(s) shall adhere to a “prudent investor” standard, as specified in 18 CFR 35.32(a)(3) of the Federal Energy Regulatory Commission's regulations.
(4) FPLE Seabrook shall take all necessary steps to ensure that the decommissioning trust(s) are maintained in accordance with the application and the requirements of this Order, and consistent with the safety evaluation supporting this Order.
(5) FPLE Seabrook shall take no action to cause FPL Group Capital, Inc. or its parent companies to void, cancel, or modify the Support Agreement to provide funding of up to $110 million for FPLE Seabrook as represented in the application without prior written consent of the Director of the Office of Nuclear Reactor Regulation.
(6) After receipt of all required regulatory approvals of the transfer of the subject interests in Seabrook Station, NAESCO and FPLE Seabrook shall inform the Director of the Office of Nuclear Reactor Regulation in writing of such receipt within 5 business days, and of the closing date(s) of the transfer no later than 2 business days prior to the date of closing. If the transfer of the license as approved by this Order is not completed by October 31, 2003, this Order shall become null and void, provided, however, on written application and for good cause shown, this date may be extended in writing.
This Order is effective upon issuance.
For further details with respect to this Order, see the initial application dated May 17, 2002, the supplemental letters dated June 28, July 1, July 24, August 29, and October 11, 2002, and the safety evaluation dated October 25, 2002, which are available for public inspection at the Commission's Public Document Room, located at One White Flint North, 11555 Rockville Pike (first floor), Rockville, Maryland, and accessible electronically through the ADAMS Public Electronic Reading Room link at the NRC Web site (
For the Nuclear Regulatory Commission.
The U.S. Nuclear Regulatory Commission (NRC or the Commission) has issued Amendment 2 to Materials License No. SNM-2509 held by Portland General Electric Company (PGE) for the receipt, possession, storage, and transfer of spent fuel at the Trojan Independent Spent Fuel Storage Installation (ISFSI), located in Columbia County, Oregon. The amendment is effective as of the date of issuance.
By application dated October 26, 2001, PGE requested an amendment to its ISFSI license to permit the use of the Holtec International Multi-Purpose Canister (MPC) to store spent fuel.
This amendment complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's rules and regulations. The Commission has made appropriate findings as required by the Act and the Commission's rules and regulations in 10 CFR Chapter I, which are set forth in the license amendment. An Environmental Assessment and Finding of No Significant Impact regarding this amendment has been issued (67 FR 63458, October 11, 2002).
In accordance with 10 CFR 72.46(b)(2), a determination has been made that the amendment does not present a genuine issue as to whether public health and safety will be significantly affected. Therefore, the publication of a notice of proposed action and an opportunity for hearing or a notice of hearing is not warranted. Notice is hereby given of the right of interested persons to request a hearing on whether the action should be rescinded or modified.
For further details with respect to this amendment, see the application dated October 26, 2001, which is available for
For the Nuclear Regulatory Commission.
Notice is hereby given that the U.S. Nuclear Regulatory Commission (the Commission) has published a draft plant-specific supplement to the Generic Environmental Impact Statement (GEIS), NUREG-1437, regarding the renewal of operating licenses DPR-67 and NPF-16 for an additional 20 years of operation at St. Lucie, Units 1 and 2 (St. Lucie). St. Lucie nuclear power station is located on Hutchinson Island in St. Lucie County, Florida. Possible alternatives to the proposed action (license renewal) include no action and reasonable alternative energy sources.
The draft supplement to the GEIS is available for public inspection in the NRC Public Document Room (PDR) located at One White Flint North, 11555 Rockville Pike (first floor), Rockville, Maryland, or, electronically, from the Publicly Available Records (PARS) component of NRC's Agencywide Documents Access and Management System (ADAMS). ADAMS is accessible from the NRC Web site at
Any interested party may submit comments on the draft supplement to the GEIS for consideration by the NRC staff. To be certain of consideration, comments on the draft supplement to the GEIS and the proposed action must be received by January 15, 2003. Comments received after the due date will be considered if it is practical to do so, but the NRC staff is able to assure consideration only for comments received on or before this date. Written comments on the draft supplement to the GEIS should be sent to: Chief, Rules and Directives Branch, Division of Administrative Services, Office of Administration, Mailstop T-6D 59, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.
Comments may be hand-delivered to the NRC's PDR, located at One White Flint North, 11555 Rockville Pike (first floor), Rockville, Maryland, between 7:45 a.m. and 4:15 p.m. on Federal workdays. Submittal of electronic comments may be sent by Internet to the NRC at
The NRC staff will hold a public meeting to present an overview of the draft plant-specific supplement to the GEIS and to accept public comments on the document. The public meeting will be held at the Council Chambers, Port St. Lucie City Hall, 121 SW Port St. Lucie Boulevard, Port St. Lucie, Florida, on December 3, 2002. There will be two sessions to accommodate interested parties. The first session will commence at 1:30 p.m. and will continue until 4:30 p.m. The second session will commence at 7 p.m. and will continue until 10 p.m. Both meetings will be transcribed and will include: (1) A presentation of the contents of the draft plant-specific supplement to the GEIS, and (2) the opportunity for interested government agencies, organizations, and individuals to provide comments on the draft report. Additionally, the NRC staff will host informal discussions one hour prior to the start of each session at the Port St. Lucie City Hall. Persons may pre-register to attend or present oral comments at the meeting by contacting Dr. Michael T. Masnik by telephone at 1-800-368-5642, extension 1191, or by Internet to the NRC at
For further information, contact: Dr. Michael T. Masnik, License Renewal and Environmental Impacts Program, Division of Regulatory Improvement Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555. Dr. Masnik may be contacted at the aforementioned telephone number or e-mail address.
For the Nuclear Regulatory Commission.
Pension Benefit Guaranty Corporation.
Notice of a new routine use of records for PBGC-6, Plan Participant and Beneficiary Data—PBGC.
The Pension Benefit Guaranty Corporation is proposing a new routine use of records for a system of records maintained pursuant to the Privacy Act of 1974, as amended, entitled PBGC-6, Plan Participant and Beneficiary Data—PBGC. The new routine use permits PBGC to disclose to the Department of Treasury and the Department of Labor
Comments on the new routine use must be received by December 2, 2002. The new routine use will become effective December 3, 2002, without further notice, unless comments result in a contrary determination and a notice is published to that effect.
Comments may be mailed to the Office of the General Counsel, Pension Benefit Guaranty Corporation, 1200 K Street, NW., Washington, DC 20005-4026, or delivered to Suite 340 at the above address. Comments also may be sent by Internet e-mail to
D. Bruce Campbell, Attorney, Office of the General Counsel, Pension Benefit Guaranty Corporation, 1200 K Street, NW., Washington, DC 20005-4016, 202-326-4020 (extension 3672). (TTY/TDD users may call the Federal relay service toll-free at 1-800-877-8339 and ask to be connected to 202-326-4020.)
The Trade Act of 2002 amended the Internal Revenue Code to create an income tax credit for health insurance costs of eligible individuals. Pub. L. 107-210, sec. 201, 116 Stat. 933, 954 (Aug. 6, 2002) (to be codified at 26 U.S.C. 35). The legislation also requires the Department of Treasury to establish a program for making advance payment to eligible individuals of the income tax credit. Pub. L. No. 107-210, sec. 202, 116 Stat. at 960 (to be codified at 26 U.S.C. 7527). The income tax credit and advance payment program are open to, among others, any individual who is an “eligible PBGC pension recipient.” 26 U.S.C. 35(c) and 26 U.S.C. 7527(d)(2). An eligible PBGC pension recipient is defined to mean, with respect to any month, an individual “who has attained age 55 as the first day of such month, and * * * is receiving a benefit for such month any portion of which is paid by the (PBGC).” 26 U.S.C. 35(c)(4).
The income tax credit and advance payment program are also open to any individual who is an “eligible TAA recipient” 26 U.S.C. 35(c) and 26 U.S.C. 7527(d)(2). The term eligible TAA recipient is defined to include, for any month, an individual who is receiving “a trade readjustment allowance under * * * the Trade Act of 1974.” The Department of Labor, with the states, is responsible for implementing the trade readjustment assistance program for eligible workers. 19 U.S.C. 2271-2296. The Trade Act of 2002 also amended the Workforce Investment Act of 1988 to permit a state to use funds made available by the Department of Labor to provide qualified health insurance assistance to eligible individuals and to pay the administrative expenses associated with implementing the income tax credit and advance payment program. Pub. L. 107-210, sec. 203, 116 Stat. 933, 963 (to be codified at 29 U.S.C. 2918(a) and (f)).
The new routine use permits the PBGC to disclose the names, addresses, social security numbers, and dates of birth of eligible PBGC pension recipients to the Department of Treasury and the Department of Labor to implement the income tax credit for health insurance costs and the advance payment program for eligible individuals.
For the convenience of the public, PBGC-6, as amended, is published in full below with new routine 14 italicized.
Plan Participant and Beneficiary Data—PBGC.
Not applicable.
Pension Benefit Guaranty Corporation, 1200 K Street, NW., Washington, DC 20005-4026 and/or field benefit administrator, plan administrator, and paying agent worksites.
Participants and beneficiaries in terminating and terminated pension plans covered by Title IV of the Employee Retirement Income Security Act of 1974, as amended (“ERISA”).
Names, addresses, telephone numbers, sex, social security numbers and other Social Security Administration information, dates of birth, dates of hire, salary, marital status, domestic relations orders, time of plan participation, eligibility status, pay status, benefit data, health-related information, insurance information where plan benefits are provided by private insurers, initial and final PBGC determinations (29 CFR § 4003.21 and 4003.59). The records listed herein are included only as pertinent or applicable to the individual plan participant or beneficiary.
29 U.S.C. 1055, 1056(d)(3), 1302, 1321, 1322, 1322a, 1341, 1342 and 1350.
This system of records is maintained for use in determining whether participants and beneficiaries are eligible for benefits under plans covered by Title IV of ERISA, the amounts of benefits to be paid, making benefit payments, and collecting benefit overpayments. Names, addresses, and telephone numbers are used to survey customers to measure their satisfaction with the PBGC 's benefit payment services and to track (for follow up) those who do not respond to surveys.
1. A record from this system of records may be disclosed to third parties, such as banks, insurance companies, or trustees, to make benefit payments to plan participants and beneficiaries.
2. A record from this system of records may be disclosed, in furtherance of proceedings under Title IV of ERISA, to a contributing sponsor (or other employer who maintained the plan), including any predecessor or successor, and any member of the same controlled group.
3. A record from this system of records may be disclosed, upon request for a purpose authorized under Title IV of ERISA, to an official of a labor organization recognized as the collective bargaining representative of the individual about whom a request is made.
4. Names, addresses, and telephone numbers of participants and beneficiaries and information pertaining to debts owed by such participants and beneficiaries to the PBGC may be disclosed to a debt collection agency or firm to collect a claim. Disclosure shall be made only under a contract that binds any such contractor or employee of such contractor to the criminal penalties of the Privacy Act. The
5. The name and social security number of a participant employed or formerly employed as a pilot by a commercial airline may be disclosed to the Federal Aviation Administration (“FAA”) to obtain information relevant to the participant's eligibility or continued eligibility for disability benefits.
6. Names and social security numbers of plan participants and beneficiaries may be disclosed to the Internal Revenue Service (“IRS”) to obtain current addresses from tax return information and to the Social Security Administration (“SSA”) to obtain current addresses. Such information will be disclosed only if the PBGC has no address for an individual or if mail sent to the individual at the last known address is returned as undeliverable.
7. Names and last known addresses may be disclosed to an official of a labor organization recognized as the collective bargaining representative of participants for posting in union halls or for other means of publication to obtain current addresses of participants and beneficiaries. Such information will be disclosed only if the PBGC has no address for an individual or if mail sent to the individual at the last known address is returned as undeliverable.
8. Names, social security numbers, last known addresses, and dates of birth and death may be disclosed to private firms and agencies that provide locator services, including credit reporting agencies and debt collection firms or agencies, to locate participants and beneficiaries. Such information will be disclosed only if the PBGC has no address for an individual or if mail sent to the individual at the last known address is returned as undeliverable. Disclosure shall be made only under a contract that binds the firm or agency providing the service and its employees to the criminal penalties of the Privacy Act. The information so disclosed shall be used exclusively pursuant to the terms and conditions of such contract and shall be used solely for the purposes prescribed therein. The contract shall provide that the information so disclosed shall be returned at the conclusion of the locating effort.
9. Names and last known addresses may be disclosed to licensees of the United States Postal Service (“USPS”) to obtain current addresses under the USPS's National Change of Address Program. Such information will be disclosed only if the PBGC has no address for an individual or if mail sent to the individual at the last known address is returned as undeliverable. Disclosure shall be made only under a contract that binds the licensee of the Postal Service and its employees to the criminal penalties of the Privacy Act. The information so disclosed shall be used exclusively pursuant to the terms and conditions of such contract and shall be used solely for the purposes prescribed therein. The contract shall provide that the information so disclosed shall be returned at the conclusion of the locating effort.
10. Names and last known addresses may be disclosed to other participants in, and beneficiaries under, a pension plan to obtain the current addresses of individuals. Such information will be disclosed only if the PBGC has no address for an individual or if mail sent to the individual at the last known address is returned as undeliverable.
11. Names and last known addresses of participants and beneficiaries, and the names and addresses of participants' former employers, may be disclosed to the public to obtain current addresses of the individuals. Such information will be disclosed to the public only if the PBGC is unable to make benefit payments to the participants and beneficiaries because the address it has does not appear to be current or correct.
12. The name of a participant's pension plan, the actual or estimated amount of a participant's benefit under Title IV of ERISA, the form(s) in which the benefit is payable, and whether the participant is currently receiving benefit payments under the plan or (if not) the earliest date(s) such payments could commence may be disclosed to the participant's spouse, former spouse, child, or other dependent solely to obtain a qualified domestic relations order under 29 U.S.C. 1056(d) and 26 U.S.C. 414(p). The PBGC will disclose the information only upon the receipt of a notarized, written request by a prospective alternate payee that describes the requester's relationship to the participant and states that the information will be used solely to obtain a qualified domestic relations order under state domestic relations law. The PBGC will notify the participant of any information disclosed to a prospective alternate payee under this routine use. Any person who knowingly and willfully requests or obtains any record concerning an individual under false pretenses is subject to a criminal penalty under 5 U.S.C. 552a(i)(3).
13. Information from a participant's initial determination under 29 CFR 4003.1(b) (excluding the participant's address, telephone number, social security number, and any sensitive medical information) may be disclosed to a participant's spouse, former spouse, child, or other dependent who is an alternate payee under a qualified domestic relations order issued pursuant to 29 U.S.C. 1056(d) and 26 U.S.C. 414(p) to explain how the PBGC determined the benefit due the alternate payee so that the alternate payee can pursue an administrative appeal of the benefit determination under 29 CFR 4003.51. The PBGC will notify the participant of the information disclosed to an alternate payee under this routine use.
14.
General Routine Uses G1 and G4 through G7 (see Prefatory Statement of General Routine Uses) apply to this system of records.
Information may be disclosed to a consumer reporting agency in accordance with 31 U.S.C. 3711(f) (5 U.S.C. 552a(b)(12)).
Records are maintained in paper and electronic form.
Records are indexed by plan and participant and/or beneficiary name. Customer satisfaction survey responses are aggregated for statistical purposes after they have been received by the PBGC and are not retrievable by a participant or beneficiary's name or other assigned identifier.
Paper records are kept in file folders in areas of restricted access that are locked after office hours. Electronic records are stored on computer networks and protected by assigning user identification numbers to individuals needing access to the records and by passwords set by authorized users that must be changed periodically.
Records for plan participants are transferred to the Washington National Federal Records Center 6 months after either the final payment to a participant and/or beneficiary or the PBGC's final determination that a participant or beneficiary is not entitled to any benefits and are destroyed 7 years after such payment or determination.
Director, Insurance Operations Department, Pension Benefit Guaranty Corporation, 1200 K Street, NW., Washington, DC 20005-4026.
Procedures are detailed in the PBGC's regulations: 29 CFR part 4902.
Same as notification procedure.
Same as notification procedure.
Plan administrators, participants and beneficiaries, the FAA, the SSA, labor organization officials, firms or agencies providing locator services, and USPS licensees.
None.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520), the Securities and Exchange Commission (the “Commission”) is soliciting comments on the collection of information summarized below. The Commission plans to submit this existing collection of information to the Office of Management and Budget (“OMB”) for extension and approval.
Rule 17a-7 [17 CFR 270.17a-7] under the Investment Company Act of 1940 (the “Act”) is entitled “Exemption of certain purchase or sale transactions between an investment company and certain affiliated persons thereof.” It provides an exemption from section 17(a) of the Act for purchases and sales of securities between registered investment companies, which are affiliated persons or affiliated persons of affiliated persons of each other, or between a registered investment company and an affiliated person or an affiliated person of an affiliated person, when the affiliation arises solely because of a common adviser, director, or officer. Rule 17a-7 requires investment companies to keep various records in connection with purchase or sale transactions affected by the rule. The rule requires the board of directors of an investment company to establish procedures reasonably designed to ensure that all conditions of the rule have been satisfied. If an investment company enters into a purchase or sale transaction with an affiliated person, the rule requires the investment company to compile and maintain written records of the transaction.
The Commission estimates that approximately 1,000 investment companies enter into transactions affected by rule 17a-7 each year and, therefore, are subject to the rule's information collection requirements.
Written comments are invited on: (a) Whether the collections of information are necessary for the proper performance of the functions of the Commission, including whether the information has practical utility; (b) the accuracy of the Commission's estimate of the burdens of the collections of information; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burdens of the collections of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted in writing within 60 days of this publication.
Please direct your written comments to Kenneth A. Fogash, Acting Associate Executive Director, Office of Information Technology, Securities and Exchange Commission, 450 5th Street, NW., Washington, DC 20549.
Notice is hereby given that the following filing has been made with the Commission pursuant to provisions of the Act and rules promulgated under the Act. All interested persons are referred to the application/declaration for a complete statements of the proposed transaction summarized below. The application/declaration is available for public inspection through the Commission's Branch of Public Reference.
Interested persons wishing to comment or request a hearing on the application/declaration should submit their views in writing by November 18, 2002, to the Secretary, Securities and Exchange Commission, Washington, DC 20549-0609, and serve a copy on the relevant applicant/declarant at the address specified below. Proof of service (by affidavit or, in the case of an attorney at law, by certificate) should be filed with the request. Any request for hearing should identify specifically the issues of facts or law that are disputed. A person who so requests will be notified of any hearing, if ordered, and will receive a copy of any notice or order issued in the matter. After November 18, 2002, the application/declaration, as filed or as amended, may be granted and/or permitted to become effective.
Ameren Corporation (“Ameren”), a registered public utility holding company, Ameren Energy Fuels and Services Company (“Ameren Fuels”), Ameren's indirect wholly owned nonutility subsidiary, both located at 1901 Chouteau Avenue, St. Louis, Missouri 63103; and CILCORP Inc. (”CILCORP”), an exempt holding company under section 3(a)(1) of the Act and a wholly owned subsidiary of The AES Corporation (“AES”), an exempt holding company under section 3(a)(5) of the Act, CILCORP's direct wholly owned public utility subsidiary, Central Illinois Light Company (”CILCO”), and CILCO's wholly owned nonutility subsidiary, Central Illinois Generation, Inc. (“CIGI”), all located at 300 Liberty Street, Peoria, Illinois 61602 (collectively, and together with Ameren and Ameren Fuels, “Applicants”), have filed an application-declaration under sections 3(a)(1), 6(a), 7, 8, 9(a), 9(c)(3), 10, 11(b), 12(b), 12(c), 12(d), 12(f), 13(b) and 32 of the Act and rules 45, 46, 51, 54, 87, 90 and 91 under the Act (“Application”).
Applicants request authority for the acquisition of CILCORP by Ameren and associated transactions (collectively, “Transaction”). The Transaction will be effected through a stock purchase agreement (“Stock Purchase Agreement” ) entered into by Ameren and The AES Corporation (”AES”), CILCORP's parent company, under which Ameren has agreed to purchase, for cash, all of the issued and outstanding shares of common stock of CILCORP. As a result of the Transaction, Ameren will indirectly acquire all of the common stock of CILCO and CIGI, which will become additional public utility subsidiaries of Ameren,
In conjunction with the Transaction, Ameren states that it has also agreed to purchase from AES all of the membership interests in AES Medina Valley (No. 4), LLC, which indirectly through intermediate subsidiaries holds all of the membership interests of AES Medina Valley Cogen, L.L.C. (”AES Medina Valley”), an EWG. AES Medina Valley owns a 40 MW gas-fired cogeneration facility in Mossville, Illinois that produces electricity, steam and chilled water that is sold to CILCO for resale to CILCO's largest customer, Caterpillar Inc.
In addition to authorization of the Transaction, CILCORP, CILCO and CIGI are requesting authorization through March 31, 2006 (“Authorization Period”) for a program of long-term and short-term financing. CILCORP is requesting authorization to issue guarantees and provide other forms of credit support on behalf of its subsidiaries, and to pay dividends out of capital and unearned surplus, subject to certain limitations. Applicants are requesting authorization to permit Ameren Services to enter into separate service agreements with CILCORP, CILCO, CIGI and certain of CILCORP's other subsidiaries. Ameren Fuels is requesting authorization to enter into a fuel services agreement with CILCO and CIGI. Ameren is requesting authority to retain certain of CILCORP's nonutility subsidiaries and investments. To the extent required, Applicants are requesting authorization to maintain in place a tolling agreement with AES Medina Valley, a fuel supply and services agreement between a gas marketing subsidiary of CILCORP and AES Medina Valley and a FERC-approved interconnection agreement between CILCO and AES Medina Valley. Finally, CILCORP and CILCO are requesting an order granting to each of them an exemption under section 3(a)(1) of the Act.
Ameren's primary operating subsidiaries are AmerenCIPS and AmerenUE, which are electric and gas utility companies, and Ameren Energy Generating Company (“Ameren Energy Generating”), which is an EWG. Together, AmerenCIPS and AmerenUE provide electric service to approximately 1.5 million customers in Missouri and Illinois and natural gas service to approximately 300 customers, also in Missouri and Illinois. Ameren Energy Generating, an indirect wholly owned subsidiary of Ameren, was organized to facilitate the restructuring of AmerenCIPS in accordance with the Illinois Electric Service Customer Choice and Rate Relief Law of 1997 (“Customer Choice Law”). In May 2000, Ameren Energy Generating acquired all of the existing generating assets of AmerenCIPS.
AmerenUE and Ameren Energy Generating together own and operate about 12,600 MW of electric generating capacity, all of which is located in Missouri and Illinois. As of December 31, 2001, AmerenUE and AmerenCIPS owned and operated, or partially owned, a total of approximately 5,400 circuit miles of electric transmission lines and approximately 7,800 miles of natural gas transmission and distribution mains, substantially all of which are located in Missouri and Illinois.
Ameren's directly owns CIPSCO Investment Company, Ameren Services Company (“Ameren Services”), Ameren Energy, Inc., Ameren Development Company and Ameren Energy Resources Company, all nonutility subsidiaries. CIPSCO Investment Company holds various nonutility businesses, including passive investments in low income housing projects and investments in equipment leases. Ameren Services is a service company subsidiary that provides administrative, accounting, legal, engineering, executive, and other corporate support services to Ameren and its associate companies. Ameren Energy, Inc. is an energy-related company under rule 58 that primarily serves as the short-term energy trading and marketing agent for AmerenUE and Ameren Energy Generating and provides a range of energy and risk management services. Ameren Development Company is an intermediate nonutility holding company that directly and indirectly owns all of the outstanding stock of two energy-related companies under rule 58 (Ameren ERC, Inc., which provides energy management services, and Missouri Central Railroad, a fuel transportation subsidiary) and of Ameren Energy Communications, Inc., an exempt telecommunications company within the meaning of section 34 of the Act. Ameren Energy Resources Company, also an intermediate nonutility holding company, holds all of the outstanding common stock of Ameren Energy Development Company, an EWG, as well as of two energy-related companies under rule 58, Ameren Energy Marketing Company, a power marketer, and Ameren Fuels, which brokers and markets energy
In addition, Ameren indirectly owns 60% of the common stock of Electric Energy, Inc. (“EEI”), an EWG. EEI owns and/or operates electric generation and transmission facilities in Illinois that supply electric power primarily to a uranium enrichment plant located in Paducah, Kentucky.
Ameren also indirectly owns all of the common stock of Ameren Fuels, an “energy-related company” under rule 58 that brokers and markets energy commodities and owns and manages fuel procurement and delivery assets.
For the twelve months ended December 31, 2001, Ameren reported total operating revenues of $4,505,867,000, operating income of $664,987,000, and net income of $468,545,000. On a consolidated basis, approximately 92.2% of Ameren's 2001 operating revenues were derived from sales of electricity, 7.6% from sales of gas and gas transportation service, and .2% from other sources. At December 31, 2001, Ameren had $10,400,575,000 in total assets, including net property and plant of $8,426,562,000. As of August 9, 2002, Ameren had issued and outstanding 144,946,829 shares of common stock, $.01 par value. Ameren's common stock is listed and traded on the New York Stock Exchange.
CILCORP, an Illinois corporation, directly owns all of the issued and outstanding common stock of CILCO, its predominant subsidiary. CILCO is engaged in the generation, transmission, distribution and sale of electric energy in an area of approximately 3,700 square miles in central and east-central Illinois, and the purchase, distribution, transportation and sale of natural gas in an area of approximately 4,500 square miles in central and east-central Illinois. CILCO furnishes electric service to approximately 201,000 retail customers in 136 Illinois communities (including Peoria, East Peoria, Pekin, Lincoln and Morton). CILCO owns and operates two coal-fired base load generating plants, a natural gas-fired cogeneration plant, two natural gas combustion turbine generators and 16 diesel-fueled power modules and leases 14 diesel-fueled power modules, all of which are located in Illinois. These facilities had an available summer capability of 1,172 MW in 2001 and 1,197 MW in 2002. CILCO's transmission system (all of which is located in Illinois) includes approximately 285 circuit miles operating at 138 kV, 48 circuit miles operating at 345 kV and 18 principal substations with an installed capacity of approximately 3,724 megavolt-amperes. CILCO's electric distribution system (all of which is located in Illinois) includes approximately 6,516 circuit miles of overhead pole and tower lines and 1,933 miles of underground distribution cables. The distribution system also includes approximately 108 substations with an installed capacity of 1,766 megavolt-amperes.
CILCO has a power purchase agreement with AmerenCIPS for the purchase of 100 MW of capacity and firm energy for the months of June through September through 2003. The agreement also provides for CILCO to purchase 100 MW of firm energy for the month of January through 2003. CILCO and Ameren also make short-term sales of power to each other from time to time under market-based rate tariffs as authorized by the FERC.
Applicants state that CILCO intends to transfer substantially all of its generating assets and certain associated transmission facilities to CIGI in exchange for all of CIGI's common stock and CIGI's assumption of certain liabilities.
CILCO's electric service territory is adjacent to AmerenCIPS' service territory. The transmission systems of the two companies are directly interconnected via a 345 kV line that runs approximately 21.3 miles between CILCO's Duck Creek station, which is southwest of Peoria, to a 345/138 kV transformer owned by AmerenCIPS near Ipava, Illinois.
CILCO also provides gas service to approximately 204,000 customers in 128 Illinois communities (including Peoria, East Peoria, Pekin, Lincoln and Springfield). CILCO's gas system includes approximately 3,632 miles of transmission and distribution mains (all of which are located in Illinois) and associated gas storage facilities.
CILCO is regulated by the ICC with respect to retail electric and gas rates and other matters and by the FERC with respect to the transmission service and wholesale electric rates. CIGI is not a public utility company under the laws of Illinois and is therefore not subject to regulation by the ICC. However, CIGI is subject to regulation by the FERC with respect to wholesale electric rates and other matters.
CILCORP directly owns all of the common stock of three nonutility subsidiaries: CILCORP Investment Management Inc., CILCORP Ventures Inc., and QST Enterprises Inc. The assets of these companies consist primarily of investments in affordable housing projects that qualify for federal tax credits and in leveraged leases of equipment and commercial real estate. Applicants maintain that other direct and indirect subsidiaries of CILCORP provide energy-related services. CILCO's nonutility subsidiaries engage in the exploration and development of gas, oil, coal and other mineral resources and research and development activities relating to new sources of energy, including the conversion of coal and other minerals into gas. With certain exceptions, Ameren is requesting approval to retain CILCORP's nonutility subsidiaries and investments.
For the twelve months ended December 31, 2001, CILCORP reported consolidated revenues of $814,870,000, of which $391,811,000 (48.1%) were derived from sales of electricity, $271,434,000 (33.3%) from sales of gas and gas transportation service, and $151,625,000 (18.6%) from CILCORP's nonutility operations. At December 31, 2001, CILCORP had $1,811,698,000 in total assets, including total net property, plant and equipment of $857,987,000.
Applicants request approval for the acquisition by Ameren of all of the issued and outstanding common stock of CILCORP pursuant to the Stock Purchase Agreement. Under the Stock Purchase Agreement, Ameren will pay AES, in consideration for all of the issued and outstanding common stock of CILCORP, cash in an amount equal to $1,340,000,000, less certain “assumed obligations”
The Stock Purchase Agreement further provides that, in the event that the closing date does not occur by the “Trigger Date,” then the
“purchase price” shall be increased by $33,699 per day from the Trigger Date through the closing date, subject to certain limitations. The Trigger Date is the later of (a) December 31, 2002, (b) the date on which AES is capable (without further action by any third party) of completing performance in all material respects of its obligations required to be performed on or prior to closing, and (c) the date which is 90 days following the date on which the ICC grants its approval of the Transaction. Subject to certain limitations and exceptions, either party may terminate the Stock Purchase Agreement if closing has not occurred by March 27, 2003.
Following the acquisition of CILCORP, Ameren proposes to retain
CILCORP as a direct subsidiary for the foreseeable future, and CILCORP will continue to own all of the common stock of CILCO. CILCO, in turn, will continue to hold all of the common stock of CIGI for the foreseeable future. CILCO will maintain its headquarters in Peoria for a period of at least five years and will maintain a local management team and adequate staffing levels to operate its utility system. CILCO will continue to operate as a separate control area. CILCO's generating plants (which CILCO intends to transfer to CIGI by the time of the closing) will not be jointly dispatched with the generating plants owned by AmerenUE and Ameren Energy Generating.
Applicants state that Ameren Services intends to enter into separate service agreements with CILCORP, CILCO, CIGI and certain of CILCORP's other subsidiaries that are identical in all material respects with an existing general service agreement between Ameren Services, Ameren, AmerenUE, AmerenCIPS and certain other associate companies. Thus, Ameren Services will provide to the new client companies the same administrative, management, and technical services that it now provides to Ameren system companies under the general services agreement, utilizing the same work order procedures and the same methods of allocating costs that are specified in that agreement. In connection with the Transaction, certain employees of CILCORP and its subsidiaries may be transferred to and become employees of Ameren Services.
Applicants state that historically, CILCO has provided certain administrative, management and technical services at cost to CILCORP and all of its other associate companies under a service agreement that has been approved by the ICC.
To the extent required, Applicants request authorization to maintain in place (a) a tolling agreement under which AES Medina Valley sells electricity, steam and chilled water to CILCO, (b) a fuel supply and services agreement between CILCORP Energy Services Inc. (“CESI”), a nonutility gas marketing subsidiary of CILCORP, and AES Medina Valley, under which CESI supplies AES Medina Valley's gas requirements and also provides certain ancillary services relating to the supply of gas to the Mossville facility, and (c) a FERC-approved interconnection agreement between CILCO and AES Medina Valley, under which CILCO provides metering and other ancillary services to AES Medina Valley, at cost.
In addition, Ameren Fuels requests authorization to enter into separate fuel services agreements with CILCO and CIGI under which Ameren Fuels will manage gas supply resources for CILCO
The existing equity and long-term and short-term debt securities of CILCORP, CILCO and CIGI will remain outstanding after the Transaction closes.
At March 31, 2002, CILCO had issued and outstanding 13,563,871 shares of common stock, no par value, all of which are held by CILCORP; 191,204 shares of cumulative preferred stock, $100 par value, and 220,000 shares of Class A preferred stock, no par value, totaling $41,120,000; and $242,250,000 of long-term debt. In addition, at December 31, 2001, CILCO had issued and outstanding $43,000,000 of commercial paper, and had in place bank lines totaling $100,000,000 which are used to backstop its commercial paper.
The financing authorizations requested in the Application will be subject to the following parameters:
• CILCORP, CILCO and CIGI state that they will not engage in any financing transactions for which approval is sought unless, on a pro forma basis to take into account the amount and types of the financing and the subsequent application of the proceeds, common equity as a percentage of capitalization (including short-term debt and current maturities of long-term debt) of each company is at least 30%;
• Except in accordance with a further order of the Commission in this proceeding, CILCORP and CIGI will not publicly issue any Long-term Securities (defined below) unless the securities are rated at the investment grade level as established by at least one nationally recognized statistical rating organization, as that term is used in paragraphs (c)(2)(vi)(E), (F) and (H) of Rule 15c3-1 under the Securities Exchange Act of 1934.
• The effective cost of money on all external short-term borrowings by CILCORP will not exceed at the time of issuance the greater of (1) 300 basis points over the six-month London Interbank Offered Rate (“LIBOR”), or (2) a gross spread over LIBOR that is consistent with similar securities of comparable credit quality and maturities issued by other companies;
• The maturity date of any new series of long-term notes issued by CILCORP will be not later than October 15, 2029, which is the maturity date of the longest of the two series of outstanding Senior Notes;
• Any new long-term notes issued by CILCORP in a refinancing transaction will bear interest at a rate not to exceed at the time of issuance the greater of (1) 500 basis points over the yield to maturity of a U.S. Treasury security having a remaining term equal to the average life of the new notes (or, if no such Treasury security is outstanding, then the yield to maturity of a 30-year U.S. Treasury Bond), or (2) a gross spread over U.S. Treasuries that is consistent with similar securities of comparable credit quality and maturities issued by other companies;
• The effective cost of money on all external short-term borrowings by CILCO and CIGI will not exceed at the time of issuance the greater of (1) 300 basis points over the six-month LIBOR, or (2) a gross spread over LIBOR that is consistent with similar securities of comparable credit quality and maturities issued by other companies;
• Any preferred stock or other types of preferred securities issued by CIGI will be redeemed no later than 50 years after issuance;
• The dividend rate on any series of preferred stock or other preferred securities issued by CIGI will not exceed at the time of issuance the greater of (1) 700 basis points over the yield to maturity of a U.S. Treasury security having a remaining term equal or closest to the term of the securities (or, if no such Treasury security is outstanding, then the yield to maturity of a 30-year U.S. Treasury Bond), or (2) a gross spread over U.S. Treasuries that is consistent with similar securities of comparable credit quality and maturities issued by other companies;
• Long-term debt issued by CIGI will have a maturity ranging from one to 50 years; and
• Long-term debt issued by CIGI will bear interest at a rate not to exceed at the time of issuance the greater of (1) 600 basis points over the yield to maturity of a U.S. Treasury security having a remaining term equal or closest to the average life of the series (or, if no such U.S. Treasury security is outstanding, then the yield to maturity of a 30-year U.S. Treasury Bond), or (2) a gross spread over U.S. Treasuries that is consistent with similar securities of comparable credit quality and maturities issued by other companies.
CILCORP requests authorization to issue and sell commercial paper and/or establish and make unsecured short-term borrowings (
CILCORP also requests authorization to issue, in one or more transactions from time to time during the Authorization Period, long-term notes for the purpose of refinancing or acquiring $475 million principal amount of senior notes (“Senior Notes”) that are currently outstanding at or prior to their scheduled maturity. The principal amount of any new long-term notes issued will not exceed the unpaid principal amount of the Senior Notes, plus any “make whole” premium required to be paid in connection with any prepayment and/or the premium, if any, that is paid in connection with any acquisition of the Senior Notes in open market purchases. In connection with any issuance, Ameren requests authorization to guaranty any new CILCORP notes issued in a refinancing transaction or to issue a guarantee of the outstanding CILCORP Senior Notes in order to obtain a termination and release of the pledge of CILCO's common stock
CILCO and CIGI are requesting authorization to issue commercial paper and establish and make unsecured short-term borrowings (
CIGI is also requesting authorization to issue and sell from time to time during the Authorization Period long-term securities consisting of any combination of preferred stock or other forms of preferred securities and long-term debt (“Long-term Securities”). Preferred stock or other types of preferred securities may be issued in one or more series with rights, preferences, and priorities as may be designated in the instrument creating each series provided that the aggregate amount of all such securities at any time outstanding, when added to the amount of any direct long-term borrowings by CIGI from Ameren (see part VI.C.1., “Intrasystem Financing Transactions” below), will not exceed $500 million.
Long-term debt of a particular series (i) may be secured or unsecured, (ii) may be subject to optional and/or mandatory redemption, in whole or in part, at par or at various premiums above the principal amount, (iii) may be entitled to mandatory or optional sinking fund provisions, (iv) may provide for reset of the coupon under a remarketing or auction arrangement, and (v) may be called from existing investors by a third party.
CILCORP and CIGI request authority to issue Long-term Securities that are rated below investment grade. Applicants request the Commission reserve jurisdiction over CILCORP and CIGI in connection with the issuance of any Long-term Securities that are rated below investment grade.
To the extent not exempt under rule 52, CILCORP, CILCO and CIGI also request authorization to enter into interest rate hedging transactions with respect to outstanding indebtedness (“Interest Rate Hedges”), subject to certain limitations and restrictions, in order to reduce or manage the effective interest rate cost. In no case will the notional amount of any Interest Rate Hedge exceed the principal amount of the underlying debt instrument. Transactions will be entered into for a fixed or determinable period. Thus, the applicants will not engage in speculative transactions. Interest Interest Rate Hedges would only be entered into with counterparties (“Approved Counterparties”) whose senior debt ratings, or the senior debt ratings of any credit support providers who have guaranteed the obligations of the Approved Counterparties, as published by S&P, are equal to or greater than BBB, or an equivalent rating from Moody's or Fitch, Inc. In addition, CILCORP, CILCO and CIGI request authorization to enter into interest rate hedging transactions with respect to anticipated debt offerings (the “Anticipatory Hedges”), subject to certain limitations and restrictions.
Applicants state that Each Interest Rate Hedge and Anticipatory Hedge will qualify for hedge accounting treatment under the current Financial Accounting Standards Board (“FASB”) guidelines in effect and as determined at the time entered into. Further, the Applicants will comply with the Statement of Financial Accounting Standards (“SFAS”) 133 (”Accounting for Derivatives Instruments and Hedging Activities”) and SFAS 138 (“Accounting for Certain Derivative Instruments and Certain Hedging Activities”) or other standards relating to accounting for derivative transactions as are adopted and implemented by the FASB.
Ameren may from time to time during the Authorization Period acquire additional shares of CILCORP's common stock, make additional capital contributions or non-interest bearing cash advances to CILCORP, and/or make loans to CILCORP, CILCO and CIGI (and acquire unsecured promissory notes of CILCORP, CILCO and CIGI evidencing the loans) in order to enable CILCORP to fund additional investments in CILCO and its other existing subsidiaries, to redeem or retire the outstanding Senior Notes, and to fund working capital. Accordingly, CILCORP requests authority to issue, and Ameren requests authority to acquire, from time to time during the Authorization Period, (a) up to $1 billion at any time outstanding of additional common stock and/or promissory notes having maturities of one year or more, and (b) up to $250 million at any time outstanding of promissory notes having maturities of less than one year. Any promissory note issued by CILCORP to Ameren evidencing a loan will be unsecured and will bear interest at a rate and have a maturity date designed to parallel the effective cost of capital and maturity date of a similar debt instrument issued by Ameren.
Ameren requests authorization to make long-term and short-term loans to CIGI (and acquire promissory notes of CIGI evidencing the loans) in order to fund CIGI's capital improvements and working capital requirements. Accordingly, CIGI requests authority to issue, and Ameren requests authority to acquire, from time to time during the Authorization Period, (a) up to $500 million at any time outstanding of promissory notes having maturities of one year or more, and (b) up to $250 million at any time outstanding of promissory notes having maturities of less than one year.
Ameren requests authorization to make short-term loans to CILCO (and acquire promissory notes of CILCO evidencing the loans) in order to fund CILCO's capital improvements and working capital requirements. Accordingly, CILCO requests authority to issue, and Ameren requests authority to acquire, from time to time during the Authorization Period, up to $250 million at any time outstanding of promissory notes having maturities of less than one year.
CILCORP and certain of its nonutility subsidiaries request authorization to maintain, renew and extend all guarantees and other forms of credit support that they have issued and which are outstanding at the time that the Transaction closes. In addition, CILCORP requests authorization to provide additional guarantees and other forms of credit support (collectively, “Guarantees”) from time to time during the Authorization Period on behalf of or for the benefit of any of its subsidiaries,
In connection with the issuance of any securities for which authorization is requested in the application/declaration, or (in the case of CILCO) under rule 52(a), CILCORP, CILCO and CIGI request authorization to acquire, directly or indirectly, the common stock or other equity securities of one or more entities (each a “Financing Subsidiary”) formed exclusively for the purpose of facilitating the issuance of long-term debt and/or preferred securities and the loan or other transfer of the proceeds to the parent company of a Financing Subsidiary. The proceeds of any financing carried out through a Financing Subsidiary will be counted against the limits proposed in the Application for the securities issued by CILCORP or CIGI, as the case may be, and the terms, conditions and other limitations applicable to any securities issued by a Financing Subsidiary will conform to those proposed for the specified type of security (
In addition, CILCORP and CIGI also request authority to issue and sell to any Financing Subsidiary, at any time or from time to time in one or more series, unsecured debentures, unsecured promissory notes or other unsecured debt instruments (individually, a “Note” and, collectively, the “Notes”) governed by an indenture or indentures or other documents, and the Financing Subsidiary will apply the proceeds of any external financing by the Financing Subsidiary plus the amount of any equity contribution made to it from time to time to purchase Notes. The terms (
Applicants state that any Financing Subsidiary organized under the authority granted by the Commission in this proceeding shall be organized only if, in management's opinion, the creation and utilization of a Financing Subsidiary will likely result in tax savings, increased access to capital markets and/or lower cost of capital for CILCORP, CILCO or CIGI, as applicable.
CILCORP requests authorization to declare and pay dividends on its common stock and/or redeem or repurchase its outstanding shares of common stock from time to time through the Authorization Period out of capital surplus (including revaluation reserve) to the extent permitted under applicable corporate law and the terms of any applicable covenants in its financing documents (including the CILCORP Indenture) in an amount equal to CILCORP's retained earnings at the time that the Transaction is consummated plus the amount, if any, recorded as an impairment to goodwill on the books of CILCORP in accordance with SFAS Nos. 141 and 142.
Finally, in its capacity as a holding company over CILCO and CIGI, CILCORP states that it will continue to be entitled to an exemption under section 3(a)(1) because CILCORP, CILCO and CIGI are all incorporated in Illinois, the state in which all of CILCO's and CIGI's public utility operations are conducted. Likewise, Applicants state that CILCO will be entitled to an exemption under section 3(a)(1) by nature of its capacity as a holding company over CIGI. Accordingly, CILCORP and CILCO request that the Commission issue an order exempting them from the registration requirements of section 5 under section 3(a)(1).
For the Commission, by the Division of Investment Management, pursuant to delegated authority.
Notice is hereby given that the following filing(s) has/have been made with the Commission pursuant to provisions of the Act and rules promulgated under the Act. All interested persons are referred to the application(s) and/or declaration(s) for complete statements of the proposed transaction(s) summarized below. The application(s) and/or declaration(s) and any amendment(s) is/are available for public inspection through the Commission's Branch of Public Reference.
Interested persons wishing to comment or request a hearing on the application(s) and/or declaration(s) should submit their views in writing by November 22, 2002, to the Secretary, Securities and Exchange Commission, Washington, DC 20549-0609, and serve a copy on the relevant applicant(s) and/or declarant(s) at the address(es) specified below. Proof of service (by affidavit or, in the case of an attorney at law, by certificate) should be filed with the request. Any request for hearing should identify specifically the issues of facts or law that are disputed. A person who so requests will be notified of any hearing, if ordered, and will receive a copy of any notice or order issued in the matter. After November 22, 2002, the application(s) and/or declaration(s), as filed or as amended, may be granted and/or permitted to become effective.
Great Plains Energy Incorporated (“GPE”), a registered holding company;
By Commission order dated September 7, 2001 (HCAR No. 27436) (“September Order”) GPE was authorized, among other things, to effectuate a reorganization by GPE forming another Missouri subsidiary and merging KCPL into the Missouri subsidiary that resulted in KCPL becoming a wholly owned subsidiary of GPE. In addition, financing was authorized for the new system. Specifically, related to the intrasystem provision of services, KCPL and GPE were given until April 30, 2002 to file an application-declaration seeking authority to create a service company and implement the final support service structure for the new GPE holding company system (“Service Company Application”). Until the Service Company Application is made effective, KCPL and GPE requested authority under section 13(b) and the rules for an interim period (“Interim Period”) for KCPL and the nonutility subsidiaries to provide support services and to sell goods to each other and to GPE. Existing and future nonutility, intermediate subsidiaries of GPE were also authorized during the Interim Period to provide management, administrative, project development and operating services at fair market prices to certain classes of nonutility subsidiaries.
Applicants filed the Service Company Application by April 30, 2002, as directed by the Commission in September Order. The Service Company Application seeks the authorization and approval by the Commission of the provision of intrasystem services and goods following the expiration of the Interim Period, under section 13 of Act and the rules. Applicants request that the Commission: (1) Approve the designation of GPES as a subsidiary service company in accordance with the provisions of rule 88 under the Act and find that GPES is so organized and will conduct its operations so as to meet the requirements of section 13 and the rules under the Act; (2) approve the service agreement (as attached in S.E.C. File No. 70-10064, Exhibit B-1 filed April 19, 2002) (“Service Agreement”); (3) authorize to the extent not exempt under rules 81 and 87, for GPE's subsidiaries to provide certain services and goods to each other and to GPE; and (4) authorize extensions of credit or guarantees under section 12(b) and rule 45 for GPES or KCPL to assume responsibility to counterparties in leases, licenses, or other arrangements for the associates' compliance under those leases, licenses, or other arrangements.
GPE requests authorizations with respect to the activities of GPES, which will be incorporated in Missouri as a wholly-owned subsidiary of GPE to serve as the service company for the GPE system. GPES will:
• Have a minimal equity capitalization of not more than 1,000 shares with total equity capitalization of not more than $10,000.
• Finance it business through the issuance of debt securities exempted under rule 52(b) to associate companies or unaffiliated parties or as otherwise authorized by the Act, rules, and Commission orders.
• Provide companies
• Be staffed by a transfer of personnel from KCPL, and in addition, KCPL will transfer personal property from KCPL to GPES.
• Be assigned certain leases and licenses currently held by KCPL, or in the alternative the leases and licenses may continue to be held by KCPL and a portion of the goods and services may be provided to other system companies. (To the extent that current leases, licenses, and other arrangements respecting goods and services used by KCPL and one or more associate companies cannot be reasonably transferred to GPES, or in situations in which KCPL is the predominant user of such goods and services, or in the event Missouri Public Service Commission approval of the proposed asset transfer is not obtained before the establishment of GPES,
• Be responsible to counterparties of the underlying leases, licenses, or other arrangements for the associates' compliance with the terms and conditions of those agreements.
• Comply with the Commission's standards for cost allocation methods and procedures for service companies in registered holding company systems;
• Use the Commission's “Uniform System of Accounts for Mutual Service Companies and Subsidiary Service Companies” for GPES's billing system.
• Provide classes of services through departments and more than one class of services. Both corporate services and shared services may be offered. Corporate services are required, but shared services will be a choice subject to the terms and conditions of the service agreement.
• Provide all services by GPES to affiliated companies on an “at cost” basis as determined by rules 90 and 91 of the Act, except as permitted by the Act or the Commission.
KCPL may provide to associate companies services incidental to its utility business, including but not limited to leases
KCPL may have responsibility for GPES's compliance under assigned leases, licenses, and other arrangements. In situations where KCPL makes available goods and services to associate companies under leases, licenses, or other arrangements between KCPL and third parties, KCPL may have responsibility for those associate companies' compliance with such leases, licenses, or other arrangements. To the extent such responsibility is deemed to be an extension of credit or guaranty by KCPL under section 12(b) of the Act, Applicants request authority for KCPL to incur such responsibility.
Applicants request authorization for WCNOC, as a nonutility subsidiary of KCPL, to provide services and goods to the owners of Wolf Creek Generating Station at cost under existing agreements (as attached in S.E.C. File No. 70-10064, Exhibit B-3) (“WCNOC Existing Agreements”). Applicants also request authorization for KCPL to provide goods and services to WCNOC at cost under WCNOC Existing Agreements. WCNOC, KCPL, and Kansas Gas and Electric Company (an owner of Wolf Creek Generating Station) also have entered into a service reciprocity agreement dated June 20, 1986 (as attached in S.E.C. File No. 70-10064, Exhibit B-6) (“Service Reciprocity Agreement”), providing for the recognition of pension service credits earned by employees who transfer to or from WCNOC. To the extent the Service Reciprocity Agreement may be deemed jurisdictional, Applicants request authorization for KCPL and WCNOC to continue with such agreement.
Applicants request that GPES and all other nonutility subsidiaries of GPE be authorized to enter into agreements to provide construction, goods or services to certain associate companies enumerated below at fair market prices determined without regard to cost, and request an exemption (to the extent that rule 90(d) of the Act does not apply) under section 13(b) from the cost standards of rules 90 and 91:
• A foreign utility company (“FUCO”) or foreign exempt wholesale generator that derives no part of its income, directly or indirectly, from the generation, transmission or distribution of electric energy for sale within the United States;
• An exempt wholesale generator (EWG) that sells electricity at market-based rates which have been approved by the Federal Energy Regulatory Commission (“FERC”), provided that the purchaser is not KCPL;
• A “qualifying facility” (“QF”) within the meaning of the Public Utility Regulatory Policies Act of 1978, as amended (“PURPA”) that sells electricity exclusively (i) at rates negotiated at arms' length to one or more industrial or commercial customers purchasing the electricity for their own use and not for resale, and/or (ii) to an electric utility company at the purchaser's “avoided cost” as determined in accordance with the regulations under PURPA;
• A domestic EWG or QF that sells electricity at rates based upon its cost of service, as approved by FERC or any state public utility commission having jurisdiction, provided that the purchaser is not KCPL; or
• A rule 58 subsidiary or any other nonutility subsidiary that (i) is partially-owned, directly or indirectly, by GPE, provided that the ultimate purchaser of such goods or services is not KCPL (or any other entity that GPE may form whose activities and operations are primarily related to the provision of goods and services to KCPL), (ii) is engaged solely in the business of developing, owning, operating and/or providing services or goods to nonutility subsidiaries described in clauses (a) through (e) immediately above, or (iii) does not derive, directly or indirectly, any material part of its income from sources within the United States and is not a public utility company operating within the United States.
For the Commission, by the Division of Investment Management, pursuant to delegated authority.
On May 31, 2002, the Cincinnati Stock Exchange, Inc. (“CSE”) on behalf of itself and the National Association of Securities Dealers, Inc. (“NASD”), the American Stock Exchange LLC (“Amex”), the Boston Stock Exchange, Inc. (“BSE”), the Chicago Stock Exchange, Inc. (“CHX”), the Pacific Exchange, Inc. (“PCX”), and the Philadelphia Stock Exchange, Inc. (“PHLX”) (hereinafter referred to collectively as “Participants”),
Through the 13th Amendment Notice, the Commission granted temporary summary effectiveness to a portion of the 13th Amendment, granted an exemption under Rule 11Aa3-2(f)
As discussed in the 13th Amendment Notice, proposed amendments to the Plan have been segregated into four categories: (1) Category 1, “Effective Upon Nasdaq's Exchange Registration;” (2) Category 2, “Effective Upon Launch of the Internal SIP;” (3) Category 3, “Effective Upon End of Parallel Period—Elimination of the Legacy SIP;” and (4) Category 4, “Timing Not An Issue.” The amendments detailed in Category 2 were granted summary effectiveness through the 13th Amendment Notice so as to allow the target launch date for the new Internal Securities Information Processor (“SIP”) data feeds to be met.
In addition, the Commission granted partial temporary approval to the 13th Amendment only with respect to extension of the expiration date of the Plan itself. The partial temporary approval extended the expiration date of the Plan through August 19, 2003.
This order approves the amendments detailed in Categories 2, 3, and 4 on a pilot basis through August 19, 2003 to be coterminous with the expiration date set by the Date Extension Approval Order. In addition, this order continues the exemption under Rule 11Aa3-2(f)
This order does not approve those amendments detailed in Category 1. The Commission intends to address those amendments detailed in Category 1 through separate action when the Commission acts on the Nasdaq exchange registration application.
The Plan governs the collection, consolidation, and dissemination of quotation and transaction information for Nasdaq/National Market (“Nasdaq/NM”) and Nasdaq SmallCap securities listed on Nasdaq and traded on an exchange pursuant to unlisted trading privileges (“UTP”).
The Commission originally approved the Plan on a pilot basis on June 26, 1990.
The complete text of the Plan, as amended, was published in the
1. Section III.I. of the Plan, which defines “UTP Quote Data Feed,” is amended to reflect that the Processor will replace the Level 1 Service as it currently exists. In its place, the
2. Section III.N. of the Plan defines the “OTC Montage Data Feed,” which will be launched as a new data feed for the dissemination of NASD ADF Participant quotations with the launch of the Internal SIP. However, as stated above in Category 1.7, NQDS will not be fully eliminated as a data feed disseminated by the Processor until Nasdaq is registered as an exchange.
3. Section III.K. of the Plan changes the name of the Nasdaq Last Sale Information Service to “UTP Trade Data Feed,” but makes no changes to the data elements contained in that data feed. While this change was effective upon launch of the Internal SIP, the Processor continues to disseminate the current Nasdaq Last Sale Information Service for a three-month parallel period to enable market data vendors to have a smooth transition to the new feed.
4. Section III.R. of the Plan, which defines “Quotation Information” is amended to reflect that the NASD ADF will send individual market participant information to the Processor. It is also amended to clarify that only displayed quotation sizes are included in the definition and that market center identifiers are also included.
5. Section VI.B. (Collection and Consolidation of Information) has been amended to clarify the devices available for sending information to the Processor and the data feeds which the Processor shall disseminate, for as long as Nasdaq remains the Processor. While this change was effective upon launch of the Internal SIP, the Processor will continue to disseminate the legacy data feeds for a three-month parallel period to enable market data vendors to have a smooth transition to the new feed.
6. Section VI.C. (Dissemination of Information) has been amended to identify the data feeds that the Processor shall disseminate. While this change was effective upon launch of the Internal SIP, the Processor continues to disseminate the current data feeds to enable market data vendors to have a smooth transition to the new feed.
7. Section VI.C.1. (Best Bid and Offer) is amended to change the method of calculating the national best bid and offer from price/time/size to price/size/time and to establish a precise methodology for calculation.
8. Section VI.C.3. is renamed “Quotation Data Stream,” and amended to reflect the change in definition of the UTP Quote Data Feed contained in Section III.I. of the Plan. While this change was effective upon launch of the Internal SIP, the Processor continues to disseminate the current Level 1 service (“Legacy SIP”) to enable market data vendors to have a smooth transition to the new feed.
9. Section VI.C.4. (Transaction Reports) is amended to reflect the change in name of the UTP Trade Data Feed contained in Section III.K. of the Plan.
10. Section XI (Hours of Operation) has been amended to change the reporting procedures for Participants that execute transactions in Eligible Securities outside of the normal trading hours of 9:30 a.m. to 4:00 p.m. EST.
1. Section VI.C.1. is amended to reflect that the Processor shall no longer carry quotation information from one trading day to the next, and that the Processor shall not calculate the best bid and offer for any individual Participant, including the NASD.
2. Section VI.C.1. is also amended to reflect that the Processor shall disseminate an internally locked or crossed quotation submitted by a single Participant.
3. Section XVIII.D.3, regarding Price Checks, is eliminated to reflect the Operating Committee's agreement that the Processor should no longer perform these functions.
4. Plan Exhibit 1, Paragraph 3(d)(5) is eliminated to reflect that MarketWatch costs are no longer eligible Processor Operating Costs, contingent upon the elimination of the Processor's ability to perform price checks on Participant's trade reports.
1. Section III.S. of the Plan, which defines “Regulatory Halt,” is amended to include halts that are called for regulatory problems relating to an Eligible Security that should be clarified before trading therein is permitted to continue.
2. Section IV.A. (Operating Committee: Composition) has been amended to permit entities that are actively pursuing registration as a national securities exchange to participate in Operating Committee meetings in limited capacities.
3. Section IV.C. (Operating Committee: Voting) has been amended to eliminate references to events and contingencies that occurred when the Plan was first adopted. It also is clarified to reflect the Participants' agreement that neither the Plan nor the Operating Committee shall have authority in any respect over any Participant's proprietary systems.
4. Section IV.D. (Operating Committee: Meetings) will permit the Operating Committee to waive the advance notice requirement contained therein.
5. Section IV.E. has been added to establish an Advisory Committee and to define its composition and authority.
6. Section V.A. (Selection and Evaluation of the Processor: Generally) has been amended to eliminate references to events and contingencies that occurred when the Plan was first adopted.
7. Section VI.C. is amended to eliminate references to agreements between the NASD and certain foreign exchanges.
8. Section VI.D. (Immediate Hard Copy Confirmations) is eliminated and the remaining subsections of Section VI. are re-lettered.
9. Section VIII.B. (Transaction Reports) is amended to clarify that this Section applies only to transactions between Plan Participants pursuant to the Plan, and to eliminate reference to shared computer-to-computer interfaces.
10. Section X. is amended to include halts that are called for regulatory problems relating to an Eligible Security that should be clarified before trading therein is permitted to continue and to state that during a halt the Processor shall collect and disseminate Transaction Information but shall cease collection and dissemination of all Quotation Information.
11. Section XI.C. is amended to reflect that late trades can be reported between the hours of 8:00 a.m. and 6:30 p.m. on the same trading day that the transaction occurred.
12. Section XI.E. governing changes to operating hours, is eliminated.
13. Section XIII (Undertakings by NASD) is eliminated, and subsequent sections re-numbered.
14. Section XXI (Depth of Book Display) is added to reflect the Operating Committee's determination that the entity that succeeds Nasdaq as the Processor, upon certain specific conditions being met through a further
15. Within the body of the 13th Amendment, there are numerous “house-keeping” corrections, including punctuation and renumbering changes.
The Commission received one comment letter on the 13th Amendment from BrokerageAmerica (“BA”).
First, BA stated that the connectivity dichotomy between Nasdaq market makers and exchange specialists causes fragmentation and inefficiencies that conflict with Congress' intent in establishing the national market system (“NMS”). Second, BA argued that the dichotomy results in unfair and disorderly functioning of the NMS with respect to Nasdaq securities. Third, BA averred that the use of multiple execution functionalities for the trading of Nasdaq securities (
The Commission finds that the Category 2, 3,
The Commission finds that amending the Plan to incorporate the amendments detailed in Categories 2, 3, and 4 above furthers these goals. The Commission believes the Category 2 and 3 amendments should, among other things, further the satisfaction of requirements of the SuperMontage approval order
The SuperMontage Approval Order imposed certain requirements upon the Participants in order for the Commission to extend the Plan. Specifically, the Participants were charged with engaging in good faith negotiations to revise the Plan to provide for (i) a fully viable alternative exclusive SIP for all Nasdaq securities, or (ii) a fully viable alternative non-exclusive SIP.
Moreover, the Commission imposed a presumption that, if the revised Plan provided for an exclusive consolidating SIP, such SIP should not be a Plan Participant. The Commission stated that, if a Plan Participant were selected to operate such exclusive SIP, there should be a further presumption that the Participant-operated SIP must operate completely separate from any order matching facility operated by that Participant. Such an order matching facility must interact with the exclusive SIP on the same terms and conditions as any other market center trading Nasdaq listed securities.
The Commission understands that the Participants are negotiating to select a non-Participant technology vendor to serve as an alternative exclusive SIP. In the event that a non-Participant technology vendor is selected, the Commission notes that the Plan may require further amendment.
The Commission also believes that the Category 4 amendments further the goals of the Act by making clarifying changes, deleting provisions that no longer apply, and making certain “house-keeping” corrections. Moreover, the Commission believes that the Category 4 amendments should further the satisfaction of requirements of the SuperMontage approval order by establishing an Advisory Committee. Finally, the Commission believes that the Depth of Book Display provision added by the Category 4 amendments is a beneficial addition to the Plan as it would increase the amount of data disseminated by the SIP for the benefit of investors generally.
The Commission has carefully considered all the issues raised by the sole commenter, BA, and is not persuaded. BA essentially argued the point that there are fundamental differences between the trading of Nasdaq securities by Nasdaq market makers and by human exchange specialists trading pursuant to UTP in the traditional auction format. BA generally argued that exchange specialists trading Nasdaq securities pursuant to UTP should be required to provide the same level of connectivity as that provided among Nasdaq market makers—electronic automatic execution. To support its main argument, BA described why it perceives the Plan-mandated telephone connectivity as being deficient and detrimental to the operation of the NMS.
The Commission notes that a market participant providing automatic execution against that market
BA argued that the trading of Nasdaq securities pursuant to UTP by exchange specialists causes inconsistent application of the Firm Quote Rule, 11Ac1-1.
BA also argued that the delay in updating quotes by human UTP exchange specialists causes UTP exchange specialists' quotes to be “not real” when compared to the quotes of Nasdaq market makers that are subject to automatic execution and electronic quote updating. The Commission notes that UTP exchange specialists must comply with the Firm Quote Rule. It may take longer to receive a fill from an exchange specialist trading pursuant to UTP and for such specialist's quote to be updated than it takes to receive a fill from a Nasdaq member that is subject to automatic execution and for the Nasdaq member's quote to be updated. This does not, however, make trading pursuant to UTP under the Plan impermissible under the Act and the rules and regulations thereunder.
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 proposed rule change consists of an interpretation of paragraph (b) of Article Fifth of the Certificate of Incorporation of the CBOE (“Article Fifth (b)”) pertaining to the right of 1,402 full members of the Board of Trade of the City of Chicago (“CBOT”) to become members of CBOE without having to purchase a CBOE membership (the “Exercise Right”). This provision has previously been interpreted by the CBOE, including an interpretation reflected in an agreement between the CBOE and CBOT dated September 1, 1992 (the “1992 Agreement”).
It has recently come to the attention of the CBOE that starting in 1999, the CBOT implemented expedited membership approval procedures applicable only to those individuals who wished to become CBOE members pursuant to the Exercise Right, but did not wish to trade as members on the CBOT itself. Under the rules of the CBOT, individuals approved for CBOT membership pursuant to these expedited procedures do not have any rights to trade as members on the CBOT, and thus the CBOE believes that these individuals do not satisfy the interpretation reflected in the 1992 Agreement as described above.
On April 17, 2002, the CBOE informed the CBOT that individuals approved for CBOT membership pursuant to these expedited procedures are not entitled to become exerciser members of the CBOE. In response, on April 22, 2002, the CBOT began advising applicants for membership on the CBOT for the purpose of becoming exerciser members of the CBOE that such individuals must complete regular CBOT membership approval procedures. All individuals exercising since that date have complied with this requirement. The CBOE represents that during the several years that CBOT's
To avoid these results, the CBOE now proposes a further interpretation of its prior interpretation of the Exercise Right as reflected in the 1992 Agreement to provide that each individual who would have been a member in good standing of the CBOE on April 17, 2002, pursuant to the Exercise Right, but for the fact that he or she was approved as a CBOT full member or full member delegate under expedited procedures and therefore does not possess the trading rights of a full member of CBOT, will nevertheless be recognized as a member of the CBOE in good standing, so long as that individual would possess all trading rights and privileges appurtenant to a CBOT full membership upon satisfaction of the CBOT's regular (not expedited) application process. Satisfaction of CBOT full membership would also include examination and approval requirements necessary for an individual to be in actual possession of all trading rights and privileges appurtenant to a CBOT full membership as defined in the 1992 Agreement.
Any CBOE member in good standing who subsequently ceases to be a CBOE member in good standing for any reason and who thereafter reapplies to become a CBOE member pursuant to the Exercise Right, and any other individual who applies to become a member of CBOE pursuant to the Exercise Right after April 17, 2002, will be required to satisfy all applicable CBOT application, examination and approval requirements necessary for such individual to be in actual possession of all trading rights and privileges appurtenant to a CBOT full membership as defined in the 1992 Agreement. Notwithstanding the foregoing, if a CBOE exerciser member in good standing subsequently ceases to be a member of the CBOE in good standing, and he or she reapplies to become a member of the CBOE pursuant to the Exercise Right within six months of the date he or she ceased to a CBOE exerciser member, the individual may be reinstated as a member of the CBOE in good standing without having to satisfy the requirements of the CBOT necessary for such individual to be in actual possession of all trading rights and privileges appurtenant to a CBOT full membership as defined in the 1992 Agreement. The CBOE intends to provide a limited exception to the CBOE Rule 3.16(b). The proposed interpretation, together with a proposed amendment to CBOE Rule 3.16 (b), constitutes the proposed rule change that is the subject of this filing. Below is the text of the proposed rule change. Additions are
(a)
(a)
In its filing with the Commission, the CBOE included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item III below. The CBOE 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 provide a further interpretation of a prior interpretation of Article Fifth (b). Article Fifth (b) governs the right of all 1,402 full members of the CBOT to become members of the CBOE without having to purchase a separate CBOE membership. Article Fifth (b) has previously been interpreted on several occasions, including an interpretation made pursuant to an agreement between the CBOT and CBOE dated September 1, 1992. According to the CBOE, the 1992 Agreement states that only an individual who is an “Eligible CBOT Full Member” or an “Eligible CBOT Full Member Delegate” constitutes a CBOT member within the meaning of Article Fifth (b) and thus would be eligible to have an Exercise Right—that is, a right to be an exerciser member of the CBOE.
The 1992 Agreement defines the terms “Eligible CBOT Full Member” and “Eligible CBOT Full Member Delegate” to require in each case that the individual must be in possession of “all trading rights and privileges appurtenant to such CBOT Full Membership.”
These provisions of the 1992 Agreement are reflected in the CBOT's rules and were adopted by the CBOT as required by the 1992 Agreement (referred to in that Agreement as the “CBOT Rule Change”). The CBOT Rule Change may not be amended without the consent of CBOE. The CBOT Rule Change has not been amended, and is currently set forth in CBOT Rules 210.00 and 221.00(g).
In 1999, without the knowledge or approval of the CBOE, the CBOT implemented certain expedited membership approval procedures applicable to those individuals who wished to become CBOT members for the sole purpose of exercising the right to become members of the CBOE pursuant to the Exercise Right, but who did not wish to be able to trade as members on the CBOT itself. Under these expedited procedures, the CBOT waived its normal application procedures and examination requirements for these individuals, and has relied on special delegated authority to approve their membership applications. Individuals approved for CBOT membership pursuant to these expedited procedures do not have any rights to trade as a member of the CBOT in any of the contracts traded on that exchange. Accordingly, such individuals cannot qualify as Eligible CBOT Full Members or Full Member Delegates for purposes of the interpretation of the Exercise Right reflected in the 1992 Agreement, and thus are not eligible to become exerciser members of the CBOE.
The CBOE did not become aware of the expedited membership approval procedures until late 2001. On April 17, 2002, the CBOE informed the CBOT that individuals approved for CBOT membership pursuant to these expedited procedures would not be entitled to become exerciser members of the CBOE because they did not satisfy the requirements of Article Fifth(b) as it had previously been interpreted under the 1992 Agreement. In response, on April 22, 2002, the CBOT began advising individuals who apply to become members of CBOT for the purpose of exercising to be members of the CBOE that such individuals must complete regular CBOT membership approval procedures in order to be able to exercise. The CBOE believes that all individuals exercising since that date have complied with this requirement.
During the several years that the CBOT's expedited membership approval procedures were in place, many CBOT members, pursuant to the expedited procedures, exercised to become members of the CBOE. Without the CBOE having been aware of the adoption of these expedited membership procedures by the CBOT or having focused on the fact that these individuals did not meet the requirements of a valid exercise, these individuals were then approved by the CBOE as exerciser members. According to the CBOE, approximately 330 individuals who were approved as CBOT members under expedited procedures are currently engaged in conducting business as exerciser members of the CBOE. If the CBOE now refused to recognize these individuals as members of the CBOE in good standing, unless and until they are re-approved as CBOT members under procedures that give them full trading rights on the CBOT, the result would impose significant hardships on these individuals. Likewise, the CBOE believes that the removal of these individuals from the CBOE trading floor, even if only for a temporary period while they are re-approved as members of the CBOT, would be disruptive to the CBOE itself.
To avoid these harmful results, the CBOE has determined to interpret its prior interpretation of Article Fifth (b) of its Certificate of Incorporation so as to allow each individual who would have been an exerciser member in good standing of the CBOE on April 17, 2002, but for the fact that he or she was approved as a CBOT member or delegate under expedited procedures, to be recognized as a member of CBOE in good standing so long as that individual would be able to have all trading rights and privileges appurtenant to a CBOT membership, including satisfying full CBOT membership or delegate application, examination and approval requirements. Any such individual who subsequently ceases to be an exerciser member in good standing for any reason and who thereafter reapplies to become an exerciser member, and any other individual who applies to become an exerciser member of the CBOE after April 17, 2002, as a condition of becoming an exerciser member of the CBOE, will be required to satisfy all applicable CBOT application, examination and approval requirements necessary for such individual to be in actual possession of “all trading rights and privileges appurtenant to such CBOT Full Membership” as defined in the 1992 Agreement. Notwithstanding the foregoing, if an individual who was an exerciser member of the CBOE in good standing pursuant to the first sentence of this paragraph subsequently ceases to be an exerciser member in good standing, and if the same individual reapplies to become an exerciser member of the CBOE within six months of the date he or she ceased to be an exerciser member in good standing, the individual may be reinstated as an exerciser member in good standing without having to satisfy the requirements of the CBOT necessary for such individual to be in actual possession of all trading rights and privileges appurtenant to a CBOT full membership as defined in the 1992 Agreement.
This interpretation will provide a limited exception to the requirement of the interpretation reflected in the 1992 Agreement that all exercisers must be in possession of “all trading rights and privileges appurtenant to such CBOT Full Membership.” It has the effect of “grandfathering” those individuals who were exerciser members of the CBOE in good standing on April 16, 2002, to the extent described above, notwithstanding that they were approved as members of the CBOT under expedited procedures and thus do not possess the right to trade as members on the CBOT. The CBOE represents that this interpretation will have no effect on the application of the requirements of the 1992 Agreement to individuals who were not exerciser members on April 17, 2002, and who seek to become exerciser members after that date.
The CBOE believes that the proposed rule change is consistent with and furthers the objectives of section 6(b)(5) of the Act
The CBOE 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 Exchange Act.
No written comments were solicited or received with respect to the proposed rule change.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change, as amended, is consistent with the Act.
Persons making written submissions should file six copies thereof with the Secretary, Securities and Exchange Commission, 450 Fifth Street, NW, Washington, DC 20549-0609. Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for inspection and copying at the Commission's Public Reference Room. Copies of such filing will also be available for inspection and copying at the principal office of the CBOE. All submissions should refer to File No. SR-CBOE-2002-41 and should be submitted by November 22, 2002.
After careful review, the Commission finds that the proposed rule change is consistent with the requirements of section 6(b)(5) of the Act,
The Commission notes that this proposed interpretation as described above by the CBOE provides a limited exception to CBOE Rule 3.16(b), which interprets Article Fifth (b) to include “Eligible CBOT Full Member[s]” and “Eligible CBOT Full Member Delegate[s],” as defined in the 1992 Agreement between the CBOE and CBOT. The Commission believes that the proposed interpretation has no investor protection implications because all CBOE members, including exerciser members, must nevertheless comply with the requirements of the Act and CBOE rules in order to utilize their trading privileges on the CBOE floor. Also, although the CBOT granted expedited approval to these 330 individuals, the CBOE conducted a full review of these 330 members before they were permitted to trade on the CBOE. In addition, the Commission believes that refusing to recognize these certain individuals as exerciser members of the CBOE in good standing unless and until they were re-approved as CBOT members under its regular membership procedures would impose significant hardship on these individuals and cause disruption to the CBOE itself. In order to avoid such harmful results, the Commission believes that the proposed interpretation described herein and the proposed rule change are appropriate, in that the CBOE is interpreting its requirements for certain CBOT members (exerciser members) to become and remain members of the CBOE. For these reasons, the Commission finds good cause for approving the proposed rule change, as amended, prior to the thirtieth day after the date of publication of notice in the
For the Commission, by the Division of Market Regulation, pursuant to the delegated authority.
On August 19, 2002, the Chicago Board Options Exchange, Incorporated (“CBOE” or “Exchange”) filed with the Securities and Exchange Commission (“Commission” or “SEC”) pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Commission has reviewed carefully the CBOE's proposed rule change and finds that the proposal is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities exchange,
The Commission notes that the Book Indicator was adopted as part of the CBOE's initiative to provide split-price Retail Automatic Execution System (“RAES”) executions for incoming customer orders when the prevailing best bid (offer) is generated by a existing customer order in the CBOE book.
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposes that all ISE's quotations would be firm for all incoming orders for their full disseminated size. The ISE would retain a one-contract minimum size for quotations when they interact with quotations entered by other ISE market makers. The proposed rule change would be implemented when the Commission approves the proposal and grants the Exchange an exemption from Rule 11Ac1-1 (the “Firm Quote Rule”) under the Act, and when the Exchange implements technical enhancements to its system necessary to support this change. Below is the text of the proposed rule change. Additions are italicized. Brackets indicate deletions.
(a) Options Classes. A quotation only may be entered by a market maker, and only in the options classes to which the market maker is appointed under Rule 802.
(b) Size Associated with Quotes. A market maker's bid and offer for a series of options contracts shall be accompanied by the number of contracts at that price the market maker is willing to buy [from] or sell
(c) Two-Sided Quotes. A market maker that enters a bid (offer) on the Exchange must enter an offer (bid) within the spread allowable under Rule 803(b)(4).
(d) Firm Quotes. (1) Market maker bids and offers are firm for
(i) a system malfunction or other circumstance impairs the Exchange's ability to disseminate or update market quotes in a timely and accurate manner;
(ii) the level of trading activities or the existence of unusual market conditions is such that the Exchange is incapable of collecting, processing, and making available to quotation vendors the data for the option in a manner that accurately reflects the current state of the market on the Exchange, and as a result, the market in the option is declared to be “fast” pursuant to Rule 704;
(iii) during trading rotations; or
(iv) any of the circumstances provided in paragraph (c)(3) of Rule 11Ac1-1 exist.
(2) Within thirty seconds of receipt of
.01 Notwithstanding the provisions of paragraph (b), for the “Enhanced Size Pilot” described in .02 below, a Primary Market Maker may not initially enter a bid or offer for a Public Customer of less than 100 contracts, and a bid or offer for Non-Customers (except for other market makers) of less than 50 contracts. Also for the purposes of the Enhanced Size Pilot, a Competitive Market Maker may not initially enter a bid or offer for a Public Customer of less than 50 contracts, and a bid or offer for Non-Customers (except for other market makers) of less than 25 contracts. Where the size associated with a market maker's bid or offer falls below such specified size, the market maker shall enter a new bid or offer for at least the specified size, either at the same or a different price.
.02 The Enhanced Size Pilot shall operate as follows:
(1) The Enhanced Size Pilot shall operate until October 31, 2002;
(2) Securities included in the Enhanced Size Pilot are options on: Nasdaq 100 Trust; Sun Microsystems; EMC Corp.; Qualcomm; Wells Fargo &Co.; Oracle; Lucent; Juniper Networks; Intel; AOL Time Warner; Tyco; Citigroup; Cisco; Applied Materials; Microsoft; General Electric; Broadcom; Nokia; Siebel Systems; Banc of America; Ciena; Dell; Fannie Mae; Motorola; Merrill Lynch; Nvidia; Xilinx; Amazon.com; Halliburton; Nextel Communications; J.P. Morgan Chase; ADC Telecommunication; Best Buy; Calpine; General Motors; and Hewlett Packard; and
(3) The size requirements in the Enhanced Size Pilot will not apply:
(a) To options that expire beyond the nearest three expiration months;
(b) To “Deep-in-the-Money” options; or
(c) On an option's last three trading days prior to expiration.
03. For the purpose of this Rule, “Deep-in-the-Money” means all options with strike prices that are in the money by 12 percent or more in relation to the at-the-money strike price.]
(c)
[Exemptive Authority. Until the earlier of (1) one year from the date on which the Exchange commences operations or (2) the date on which the Exchange opens all options Groups for trading, an Exchange official designated by the Board may grant market makers exemptions from the requirements of subparagraphs (b)(2) and (3) of this rule, subject to the following:
(1) If a market maker has only one Membership, and thus is assigned to only one Group, any exemption would end when the assigned Group is open for trading, regardless of the number of options classes that begin trading in the assigned Group;
(2) If a market maker has multiple Memberships, and thus is assigned to trading in more than one Group, the exemption would end when all the market maker's Groups are open for trading, again regardless of the number of options classes that begin trading in the assigned Groups; as the market maker's assigned Groups open for trading, the amount of trading the market maker would be permitted to execute outside of its assigned Groups would be reduced;
(3) Any exemption would be conditioned on the member performing market maker functions in the classes they trade;
(4) An exemption could be revoked by the Exchange at any time if the market maker is not acting in accordance with the terms of the exemption; and
(5) No exemption would have a term of more than one month, but would be renewable on a monthly basis until the market maker's group(s) was open for trading.]
In its filing with the Commission, the ISE 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 ISE has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The purpose of this proposed rule change is to provide that all ISE quotations would be firm for all incoming orders for their full disseminated size. This would be the first time that any options exchange provides non-customers (that is, broker-dealers) with full access to the entire disseminated size of the exchange's quotations for all their orders. The specifics of the proposal are as follows:
• Each ISE Primary Market Maker and Competitive Market Maker would enter a quotation with a single size, available in full for all incoming orders, whether from customers, broker-dealers, ISE market makers or market makers on other exchanges.
• Each market maker also would be able to establish a second quotation size that would be available when its quotation interacts with another ISE market maker quotation. This would limit an ISE market maker's exposure when it establishes a quotation at the same price as an existing ISE market maker quotation in the system. While this interaction of quotations is beneficial from a price-discovery standpoint, there is significant risk in this situation because execution can occur simultaneously in multiple series. While market makers would be able to limit this risk by setting their size to a smaller number of at least one contract, ISE market makers would be able to access the full size of another market maker's quotation by sending an order in that series.
• The ISE also proposes to prohibit market makers from sending more than one order every 15 seconds in options on the same underlying security. ISE Rule 717(h) currently imposes this limitation on orders that Electronic Access Members send to the Exchange. This limitation reduces a market maker's exposure across multiple series of options.
• Finally, the ISE proposes two technical “clean up” changes to its rules. First, the Exchange proposes to delete language from Rule 804 regarding the “enhanced size pilot” that would expire on October 31, 2002. Second, the Exchange proposes to delete language from Rule 805 regarding limited exemptive authority that expired a year after the Exchange commenced trading.
The basis for this proposed rule change is the requirement under section 6(b)(5) of the Act
The ISE believes that the proposed rule change does not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
No written comments were solicited or received with respect to the proposed rule change.
Within 35 days of the date of publication of this notice in the
(A) by order approve such proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Persons making written submissions should file six copies thereof with the Secretary, Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549-0609. Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for inspection and copying in the Commission's Public Reference Room. Copies of such filing also will be available for inspection and copying at the principal office of the ISE. All submissions should refer to File No. SR-ISE-2002-24 and should be submitted by November 22, 2002.
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”),
Nasdaq is filing with the Commission technical rule changes to NASD Rule 4613(e)(1) to harmonize the language with recent approved rule proposals.
The text of the proposed rule change is available at the Office of the Secretary, the Nasdaq and at the Commission.
In its filing with the Commission, Nasdaq included statements concerning the purpose of and basis for the proposed rule change, as amended, 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. Nasdaq has prepared summaries, set forth in Sections A, B and C below, of the most significant aspects of such statements.
Nasdaq has filed numerous rule proposals relating to NASD Rule 4613(e), and also has filed numerous rule proposals relating to SuperMontage. In the process of compiling the changes to Rule 4613(e), Nasdaq has discovered several
First, Nasdaq is changing the acronym “MMID” to “MPID” to be consistent with its use of those terms throughout the rules governing usage of the SuperMontage system. Second, Nasdaq is replacing references to “messages” to “orders” or “Directed Orders,” as appropriate. This change makes consistent the use of such terms across NASD Rule 4613(e)(1). In addition, Nasdaq is adding the word “for” when describing the minimum number of shares for which a Trade or Move Directed Order is required to be sent. Finally, Nasdaq is changing Rule 4613(e)(1)(c)(ii)(a) to reflect that an ECN that wishes to lock or cross the market between 9:20:00 and 9:29:29 must send a Trade or Move Directed Order. The current rule language erroneously indicates that ECNs are obligated to send such Directed Orders up until 9:29:59. This technical change conforms the rule to the clear intent of SR-NASD-2002-56, which was approved on August 23, 2002.
Nasdaq believes that the proposed rule change, as amended, is consistent with section 15A of the Act in general,
Nasdaq does not believe that the proposed rule change, as amended, will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
No written comments were either solicited or received.
The foregoing proposed rule change, as amended, (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. The proposed rule change, as amended, has therefore become effective pursuant to section 19(b)(3)(A) of the Act
Nasdaq has requested that the Commission waive the usual five-day notice and 30-day pre-operative waiting periods. The Commission believes that it is consistent with the protection of investors and the public interest to accelerate the operative date and to waive the five-day notice period since the proposed rule change, as amended, makes only technical corrections to the rule text. For these reasons, the Commission designates the proposal, as amended, to be effective and operative upon filing with the Commission.
At any time within 60 days of the filing of the proposed rule change, as amended, 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, as amended, is consistent with the Act. Persons making written submissions should file six copies thereof with the Secretary, Securities and Exchange Commission, 450 Fifth Street, NW, Washington, DC 20549-0609. Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for inspection and copying in the Commission's Public Reference Room. Copies of such filing will also be available for inspection and copying at the principal office of the NASD. All submissions should refer to File No. SR-NASD-2002-137 and should be submitted by November 22, 2002.
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 proposed rule change will establish a base participation fee for NSCC participants using NSCC's Mutual Fund Services Profile service.
In its filing with the Commission, NSCC included statements concerning the purpose of and basis for the
The purpose of the proposed rule change is to establish a base participation fee for NSCC participants using NSCC's Mutual Fund Services Profile service (“Profile service”).
However, consistent with its goal to align fees with costs and to reflect the numerous enhancements that NSCC has made to the service, NSCC is establishing a Profile membership fee payable by the users of the service. Accordingly, participating settling members and fund members will now be charged a $325 monthly membership fee to use the Profile service, regardless of usage.
NSCC believes that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder because it provides for the equitable allocation of dues, fees, and other charges among NSCC's participants.
NSCC does not believe that the proposed rule change will have an impact on or impose a burden on competition.
No written comments relating to the proposed rule change have been solicited or received. NSCC has notified participants who use the Profile service of the new fee charges and will notify the Commission of any written comments it receives.
The foregoing rule change has become effective pursuant to section 19(b)(3)(A)(ii) 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. Persons making written submissions should file six copies thereof with the Secretary, U.S. Securities and Exchange Commission, 450 Fifth Street NW, Washington, DC 20549-0609. Copies of the submission, all subsequent amendments, all written statements with respect to the rule proposal that are filed with the Commission, and all written communications relating to the rule proposal between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for inspection and copying in the Commission's Public Reference Room in Washington, DC. Copies of such filing will also be available for inspection and copying at NSCC's principal office. All submissions should refer to File No. SR-NSCC-2002-03 and should be submitted by November 22, 2002.
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 Phlx, pursuant to Section 19(b)(1) of the Act
The proposed fee of $55.00 for maintenance and transfer registration for registered representatives will apply to 2003 registered representative registrations.
The text of the proposed rule is available at the Office of the Secretary, the Phlx, and the Commission.
In its filing with the Commission, the Phlx included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in Sections A, B and C below, of the most significant aspects of such statements.
The purpose of the proposed rule change is to generate additional revenue for the Exchange by increasing the maintenance (renewal) and transfer registered representative registration fees from $50.00 to $55.00.
The Exchange is also amending its schedule of dues, fees and charges by changing the word “Maintenance” that appears under Registered Representative Registration to “Renewal.” The Exchange believes that the word “Renewal” more readily reflects how the fee is implemented.
The Exchange believes the proposed rule change is consistent with Section 6(b) of the Act
The Phlx does not believe that the proposed rule change will impose any inappropriate burden on competition.
No written comments were either solicited or received.
Because the foregoing proposed rule change establishes or changes a due, fee or other charge, it has become effective pursuant to Section 19(b)(3)(A)(ii) 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. Persons making written submissions should file six copies thereof with the Secretary, Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549-0609. Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for inspection and copying in the Commission's Public Reference Room. Copies of such filing will also be available for inspection and copying at the principal office of the Exchange. All submissions should refer to File No. SR-Phlx-2002-63 and should be submitted by November 22, 2002.
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
The Small Business Administration Region IX Regulatory Fairness Board and the SBA Office of the National Ombudsman will hold a Public Hearing on Tuesday, November 12, 2002 at 1 p.m. at the Small Business Administration, District Office Training Room, 455 Market Street, 6th Floor, San Francisco, CA 94105, to receive comments and testimony from small business owners, small government entities, and small non-profit organizations concerning regulatory enforcement and compliance actions taken by federal agencies.
Anyone wishing to attend or to make a presentation must contact Judy Ishizu in writing or by fax, in order to be put on the agenda. Judy Ishizu, U.S. Small Business Administration, San Francisco District Office, 455 Market Street, 6th floor, Suite 2200, San Francisco, CA 94105, phone (415) 744-6801, fax (415) 744-6812, e-mail
For more information, see our Web site at
The Small Business Administration Region VII Regulatory Fairness Board and the SBA Office of the National Ombudsman will hold a Public Roundtable on Thursday, November 7, 2002 at 9 a.m. at the Exchange Bank, 132 E. High Street, Jefferson City, MO 65102, to provide small business owners and representatives of trade associations
Anyone wishing to attend or to make a presentation must contact Rose Garland in writing or by fax, in order to be put on the agenda. Rose Garland, U.S. Small Business Administration, St. Louis District Office, 815 Olive Street, Room 242, St. Louis, MO 63101, phone (314) 539-6600 ext. 232, fax (314) 539-3785, e-mail:
For more information, see our Web site at
U.S. Office of Special Counsel
Notice.
Notice is hereby given of the appointment of a member of the OSC Performance Review Board. The following person has been appointed to the SES Performance Review Board in the U.S. Office of Special Counsel: Bernestine Allen, Director, Office of International Transportation and Trade, Department of Transportation.
M. Marie Glover, Director of Human Resources, U.S. Office of Special Counsel, 1730 M Street, NW., Suite 218, Washington, D.C. 20036-4505, (202) 653-9485.
Section 4314(c)(1) through (5) of Title 5, U.S.C., requires each agency to establish, in accordance with regulations prescribed by the Office of Personnel Management, one or more SES performance review boards. The board reviews and evaluates the initial appraisal of a senior executive's performance by the supervisor, and considers recommendations to the appointing authority regarding the performance of the senior executive.
Office of the United States Trade Representative.
Notice.
This notice announces the initiation of the 2002 Annual GSP Product and Country Eligibility Practices Review and sets the deadline for the submission of petitions on December 2, 2002. The notification of which petitions have been accepted for the 2002 and 2001 Annual GSP Reviews and other relevant dates will be issued in the
Contact the GSP Subcommittee, Office of the United States Trade Representative (USTR), 1724 F Street, NW., Room F-220, Washington, DC 20508. The telephone number is (202) 395-6971 and the facsimile number is (202) 395-9481.
The GSP provides for the duty-free importation of designated articles when imported from designated beneficiary developing countries. The GSP is authorized by title V of the Trade Act of 1974 (19 U.S.C. 2461,
The GSP regulations (15 CFR Part 2007) provide the schedule of dates for conducting an annual review unless otherwise specified by a
Interested parties or foreign governments may submit petitions to: (1) Designate additional articles as eligible for GSP; (2) withdraw, suspend or limit GSP duty-free treatment accorded either to eligible articles under the GSP or to individual beneficiary developing countries with respect to specific GSP eligible articles; (3) waive the “competitive need limits” for individual beneficiary developing countries with respect to specific GSP eligible articles; and (4) otherwise modify GSP coverage. As specified in 15 CFR 2007.1, all product petitions must include a detailed description of the product and the subheading of the Harmonized Tariff Schedule (HTS) of the United States under which the product is classified.
Interested parties may also submit petitions to have the GSP status of any eligible beneficiary developing country reviewed with respect to any of the designation criteria listed in sections 502(b) or 502(c) of the Trade Act (19 U.S.C. 2462(b) and (c)). Such petitions must comply with the requirements of 15 CFR 2007.0(b).
All such submissions must conform to the GSP regulations set forth at 15 CFR part 2007, except as modified below. These regulations are also included in “A Guide to the U.S. Generalized System of Preferences (GSP)” (August 1991) (“GSP Guidebook”), available at
Petitions and requests must be submitted, in English, to the Chairman of the GSP Subcommittee, Trade Policy Staff Committee and must be received no later than December 2, 2002. Submissions in response to this notice will be subject to public inspection by appointment with the staff of the USTR
In order to facilitate prompt consideration of submissions, USTR strongly urges and prefers electronic e-mail submissions in response to this notice. In the event that an e-mail submission is impossible, submissions should be made by facsimile. These submissions should be single copy transmissions in English with the total submission not to exceed 50 single-spaced pages and 3 megabytes as a digital file attached to an e-mail transmission. Persons making submissions by e-mail should use the following subject line: “2002 Annual GSP Review—Petition.” Documents must be submitted as either WordPerfect (“.WPD”), MSWord (“.DOC”), or text (”.TXT”) files. Documents should not be submitted as electronic image files or contain imbedded images (for example, “.JPG”, “PDF”, “.BMP”, or “.GIF”) as these type files are generally excessively large. E-mail submissions containing such files may not be accepted. Supporting documentation submitted as spreadsheets are acceptable as Quattro Pro or Excel, pre-formatted for printing on 8
For any document containing business confidential information submitted as an electronic attached file to an e-mail transmission, the file name of the business confidential version should begin with the characters “BC-”, and the file name of the public version should begin with the characters “P-”. The “P-” or “BC-” should be followed by the name of the party (government, company, union, association, etc.) which is submitting the petition. Parties who make submissions by e-mail should not provide separate cover letters or messages in the message area of the e-mail; information that might appear in any cover letter should be included directly in the attached file containing the submission itself. The e-mail address for these submissions is
Public versions of all documents relating to this review will be available for review approximately three weeks after the due date by appointment in the USTR Public Reading Room, 1724 F Street NW., Washington, DC. Availability of documents may be ascertained, and appointments may be made from 9:30 a.m. to noon and 1 p.m. to 4 p.m., Monday through Friday, by calling (202) 395-6186.
The GSP program expired on September 30, 2001, and was not reauthorized until August 6, 2002. Consequently, the announcement of which petitions were to be accepted for the 2001 Annual GSP Review was not made, except for the announcement in the August 28, 2002
Office of the United States Trade Representative.
Notice.
Pursuant to section 303 of the Trade and Tariff Act of 1984, as amended, USTR is required to publish annually the National Trade Estimate Report on Foreign Trade Barriers (NTE). With this notice, the Trade Policy Staff Committee (TPSC) is requesting interested parties to assist it in identifying significant barriers to U.S. exports of goods, services and overseas direct investment for inclusion in the NTE. Particularly important are impediments materially affecting the actual and potential financial performance of an industry sector. The TPSC invites written comments that provide views relevant to the issues to be examined in preparing the NTE. In order to ensure the most timely processing of submissions, the Department of Commerce will receive comments in response to this Notice. Commenters should review carefully the written comments section of this Notice for special procedures for filing comments this year.
Public comments are due not later than Friday, December 13, 2002. This deadline is firm. No submissions will be accepted after December 13.
Procedural questions about transmitting comments or viewing public submissions should be directed to Ms. Marva Thompson (202-482-2185) or Mr. Howard Schreier (202-482-4180), U.S. Department of Commerce. Questions regarding the report or its subject matter should be directed to Ms. Gloria Blue, Office of Policy Coordination, Office of the United States Trade Representative (202-395-3475).
Last year's report may be found on USTR's Internet Home Page (
The information submitted should relate to one or more of the following ten categories of foreign trade barriers:
(1) Import policies (
(2) Standards, testing, labeling, and certification (including unnecessarily restrictive application of phytosanitary standards, refusal to accept U.S. manufacturers' self-certification of
(3) Government procurement (
(4) Export subsidies (
(5) Lack of intellectual property protection (
(6) Services barriers (
(7) Investment barriers (
(8) Anticompetitive practices with trade effects tolerated by foreign governments (including anticompetitve activities of both state-owned and private firms that apply to services or to goods and that restrict the sale of U.S. products to any firm, not just to foreign firms that perpetuate the practices);
(9) Trade restrictions affecting electronic commerce (
(10) Other barriers (
As in the case of last year's NTE, we are asking that particular emphasis be placed on any practices that may violate U.S. trade agreements. We are also interested in receiving any new or updated information pertinent to the barriers covered in last year's report as well as new information. Please note that the information not used in the NTE will be maintained for use in future negotiations.
It is most important that your submission contain estimates of the potential increase in exports that would result from the removal of the barrier, as well as a clear discussion of the method(s) by which the estimates were computed. Estimates should fall within the following value ranges: Less than $5 million; $5 to $25 million; $25 million to $50 million; $50 million to $100 million; $100 million to $500 million; or over $500 million. Such assessments enhance USTR's ability to conduct meaningful comparative analyses of a barrier's effect over a range of industries.
Please note that interested parties discussing barriers in more than one country should provide a separate submission (
(1) All comments will be received at the U.S. Department of Commerce rather than the Office of the United States Trade Representative;
(2) The Department of Commerce has arranged to accept non-confidential, public submissions by electronic mail (e-mail). An automatic reply confirming receipt of e-mail submissions will be sent. E-mail submissions in Microsoft Word or Corel WordPerfect are preferred. If a word processing application other than those two is used, please advise us in your submission of the specific application used;
(3) In order to facilitate prompt processing of submissions, the Department of Commerce strongly urges and prefers e-mail submission of non-confidential, public comments;
(4) To ensure security, submissions containing business confidential information should not be sent by e-mail, but via the U.S. Postal Service or commercial express delivery (see paragraph 6 and 7 below for special requirements applying to such submissions). If a submission contains business confidential information, a non-confidential public version must also be submitted along with the business confidential version.
(5) Business-confidential submissions must be accompanied by a justification as to why the information contained in the submission should be treated confidentially. In addition, any submissions containing business confidential information must be clearly marked “Confidential” at the top and bottom of the cover page (or letter) and of each succeeding page of the submission. The version that does not contain confidential information should also be clearly marked, at the top and bottom of each page, “public version” or “non-confidential”.
(6) When comments are submitted using the U.S. Postal Service or commercial couriers, it is strongly recommended that submitters notify the Department of Commerce by e-mail as to the date of transmittal and method of delivery (U.S. Postal Service or name of courier company).
(7) All submissions must be in English and should conform to the information requirements of 15 CFR 2003. If submissions are made via U.S. Postal Service or commercial express delivery, a party must provide five copies of its submission and the submission should be accompanied by a computer disk containing a machine-readable version. The disk should have a label identifying the software used, the submitter and the title of the submission. In addition, business confidential and public or non-confidential submissions should be submitted on separate disks which are clearly marked “business confidential” or “non-confidential”, as appropriate.
Submissions must be received at the Department of Commerce no later than Friday, December 13, 2002.
Written comments submitted in connection with this request, except for information granted “business confidential” status pursuant to 15 CFR 2003.6, will be available for public inspection shortly after the filing deadline in the Foreign Trade Reference Room (Room 2233) in the U.S. Department of Commerce. The Department of Commerce is located at 14th St. and Constitution Ave., NW., in Washington, DC. Customary hours of operation for the Foreign Trade Reference Room are from 9 a.m. to 4 p.m., Monday through Friday. Call (202) 482-2185 to confirm. Questions regarding the operation of the Reference Room should be directed to Ms. Marva Thompson at 202-482-2185. Non-proprietary public comments will also be available for review on the web at:
Office of the Secretary, DOT.
Notice to establish a system of records.
DOT intends to establish a system of records under the Privacy Act of 1974.
December 11, 2002. If no comments are received, the proposal will become effective on the above date. If comments are received, the comments will be considered and, where adopted, the documents will be republished with changes.
Yvonne L. Coates, Department of Transportation, Office of the Secretary, 400 7th Street, SW., Washington, DC 20590, (202) 366-6964 (telephone), (202) 366-7024 (fax),
The Department of Transportation system of records notice subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, has been published in the
Docket Management System (DMS).
Unclassified, non-sensitive.
The system is located in Department of Transportation (DOT), Dockets and Media Management Center, Transportation Administrative Service Center, 400 7th Street, SW., Room PL-401, Washington, DC, 20590.
Individuals who participate in proceedings at the DOT that are covered by the Administrative Procedure Act (APA), and who provide information about their identities.
DOT rulemaking and related documents issued in informal rulemakings, and public comments thereon; non-rulemaking and related documents, and public comments thereon; in formal rulemakings, motions, petitions, complaints, and related documents and formal responses thereto.
5 U.S.C. 551 et seq.
To facilitate involvement of the public in APA and related proceedings.
See Prefatory Statement of General Routine Uses.
None.
Electronically on a publicly-accessible website.
Documents are retrievable through DMS by name and by docket number.
Records are freely available to anyone.
Paper copies are returned to the originating office upon transfer to electronic medium. Electronic version is retained indefinitely at the discretion of the DOT.
U.S. Department of Transportation, Chief, Dockets and Media Management Center (SVC-124), 400 7th Street, SW., Room PL-401, Washington, DC 20590.
Same as “System Manager.”
Same as “System Manager.”
Same as “System Manager.”
Individuals participating in DOT APA proceedings.
None.
Federal Aviation Administration (FAA), DOT.
Notice of petition for exemption received.
Pursuant to FAA's rulemaking provisions governing the application, processing, and disposition of petitions for exemption, part 11 of Title 14, Code of Federal Regulations (14 CFR), this notice contains a summary of a certain petition seeking relief from specified requirements of 14 CFR. The purpose of this notice is to improve the public's awareness of, and participation in, this aspect of FAA's regulatory activities. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of any petition or its final disposition.
Comments on petitions received must identify the petition docket number involved and must be received on or before November 21, 2002.
Send comments on the petition to the Docket Management System, U.S. Department of Transportation, Room Plaza 401, 400 Seventh Street, SW., Washington, DC 20590-0001. You must identify the docket number FAA-2002-13062 at the beginning of your comments. If you wish to receive confirmation that the FAA received your comments, include a self-addressed, stamped postcard.
You may also submit comments through the Internet to
Susan Boylon (425-227-1152), Transport Airplane Directorate (ANM-113), Federal Aviation Administration, 1601 Lind Ave. SW., Renton, WA 98055-4056; or Vanessa Wilkins (202-267-8029), Office of Rulemaking (ARM-1), Federal Aviation Administration, 800 Independence Avenue, SW., Washington, DC 20591.
This notice is published pursuant to 14 CFR 11.85 and 11.91.
Federal Aviation Administration (FAA), DOT.
Notice of intent to rule on application.
The FAA proposes to rule and invites public comment on the application to impose and use the revenue from a PFC at Brownsville/South Padre Island International Airport under the provisions of the Aviation Safety and Capacity Expansion Act of 1990 (Title IX of the Omnibus Budget Reconciliation Act of 1990) (Pub. L. 101-508) and part 158 of the Federal Aviation Regulations (14 CFR part 158).
Comments must be received on or before December 2, 2002.
Comments on this application may be mailed or delivered in triplicate copies to the FAA at the following address: Mr. G. Thomas Wade, Federal Aviation Administration, Southwest Region, Airports Division, Planning and Programming Branch, ASW-611, Fort Worth, Texas 76193—0610.
In addition, one copy of any comments submitted to the FAA must be mailed or delivered to Mr. Larry Brown, Acting Manager of Brownsville/South Padre Island International Airport at the following address: Mr. Larry Brown, Acting Manager, Brownsville/South Padre International Airport, 700 S. Minnesota Avenue, Brownsville, TX 78521.
Air carriers and foreign air carriers may submit copies of the written comments previously provided to the Airport under section 158.23 of part 158.
Mr. G. Thomas Wade, Federal Aviation Administration, Southwest Region, Airports Division, Planning and Programming Branch, ASW-611, Fort Worth, Texas 76193-0610, (817) 222-5613.
The application may be reviewed in person at this same location.
The FAA proposes to rule and invites public comment on the application to impose and use the revenue from a PFC at Brownsville/South Padre Island International Airport under the provisions of the Aviation Safety and Capacity Expansion Act of 1990 (Title IX of the Omnibus Budget Reconciliation Act of 1990) (Pub. L. 101-508) and part 158 of the Federal Aviation Regulations (14 CFR part 158).
On October 25, 2002, the FAA determined that the application to impose and use the revenue from a PFC submitted by the Airport was substantially complete within the requirements of § 158.25 of part 158. The FAA will approve or disapprove the application, in whole or in part, no later than February 20, 2003.
The following is a brief overview of the application.
Brief description of proposed project(s):
Any person may inspect the application in person at the FAA office listed above under
In addition, any person may, upon request, inspect the application, notice and other documents germane to the application in person at Brownsville/South Padre Island International Airport.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice of criteria and application procedure for designation or redesignation, for the fiscal year 2003 MAP.
This notice announces the criteria, application procedures and schedule to be applied by the Secretary of Transportation in designating or redesignating, and funding capital development annually for 15 current (joint-use) or former military airports seeking designation or redesignation to participate in the MAP. This Notice reflects and incorporates changes made to MAP in the Wendell H. Ford Aviation Investment and Reform Act for the 21st Century.
The MAP allows the Secretary to designate current (joint-use) or former military airports for which grants may be made under the Airport Improvement Program (AIP). The Secretary is authorized to designate an airport (other than an airport so designated before August 24, 1994) if: (1) The airport is a former military installation closed or realigned under the Title 10 U.S.C. 2687 announcement of closures of large Department of Defense installations after September 30, 1977, or under section 201 or 2905 of the Defense Authorization Amendments and Base Closure and Realignment Acts; or (2) the airport is a military installation with both military and civil aircraft operations. The Secretary shall consider for designation only those current or former military airports, at least partly converted to civilian airports as part of the national air transportation system, that will reduce delays at airports with more than 20,000 hours of annual delays in commercial passenger aircraft takeoffs and landings, or will enhance
Airport sponsors should address written applications for new designation and redesignation in the MAP to the FAA Regional Airports Division or Airports District Office that serves the airport. That office of the FAA must receive applications on or before December 6, 2002.
Submit an original and two copies of Standard Form (SF) 424, “Application for Federal Assistance,” prescribed by the Office of Management and Budget Circular A-102, available at
Mr. Murdock (
The MAP provides capital development assistance to civil airport sponsors of designated current (joint-use) military airfields or former military airports that are included in the FAA's National Plan of Integrated Airport Systems (NPIAS). Airports designated under the program may obtain funds from a set-aside (currently four percent) of AIP discretionary funds to undertake eligible airport development, including certain types of projects not otherwise eligible for AIP assistance. Such airports may also be eligible to receive grants from other categories of AIP funding.
A maximum of 15 airports per fiscal year may participate in the MAP at any time. There are 5 slots available for designation or redesignation in FY 2003. One airport may be designated as a general aviation airport.
The maximum period of eligibility for any airport to participate in the MAP is five fiscal years following designation. An airport sponsor having previously been in the program may apply for redesignation and, if found to satisfy the designation criteria upon reapplication, may have the opportunity to participate for subsequent periods, each not to exceed five fiscal years. The FAA can designate airports for a period less than five years. The FAA will evaluate the conversion needs of the airport in its five-year capital development plan to determine the appropriate length of designation.
Title 49 of the United States Code 47118(d), permits previously designated airports to apply for redesignation. Applicants reapplying need to meet current eligibility criteria set forth at 49 U.S.C. 47118(a). Redesignation will be considered largely in terms of warranted projects fundable under AIP solely through the MAP, such as utility systems, surface parking, hangars, fuel farms, and air cargo terminals up to 50,000 square feet. The airport must have MAP eligible projects and the airport must continue to satisfy the designation criteria for the MAP. The FAA will carefully scrutinize applications for redesignation, since redesignation candidates tend to have lesser conversion needs than new candidates. The FAA desires that MAP airports graduate to regular AIP participation.
In addition to other eligible AIP projects, passenger terminal facilities, fuel farms, utility systems, surface automobile parking lots, hangars, and air cargo terminals up to 50,000 square feet of floor space are all eligible to be funded from the MAP. Designated or redesignated military airports can receive not more than $7,000,000 each fiscal year for projects to construct, improve, or repair terminal building facilities. Also, designated or redesignated military airports can receive not more than a total of $7,000,000 for MAP eligible projects that include hangars, cargo facilities, fuel farms, automobile surface parking, and utility work.
In making designations of new candidate airports, the Secretary of Transportation may only designate an airport (other than an airport so designated before August 24, 1994) if it meets the following general requirements:
(I)(1) The airport is a former military installation closed or realigned under—
(A) Section 2687 of title 10;
(B) Section 201 of the Defense Authorization Amendments and Base Realignment and Closure Act (BRAC) (10 U.S.C. 2687 note); or
(C) Section 2905 of the Defense Base Realignment and Closure Act of 1990 (10 U.S.C. 2687 note); or
(2) The airport is a military installation with both military and civil aircraft operations.
(II) The airport is classified as a commercial service or reliever airport in the NPIAS. One of the designated airports, if included in the NPIAS, may be a general aviation (GA) airport (public airport other than an air carrier airport, 14 CFR 152.3) that was a former military installation closed or realigned under BRAC, as amended, or 10 U.S.C. 2687 (49 U.S.C. 47118(g)). A general aviation airport must qualify under (1) above.
(III) In designating new candidate airports, the Secretary shall consider if a grant would:
(1) Reduce delays at an airport with more than 20,000 hours of annual delays in commercial passenger aircraft takeoffs and landings; or
(2) Enhance airport and air traffic control system capacity in a metropolitan area or reduce current and projected flight delays.
The application for new designations will be evaluated in terms of how the proposed airport and associated projects would contribute to congestion relief and/or how the airport would enhance air traffic or airport system capacity and provide adequate user services.
Recently approved Base Realignment and Closure Acts or Title 10 U.S.C. 2678 military airports as well as active military airfields with new joint use agreements will be in the greatest need of funding to convert to or to incorporate civil airport operations successfully. Newly converted airports and new joint-use locations frequently have minimal capital development resources and will therefore receive priority consideration for designation and MAP funding. The FAA will evaluate the need for eligible projects based upon information in the candidate airport's five year Airport Capital Improvement Plan (ACIP). Of particular concern is whether these projects are related to development of that airport and/or the air traffic control system. It is the intent of the Secretary of Transportation to fund those airport
1. The FAA will evaluate the candidate airports and/or the airports such candidate airports would relieve based on the following specific factors:
• Compatibility of airport roles and the ability of the airport to provide an adequate airport facility;
• The capability of the candidate airport and its airside and landside complex to serve aircraft that otherwise must use the relieved airport;
• Landside surface access;
• Airport operational capability, including peak hour and annual capacities of the candidate airport;
• Potential of other metropolitan area airports to relieve the congested airport;
• Ability to satisfy, relieve or meet air cargo demand within the metropolitan area;
• Forecasted aircraft and passenger levels, type of commercial service anticipated,
• Type and capacity of aircraft projected to serve the airport and level of operations at the relieved airport and the candidate airport;
• The potential for the candidate airport to be served by aircraft or users, including the airlines, serving the congested airport;
• Ability to replace an existing commercial service or reliever airport serving the area; and
• Any other documentation to support the FAA designation of the candidate airport.
2. The FAA will evaluate the development needs that, if funded, would make the airport a viable civil airport that will enhance system capacity or reduce delays. Newly closed installations or airport sponsors with new joint-use agreements with existing military aviation facilities will be strongly considered for designation since they tend to have the greatest conversion needs.
Airport sponsors applying for designation or redesignation must complete and submit an SF 424, “Application for Federal Assistance,” and supporting documentation to the appropriate FAA office serving that airport. In Item 15a of the SF 424, the applicant must indicate the total amount of funding requested from the MAP during the entire term for which it is applying. The SF 424 must indicate whether it is an initial application or reapplication for the MAP, and must be accompanied by the documentation and justification listed below:
The application must identify the airport as either a current or former military airport and indicate whether it was:
(1) Closed or realigned under section 201 of the Defense Authorization Amendments and Base Realignment and Closure Act, and/or section 2905 of the Defense Base Realignment and Closure Act of 1990 (Installations Approved for Closure by the Defense Base Realignment and Closure Commissions), or
(2) Closed or realigned pursuant to 10 U.S.C. 2687 as excess property (bases announced for closure by DOD pursuant to this title after September 30, 1977 (this is the date of announcement for closure and not the date of the deed to the airport sponsor)), or
(3) A military installation with both military and civil aircraft operations. The general aviation airport may be joint use but must qualify under (1) or (2) above.
For (1) through (7) below the applicant does not need to resubmit any unchanged documentation that has been previously submitted to the Regional Airports Division or Airports District Office.
(1) Documentation that the airport meets the definition of a “public airport” as defined in 49 U.S.C. 47102(16).
(2) Documentation indicating that the required environmental review process for civil reuse or joint-use of the military airfield has been completed. This environmental review need not include review of the individual projects to be funded by the MAP. Rather, the documentation should reflect that the environmental review necessary to convey the property, enter into a long-term lease, or sign a joint use agreement has been completed. The military department conveying or leasing the property, or entering into a joint use agreement, generally has the lead responsibility for this environmental review. The environmental review and approvals must indicate that the operator or owner of the airport has good title, satisfactory to the Secretary, or gives assurance that good title will be acquired, to meet AIP requirements.
(3) In the case of a former military airport, documentation that the eligible airport sponsor holds or will hold satisfactory title, a long-term lease in furtherance of conveyance of property for airport purposes, or a long-term interim lease for 25 years or more, to the property on which the civil airport is being located. Documentation that an application for surplus or BRAC airport property has been accepted by the Government is sufficient to indicate the eligible airport sponsor holds or will hold adequate title or a long-term lease.
(4) In the case of a current military airport documentation that the airport sponsor has an existing joint-use agreement with the military department having jurisdiction over the airport. This is necessary so the FAA can legally issue grants to the sponsor. In (3) and (4) above, the airport must possess the necessary property rights in order to accept a grant for its proposed projects during FY 2003.
(5) Documentation that the airport is classified as a “commercial service airport” or a “reliever airport” as defined in 49 U.S.C. 47102(7) and 47102(18), unless it is applying for the general aviation slot.
(6) Documentation that the airport owner is an eligible airport “sponsor” as defined in 49 U.S.C. 47102(19).
(7) Documentation that the airport has an approved airport layout plan (ALP) and a five-year Airport Capital Improvement Program (ACIP) indicating all eligible grant projects proposed to be funded either from the MAP or other portions of the AIP.
(8) Information identifying the existing and potential levels of visual or instrument operations and aeronautical activity at the current or former military airport and, if applicable, the relieved airport. Also, if applicable, information on how the airport contributes to air traffic system or airport system capacity. If served by commercial air carriers, the revenue passenger and cargo levels should be provided.
(9) A description of the airport's projected civil role and development needs for transitioning from use as a military airfield to a civil airport, including how development projects would serve to reduce delays at an airport with more than 20,000 hours of annual delays by commercial passenger aircraft takeoffs and landings or enhance capacity in a metropolitan area.
(10) A description of the existing airspace capacity. Describe how anticipated new operations would affect the surrounding airspace and air traffic flow patterns in the metropolitan area in or near which a current or former military airport is located. Include a discussion of the level to which operations at this airport create airspace conflicts that may cause congestion or
(11) A description of the airport's five-year ACIP, including a discussion of major projects, their priorities, projected schedule for project accomplishment, and estimated costs. The ACIP must specifically identify the safety, capacity and conversion related projects, associated costs, and projected five-year schedule of project construction, including those requested for consideration for MAP funding.
(12) A description of those projects that are consistent with the role of the airport and effectively contribute to the joint use or conversion of the airfield to a civil airport. The projects can be related to various improvement categories depending on what is needed to convert from military to civil airport use, to meet required civil airport standards, and/or to provide capacity to the airport and/or airport system. The projects selected;
• Modification of airport or military airfield for safety purposes, including airport pavement modifications (
• Construction of facilities or support facilities such as passenger terminal gates, aprons for passenger terminals, taxiways to new terminal facilities, aircraft parking, and cargo facilities to accommodate civil use.
• Modification of airport or military utilities (electrical distribution systems, communications lines, water, sewer, storm drainage) to meet civil standards. Also, modifications that allow utilities on the civil airport to operate independently, where other portions of the base are conveyed to entities other than the airport sponsor or retained by the Government.
• Purchase, rehabilitation, or modification of airport and airport support facilities and equipment, including snow removal, aircraft rescue, fire fighting buildings and equipment, airport security, lighting vaults, and reconfiguration or relocation of eligible buildings for more efficient civil airport operations.
• Modification of airport or military airfield fuel systems and fuel farms to accommodate civil aviation use.
• Acquisition of additional land for runway protection zones, other approach protection, or airport development.
• Cargo facility requirements.
• Modifications which will permit the airfield to accommodate general aviation users.
• Construction of surface parking areas and access roads to accommodate automobiles in the airport terminal and air cargo areas and provide an adequate level of access to the airport.
• Construction or relocation of access roads to provide efficient and convenient movement of vehicular traffic to, on, and from the airport, including access to passenger, air cargo, fixed base operations, and aircraft maintenance areas.
• Modification or construction of facilities such as passenger terminals, surface automobile parking lots, hangars, air cargo terminal buildings, and access roads to cargo facilities to accommodate civil use.
(13) An evaluation of the ability of surface transportation facilities (road, rail, high-speed rail, maritime) to provide intermodal connections.
(14) A description of the type and level of aviation and community interest in the civil use of a current or former military airport.
(15) One copy of the FAA-approved ALP for each copy of the application. The ALP or supporting information should clearly show capacity and conversion related projects. Also, other information such as project costs, schedule, project justification, other maps and drawings showing the project locations, and any other supporting documentation that would make the application easier to understand should be included. These maps and ALP's should be cross-referenced with the project costs and project descriptions.
Airports applying for redesignation to the Military Airport Program should submit the same information required by new candidate airports applying for a new designation. On the SF 424, Application for Federal Assistance, prescribed by the Office of Management and Budget Circular A-102, airports must indicate their application is for redesignation to the MAP. In addition to the above information, they must explain:
(1) Why a redesignation and additional MAP eligible project funding is needed to accomplish the conversion to meet the civil role of the airport and the preferred time period for redesignation;
(2) Why funding of eligible work under other categories of AIP or other sources of funding would not accomplish the development needs of the airport;
(3) Why, based on the previously funded MAP projects, the projects and/or funding level were insufficient to accomplish the airport conversion needs and development goals; and
(4) The term of the redesignation, not to exceed five years, for which the airport is applying.
This notice is issued pursuant to Title 49 U.S.C. 47118.
Illinois Indiana Development Company, LLC (IIDC), a Class III carrier, has filed a verified notice of exemption under 49 CFR 1150.41 to acquire and operate approximately 6.2 miles of rail line from Chicago SouthShore & South Bend Railroad Co. (CSS). The rail line extends approximately from 115th Street in Chicago, IL (milepost 0.0) to the Illinois-Indiana state line in Burnham, IL, opposite Hammond, IN (milepost 6.2). IIDC certifies that its projected revenues as a result of this transaction will not result in the creation of a Class II or Class I rail carrier.
The transaction was scheduled to be consummated on or after October 9, 2002, the effective date of the exemption (7 days after the exemption was filed).
This transaction is related to STB Finance Docket No. 34263,
If the verified notice contains false or misleading information, the exemption is void
An original and 10 copies of all pleadings, referring to STB Finance Docket No. 34262, must be filed with the Surface Transportation Board, 1925 K Street, NW., Washington, DC 20423-0001. In addition, one copy of each pleading must be served on Rose-Michele Weinryb, Weiner Brodsky, Sidman Kider, PC, 1300 19th Street, NW., 5th Floor, Washington, DC 20036.
Board decisions and notices are available on our Web site at “
By the Board, David M. Konschnik, Director, Office of Proceedings.
Chicago SouthShore & South Bend Railroad (CSS), a Class III rail carrier, has filed a verified notice of exemption under 49 CFR 1150.41 to operate approximately 6.2 miles of rail line from Illinois Indiana Development, LLC (IIDC). The line extends approximately from 115th Street in Chicago, IL (milepost 0.0) to the Illinois-Indiana state line in Burnham, IL, opposite Hammond, IN (milepost 6.2). CSS certifies that its projected revenues as a result of this transaction will not result in the creation of Class II or Class I rail carrier.
The transaction was scheduled to be consummated on or after October 9, 2002, the effective date of the exemption (7 days after the exemption was filed).
This transaction is related to a concurrently filed verified notice of exemption in STB Finance Docket No. 34262,
If the verified notice contains false or misleading information, the exemption is void
An original and 10 copies of all pleadings, referring to STB Finance Docket No. 34263, must be filed with the Surface Transportation Board, 1925 K Street, NW., Washington, DC 20423-0001. In addition, one copy of each pleading must be served on Rose-Michele Weinryb, Weiner Brodsky, Sidman Kider, PC, 1300 19th Street, NW., 5th Floor, Washington, DC 20036.
Board decisions and notices are available on our Web site at “
By the Board, David M. Konschnik, Director, Office of Proceedings.
Office of Foreign Assets Control, Treasury.
Notice.
The Treasury Department's Office of Foreign Assets Control is publishing the name of one additional person whose property and interests in property has been blocked pursuant to Executive Order 13224 of September 23, 2001, pertaining to persons who commit, threaten to commit, or support terrorism.
The designation by the Secretary of the Treasury of the one additional person identified in this notice whose property and interests in property have been blocked pursuant to Executive Order 13224 is effective as of September 6, 2002.
Office of Foreign Assets Control, Department of the Treasury, Washington, DC 20220,
This document is available as an electronic file on The Federal Bulletin Board the day of publication in the
On September 23, 2001, President Bush issued Executive Order 13224 (the “Order”) imposing economic sanctions on persons who commit, threaten to commit, or support certain acts of terrorism. In an annex to the Order, President Bush identified 12 individuals and 15 entities whose assets are blocked pursuant to the Order (66 FR 49079, September 25, 2001). Additional persons have been blocked pursuant to authorities set forth in the Order since that date and notice of such blockings have been published in the
The designation by the Secretary of the Treasury pursuant to Executive Order 13224 of this additional person listed below is effective on September 6,
In Section 10 of the Order, the President determined that because of the ability to transfer funds or assets instantaneously, prior notice to persons listed in the Annex to, or determined to be subject to, the Order who might have a constitutional presence in the United States, would render ineffectual the blocking and other measures authorized in the Order. The President further determined that no prior notification of a determination need be provided to any person who might have a constitutional presence in the United States. In furtherance of the objectives of the Order, the Secretary of the Treasury has determined that no prior notice should be afforded to the subjects of the determinations reflected in this notice because to do so would give the subjects the opportunity to evade the measures described in the Order and, consequently, render those measures ineffectual toward addressing the national emergency declared in the Order.
Office of Foreign Assets Control, Treasury.
Notice.
The Treasury Department's Office of Foreign Assets Control is publishing the names of 25 additional persons whose property and interests in property have been blocked pursuant to Executive Order 13224 of September 23, 2001, pertaining to persons who commit, threaten to commit, or support terrorism.
The designations by the Secretary of the Treasury of additional persons identified in this notice whose property and interests in property have been blocked pursuant to Executive Order 13224 are effective on August 29, 2002.
Office of Foreign Assets Control, Department of the Treasury, Washington, DC 20220, tel.: 202/622-2520.
This document is available as an electronic file on The Federal Bulletin Board the day of publication in the
On September 23, 2001, President Bush issued Executive Order 13224 (the “Order”) imposing economic sanctions on persons who commit, threaten to commit, or support certain acts of terrorism. In an annex to the Order, President Bush identified 12 individuals and 15 entities whose assets are blocked pursuant to the Order (66 FR 49079, September 25, 2001). Additional persons have been blocked pursuant to authorities set forth in the Order since that date and notice of these additional blockings have been published in the
The designations by the Secretary of the Treasury pursuant to Executive Order 13224 of these additional persons listed below are effective on August 29, 2002. All property and interests in property of any designated person, including but not limited to all accounts, that are or come within the United States or that are or come within the possession or control of United States persons, including their overseas branches, are blocked and may not be transferred, paid, exported, withdrawn, or otherwise dealt in, and all transactions or dealings by U.S. persons or within the United States in property or interests in property of any designated person are prohibited, unless licensed by the Office of Foreign Assets Control or exempted by statute.
In Section 10 of the Order, the President determined that because of the ability to transfer funds or assets instantaneously, prior notice to persons listed in the Annex to, or determined to be subject to, the Order who might have a constitutional presence in the United States, would render ineffectual the blocking and other measures authorized in the Order. The President further determined that no prior notification of a determination need be provided to any person who might have a constitutional presence in the United States. In furtherance of the objectives of the Order, the Secretary of the Treasury has determined that no prior notice should be afforded to the subjects of the determinations reflected in this notice because to do so would give the subjects the opportunity to evade the measures described in the Order and,
The list of additional designations follow:
Office of Foreign Assets Control, Treasury.
Notice.
The Treasury Department's Office of Foreign Assets Control is publishing the names of four additional persons whose property and interests in property have been blocked pursuant to Executive Order 13224 of September 23, 2001, pertaining to persons who commit, threaten to commit, or support terrorism.
The designations by the Secretary of the Treasury of additional persons identified in this notice whose property and interests in property have been blocked pursuant to Executive Order 13224 are effective on September 30, 2002.
Office of Foreign Assets Control, Department of the Treasury, Washington, DC 20220, tel.: 202/622-2520.
This document is available as an electronic file on The Federal Bulletin Board the day of publication in the
On September 23, 2001, President Bush issued Executive Order 13224 (the “Order”) imposing economic sanctions on persons who commit, threaten to commit, or support certain acts of terrorism. In an annex to the Order, President Bush identified 12 individuals and 15 entities whose assets are blocked pursuant to the Order (66 FR 49079, September 25, 2001). Additional persons have been blocked pursuant to authorities set forth in the Order since that date and notice of these additional blockings have been published in the
The designations by the Secretary of the Treasury pursuant to Executive Order 13224 of these additional persons listed below are effective on September 30, 2002. All property and interests in property of any designated person, including but not limited to all accounts, that are or come within the United States or that are or come within the possession or control of United States persons, including their overseas branches, are blocked and may not be transferred, paid, exported, withdrawn, or otherwise dealt in, and all transactions or dealings by U.S. persons or within the United States in property or interests in property of any designated person are prohibited, unless licensed by the Office of Foreign Assets Control or exempted by statute.
In Section 10 of the Order, the President determined that because of the ability to transfer funds or assets instantaneously, prior notice to persons listed in the Annex to, or determined to be subject to, the Order who might have a constitutional presence in the United States, would render ineffectual the blocking and other measures authorized in the Order. The President further determined that no prior notification of a determination need be provided to any person who might have a constitutional presence in the United States. In furtherance of the objectives of the Order, the Secretary of the Treasury has determined that no prior notice should be afforded to the subjects of the determinations reflected in this notice because to do so would give the subjects the opportunity to evade the measures described in the Order and, consequently, render those measures ineffectual toward addressing the national emergency declared in the Order.
The list of additional designations follow:
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Written comments and recommendations on the proposed collection of information should be received on or before December 31, 2002.
Submit written comments on the collection of information to Nancy J. Kessinger, Veterans Benefits Administration (20S52), Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420 or e-mail:
Nancy J. Kessinger at (202) 273-7079 or FAX (202) 275-5947.
Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C., 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VBA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility; (2) the accuracy of VBA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Written comments and recommendations on the proposed collection of information should be received on or before December 31, 2002.
Submit written comments on the collection of information to Nancy J. Kessinger, Veterans Benefits Administration (20S52), Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420 or e-mail:
Nancy J. Kessinger at (202) 273-7079 or FAX (202) 275-5947.
Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C., 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VBA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility; (2) the accuracy of VBA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C., 3501
Comments must be submitted on or before December 2, 2002.
Denise McLamb, Records Management Service (005E3), Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420, (202) 273-8030, FAX (202) 273-5981 or e-mail:
Send comments and recommendations concerning any aspect of the information collection to VA's OMB Desk Officer, OMB Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, DC 20503 (202) 395-7316. Please refer to “OMB Control No. 2900-0004” in any correspondence.
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995
Comments must be submitted on or before December 2, 2002.
Denise McLamb, Records Management Service (005E3), Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420, (202) 273-8030, FAX (202) 273-5981 or e-mail:
Send comments and recommendations concerning any aspect of the information collection to VA's OMB Desk Officer, OMB Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, DC 20503 (202) 395-7316. Please refer to “OMB Control No. 2900-0016” in any correspondence.
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
By direction of the Secretary.
Department of Veterans Affairs (VA).
Notice of establishment of new system of records.
The Privacy Act of 1974 (5 U.S.C. 552(e) (4)) requires that all agencies publish in the
Comments on the establishment of this system of records must be received no later than December 2, 2002. If no public comment is received, the new system will become effective December 2, 2002.
You may mail or hand-deliver written comments concerning the proposed new system of records to the Office of Regulations Management (02D), Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420; or fax comments to (202) 273-9289; or email comments to
Veterans Health Administration (VHA) Privacy Act Officer, Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420, telephone (727) 320-1839.
The Employee Incentive Scholarship Program (EISP) allows VA to award scholarships to employees pursuing degrees or training leading to appointment or retention in the following health professions: physician, dentist, podiatrist, pharmacist, licensed practical/vocational nurse, expanded-function dental auxiliary, registered nurse, certified registered nurse anesthetist, physician assistant, optometrist, physical therapist, occupational therapist, certified respiratory therapy technician, and registered respiratory therapist. The purpose of the program is to help VA meet its needs for qualified healthcare staff.
The Employee Incentive Scholarship Program—VA (110VA10) system of records contains personal identification information related to the application material, to award processes, to employment status, and to obligated service such as name, address, Social Security number, employing facility name, job title, grade, education level, degree sought, award amounts, obligated service incurred, and name and address of the educational institution. It also contains individual information about applicants who have been denied scholarships, program participants who have been terminated from VA employment, program participants who have breached their program contracts and any amount of indebtedness arising from a scholarship and owed back to VA. Additionally, it may contain information about why an applicant declined to accept a scholarship if the applicant furnished such information. Since applicants typically are denied scholarships because they do not meet the eligibility requirements to participate in the program, the specific nature of an applicant's ineligibility would be another element of information contained in the system of records. Scholarship recipients may request that a payment or service obligation be waived or suspended if circumstances beyond their control make it impossible to comply with the terms and conditions of the educational assistance program. The system of records would include information about the specific nature of the request and the related decision.
Any information in this system may be used by local VA supervisory officials and program coordinators to ensure that individual data in the system of records is accurate and up to date and that award recipients are in compliance with the terms of the scholarship program contract. Data about individual award recipients may change (e.g., adjustments to academic course load) and could impact certain terms of their scholarships such as the amounts of the awards and/or the beginning and ending dates of their periods of obligated service. Data changes may also impact assessments of the effectiveness of the scholarship
The information in this system of records is maintained in electronic and hard copy format and is periodically updated through recurring reports, provided by local VA facilities, about the progress of their program participants. This information is necessary to effectively administer the scholarship program. It is used to determine and document individual applicants' initial eligibility for scholarship awards, calculate the service commitments for scholarship recipients, ensure program financial accountability which means that award amounts are consistent with applicable law, regulations and policy, monitor individual applicant educational progress, monitor the employment status of scholarship recipients during their periods of obligated service, and evaluate and report program results and effectiveness. The information would be used to determine the financial liability of individuals who breach their EISP contracts.
We are proposing to establish the following routine use disclosures of information which will be maintained in the system:
• Any information in this system that is necessary to verify accuracy and completeness of the application information may be disclosed to educational institutions and other relevant organizations or individuals.
Employees must meet certain requirements to be eligible to participate in the scholarship program. For example, the applicants must have been formally accepted to or enrolled in authorized education or training programs as of the date that they submit their official applications for scholarship awards. Some schools may offer students who do not meet all of the requirements for formal (unconditional) acceptances into their academic programs (typically, Grade Point Average (GPA) or standardized test scores that are below established cutoff points), conditional acceptances. These students may be granted formal or unconditional acceptances once they meet certain requirements such as completing specified coursework and earning a minimum GPA. Students who have been conditionally or informally accepted into an academic program are not eligible to participate in the EISP. VA may need to disclose applicant information in order to verify that candidates for scholarship awards meet applicable program requirements.
• Any information in this system may be disclosed to a Federal agency in order to determine if an applicant has an obligation for service under another Federal program, thus rendering the applicant ineligible for a VA Employee Incentive Scholarship Program Award.
Scholarship program participants are required to serve a period of obligated service after completing their VA-sponsored courses of education or training. Employees are ineligible to receive scholarships if their VA periods of obligated service conflict with obligations to perform service under any other Federal educational program(s). VA may need to disclose applicant information to other Federal agencies to verify that employees do not have obligations to perform service that would render them ineligible to participate in the scholarship program.
• Any information in the system may be used to evaluate and report program results and effectiveness to appropriate officials including members of Congress on a routine and ad hoc basis.
The purpose of the scholarship program is to assist in meeting the staffing needs of VHA for health professional occupations for which recruitment or retention of qualified personnel is difficult. Top-level VA officials and Congress must have access to information from the system to assess how effectively the program accomplishes its purpose and to support decisions to continue, to modify or curtail its use.
• The record of an individual who is covered by this system may be disclosed to a member of Congress or staff person acting for the member when the member or staff person requests the record on behalf of and at the request of that individual.
Individuals sometimes request the help of a member of Congress in resolving some issues relating to a matter before VA. The member of Congress then writes VA, and VA must be able to give sufficient information to be responsive to the inquiry.
• Disclosure of information may be made to the National Archives and Record Administration (NARA) in records management inspections conducted under authority of Title 44 United States Code.
NARA is responsible for archiving old records no longer actively used but which may be appropriate for preservation; they are responsible in general for the physical maintenance of the Federal government's records. VA must be able to turn records over to this agency in order to determine the proper disposition of such records.
• Disclosure of information to the Federal Labor Relations Authority (FLRA) (including its General Counsel) when requested in connection with the investigation and resolution of allegations of unfair labor practices, in connection with the resolution of exceptions to arbitrator awards when a question of material fact is raised, in connection with matters before the Federal Service Impasses Panel, and to investigate representation petitions and conduct or supervise representation elections.
The release of information to FLRA from this Privacy Act system of records is necessary to comply with the statutory mandate under which FLRA operates.
• Disclosure may be made to officials of labor organizations recognized under 5 U.S.C. chapter 71 when relevant and necessary to their duties of exclusive representation concerning personnel policies, practices, and matters affecting working conditions.
• Disclosure may be made to the VA-appointed representative of an employee, including all notices, determinations, decisions, or other written communications issued to the employee in connection with an examination ordered by VA under medical evaluation (formerly fitness-for-duty) examination procedures or Department-filed disability retirement procedures.
• Disclosure may be made to officials of the Merit Systems Protection Board, including the Office of the Special Counsel, when requested in connection with appeals, special studies of the civil service and other merit systems, review of rules and regulations, investigation of alleged or possible prohibited personnel practices, and such other functions, promulgated in 5 U.S.C. 1205 and 1206, or as may be authorized by law.
• Disclosure may be made to the Equal Employment Opportunity Commission when requested in connection with investigations of alleged or possible discrimination practices, examination of Federal affirmative employment programs, compliance with the Uniform Guidelines of Employee Selection Procedures, or other functions vested in the Commission by the President's Reorganization Plan No. 1 of 1978.
The Privacy Act permits VA to disclose information about individuals without their consent for a routine use when the information will be used for
The notice of intent to publish and an advance copy of the system notice have been sent to the appropriate Congressional committees and to the Director of the Office of Management and Budget (OMB) as required by 5 U.S.C. 552a(r) (Privacy Act) and guidelines issued by OMB (65 FR 77677), December 12, 2000.
Employee Incentive Scholarship Program (EISP)-VA.
Active records will be maintained at the Health Care Staff Development and Retention Office (HCSDRO/10A2D), Veterans Health Administration (VHA), Department of Veterans Affairs (VA), 1555 Poydras Street, Suite 1971, New Orleans, Louisiana 70112; the Austin Automation Center (AAC), Department of Veterans Affairs, 1615 East Woodward Street, Austin, Texas 78772; and the VA healthcare facilities and VISN offices where scholarship recipients are employed. Address locations for VA healthcare facilities are listed in VA Appendix 1 of the Biennial Publication of Privacy Act Issuances. Complete records will be maintained only at the HCSDRO address.
VA employees who apply for and are denied or granted educational assistance awards under the provisions of the VA Employee Incentive Scholarship Program (EISP) in a field leading to appointment or retention in a position listed in 38 U.S.C., Section 7401.
Records (or information contained in records) in this system may include personal identification information related to the application material, to award processes, to employment, to obligated service, and to requests for waivers or suspensions of obligated service or financial indebtedness to VA such as (1) name, (2) employing facility number, (3) telephone number(s), (4) Social Security number, (5) award amount, (6) obligated service incurred, and (7) name and address of the educational institution; or any amount of indebtedness (accounts receivable) arising from the scholarship and owed to VA. The application for an EISP award includes the applicant's full name, employing facility number, home and work telephone numbers, Social Security number, job title, current education level, degree sought, description of the academic program covered by the scholarship, the starting and completion dates of the employee's academic program, the name and address of the academic institution, the number of credits in the student's academic program plan and the cost of the education covered by the academic program plan. Records may include memoranda submitted by the employees, calculations for the service obligations, copies of letters and/or memoranda from employees making the requests and in correspondence to employees and appropriate local program officials delineating the decisions on such requests.
Title 38, U.S.C., Sections 501, 503, 7451, 7452, and 7431-7440.
The records and information may be used for determining and documenting individual applicant eligibility for scholarship awards, calculating the service commitments for scholarship recipients, ensuring program financial accountability, monitoring individual applicant educational progress, monitoring the employment status of scholarship recipients during their periods of obligated service, terminating the employee from the program, and evaluating and reporting program results and effectiveness. The information would be used to determine the financial liability of individuals who breach their EISP contracts.
1. Disclosure of any information in this system that is necessary to verify authenticity and completeness of the application may be made to educational institutions and other relevant organizations or individuals.
2. Disclosure of any information in this system may be made to a Federal agency in order to determine if an applicant has an obligation for service under another Federal program, thus rendering the applicant ineligible for a VA Employee Incentive Scholarship Program Award.
3. Disclosure of any information in this system may be made to the local supervisory officials and program coordinators to ensure that individual data in the system of records is up to date and that award recipients are in compliance with the terms of the scholarship program contract.
4. Any information in the system may be used to evaluate and report program results and effectiveness to appropriate officials including members of Congress on a routine and ad hoc basis.
5. Disclosure of information in this system may be made to a member of Congress or staff person acting for the member when the member or staff person requests the records on behalf of and at the request of that individual.
6. Disclosure of information may be made to the National Archives and Record Administration (NARA) in records management inspections conducted under authority of Title 44, United States Code.
7. Disclosure of information to the FLRA (including its General Counsel) when requested in connection with the investigation and resolution of allegations of unfair labor practices, in connection with the resolution of exceptions to arbitrator awards when a question of material fact is raised, in connection with matters before the Federal Service Impasses Panel, and to investigate representation petitions and conduct or supervise representation elections.
8. Disclosure may be made to officials of labor organizations recognized under 5 U.S.C. chapter 71 when relevant and necessary to their duties of exclusive representation concerning personnel policies, practices, and matters affecting working conditions.
9. Disclosure may be made to officials of the Merit Systems Protection Board, including the Office of the Special Counsel, when requested in connection with appeals, special studies of the civil service and other merit systems, review of rules and regulations, investigation of alleged or possible prohibited personnel practices, and such other functions, promulgated in 5 U.S.C. 1205 and 1206, or as may be authorized by law.
10. Disclosure may be made to the Equal Employment Opportunity Commission when requested in connection with investigations of alleged or possible discrimination practices, examination of Federal affirmative employment programs, compliance with the Uniform Guidelines of Employee Selection Procedures, or other functions vested in the Commission by the President's Reorganization Plan No. 1 of 1978.
Pursuant to 5 U.S.C. 552a(b)(12), VA may disclose records from this system to consumer reporting agencies as defined in the Fair Credit Reporting Act (15 U.S.C. 1681a(f)) or the Federal Claims Collection Act of 1966 (31 U.S.C. 3701(a)(3)).
Records are maintained on paper, electronic media and computer printouts.
Records are retrieved by use of the award number or an equivalent participant account number assigned by HCSDRO, social security number and the name of the individual.
Access to the basic file in HCSDRO is restricted to authorized VA employees and vendors. Access to the office spaces where electronic media is maintained within HCSDRO is further restricted to specifically authorized employees and is protected by contracted building security services. Records (typically computer printouts) at HCSDRO will be kept in locked files and made available only to authorized personnel on a need-to-know basis. During non-working hours the file is locked and the building is protected by contracted building security services. Records stored on electronic media are maintained on a VA-approved and managed, password-protected, secure local area network (LAN) located within HCSDRO office spaces and safeguarded as described above. Records stored on electronic media at Veterans Integrated Service Network (VISN) Offices, VA healthcare facilities, and the AAC in Austin, Texas are provided equivalent safeguards subject to local policies mandating protection of information subject to federal safeguards.
Records will be maintained and disposed of in accordance with records disposition authority approved by the Archivist of the United States.
Director, Health Care Staff Development and Retention Office (10A2D), Veterans Health Administration, Department of Veterans Affairs, 1555 Poydras Street, Suite 1971, New Orleans, Louisiana 70112.
Any individual who wishes to determine whether a record is being maintained in this system under his or her name or other personal identifier, or wants to determine the contents of such records, should submit a written request or apply in person to the Director, Health Care Staff Development and Retention Office, Veterans Health Administration, Department of Veterans Affairs, 1555 Poydras Street, Suite 1971, New Orleans, Louisiana 70112.
Individuals seeking information regarding access to and contesting of VA records in this system may write, call or visit the Director, Health Care Staff Development and Retention Office (10A2D), Veterans Health Administration, Department of Veterans Affairs, 1555 Poydras Street, Suite 1971, New Orleans, Louisiana 70112. The telephone number is (504) 589-5267.
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Information contained in the records is obtained from the individual, references given in application material, educational institutions, VA medical facilities, the VA AAC, other Federal agencies, State agencies and consumer reporting agencies.
Centers for Medicare & Medicaid Services (CMS), HHS.
Final rule with comment period.
This final rule with comment period revises the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. In addition, it describes changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. These changes are applicable to services furnished on or after January 1, 2003. This rule also allows the Secretary to suspend Medicare payments “in whole or in part” if a provider fails to file a timely and acceptable cost report.
In addition, this rule responds to public comments received on the November 2, 2001 interim final rule with comment period (66 FR 55850) that set forth the criteria the Secretary will use to establish new categories of medical devices eligible for transitional pass-through payment under the Medicare's hospital outpatient prospective payment system. Finally, this rule responds to public comments received on the August 9, 2002 proposed rule for revisions to the hospital outpatient prospective payment system and payment rates (67 FR 52092). CMS finds good cause to waive proposed rulemaking for the assignment of new codes to Ambulatory Payment Classifications and for the payment of influenza and pneuomococcal vaccines under reasonable cost; justification for the waiver will follow in a subsequent
Anita Heygster, (410) 786-0378—outpatient prospective payment issues; Lana Price, (410) 786-4533—partial hospitalization and end-stage renal disease issues; Gerald Walters, (410) 786-2070—payment suspension issues.
This
When the Medicare statute was originally enacted, Medicare payment for hospital outpatient services was based on hospital-specific costs. In an effort to ensure that Medicare and its beneficiaries pay appropriately for services and to encourage more efficient delivery of care, the Congress mandated replacement of the cost-based payment methodology with a prospective payment system (PPS). The Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33), enacted on August 5, 1997, added section 1833(t) to the Social Security Act (the Act) authorizing implementation of a PPS for hospital outpatient services. The Balanced Budget Refinement Act of 1999 (BBRA) (Pub. L. 106-113), enacted on November 29, 1999, made major changes that affected the hospital outpatient PPS (OPPS). The Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554), enacted on December 21, 2000, made further changes in the OPPS. The OPPS was first implemented for services furnished on or after August 1, 2000.
• On September 8, 1998, we published a proposed rule (63 FR 47552) to establish in regulations a PPS for hospital outpatient services, to eliminate the formula-driven overpayment for certain hospital outpatient services, and to extend reductions in payment for costs of hospital outpatient services. On June 30, 1999, we published a correction notice (64 FR 35258) to correct a number of technical and typographic errors in the September 1998 proposed rule including the proposed amounts and factors used to determine the payment rates.
• On April 7, 2000, we published a final rule with comment period (65 FR 18434) that addressed the provisions of the PPS for hospital outpatient services scheduled to be effective for services furnished on or after July 1, 2000. Under this system, Medicare payment for hospital outpatient services included in the PPS is made at a predetermined, specific rate. These outpatient services are classified according to a list of ambulatory payment classifications (APCs). The April 7, 2000 final rule with comment period also established requirements for provider departments and provider-based entities and prohibited Medicare payment for nonphysician services furnished to a hospital outpatient by a provider or supplier other than a hospital unless the services are furnished under arrangement. In addition, this rule extended reductions in payment for costs of hospital outpatient services as required by the BBA and amended by the BBRA. Medicare regulations governing the hospital OPPS are set forth at 42 CFR part 419.
• On June 30, 2000, we published a notice (65 FR 40535) announcing a delay in implementation of the OPPS from July 1, 2000 to August 1, 2000. We implemented the OPPS on August 1, 2000.
• On August 3, 2000, we published an interim final rule with comment period (65 FR 47670) that modified criteria that we use to determine which medical devices are eligible for transitional pass-through payments. The August 3, 2000 rule also corrected and clarified certain provider-based provisions included in the April 7, 2000 rule.
• On November 13, 2000, we published an interim final rule with comment period (65 FR 67798). This rule provided for the annual update to the amounts and factors for OPPS payment rates effective for services furnished on or after January 1, 2001. We implemented the 2001 OPPS on January 1, 2001. We also responded to public comments on those portions of the April 7, 2000 final rule that implemented related provisions of the BBRA and public comments on the August 3, 2000 rule.
• On August 24, 2001, we published a proposed rule (66 FR 44672) that would revise the OPPS to implement applicable statutory requirements, including relevant provisions of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2002 (BIPA) and changes arising from our continuing experience with this system. It also described proposed changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the PPS. The changes applied to services furnished on or after January 1, 2002.
• On November 2, 2001, we published a final rule (66 FR 55857) that announced the Medicare OPPS conversion factor for calendar year 2002. In addition, it described the Secretary's estimate of the total amount of the transitional pass-through payments for CY 2002 and the implementation of a uniform reduction in each of the pass-through payments for that year.
• On November 2, 2001, we also published an interim final rule with comment period (66 FR 55850) that set forth the criteria the Secretary will use to establish new categories of medical devices eligible for transitional pass-through payments under Medicare's OPPS.
• On November 30, 2001, we published a final rule (66 FR 59856) that revised the Medicare OPPS to implement applicable statutory requirements, including relevant provisions of BIPA, and changes resulting from continuing experience with this system. It addition, it described the CY 2002 payment rates for Medicare hospital outpatient services paid under the PPS. This final rule also announced a uniform reduction of 68.9 percent to be applied to each of the transitional pass-through payments for certain categories of medical devices and drugs and biologicals.
• On December 31, 2001, we published a final rule (66 FR 67494) that delayed, until no later than April 1, 2002, the effective date of CY 2002 payment rates and the uniform reduction of transitional pass-through payments that were announced in the November 30, 2001 final rule. In addition, this final rule indefinitely delayed certain related regulatory provisions.
• On March 1, 2002, we published a final rule (67 FR 9556) that corrected technical errors that affected the amounts and factors used to determine the payment rates for services paid under the Medicare OPPS and corrected the uniform reduction to be applied to transitional pass-through payments for CY 2002 as published in the November 30, 2001 final rule. These corrections and the regulatory provisions that had been delayed became effective on April 1, 2002.
• On August 9, 2002, we published a proposed rule (67 FR 52092) that would revise the OPPS to implement applicable statutory requirements and changes arising from our continuing experience with this system. The changes would be applicable to services furnished on or after January 1, 2003. This rule also proposed to allow the Secretary to suspend Medicare payments “in whole or in part” if a provider fails to file a timely and acceptable cost report.
Authority for the provision regarding payment suspensions for unfiled cost reports is contained within the authority for subpart C of 42 CFR part 405, that is, sections 1102, 1815, 1833, 1842, 1866, 1870, 1871, 1879, and 1892 of the Social Security Act (42 U.S.C. 1302, 1395g, 1395l, 1395u, 1395cc, 1395gg, 1395hh, 1395pp, and 1395ccc) and 31 U.S.C. 3711.
On August 9, 2002, we published a proposed rule (67 FR 52092) that set forth proposed changes to the Medicare hospital OPPS and CY 2003 payment rates including changes used to determine these payment rates. The following is a summary of the major changes that we proposed and the issues we addressed in the August 9, 2002 proposed rule.
a.
We proposed the following changes to implement statutory requirements:
• Add APCs, delete APCs, and modify the composition of some existing APCs.
• Recalibrate the relative payment weights of the APCs.
• Update the conversion factor and the wage index.
• Revise the APC payment amounts to reflect the APC reclassifications, the recalibration of payment weights, and the other required updates and adjustments.
• Cease transitional pass-through payments for drugs and biologicals (including blood and blood products) and devices (including brachytherapy), that will, on January 1, 2003, have been paid under transitional pass-through methodology for at least 2 years.
b.
We proposed the following additional changes to the OPPS and Payment Suspension Provisions:
• Creation of new evaluation and management service codes for outpatient clinic and emergency department encounters for implementation no earlier than January 1, 2004.
• Changes to the list of services that we do not pay in outpatient departments because we define them as inpatient only procedures.
• Changes to our policy of nonpayment for procedures on the inpatient only list in special cases involving death or transfer before inpatient admission.
• Changes to our policy governing observation in cases of direct admission to observation.
• Changes to status indicators for Healthcare Common Procedure Coding System (HCPCS) codes.
• Changes to our policies governing dialysis for end-stage renal disease (ESRD) patients and regarding partial hospitalization.
C. Changes to the Regulations Text
A. We proposed to make the following changes to our regulations:
Amend § 419.66(c)(1) to specify that we must establish a new category for a medical device if it is not described by any category previously in effect as well as an existing category.
2. Changes Relating to Payment Suspension for Unfiled Cost Reports
We proposed to revise § 405.371(c) to specify that we may suspend Medicare payments “in whole or in part” if a provider has failed to timely file an acceptable cost report. This provision is consistent with the existing provisions in § 405.371(a) governing the suspension of Medicare payments “in whole or in part” under certain conditions. We believe the Medicare program would benefit because immediate complete payment suspension can be disruptive to providers and may negatively affect the care of Medicare patients.
On November 2, 2001, we published an interim final rule with comment period in the
In the April 7, 2000 final rule with comment period (65 FR 18480), we defined new or innovative devices using eight criteria, three of which were revised in our August 3, 2000 interim final rule with comment period (65 FR 47673-74). These criteria remained applicable when defining a new category for devices, (that is, devices to be included in a category must meet all previously established applicable criteria for a device eligible for transitional pass-through payments) but we revised the definition of an eligible device to conform the requirements of amended section 1833(t)(6)(B)(ii) of the Act.
We also clarified our criterion that states that a device must be approved or cleared by the Food and Drug Administration (FDA).
In establishing the criteria for establishing additional categories, the Act mandates that new categories be established for devices that were not being paid for as an outpatient hospital service as of December 31, 1996 and for which no categories in effect (or previously in effect) are appropriate, in such a way that no device is described by more than one category and the average cost of devices to be included in the category is not insignificant in relation to the APC payment amount for the associated service. Based on these requirements, we used the following criteria to establish a category of devices:
•
•
We received five timely items of correspondence on the November 2, 2001 interim final rule with comment period. Summaries of the public comments and our responses to those comments are set forth below under the appropriate section heading of this final rule with comment period.
We received approximately 1,000 timely items of correspondence containing multiple comments on the August 9, 2002 proposed rule. Of that total, we received eight comments relating to the payment suspension provision described in section I.D.2. Summaries of the public comments received on other provisions and our responses to those comments are provided below in section I.F.2 of this preamble.
We received comments from various sources including but not limited to health care facilities, physicians, drug and device manufacturers, and beneficiaries. Hospital associations and the Medicare Payment Advisory Commission (MedPAC) generally supported our proposed approach to revising the relative weights and incorporating the drugs and devices into payment for APCs. Pharmaceutial and medical device manufacturers and some individual hospitals that furnish particular devices or drugs were concerned with the proposed reductions in payment for medical devices and drugs. We received many thoughtful comments from a wide range of commenters with regard to methodological issues in OPPS. In addition, several comments provided data to support their assertions. The following are the major OPPS related issues addressed by the commenters:
• Expiration of pass-through payment for most devices and drugs/biologicals.
• Extent of reduction in payments for devices compared to payments in 2002.
• Potential impact on access to care of proposed payments.
• The proposal to package drugs with a per line cost less than $150 and to pay separately for others.
• Assignment and reassignment of codes to APCs (including assignments to procedural APCs from new tech APCs).
• Quality, quantity and content of claims data used to set payment weights.
• Continuation of a list of procedures that are not paid under OPPS because we believe that they should be performed as inpatient services.
• Policy on payment for outpatient observation care.
• Creation of evaluation and management codes for OPPS use.
Summaries of the public comments received and our responses to those comments are set forth below under the appropriate headings of this final rule with comment period.
Under the OPPS, we pay for hospital outpatient services on a rate-per-service basis that varies according to the APC group to which the service is assigned. Each APC weight represents the median
Section 1833(t)(9)(A) of the Act requires the Secretary to review the components of the OPPS not less often than annually and to revise the groups and related payment adjustment factors to take into account changes in medical practice, changes in technology, and the addition of new services, new cost data, and other relevant information. Section 1833(t)(9)(A) of the Act requires the Secretary, beginning in 2001, to consult with an outside panel of experts when annually reviewing and updating the APC groups and the relative payment weights.
Finally, section 1833(t)(2) of the Act provides that, subject to certain exceptions, the items and services within an APC group cannot be considered comparable with respect to the use of resources if the highest median or mean cost item or service in the group is more than 2 times greater than the lowest median cost item or service within the same group (referred to as the “2 times rule”).
We use the median cost of the item or service in implementing this provision. The statute authorizes the Secretary to make exceptions to the 2 times rule “in unusual cases, such as low volume items and services.”
For purposes of the proposed rule and for this final rule with comment period, we analyzed the APC groups within this statutory framework.
Section 1833(t)(9)(A) of the Act, requires that we consult with an outside panel of experts when annually reviewing and updating the APC groups and the relative weights. The Act specifies that the panel will act in an advisory capacity. The expert panel, which is to be composed of representatives of providers, is to review and advise us about the clinical integrity of the APC groups and their weights. The panel is not restricted to using our data and may use data collected or developed by organizations outside the Department in conducting its review.
On November 21, 2000, the Secretary signed the charter establishing an “Advisory Panel on APC Groups” (the Panel). The Panel is technical in nature and is governed by the provisions of the Federal Advisory Committee Act (FACA) as amended (Pub. L. 92-463). To establish the Panel, we solicited members in a notice published in the
We published a notice in the
In the proposed rule, we summarized the Panel's discussion of a recommendation by the Panel's Research Subcommittee concerning the format of written submissions and oral presentations to the Panel and of several general OPPS payment issues.
During the 2001 meeting, the Panel members felt that requiring consistency for all presentations with regard to format, data submission, and general information would assist them in analyzing the submissions and presentations and making recommendations. Therefore, upon the Panel's recommendation, the Research Subcommittee was established during the 2001 meeting.
The Panel began its 2002 meeting by considering the Research Subcommittee's recommendation to the Panel on requirements for written submissions and oral presentations. The Research Subcommittee recommended that all future oral presentations and written submissions contain the following:
• Name, address, and telephone number of the proposed presenter.
• Financial relationship(s), if any, with any company whose products, services, or procedures are under consideration.
• CPT codes involved.
• APC(s) affected.
• Description of the issue.
• Clinical description of the service under discussion, with comparison to other services within the APC.
• Description of the resource inputs associated with the service under discussion, with a comparison to resource inputs for other services within the APC.
• Recommendations and rationale for change.
• Expected outcome of change and potential consequences of no change.
The Panel adopted the Subcommittee s recommendation. Presentations for the 2003 meeting must contain, at a minimum, this information.
At its February 2001 meeting, the Panel discussed the existence of the inpatient list. The Panel favored its elimination. At the January 2002 meeting, Panel members noted that hospitals receive no payment for a service performed in an outpatient department that appears on the inpatient list, even though the physician performing that service will receive payment for his or her services. The Panel believes the physician should determine what procedure to perform and that both the hospital and the physician should receive payment for the procedure. We continue to disagree with the position taken by the Panel regarding the inpatient list for reasons that we discuss in detail in the April 7, 2000 final rule (65 FR 18456).
Prior to the 2002 Panel meeting, we received requests from hospital and surgical associations and societies to remove certain procedures from the inpatient list. We reviewed those requests and presented to the Panel the requests for which we were unable to make a determination based on the information submitted with the request.
The Panel considered removing the following procedures from the inpatient list:
As the Panel recommended, we solicited comments and additional information from hospitals and medical specialty societies that have an interest in these procedures. At their 2003 meeting, the Panel also recommended that we present to them any such comments that we receive to assist in their evaluation of whether to recommend removing the codes from the inpatient list.
The Panel did recommend that we remove from the inpatient list CPT code 47001, Biopsy of liver, needle; when done for indicated purpose at time of other major procedure. We agreed with the Panel's recommendation and we proposed to remove 47001 from the inpatient list. We further proposed to assign it status indicator “N” so that costs associated with CPT code 47001 would be packaged into the APC payment for the primary procedure performed during the same operative session.
In section II.B.5 of the proposed rule, we discussed additional procedures, which were not considered by the Panel, that we proposed to remove from the inpatient list. We discussed in detail our reasons for proposing these additional changes, and we proposed two new criteria that we would adopt in the future when evaluating whether to make a procedure on the inpatient list payable under the OPPS. Table 6 in section II.B.5 of the proposed rule lists all the procedures we proposed to remove from the inpatient list, including those discussed by the Panel. We considered the removal of CPT code 33967, Insertion of intra-aortic balloon assist device, percutaneous from the inpatient list, but did not include it in Table 6. The Panel considered this code for removal from the inpatient list and had concerns about whether performing this procedure in an outpatient setting is appropriate. Further, we were not able to confirm that this procedure is being performed on Medicare beneficiaries in an outpatient setting. We solicited comments, including clinical data and specific case reports, which would support payment for CPT 33967 under the OPPS.
Our discussion of the comments we received on this issue, our response and the statement of final action regarding what services to remove from the inpatient list is contained in section II.B.5.
During its February 2001 meeting, the Panel received oral testimony identifying CMS exclusive use of single procedure claims to set relative weights for APCs as a potential problem in setting appropriate payment rates for APCs. Therefore, the panel asked its Research Subcommittee to work with CMS staff, using the Endoscopic Retrograde Cholangiopancreatography (ERCP) code family as a case study, to explore the use of multiple procedure claims data for setting relative weights.
The Subcommittee made the following recommendations to the Panel, which the Panel approved:
• We should continue to explore the use of multiple procedure claims data for setting payment rates but should continue to use only single procedure claims data to determine relative payment weights for CY 2003.
• We should work with the APC Panel to explore the use of multiple claims data drawn from OPPS claims for services such as radiation oncology in time for the next APC Panel meeting.
• We should educate hospitals on appropriate coding and billing practices to ensure that claims with multiple procedures are properly coded and that costs are properly allocated to each procedure.
One presenter to the panel suggested a method to increase the number of claims that could be considered as single claims. Currently, we consider any claim submitted with two or more primary codes (that is, a code assigned to an APC for separate payment) to be a multiple procedure claim. When these claims contain line items for revenue centers without an accompanying Healthcare Common Procedure Coding System (HCPCS) code there is no way to determine the appropriate primary code with which to package the revenue center. The presenter suggested that we consider all claims where every line contains a separately payable HCPCS code as a single procedure claim, reasoning that on such claims we do not have to determine how and where to “package” line items not identified by a separately payable HCPCS code. Where every line item contains a separately payable HCPCS code, every cost can easily be allocated to a separately payable HCPCS code on the line item and all costs for each HCPCS code can then be accurately and completely determined.
We agreed with that suggestion. In section II.B.4 of the proposed rule, we described how we determined the number of single claims used to set the APC relative weights proposed for 2003 using this methodology. We requested comments on our methodology.
Discussion of the comments we received on this issue, our responses, and the statement of final action are contained in section III.A.
We sought the Panel's guidance on whether we should package the costs of HCPCS codes for radiologic guidance and radiologic supervision and interpretation services whose descriptors require that they only be performed in conjunction with a surgical procedure.
In the proposed rule, we discussed why we package the costs of certain procedures. We specified for example, that “add-on” procedures and radiologic guidance procedures should never be billed on a claim without the code for an associated procedure. A facility should not submit a claim for ultrasound guidance for a biopsy unless the claim also includes the biopsy procedure, because the guidance is necessary only when a biopsy is performed. A claim for a packaged guidance procedure (or a supervision and interpretation procedure whose descriptor requires it be performed in association with a surgical procedure)
Also, we explained that we use packaging because billing conventions allow hospitals to report costs for certain services using only revenue center codes (that is, hospitals are not required to specify HCPCS codes for certain services). Packaging allows these costs to be captured in the data used to calculate median costs for services with an APC.
After hearing the requests of several presenters, (details discussed at 66 FR 52098 of the proposed rule) the Panel concluded that, even though we could be setting relative weights based on error claims, we should not package additional radiologic guidance and supervision and interpretation procedures and should continue to explore methodologies that would allow these procedures to be recognized for separate payment. The Panel also recommended that radiology guidance codes that were in APC 268 for CY 2001 but that were designated with status indicator “N” as packaged services in 2002, be restored as separately payable services for CY 2003. The Panel requested that this topic be placed on the agenda for the next Panel meeting.
Our discussion of the comments we received on this issue, our responses and a statement of final action is contained in section III.B.
As discussed in the proposed rule (66 FR 52098), we presented for the Panel's consideration several options for payment of add-on codes, including assignment of status indicator “N” to package them into the payment for the base procedure. After thorough review, the Panel concluded that we should continue to pay for add-on codes separately, setting relative weights with the use of single procedure claims in spite of the fact that these were error claims. The Panel asked us to continue exploring ways to most appropriately pay for these services. They requested that this item also be placed on the agenda for the next Panel meeting.
We proposed to accept the recommendations of the APC Panel both for packaging radiology guidance and supervision and interpretation codes and for payment of add-on codes. We proposed to pay separately in 2003 for radiology guidance codes that were paid in APC 268 in CY 2001 but that were packaged in 2002.
In the proposed rule, we summarized the issues considered by the Panel, the Panel's APC recommendations and our subsequent action with regard to the Panel's recommendations. The most recent data available for the Panel to review in considering specific APC groupings were the 1999-2000 pre-OPPS claims data that were the basis of the CY 2002 relative payment weights. In the proposed rule, we provided a detailed summary of the Panel discussion and recommendations (67 FR 52098-52102). See the proposed rule for more details regarding these discussions. The APC titles are shown in this discussion of the APC Panel recommendations as they existed when the APC Panel met in January 2002. In a few cases the APC titles were changed for the proposed 2003 OPPS and therefore some APCs do not have the same title in Addendum A as they have in this section.
As discussed below, the Panel sometimes declined to recommend a change in an APC even though the APC violated the 2 times rule. In section II.B.1 of this preamble, we discuss our proposals regarding the 2 times rule based on the CY 2001 data we are using to recalibrate the 2003 APC relative weights. Section II.B.1 also details the criteria we use in deciding to make an exception to the 2 times rule. We asked the Panel to review many of the exceptions we implemented in 2001 and 2002. We refer to the exceptions as “violations of the 2 times” rule in the following discussion.
We presented this agenda item because APC 215 appeared to violate the 2 times rule. In order to remedy this violation, we asked the Panel to consider the following changes:
• Move CPT codes 95858, 95921, and 95922 from APC 215 to APC 218.
• Move CPT code 95930 from APC 216 to APC 218.
• Move CPT code 92275 from APC 216 to APC 231.
• Move CPT code 95920 from APC 218 to APC 216.
The Panel recommended that the changes we asked them to consider be made, that is, to move CPT codes 95921 and 95922 to APC 218. However, if the calendar year 2001 data support a move of 95921 to APC 216, the Panel recommended that we consider that move.
We discussed the Panel's recommendations related to facility coding for clinic and emergency department visits are discussed below, in (section X.A of this rule).
APCs 296, 263, and 264 appear to violate the 2 times rule. We asked the Panel to consider three options for reconfiguring these APCs so that they would conform with the 2 times rule.
Procedures, by moving CPT codes 76080, 7036736, 76101, 70390, 74190, and 71060 from APC 263. Move CPT code 74327 from APC 296 to APC 263 and move CPT code 75980 from APC 297 to APC 296. APC 264 remains unchanged.
The Panel noted that none of the options that we presented resolve all of the 2 times violations. However, the Panel agreed that Option 2 would create more clinically coherent APCs without creating a new APC based on anticipated device costs that would be billed in 2002. In addition, the Panel invited the American College of Radiology and other interested parties to proposed further changes for the Panel's consideration next year.
We proposed to accept the Panel's recommendations that option 2 be implemented.
We asked the Panel to review these APCs to address clinical inconsistencies and violations of the 2 times rule. We suggested creating a new level for posterior segment eye procedures and other changes in order to make the groups more clinically coherent, as follows:
• Move CPT codes 65260 and 67218 from APC 237 to 236.
• Create a new APC (Level IV Posterior Segment Eye Procedures) by moving CPT codes 67107, 67112, 67040, and 67108 from APC 237.
• Move CPT codes 67145, 67105, and 67210 from APC 247 to APC 248.
• Move CPT code 66999 from APC 247 to APC 232.
• Move CPT code 67299 from APC 248 to APC 235.
• Move CPT codes 65855, 66761, and 66821 from APC 248 to APC 247.
• Move CPT code 67820 from APC 698 to APC 230.
• Move CPT code 67208 from APC 231 to APC 235.
• Move CPT codes 92226, 92284, 65205, 92140 from APC 231 to APC 698.
• Move CPT code 92235 from APC 231 to APC 699.
• Move CPT code 68100 from APC 233 to APC 232.
• Move CPT code 65180 from APC 233 to APC 234.
• Create a new APC (Level IV Anterior Segment Eye Procedures) by moving CPT codes 66172, 66185, 66180, 66225 from APC 234.
• Move CPT code 92275 from APC 216 to APC 231.
No presenters commented on these APCs, and, after brief discussion, the Panel recommended concurrence with our suggested changes. We proposed to accept the Panel's recommendations. We noted in the proposed rule that when we were able to use 2001 claims data to re-evaluate the changes recommended by the Panel for these APCs, we found violations of the 2 times rule in the reconfigured APCs. Nonetheless, we proposed to accept the Panel's recommendations because they result in more clinically coherent APCs. We solicited comments on further changes that would address the violations of the 2 times rule.
We presented these APCs to the Panel in 2001 because of their low payment rates and concern that our cost data were inaccurate. These APCs were on the 2002 agenda in order to obtain further comment on our cost data. We suggested no changes in the structure of these APCs.
The Panel recommended that plasma derivatives be placed in their own APCs and classified in the same manner as whole blood products. In addition, the Panel observed that hospitals incur additional costs with each unit of blood product transfused and, therefore, recommended that APC 110 be revised to allow for the costs of additional units of blood product and clinical services.
In section IV.D of this rule, we discussed our payment proposals for drugs and biologicals for which pass-through payments are scheduled to expire in 2003. Those proposals would affect payment for blood and blood products. We proposed not to accept the Panel's recommendation to change current OPPS payment policy for transfusions.
Regarding the remaining APC groups that are addressed below, the Panel recommended that we make no changes until data from claims billed in 2001 under the OPPS become available for analysis. The Panel further requested that we place the APC groups in this section on the agenda for consideration at its meeting in 2003. The changes that we proposed for the APCs in this section are based upon our review of the 2001 claims data, which did not become available until March 2002.
Several presenters to the Panel suggested changes in the configuration of these APCs because of concerns that the current classifications result in payment rates that are too low relative to the resource costs associated with certain procedures in the APCs. Several of these APCs include procedures associated with drugs or with device categories for which pass-through payments are scheduled to expire in 2003. The Panel recommended that we not change the structure of these APCs at this time. Because the structure of these APCs was substantially changed for 2002, and 2002 cost data was not yet available, the Panel felt it would be appropriate to review 2002 cost data prior to making further structural changes to these APCs. We proposed to accept the Panel's recommendation.
We will place these APCs on the Panel's agenda when 2002 cost data becomes available.
On the basis of 1999-2000 claims data, these APCs violate the 2 times rule. The Panel reviewed these APCs and recommended no changes.
Our subsequent review of 2001 OPPS cost data shows continuing violations of the 2 times rule and that costs within these APCs are virtually identical. Therefore, we proposed to combine APCs 43 and 44 into APC 43. The procedures in the consolidated APC are clinically homogeneous.
The Panel reviewed these APCs and recommended that no changes be made pending analysis of 2001 claims data. The Panel did recommend that billing instructions be developed on the appropriate use of the codes in these APCs. We agreed with the Panel's recommendation regarding the need for billing instructions, and we expect to develop such instructions for hospitals to use in 2003.
Our subsequent review of 2001 claims data reveals that, in some cases, costs for short casts and splints are greater than costs for long casts and splints. Moreover, the proposed payments for these two APCs, based on 2001 OPPS data, would not differ significantly from each other. Therefore, we proposed to combine the codes in APC 58 and APC 59 into a single APC, APC 58. Combining these APCs does not compromise clinical homogeneity. The relative weight of the proposed single APC is virtually identical to the relative weight of each of the two current APCs. We proposed to continue to work with hospitals to develop appropriate coding
Without the benefit of 2001 OPPS claims data, it was difficult for the Panel to determine whether the apparent violation of the 2 times rule in APCs 279 and 280 was attributable to underreporting of procedures or inaccurate coding. Therefore, the Panel recommended no changes pending the availability of the more recent claims data. After subsequently reviewing the 2001 claims data, we proposed to move CPT codes 75978, Transluminal balloon angioplasty, venous, radiological supervision and interpretation, and 75774, Angiography, selective, each additional vessel studied after basic examination, radiological supervision and interpretation, to new APC 0668. This would resolve violations of the 2 times rule and result in clinically coherent APCs.
We proposed to move CPT code 36860, External Cannula Declotting; without balloon catheter, to APC 103, Miscellaneous Vascular Procedures. We believe this makes both APC 115 and APC 103 more clinically homogeneous and it resolves a violation of the 2 times rule in APC 115 that was caused by the presence of CPT code 36860.
Our subsequent review of 2001 claims data suggests that the cost data for APCs 144 and 145 are aberrant. The cost data for these APCs yield relative weights and payments that are significantly higher than the relative weights for APCs 146 and 147, which consist of similar procedures performed through a sigmoidoscope rather than an anoscope. As currently arranged, the APC configuration for these services could provide a financial incentive for hospitals to perform unnecessary anoscopic procedures, either alone or with a sigmoidoscopy. To rectify this problem, we proposed to move the procedures in APCs 144 and 145 to APC 147 with the exception of CPT code 46600, Anoscopy; diagnostic, which we proposed to assign to APC 340, Minor Ancillary procedures. We believe these changes would result in clinically coherent APCs with appropriate relative weights and payment rates.
Based on 2001 claims data, we proposed to move CPT codes 92543, 92588, 92520, 92546, 92516, 92548, and 92584 to new APC 0660 (Level III Otorhinolaryngolgic Function Tests). This change would resolve a 2 times rule violation and create clinically coherent APCs.
The APC Panel recommended making no changes in the configuration of these APCs. Based on 2001 claims data, we proposed to make several changes in order to resolve 2 times rule violations and to make these APCs more clinically coherent. Specifically, we proposed to move CPT code 43499 from APC 0140 to APC 141; CPT code 93721 from APC 0096 to APC 368; CPT code 93740 from APC 0096 to APC 367; CPT code 93888 from APC 0267 to APC 266; and CPT code 93931 from APC 0267 to APC 266. We also proposed to move CPT codes 78627, 76825, and 93320 from APC 0269 to new APC 0671 to achieve more clinical coherence. We also proposed to create new APC 0670 for intravascular ultrasound and intracardiac echocardiography consisting of CPT codes 37250, 37251, 92978, 92979, and 93662.
Subsequent to the APC Panel meeting, we received comments on these APCs from the Nuclear Medicine Task Force. After a thorough review of that proposal within the context of the 2001 claims data, we proposed to accept the recommendations of the Nuclear Medicine Task Force, which would result in a complete reconfiguration of APCs 290, 291, and 292. Although the reconfiguration would create violations of the 2 times rule, we agree with the Task Force that the reconfigured APCs are more clinically coherent. We note that APCs 290, 291, and 292 as currently configured would also violate the 2 times rule. Therefore, we solicited comments on the proposed reconfiguration of APCs 290, 291, and 292 and on alternative groupings that would achieve clinical coherence without violating the 2 times rule.
Based on 2001 claims data, we proposed to move several codes from APC 19 to APC 20 and several codes from ACP 20 to APC 21. Additionally, we proposed to move CPT codes 11770, 54105, and 60512 to APC 22. We also proposed to move CPT code 58999 to APC 191 and CPT code 37799 to APC 35. These changes would result in clinically coherent APCs that do not violate the 2 times rule.
Based on 2001 claims data, we proposed to move CPT code 43870 from APC 0025 to APC 141; and CPT codes with high costs from APC 26 to APC 27. We also proposed to move the codes remaining in APC 26 to APC 25. APC 26 would then be deleted. These changes would result in a more compact APC structure without compromising the clinical homogeneity of the reconfigured APCs and without violating the 2 times rule. See Table 1 for the final list of codes to be moved from APC 26 to APC 25 or APC 27.
Based on 2001 claims data, we proposed to address violations of the 2 times rule by moving CPT codes 40812, 42330, and 21015 from APC 0252 to APC 253 and by moving CPT codes 41120 and 30520 to APC 254.
We are adopting the changes discussed in the proposed rule as final except as noted in our discussion of specific APC changes in section II.B, below.
1. Limit on Variation of Costs of Services Classified Within a Group
Section 1833(t)(2) of the Act provides that the items and services within an APC group cannot be considered comparable with respect to the use of resources if the highest cost item or service within a group is more than 2 times greater than the lowest cost item or service within the same group. However, the statute authorizes the Secretary to make exceptions to this limit on the variation of costs within each group in unusual cases such as low-volume items and services. No exception may be made, however, in the case of a drug or biological that has been designated as an orphan drug under section 526 of the Federal Food, Drug, and Cosmetic Act.
Taking into account the APC changes discussed in relation to the APC panel recommendations in this section of this preamble and the use of 2001 claims data to calculate the median cost of procedures classified to APCs, we reviewed all APCs to determine which of them would not meet the 2 times limit. We use the following criteria when deciding whether to make exceptions to the 2 times rule for affected APCs:
• Resource homogeneity.
• Clinical homogeneity.
• Hospital concentration.
• Frequency of service (volume).
• Opportunity for upcoding and code fragmentation.
We received several comments on this proposal. A summary of these comments and our responses are provided below.
Table 2 contains the final list of APCs that we exempt from the 2 times rule based on the criteria cited above. In cases in which compliance with the 2 times rule appeared to conflict with a recommendation of the APC Advisory Panel, we generally accepted the Panel recommendation. This was because Panel recommendations were based on explicit consideration of resource use, clinical homogeneity, hospital specialization, and the quality of the data used to determine payment rates.
The median cost for hospital outpatient services for these and all other APCs can be found at Web site:
In the November 30, 2001 final rule, we made final our proposal to change the period of time during which a service may be paid under a new technology APC (66 FR 59903), initially established in the April 7, 2000 final rule. That is, beginning in 2002, we will retain a service within a new technology APC group until we have acquired adequate data that allow us to assign the service to a clinically appropriate APC. This policy allows us to move a service from a new technology APC in less than 2 years if sufficient data are available, and it also allows us to retain a service in a new technology APC for more than 3 years if sufficient data upon which to base a decision for reassignment have not been collected.
Effective in 2003, we will move several procedures from new technology APCs to clinical APCs. Those procedures and the clinical APCs to which we are assigning the procedures for payment in 2003 are identified in Table 3. Based upon our review of the 2001 outpatient prospective payment system (OPPS) claims data, we believe that we have sufficient information upon which to base assignment of these procedures to clinical APCs. In making this determination, we reviewed both single and multiple procedure claims. In the proposed rule at 67 FR 52103, we discuss the procedures that we followed to make this determination. In some cases we proposed classification of a new technology procedure in an APC with procedures that are similar both clinically and in terms of resource consumption. In other cases, we proposed to create a new APC for a new technology procedure because we do not believe any of the existing APCs contain procedures that are clinically similar and similar in terms of resource consumption. We solicited comments on our proposed reassignment of the new technology procedures listed in Table 3 of the proposed rule (67 FR 52103-52104).
We received several comments on this proposal which are summarized below.
On June 29, 2001, CMS announced its intention to issue a national coverage determination (NCD) limiting the type of technology that can be used to perform Medicare-covered PET scans. This NCD became effective January 1, 2002. We believe that our claims data includes a significant number of PET scans performed on coincidence cameras that are no longer covered by Medicare. This could have the effect of lowering the median cost as compared to our future claims data that will reflect (due to the NCD) only the use of full-ring or partial-ring PET scanners. For this reason, until we are confident that our claims data reflects the predominant use of dedicated PET scanners, we will continue to pay for FDG PET in APC 714 (New Technology—Level IX $1250-$1500) until further review of claims data for the 2004 final rule.
Table 3 below is the final list of Healthcare Common Procedure Coding System (HCPCS) reassignments of new technology procedures.
During CY 2002, we created several HCPCS codes to describe services newly covered by Medicare and payable under the hospital OPPS. While we have assigned these services to APCs for CY 2002, we opened the assignments to public comment in the proposed rule. In addition, in the proposed rule, we proposed to create several new HCPCS codes and APC assignments with an effective date of January 1, 2003 and we solicited comments on these proposed codes and proposed APC assignments. Table 4 below includes new procedural HCPCS codes either created for implementation in July 2002, which we intend to implement in October 2002, or which we will implement in January 2003.
Table 4 does not include new codes for drugs and devices for which we established or intend to establish pass-through payment eligibility in July or October 2002.
The G codes G0245 through G0250 were created to implement payment for newly covered Medicare services due to national coverage determinations. The G codes G0252-G0255 were established October 1, 2002, as a result of national coverage policies that became effective October 1, 2002. These codes were created to accurately describe the services covered, to ensure that they were reported correctly, to track their utilization, and to establish payment. We solicited comments on the APC assignment of these services. The codes describing evaluation and management services were assigned to clinic visit APCs containing similar services, and the codes describing procedural services were assigned to new technology APCs or to APCs containing procedures requiring similar resource consumption. Because G0250 is a professional service furnished by a physician, it is not payable under OPPS.
We did not receive any comments on the codes or APC assignments for G0245, G0246, G0247, G0248, G0249, G0250, or G0255. Therefore, we are finalizing them as shown.
We are also finalizing APC assignments for G0252, G0253, and G0254. The comments and responses for these services are discussed elsewhere in this preamble.
We implemented HCPCS code G0258 (Intravenous Infusion(s) During Separately Payable Observation Stay)
In the August 9, 2002, proposed rule, we proposed to create several new HCPCS codes for 2003 to address issues that have come to our attention, to describe new technology procedures, to implement policy proposals discussed in the rule, and to allow more appropriate reporting of procedures currently described by (physician's) current procedural terminology (CPT) (HCPCS Level I) codes. The codes we proposed are as follows:
(1) G0FFF—Bone Marrow Aspiration and Biopsy Services—we proposed to create this code to describe bone marrow aspiration and biopsy performed through the same incision. We proposed to place this code in APC 0003. This code also appears in the proposed rule for the physician fee schedule, published in the June 28, 2002, issue of the
As discussed under general comments and responses below, we received many comments that objected to the proliferation of G codes for the services for which the CPT or HCPCS level II process could be used to create a code. After review of the comments, we agree that this code should go through the CPT process. Therefore, we have not implemented the G code we proposed. We will instead, submit a code for “Bone Marrow Biopsy and Aspiration Performed in the Same Bone” to CPT in time for the 2004 CPT code cycle.
(2) G0257—Unscheduled and Emergency Treatment for ESRD Patients—we proposed this code to facilitate payment for dialysis provided to ESRD patients in the outpatient department of a hospital that does not have a certified ESRD facility. The comments, responses, and final action regarding these services are discussed in section X.F of this rule.
(3) G0259 and G0260—Sacroiliac Joint Injections—we proposed to create these two codes to replace CPT code 27096, Injection procedure for sacroiliac joint, arthrography and/or anesthetic steroid. CPT code 27096 describes two distinct procedures requiring different resource consumption. Moreover, our policy of packaging injection procedures for imaging required packaging of this procedure even when it was used to report injection of a steroid or anesthetic. In these cases, it was appropriately billed without another procedure and should have been payable. Therefore, in order to facilitate appropriate reporting and payment for the procedures described by CPT code 27096, we proposed to create G0259, Injection procedure for sacroiliac joint, arthrography, and G0260, Injection procedure for sacroiliac joint, provision of anesthetic and/or steroid. We proposed to give G0259 status indicator N, and we proposed to assign G0260 to APC 0204.
(4) G0KKK—Prostate Brachytherapy—we proposed this code to implement our policy decision discussed in section III.C.3 of the proposed rule (section IV.E of this rule). As a result of comments we created two new codes G0256 and G0261. See section IV.E. for the discussion of prostate brachytherapy.
(5) G0263 and G0264—Observation Care—we proposed to create these codes to describe observation care provided to a patient who is directly admitted from a physician's office to a hospital for observation care. We discussed these codes in detail in section VIII.B of the proposed rule. Our discussion of the final action, comments, and responses is contained in section X.B of this rule.
(6) G0290, G0291; Drug Eluting Stents—We discuss these codes in the immediately following section.
In the August 9, 2002 proposed rule, we discussed the exceptional circumstances that led us to propose a departure from our standard OPPS payment methodology as we have done under the inpatient PPS for Federal fiscal year (FY) 2003 (67 FR 50003-50005). We made this unusual proposal to ensure consistent payment for drug-eluting stents in both the inpatient and outpatient settings; to ensure that hospital resources are not negatively affected by a sudden surge in demand for this new technology if FDA approval is received; and to ensure that Medicare payment does not impede beneficiary access to what appears to be a potentially landmark advance in the treatment of coronary disease. Consistent with the special approach we implemented in the inpatient PPS final rule, we proposed to create two new HCPCS codes and a new APC that may be used to pay for the insertion of coronary artery drug-eluting stents under the OPPS to be effective if these stents receive FDA approval for general use. Of course, as with other new procedures, FDA approval does not mean that Medicare will always cover the approved item. Medicare coverage depends upon whether an item or service is medically necessary to treat an illness or injury as determined by Medicare contractors based on the specifics of individual cases.
The new HCPCS codes that we proposed are as follows:
G0290—Transcatheter placement of a drug eluting intracoronary stent(s), percutaneous, with or without other therapeutic intervention, any method; single vessel
G0291—Transcatheter placement of a drug eluting intracoronary stent(s), percutaneous, with or without other therapeutic intervention, any method; each additional vessel
We proposed to assign G0290 and G0291 to new APC 0656, Transcatheter Placement of Drug-Eluting Coronary Stents, with a status indicator of T.
To establish a payment amount for the proposed new APC, we proposed to apply the same assumptions that we used in establishing the weights for diagnosis-related group (DRG) 526 (Percutaneous Cardiovascular Procedure with Drug-Eluting Stent with AMI) and DRG 527 (Percutaneous Cardiovascular Procedure With Drug-Eluting Stent Without AMI) as described in the final
We proposed to implement payment under APC 0656 effective April 1, 2003, consistent with the effective date for implementation of the drug-eluting DRGs under the OPPS and contingent upon FDA approval by that date. If the FDA grants approval prior to April 1, 2003, hospitals would be paid for insertion of coronary artery drug-eluting stents under APC 104. Such claims may qualify for outlier payments.
We proposed to establish the new HCPCS codes and APC group for coronary artery drug-eluting stents to allow close tracking of the utilization and costs associated with these services. In the proposed rule, we invited comments on this proposed methodology for recognizing the additional costs of drug-eluting stents under the OPPS.
We do not agree that the incremental payment should be $1,800. Although it is true that 1.5 stents are typically placed per procedure, it is rare for two stents to be placed in one coronary artery in an outpatient setting. Furthermore, hospitals can bill under the OPPS a separate code for each vessel in which a stent is placed, unlike the inpatient PPS. Because hospitals will in most cases be able to report each stent placement separately in the outpatient setting, making an incremental payment of $1800 would significantly overpay for each stent.
As we explain elsewhere in this preamble, the payment rates that this final rule implements are based on more current data than those that were available when we set the rates proposed in the August 9, 2002 rule. The rates in this final rule also reflect adjustments intended to level the transition from rates based on pre-OPPS data and estimated pass-through device and drug costs to rates based entirely on OPPS data that reflect actual device and drug costs reported by hospitals.
However, because the drug-eluting stent does not meet the criteria established for these two methods of payment for new technology under the OPPS, we were compelled to seek an alternative approach in order to ensure beneficiary access to this extraordinary new treatment, once it receives FDA approval, without placing an extraordinary burden on hospital resources. We expect that either a pass-through payment or assignment to a new technology APC will, in the overwhelming preponderance of cases, provide adequate and timely payment under the OPPS for new technology. We agree with the commenter who supported maintaining highly selective standards when establishing codes for new technology. The threshold for such an approach must be exceptionally high and applicable only in the most extraordinary and unusual cases.
Effective for services furnished on or after April 1, 2003, contingent upon FDA approval of the drug-eluting stents, we are implementing payment under APC 656, Transcatheter Placement of Drug-Eluting Coronary Stents, for two temporary HCPCS codes:
G0290 Transcatheter placement of a drug-eluting intracoronary stent(s), percutaneous, with or without other therapeutic intervention, any method; single vessel.
G0291 Transcatheter placement of a drug-eluting intracoronary stent(s), percutaneous, with or without other therapeutic intervention, any method; each additional vessel.
Note that Table 6 and Addendum B show status indicator E for HCPCS codes G0290 and G0291 since payment under these codes will not be effective before April 1, 2001. However, we include the APC for drug eluting stent procedures (APC 0656) in Addendum A with the payment rate and status indicator of T to identify how these new codes will be paid once they are implemented.
If the FDA grants approval before April 1, 2003, hospitals will be paid for placement of drug-eluting stents under APC 104. If the FDA does not grant approval by April 1, 2003, we will announce a new effective date for APC 0656 and for HCPCS codes G0290 and G0291 by Program Memorandum.
We have created three new G codes for use in reporting services furnished in hospital outpatient departments under national clinical trials: G0292 Administration(s) of experimental drug(s) only in a Medicare qualifying clinical trial (includes administration for chemotherapy and other types of therapy via infusion and/or other than infusion), per day.
G0293 Noncovered surgical procedure(s) using conscious sedation, regional, general or spinal anesthesia in a Medicare qualifying clinical trial, per day.
G0294 Noncovered surgical procedure(s) using either no anesthesia or local anesthesia only, in a Medicare qualifying clinical trial, per day.
On September 19, 2000, Medicare issued a national coverage decision stating that Medicare will pay for the routine costs of clinical trials. This policy is published as section 30-1 of Medicare's Coverage Issues Manual. Because the experimental intervention is not covered but items and services required solely because of the intervention are covered, we needed to identify ways to properly code for and pay for the routine costs when delivered in a hospital outpatient department.
We believe that to accurately pay for the covered services associated with the administration of drugs as part of a clinical trial, we need to create a new code to allow for correct billing and payment for routine costs, as defined by the national coverage determination. Therefore, the code G0292, “Administration(s) of experimental drug(s) only in a Medicare qualifying clinical trial (includes administration for chemotherapy and other types of therapy via infusion and/or other than infusion), per day,” should be billed when only experimental drugs are administered as part of a Medicare qualifying clinical trial. When an experimental drug is being administered in conjunction with payable drugs or on the same day as payable drugs, G0292 should not be used. Instead, the appropriate drug administration code should be billed.
There are also procedures that may be performed in the hospital outpatient department as part of a qualifying clinical trial. Because the intervention is not covered under Medicare's clinical trial policy, we need a mechanism to pay the hospital for its covered fixed costs associated with providing the service under the clinical trial. We have created two codes to allow for correct billing of procedures performed as the focus of qualifying clinical trials, G0293 and G0294. G0293 is defined as “Noncovered surgical procedure(s) using conscious sedation, regional, general or spinal anesthesia in a Medicare qualifying clinical trial, per day,” and G0294 is defined as “Noncovered surgical procedure(s) using either no anesthesia or local anesthesia only, in a Medicare qualifying clinical trial, per day.”
All three of these codes are for OPPS use only. Other provider types may not bill these codes.
The interim APC assignments for G0292, G0293, and G0294 are APC 0708, 0710, and 0707, respectively. The status indicator for these three codes is S. As discussed below, this APC assignment is subject to comment during the comment period discussed in section I of this rule.
As discussed in section I, we are accepting public comment on the interim APC assignments for the new codes shown in Addendum A with the indicator NI. These codes are new for 2003 and the APC assignment was not subjected to public comment in the August 9, 2002 proposed rule. We are not accepting comment on APC assignments that were proposed in the August 9, 2002 proposed rule and are being shown as NF in Addendum B since they have already been subjected to public comment and are made final in this rule.
In 2002, CMS and CPT staff, working together, reviewed all existing G codes and agreed to transition over 20 of them to CPT codes. Therefore, for 2003 many G codes will be deleted in favor of newly created CPT codes. We believe that an annual review of G codes by CMS and CPT staff is the best way to determine which G codes should be transitioned to CPT codes and the process to use for such a transition. Therefore, we plan to continue working with CPT staff on an annual basis to continue transitioning existing G codes to CPT codes. We believe such an annual, comprehensive review will address the commenters' concerns. However, we do wish to emphasize that CMS, where appropriate, does consult with interested providers prior to the creation of G codes in order to facilitate coding clarity and minimize the coding burden on hospitals.
The descriptor for G0236 has been revised to read as follows: digitalization of film radiographic images with computer analysis for lesion detection, or computer analysis of digital mammogram for lesion detection, and further physician review for interpretation, diagnostic mammography (list separately in addition to code for primary procedure). We believe that we have sufficient claims data to use in assigning digital mammography to an APC.
Furthermore, we looked at the 10 most frequent combinations of codes billed with CPT codes 19102 and 19103 and summed the proposed APC payments that would be made for these combinations of codes. This represents the true Medicare payment for CPT codes 19102 and 19103. For CPT code 19102 (for which the proposed rule proposed payment under APC 0005 of $157.01), total payment by Medicare would range from $181.45 to $549.16 when the 10 most common combinations of services are provided. Similarly for CPT code 19103 (for which the proposed rule proposed payment under APC 0658 of $289.69), total payment by Medicare would range from $532.05 to $681.84. These combination totals are less than the proposed payment for open breast biopsy (APC 0028, CPT codes 19105, 19120 and 19125, for which we proposed to pay $908.04); however, as the commenters themselves asserted, the resources required for an open surgical procedure are greater than those used for a percutaneous procedure. We agree with the commenters that the costs to the Medicare program of an open breast biopsy are greater than the cost of a percutaneous biopsy. We also believe that the relative total payment rates, as discussed above, for open and percutaneous procedures are appropriate.
With regard to hospital miscoding, even if hospitals took time to transition from using CPT code 19101 to CPT codes 19102 and 19103, the cost data for CPT codes 19102 and 19103 should be accurate. While it is possible that the cost data for CPT code 19101 could be high as it may include some percutaneous procedures, this would not be true for cost data from CPT codes 19102 and 19103. Further, we would note that each of CPT codes 19102 and 19103 were reported over 20,000 times by hospital outpatient departments and that we had several thousand single claims for each code upon which to base relative weights.
We do not believe that the proposed payments will create incentives to perform inappropriate open breast biopsies. We believe that physicians will select the procedure that best meets the needs of the patient and that the hospital will provide the services
Section 1833(t)(1)(B)(i) of the Act gives the Secretary broad authority to determine the services to be covered and paid for under the OPPS. In the April 7, 2000, final rule, we identified procedures that are typically provided only in an inpatient setting and, therefore, would not be paid by Medicare under the OPPS (65 FR 18455). These procedures comprise what is referred to as the “inpatient list.” The inpatient list specifies those services that are only paid when provided in an inpatient setting. As we discussed in the April 7, 2000, and the November 30, 2001, final rules, we use the following criteria when reviewing procedures to determine whether or not they should be moved from the inpatient list and assigned to an APC group for payment under the OPPS:
• Most outpatient departments are equipped to provide the services to the Medicare population.
• The simplest procedure described by the code may be performed in most outpatient departments.
• The procedure is related to codes we have already moved off the inpatient list.
We last updated the inpatient list in the November 30, 2001 final rule. As we discuss in section II.A.2 above, the APC Panel at its January 2002 meeting reviewed certain procedures on the inpatient list for which we had received requests that they be made payable under the OPPS. As the Panel members recommended, we solicited comments and further information about all of these procedures except for CPT code 47001, which they recommended to be removed from the inpatient list.
In addition to considering the comments of the APC Panel, we compared procedures with status indicator “C” (status indicator “C” is assigned to inpatient procedures that are not payable under the OPPS) to the list of procedures that are currently on the ambulatory surgical center (ASC) list of approved procedures, to procedures that we proposed to add to the ASC list in a proposed rule published in the
• We have determined that the procedure is being performed in numerous hospitals on an outpatient basis; or
• We have determined that the procedure can be appropriately and safely performed in an ASC and is on the list of approved ASC procedures or proposed by us for addition to the ASC list.
In addition to the procedures considered by the APC Panel for removal from the inpatient list, Table 6 in the proposed rule includes other procedures that we proposed to remove from the inpatient list for payment under the OPPS for 2003. We applied the criteria discussed above in order to be consistent with the ASC list of approved procedures and with utilization data that indicate the procedures are being performed on an outpatient basis. We solicited comments on whether the procedures listed in Table 6 of the proposed rule should be paid under the OPPS. We also solicited comments on the APC assignment that we proposed for these procedures in the event we determine in the final rule, based on comments, that these procedures would be payable under the OPPS in 2003. We asked that commenters recommending reclassification of a procedure to an APC include evidence (preferably from peer-reviewed medical literature) that the procedure is being performed on an outpatient basis in a safe and appropriate manner.
Following our review of the comments, we either assigned a CPT code for a service formerly on the inpatient list to an APC for payment under the OPPS or, if the comments did not provide sufficient information and data to enable us to make a decision, we chose to keep the service on the inpatient list for 2003 and to present the comments to the APC Panel at its 2003 meeting. Table 6 identifies codes that were on the inpatient list in 2002 but are not on the inpatient list in 2003 and which, therefore, will be payable under the OPPS on and after January 1, 2003.
We received numerous comments on this proposal, which we summarize below.
Hospitals or associations representing hospitals submitted the overwhelming majority of comments recommending elimination of the inpatient list. Their comments expressed considerable frustration resulting from apparent conflicts with physicians over which procedures Medicare will pay for under the OPPS. Although we understand the frustration that exists in the hospital community about the inpatient list, we believe that appropriate education of physicians and other hospital staff by CMS, hospitals, and organizations representing hospitals is the best way to minimize any existing confusion. We are prepared to remove procedures from the inpatient list as part of the quarterly OPPS updates. If a physician believes that a procedure should be payable under the OPPS, we urge the hospital and physician to provide operative reports about specific procedures on the inpatient list are being performed on Medicare beneficiaries who are outpatients. In the meantime, we are reviewing with CMS provider education staff ways that we can support carrier and fiscal intermediary efforts to clarify the reasons for the OPPS inpatient list and its billing and payment implications. Also, in section X.C. of this preamble, we explain how hospitals can receive payment under certain conditions for procedures on the inpatient list that are performed on an emergency basis when the status of a patient is that of an outpatient.
When this information is received, it is thoroughly reviewed by our medical advisors within the context of the criteria we have established. Further information or clarification may be requested. If, following this review, we determine that there is sufficient evidence to confirm that the code can be safely and appropriately performed on an outpatient basis, we will assign the procedure to an APC and include it as a payable procedure in the next OPPS quarterly update. The change in payment status will be subject to public comment as part of the subsequent annual OPPS update.
Interested parties may also submit a request to change the payment status of a code on the inpatient list for consideration as an agenda item at the next meeting of the APC Advisory Panel.
We are making final our proposal to remove this code from the inpatient list, but we will consider presenting this concern to the APC Panel. In the absence of comments disagreeing with our proposal to pay under the OPPS for the 41 CPT codes listed in Table 6 of the August 2002 proposed rule (67 FR 52115), we are making these proposed changes final.
We did not propose to remove the other codes suggested by the commenter from the inpatient list, and the commenter submitted no evidence to support payment for these codes under the OPPS. Nor could we find any information to indicate that these codes meet the criteria for moving them off the inpatient list. Therefore, we will continue to designate these CPT codes with status indicator “C” in 2003.
• We are adopting two additional criteria to guide our determination of whether a procedure should be removed from the inpatient list:
• The procedure is being performed in numerous hospitals on an outpatient basis; or
• The procedure can be appropriately and safely performed in an ASC and is on the list of approved ASC procedures or proposed by us for addition to the ASC list.
• We are adding CPT codes 22612 and 22614 to APC 0208 effective for services furnished on or after January 1, 2003.
• We are making final our proposal in the August 2002 rule to pay under the OPPS for the CPT codes listed in Table 5, below.
As we discussed in the proposed rule, partial hospitalization is an intensive outpatient program of psychiatric services provided to patients in the place of inpatient care. A partial hospitalization program (PHP) may be provided by a hospital to its outpatients or by a Medicare-certified community mental health center (CMHC). In the August 1, 2000 final rule (65 FR 18452), we established a per diem payment methodology for the PHP APC based on hospital data. The current per diem payment amount is $212.27. This amount represents the hospital or CMHC overhead costs associated with the program.
In the August 9, 2002 OPPS proposed rule, we proposed to revise the PHP APC using 2001 claims data from hospitals and CMHCs and computed a median per diem using the same methodology as that used for all other APCs. As we explained in the August 9, 2002 proposed rule, we adjusted the CMHC costs to account for the difference between settled and as-filed cost reports. We proposed that the resulting per diem is $256.96, of which $51.39 is the beneficiary's coinsurance.
In addition, to facilitate proper billing and ensure comparable reporting of costs by hospitals and CMHCs, we proposed to revise § 410.43 (Partial hospitalization services: Conditions and exclusions) to add CSW services that meet the requirements of section 1861(hh)(2) of the Act to the list of professional services not considered to be PHP services. Such revision would mean that hospitals and CMHCs could bill the carrier for CSW services furnished to PHP patients.
As part of our analysis of current billing instructions for PHP, we discovered that Addendum B of the November 30, 2001, CY 2002 OPPS final rule does not clearly identify all the HCPCS codes that may be billed for PHP patients. We plan to revise this addendum in the 2004 update so that all PHP services are identified. However, in order to avoid billing errors, we are providing the following list of the current HCPCS codes for PHPs:
Section 1833(t)(9)(A) of the Act requires that the Secretary review and revise the relative payment weights for APCs at least annually, beginning in 2001 for application in 2002. In the April 7, 2000 final rule (65 FR 18482), we explained in detail how we calculated the relative payment weights that were implemented on August 1, 2000 for each APC group. Except for some reweighting due to APC changes, these relative weights continued to be in effect for 2001. (See the November 13, 2000, interim final rule (65 FR 67824 to 67827).)
To recalibrate the relative APC weights for services furnished on or after January 1, 2003, and before January 1, 2004, we proposed to use the same basic methodology that we described in the April 7, 2000 final rule. That is, we would recalibrate the weights based on claims and cost report data for outpatient services. We proposed to use the most recent available data to construct the database for calculating APC group weights. For the purpose of recalibrating APC relative weights for CY 2003, the most recent available claims data are more than 90 million final action claims for hospital outpatient department services furnished on or after April 1, 2001, and before March 31, 2002, and processed through July 2002. In the proposed rule, we proposed to base the 2003 OPPS on claims for services furnished January 1, 2001 through December 31, 2001. However, after issuance of the proposed rule we determined that coding and charges for the period of April 1, 2001 thru March 31, 2002 would be a better base for recalculation of weights.
We believe that using claims data from this period is consistent with section 1833(t)(9)(A) of the Act, which directs us to take into account “new cost data” in our annual review and adjustment of components of the OPPS. This is also consistent with our proposal in the August 9, 2002 proposed rule (67 FR 52108) to use the most recent available claims data to set the weights. We had several reasons for using claims from this period: claims from this period provide the most recent charge data available to us. Since we did not implement the 2002 OPPS until April 1, 2002, we can use the claims for the period from January 1, 2002, through and including March 31, 2002, together with claims data from the period of April 1, 2001 to December 31, 2001 to set weights. Using claims data for services furnished during this period of time also provides the most reliable charge data for devices and services that use medical devices because the device category codes were in effect for the entire period. Hence, we believe that claims from this period are the most reliable basis for setting relative weights for CY 2003 OPPS.
Many of the claims from hospitals were for services that are not paid under OPPS (such as clinical laboratory tests). We matched the claims that are paid under OPPS to the most recent cost report filed by the individual hospitals represented in our claims data. The APC relative weights would continue to be based on the median hospital costs for services in the APC groups.
In the August 9, 2002 proposed rule, we discussed in detail the circumstances in which we had difficulty with using the data from claims that had multiple procedures (67 FR 52108). We solicited public comment on the methods we considered for apportioning the total charges to individual HCPCS codes as described above. These possible methods included: dividing the total charges in a revenue center, or for a packaged HCPCS code, by the number of payable HCPCS codes for the multiple procedures on the claim; apportioning the charges among the codes based on physician work relative value units (RVUs); apportioning the charges among the codes based on physician nonfacility practice expense RVUs; or requiring the hospital to apportion all charges currently shown in revenue centers to the HCPCS codes billed so that we could use all multiple services claims in the calculation of relative weights. We also invited suggestions of other alternative means of apportioning the total costs on multiple procedure claims to the HCPCS codes for the procedures so that we can use more data from multiple procedure claims in the 2004 update of the OPPS.
We also solicited information on existing studies that would provide comparative hospital outpatient resource inputs by HCPCS code. In addition, we welcomed suggestions for studies that we might undertake either to determine the relative value of OPD resources by HCPCS code or to provide a valid means of apportioning the charges among HCPCS codes when multiple surgical procedures are billed on the same claim with a single total charge for all services.
Finally, we solicited information regarding the extent to which efficiencies are realized when multiple services are furnished during the same visit or operative session.
The discussion of recalibration of relative weights in section III.B of this final rule summarizes the process that we used to determine the claims that could be used to set the weights.
Comments and our responses are summarized below:
With regard to the trimming methodology, it is a routine and accepted statistical practice that is well established in inpatient PPS data examination and has served well in the past to eliminate anomalies that could further skew the data. We will consider whether it is useful and to what extent it is practical to examine all trimmed claims to determine if they represent the first claims for a new technology and should remain in the body of claims.
In the August 9, 2002 proposed rule, we discussed our concerns with the claims data for the devices losing eligible for transitional pass-through status in CY 2003 (67 FR 52110). We had been advised that during the period in which the 2001 OPPS was in effect, hospitals may not have billed properly for devices eligible for transitional pass-through payments. We acknowledged in the 2002 proposed rule that changes in billing format and systems for implementation of the OPPS may have compounded the problems of billing using the device-specific codes during the first 9 months of the OPPS. We had been informed that these problems were
We proposed to package payment for devices into payment for the procedure in which they were furnished because doing so is consistent with the concept of a prospective payment system and because we believed that it would give us the best data on which to pay devices once they ceased to be paid at cost via the pass-through methodology. We thought that by packaging the cost of the devices into the cost of the procedure with which they were used, we would capture the charges for the devices whether billed in revenue centers or with the HCPCS code for the device.
Our subsequent review of the data for the period of April 1, 2001, through March 31, 2002, indicated that there was a notable absence of hospital billing for devices category codes, even when the procedure billed could not be done without a pass-through device. We calculated the median costs for the APCs containing procedures that we believed required use of devices (including both claims with and claims without device C codes on the claim) and compared them to the median costs for the procedures from only claims that were billed with devices. We found that the median costs on claims billed with devices were more consistent with the median costs that we would expect to see for these APCs. Hence, for these APCs, we used the median costs calculated from claims that reported a device C code in place of the median costs calculated from all claims (claims billed both with devices and without device C codes). We did not eliminate claims that did not contain a device C code where HCPCS codes within an APC indicated that the procedure did not require a pass-through device. In such cases, HCPCS codes were, appropriately, rarely reported with C codes. The APCs for which we used the medians from claims with device C codes billed are listed in Table 6. This methodology resulted in higher median costs and, therefore, higher weights for these APCs than would have occurred had we included claims that did not contain coding for a device. The medians we used for all APCs are contained in Addendum C, which is on our Web site at
As discussed previously in this section, we first selected claims for services provided from April 1, 2001 through March 31, 2002. The methodology we followed to calculate the final APC relative payment weights for CY 2003 is as follows:
• We excluded from the data claims for those bill and claim types that would not be paid under the OPPS (for example, bill type 72X for dialysis services for patients with ESRD).
• We eliminated 1.6 million claims from hospitals located in Maryland, Guam, and the U. S. Virgin Islands.
• Using the most recent available cost report from each hospital, we converted billed charges to costs and aggregated them to the procedure or visit level first by identifying the cost-to-charge ratio specific to each hospital's cost centers (“cost center specific cost-to-charge ratios” or CCRs) and then by matching the CCRs to revenue centers used on the hospital's 2001 outpatient bills. The CCRs include operating and capital costs but exclude items paid on a reasonable cost basis.
• We eliminated from the hospital CCR data 301 hospitals that we identified as having reported charges on their cost reports, which were not actual charges (for example, a uniform charge applied to all services).
• We calculated the geometric mean of the total operating CCRs of hospitals remaining in the CCR data. We removed from the CCR data 67 hospitals whose total operating CCR exceeded the geometric mean by more than 3 standard deviations.
• We excluded from our data approximately 3.6 million claims submitted by the hospitals that we removed or trimmed from the hospital CCR data.
• We matched revenue centers from the remaining universe of approximately 92.9 million claims to CCRs for remaining hospitals.
• We separated the 92.9 million claims that we had matched with a cost report into the following three distinct groups:
(1) Single-procedure claims.
(2) Multiple-procedure claims.
(3) Claims on which we could not identify at least one OPPS covered service.
Single-procedure claims are those that include only one HCPCS code (other than laboratory and incidentals such as packaged drugs and venipuncture), which could be grouped to an APC. Multiple-procedure claims include more than one HCPCS code that could be mapped to an APC. Dividing the claims in this manner yielded approximately 30.7 million single-procedure claims and 20.4 million multiple-procedure claims. Approximately 41.8 million claims without at least one covered OPPS service were set aside.
We converted 10.8 million multiple-procedure claims to single-procedure claims using the following criteria:
(1) If a multiple-procedure claim contained lines with a HCPCS code in the pathology series (that is, CPT 80000 series of codes), we treated each of those lines as a single claim.
(2) For multiple procedure claims with a packaged HCPCS code (status indicator “N”) on the claim, we ignored line items for chest X-rays (HCPCS codes 71010 and/or 71020) and/or EKGs (HCPCS code 93005) on these claims. If only one procedure (other than HCPCS codes 71010, 71020, and 93005) existed on the claim, we treated it as a single-procedure claim.
(3) If the claim had no packaged HCPCS codes and if there were no packaged revenue centers on the claim, we treated each line with a procedure as a single claim if the line item was billed as a single unit.
(4) If the claim had no packaged HCPCS codes on the claim but had packaged revenue centers for the procedure, we ignored the line item for chest X-rays and/or EKG codes (as identified above) and if only one HCPCS code remained, we treated the claim as a single procedure claim. We created an additional 31.5 million single-procedure bills through this process, which enabled us to use these data from multiple-procedure claims in calculation of the APC relative payment weights.
• To calculate median costs for services within an APC, we used only single-procedure bills and those multiple procedure bills that we converted into single claims. If a claim had a single code with a zero charge (that would have been considered a single-procedure claim), we did not use it. As we discussed in section III.A.1 of this final rule, we did not use multiple-procedure claims that included more than one separately payable HCPCS code with charges for packaged items and services such as anesthesia, recovery room, or supplies that could not be reliably allocated or apportioned among the primary HCPCS codes on the claim. We have not yet developed what we regard as an acceptable method of using other multiple-procedure bills to recalibrate APC weights that minimizes the risk of improperly assigning charges to the wrong procedure or visit.
• For each single-procedure claim, we calculated a cost for every billed line item charge by multiplying each revenue center charge by the appropriate hospital-specific departmental CCR. If an appropriate cost center did not exist for a given hospital, we crosswalked the revenue center to a secondary cost center when possible, or we used the hospital's overall cost-to-charge ratio for outpatient department services. We excluded from this calculation all charges associated with HCPCS codes previously defined as not paid under the OPPS (for example, laboratory, ambulance, and therapy services). We included all charges associated with HCPCS codes that are designated as packaged services (that is, HCPCS codes with the status indicator of “N”).
• To calculate per-service costs, we used the charges shown in revenue centers that contained items integral to performing the service. We observed the packaging provisions set forth in the April 7, 2000 final rule with comment period that were in effect during 2001 (65 FR 18484). For instance, in calculating the cost of a surgical procedure, we included charges for the operating room; treatment rooms; recovery; observation; medical and surgical supplies; pharmacy; anesthesia; casts and splints; and donor tissue, bone, and organs. To determine medical visit costs, we included charges for items such as medical and surgical supplies, drugs, and observation in those instances where they are still packaged. Table 7 lists packaged services by revenue center that we proposed to use to calculate per-service
• We standardized costs for geographic wage variation by dividing the labor-related portion of the operating and capital costs for each billed item by the FY 2003 hospital inpatient prospective payment system (IPPS) wage index published in the
• We summed the standardized labor-related cost and the nonlabor-related cost component for each billed item to derive the total standardized cost for each procedure or medical visit.
• We removed extremely unusual costs that appeared to be errors in the data using a trimming methodology analogous to what we use in calculating the diagnosis-related group (DRG) weights for the hospital IPPS. That is, we eliminated any bills with costs outside of three standard deviations from the geometric mean.
• After trimming the procedure and visit level costs, we mapped each procedure or visit cost to its assigned APC, including the proposed APC changes described in section II.A of this final rule.
• We calculated the median cost for each APC by using the claims for services included in the APC. In the case of APCs for which we eliminated the claims that did not contain device
• Using these median APC costs, we calculated the relative payment weights for each APC. As in prior years, we scaled all the relative payment weights to APC 0601, mid-level clinic visit, because it is one of the most frequently performed services in the hospital outpatient setting. This approach is consistent with that used in developing RVUs for the Medicare physician fee schedule. We assigned APC 0601 a relative payment weight of 1.00 and divided the median cost for each APC by the median cost for APC 0601 to derive the relative payment weight for each APC. Using the 2001 through 2002 data, the median cost for APC 0601 is $57.56.
Section 1833(t)(9)(B) of the Act requires that APC reclassification and recalibration changes and wage index changes be made in a manner that ensures that aggregate payments under the OPPS for 2003 are neither greater than nor less than, the aggregate payments that would have been made without the changes. To comply with this requirement concerning the APC changes, we compared aggregate payments using the CY 2002 relative weights to aggregate payments using the CY 2003 final weights. Based on this comparison, in this final rule, we are making an adjustment of .969 to the weights. The final weights for CY 2003, which incorporate the recalibration adjustments explained in this section, are listed in Addendum A and Addendum B of this final rule with comment period. The final weights are rounded to 4 decimals for greater precision.
We received many comments on the issues related to calculation of the OPPS payment weights, which we summarize and address below:
We note that the OPPS is not designed to pay hospitals their full accounting costs for delivery of particular services. The system was set up to be budget neutral to the prior system, which, under several provisions of the statute, paid approximately 82 percent of reported hospital outpatient department costs as shown on the cost reports. Payment rates for individual services are set, in essence, to reflect relative resource use within a payment system that pays at what was a discount of approximately 18 percent. Thus, for us to make changes to ensure that a particular service receives what observers believe is its “full” cost is difficult, partly because determination of “full” cost for a particular service is an uncertain exercise and partly because such a service could only be paid “full” cost at the expense of all other services, which in principle would be paid at an even greater discount than that already implied by the operation of the system. Accordingly, while we have used data from external sources to evaluate the reasonableness of our payment rates and to guide us in choice of methods that would achieve results as reasonable as possible, we have not directly substituted such data into our estimates.
• Changes in the payment methodology for those drugs and devices that will no longer be eligible for pass-through payments,
• Miscoding,
• Restructuring of APCs (in which movement of a single code from one APC to another may change the median cost of both APCs), or
• Use of data from the period following implementation of the OPPS.
In the interest of using a method that could be employed simply and that could ensure that all APCs were treated similarly regardless of whether interested parties had identified them as sources of concern, we adopted a method that we applied to all APCs except new technology APCs, and APCs for drugs and devices that will receive pass-through payments in 2003.
We considered a number of different ways of moderating the reductions in payment that would have occurred under the August 9, 2002 proposed rule. We considered options that would have limited both significant increases and significant decreases in some fashion. However, we rejected these options because they would have reduced payments for those services that would otherwise have significant increases. Inspection of APCs that would have significant increases suggested that many of these increases were reasonable, and we did not want to reduce them more than necessary.
We considered options that would have created a fixed corridor that would have limited any reduction to some fixed value, such as 10 or 15 percent, as suggested by some commenters. However, we rejected this option, because it would have reduced the role of the claims data to a minimum, even though these data do reflect hospital charging behavior and are likely to have some degree of accuracy. In addition, setting an absolute floor on reductions would have shifted significant resources away from all other APCs.
We considered targeting those APCs that would experience a reduction in median costs beyond a threshold and limiting the reduction in median costs to half of the difference between the threshold level and the total reduction. Because of budget neutrality constraints, the costs of this approach must be met by reductions in other services. We concluded that setting a threshold at a 15 percent reduction and decreasing the reduction in median costs by half of the difference between the total proposed reduction and the threshold provided an appropriate balance, reflecting our assessment of the relative quality of claims data, other information from commenters, and the effects on services overall.
Thus, we adopt the following procedure. For any APC where the median cost would have fallen by 15 percent or more from between 2002 to 2003 from the values that would be otherwise applicable for 2003, after the data and method improvements noted above, we first decreased the reduction in median cost by one half of the difference between the value derived from the claims data and 15 percent. This methodology was applied to all APCs, not just those involving drugs or devices losing pass-through eligibility. We then assessed the results of this procedure with information from comments and concluded that several additional but more targeted steps were appropriate.
We examined further those APCs containing procedures involving devices where the device represented a very large portion of the overall costs. Noting that the overall reduction from cost discussed elsewhere in this section would mean that services where devices represented 80 percent or more of the total costs would leave virtually no margin to cover hospital costs in performing the procedure, we limited our attention to those APCs with device costs of 80 percent of more. We then calculated adjusted APC median costs for these APCs by determining the portion of the cost that was attributable to the procedure and summing it with a weighted average of the cost of the device. We determined the weighted average of the cost of the device by giving a weight of 3 to the median acquisition cost of the device as provided by external data and a weight of 1 to the median cost from our claims data. We then added the adjusted cost of the device to the unadjusted cost of the procedure to calculate the total cost of the procedure. Our dampening policy was then applied to the adjusted total cost of the procedure.
We believe that this process gave us credible adjusted medians for APCs 107, 108, 222 and 259. We gave external acquisition cost data a weight 3 times that of the adjusted claims median data because these APCs are disproportionately highly weighted with device costs and we recognize that our device data have weaknesses that would otherwise result in payments that are so low as to limit beneficiary access to these services.
We also examined further those APCs involving blood and blood products, and vaccines. Information from comments raised significant concerns about the payment reductions that would result, even after improvements in data and methods and the adjustments described above were applied, on blood and certain blood products (including antihemophilia factors). Considering the importance of these products to ongoing operation of hospitals, the short shelf life of many of them, other peculiarities of their distribution, and possible adverse effects on public health, we concluded that these products should be further protected from decreases. Accordingly, we limited the reduction in the median cost from 2002 to 2003 for these products to 11 percent, which resulted in limiting the reduction in payment from 2002 to 2003 to about 15 percent. We did this for the APCs listed in Table 8.
We also adopted specific changes relating to vaccines and certain orphan drugs, as described elsewhere in this final rule.
We created unscaled weights for all APCs by dividing the adjusted medians by the median cost for APC 601 (mid level visit). We then scaled the weights for budget neutrality. The budget neutrality scaler that we applied to the weights was .968969.
To illustrate, assume cost-to-charge ratios are about generally 50 percent. That would imply that an item that cost, for example, $100, would be marked up by 100 percent to $200. ($100/$200 = .5) If the hospital decided to mark up the cost of a high cost item by only 50 percent, the charge for an item that cost $1,000 would be $1,500, and the cost-to-charge ratio would be 67 percent. ($1,000/$1,500 = .67) On the other hand, the hospital might choose to mark up a low cost item by 150 percent: The charge for an item that cost $10 would be $25, and the cost-to-charge ratio would be 40 percent ($10/$25 = .4).
Commenters did not provide any useful empirical information on issues such as those above. One commenter presented results of a statistical analysis of the relation of average wholesale price (AWP) of some drugs to our proposed payments, but we do not know if average wholesale prices vary uniformly in proportion to the acquisition costs of hospitals and consequently do not find this analysis particularly informative.
In making this calculation, we are assuming that the ratio of cost to charges is constant across all services to which it is applied. This assumption has proved workable in the inpatient setting for almost 20 years. The calculations may not perfectly capture the costs identified for particular services, but as long as we use them in a set of relative calculations, any deviations should largely cancel out. However, if hospitals do not mark-up services in a uniform fashion within departments, the payment rates resulting from application of this assumption would be too low for some services (and too high for others), and the rates would create incentives for hospitals to avoid (or favor) particular services.
This postulated behavior of hospitals is not implausible, as they may attempt to avoid adverse reactions to high prices among consumers and to reduce coinsurance burden on high cost items used infrequently. However, the possibility of differential mark-up behavior is not well documented empirically. We do not know if differential mark-ups are common across many hospitals or across many services. Further, we do not know the size of any differential that may exist. Do hospitals apply differential mark-ups to all services or only to certain purchased inputs? Do they apply differential mark-ups only above some threshold (such as $1,000), or does the mark-up vary in some uniform fashion with the cost of the service?
In the face of the paucity of reliable empirical information on this issue, we find that we cannot move quickly to revise our current methodology. We are adopting our proposed methodology for calculating cost-to-charge ratios for 2003. We believe this issue merits further study, and we expect to address it further in the future.
In general, the statute requires us to use costs as the basis for the weights.
With respect to budget neutrality, section 1833(t)(9)(B) of the Act makes clear that any adjustments to the OPPS made by the Secretary may not cause estimated expenditures to increase or decrease. We do not believe the statute provides us authority to depart from budget neutrality simply because it uses the word “estimated.”
We are finalizing our rate methodology for PHP, including data from hospital outpatient and CMHC programs. The national unadjusted rate for CY 2003 will be $240.03, of which $48.17 is the beneficiary's national unadjusted coinsurance. Upon further review we have determined that we will not include the issue of separate billing for clinical social worker services provided to PHP patients in this final rule but will address it in future rulemaking.
Section 1833(t)(6) of the Act provides for temporary additional payments or “transitional pass-through payments” for certain medical devices, drugs, and biologicals.
For those drugs, biologicals, and devices referred to as “current,” the transitional pass-through payment began on the first date the hospital OPPS was implemented (before enactment of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act (BIPA), Public Law 106-554, enacted December 21, 2000).
Transitional pass-through payments are also required for certain “new” medical devices, drugs, and biological agents that could not be described as current, that were not being paid for as a hospital outpatient service as of December 31, 1996 and whose cost is “not insignificant” in relation to the OPPS payment for the procedures or services associated with the new device, drug, or biological. Under the statute, transitional pass-through payments are to be made for at least 2 years but not more than 3 years.
Section 1833(t)(6)(B)(i) of the Act required that we establish, by April 1, 2001, initial categories to be used for purposes of determining which medical devices are eligible for transitional pass-through payments. Section 1833(t)(6)(B)(i)(II) of the Act explicitly authorized us to establish initial categories by program memorandum. On March 22, 2001, we issued two Program Memoranda, Transmittals A-01-40 and A-01-41 that established the initial categories. We posted them on our Web site at
Transmittal A-01-41 includes a list of the initial device categories and a crosswalk of all the item-specific codes for individual devices that were approved for transitional pass-through payments as of January 21, 2001 to the initial category code by which the device is to be billed beginning April 1, 2001. Items eligible for transitional pass-through payments are generally coded using a Level II HCPCS code with an alpha prefix of “C.” Pass-through device categories are identified by status indicator “H” and pass-through drugs and biologicals are identified by status indicator “G.” Subsequently, we added two additional categories and made clarifications to some of the categories' long descriptors found in transmittal A-01-73. A current list of device category codes in effect as of July 1, 2002 can be found in Transmittal A-02-050, which was issued on June 17, 2002. This Program Memorandum can be accessed on our Web site at
Section 1833(t)(6)(B)(ii) of the Act also requires us to establish, through rulemaking, criteria that will be used to create additional device categories. The criteria for new categories are the subject of a separate interim final rule with comment period that we published in the
Transitional pass-through categories are for devices only; they do not apply to drugs or biologicals. The regulations at § 419.64 governing transitional pass-through payments for eligible drugs and biologicals are unaffected by the creation of categories.
The processes to apply for transitional pass-through payment for eligible drugs and biological agents or for additional device categories can be found on respective pages on our Web site at
As we indicated in the NPRM (67FR52130), Determining that a drug or biological is eligible for a pass-through payment or making a decision to pay a drug or biological on a separate APC basis (rather than packaging payment into payment for a procedure) does not represent a determination that the drug or biological is covered by the Medicare program.
CMS and its contractors make coverage determinations and the FDA makes premarket approval decisions under different statutory standards. Whereas the FDA must determine that a product is safe and effective as a condition of approval, CMS must determine that the product is reasonable and necessary as a condition of coverage under section 1862(a)(1)(A) of the Social Security Act. Under a premarket approval review, the FDA determines whether or not the product is safe and effective for its intended use that is
In the case of an FDA-approved indication for drugs and biologicals, CMS and its contractors have generally considered that use to be reasonable and necessary, without performing a separate review, although Medicare has always retained the right to perform a separate evaluation. (See, for example, 54 FR 4302, 4306, January 30, 1989) (Proposed Rule-Coverage Criteria) (“Questions regarding coverage of drugs and biologicals are rarely referred to PHS since we have determined as a matter of national policy that drugs or biologicals approved for marketing by FDA are safe and effective when used for indications specified in their labeling.”) (emphasis added); Medicare Carriers Manual section 2049.4 (“Use of the drug or biological must be safe and effective
CMS developed this approach, because, in the past, it was a more efficient mechanism for coverage and the impact of drugs and biologicals on the Medicare program was relatively small. Now, as a result of the increasing number of novel therapies on the market and the impact of new drugs and biologicals on the Medicare program, it is prudent for Medicare to perform its traditional coverage analysis for appropriate drugs and biologicals as it does for all other items and services to ensure that it only pays for those products that are clinically effective. For drugs and biologicals, Medicare will continue to use FDA approval as a default for a reasonable and necessary determination of an FDA-approved indication unless CMS decides otherwise. CMS may choose to perform a reasonable and necessary determination in several circumstances, including, but not limited to the following: the drug or biological in question represents a novel, complex or controversial treatment, may be costly to the Medicare program, may be subject to overutilization or misuse, or received marketing approval based on the use of surrogate outcomes.
Section 1833(t)(6)(E) of the Act limits the total projected amount of transitional pass-through payments for a given year to an “applicable percentage” of projected total payments under the hospital OPPS. For a year before 2004, the applicable percentage is 2.5 percent; for 2004 and subsequent years, we specify the applicable percentage up to 2.0 percent. If we estimate before the beginning of the calendar year that the total amount of pass-through payments in that year would exceed the applicable percentage, section 1833(t)(6)(E)(iii) of the Act requires a (prospective) uniform reduction in the amount of each of the transitional pass-through payments made in that year to ensure that the limit is not exceeded. We make an estimate of pass-through spending to determine not only whether pass-through payments will exceed the applicable percentage but also to determine the appropriate reduction to the conversion factor.
In the August 9, 2002 proposed rule, we describe in detail the methodology we would use to make an estimate of pass-through spending in 2003 (67 FR 52117 through 52118). Very generally, after projecting 2003 pass-through spending for the groups of devices, drugs, biologicals, and radiopharmaceuticals as described in the proposed rule, we would calculate total projected 2003 pass-through spending as a percentage of the total (that is, Medicare and beneficiary payments) projected payments under OPPS to determine if the pro rata reduction would be required.
Below is a table showing our current estimate of 2003 pass-through spending based on information available at the time the table was developed. In the August 9, 2002 proposed rule we indicated that we were uncertain whether pass-through spending in 2003 will exceed $467 million or 2.5 percent of total estimated OPPS spending because we had not yet completed the estimate of pass-through spending for a number of drugs. We invited comments on the methodology we proposed to use to determine if a pro rata reduction would be necessary as well as the assumptions shown in Table X of the August 9, 2002 proposed rule that included anticipated utilization and utilization not yet determined.
We received several comments on this proposal, which are summarized below.
We have refined and finalized our estimate of pass-through spending in 2003 and, for the reasons discussed below, we have determined that no pro rata reduction will be required in 2003. Moreover, as discussed below the estimate falls under the statutory limit of 2.5 percent. Therefore, the conversion factor has been increased.
Section 1861(t)(1) provides that the terms drugs and biologicals “include only such drugs (including contrast agents) and biologicals, respectively, as are included (or approved for inclusion) in [one of several pharmacopoeias] (except for any drugs and biologicals unfavorably evaluated therein), or as are approved by the pharmacy and drug therapeutics committee (or equivalent committee) of the medical staff of the hospital furnishing such drugs and biologicals for use in such hospital.” A careful reading of this statutory language convinces us that inclusion of an item in, for example, the USPDI (as Zevalin is included, as a biological), does not necessarily mean that the item is a drug or biological. Inclusion in such reference (or approval by a hospital committee) is a necessary condition for us to call a product a drug or biological, but it is not enough. Rather, if we are to call a product a drug or a biological for our purposes, CMS must still make its own determination that the product is a drug or biological. In the case of Zevalin, we have determined that Zevalin is not a drug or a biological.
Zevalin consists of a radioactive isotope that is delivered to its target tissue by a monoclonal antibody. Because of the specific requirements associated with delivery of radioactive isotope therapy, any product containing a therapeutic radioisotope, including Y-90 Zevalin, will be considered to be in the category of benefits described under section 1861(s)(4) of the Act. Similarly, the appropriate benefit category for all diagnostic radiopharmaceuticals, including IN-111 Zevalin, is 1861(s)(3). We will consider neither diagnostic nor theraputic radiopharmaceuticals to be drugs as described in section 1861(t).
Thus, we have determined that the most appropriate Medicare benefit categories for IN-111 Zevalin and Y-90 Zevalin are as provided in sections 1861(s)(3) and (4) of the Act because they are a new diagnostic test and new radioactive isotope therapy, respectively. We will pay for IN-111 Zevalin under the New Technology APC 718 and for Y-90 Zevalin under the New Technology APC 725 until we have sufficient hospital charge data upon which to use in assigning these services to clinical APCs. Because we have decided that Zevalin does not qualify for transitional pass-through payments, we have not included the estimated payments for Zevalin in our revised estimates of total 2003 transitional pass-through payments.
We have based the determination of New Technology APCs for IN-111 Zevalin and Y-90 Zevalin on information received from the manufacturer and invoices made available to us, and we believe the resulting payment rates to hospitals should be adequate. We note that had we found it necessary to pay for these products as drugs, the average wholesale price alone could have exceeded $28,000 per treatment. We believe his pricing is excessive and that it would have placed an unnecessarily large burden on the Medicare Trust Funds. Had we found it necessary to treat these products as drugs, however, we could have invoked the authority of section 1833(t)(2)(E) to establish a more equitable payment rate.
A hospital may bill for the number of millicuries billed to them by a radiopharmacy or, if the hospital prepares Zevalin itself, the number of millicuries prepared for administration to the patient but, in either case, no more than 40 millicuries.
CMS has also undertaken a national coverage determination (NCD) for Zevalin, which has been approved by the Food and Drug Administration (FDA) to treat certain types of non-Hodgkin's lymphoma, to assure that the product is appropriately used in the Medicare program. A decision memorandum addressing the clinical uses of Zevalin to be covered by Medicare will appear on the CMS coverage Web site (
In the late 1980's, scientists used recombinant DNA technology to produce an erythropoietin-like protein called epoetin alpha. Epoetin alpha has exactly the same amino acid structure as the erythropoietin humans produce naturally, and, when given to patients with anemia, stimulates red blood cell production.
Two commercial epoetin-alpha products are currently marketed in the United States: Epogen
Amgen has recently developed a new erythropoietin-like product, darbepoetin alpha, which it markets as Aranesp
Because darbepoetin alpha has two additional carbohydrate side-chains, it is not structurally identical to epoetin alpha. However, the two products are functionally equivalent: In this case, both products use the same biological mechanism to produce the same clinical result, stimulation of the bone marrow to produce red blood cells. Thus, Epogen
These biologicals are dosed in different units. Epoetin alpha is dosed in Units per kilogram (U/kg) of patient weight and darbepoetin alpha in micrograms per kilogram (mcg/kg). The difference in dosing metric is due to changes in the accepted convention at the time of each product's development. At the time epoetin alpha was developed, biologicals (such as those developed through recombinant DNA) were typically dosed in International Units (or Units for short), a measure of the product's biologic activity. They were not dosed by weight (for example, micrograms) because of a concern that weight might not accurately reflect their standard biologic activity. The biologic activity of such products can now be accurately predicted by weight, however, and manufacturers have begun specifying the doses of such biologicals by weight. No standard formula exists for converting amounts of a biologic dosed in Units to amounts of a drug dosed by weight.
In clinical practice, CMS recognizes that no strict method of converting an epoetin alpha dose to a darbepoetin alpha dose exists. There are general guidelines for conversion, and clinicians modify the dose based on the patient's hematopoietic response. For developing a payment policy, however, it is feasible to establish a method of converting the dose of each of these drugs to the other.
As part of the process to define a conversion ratio between these biologicals, CMS held a series of meetings with both Amgen and Ortho Biotech. Both companies provided substantial written and published information. We reviewed the Food and Drug Administration labeling for each product (Epogen
In selecting articles for review, CMS sought studies that (1) provided a “head-to-head” comparison of epoetin alpha to darbepoetin alpha either in patients with chronic kidney disease (on or not on dialysis) or in cancer patients with chemotherapy-induced anemia, and (2) in which an appropriate outcome measure was used. In the absence of such data, we also considered clinical studies that either compared both products to each other or that linked the dose of a particular product with an appropriate health outcome measure.
CMS's identification of a conversion ratio between the dosages of these two products, darbepoetin alpha and epoetin alpha, is solely for the purpose of developing a Medicare payment policy. It is not meant to imply or suggest what should be done for individual patients in clinical practice. In addition, by using a conversion ratio CMS is not attempting to establish a lower or upper limit on the amount of either biological a physician can prescribe to a patient. CMS expects that physicians will continue to prescribe these biologicals based on the needs of individual patients. In terms of payment, however, CMS considers these biologicals to be functionally equivalent (even if structurally different), and, therefore, will establish an equitable payment policy that relates dosage of the agents to each other.
In our review, we placed the greatest emphasis on published, high quality clinical studies and looked for the best possible estimates based on an evaluation of the dosing of each product that, on average, produced the same clinical response. Based on our own review of the evidence, our consultation with the independent contactor who also reviewed the evidence, and our discussions with Amgen and Ortho Biotech, CMS concludes that an appropriate conversion ratio for the purposes of a payment policy is to 260 International Units of epoetin alpha to one microgram of darbepoetin alpha (260:1).
We think that improved information from clinical trials involving “head-to-head” comparisons of these two products could help us insure our policy is correct and if necessary update this policy in the future. In this vein, the National Cancer Institute has been directed to work with CMS to quickly develop and sponsor a trial or trials to evaluate the appropriate conversion ratio between these products for the purpose of Medicare pricing. We expect this project to be completed during the cycle for development of the 2004 OPPS update regulation. If we can estimate a more accurate conversion ratio based on this study or from our review of our own payment data, we will make a change to reflect this ratio so as soon as practicable.
We proposed that transitional pass-through payments for epoetin alpha end at the end of this calendar year, and that payment be made in calendar year 2003 in a separate, unpackaged APC. We are adopting these policies for the final rule.
We had proposed to continue transitional pass-through payments for darbepoetin alpha. We accept, however, the comment suggesting that these two biologicals should be paid at the same rate. As noted above, the products are almost identical; nevertheless there is a great disparity in their costs. In this situation, we believe it is appropriate for us to rely on our authority in section 1833(t)(2)(E) of the Social Security Act to make an adjustment we determine “necessary to ensure equitable payments.” We do not believe it would be equitable or an efficient use of Medicare funds to pay for these two functionally equivalent products at greatly different rates. We would package these two biologicals into the same APC, but the difference in dosage metrics makes this step technically impossible if we are to maintain the ability to pay on the basis of the actual dose used. Consequently, they will be in separate APCs but paid at equivalent rates. The 2003 payment rate for non-ESRD epoetin alpha is established as $9.10 per 1000 Units elsewhere in this
An alternative line of reasoning would produce the same result. Section 1833(t)(6)(A) of the Social Security Act distinguishes between “current” and “new” biologicals. Epoetin alpha is a “current” biological. Since April 2002, we have treated darbepoetin alpha as a “new” biological. However, section 1833(t)(6)(A)(iv) sets forth the criteria that must be met for a biological to be considered “new.” One criterion is that the biological is not described by any item described in clauses (i), (ii) or (iii) of section 1833(t)(6)(A) of the Act, which define “current” drugs, biologicals, and devices. Given the determination stated above that these products are functionally equivalent, we believe that darbepoetin alpha is already described by epoetin alpha, a “current” biological. Because darbepoetin alpha is functionally equivalent to epoetin alpha, we believe we could conclude that it would be most appropriate to consider darbepoetin alpha a “current” biological. In that event, it would not qualify for a pass-through payment as a “new” biological. Accordingly, under this analysis, we would terminate the duration of transitional pass-through payment eligibility for darbepoetin alpha on December 31, 2002, and pay for it in a fashion comparable to other products that lose eligibility for transitional pass-through status on that date. More particularly, we would pay it equivalently to epoetin alpha.
Beneficiary copayments are unchanged as a result of the change in payment for darbepoetin alpha, because under this rule the copayment amount for both biologicals would have equaled that calculated for epoetin alpha in any case.
This change is budget neutral. As a result of this change, our estimate of total transitional pass-through payments is smaller than it would otherwise have been. The percentage we have reduced the conversion factor to compensate for transitional pass-through spending is accordingly smaller, and in a budget neutral fashion payment rates for other services are correspondingly higher.
We do not expect to make nationally-applicable determinations of similarity of drugs or biologicals, such as that discussed above, on a routine basis. We regard this situation as unusual, distinguished by the very strong similarity of the two products and by the size of the potential effects on the Medicare program. We thus believe that making this determination and insuring comparable payment is justified in this particular instance.
Some commenters suggested that we refine our estimation procedures by utilizing alternative modeling techniques and by using data from claims experience. Several of the comments included, in depth, data analysis along with models used to predict pass-through drug spending for calendar year 2003. Spending estimates ranged from $213 million to $441 million dollars.
Other commenters objected to the techniques used to estimate pass-through spending for future products, those items first eligible for pass-though payments in April 2003 or later. A manufacturer's association objected to the use of drugs eligible for pass-through payment beginning in January 1, 2003 as the basis of a forecast of drugs likely to acquire pass-through status throughout the remainder of the year. This objection stems from what the association views as the lack of similarities between drugs first eligible for pass-through payments on January 1, 2003 and those eligible later in the year. Further, they object to estimating any additional pass-through payments when it is not clear whether or not a product will be added to the list during 2003.
Another commenter proposed the use of a more sophisticated model based on drugs currently in the FDA pipeline to be used to project spending of drugs first eligible for pass-through payment between April and December 2003.
Other commenters objected to our estimates for specific drugs.
We address below several other issues that arose during our refinement of Table X in the proposed rule. We proposed to continue pass-through payment status for TC 99M oxidronate under HCPCS C1058. However, following publication of the August 9, 2002 proposed rule, we determined that this drug was also represented by HCPCS code Q3009. Under HCPCS code Q3009, this radiopharmaceutical agent has received pass-through payment status for at least 2 years, and will no longer be eligible for pass-through payment under either HCPCS code Q3009 or C1058 beginning on January 1, 2003. As proposed, we are packaging the cost of Q3009 into the procedures with which the code was billed.
Two other HCPCS codes representing radiopharmaceutical agents were inadvertently included in the list of 2003 pass-through drugs in the proposed rule. HCPCS codes C1064 and C1065 were add-on codes used to bill for an additional mCi of I-131. These codes, along with the related HCPCS code C1188 and C1348, which are used to report an initial 1-5 or 1-6 mCi, respectively, will no longer be eligible for pass-through payment on January 1, 2003.
Table 9 contains the final list of items that are eligible for pass-through payments in 2002 and will remain eligible in 2003. Table 9 also contains items that have been approved for pass-through payments beginning in 2003.
It does not contain categories of devices or drugs for which pass-through applications are still pending at the time of issuance of this final rule or for which applications have yet to be received.
We used the following methodology to estimate the pass-through payments for 2003.
1. Devices eligible in 2002 [Device categories beginning July 1, 2002 (C1783, C1888, C1900)] that will continue in 2003: We used manufacturers' retail prices along with
2. Drugs eligible in 2002 that will continue in 2003: We used the July 2002 Redbook prices to determine the AWP, which we used in combination with our ratios for establishing estimated acquisition costs to derive pass-through payments for drugs in 2003. We determined the volume for pass-through drugs by soliciting manufacturer estimates of volume for the Medicare population where possible and relying upon a commenter's estimates for the volumes of other drugs.
3. Devices eligible in January 2003: We used manufacturers' retail prices along with claims utilization estimated for 2003 by our clinical staff, based on our claims data and coding and projected utilization information supplied in the applications. We applied offsets to procedures associated with devices that mapped to APCs with offsets.
4. Drugs eligible in January 2003: We used the July 2002 Redbook prices to determine the AWP which we used in combination with our ratios for establishing estimated acquisition costs to derive pass-through payments for drugs in 2003. We determined the volume for pass-through drugs by soliciting manufacturer estimates of volume for the Medicare population where possible and relying upon a commenter's estimates for the volumes of other drugs.
5. Devices eligible in 2001 and will continue in 2003: We used manufacturers' retail prices along with claims utilization for the 12 months that ended March 31, 2002, increased to 2003 by the growth rate provided by our actuary.
Our final estimate of transitional pass-through spending for 2003 also includes projected spending for items that have not yet been approved for 2003. We had proposed to base our estimate of spending for such items on items that have been newly approved for January 1, 2003. In response to comments, we have based our projection for items that will be approved later in 2003 on items that were newly approved for October 1, 2002 and January 1, 2003. We have based our estimate on the two most recent quarters of approval because we anticipate a higher volume of pass-through approvals compared to early 2002 for two reasons. First, we began paying for categories of devices on April 1, 2001. The vast majority of items in use at that time, as well as newly FDA approved items, could receive pass-through payments under a category code. We received, and subsequently approved, a relatively small number of pass-through applications in the first half of 2002. Consequently, we based our projection of spending for items that will be determined eligible for pass-through status in 2003 based on items determined eligible for October 1, 2002 and items determined eligible or expected to be determined eligible for January 1, 2003.
In summary, we estimate that pass-through spending in 2003 will approximate $427.4 million. We believe that pass-through spending in 2003 will break out into the following categories for 2003:
Our total 2003 estimate of $427.4 million is 2.3 percent of total estimated program payment. We proposed to reduce the conversion factor by 2.5 percent to account for pass-through spending. Since our estimate is now below 2.5 percent, we have adopted a reduction of 2.3 percent to the conversion factor in accord with our estimate of pass-through payments. Our final assumptions used to create the estimate are shown in Table 9 above.
Section 1833(t)(6)(B)(iii) of the Act requires that a category of devices be eligible for transitional pass-through payments for at least 2, but not more than 3, years. This period begins with the first date on which a transitional pass-through payment is made for any medical device that is described by the category. We proposed that 95 device categories currently in effect will expire effective January 1, 2003. Our proposed payment methodology for devices that have been paid by means of pass-through categories, but for which pass-through status will expire effective January 1, 2003, is discussed in the section below.
Although the device category codes became effective on April 1, 2001, many of the item-specific C-codes for pass-through devices that were crosswalked to the new category codes were approved for pass-through payment in CY 2000, or as of January 1, 2001. (The crosswalk for item-specific C-codes to category codes was issued in Transmittals A-01-41 and A-01-97,) To establish the expiration date for the category codes listed in Table 10, we determined when item-specific devices that are described by the categories were first made effective for pass-through payment before the implementation of device categories. These dates are listed in Table 7 in the column entitled “Date First Populated.” We proposed to base the expiration date for a device category on the earliest effective date of pass-through status for any device that populates that category. Thus, the 95 categories for devices that will have been eligible for pass-through payments for at least 2 years as of December 31, 2002 would not be eligible for pass-through payments effective January 1, 2003.
Below is Table 7, which includes a comprehensive list of all pass-through device categories effective on or before July 1, 2002 with the date that devices described by the category first became effective for payment under the pass-through provisions and their respective proposed expiration dates.
We considered a number of options on how to pay for devices after their pass-through payment status expires effective January 1, 2003. We held a Town Hall Meeting on April 5, 2002, to solicit recommendations on how to pay for drugs, biologicals, and devices once their eligibility for transitional pass-through payments expires in accordance with the time limits set by the statute. Interested parties representing hospitals, physician specialty groups, device and drug manufacturers and trade associations, and other organizations presented their views on these issues.
After carefully considering all the comments, concerns, and recommendations submitted to us regarding payment for devices and drugs and biologicals that would no longer be eligible for pass-through payments in 2003, we proposed to package the costs of medical devices no longer eligible for pass-through payment in 2003 into the costs of the procedures with which the devices were billed in 2001. (Our proposal to pay for pass-through drugs and biologicals whose pass-through status expires in 2003 is discussed below, in section IV.D.)
The methodology that we proposed to use to package pass-through device costs is consistent with the methodology for packaging that we describe in section III.B of this preamble. That is, to calculate the total cost for a service on a per-service basis, we included all charges billed with the service in a revenue center in addition to packaged HCPCS codes with status indicator “N.” We also packaged the 2001 charges for devices that will cease to be eligible for pass-through payment in 2003 into the changes for the HCPCS codes with which the devices were billed. We relied on the hospitals to correctly code their bills for all costs, including pass-through devices, using HCPCS codes and revenue centers as appropriate to describe the services that they furnished.
To prevent the loss of the device costs billed by hospitals through revenue centers in developing our relative weights for APCs, we proposed to package the costs of both the device “C” codes and the billed revenue centers, whichever appeared on the claim. At the time, we believed that this method would allow us to capture all device related costs billed by hospitals. See our discussion of charges for devices in section III.A.2 of the preamble for this issue.
We customarily allow a grace period for HCPCS codes that are scheduled for deletion. When we allow a grace period for deleted codes, we permit deleted codes to continue to be billed and paid for 90 days after the effective date of the changes that require their deletion. However, we proposed to not allow a grace period for expiring pass-through codes because permitting a grace period would result in pass-through payment for the items for which we proposed to cease pass-through payment effective with services furnished on or after January 1, 2003. Effective for services furnished on or after January 1, 2003, hospitals would submit charges for all surgically inserted devices in the supply, implant, or device revenue center that most appropriately describes the implant. Device costs will thus be packaged into and reflected in the costs for the procedure with which they are associated. Therefore, effective for services furnished on or after January 1, 2003, we proposed to reject line items containing a “C” code for a device category scheduled to expire effective January 1, 2003.
We received several comments on this proposal, which are summarized below.
Revising rates in mid-year is not generally part of Medicare rate-making policy and is not appropriate in this instance either. It is not only burdensome for this agency, it also burdens the providers and fiscal intermediaries, and it would add confusion to an already complex system.
The commenter provided two suggestions regarding the expiring category code for dialysis access systems, C1881. One option suggested is for us to assign a unique HCPCS code for placement of the manufacturer's brand specific dialysis system and place it in a new or existing APC that has appropriate payment. This commenter contended that bundling C1881 within APC 115 will result in inadequate payment, because the device will be bundled with standard hemodialysis catheters and chemotherapy ports. The second option suggested is to extend pass-through payment status for category C1881. This commenter stated its dialysis system was approved for pass-through payment in August 2000, and there were limited sales and therefore claims in 2000 and the first half of 2001. Thus, this commenter expressed the opinion that there is approximately 1 year of data for this category, not the 2 to 3 years required.
Under the OPPS, we currently pay for drugs and biologicals, including radiopharmaceutical agents, blood, and blood products, in one of three ways: packaged payment, separate APCs and transitional pass-through payment.
As we explained in the April 7, 2000 final rule, we generally package the cost of drugs and biologicals into the APC payment rate for the primary procedure or treatment with which the drugs are usually furnished (65 FR 18450). Hospitals do not receive separate payment from Medicare for packaged items and supplies, and hospitals may not bill beneficiaries separately for any such packaged items and supplies whose costs are recognized and paid for within the national OPPS payment rate for the associated procedure or service. (Transmittal A-01-133, a Program Memorandum issued to Intermediaries on November 20, 2001, explains in greater detail the rules regarding separate payment for packaged services.) Hospitals bill for costs directly related and integral to performing a procedure or furnishing a service using a revenue center or packaged HCPCS code (status indicator “N”). As discussed earlier in section III.A.2 of the preamble, we list the packaged services, by revenue center, that we use to calculate per-service costs.
As specified in the regulations at § 419.2(b), costs directly related and integral to performing a procedure or furnishing a service on an outpatient basis are included in the determination of OPPS payment rates for the procedure or service. In the August 9, 2002 proposed rule, we provided some illustrations of situations in which drugs are considered to be supplies. For example, sedatives administered to patients while they are in the preoperative area being prepared for a procedure are supplies that are integral to being able to perform the procedure. Similarly, mydriatic drops instilled into the eye to dilate the pupils, anti-inflammatory drops, antibiotic ointments, and ocular hypotensives that are administered to the patient immediately before, during, or immediately following an ophthalmic procedure are considered an integral part of the procedure without which the procedure could not be performed. The costs of these items are packaged into and reflected within the OPPS payment rate for the procedure. Likewise, barium or low osmolar contrast media are supplies that are integral to a diagnostic imaging procedure as is the topical solution used with photodynamic therapy furnished at the hospital to treat non-hyperkeratotic actinic keratosis lesions of the face or scalp. Local anesthetics such as marcaine, lidocaine (with or without epinephrine) and antibiotic ointments such as bacitracin, placed on a wound or surgical incision at the completion of a procedure, are other examples we cited in the proposed rule. The hospital furnishes these items while the patient is in the hospital and registered as an outpatient for the purpose of receiving a therapy, treatment, procedure, or service. These and other such supplies may be furnished pre-operatively, while the patient is being prepared for a procedure; intra-operatively, while the procedure is being performed; or post-operatively, while the patient is in the recovery area prior to discharge. Or, these items may be part of an E/M service furnished during a clinic visit or in the emergency department. All of these supplies are directly related and integral to the performance of a separately payable therapy, treatment, procedure, or service with which they are furnished. Therefore, we do not generally recognize them as separately payable services. We package their cost into the cost of the primary procedure, and we pay for them as part of the APC payment.
We received several comments concerning the treatment of drugs as supplies, which are summarized below, along with our responses.
The commenter indicates that the hospital is not being paid adequately for stem cell acquisition costs. However, the commenter should note that hospitals should be reporting all charges associated with the purchase of stem cells under Revenue Code 819. Therefore, to the extent that hospitals are billing a charge for the cost of acquiring stem cells under Revenue Code 819, those costs would be packaged into the median cost of CPT 38240 and be reflected in the APC payment rate. These services may also qualify for outlier payments.
There are certain new technology drugs and biologicals that are not eligible for transitional pass-through payments but for which we have made separate payment. Beginning with the April 7, 2000 rule (65 FR 18476), we created separate APCs for these drugs and biologicals as well as devices. We proposed to create temporary individual APC groups for the various drugs classified as tissue plasminogen activators and other thromobolytic agents that are used to treat patients with myocardial infarctions as well as certain vaccines to allow separate payment so as not to discourage their use where appropriate. In the case of blood and blood products, wide variations in patient requirements convinced us that we should pay for these items separately rather than packaging their costs into the procedural APCs. Moreover, the Secretary's Advisory Council on Blood Safety and Access recommended that blood and blood products be paid separately to ensure that to minimize incentives that would be inconsistent with the promotion of blood safety and access.
In the case of the other drugs and vaccines that we proposed not package into payment for visits or procedures, we paid separately for them because we wanted to avoid creating an incentive to cease providing these drugs when they were medically indicated.
We based the payment rate for the APCs for these drugs and biologicals on median hospital acquisition costs using 2001 claims data. We set beneficiary copayment amounts for these drug and biological APCs at 20 percent of the payment amount. In 2003 we will use status indicator “K” to denote the APCs for drugs and biologicals (including blood and blood products) and certain brachytherapy seeds that are paid separately from and in addition to the procedure or treatment with which they are associated but that are not eligible for transitional pass-through payment.
BBRA provided for special transitional pass-through payments for a period of 2 to 3 years for the following drugs and biologicals (pass-through payments for devices are addressed in section IV.C. of the preamble):
• Current orphan drugs, as designated under section 526 of the Federal Food, Drug, and Cosmetic Act.
• Current drugs and biologic agents used for treatment of cancer.
• Current radiopharmaceutical drugs and biological products.
• New drugs and biological agents.
In this context, “current” refers to those items for which hospital outpatient payment was being made on August 1, 2000, the date on which the OPPS was implemented. A “new” drug or biological is a product that is not paid under the OPPS as a “current” drug or biological, was not paid as a hospital outpatient service before January 1, 1997, and for which the cost is not insignificant in relation to the payment for the APC with which it is associated.
Section 1833(t)(6)(D)(i) of the Act sets the payment rate for pass-through eligible drugs as the amount by which the amount determined under section 1842(o) of the Act, that is, 95 percent of the applicable average wholesale price (AWP), exceeds the difference between 95 percent of the applicable AWP and the portion of the otherwise applicable fee schedule amount (that is, the APC payment rate) that the Secretary determines is associated with the drug or biological. Therefore, in order to determine the pass-through payment amount, we first had to determine the cost that was packaged for the drug or biological within its related APC. In order to determine this amount, we used data on hospital acquisition costs for drugs from a survey that is described more fully in the April 7, 2000 and the November 30, 2001 final rules. The ratio of hospital acquisition cost, on average, to AWP that we used is as follows:
• For sole-source drugs, the ratio of acquisition cost to AWP equals 0.68.
• For multisource drugs, the ratio of acquisition cost to AWP equals 0.61.
• For multisource drugs with generic competitors, the ratio of acquisition cost to AWP equals 0.43.
Section 1833(t)(6)(C)(i) of the Act specifies that the duration of transitional pass-through payments for current drugs and biologicals must be no less than 2 years nor any longer than 3 years beginning on the date that the OPPS is implemented. Therefore, the latest date for which current drugs that have been in transitional pass-through status since August 1, 2000 will be eligible for transitional pass-through payments is July 31, 2003. We proposed to remove these drugs from transitional pass-through status effective January 1, 2003 because the statute gives us the discretion to do so and because we generally implement annual OPPS updates on January 1 of each year. We would be in violation of the law if we were to not remove these drugs and biologicals from transitional pass-through status by August 1, 2003. The next update of the OPPS that will go into place will not be effective until January 1, 2004, at which time the statute's 3-year limit on pass-through payments for these drugs would have been exceeded. We further proposed to remove from transitional pass-through status, beginning January 1, 2003, those drugs for which transitional pass-through payments were made effective on or prior to January 1, 2001 because the law gives us the discretion to do so and we believe that, to the extent possible, payments should be made under the OPPS, without pass-through payment, when the law permits, as it does in this case.
As explained above, our policy has been to package payment for drugs and
In spite of our commitment to package as many costs as possible, we are aware of concerns that were presented at the April 5, 2002 Town Hall meeting and that have been brought to our attention by various interested parties, that packaging payments for certain drugs, especially those that are particularly expensive or rarely used, might result in insufficient payments to hospitals, which could adversely affect beneficiary access to medically necessary services.
The options that we considered included packaging the costs of all drugs and biologicals, both those with status indicator “K” in 2002 and those that would no longer receive pass-through payments in 2003, or continuing to make separate payment for both categories of drugs and biologicals through separate APCs. After careful consideration of the various options for 2003, we proposed to package the cost of many drugs for which separate payment is made currently. But we also proposed to continue making separate payment for certain orphan drugs (as discussed below), blood and blood products, vaccines that are paid under a benefit separate from the outpatient hospital benefit (that is, influenza, pneumococcal pneumonia, and hepatitis B), and certain higher cost drugs as explained below. The payment rates for those drugs for which we would make separate payment in 2003 would be an APC payment rate based on a relative weight calculated in the same way that relative weights for procedural APCs are calculated.
Comments on this proposal and our responses are summarized below:
After carefully reviewing all of the comments, a dampening option seemed most plausible and practical for us to undertake. Most of the recommendations proposed by the commenters were not feasible or not suitable for the purposes of OPPS.
We recognize that some drugs may be available only in packaged amounts that exceed the needs of an individual patient. Once the drug is reconstituted in the hospital's pharmacy, it may have a limited shelf life. Since an individual patient may receive less than the fully reconstituted amount, we encourage hospitals to schedule patients in such a way that the hospital can use the drug most efficiently. However, if the hospital must discard the remainder of a vial after administering part of it to a Medicare patient, the provider may bill for the amount of drug discarded along with the amount administered.
Drug X is available only in a 100-unit size. A hospital schedules three Medicare patients to receive drug X on the same day within the designated shelf life of the product. An appropriate hospital staff member administers 30 units to each patient. The remaining 10 units are billed to Medicare on the account of the last patient. Therefore, 30 units are billed on behalf of the first patient seen and 30 units are billed on behalf of the second patient seen. Forty units are billed on behalf of the last patient seen because the hospital had to discard 10 units at that point.
An appropriate hospital staff must administer 30 units of drug X to a Medicare patient, and it is not practical to schedule another patient who requires the same drug. For example, the hospital has only one patient who requires drug X, or the hospital sees the patient for the first time and did not know the patient's condition. The hospital bills for 100 units on behalf of the patient, and Medicare pays for 100 units.
The “two times” rule requires that the highest median cost of a service or item within an APC cannot be more than two times greater than the lowest median cost of a service or item within that APC. We apply the “two-times” rule to the total cost of each procedure (which includes items that are packaged within that procedure). In the case of APCs containing only items, we apply the rule to the cost of each item that is grouped in the APC. We do not apply the two times rule to the variation in cost of individual items or ancillary services we attribute to a single HCPCS code.
If we were to attempt to apply the rule to all items within the various procedures, accounting for the variation in cost of supplies such as bandages, reusable instruments, and other medical supplies would be a practical impossibility. It would lead to a highly fragmented set of payment cells and a greatly more complex payment system that would reduce the incentives for effective management by hospitals. We do not believe the Congress would have intended such a result.
Consistent with the principles of prospective payment, we package the cost of as many items as possible into the median cost of a procedure. Therefore, our payment methodology for 2003 includes packaging the costs of drugs and biologicals with median costs below $150 per line into the costs of the procedures with which they were billed. We reviewed the median cost of the procedures used for administration of drugs and biologicals, before and after we packaged the costs of drugs and biologicals. Our review indicates that the final median cost appropriately accounts for the administration procedure and the cost of the administered drug and/or biologic.
We recognize that orphan drugs that are used solely for an orphan condition or conditions are generally expensive and, by definition, are rarely used. We believe that if the cost of these drugs were packaged into the payment for an associated procedure or visit, the payment for the procedure might be insufficient to compensate a hospital for the typically high cost of this special type of drug. Therefore, we proposed to establish separate APCs to pay for those orphan drugs that are used solely for orphan conditions.
To identify the orphan drugs for which we would continue to make separate payment, we applied the following criteria:
• The drug must be designated as an orphan drug by FDA and approved by FDA for the orphan condition.
• The current United States Pharmacopoeia Drug Information (USPDI) shows that the drug had neither an approved use for other than an orphan condition nor an off label use for conditions other than the orphan condition. There are three orphan drugs that are used solely for orphan conditions for which we proposed to make separate payment: J0205 Alglucerase injection; J0256 Alpha 1 proteinase inhibitor; and J09300 Gemtuzumab ozogamicin.
From the onset of the OPPS, we have made separate payment for blood and blood products either in APCs with status indicator “K” or as pass-through drugs and biologicals with status indicator “G” rather than packaging them into payment for the procedures with which they were administered. As we explained in the April 7, 2000 final rule (65 FR 18449), the high degree of variability in blood use among patients could result in payment inequities if the costs of blood and blood products were packaged with their administration. We also want to ensure that costs associated with blood safety testing are fully recognized. The safety of the nation's blood supply continues to be among the highest priorities of the Secretary's council on Blood Safety and Access. Therefore, we proposed to continue to pay separately for blood and blood products.
The commenters provided several suggestions. They recommended that we base the payment rates for blood products on current year acquisition costs and actual total costs rather than on hospital claims from previous years, and use industry data on the current hospital costs of blood and blood products that have been submitted to us; consider costs related to additional costs that hospitals incur in storing and preparing units for transfusion when assigning APC relative weights to blood and blood products; continue the 2002 payment rates until more accurate information on the actual costs of blood and blood products are gathered; or reimburse hospitals on a reasonable cost basis for blood and blood products.
Outpatient hospital departments administer large numbers of the vaccines for influenza (flu), pneumococcal pneumonia (PPV), and hepatitis B, typically by participating in immunization programs encouraged by the Secretary because these vaccinations greatly reduce death and illness in vulnerable populations. In recent years, the availability and cost of the vaccines (particularly the flu vaccine) have varied considerably. We want to avoid creating any disincentives to provide these important preventative services that might result from packaging their costs into those of primary procedures, visits, or administration codes. Therefore, we proposed to pay for these vaccines under OPPS through the establishment of separate APCs.
We received no comments on our proposal to pay for these vaccines under separate APCs. However, we have had considerable discussion with providers in the past about the cost to hospitals of influenza and pneumococcal pneumonia vaccines in particular. In particular, we have had many discussions in which we were advised by providers that OPPS payment was insufficient for them to be able to guarantee that they would be able to offer these important vaccines to Medicare patients they treat. They cited the timing of updates to OPPS rates as well as volatility of costs as a result of irregular supplies of these vaccines as their major concern. Public health officials encourage high risk individuals, including Medicare beneficiaries, to receive flu immunitions beginning each September. Each flu season, a new vaccine is produced; the cost of the vaccine is also typically higher than the previous year's vaccine cost. Thus, from September through December, providers paid under the OPPS for administering flu vaccines do not receive the benefit of the update that occurs in January. In recent years, the cost of the vaccine has been volatile because of irregular supplies.
Therefore, we have decided to pay hospitals for influenza and pneumococcal pneumonia vaccines under reasonable cost methodology. Section 1833(t)(2)(A)(i) of the Act gives the Secretary discretion to define outpatient hospital services for purposes of payment under the OPPS. Until now we have defined it to include influenza and pneumococcal pneumonia vaccines. However, in view of the importance of these vaccines to the public health and our strong desire to ensure that hospitals are paid appropriately for these vaccines, we have decided to exclude them from OPPS.
We are therefore revising regulations at § 419.21(d)(3) to remove the words “influenza” and “pneumococcal pneumonia.” As a result of this change, hospitals, HHAs and hospices which were paid for these vaccines under OPPS will be paid reasonable cost for these vaccines. We will issue further instructions regarding how CORFs will be paid for these vaccines in 2003 and will issue implementation instructions for hospitals, HHAs and hospices.
While our preferred policy is to package the cost of drugs and other items into the cost of the procedures with which they are associated, we are concerned that beneficiary access to care may be affected by packaging certain higher cost drugs. For this reason, we proposed to allow payment under separate APCs for high cost drugs for an additional year while we further study various payment options. Specifically, we proposed to pay separately for drugs for which the median cost per line (cost per unit multiplied by the number of units billed on the claim) exceeded $150, as we briefly describe below. We provide more detail in the proposed rule regarding the methodology we used to determine this threshold (67 FR 52124-52125).
To establish a reasonable threshold for determining which drugs we would pay under separate APCs rather than through packaging, we calculated the median cost per unit using 2001 claims data for each of the drugs for which transitional pass-through payment ceases January 1, 2003 and for those additional drugs that we have paid separately (status indicator “K”) since the outset of OPPS.
We excluded from these calculations the orphan drugs, vaccines, and blood and blood products discussed above. Because many drugs are used and billed in multiple unit doses, we then multiplied the median cost per unit for the drug by the average number of units that were billed per line. Once we calculated an approximate median cost per line for the drug, we then arrayed the median cost per line in ascending order and examined the distribution. A natural break occurs at $150 per line, the midpoint of a $10 span between the drug immediately above and below the $150 point. Within the array, approximately 61 percent of the drugs fall below the $150 point and 39 percent of the array are above the point. Among the drugs that we proposed to package are some radiopharmaceuticals, vaccines, anesthetics, and anticancer agents. After including the costs of packaged drugs in the services with which they were provided, we noted that the median costs of those services increased. We solicited comments that address specific alternative protocols we might use when several packaged drugs whose total cost significantly exceeds the applicable APC payment amount may be administered to a patient on the same day (for example, multiple agent cancer chemotherapy).
We requested comments on the factors we considered in determining which drugs to package in 2003. We were particularly interested in comments for the exclusion of high cost drugs from packaging. We added that we would continue to analyze the effect
Although we expect to expand packaging of drugs to package payment for more drugs into the APC for the services with which they are billed, we nonetheless, requested comments on alternatives to packaging. One example of an alternative approach is to use different criteria from those we propose in this proposed rule to identify the drugs to package into procedure APCs and the drugs to pay separately. Another alternative approach would be to create APCs for groups of drugs based on their costs. Still another approach would be to create separate APCs for each drug. We emphasized in the proposed rule that we welcomed a full discussion of the alternatives as we determine the best way to ensure that hospitals are paid appropriately for the drugs they administer to the Medicare beneficiaries whom they treat in their outpatient departments.
Drugs that we pay for separately in 2003 are designated in Addendum B by status indicator “K” or “G.”
A summary of the comments we received on this proposal and our responses to them are summarized below.
In contrast, one national hospital organization recommended that we adopt a much higher threshold of $1,000 for a drug to warrant separate payment and package all other drugs that fall below the threshold. Furthermore, another national hospital association encouraged us to expeditiously incorporate into APCs both low and high cost drugs that will lose their eligibility for transitional pass-through payments, while limiting separate APC payment only to orphan drugs, blood and blood products, certain vaccines and extremely costly drugs. The commenter also stated that integrating payments for packaged services will be less burdensome for hospitals and will eliminate incentives for higher costs that might be created by special additional reimbursement. As noted in section XI, the Medicare Payment Advisory Committee also urged CMS to incorporate more drugs into the base APCs.
The “two times” rule requires that the highest median cost of a within an APC cannot be more than two times greater than the lowest median cost of a procedure within that APC. We apply the “two-times” rule to the total cost of each procedure (which includes items and services that are packaged within that procedure). In the case of APCs containing only items, we apply the rule to the cost of each item that is grouped in the APC. We do not apply the two times rule to the variation in cost of individual items or ancillary services we attribute to a single HCPCS code.
If we were to attempt to apply the rule to all items and ancillary services within the various procedures, accounting for the variation in cost of supplies such as bandages, reusable instruments, and other medical supplies would be a practical impossibility. It would lead to a highly fragmented set of payment cells and a greatly more complex payment system that would reduce the incentives for effective management by hospitals. We do not believe Congress would have intended such a result.
Consistent with the principles of prospective payment, we package the cost of as many items and ancillary services as possible into the median cost of a procedure. Therefore, our payment methodology for 2003, includes packaging the costs of drugs and biologicals with median costs below $150 per line into the costs of the procedures with which they were billed. We reviewed the median cost of the procedures used for administration of drugs and biologicals, before and after we packaged the costs of drugs and biologicals. Our review indicates that the final median cost appropriately accounts for the administration procedure and the cost of the administered drug and/or biologic.
• In accordance with the in section 1861(s)(2)(B) of the Act and related Medicare regulations and program issuances, drugs and biologicals that are not usually self-administered by the patient are payable under the OPPS. As we explain elsewhere in this final rule, Medicare makes separate payment for certain drugs and biologicals and packages payment for others into the procedure with which they are billed.
• The fact that a drug has a HCPCS code and a payment rate under the OPPS does not imply that the drug is covered by the Medicare program, but only indicates how the drug may be paid if it is covered by the program.
• A code and payment amount does not represent a determination that the Medicare program covers a drug. Contractors must determine whether the drug meets all program requirements for coverage; for example, that the drug is reasonable and necessary to treat the beneficiary's condition and whether it is excluded from payment because it is usually self-administered.
• Certain drugs are so integral to a treatment or procedure that the treatment or procedure could not be performed without them. Because such drugs are so clearly an integral component part of the procedure or treatment, they are packaged as supplies under the OPPS into the APC for the procedure or treatment. Consequently, payment for them is included in the APC payment for the procedure or treatment of which they are an integral part.
• Under the OPPS, hospitals may not separately bill beneficiaries for items whose costs are packaged into the APC payment for the procedure with which they are used (except for the copayment that applies to the APC).
In short, neither the OPPS nor other Medicare reimbursement rules regulate the provision or billing by hospitals of non-covered drugs to Medicare beneficiaries. Accordingly, it would be inappropriate to include the statement in the 1998 rule. However, in some circumstances, such practices potentially implicate other statutory and regulatory provisions, including the prohibition on inducements to beneficiaries, section 1128A(a)(5) of the Act, or the anti-kickback statute, section 1128B(b) of the Act.
Section 1833(t)(6) of the Act requires us to establish transitional pass-through payments for devices of brachytherapy. As of August 1, 2000, we established item-specific device codes including codes for brachytherapy seeds, needles, and catheters. Effective April 1, 2001, we established category codes for brachytherapy seeds on a per seed basis (one for each isotope), brachytherapy needles on a per needle basis, and brachytherapy catheters on a per catheter basis. Because initial payment was made for a device in each of these categories in August 2000, we proposed that these categories (and the transitional pass-through payments) will be discontinued as of January 1, 2003. Furthermore, as discussed above, we
We received comments, both in writing and at the April 2002 Town Hall meeting, recommending that we continue to make separate payment for brachytherapy seeds. The basis for this recommendation is that the number of brachytherapy seeds implanted per procedure is variable. These commenters stated that the number and type of seeds implanted in a given patient depends on the type of tumor, its size, extent, and biology, and the amount of radioactivity contained in each seed. To further complicate the matter, the HCPCS codes used to report implantation of brachytherapy seeds are not tumor-specific. Instead, they are defined based on the number of sources, that is, the number of seeds or ribbons used in the procedure. This means that the treatment of many different tumors requiring implantation of widely varying numbers of seeds is described by a single HCPCS code. Therefore, it has been argued that given the costs of seeds and the variety of treatments described by a single HCPCS code, the cost of brachytherapy billed under a single HCPCS code could vary by as much as $3,000.
In determining whether to package seeds into their associated procedures, we considered all these factors as well as our claims data. Consistent with our proposed policy for other device costs and the cost of many drugs, as well as with the principles of a prospective payment system, our preferred policy is to package the cost of brachytherapy devices into their associated procedures. For 2003, in the case of remote afterloading high intensity brachytherapy and prostate brachytherapy, which we discuss below, we proposed to package the costs into payment for the procedures with which they are billed.
For other uses of brachytherapy, we proposed to defer packaging of brachytherapy seeds for at least 1 year. In those cases, when paying separately in 2003 for brachytherapy seeds, we proposed to continue payment on a per seed basis. The payment amount would be based on the median cost of brachytherapy seeds, per seed, as determined from our claims data.
We solicited comments on methodologies we might use to package all brachytherapy seeds beginning in CY 2004. For example, creation of tumor-specific brachytherapy HCPCS codes would reduce the variability in seed implantation costs associated with the current HCPCS codes used for seed implantation.
As stated above, beginning January 1, 2003, we proposed to package payment for brachytherapy seeds into the payment for the following two types of brachytherapy services:
Participants in the April 5, 2002 Town Hall meeting expressed concern about packaging single use brachytherapy seeds into payment for procedures.
Remote afterloading high intensity brachytherapy treatment does not involve implantation of seeds. Instead, it utilizes a single radioactive “source” of high dose iridium with a 90-day life span. This single source is purchased and used multiple times in multiple patients over its life. One or more temporary catheters are inserted into the area requiring treatment, and the radioactive source is briefly inserted into each catheter and then removed. Because the source never comes in direct contact with the patient, it may be used for multiple patients. We note that the cost of the radioactive source, per procedure, is the same irrespective of how many catheters are inserted into the patient. We believe that the costs of this type of source should be amortized over the life of the source. Therefore, each hospital administering this type of therapy should include its own charge for the radiation source in the charge for the procedure. Therefore, we proposed to package the costs associated with high dose iridium into the HCPCS codes used to describe this procedure. Those codes are: 77781, 77782, 77783, and 77784.
The preponderance of brachytherapy claims under OPPS to date is for prostate brachytherapy. Brachytherapy is administered in several other organ systems, but the claims volume for non-prostate brachytherapy is very small, and hence our base of information on which to make payment decisions is slim. Furthermore, prostate brachytherapy uses only two isotopes, which are similar in cost, while brachytherapy on other organs involves a variety of isotopes with greater variation in cost. Consequently, we believe it would be prudent to wait for further experience to develop before proceeding to package non-prostate brachytherapy seeds.
A number of commenters at the April 5, 2002, Town Hall Meeting and elsewhere have stressed to us their views that brachytherapy seeds should remain unpackaged. The principle argument put forth in favor of this approach is that the number of seeds used is highly variable across patients. We do not find this argument compelling. Payments in the OPPS, as in other prospective payment systems, are based on averages. We believe the service volume at hospitals providing prostate brachytherapy is likely to be large enough for a payment reflecting average use of seeds to be appropriate.
Additionally, appropriate payment for prostate brachytherapy has been of concern to many commenters since implementation of the OPPS because facilities must use multiple HCPCS codes on a single claim to accurately describe the entire procedure. Because we determine APC relative weights using single procedure claims, commenters have argued that payments for prostate brachytherapy are, in part, based on error claims, resulting in underpayment for this important service. We agree that basing the relative weights for APCs reported for prostate brachytherapy services on only the small number of claims related to this service that are single procedure claims may be problematic. To increase the number of claims we could use to develop the proposed 2003 relative payment weights for prostate brachytherapy, we began by identifying all claims billed in 2001 for prostate brachytherapy. Unfortunately, closer analysis of these claims revealed that hospitals do not report prostate brachytherapy using a uniform combination of codes. Of the more than 12,000 claims for prostate brachytherapy that we identified in the 2001 claims data, no single combination of HCPCS codes occurred more than 25 times.
Therefore, in order to facilitate tracking of this service, we proposed to establish a G code for hospital use only that will specifically identify prostate brachytherapy. We proposed as the descriptor for this G code the following: “Prostate brachytherapy, including transperineal placement of needles or catheters into the prostate, cystoscopy, and interstitial radiation source application.” This G code would be used by hospitals instead of HCPCS codes 55859 and 77778 to bill for prostate brachytherapy. Hospitals would continue to use HCPCS codes 55859 and 77778 when reporting services other than prostate brachytherapy. We would also instruct hospitals to continue to report separately other services provided in conjunction with prostate brachytherapy, such as dosimetry and ultrasound guidance. These additional services would be paid according to the APC payment rate established by our usual methodology.
This G code will allow us to package brachytherapy seeds into the procedures for administering prostate brachytherapy while permitting us to pay separately for brachytherapy seeds which are administered for other procedures. Therefore, we proposed to package the costs of the brachytherapy seeds, catheters, and needles into the payment for the prostate brachytherapy G code. In order to develop a payment amount for this G code, we used all claims where both HCPCS codes 55859 and 77778 appeared. We packaged all revenue centers and appropriate HCPCS codes, that is, HCPCS with status indicator “N.” We then determined median costs of the line items for HCPCS codes 55859 and 77778 and added the two. Next, we packaged the costs of all C codes, whether an item-specific or a device category code, into the payment amount. We proposed to assign APC 0684 with status indicator “T.” We believe the payment rate proposed for this G code appropriately reflects the costs of the procedures, the brachytherapy seeds, and any other devices associated with these procedures. We solicited comments on this proposal.
We proposed to package the costs of brachytherapy needles and catheters with whichever procedures they are reported, similar to our proposal for packaging the costs of other devices that will no longer be eligible for a transitional pass-through payment in 2003. Because the HCPCS code descriptors for brachytherapy are based on the number of catheters or needles used, we believe the costs of these devices would be appropriately reflected within the costs of the associated procedure.
• The high variability in the number of sources used per treatment.
• The difference in cost between iodine and palladium seeds.
• Packaging of seeds violates the two times rule.
• Some hospitals specialize in complex cases requiring high numbers of seeds and would always be underpaid.
• A single payment rate would provide incentives to use cheaper (iodine) seeds when more expensive seeds (palladium) were clinically appropriate.
• A single payment rate would provide an incentive to use fewer, higher activity seeds even if use of more lower activity seeds was clinically appropriate.
• Underpayment for prostate brachytherapy will create an incentive to use more invasive, riskier, and costly treatments for prostate cancer.
• The proposed payment rate is too low as a result of using improperly coded claims.
• Creating a new G code is administratively burdensome.
Most commenters recommended that we continue to pay separately for brachytherapy sources used for prostate cancer, as we proposed to do for other forms of cancer. Some commenters requested that we withdraw our proposal for the G code describing brachytherapy and continue to recognize CPT codes 55859 and 77778 while other commenters agreed with our proposal to create the G code with packaged needles and catheters but asked that we not package brachytherapy sources into it. Some commenters requested that, if we finalize our G code, that it be paid as least as much as combined payment rate for the APCs containing CPT codes 55859 and 77778.
A few commenters agreed with our proposed G code approach but asked that we create 2 G codes, one for prostate brachytherapy using iodine seeds and another for prostate brachytherapy using palladium seeds. They also suggested that if CMS finalizes one or more G codes, coding edits should be developed to ensure proper coding of these procedures.
We believe that implementation of these G codes should address the clinical concerns of the commenters. We do not believe these codes will create an incentive to use one type of source rather than another. Additionally, because of the number of seeds packaged we do not believe there will be an incentive to use fewer seeds inappropriately. Furthermore, we believe the number of packaged seeds addresses the concerns about seed variability as we are not aware of facilities that specialize in using more palladium or iodine than are packaged in these codes. Finally, we do not have evidence that implementation of these G codes and their payment rates will create an incentive to treat prostate cancer with more invasive, more costly treatments.
For non-clinical concerns, we think that implementation of the G codes will actually decrease administrative burden as it will now be easier for hospitals to properly code for prostate brachytherapy procedures, and we believe that the methodology we used to develop median costs addresses the concerns about underpayment.
When performing prostate brachytherapy hospitals should use G0256 and G0261 and should not report CPT codes 55859 and 77778. Furthermore hospitals should not report the APCs for iodine and palladium brachytherapy sources. CMS will create edits to prevent billing of these items and services with prostate brachytherapy. However, other services provided during the provision of prostate brachytherapy such as intraoperative ultrasound, dosimetry, etc., are separately payable and should be reported on the claim if performed.
As discussed in the November 13, 2000 interim final rule (65 FR 67809) and the November 30, 2001 final rule (66 FR 59895), we update the payment rates for pass-through drugs on an annual basis. Therefore, as we have done for prior updates, we proposed to update the APC rates for drugs that are eligible for pass-through payments in 2003 using the most recent version of the Red Book, the July 2002 version in this case. The updated rates effective January 1, 2003 would remain in effect until we implement the next annual
As described in our final rule of November 30, 2001 (66 FR 59894), in order to establish the applicable beneficiary copayment amount and the pass-through payment amount, we must determine the cost of the pass-through eligible drug or biological that would have been included in the payment rate for its associated APC had the drug or biological been packaged. We used hospital acquisition costs as a proxy for the amount that would have been packaged, based on data from an external survey of hospital drug costs (see the April 7, 2000 final rule (65 FR 18481)). That survey concluded that—
• For drugs available through only one source drugs, the ratio of acquisition cost to AWP equals 0.68;
• For multisource drugs, the ratio of acquisition cost to AWP equals 0.61;
• For drugs with generic competitors, the ratio is 0.43.
As we stated in our final rule of November 30, 2001 (66 FR 59896), we considered the use of the study-derived ratios of drug costs to AWP to be an interim measure until we could obtain data on hospital costs from claims. We stated that we anticipated having this data to use in setting payment rates for 2003.
As described elsewhere in this preamble, we used 2001 claims data to calculate a median cost per unit of drug for each drug for which we are currently paying separately. We compared the median per unit cost of each drug to the AWP to determine a ratio of acquisition cost to AWP. Using the total units billed for each drug, we then calculated a weighted average for each of the above three categories of drugs. These calculations resulted in the following weighted average ratios:
• For sole-source drugs, the ratio of cost to AWP equals 71.0 percent.
• For multisource drugs, the ratio of cost to AWP equals 68.0 percent.
• For drugs with generic competitors, the ratio of cost to AWP equals 46.0 percent.
We proposed to use these percentages for determining the applicable beneficiary copayment amount and the pass-through payment amount for most drugs eligible for pass-through payment in 2003. However some drugs may fall into two other classes. The first class includes a drug that is new and for which no cost is yet included in an associated APC. For such a drug, because there is no cost for the drug yet included in an associated APC, the pass-through amount will be 95 percent of the AWP and there would be no copayment. The second class includes a drug that is new and is a substitute for only one drug that is recognized in the OPPS through an unpackaged APC. For drugs in this second class, the pass-through amount would be the difference between 95 percent of the AWP for the pass-through drug and the payment rate for the comparable dose of the associated drug's APC. The copayment would be based on the payment rate of its associated APC. We believe that using this methodology will yield a more accurate payment rate.
We have received questions for our definition of multisource drugs. In determining whether a drug is available from multiple sources, we consider repackagers to be among the sources. This is consistent with the findings of the survey cited above which indicated a lower ratio of acquisition cost to AWP from multiple sources including repackagers.
We note that determining that a drug is eligible for a pass-through payment or assigning a status indicator “K” to a drug or biological (indicating that the drugs or biologicals is paid based on a separate APC rate) indicates only the method by which the drug or biological is paid if it is covered by the Medicare program. It does not represent a determination that the drug is covered by the Medicare program. For example, Medicare contractors must determine whether the drug or biological is: (1) Reasonable and necessary to treat the beneficiary's conditions; and (2) excluded from payment because it is usually self-administered by the patient.
We received several comments on this proposal, which are summarized below.
We have instructed hospitals through our fiscal intermediaries that hospitals may bill for new drugs following FDA approval using an unspecified HCPCS code until a permanent HCPCS is established for the drug and/or we have approved pass-through payment for the drug. Payment for a new drug, if determined by the fiscal intermediary to be a covered drug, would be packaged. However inclusion of the drug charges for the procedure will be considered in determining outlier payments and will be used in future rate setting for the procedure and/or the drug once its pass-through status expires. Hospitals should note that we have lowered the threshold for outlier payments for 2003, and this new threshold requirement is described in section IX of the preamble.
We intend to minimize the delays in the review process as much as possible so that we can facilitate access to new products and services for our beneficiaries, which is why we review new pass-through applications on a quarterly basis. We disagree with the commenters who suggested that we allow retroactive reimbursement for hospitals to the date of FDA approval. Moving to such a policy would greatly increase the burden on our and hospitals' computer systems in programming, testing, and implementing updates to the payment system. We do not provide for retroactive changes in reimbursement because this is a prospectively
We appreciate the suggestion to create an on-line listing of all transitional pass-through items and applications that are under review, and will consider it for the future.
We carefully considered the proposal to update the pass-through payments on a quarterly basis and decided to continue with only annual updates of the rates. From previous experience, we know that doing a quarterly update of the prices for all the pass-through drugs and biologicals would be burdensome on our contractors and disruptive to both our computer systems and pricing software. Although we make other updates on a quarterly basis, we do not include revision of rates in these updates unless an error was made in the calculation of the rate. We see no compelling reason to update the transitional pass-through drug prices under the OPPS more frequently than the other payment rates in the outpatient system.
The Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999 (BBRA), Public Law 106-113, amended section 1833(t) of the Act to make major changes that affected the new PPS for hospital outpatient services. Section 1833(t)(6) of the Act, which was added by section 201(b) of the BBRA, provided for temporary additional payments, referred to as “transitional pass-through payments,” for certain drugs, biologicals, and devices. Section 1833(t)(b) of the Act provided for payment of new medical devices, as well as new drugs and biologicals, in instances in which the item was not being paid as a hospital outpatient service as of December 31, 1996, and when the cost of the item is “not insignificant” in relation to the OPPS payment amount. Section 402 of BIPA, which amends section 1833(t)(6) of the Act, requires us to use categories in determining the eligibility of devices for transitional pass-through payments effective April 1, 2001. Section 1833(t)(6)(B)(ii)(IV) of the Act, as added by section 402(a) of BIPA, requires us to establish a new category for a medical device when—
• The cost of the device is not insignificant in relation to the OPPS payment amount;
• No existing or previously existing device category is appropriate for the device; and
• Payment was not being made for the device as an outpatient hospital service as of December 31, 1996. However, section 1833(t)(6)(B)(iv) of the Act, also added by section 402(a) of BIPA, provides that a medical device shall be treated as meeting the first and third requirements if either—
• The device is described by one of the initial categories established and in effect or
• The device is described by one of the additional categories we established and in effect, and—
Section 1833(t)(6)(B)(i)(I) of the Act, as amended by BIPA, required us to establish, by April 1, 2001, an initial set of categories based on device by type in such a way that specific devices eligible
Section 1833(t)(6)(B)(ii)(III) of the Act, as amended by BIPA, requires us to establish criteria by July 1, 2001 that will be used to create additional categories. Section 1833(t)(6)(B)(ii)(II) of the Act requires that no medical device is described by more than one category. In addition, the criteria must include a test of whether the average cost of devices that would be included in a category is “not insignificant” in relation to the APC payment amount for the associated service.
On November 2, 2001, we set forth in an interim final rule (66 FR 55850) the criteria for establishing new (that is, additional) categories of medical devices eligible for transitional pass-through payments under the OPPS as required by section 1833(t)(6)(B)(ii) of the Act. We received five comments regarding our criteria published in the November 2, 2001 interim final rule with comment period. We summarize and respond to these comments below.
As noted above, in our April 7, 2000 final rule with comment period (65 FR 18480), we defined new or innovative devices using eight criteria, three of which were revised in our August 3, 2000 interim final rule with comment period (65 FR 47673 through 47674). These criteria were set forth in regulations at § 419.43(e)(4). For the most part, these criteria remained applicable when defining a new category for devices. That is, devices to be included in a category must meet all previously established applicable criteria for a device eligible for transitional pass-through payments. The definition of an eligible device, however, needed to change to conform to the requirements of the amended section 1833(t)(6)(B)(ii) of the Act, that is, the requirement to establish additional categories, which we accomplished in our November 2, 2001 interim final rule.
In addition, we clarified our criterion that states that a device must be approved or cleared by the FDA. The approval or clearance criterion applies only if FDA approval or clearance is required for the device as specified at new § 419.66(b)(1). For example, a device that has received an FDA investigational device exemption (IDE) and has been classified as a Category B device by the FDA in accordance with § 405.203 through § 405.207 and § 405.211 through § 405.215 is exempt from this requirement. A device that has received an FDA IDE and is classified by the FDA as a Category B device is eligible for a transitional pass-through payment if all other requirements are met.
As described above, in determining the criteria for establishing additional categories, section 1833(t)(6)(B)(ii) of the Act mandates that new categories must be established for devices that were not being paid for as an outpatient hospital service as of December 31, 1996, and for which no category in effect (or previously in effect) is appropriate in such a way that no device is described by more than one category and the average cost of devices to be included in a category is not insignificant in relation to the APC payment amount for the associated service. Based on these requirements, we announced in the November 2, 2001 interim final rule that we will use the following criteria to establish a category of devices:
•
We stated our belief that this criterion ensures that no existing or previously existing category contains devices that are substantially similar to the devices to be included in the new category. This criterion is consistent with the statutory mandate that no device is described by more than one category.
In addition, we said that this criterion limits the number of new categories, and consequently transitional pass-through payments, to those categories containing devices that offer the prospect of substantial clinical improvement in the care of Medicare beneficiaries. Section 1833(t)(6)(E)(iii) of the Act, requires that, if the Secretary estimates before the beginning of the year that the total estimated amount of pass-through payments would exceed a specified percentage of total program payments (2.5 percent before 2004 and no more than 2 percent thereafter), we must uniformly reduce (prospectively) each pass-through payment in that year by an amount adequate to ensure that the limit is not exceeded.
We established this criterion because it is important for hospitals to receive pass-through payments for devices that offer substantial clinical improvement in the treatment of Medicare beneficiaries to facilitate access by beneficiaries to the advantages of the new technology. Conversely, the need for additional payments for devices that offer little or no clinical improvement over a previously existing device is less apparent. These devices can still be used by hospitals, and hospitals will be paid for them through the appropriate APC payment. To the extent these devices are used, the hospitals' charges for the associated procedures will reflect their use. We will use data on hospital charges to update the APC payment rates as part of the annual update cycle. Thus, the payment process will provide an avenue to reflect appropriate payments for devices that are not substantial improvements.
We are currently evaluating requests for a new category of devices against the following criteria in order to determine if it meets the substantial clinical improvement requirement:
• The device offers a treatment option for a patient population unresponsive to, or ineligible for, currently available treatments.
• The device offers the ability to diagnose a medical condition in a patient population where that medical condition is currently undetectable or offers the ability to diagnose a medical condition earlier in a patient population than allowed by currently available methods. There must also be evidence that use of the device to make a diagnosis affects the management of the patient.
• Use of the device significantly improves clinical outcomes for a patient population as compared to currently available treatments. Some examples of outcomes that are frequently evaluated in studies of medical devices are the following:
As part of the application process (described in section V.B.1 of this final rule), we require the requesting party to submit evidence that the category of devices meets one or more of these criteria. We noted that the requirements set forth above will be used only for determining whether a device is eligible for a new category under section 1833(t)(6)(B) of the Act, which authorizes transitional pass-through payments for categories of devices. These criteria are not intended for use in making coverage decisions under section 1862(a)(1)(A) of the Act. We noted that adoption of these criteria is consistent with the recommendation of the Medicare Payment Advisory Commission, in its March 2001 Report to Congress, that pass-through payments for specific technologies be made only when a technology is new or substantially improved.
We stated that we determine which devices represent a substantial clinical improvement over existing devices by using a panel of Federal clinical and other experts, supplemented if appropriate by individual consultation with outside experts. These decisions are, in general, based on information submitted by the requester about the clinical benefit of the devices as described in the above criteria, including, where available, evidence from clinical trials or other clinical investigations. A panel of clinical experts from CMS has thus far made all of our decisions on eligibility for an additional device category.
As indicated in the November 2, 2001 interim final rule, we believe that almost all substantial clinical improvements in technology that are appropriately paid for under the transitional pass-through provisions result in measurable improvements in care from the perspective of the beneficiary. Nevertheless, there may be some improvements in the medical technology itself that are so significant that we may wish to recognize them for separate payment (as opposed to packaged payments) even though they do not directly result in substantial clinical improvements. For example, improvements in such factors as the strength of materials, increased battery life, miniaturization, might so improve convenience, durability, ease of operation, etc., that such an improvement in medical technology might be considered as a separate factor from “substantial clinical improvement” in beneficiary care.
We invited public comment on this issue and particularly asked for examples of medical technologies for which pass-through payments might be appropriate even though they would not also pass a test based on substantial improvement in beneficiary outcomes. Although we received a number of comments on this criterion, only one attempted to provide an example of new medical technology that might not also pass a test based on substantial improvement in beneficiary outcomes. This example is described in our summary of comments and responses below.
As we noted in the November 2, 2001 interim final rule, we will continue to evaluate these criteria as we gain experience in applying them, and we will consider revisions and refinements to them over time as appropriate.
One device manufacturer was concerned that any employment of inappropriate evidentiary standards in evaluating improvement in diagnosis or treatment when applying this criterion could be a barrier to pass-through payment for some new technologies.
Yet, some manufacturers agree that pass-through payment should be limited to technologies that represent significant advancements in providing beneficial new therapy options. A number of commenters felt we should take into account improvements in devices' technology per se, for example, material, power source, size, etc., and not limit our criterion of improvement to clinical improvement. Some commenters held that only technological aspects of new medical devices should be analyzed to determine whether there are advancements over existing pass-through devices to determine whether a device should be considered for an additional category. A manufacturer stated that if we feel that a criterion based on clinical benefits is needed, we should employ a “substantially different” criterion to determine eligibility for a new category. Under this suggestion, any difference in therapeutic effect, indication, surgical approach, safety or side effects, mechanics or function that offers a “new beneficial therapeutic alternative” would be considered “substantial.”
One manufacturer also stated that a “substantial clinical improvement” criterion may be unnecessary, because we already have a criterion that addresses costs that are “not insignificant.”
Those who argue that we should employ a “substantially different” or a “clinical benefit” criterion rather than the “substantial clinical improvement” do not answer the question as to how different a new technology should be to be considered eligible for a new device category. It seems to us that many of the differences listed in the suggestion to base a criterion on “substantial differences” noted above may not reflect qualitatively meaningful differences and such devices could be adequately described by the existing or previously existing categories. If a new device technology were adequately described by a category of devices in terms of its clinical application and benefits, then an additional category would not seem
We believe it is harder to make a determination of substantial difference than it is to make a determination as to substantial clinical benefit. Furthermore, we believe that, in general, transitional pass through payments should be made only for technologies that benefit beneficiaries beyond the technologies currently available.”
We believe it is harder to make a determination of substantial difference than it is to make a determination as to substantial clinical benefit. Furthermore, we believe that, in general, transitional pass-through payments should be made only for technologies that benefit beneficiaries beyond the technologies currently available.
The notion that a “substantial clinical improvement” criterion may be unnecessary, because we already have a criterion that addresses “not insignificant cost,” is misplaced. The cost of the new technology may or may not directly address a nominated device's clinical benefits. Payment for a costly device may be related to a number of factors, such as Medicare payment policy for a technology or the cost of raw materials or manufacturing process, irrespective of substantial clinical improvement. We established the clinical improvement criterion in addition to the cost significance criterion mandated under statute because one cannot accurately infer that a high relative cost is indicative that a device cannot be described by an existing or previous category of devices. Nor can we automatically infer that a substantially clinically improved device necessarily bears significantly higher cost than what we are currently paying for pass-through devices and procedural payments through the APC payment rates. Therefore, both criteria are needed.
We are continuing to review the issue of technological change that is not associated with substantial clinical benefit to beneficiaries. We will continue to review applications for such devices on a case by case basis and work with applicants to understand exactly what technological changes were made to a device that would make the device eligible for transitional pass through payments. We solicit further examples of such devices so that, in the future, we may establish a more definite criterion for when such changes make a device eligible for transitional pass through payments.
Similarly, another manufacturers' association asserted that clinical outcomes information should not be required for eligibility for a new pass-through category. This commenter suggested that our rules should request information that is appropriate and
We will consider other information in addition to clinical outcomes that is available when clinical trial data are not yet available.
We do not know how one can demonstrate “potential” clinical improvement. “Potential” refers to the anticipated or possible capability, belief, or expectation for clinical improvement, without the evidentiary demonstration yet.
We do not believe potential improvement is an appropriate criterion. First, it would be difficult to prove; second, we would be in the position of potentially making extra payments for technologies that actually harmed beneficiaries. Thus using “potential” clinical improvement would assure that all new devices would meet such a criteria if the manufacturer asserted that the device in question offers a “potential” clinical improvement.”
Some commenters felt that new categories would need to be created in order to track cost of newer devices, even if they are described by existing categories. These commenters asserted that device costs eventually must be placed into APCs that appropriately reflect costs for future payment. Some commenters claimed that investigational devices that attained pass-through status have low procedural volumes and therefore they are underrepresented in the cost data.
Some category descriptions have been modified when it has been brought to our attention that the descriptor is unclear. We first revised the descriptors of device categories in Program Memorandum A-01-73, effective July 1, 2001, in order to clarify the devices covered by categories. However, we do not intend to revise descriptors solely to allow the creation of new categories. If a device or class of devices is described by the categories we initially created, we will apply the criteria we implemented to determine whether an additional category is warranted. If we determine that an additional category is needed to adequately describe and pay for new devices, we will create a category. If in the course of that determination, we find that clarification of an existing or previously existing category is needed so that only one category describes the device, as required by statute, then we will modify the description of the existing or previously existing category or categories, in order to achieve that clarification.
We are maintaining our criteria to establish a new category of devices for pass-through payment.
• The estimated average reasonable cost of devices in the category exceeds 25 percent of the applicable APC payment amount for the service associated with the category of devices.
• The estimated average reasonable cost of devices in the category exceeds the cost of the device-related portion of the APC payment amount for the service associated with the category of devices by at least 25 percent.
• The difference between the estimated average reasonable cost of the devices in the category and the portion of the APC payment amount determined to be associated with the device in the associated APC exceeds 10 percent of the total APC payment.
Of these three cost criteria, the latter two remain unchanged from the existing thresholds for individual devices (however, as discussed below, their effective date was revised). The first criterion, however, represents a change in the percentage threshold.
In the April 7, 2000 final rule, we provided that a device's expected reasonable cost must exceed 25 percent of the applicable APC payment for the associated service as the criterion for determining when the cost of a specific device is “not insignificant” in relation to the APC payment (65 FR 18480). In the August 3, 2000 interim final rule, we lowered the threshold to 10 percent because we believed the 25 percent limit was too restrictive based on the brand specific approach at the time (65 FR 47673; § 419.43(e)(1)(iv)(C)). However, given our payment experience in 2001 using the 10 percent threshold, including our information on the estimated amount of pass-through payments in CY 2002, we determined a higher threshold was warranted. We believed that setting a higher cost threshold ensures that new categories are created only in those instances where they are most valuable to beneficiaries and hospitals, given the overall limits on pass-through payments. That is, pass-through payments will be targeted only to those devices where cost considerations might be most likely to interfere with patient access.
We found that once we lowered the threshold to 10 percent, a very small minority (less than 10 percent) of devices that met all other criteria for the pass-through payment was rejected on the basis of this criterion. Partly as a result, the list of devices qualified for pass-through payments increased to well over 1,000 devices by the end of 2000. Although the extensive number of qualified devices allowed hospitals to receive additional payment for many devices, we estimated that the overall pass-through payment amount for calendar year 2002 would exceed the 2.5 percent cap. Therefore, for that year, a substantial reduction in the amount of each pass-through payment, as required by section 1833(t)(6)(E)(iii) of the Act, was established. Thus, allowing a large number of marginally costly devices to qualify for the pass-through payment
In addition, once a category is established, devices included in the category are eligible for pass-through payments regardless of the cost of the devices. Therefore, we determined that it is reasonable to set a higher threshold than 10 percent to establish a new category. While the cost of most devices described by a category may equal or exceed the threshold we use in establishing a category, the cost of individual devices could easily fall below the threshold. Therefore, we believe that it is reasonable to use a higher threshold in establishing a category than in qualifying individual devices.
Concerning the latter two criteria for determining that the estimated cost of a category of devices is not insignificant, we intended to apply these criteria to devices for which a pass-through payment is first made on or after January 1, 2003, as we provided in the August 3, 2000 interim final rule (65 FR 47673). We stated that the delay would allow us sufficient time to gather and analyze data needed to determine the current portion of the APC payment associated with the devices.
Based on the outpatient claims data we have been using for analysis, we have been able, in many cases, to use these criteria as of the November 2, 2001 interim final rule. Although the 1996 data did not provide a level of information that allowed us to determine the portion of the APC payment that was related to the device (except in a very few cases such as pacemakers), the later data have generally provided this level of detail. Therefore we applied the second and third cost criteria for the purpose of determining eligibility of proposed new categories, as described in regulations at § 419.66(d)(2) and § 419.66(d)(3), as soon after the implementation of the November 2, 2001 interim final rule as we had data to do so rather than on January 1, 2003. Although in some instances the lack of specific data prevented the application of these criteria, we believed that should not delay our use of these criteria in those situations in which the data have been available.
In order to implement these second and third criteria for the purpose of creating new device categories, it is necessary to obtain the cost of the device-related portion of the APC payment amount. For evaluations of device category applications in 2002, we used the device-offset amounts published in our March 1, 2002 final rule (67 FR 9557 through 9558), which are used to calculate the subtractions to device pass-through payments. For 2003, we will use the device-offset amounts found in Table 11 in this rule as the device-related portion of the APC payment needed for cost criteria 2 and 3. The device-offset amounts represent the device costs that have been folded into the respective APC payment rates. In those cases where an application is received in which the service-related HCPCS codes for the device is mapped to no APC that has a device offset amount, we apply only the first cost criterion.
We do not see any compelling reason to adopt the proposed alternate percentages of the APC amount as the threshold of using as an alternative to our current cost significance threshold of 25 percent for device portions related to any respective APC. Moreover, the initial pass-through categories were based on devices that achieved pass-through status with a lower 10 percent threshold.
In developing the specific criteria for meeting the statutory cost significance requirement, we established thresholds which we believe ensure that new categories are created where they are most valuable to beneficiaries and hospitals, given the overall limits on pass-through payments. Our goal is to target pass-through payments at those devices where cost considerations might be most likely to interfere with patient access.
To properly target the pass-through payments at devices that could represent a substantial loss to the hospital, it is important to both assess the incremental cost of performing the procedure using the new device as well as to compare the cost of the new device against the costs of existing devices already packaged into the APC payment for the procedure.
The first prong of our three prong criterion tests only the relationship of the new device to the cost of the entire procedure whereas the second and third prongs test for the relationship to device costs already incorporated into the payment rate for the procedure.
This organization also felt that the (then) current number of initial categories is appropriate. It urged us to make application information regarding any proposed new categories public for comment before final creation of a new category.
We will continue to use the three prongs of the not insignificant cost test as published in the November 2, 2001 interim final rule.
Device manufacturers, hospitals, or other interested parties may apply for a new device category for transitional pass-through payments. Details regarding the informational requirements, deadlines for quarterly review, and other aspects of the application process are available on our Web site,
We will accept applications at any time. However, we will establish new categories only at the beginning of a calendar quarter, in deference to our computer systems needs and those of our contractors and hospitals. We must receive applications in sufficient time before the beginning of the calendar quarter in which a category would be established to allow for decision-making and programming. For now, we will require that applications be received at least 4 months before the beginning of the quarter. Moreover, we have found, that, due to the complexity of the information and review process for additional categories, we cannot always complete our review within that time frame. Review of applications involving devices with new technologies often involves requesting additional information from the applicants, as well as consultation with experts in certain clinical specialties (usually here at CMS) or with other clinical personnel at CMS with expertise in Medicare coverage issues, as needed (for example, the hearing aid issue).
We may change the details of this application process in the future to reflect experience in evaluating applications and programmatic needs. If we revise these instructions, we will submit the revisions to the Office of Management and Budget under the Paperwork Reduction Act. We will also post the revisions on our Web site.
We are making no change to our application process at this time.
When we determine a new category is warranted, we issue a Program Memorandum specifying a new Healthcare Common Procedure Coding System (HCPCS, formerly known as HCFA Common Procedure Coding System) code and short and long descriptors for the category. We may also include additional clarifying or definitional information to help distinguish the new category from other existing or previously existing categories. It may be necessary to redefine, or make other changes to, existing or previously existing categories to accommodate a new category and ensure that no medical device is described by more than one category, though we attempt to keep these changes to a minimum. We will post these Program Memoranda on our Web site on a quarterly basis. We may find it necessary occasionally to correct or amend the list of (and clarifying information associated with) pass-through device categories. We do not expect this step will be needed often, but if it is necessary, we will issue any changes in a Program Memorandum.
Section 1833(t)(2)(D) of the Act requires that we determine a wage adjustment factor to adjust for geographic wage differences, in a budget-neutral manner, the portion of the OPPS payment rate and copayment amount that is attributable to labor and labor-related costs.
We used the proposed Federal fiscal year (FY) 2003 hospital inpatient PPS
Section 1833(t)(8)(C)(ii) of the Act accelerates the reduction of beneficiary copayment amounts, providing that, for services furnished on or after April 1, 2001, and before January 1, 2002, the national unadjusted coinsurance for an APC cannot exceed 57 percent of the APC payment rate. The statute provides that the national unadjusted coinsurance for an APC cannot exceed 55 percent in 2002 and 2003. The statute provides for further reductions in future years so that the national unadjusted coinsurance for an APC cannot exceed 55 percent of the APC payment rate in 2002 and 2003, 50 percent in 2004, 45 percent in 2005, and 40 percent in 2006 and thereafter.
For 2003, we determined copayment amounts for new and revised APCs using the same methodology that we implemented for 2002 (see the November 30, 2001 final at 66 FR 59888). See Addendum B for national unadjusted copayments for 2003. Our regulations at § 419.41 conform to this provision of the Act.
Section 1833(t)(3)(C)(ii) of the Act requires us to update the conversion factor used to determine payment rates under the OPPS on an annual basis.
Section 1833(t)(3)(C)(iv) of the Act provides that for 2003, the update is equal to the hospital inpatient market basket percentage increase applicable to hospital discharges under section 1886(b)(3)(B)(iii) of the Act.
The most recent forecast of the hospital market basket increase for FY 2003 is 3.5 percent. To set the proposed OPPS conversion factor for 2003, we increased the 2002 conversion factor of $50.904 (the figure from the March 1, 2002 final rule (67 FR 9556)) by 3.5 percent.
In accordance with section 1833(t)(9)(B) of the Act, we further adjusted the conversion factor for 2003 to ensure that the revisions we made to update the wage index are made on a budget-neutral basis. We calculated the proposed budget-neutrality factor of .98778 for wage-index changes by comparing total payments from our simulation model using the proposed FY 2003 hospital inpatient PPS wage-index values to those payments using the current (FY 2002) wage-index values.
The increase factor of 3.5 percent for 2003 and the required wage-index budget-neutrality adjustment of .98715 resulted in a proposed conversion factor for 2003 of 52.009.
In determining the proposed conversion factor of 52.009, we projected 2.5 percent pass-through payments based on our preliminary estimates of pass-through payments for CY 2003. As described in the section IV discussion of the pro-rata provisions, our final estimate of pass-through payments in CY 2003 is 2.3 percent of the total program payments for covered OPD services. Therefore, we have increased the final conversion factor to reflect the projected change in pass-through spending from 2.5 percent to 2.3 percent. After applying this adjustment, the 3.5 percent update factor and the final budget-neutrality adjustment of .98778 to account for changes due to the final FY 2003 hospital inpatient wage-index values, we establish the final conversion factor for 2003 at $52.151 (or 52.152).
We received several comments concerning the conversion factor update for 2003, which are summarized below along with our responses.
For OPPS services furnished between August 1, 2000, and April 1, 2002, we calculated outlier payments in the aggregate for all OPPS services that appear on a bill in accordance with section 1833(t)(5)(D) of the Act. In the November 30, 2001 final rule (66 FR 59856, 59888), we specified that beginning with 2002, we will calculate outlier payments based on each individual OPPS service. We revised the aggregate method that we had used to calculate outlier payments and began to determine outliers on a service-by-service basis.
As explained in the April 7, 2000 final rule (65 FR 18498), we set a target for outlier payments at 2.0 percent of total payments. For purposes of simulating payments to calculate outlier thresholds, we proposed to set the target for outlier payments at 2.0 percent. The target was 2.0 percent for CY 2001 and 1.5 percent for 2002. For 2002, the outlier threshold is met when costs of furnishing a service or procedure exceed 3.5 times the APC payment amount, and the current outlier payment percentage is 50 percent of the amount of costs in excess of the threshold. Based on our simulations for 2003, we proposed to set the threshold for 2003 at 2.75 times the APC payment amounts, and the proposed 2003 payment percentage applicable to costs over the threshold at 50 percent.
In this final rule we are setting the target amount for outlier payments at 2 percent of total payments. Based on revised simulations performed for the final rule, in order to pay outlier payments at the target amount, we are adopting the proposed outlier threshold of 2.75 but decreasing the outlier payment percentage to 45 percent. Simulations using the final APC rates and projecting outlier payments for 2003 using a different set of claims than we used for the proposed rule (claims for the period April 1, 2001 through March 31, 2002 instead of claims for calendar year 2001) resulted in outlier payments that were in excess of the 2 percent outlier payment target. In order to meet, but not exceed, the target we found it necessary to either increase the proposed outlier threshold of 2.75 or reduce the proposed outlier payment percentage of 50 percent. Because we wanted to make it easier for more for high cost services to qualify for outlier payments, we chose to adopt the proposed outlier threshold but reduce the outlier payment percentage to 45 percent. For 2003, the outlier threshold will be met when costs of furnishing a service or procedure exceed 2.75 times the APC payment amount, and the outlier payment percent will be 45 percent of the amount of costs in excess of the threshold.
We received a number of comments concerning our proposed threshold and percentages for outlier payments, which are summarized below along with our responses. We also received comments concerning the changes that we proposed and finalized in 2002 with respect to the calculation of outliers on a service-by-service basis. Because we have not proposed any changes to the current policy, we do not summarize those comments in this preamble.
Currently, facilities code clinic and emergency department visits using the same current procedural terminology (CPT) codes as physicians. For both clinic and emergency department visits, there are five levels of care. While there is only one set of codes for emergency visits, clinic visits are differentiated by new patient, established patient, and consultation visits. CPT codes 99201 through 99205 are used for new patients, CPT codes 99211 through 99215 are used for established patients, and CPT codes 99281 through 99285 for emergency patients.
Physicians determine the proper code for reporting their services by referring to CPT descriptors and our documentation guidelines. The descriptors and guidelines are helpful to physicians because they reference taking a history, performing an examination, and making medical decisions. The lower levels of service (for example, CPT codes 99201, 99211, and 99281) are used for shorter visits and for patients with uncomplicated problems, and the higher levels of service (for example, CPT codes 99205, 99215, and 99285) are used for longer visits and patients with complex problems.
These codes were defined to reflect the activities of physicians. It is generally agreed, however, that they do not describe well the range and mix of services provided by facilities to clinic and emergency patients (for example, ongoing nursing care, preparation for diagnostic tests, and patient education).
Before the implementation of the OPPS, facilities were paid on the basis of charges reduced to costs. In that system, because use of a correct HCPCS code did not influence payment, there was little incentive to correctly report the level of service. In fact, many facilities reported all clinic and emergency visits with the lowest level of service (for example, CPT codes 99211, 99201, and 99281) simply to minimize administrative burden (for example, charge-masters might include only one level of service).
This situation changed with the implementation of the OPPS. The OPPS requires correct reporting of services using HCPCS codes as a prerequisite to payment. For emergency and clinic visits, the OPPS distinguishes three levels of service for payment purposes. These are referred to as “low-level,” “mid-level,” and “high-level” emergency or clinic visits. Payment rates for low-level visits are less than for mid-level visits, which are less than rates for high-level visits.
In the April 7, 2000 final rule (65 FR 18434), we stated that to pay hospitals properly, it was important that emergency and clinic visits be coded properly. To facilitate proper coding, we required each hospital to create an internal set of guidelines to determine what level of visit to report for each patient. We stated in the rule, that if hospitals set up these guidelines and follow them, they would be in compliance with OPPS coding requirements for the visits. Furthermore, we announced that we would be reviewing this issue and planned to set national guidelines for coding clinic and emergency visits in the future. In the August 24, 2001 proposed rule (66 FR 44672), we asked for public comments regarding national guidelines for hospital coding of emergency and clinic visits. We also announced that we would compile these comments and present them to our APC Panel at the January 2002 meeting. We also announced that we planned to propose uniform national facility coding guidelines in the proposed rule for the 2003 OPPS.
During its January 2002 meeting, the APC Panel reviewed written comments, heard oral testimony, discussed the issue, and made recommendations concerning establishment of facility coding guidelines for emergency and clinic visits. Among those who submitted oral and written comments to us and to the Panel were national hospital organizations, national physician organizations, hospital systems, individual hospitals, coding organizations, and consultants.
The APC Panel reviewed the comments that we received, reviewed background material we prepared, and heard oral testimony. Most commenters recommended that we adopt the ACEP guidelines. However, one organization representing cancer centers stated that the most appropriate proxy for facility resource consumption in cancer care is staff time and asked that we consider basing our guidelines on staff time. Commenters agreed that we needed to address this problem in the proposed rule for CY 2003. They also agreed that to address potential HIPAA compliance issues, we should develop new HCPCS codes for facility visits; and that we should maintain five levels of service for emergency and clinic visits until data are available to show that only three levels of service are required to ensure accurate payments. Commenters also agreed that, for the same level of service, clinic resource consumption should be similar for new, established, and consultation patients. Therefore, we need only create a single set of five codes for clinic visits.
After a thorough discussion, the APC technical panel made the following recommendations:
1. Propose and make final facility coding guidelines for E/M services for calendar year 2003.
2. Create a series of G codes with appropriate descriptors for facility E/M services.
3. Maintain a single set of codes, with five levels of service, for emergency department visits.
4. Develop a single set of codes, with five levels of service, for clinic visits.
5. Adopt the ACEP facility coding guidelines as the national guidelines for facility coding of emergency department visits.
6. Develop guidelines for clinic visits that are modeled on the ACEP guidelines but are appropriate for clinic visits.
7. Implement these guidelines as interim and continue to work with appropriate organizations and stakeholders to develop final guidelines.
We reviewed the written comments, the oral testimony before the APC Panel, and the Panel's recommendations; we agreed that facility-coding guidelines should be implemented as soon as possible. We were particularly concerned that facilities be able to comply with HIPAA requirements. We announced that we have worked, and will continue to work, on this issue with hospitals, organizations representing hospitals, physicians, and organizations representing physicians. We noted that the AMA CPT Editorial Panel is not currently considering the issue of facility coding guidelines for clinic visits and that the earliest any CPT guidelines could be implemented would be in January 2004. Additionally, consistent with the intent of the outpatient prospective payment system, we wanted to ensure that reporting of hospital emergency and clinic visits is resource based.
After careful review and consideration of written comments, oral testimony and the APC Panel's recommendations, we proposed the following (for implementation no earlier than January 2004):
1. To develop five G codes to describe emergency department services: GXXX1—Level 1 Facility Emergency Services, GXXX2—Level 2 Facility Emergency Services, GXXX3—Level 3 Facility Emergency Services, GXXX4—Level 4 Facility Emergency Services, and GXXX5—Level 5 Facility Emergency Services.
2. To develop five G codes to describe clinic visits: GXXX6—Level 1 Facility Clinic Services, GXXX7—Level 2 Facility Clinic Services, GXXX8—Level 3 Facility Clinic Services, GXXX9—Level 4 Facility Clinic Services, and GXXX10—Level 5 Facility Clinic Services.
3. To replace CPT Visit Codes with the 10 new G codes for OPPS payment purposes.
4. To establish separate documentation guidelines for emergency visits and clinic visits.
With regard to the documentation guidelines, our primary concerns were to make appropriate payment for medically necessary care, to minimize the information collection and reporting burden on facilities, and to minimize any incentive to provide unnecessary or low quality care. We realized that many facilities use complaint or diagnosis driven care protocols and that current documentation standards do not include documentation of staff time or the complexity of diagnostic and therapeutic services provided. Therefore, in the interest of facilitating the delivery of medically necessary care in a clinically appropriate way, we believed that the potential drawbacks of each of the recommended sets of guidelines outweighed the potential benefits of creating uniformity and reproducibility. For example, any documentation system requiring counting or quantification of resource use has the potential to be burdensome, require clinically unnecessary documentation, and be susceptible to upcoding and gaming. Documentation systems using coding grids or a series of clinical examples for each level of service are subject to interpretation, may induce variability, may be overly complex and burdensome, and may result in disagreements with medical reviewers. We were also concerned that all the proposed guidelines allow counting of separately paid services (for example, intravenous infusion, x-ray, EKG, lab tests, and so forth) as “interventions” or “staff time” in determining a level of service. We believe that, within the constraints of clinical care and management protocols, the level of service for emergency and clinic visits should be determined by resource consumption that is not otherwise separately payable.
To address these concerns, in addition to reviewing written comments, oral comments, and the APC Panel recommendations, we also reviewed, for the proposed rule, the current distribution of paid emergency and clinic visit codes in the OPPS. With regard to emergency visits, we observed that well over 50 percent of the visits were considered “multiple procedure claims” because the claim includes services such as diagnostic tests (for example, EKGs and x-rays) or therapeutic interventions (for example, intravenous infusions). The distribution of all emergency services was in a bell-shaped curve with a slight left shift because there were more claims for CPT codes 99281 and 99282 than for CPT codes 99284 and 99285. This pattern of coding is significantly different from physician billing for emergency services, which is skewed and peaks at CPT code 99284. We also noted that the median costs for successive levels of emergency visits show an expected increase across APCs.
With regard to clinic visits, we observed that more than 50 percent of the services were considered “single claims” meaning that they were billed without any other significant procedures such as diagnostic tests or therapeutic interventions. We also noted that the distribution of clinic visits is skewed with the majority being low-level clinic visits. This distribution was consistent with pre-OPPS billing patterns where many facilities billed all clinic visits as low level visits. However, the median costs for different levels of clinic services, while similar within an APC, did not show the expected increase across the clinic visit APCs.
Based on our review, on the current distribution of coding for emergency and clinic visits, and on our understanding that hospitals set charges for services based on the resources used to provide those services, we believed that an incremental approach to developing and implementing documentation guidelines for emergency and clinic visits was appropriate. For example, as hospitals became more familiar with the OPPS and with the need to differentiate emergency and clinic visits based on resource consumption, we would continue to review the advantages and disadvantages of detailed, uniform documentation guidelines. We planned to begin the development of uniform guidelines over the next year. If we were ready, we would propose the guidelines for comments in our
Because, our data indicated that, in general, hospitals under the OPPS were reporting emergency visits appropriately, we believed that insofar as hospitals have existing guidelines for determining the level of emergency service, those guidelines reflected facility resource consumption. Therefore, we proposed that GXXX1—Level 1 Facility Emergency Services be reported when facilities deliver, and document, basic emergency department services. These services included registration, triage, initial nursing assessment, minimal monitoring in the emergency department (for example,
With regard to GXXX2 through GXXX5, we proposed to require that facilities develop internal documentation guidelines based on hospital resource consumption (for example, staff time). These guidelines would be appropriate for the type of services provided in the hospital and also clearly differentiate the relative resource consumption for each level of service so that a medical reviewer could easily infer the type, complexity, and medical necessity of the services provided and validate the level of service reported. Because of the great variability in available facility resources, staff, and clinical protocols among facilities, we did not believe that it is advisable to require a single set of guidelines for all facilities. Instead, we believed it is appropriate for each facility to develop its own documentation guidelines that took into account the facility's clinical protocols, available facility resources, and staff types. As stated above, we did not propose any specific requirements with regard to the basis of these guidelines. However, the guidelines were to be tied to actual resource consumption in the emergency department such as number and type of staff interventions, staff time, clinical examples, or patient acuity. We also proposed to require that facilities have documentation guidelines available for review upon request. The guidelines had to emphasize relative resource consumption and not, to the extent possible, set minimal requirements as a basis for determining the level of service (for example, require 30 minutes of staff time or five staff interventions to bill a level three emergency visit).
We proposed that these requirements, if made final, would be interim. We proposed to work with interested parties to revise these requirements and to propose any revision to these requirements in a future proposed rule.
We believed that the current distribution of codes for clinic visits were due to a facility's continued use of pre-OPPS coding policies for clinic visits. We believed that over time facilities would become as experienced differentiating levels of clinic visits as they were at differentiating levels of emergency visits. Therefore, we proposed a set of guidelines for clinic visits that paralleled the requirements for emergency visits. We proposed that GXXX6—Level 1 Facility Clinic Services, be reported when facilities deliver, and document, basic clinic services. These services included registration, triage, initial nursing assessment, minimal monitoring in the clinic (for example, one additional set of vital signs), minimal diagnostic and therapeutic services (for example, rapid strep test, urine dipstick), nursing discharge (including brief home instructions), and exam room set up/clean up. Our proposal for GXXX7 through GXXX10 was the same as for GXXX2 through GXXX5 except that the facility-specific guidelines were tied to actual resource consumption in the clinic such as number and type of staff intervention, staff time, clinical examples, or patient acuity. The guidelines had to differentiate the relative resource consumption in the clinic for each level of service sufficiently so that a medical reviewer could easily infer the type, complexity, and medical necessity of the services provided to validate the level of service provided.
We proposed that, if made final, these requirements would be interim. Any changes would be proposed in a future proposed rule.
We proposed to make final, in the 2003 OPPS final rule, changes in coding for clinic and emergency department visits and requirements related to the development of documentation guidelines for the new codes. However, we proposed to implement the new codes and documentation guidelines no earlier than January 1, 2004. This would have given hospitals time to develop documentation guidelines for the new codes and prepare their internal billing systems to accommodate the changes. We proposed to continue to work with hospitals throughout CY 2003 as they developed the documentation guidelines. In the proposed rule, we solicited comments on this proposal overall as well as the specific components of the proposal.
In view of the comments received we believe that the most appropriate forum for development of code definitions and guidelines is an independent expert panel that makes recommendations to CMS in time for CMS to propose specific code definitions in the next year's proposed rule. Organizations such as the American Hospital Association (AHA) and the American Health Information Management Association (AHIMA) have such expertise and are particularly well equipped to provide the ongoing education of providers. We believe it is critically important to the development, acceptance, and implementation of code definitions and guidelines for the organizations that develop the guidelines to also maintain them, update them, and provide ongoing education to providers concerning them. We would be happy to work with such an expert panel as code definitions and guidelines are developed.
We encourage any independent expert panel sending recommendations to CMS concerning guidelines to carefully review the principles and requirements for codes and guidelines that we announced in the proposed rule. We still believe that any set of national guidelines must adhere to those principles and requirements (for example, guidelines must be resource-based). Moreover, we encourage any such panel to address our concerns about existing guidelines (for example, potential for upcoding) in its recommendations to CMS. For example, our Advisory Panel on APC Groups recommended that CMS adopt the facility coding guidelines developed by the American College of Emergency Physicians (ACEP). While we understand that those guidelines have widespread support in the hospital community and that an independent panel may review them while developing guidelines, we would encourage such a panel to review the
CMS hopes to receive recommendations on code definitions in time to include them in the notice of proposed rulemaking for 2004. We agree with the commenters who were concerned about implementing code definitions without national guidelines, and we will not propose or finalize code definitions until national guidelines for them have been developed.
However, if a visit and another service is also billed (that is, chemotherapy, diagnostic test, surgical procedure) the visit must be separately identifiable from the other service because the resources used to provide non-visit services including staff time, equipment, supplies, and so forth, are captured in the line item for that service. Billing a visit in addition to another service merely because the patient interacted with hospital staff or spent time in a room for that service is inappropriate.
On November 30, 2001, we published a final rule updating changes to the OPPS for 2002. We implemented provisions that allow separate payment for observation services under certain conditions. That is, a hospital may bill for a separate APC payment (APC 0339) for observation services for patients with diagnoses of chest pain, asthma, or congestive heart failure when certain criteria are met. The criteria discussed in the November 30, 2001 final rule and as corrected in the March 1, 2002 final rule are also explained in detail in section XI of a Program Memorandum to intermediaries issued on March 28, 2002 (Transmittal A-02-026). Payment for HCPCS code G0244, observation care provided by a facility to a patient with congestive heart failure, chest pain or asthma, minimum eight hours, maximum 48 hours, was effective for services furnished on or after April 1, 2002.
Section XI of Transmittal A-02-026 that was issued on March 28, 2002, provides additional billing and coding instructions and requirements that flow from the basic criteria that we implemented in the November 30, 2001 and the March 1, 2002 final rules. Although we do not address them explicitly in the final rules, the additional instructions and requirements in Transmittal A-02-026 were developed to implement the basic observation criteria within the programming logic of the outpatient code editor (OCE), which is used to process claims submitted by hospitals for payment under the OPPS. For example, in the November 30, 2001 final rule, we state that an emergency department visit (APC 0610, 0611, or 0612) or a clinic visit (APC 0600, 0601, or 0602) must be billed in conjunction with each bill for observation services (66 FR 59879). In section XI of Transmittal A-02-026, we state that an E/M code (referred to, incorrectly, in Transmittal A-02-026 as an “Emergency Management” code), for the emergency room, clinic visit, or critical care is required to be billed on the day before or the day that the patient is admitted to observation. That is, unless one of the CPT codes assigned to APCs 0600, 0601, 0602, 0610, 0611, 0612, or 0620 is billed on the day before or the day that the patient is admitted to observation, separate payment for G0244 is not allowed. The codes assigned to these APCs are categorized by CPT as E/M codes. Although we did not include APC 0620, Critical Care, among the APCs that must be billed in order to receive separate payment for observation services, we added it in the program memorandum because critical care is an E/M service that can be furnished in a clinic or an emergency department. Critical care may appropriately precede admission to observation for chest pain, asthma, or congestive heart failure. We clarify in Transmittal A-02-026 that both the associated E/M code and G0244 are paid separately if the observation criteria are met. We also specify that the E/M code associated with observation must be billed on the same claim as the observation service.
Similarly, in the November 30, 2001 and the March 1, 2002 final rules, we require that certain diagnostic tests be performed in order to bill for separate payment for observation services. In Transmittal A-02-026, in section XI.B.2, we list the diagnostic tests that the OCE looks for on a bill for G0244. This list, which amplifies what we published in the November 30, 2001 and March 1, 2002 final rules, is incomplete and should read as follows to reflect the current OCE logic that is applied to claims for G0244:
• For chest pain, at least two sets of cardiac enzymes [either two CPK (82550, 82552, or 82553), or two troponin (84484 or 84512)], and two sequential electrocardiograms (93005);
• For asthma, a peak expiratory flow rate (94010) or pulse oximetry (94760, 94761, or 94762);
• For congestive heart failure, a chest x-ray (71010, 71020, or 71030) and an electrocardiogram (93005) and pulse oximetry (94760, 94761, or 94762).
• Note: Pulse oximetry codes 94760, 94761, and 94762 are treated as packaged services under the OPPS. Although no separate payment is made for packaged codes, hospitals must separately report the HCPCS code and a charge for pulse oximetry in order to establish that observation services for congestive heart failure and asthma diagnoses meet the criteria for separate payment.
Transmittal A-02-026 also provides specific coding instructions that hospitals must use when billing for observation services that do not meet the criteria for separate payment under APC 0339. In addition, Transmittal A-02-026 addresses the use of modifier -25 with the E/M code billed with G0244.
Since implementation of the provision for separate payment for observation services under APC 0339, a number of hospitals, hospital associations, and other interested parties have asked if separate payment for observation services would be allowed for a patient with chest pain, asthma, or congestive heart failure who is admitted directly into observation by order of the patient's physician but without having received critical care or E/M services in a hospital clinic or the emergency department on the day before or the day of admission to observation. We have responded during monthly CMS hospital open forum calls that, consistent with the criteria in the November 30, 2001 final rule, effective for services furnished on or after April
A related question has arisen in connection with a policy interpretation that was posted as a response to a “Frequently Asked Question” (FAQ) on our Web site on September 12, 2000. The FAQ follows:
“Q.97: If a patient is admitted from the physician's office to the observation room, will there be no reimbursement?
“A.97: Since observation is a packaged service, payment cannot be made if it is the only OPPS service on a claim. However, we believe that the “admission” of a patient to observation involves a low-level visit billed by the hospital, as well as whatever office visit the physician who arranged for the admission billed. Thus, when a patient arrives for observation arranged for by a physician in the community (that is, “direct admit to observation”), and is not seen or assessed by a hospital-based physician, the hospital may bill a low-level visit code. This low-level visit code will capture the baseline nursing assessment, the creation of a medical record, the recording and initiation of telephone orders, and so forth. This visit may be coded only once during the period of observation. The observation charges should be shown in revenue code 762. The number of hours the patient was in observation status should be shown in the units field. Payment for those services is packaged into the APC for the visit. Other services performed in connection with observation, such as lab, radiology, and so forth, should be billed for as well. * * *”
We have been asked to clarify whether or not the low-level visit code suggested in the FAQ for patients directly admitted for observation services would satisfy the requirement that a line item for a hospital emergency visit, hospital clinic visit, or critical care appear on the same bill as HCPCS code G0244. Our response is that when we established the final criteria effective for services furnished on or after April 1, 2002, we did not contemplate that the low-level visit described in the FAQ would satisfy the requirement for the E/M code that a hospital must bill to show a hospital clinic visit or hospital emergency department visit was performed before observation services for asthma, congestive heart failure, or chest pain to bill and receive payment for G0244 under APC 0339.
In light of these questions, we have reviewed the criteria for separate payment for observation services under APC 0339, and we proposed to modify the criteria and coding for observation services furnished on or after January 1, 2003. Specifically, we proposed to create two new codes. These additional codes would allow us to collect data on the extent to which patients are directly admitted to hospital observation services without an associated hospital clinic visit or emergency department visit. The proposed codes were as follows:
G0LLL-Initial nursing assessment of patient directly admitted to observation with diagnosis of congestive heart failure, chest pain, or asthma.
G0MMM-Initial nursing assessment of patient directly admitted to observation with diagnosis other than congestive heart failure, chest pain, or asthma.
If a hospital directly admits to observation from a physician's office a patient with a diagnosis of congestive heart failure, asthma, or chest pain, we proposed to require that G0LLL be billed with G0244. The current requirement that the hospital bill an emergency department visit (APC 0600, 0601, or 0602) or a clinic visit (APC 0610, 0611, or 0612) or a critical care service (APC 0620) in order to receive separate payment for observation services for patients not admitted directly from a physician's office would remain in effect. However, because the initial nursing assessment is part of any observation service, we proposed not to make separate payment for G0LLL. Rather, we proposed to assign status indicator “N” to G0LLL, to designate that charges submitted with G0LLL would be packaged into the costs associated with APC 0339. If G0LLL is billed, we would require that the medical record show that the patient was admitted directly from a physician's office for purposes of evaluating and treating chest pain, asthma, or congestive heart failure.
G0MMM describes the initial nursing assessment of a patient directly admitted to observation with a diagnosis other than chest pain, asthma, or congestive heart failure. We proposed to assign G0MMM for payment under APC 0706, New Technology—Level I. We proposed to require hospitals to bill G0MMM instead of the low level clinic visit referred to in the FAQ above to describe the initial nursing assessment of a patient directly admitted to observation with a diagnosis other than chest pain, asthma, or congestive heart failure. Separate payment would not be made for observation services billed with G0MMM. Rather, when billing G0MMM, hospitals would be required to use revenue code 762 alone or revenue code 762 with one of the HCPCS codes for packaged observation services (99218, 99219, 99220, 99234, 992335, or 99236). We proposed to create G0MMM to establish a separately payable code into which costs for observation care for patients directly admitted for diagnoses other than asthma, chest pain, or congestive heart failure can be packaged and recognized.
We would use billing data for G0LLL and G0MMM in reviewing the provisions for payment of observation services in future updates of the OPPS. In the proposed rule, we invited comment on the extent to which these codes address the concerns that have been raised in connection with patients who are directly admitted to observation services.
Commenters stated that having to use G0LLL and G0MMM, combined with the other requirements that have to be met in order to receive separate payment for observation of patients with asthma, congestive heart failure, and chest pain, would be burdensome and confusing, and would create operational inconsistencies and problems for hospitals. Several commenters urged CMS to simplify, the observation rules in order to reduce their complexity and lessen the burden they currently impose on hospitals. Some commenters were concerned that other payors might not accept the proposed new codes and that the codes would not be HIPAA compliant.
A number of commenters recommended alternatives to the establishment of G0LLL and G0MMM that would utilize information already being reported by hospitals on the UB-92 within the existing coding system for revenue centers, diagnoses, and source and type of admission. One commenter suggested a single G code for “Intake into observation after outside evaluation” supported by appropriate diagnosis coding and claims edits. One
A number of the alternatives suggested by commenters are promising and merit further analysis and review. However, our preliminary inquiries revealed that most of the suggested alternatives would require systems changes that could take six months or longer to develop and install, and that such changes could not be implemented effective January 1, 2003. Therefore, we have decided to implement the proposed G codes as follows:
G0263, Direct admission of patient with diagnosis of congestive heart failure, chest pain or asthma for observation.
G0264, Initial nursing assessment of patient directly admitted to observation with diagnosis other than congestive heart failure, chest pain, or asthma.
These codes would be HIPPA compliant. Other payers would make their own decisions about whether to use these codes for their own payment purposes.
Based on questions and concerns raised by hospitals since implementation of payment for APC 0339 effective April 1, 2002, we have also reviewed the current status of billing intravenous infusions with observation. Several hospitals have noted that claims for G0244 when billed with intravenous infusion services reported with HCPCS code Q0081 are denied because of the “T” status indicator assigned to HCPCS code Q0081. Our current payment rules for G0244 require that G0244 be denied if a service with status indicator “T” is performed the day before, the day of, or the day after observation care. Because patients in observation may require intravenous infusions of fluid, we proposed to create code G0EEE, Intravenous infusion during separately payable observation stay, per observation, payable under APC 0340 with status indicator “X.” When observation services that otherwise meet the billing requirements for separate payment under APC 0339 include an intravenous infusion administered as part of the observation care, G0EEE would be used to report the infusion service. We included instructions on the use of G0258 in the program memorandum issued to implement OPPS coding changes for the October 1, 2002 OCE. In the proposed rule, we solicited comment on the use of this code.
Commenters asked if CMS intends hospital to use G0258 instead of Q0081 when the infusion therapy is provided to the patient in the emergency department or clinic prior to patient's placement in observation when the observation stay ultimately qualifies for separate payment. The commenters pointed out that the hospital may not know when the patient is in the emergency department or clinic and the infusion therapy is initiated that the patient will subsequently be placed in an observation stay that qualifies for payment under G0244. Commenters
One commenter recommended, that we install an OCE edit to ignore Q0081 when checking for the presence of a procedure with SI=T.
Many commenters stated that the payment for G0248 should be the same as the payment for Q0081 because the resources expended for infusion therapy performed during a packaged observation stay are the same as those required for Q0081 furnished. These commenters disagreed with CMS's assertion that payment for G0258 should be discounted to equal 50 percent of the payment for Q0081 because Q0081 is invariably billed with a higher-paying procedure and is, therefore, discounted. Another commenter advocated adjusting the payment for G0244 to include the cost of infusion and eliminating a separate new code. The same commenter supported payment at 50 percent of the rate set for Q0081 because Q0081 would always be discounted because it is always billed with another procedure.
To receive payment for G0244, we require hospitals to bill specified ICD-9-CM diagnosis code(s). Because ICD-9-CM codes are updated effective October 1 of each year, we proposed to issue by Program Memorandum any changes in the diagnosis codes required for payment of G0244 resulting from the ICD-9-CM annual update.
In the March 1, 2002 final rule (67 FR 9559) and in Transmittal A-02-026 issued on March 28, 2002, we listed the diagnosis codes required in order for separate payment of observation services under APC 0339 to be made for patients with congestive heart failure. We added by program memorandum the following new ICD-9-CM codes to the list of allowed diagnosis codes for separate payment for observation of patients with congestive heart failure, effective for services furnished on or after October 1, 2002:
In the August 9, 2002 proposed rule, we invited comment on the addition of these diagnosis codes to the criteria for separate payment for observation services under APC 0339.
• Effective for services furnished on or after January 1, 2003, hospitals may bill for patients directly admitted for observation services using the following codes:
G0263, Direct admission of patient with diagnosis of congestive heart failure, chest pain or asthma for observation.
G0264, Initial nursing assessment of patient directly admitted to observation with diagnosis other than congestive heart failure, chest pain, or asthma.
• Payment for G0264 will be made under APC 600.
• Payment for G0263 will be packaged into the payment for APC 339
• Payment for G0244 will be allowed when billed with Q0081, Infusion therapy other than chemotherapy, when furnished to patients with asthma, congestive heart failure, or chest pain, subject to all other conditions for payment having been met.
As we state in section II.B.5 of this preamble, the inpatient list specifies those services that are only paid when provided in an inpatient setting. The inpatient list proposed for 2003 is printed as Addendum E. In Addendum B, status indicator C designates a HCPCS code that is on the inpatient list.
Over the past year, some hospitals and hospital associations have asked how a hospital could receive Medicare payment for a procedure on the inpatient list that had to be performed to resuscitate or stabilize a patient with an emergent, life-threatening condition who was transferred or died before being admitted as an inpatient. We reviewed within the context of our current policy the cases brought to our attention for which payment under the OPPS was denied because a procedure with status indicator C was on the bill. Based on that review, we proposed to clarify our policy regarding Medicare payment when a procedure with status indicator C is performed under certain life-threatening, emergent conditions. In the proposed rule, we solicited comments on the extent to which the payment policy described below addresses hospitals' concerns. We stated it would be most helpful if commenters provided specific examples of cases when hospitals have, in these instances, submitted bills for a procedure with OPPS status indicator C that were not paid.
In the April 7, 2000 final rule (65 FR 18451), in response to comments about the appropriate level of payment for patients who die in the emergency department, we set forth the following guidelines for fiscal intermediaries to use in determining how to make payment when a patient dies in the emergency department or is sent directly to surgery and dies there.
• If the patient dies in the emergency department, make payment under the outpatient PPS for services furnished.
• If the emergency department or other physician orders the patient to the operating room for a surgical procedure, and the patient dies in surgery, payment will be made based on the status of the patient. If the patient had been admitted as an inpatient, pay under the hospital inpatient PPS (a DRG-based payment).
• If the patient was not admitted as an inpatient, pay under the outpatient PPS (an APC-based payment).
• If the patient was not admitted as an inpatient and the procedure is
The OPPS outpatient code editor (OCE) currently has an edit in place that generates a “line item denial” for a line on a claim that has a status indicator C. A line item denial means that the claim can be processed for payment but with some line items denied for payment. A line item denial can be appealed under the provisions of section 1869 of the Act. The OCE includes another edit that denies all other line items furnished on the same day as a line item with a status indicator C. The rationale for this edit is that all line items for services furnished on the same date as the procedure with status indicator C would be considered inpatient services and paid under the appropriate DRG.
As part of the definition of line item denial in the program memorandum that we issue quarterly to update the OCE specifications (for example, see Program Memorandum/Intermediaries, Transmittal A-02-052, June 18, 2002, which is available on our Web site at
In Addendum D of the March 1, 2002 final rule, we designate payment status indicator “C” as follows: “Admit patient; bill as inpatient.”
Hospitals have requested clarification regarding billing and payment in certain situations that our current policy does not seem to explicitly address. The following scenarios synthesize cases described by hospitals for which they have encountered problems when billing for a procedure with status indicator C.
We proposed the following policy for fiscal intermediaries and providers to use in determining the appropriate Medicare payment in cases such as those described in the section above.
A procedure assigned status indicator C under the OPPS is never payable under the OPPS. Therefore, for a hospital to receive payment when a procedure with OPPS status indicator C is performed and: (1) The patient dies during or after the procedure, before being admitted, or (2) the patient survives the procedure and is transferred following the procedure, the patient's medical record must contain all of the following information:
• Either orders to admit written by the physician responsible for the patient's care at the hospital to which the patient was to be admitted following the procedure for the purpose of receiving inpatient hospital services and occupying an inpatient bed, or written orders to admit and transfer the patient to another hospital following the procedure.
• Documentation that the reported HCPCS code for the surgical procedure with OPPS payment status indicator C (such as CPT code 61345) was actually performed.
• Documentation that the reported surgical procedure with status indicator C was medically necessary.
• If the patient is admitted and subsequently transferred to another facility, documentation that the transfer was medically necessary, such as the patient requiring postoperative treatment unavailable at the transferring facility.
In the case of a patient who dies during performance of a procedure with OPPS status indicator C before being admitted, the hospital would submit a claim for all services provided, including a line item for the status indicator C procedure. The claim would be rejected for payment under the OPPS and returned to the hospital. The hospital would resubmit the claim for payment as an inpatient stay under the appropriate DRG.
In the case of a patient who is admitted and transferred, the transferring hospital would be paid a per diem DRG rate if all the above conditions are met. (We proposed to revise § 3610.5 of the Medicare Intermediary Manual accordingly.) Because these services would be paid according to the appropriate DRG or per diem (see below), all services that were furnished before admission that would otherwise be payable under the OPPS would be paid in accordance with the provisions of § 3610.3 of the Medicare Intermediary Manual (“3-day rule”) and § 415.6 of the Medicare Hospital Manual.
Note that a physician's order to admit a patient to an observation bed following a procedure designated with OPPS status indicator C would not constitute an inpatient admission and, therefore, would not qualify the procedure with status indicator C for payment. In this instance, the only allowable Medicare payment would be for a code payable under APC 0610, 0611, or 0612 if those services were provided. Payment would not be allowed for either the procedure with status indicator C or for any ancillary services furnished on the same date.
Commenters offered several alternatives to our proposal. Several commenters suggested that these cases be initially billed as inpatient stays,
The underlying principle is our policy that procedures on the inpatient list performed on patients whose status is that of outpatient are not payable as outpatient services.
However, we recognize that there are occasions when a procedure on the inpatient list must be performed to resuscitate or stabilize a patient with an emergent, life-threatening condition whose status is that of an outpatient. To receive payment in those cases, hospitals admit the patient and submit an inpatient claim.
In cases where a procedure on the inpatient list must be performed to resuscitate or stabilize a patient with an emergent, life-threatening condition whose status is that of an outpatient, the patient may be admitted and transferred to another hospital. In these cases, the transferring hospital is paid a per diem DRG rate. We shall revise section 3610.5 of the Medicare Intermediary Manual to reflect this policy.
On rare occasions, a procedure on the inpatient list must be performed to resuscitate or stabilize a patient with an emergent, life-threatening condition whose status is that of an outpatient and the patient dies before being admitted as an inpatient. For those rare and unusual cases, we are instructing hospitals to submit an outpatient claim for all services furnished, including the procedure code with status indicator C to which a new modifier is attached. The exact modifier that is to be used in these cases had not been issued by the HCPCS alpha-numeric workgroup in time for publication in this final rule. The modifier and instructions for its use will be included in the program memorandum for the January 2003 update. We believe that such patients would typically receive services such as those provided during a high-level emergency visit, appropriate diagnostic testing (X-ray, CT scan, EKG, and so forth), and administration of intravenous fluids and medication prior to the surgical procedure. Because these combined services constitute an episode of care, we will pay claims with a procedure code on the inpatient list that are billed with the new modifier under new technology APC 977. Separate payment will not be allowed for other services furnished on the same date. This approach allows hospitals to submit an outpatient claim and receive payment without additional paperwork, it results in consistency between the medical record and patient status, and it allows us to collect data on the costs associated with these very unusual and infrequent cases for future use in updating the OPPS.
Procedures with status indicator C but without the new modifier that are submitted on an outpatient bill will receive a line item denial, and no other services furnished on the same date are payable.
If an outpatient has a procedure that is on the inpatient list performed, and is subsequently admitted to an observation bed, the procedure with status indicator C submitted on an outpatient bill will receive a line item denial. Further, we have decided not to make final our proposal to make payment for APC 610, 611 or 612 under such circumstances. Rather, in such cases no other services furnished on the same date are payable.
We did not receive any comments on the documentation that we proposed to require in the patient's medical record when a procedure with status indicator C is performed and: (1) The patient dies before being admitted as an inpatient, or (2) the patient survives the procedure and is admitted and transferred. Therefore, we are making those requirements final.
Some hospitals have raised questions about the timing of a physician's order to admit a patient. The requirements for authenticating physician orders and the standards for medical record keeping fall outside the scope of this rule and OPPS payment policy. The payment provisions that we are making final in this rule are to assist hospitals and contractors in determining how to bill and pay for services appropriately under Medicare. The patient's admission status, as documented by the medical records, determines what Medicare payment is appropriate. Medical record keeping and documentation requirements are addressed in the Medicare hospital conditions of participation at § 482.24, and are governed by applicable State law and State licensing rules and hospital accreditation standards.
When a procedure on the inpatient list must be performed to resuscitate or stabilize a patient with an emergent, life-threatening condition whose status is that of an outpatient and the patient dies before being admitted as an inpatient, the hospital should submit an outpatient claim for all services furnished, including the procedure with status indicator C to which a new modifier, which will be announced by program memorandum is attached. Claims with a procedure code on the inpatient list that are billed with the new modifier will be paid under APC 977.
We are making final the requirement that information specified in the proposed rule be included in the medical record to support payment when a procedure with status indicator C is performed on an outpatient and the patient dies or is admitted and transferred.
The status indicators we assign to HCPCS codes and APCs under the OPPS have an important role in payment for services under the OPPS because they indicate if a service represented by a HCPCS code is payable under the OPPS or another payment system and also if particular OPPS policies apply to the code. We are providing our status indicator assignments for APCs in Addendum A, HCPCS codes in
The OPPS is based on HCPCS codes for medical and other health services. These codes are used for a wide variety of payment systems under Medicare, including, but not limited to, the Medicare fee schedule for physician services, the Medicare fee schedule for durable medical equipment and prosthetic devices, and the Medicare clinical laboratory fee schedule. For purposes of making payment under the OPPS, we need a way to signal the claims processing system which HCPCS codes are paid under the OPPS and those codes to which particular OPPS payment policies apply. We accomplish this identification in the OPPS through the establishment of a system of status indicators with specific meanings. Addendum D defines the meaning of each status indicator for purposes of the OPPS.
We assign one and only one status indicator to each APC and to each HCPCS code. Each HCPCS code that is assigned to an APC has the same status indicator as the APC to which it is assigned.
Specifically, in 2003, we proposed to use the status indicators in the following manner:
• “A” to indicate services that are paid under some payment method other than OPPS, such as the durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) fee schedule or the physician fee schedule. Some but not all—of these other payment systems are identified in Addendum D.
• “C” to indicate inpatient services that are not payable under the OPPS.
• “D” to indicate a code that was deleted effective with the beginning of the calendar year.
• “E” to indicate services for which payment is not allowed under the OPPS or that are not covered by Medicare.
• “F” to indicate acquisition of corneal tissue, which is paid at reasonable cost.
• “G” to indicate drugs and biologicals that are paid under OPPS transitional pass-through rules.
• “H” to indicate devices that are paid under OPPS transitional pass-through rules.
• “K” to indicate drugs and biologicals (including blood and blood products) and certain brachytherapy seeds that are paid in separate APCs under the OPPS, but that are not paid under OPPS transitional pass-through rules.
• “N” to indicate services that are paid under the OPPS for which payment is packaged into another service or APC group.
• “P” to indicate services that are paid under the OPPS but only in partial hospitalization programs.
• “S” to indicate significant procedures that are paid under OPPS but to which the multiple procedure reduction does not apply.
• “T” to indicate significant services that are paid under the OPPS and to which the multiple procedure payment discount under OPPS applies.
• “V” to indicate medical visits (including clinic or emergency department visits) that are paid under the OPPS.
• “X” to indicate ancillary services that are paid under the OPPS.
The software that controls Medicare payment looks to the status indicators attached to the HCPCS codes and APCs for direction in the processing of the claim. Therefore, the assignment of the status indicators has significance for the payment of services. We sometimes change these indicators in the course of a year through program memoranda. Moreover, indicators are established for new codes that we establish in the middle of the year, either as a result of a national coverage decision or otherwise. A status indicator, as well as an APC, must be assigned so that payment can be made for the service identified by the new code.
Our proposed status indicators identified for each HCPCS code and each APC appear in Addenda A and B of the proposed rule. We requested comments on the appropriateness of the indicators we have assigned.
We received several comments on this proposal, which are summarized below:
With regard to influenza and pneumococcal pneumonia vaccine, which we will also pay on a reasonable cost basis, effective January 1, 2003, we have created a new status indicator “L” “Influenza vaccine; pneumococcal pneumonia vaccine” to indicate that these vaccines are paid on a reasonable cost basis but deductible and coinsurance do not apply to the payment. We show the new status indicator in Addendum D and we show it for these services in Addendum B. We are doing the following:
• Redefining status F to indicate an item or service that is paid on a reasonable-cost basis.
• Changing the status indicator for influenza and pneumococceal pneumonia vaccines to status indicator L and change orphan drugs to status indicator F.
• Changing the status indicator for APC 225 to S.
In the November 30, 2001 final rule, we explained the methodology we used to estimate the portion of each APC rate that could reasonably be attributed to the cost of associated devices that are eligible for pass-through payments (66 FR 59904). Effective with implementation of the 2002 OPPS update on April 1, 2002, we deduct from the pass-through payments for those devices an amount that offsets the portion of the otherwise applicable APC payment amount that we determined is associated with the device, as required by section 1833(t)(6)(D)(ii) of the Act. In the March 1, 2002 final rule, we published the applicable offset amounts for 2002, which we had recalculated to reflect certain device cost assignments that were corrected in the same final rule (67 FR 9557).
For the 2003 OPPS update, we proposed to estimate the portion of each APC rate that could reasonably be attributed to the cost of an associated pass-through device that is eligible for pass-through payment using claims data for services furnished between July 1, 2001, through December 31, 2001. We proposed to use only the last 6 months of 2001 claims data because bills for pass-through devices submitted during this time period would use only device category codes, allowing a more consistent analysis than would result were we to include pre-July 1 claims that might still show item-specific codes for pass-through devices. Using these claims, we would calculate a median cost for every APC without packaging the costs of associated C-codes for device categories that were billed with the APC. We would then calculate a median cost for every APC with the
For this final rule, we used the device data for the 12 months ended March 31, 2002 to calculate the device and non-device portions of APCs median costs. We began with the same APCs that were listed on Table 9 of our proposed rule, with two additions. We added APCs 0648 and 0651, because they showed appreciable device percentages using our methodology. We again applied these percentages to the APC payment amounts and excluded any APC's percentage of device costs less than one percent and calculated offset amounts less than one dollar.
We received some comments on this proposal, which are summarized below:
As explained above, under section 1833(t)(6)(D)(ii) of the Act, the amount of additional payment for a device eligible for pass-through payment is the amount by which the hospital's cost exceeds the portion of the otherwise applicable APC payment amount that the Secretary determines is associated with the device. Thus, for devices eligible for pass-through payment, we reduce the pass-through payment amount by the cost attributable to the device that is already packaged into the APC payment for an associated procedure. For 2002, we developed offset amounts for 59 APCs (March 1, 2002 final rule, 67 FR 9556 through 9557, Table 1).
In our November 30, 2001 final rule (66 FR 59856), we articulated a policy regarding the calculation of the offsets for device costs already reflected in APCs in cases where the payment for the associated APC is reduced due to the multiple procedure discount. The policy was in response to several commenting parties that recommended that we apply the multiple procedure discount only to the non-device-related portion of the APC payment amount (66 FR 59906).
We agreed with the commenters that the full pass-through offset should not be applied when the APC payment is subject to the multiple procedure discount of 50 percent.
The purpose of the offset is to ensure that the OPPS is not making double payments for any portion of the cost associated with the use of the pass-through item. We stated in the November 30, 2001 rule that the offset should reflect that portion of the cost for the pass-through device actually reflected in the payment that is received for the associated APC. We consequently ruled that the most straightforward methodology for applying this principle is to reduce the amount of the offset amount by 50 percent whenever the multiple procedure discount applies to the associated APC. This discounting of the offset is applied in 2002 to bills subject to multiple procedure discounting that also include devices eligible for pass-through payment.
The significant number of device categories that are expiring in 2003 combined with our proposal to package 100 percent of device costs into their associated APCs has prompted us to revisit the current policy of reducing offsets for pass-through devices in instances when multiple procedure discounts are applied to procedures
We then determined which APCs containing devices would be billed together. We next determined, based on median cost data, which device containing APCs would be subject to the 50 percent multiple procedure reduction. After identifying these APCs, we applied a 50 percent reduction to arrive at a discounted payment amount. We then reviewed the contribution of device costs to the discounted APC both as a percentage and in absolute dollars to determine if applying the 50 percent reduction would result in underpayment for the service. We determined that the reduced payment was adequate to pay both for the devices incorporated into the APC and for the procedure cost in the context of performing multiple procedures. We obtained the same results even when we overstated device costs in our model by 5 or 10 percent to offset concerns expressed by some manufacturers and physicians that hospital charges for transitional pass-through devices may be understated.
We noted that almost all APCs with high device costs (such as insertion of pacemakers, insertion of cardioverter-defibrillators, insertion of infusion pumps and neurostimulator electrodes) would never be subject to a multiple procedure discount. They have the highest relative weights in the OPPS, and we would not expect these procedures to be performed during the same operative session with a higher paying procedure with status indicator “T.” Therefore, we proposed to continue our current policy of multiple procedure discounting. That is, when two or more APCS with status indicator “T” are billed together we proposed to pay 100 percent for the highest cost APC and 50 percent for all other APCs with status indicator “T.” We proposed not to adjust these payments to account for device costs in the APCs.
We received a large number of comments on this proposal, which are summarized below:
In the case of APC 225, however, we did change the status indicator to “S” because we were convinced that it must be performed when APC 222 also performed and that, therefore, a status indicator of “T” would not result in appropriate payment for 225.
Currently, Medicare does not pay for dialysis treatments furnished to End-Stage Renal Disease (ESRD) patients on an outpatient basis, unless the hospital also has a certified hospital-based ESRD facility. As a result of this policy, ESRD patients in need of emergency dialysis have been admitted to the hospital. These admissions have been found to be inappropriate by the Quality Improvement Organizations, and payment has been denied.
When ESRD patients come to the hospital for a medical emergency or for problems with their access sites, they typically miss their regularly scheduled dialysis appointments. If the ESRD patient's usual facility is unable to reschedule the dialysis treatment, the ESRD patient has to wait until the next scheduled dialysis appointment. We are concerned that by maintaining this policy, ESRD patients may be receiving interrupted care because there will be unnecessary lapses in treatment. The ESRD patient should not be prevented from receiving her or his normal dialysis because he or she experienced another unrelated medical situation. Therefore, we proposed to allow payment for dialysis treatments for ESRD patients in the outpatient department of a hospital in specific situations. Payment would be limited to unscheduled dialysis for ESRD patients in exceptional circumstances. Outpatient dialysis for acute patients
In certain instances, it is appropriate to dialyze ESRD patients on an outpatient basis. We proposed to allow payment for these nonroutine dialysis treatments in medical situations in which the ESRD patient cannot obtain her or his regularly scheduled dialysis treatment at a certified ESRD facility. The circumstances in which we proposed to allow payment are limited to:
• Dialysis performed following or in connection with a vascular access procedure;
• Dialysis performed following treatment for an unrelated medical emergency; for example, if a patient goes to the emergency room for chest pains and misses a regularly scheduled dialysis treatment that cannot be rescheduled, we would allow the hospital to provide and bill Medicare for the dialysis treatment; and
• Emergency dialysis—Currently, the only mechanism available for payment in this situation is through an inpatient admission. We will maintain our policy that routine treatments in non-ESRD certified hospitals would not be payable under OPPS.
We believe it is important to make this change in the policy for two reasons:
• To ensure that hospital outpatient departments are paid for providing this much needed service; and
• To prevent dialysis patients from receiving interrupted care. Non-ESRD certified hospital outpatient facilities would bill Medicare using a new G code, G0GGG, “Unscheduled or emergency treatment for dialysis for ESRD patient in the outpatient department of a hospital that does not have a certified ESRD facility.” We proposed that this new code will have status indicator “S” and be assigned to APC 0170. Payment would be roughly equivalent to the reimbursement rate for acute dialysis. We proposed to implement this change effective January 1, 2003. Effective January 1, 2003, this would be the only way for non-ESRD certified hospital outpatient facilities to bill Medicare and be paid for providing nonroutine outpatient dialysis to ESRD patients.
We will be monitoring the use of this new code to ensure the following:
• Certified dialysis facilities are not incorrectly using this code.
• The same dialysis patient is not repeatedly using this code, which would indicate routine dialysis treatment.
When ESRD patients receive outpatient dialysis in non-ESRD certified hospital outpatient facilities, the patient's home facility would be responsible for obtaining and reviewing the patient's medical records to ensure that appropriate care was provided in the hospital and that modifications are made, if necessary, to the patient's plan of care upon her or his return to the facility. This ensures continuity of care for the patient.
We received eight comments on our proposal to allow payment for dialysis treatments for ESRD patients in the outpatient department of a hospital. Although all of the comments support our proposed changes, some commenters asked for clarification on issues pertaining to this provision.
The August 9, 2002 proposed rule states that we would allow payment for this unscheduled dialysis under exceptional circumstances, and these circumstances would be (1) dialysis
In the August 9, 2002 proposed rule, we responded to the Medicare Payment Advisory Commission (MedPAC) March 2002 Report to the Congress: “Medicare Payment Policy,” recommendations relating to the OPPS (67 FR 52141 through 52143). We received no comments on our responses to MedPAC's recommendations. Therefore, we will not discuss that response further here. We did receive comments from MedPAC on other issues in the proposed rule. For convenience we group those comments and our responses here:
The provisions of this final rule with comment restate changes to the Medicare hospital OPPS and CY 2003 payment rates including changes used to determine these payment rates set forth in the August 9, 2002 proposed rule, except as noted elsewhere in the preamble. The following is a highlight of provisions implemented in this final rule, which are discussed in detail above.
• We revised the methodology for calculating relative weights to dampen the difference in the median costs for all APCs for which the median costs fell more than 15 percent from 2002 to 2003; used only claims on which devices were reported to set the median for APCs for which the device was either essential or frequently used in the procedures in the APC; split some APCs for which devices were an issue to achieve more accurate pricing; limited the reduction in median costs for blood and certain blood products to 11 percent, which limited the reduction in payment from 2002 to 2003 to about 15 percent; used acquisition costs from external sources as a factor together with claims data in setting adjusted medians for four APCs.
• We reviewed and revised the composition of APCs to comply with the limitation on variation in procedure medians and to achieve more accurate reflections of the costs.
• We removed from pass-through status those drugs and devices that will have been on pass-through status for at least 2 years on January 1, 2003. We packaged the costs of the expiring devices into the payments for the APCs with which the devices were billed. We packaged the costs of the expiring drugs into the APCs with which the drugs were billed if the per encounter drug cost was less than $150; we established APCs for those drugs for which the per encounter drug cost was more than $150 and for blood and certain blood products. We paid for influenza and pneumococcal pneumonia vaccines and orphan drugs on a reasonable cost basis.
• We estimated the amount of payment that would be made under the pass through provisions and compared it to 2.5 percent of the projected program expenditures; we determined that no pro rata reduction would be needed for 2003, and we adjusted the conversion factor accordingly.
• We established the percentages by which pass-through devices would be reduced to remove the part of the payment that is packaged into the APC when it is billed with the device.
• We finalized the regulations that describe the criteria that must be met for a device to get a pass-through code.
• We issued the 2003 wage index and conversion factor that would be applied to the relative weights to determine the amount of payment for a particular hospital.
• We amended § 419.21(d)(3) to delete influenza and pneumococcal pneumonia vaccines from the list of items that are paid to CORFs, HHAs, and hospices under OPPS.
• We amended § 419.66(c)(1) to specify that we must establish a new category for a medical device if it is not described by any category previously in effect as well as an existing category. We received no comments concerning this technical correction to our regulations text. We are making this proposal final in this final rule.
We are adopting the provisions set forth in the proposed rule without change.
In the August 9, 2002 proposed rule, we indicated we would be addressing comments received on our proposal to establish a new payment amount for partial hospitalization services and remove clinical social worker services from the partial hospitalization benefit. Upon further review we have determined that we will not include this issue in this final rule, but will address it in future rulemaking.
Section 419.21(d)(3) states that “Pneumococcal vaccine, influenza vaccine, and hepatitis B vaccine” are paid under the OPPS for comprehensive outpatient rehabilitation facilities, home health agencies, and hospices. There is no specific inclusion of hospitals, but we have paid hospitals for them under the OPPS since the OPPS began. We are removing the pneumococcal vaccine and influenza vaccine from this paragraph and want to pay for it under reasonable cost. We are requesting public comment on this change.
Because of the large number of items of correspondence we normally receive on
This rule does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995.
The regulatory impact analysis for this final rule consists of an impact analysis for the OPPS provisions and a regulatory impact statement for the provision for payment suspension for unfiled cost reports.
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).
We estimate the effects of the provisions that will be implemented by this final rule will result in expenditures exceeding $100 million in any 1 year. We estimate the total increase (from changes in the final rule as well as enrollment, utilization, and case mix changes) in expenditures under the OPPS for CY 2003 compared to CY 2002 to be approximately $1.372 billion. Therefore, this final rule is an economically significant rule under Executive Order 12866, and a major rule under 5 U.S.C. 804(2).
The RFA requires agencies to determine whether a rule will have a significant economic impact on a substantial number of small entities. 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 in any 1 year (see 65 FR 69432).
For purposes of the RFA, we have determined that approximately 37 percent of hospitals will be considered small entities according to the Small Business Administration (SBA) size standards. We do not have data available to calculate the percentages of entities in the pharmaceutical preparation manufacturing, biological products, or medical instrument industries that would be considered to be small entities according to the SBA size standards. For the pharmaceutical preparation manufacturing industry (NAICS 325412), the size standard is 750 or fewer employees and $67.6 billion in annual sales (1997 business census). For biological products (except diagnostic) (NAICS 325414), with $5.7 billion in annual sales, and medical instruments (NAICS 339112), with $18.5 billion in annual sales, the standard is 50 or fewer employees (see the standards Web site at
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 604 of the RFA. With the exception of hospitals located in certain New England counties, 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 (or New England County Metropolitan Area (NECMA)). Section 601(g) of the Social Security Amendments of 1983 (Pub. L. 98-21) designated hospitals in certain New England counties as belonging to the adjacent NECMA. Thus, for purposes of the OPPS, we classify these hospitals as urban hospitals. We believe that the changes in this final rule will affect both a substantial number of rural hospitals as well as other classes of hospitals and that the effects on some may be significant. Therefore, we conclude that this final rule has a significant impact on a substantial number of small entities. However, the statute provides for small rural hospitals (of fewer than 100 beds) to be held harmless by the law and to continue to be paid at cost; therefore this final rule has no impact on them.
Section 202 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) also requires that agencies assess anticipated costs and benefits before issuing any rule that may result in an expenditure in any 1 year by State, local, or tribal governments, in the aggregate, or by the private sector, of $110 million. This final rule will not mandate any requirements for State, local, or tribal governments. This final rule imposes no unfunded mandates on the private sector.
Executive Order 13132 establishes certain requirements that an agency must meet when it publishes a proposed rule (and subsequent final rule) that imposes substantial direct costs on State and local governments, preempts State law, or otherwise has Federalism implications.
We have examined this final rule in accordance with Executive Order 13132, Federalism, and have determined that it will not have an impact on the rights, roles, and responsibilities of State, local or tribal governments. The impact analysis (see Table 10) shows that payments to governmental hospitals (including State, local, and tribal governmental hospitals) will increase by 5 percent under the final rule.
We are making several changes to the OPPS that are required by the statute. We are required under section 1833(t)(3)(C)(ii) of the Act to update annually the conversion factor used to determine the APC payment rates. We are also required under section 1833(t)(9)(A) of the Act to revise, not less often than annually, the wage index and other adjustments. In addition, we must review the clinical integrity of payment groups and weights at least annually. Accordingly, in this final rule, we are updating the conversion factor and the wage index adjustment for hospital outpatient services furnished beginning January 1, 2003 as we discuss in sections VIII and VI, respectively, of this preamble. We are also revising the relative APC payment weights based on claims data from January 1, 2001 through December 31, 2001. Finally, we are removing 95 devices and more than 200 drugs and biologicals from pass-through payment status.
Under this final rule, the change to the conversion factor as provided by statute will increase total OPPS payments by 3.7 percent in 2003. The changes to the wage index and to the APC weights (which incorporate the cessation of pass-through payments for many drugs and devices) do not increase OPPS payments because the OPPS is budget neutral. However, the
Alternatives to the changes we are making and the reasons that we are choosing not to make them are discussed throughout this final rule. Below we discuss options we considered when analyzing methodologies to appropriately recognize the costs of former pass-through items. For a more detailed discussion, see section IV.C regarding the expiration of pass-through payment for devices and section IV.D regarding the expiration of pass-through payment for drugs and biologicals.
We considered establishing separate APCs for categories of devices and paying for them separately. We are not choosing this option because we believe that to the extent possible, hospital payment for procedures and visits should include all of the costs required to provide the procedures and visits.
A second option we considered involved (1) packaging some categories of devices into the procedures with which they were billed in 2001 and (2) paying the rest through separate APCs (as discussed in section IV of this final rule.). We are not choosing this option because we believe that devices are routinely used in the services for which they are needed and therefore are consistently paid at the cost of providing the service. Furthermore, criteria that will provide a basis for some devices to be packaged and for others to be paid separately must be developed and approved, thereby further complicating an already complex payment system.
We considered continuing to make separate payment for all drugs and biologicals through separate APCs. We are not choosing to pay separately for all drugs through separate APCs because we believe that, to the extent possible, hospital payment for services should include all of the costs of the services. We believe that drugs should be packaged with the services in which they are furnished except when we determine that there is a valid reason to do otherwise. However, we recognize that (unlike the stability that exists with device usage with the applicable procedures) the use of drugs may vary widely depending upon patient and disease characteristics. Therefore, packaging payment for all drugs may, in some cases, provide inadequate payment for the services furnished. Where a hospital has a disproportionate share of patients who need greater amounts of expensive drugs, underpayment for the drugs needed by these patients could result in cessation of needed services. For the first year that we are ceasing transitional pass-through payment for drugs, we decided to proceed cautiously by paying separately for drugs when the cost per encounter was more than $150 or when special characteristics existed (for example, orphan drugs, blood products).
We also considered packaging the costs of all drugs into the cost of the associated procedures with which they were billed in 2001. We did not package all payment for drugs into the payment for the procedures because, while this packaging is ultimately our goal, we believe, for the reasons indicated above, that we need to proceed cautiously to ensure that we do not inadvertently threaten access to needed care.
It is clear that the changes in this final rule will affect both a substantial number of rural hospitals as well as other classes of hospitals, and the effects on some may be significant. Therefore, the discussion below, in combination with the rest of this final rule, constitutes a regulatory impact analysis.
The OPPS rates for CY 2003 will have, overall, a positive effect for every category of hospital with the exception of children's hospitals, which are held harmless under the OPPS. These changes in the OPPS for 2003 will result in an overall 3.7 percent increase in Medicare payments to hospitals, exclusive of outlier and transitional pass-through payments and transitional corridor payments. As described in the preamble, budget neutrality adjustments are made to the conversion factor and the weights to ensure that the revisions in the wage index, APC groups, and relative weights do not affect aggregate payments. The impact of the wage and recalibration changes does vary somewhat by hospital group. Estimates of these impacts are displayed on Table 10.
The overall projected increase in payments for urban hospitals is slightly lower (3.1 percent) than the average increase for all hospitals (3.7 percent) while the increase for rural hospitals is significantly greater (6.2 percent) than the average increase. Rural hospitals gain 2.2 percent from the wage index change, and also gain 0.1 percent from APC changes. A discussion of the distribution of outlier payments that we project under this final rule can be found under section XV.A.4 below. Table 11 presents the outlier distribution that we expect to see under this final rule.
The distributional impacts represent the projected effects of the policy changes, as well as statutory changes effective for 2003, on various hospital groups. We estimate the effects of individual policy changes by estimating payments per service while holding all other payment policies constant. We use the best data available but do not attempt to predict behavioral responses to our policy changes. In addition, we do not make adjustments for future changes in variables such as service volume, service mix, or number of encounters.
The OPPS is a budget neutral payment system under which the increase to the total payments made under OPPS is limited by the increase to the conversion factor set under the methodology in the statute. The impact tables show the redistributive effects of the wage index and APC changes. In some cases, under this final rule, hospitals will receive more total payment than in 2002 while in other cases they will receive less total payment than they received in 2002. The impact of this final rule will depend on a number of factors, most significant of which are the mix of services furnished by a hospital (for example, how the APCs for the hospital's most frequently furnished services will change) and the impact of the wage index changes on the hospital.
Column 4 in Table 12 represents the full impact on each hospital group of all the changes for 2003. Columns 2 and 3 in the table reflect the independent effects of the change in the wage index and the APC reclassification and recalibration changes, respectively. We excluded critical access hospitals (CAHs) from the analysis of the impact of the 2003 OPPS rates that is summarized in Table 12. For that reason, the total number of hospitals included in Table 10 (4,551) is lower than in previous years. CAHs are excluded from the OPPS.
In general, the wage index changes favor rural hospitals, particularly the largest in bed size and volume. The only rural hospitals that will experience a negative impact due to wage index changes are those in Puerto Rico, a decrease of 3.2 percent. Conversely, the urban hospitals are generally negatively
The APC reclassification and recalibration changes also favor rural hospitals and have a negative effect on urban hospitals in excess of 200 beds. Specifically, urban hospitals with 300 to 499 beds (−0.6 percent decrease) and urban hospitals in excess of 500 beds (a −0.8 percent decrease) all show a decrease attributed to APC recalibration. However, this decrease is much less than what would have occurred under the proposed rule.
In urban areas, hospitals that provide a lower volume of outpatient services are projected to receive a larger increase in payments than higher volume hospitals. In rural areas, hospitals with higher volumes are expected to receive higher increases in payments. In rural areas, hospitals with volumes greater than 42,999 services are projected to experience a significant increase in payments (7.7 percent). The less favorable impact for the high volume urban hospitals is attributable to both wage index and APC changes. For example, urban hospitals providing more than 42,999 services are projected to gain a combined 2.8 percent due to these changes.
Major teaching hospitals are projected to experience a smaller increase in payments (2.7 percent) than the aggregate for all hospitals (3.7 percent) due to negative impacts of the wage index (−0.3 percent) and recalibration (−0.8 percent). Hospitals with less intensive teaching programs are projected to experience an overall increase (3.2 percent) that is smaller than the average for all hospitals.
For CY 2003, under the OPPS transitional corridor policy, the following categories of hospitals are held harmless compared to their 1996 payment margin for these services: cancer and children's hospitals and rural hospitals with 100 or fewer beds.
As stated elsewhere in this preamble, we have allocated 2 percent of the estimated 2003 expenditures to outlier payments. In Table 13 below, we provide a distribution by percentage of the total projected outlier payments for the categories of hospitals that we show in the impact table (Table 10).
We project, based on the mix of services for the hospitals that will be paid under the OPPS in 2003, that most hospitals will receive outlier payments.
The anticipated outlier payments for urban hospitals can be expected to ameliorate the impact of the wage index and APC changes on payments to urban hospitals.
For services for which the beneficiary pays a coinsurance of 20 percent of the payment rate, the beneficiary share of payment will increase for services for which OPPS payments will rise and will decrease for services for which OPPS payments will fall. For example for a mid level office visit (APC 0601), the minimum unadjusted copayment in 2002 was $9.67; under this final rule, the minimum unadjusted copayment for APC 601 is $10.11 because the OPPS payment for the service will increase under this final rule. For some services (those services for which a national unadjusted copayment amount is shown in Addendum B), however, the beneficiary copayment is frozen based on historic data and will not change, therefore not presenting any potential impact on beneficiaries.
However, in all cases, the statute limits beneficiary liability for copayment for a service to the inpatient hospital deductible for the applicable year. This amount was $812 for 2002, and is $840 for 2003. In general, the impact of this final rule on beneficiaries will vary based on the service the beneficiary receives and whether the copayment for the service is one that is frozen under the OPPS.
We have examined the impacts of this final rule as required by Executive Order 12866 (September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act (RFA) (September 16, 1980, Public Law 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. (A description of each of these requirements is stated above in section XV.A.1.)
We have determined that the payment suspension provision does not have an economic impact on Medicare payments or other payments to providers. We are allowing the Secretary flexibility in payment suspensions, but we are not altering the final payment determination in any way. With the implementation of the various prospective payment systems, the majority of the payment to providers is based on the PPS methodology and not on the cost report. Suspending all payments because the cost report is not timely filed negatively affects providers. Providing the Secretary with flexibility in payment suspension can lessen the financial impact on providers. For these reasons, we are not preparing analyses for either the RFA or section 1102(b) of the Act because we have determined, and we certify, that this rule will not have a significant economic impact on a substantial number of small entities or a significant impact on the operations of a substantial number of small rural hospitals. Under the requirement for Unfunded Mandates, this final rule will not have an economic effect on State, local, or tribal governments, in the aggregate, or on the private sector.
The majority of providers that file cost reports comply with the timeliness provisions and will be unaffected by this regulation. In FY 2000, collectively 16 percent of hospitals, skilled nursing facilities, and home health agencies filed late cost reports. Of this 16 percent, 65 percent of those were only 1 day late. Currently, when a provider fails to file an acceptable cost report, the provider is placed on a complete payment suspension. Under this provision, for those providers who do not file timely, an immediate payment suspension less than the total suspension currently required might be imposed if the Secretary deemed it appropriate, which will allow the provider to more easily continue operations while completing and submitting the acceptable cost report.
The payment suspension provision does not affect other providers.
The provision will allow the Secretary to more effectively manage the Medicare program by imposing other than complete payment suspension when it is appropriate to do so. The Medicare program benefits because immediate complete payment suspension can be disruptive to providers and may negatively affect the care of Medicare patients. There are no costs to the Medicare program to doing so, because when the cost report is submitted, the suspended payments are returned to the provider.
We have determined that this provision has a potentially positive impact on beneficiaries. Under this provision, the Secretary will have the
We considered not revising existing § 405.371(c) to provide that payment suspension could be “in whole or in part.” However, we did not choose this option because we believe the Secretary should have the discretion to impose partial payment suspensions when circumstances warrant in order to more effectively manage the Medicare program.
In conclusion, we have determined that the payment suspension provision does not have an economic impact on Medicare payments.
Since this regulation does not impose any costs on State or local governments, it will not have an effect on State or local governments. State or local governments will have no roles or responsibilities associated with this provision.
In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.
Administrative practice and procedure, Health facilities, Health professions, Kidney diseases, Medicare, Reporting and recordkeeping requirements, Rural areas, X-rays.
Hospitals, Medicare, Reporting and recordkeeping requirements.
Secs. 1102, 1815, 1833, 1842, 1866, 1870, 1871, 1879, and 1892 of the Social Security Act (42 U.S.C. 1302, 1395g, 1395l, 1395u, 1395cc, 1395gg, 1395hh, 1395pp, and 1395ccc) and 31 U.S.C. 3711.
(c) Suspension of payment in the case of unfiled cost reports. If a provider has failed to timely file an acceptable cost report, payment to the provider is immediately suspended in whole or in part until a cost report is filed and determined by the intermediary to be acceptable. In the case of an unfiled cost report, the provisions of § 405.372 do not apply. (See § 405.372(a)(2) concerning failure to furnish other information.)
Secs. 1102, 1833(t), and 1871 of the Social Security Act (42 U.S.C. 1302, 1395l(t), and 1395hh).
(d) * * *
(3) Hepatitis B vaccine.