OMB No.: OMB 0412-0510.

Form No.: N/A.

Title: Administration or Assistance Awards to U.S. Non-Government Organizations—22 CFR part 226 and USAID's Automated Directive Systems Chapter 303.

Type of Review: Renewal of Information Collection.

Purpose: Section 635(b) of the Foreign Assistance Act (FAA) authorizes USAID to make grants and cooperative agreements with any organization and within limits of the FAA. Most of the information that USAID requests of its recipients is necessary to fulfill the requirement that USAID, as a Federal agency, ensure prudent management of public funds under all of its assistance instruments. The pre-award information is necessary to assure that funds are provided for programs that further the purposes of the FAA and that the recipients have the capability to manage the program administratively and financially. The administration (post-award) requirements are based on the need to assure that the program is functioning adequately, that the funds are managed properly and that statutory and regulatory requirements are complied with.

Annual Reporting Burden:

Respondents: 400.

Total annual responses: 1,100.

Total annual hours requested: 37,400 hours.

On March 14, 1997, at the request of petitioner, Kentucky Electric Steel (“KES”), the Department of Commerce (“the Department”) initiated a scope inquiry to determine whether certain cut-to-length carbon steel plate used to make grader blades and draft keys (“grader blade” and “draft key” steel) that contain small amounts of boron fall within the scope of the order on certain cut-to-length carbon steel plate from Canada.

On January 16, 1998, the Department issued a ruling, based on 19 CFR section 353.29(i), that boron-added grader blade and draft key steel falls outside the literal scope of the order. The scope of the original antidumping investigation relied on the HTSUS definition of carbon steel, which distinguishes other-alloy steel ( i.e. including steel containing more that 0.0008 percent boron). Because the petition equated the term “carbon steel” with the HTSUS term “non-alloy steel”, variants of grader blade and draft key steel which contain at least 0.0008 percent boron by weight fell outside the literal scope of the order.

On January 30, 1998, KES requested that the Department conduct an anticircumvention inquiry pursuant to section 781(c) of the Act to determine whether imports of certain cut-to-length steel plate used to make grader blades and draft keys that contain small amounts of boron and fall within the physical dimensions outlined in the scope of the order, are circumventing the antidumping duty order on certain cut-to-length carbon steel plate from Canada. KES alleged that, since publication of the antidumping duty order, exporters of certain cut-to-length carbon steel plate from Canada have been circumventing the order by exporting carbon steel plate with small amounts of boron added so as to avoid coverage under the order. According to KES, the “inclusion of 0.0016 percent boron by weight to high carbon grader blade and draft key steel constitutes a minor alteration” and is, therefore, within the meaning of the provisions detailed in section 781(c) of the Act. See Anticircumvention Application, January 30, 1998 at 4.

On May 20, 1998, the Department initiated an anticircumvention inquiry on the antidumping order on Cut-to-Length Carbon Steel Plate from Canada. See Notice of Initiation of Anticircumvention Inquiry: Cut-to-Length Carbon Steel Plate from Canada , 63 FR 29179 (May 28, 1998). On June 5, 1998, the Department requested information from Canadian producers which were listed as producers of either grader blade or draft key steel in Iron and Steel Works of the World, 12th edition. On June 26, 1998 and July 17, 1998, Gerdau MRM Steel (“MRM”) and Co-Steel Lasco (“CSL”), respectively, responded to the Department's questionnaire, identifying themselves as producers of carbon steel products with over 0.0008 percent boron. Based on these responses, the Department issued a full questionnaire to both CSL and MRM on July 30, 1998. CSL filed its response on September 28, 1998. MRM filed its response on October 6, 1998. On October 7, 1998, the Department issued a supplemental questionnaire to CSL, who responded on October 14, 1998. On November 6, 1998, the Department issued a supplemental questionnaire to MRM, which responded on December 7, 1998.

From October 26 through October 28, 1998, Department officials conducted a verification of CSL. The Department reviewed documents and made inquiries of CSL officials with regard to the sales and production of grader blade and draft key carbon steel with and without boron added.

Algoma Steel Inc. and Caterpillar Inc. have also filed notices of appearance with the Department as interested parties to this inquiry.

On December 16, 1998, the Court of International Trade (“CIT”) enjoined further proceeding with this inquiry. See Co-Steel Lasco v. United States ( Co-Steel ) Court No. 98-08-02684. However, the Court of Appeals for the Federal Circuit subsequently reversed the injunction, and on October 12, 2000, the CIT dismissed the case. Thus, we are proceeding with this inquiry and we will make our final determination no later than January 10, 2001.

The scope language contained in the final determination and antidumping duty order describes the covered merchandise as follows:

Determination; Certain Cold-Rolled Carbon Steel Flat Products From Argentina, 58 FR 37063 (July 9, 1993), Appendix I. See also Antidumping Duty Orders: Certain Corrosion-Resistant Carbon Steel Flat Products and Certain Cut-to-Length Carbon Steel Plate From Canada, 58 FR 44162 (August 19, 1993).

The merchandise subject to this inquiry is certain cut-to-length plate, commonly known as grader blade and draft key steel, made of in-scope high carbon steel to which a small amount of boron (minimum 0.0008 percent boron by weight) has been added, falling within the physical dimensions outlined in the scope of the order. High carbon steel is defined as steel of AISI or SAE grades 1050, 1152, or 1552, or higher, i.e., carbon steels that may contain 0.55 percent or more carbon by weight. “Grader blade” steel is typically used in grading equipment such as bulldozers and snowplows. “Draft key” steel is used specifically to make locking mechanisms for railroad couplings. Unless otherwise indicated, the terms “boron-added grader blade and draft key carbon steel”, “boron-added steel for use in grader blades and draft keys” and “boron-added steel” are synonymous for the purpose of this notice.

Section 781 of the Act addresses the prevention of circumvention of antidumping and countervailing duty orders. Subsection 781(c) specifically provides that:

(1) In general—The class or kind of merchandise subject to—

(A) an investigation under this title,

(B) an antidumping duty order issued under section 736,

(C) a finding under the Antidumping Act of 1921, or

(D) a countervailing duty order issued under section 706 or section 303, shall include articles altered in form or appearance in minor respects (including raw agricultural products that have undergone minor processing), whether or not included in the same tariff classification.

(2) Exception—Paragraph (1) shall not apply with respect to altered merchandise if the administering authority determines that it would be unnecessary to consider the altered merchandise within the scope of the investigation, order or finding.

In its final determination of the scope ruling noted above, the Department found that the scope did not include grader blade steel and draft key steel produced with 0.0008 percent boron or more by weight (“boron-added steel”), the merchandise in question in this inquiry. Respondents have argued in this case that by finding that the product is outside the scope of the order, the Department may not initiate a “minor alterations” anticircumvention inquiry, citing the decision of the CIT in Wheatland Tube Co. v. United States, 973 F.Supp. 149 (CIT 1997).

Since the time of initiation, the United States Court of Appeals for the Federal Circuit (“CAFC”) has clarified the law in this area. In Wheatland Tube Co. v. United States, the CAFC held that, under the facts of that case, an anticircumvention inquiry was not appropriate. However, the appellate court also determined that “(i)n essence, section 1677j(c) includes within the scope of an antidumping order products that are so insignificantly changed from a covered product that they should be considered within the scope of the order even though the alterations remove them from the order's literal scope. ” See Wheatland Tube Co. v. United States, 161 F.3d 1365 (1998) at 12. Thus, under Wheatland, the Department may properly inquire whether, although the merchandise in question is outside the order's literal scope, the merchandise has been altered from an in-scope product in such a minor way that it should be considered within the scope of the order.

Petitioner has alleged, and the facts discovered by the Department to-date have shown, that the out-of-scope boron-added carbon grader blade and draft key steel is made through an economically and metallurgically insignificant alteration of in-scope carbon steel. Consequently, this case presents precisely the sort of inquiry authorized by the court in Wheatland.

Additionally, in a related case involving nearly identical facts and the same scope issue, Nippon Steel Corporation v. United States, 219 F.3d 1348 (Fed. Cir., July 26, 2000) (“Nippon”), the CAFC further clarified that the minor alteration inquiry in Wheatland was prohibited only because the product in question was well-known prior to the order and was specifically excluded from the investigation. In this respect, the Court in Nippon distinguished Wheatland from the inquiry involving boron-added carbon steel, and determined that a circumvention inquiry of such a product (boron-added carbon steel) was proper. See Decision Memorandum: Preliminary Determination of Circumvention of the Antidumping Duty Order: Certain Cut-to-Length Carbon Steel Plate from Canada (“ Decision Memo ”) from Joseph A. Spetrini to Troy Cribb dated October 23, 2000. Moreover, the Federal Circuit in this case ( Co-Steel ) adopted the Nippon opinion by reference and found that the circumvention inquiry was indeed proper. See Co-Steel Lasco v. United States, 99-1339 (September 22, 2000). As a result, on October 12, 2000, the CIT in this case dissolved the injunction and dismissed the complaint.

Petitioner alleges that imports of grader blade and draft key steel that contain small amounts of boron are circumventing the order on cut-to-length carbon steel plate from Canada. As discussed above, minor alteration anticircumvention inquiries are used when a petitioner claims that, although a product falls outside the literal scope of an order, the product should nevertheless be considered within the scope of an order because it results from an insignificant minor alteration of the in-scope product.

Carbon steel is produced by first melting scrap and/or iron ore with charge carbon in a furnace. Once the steel is sufficiently heated, it is transferred to a ladle arc refiner, where alloys are added according to the specification required. When the steel's chemistry meets specifications, it is poured into a caster to form billets. These billets are cut and cooled. After the billets have cooled, they are reheated and sent to the structural mill, where the billets are rolled and cut according to the customer's specifications.

The only difference in the production of boron-added carbon steel versus ordinary carbon steel is in the refining stage, where boron is simply added to the molten steel. All that is required to meet the HTSUS threshold level of 0.0008 percent boron is the addition of less than 100 pounds of boron to more than a hundred tons of molten steel. All other aspects of production are exactly the same as those for carbon steel. As discussed in “Cost of Modification” below, not only was the alteration to the production “minor” in all respects, the cost of this alteration was also “minor”: approximately one third of one percent of the sales price. For a further discussion of this issue, see Decision Memo at 6.

Respondent CSL argues that “alloy steel plate,” or boron-added grader blade and draft key steel, cannot be made by altering carbon steel plate. CSL states that in order for carbon steel plate, the subject merchandise, to be altered into alloy steel plate, the carbon steel plate would have to be remelted in order to introduce boron into the molten steel, and then follow the production process from pouring billets to cutting rolled plate. However, respondent misinterprets the minor alterations provision. Neither the statute nor its legislative history require that a minor alteration be made to a finished product. Indeed, the legislative history indicates that Congress anticipated that slight changes in production might allow an exporter to circumvent an order.

While the statute is silent regarding what factors to consider in determining whether alterations are properly considered “minor,” the legislative history of this provision indicates that there are certain factors which should be considered before reaching an anticircumvention determination. The petitioner cites to the Senate Finance Committee report on the Omnibus Trade and Competitiveness Act of 1988 (which amended the Tariff Act of 1930 to include the anticircumvention provisions contained in section 781), which states:

KES presented evidence with respect to each of the criteria listed in the Senate report, and the Department has examined the information on the record regarding each of these criteria. Our findings are discussed below.

The cut-to-length plate product at issue in this inquiry is a high carbon steel (minimum 0.55 percent by weight) with small amounts of boron added. The petitioner claims that while boron is traditionally added to steel to improve “hardenability,” when the level of carbon is already at 0.60 percent by weight or above, the added boron's effect on the final product is negligible. For this reason, petitioner claims that it is the steelmaking industry's practice not to add boron to high-carbon grades.

According to CSL, the only metallurgical difference between boron-added steel and carbon steel is the amount of boron added. All other specifications remain the same, within a given ASTM grade. CSL contends that its rationale for adding boron is not to increase hardness, but to improve the grain size, and therefore, the “toughness” of the steel. “Toughness” refers to the steel's ability to withstand shearing, breaking and cracking on impact. At verification, CSL officials stated that members of the steelmaking industry were “skeptical” regarding whether boron added to high carbon steel improves toughness. CSL officials also stated that to the best of their knowledge, no other producer uses boron as a grain refiner in high carbon steel. See Verification Report at 14. CSL stated that it did not represent to its customers that the boron-added steel was an improvement over the carbon steel, because it could not quantify the improvement. However, CSL was aware that there were tests that could indicate if the boron was improving toughness. One of these tests is a test for grain size. The smaller the grain size of the steel, the tougher it is. We believe that record evidence indicates that CSL did not assign a high priority to confirming the alleged improvement to the boron-added steel. See Decision Memorandum.

Respondent MRM contends that the addition of boron facilitates the formation of martensite, which, if the steel is subsequently heat treated and quick-quenched (a process of raising the temperature of the metal to a “critical” level and cooling it rapidly), imparts greater hardenability to the steel, particularly “through hardness.” MRM has stated that “it is of the opinion that all customers who purchase alloy grade steel do include heat treatment and/or flame hardening as part of their production process.” See MRM submission, dated October 6, 1998. However, both CSL and petitioner have stated that grader blade and draft key customers do not heat treat steel. Moreover, MRM's discussion of martensite only appears to apply to low carbon steel, not to the high carbon grade blade and draft key steels which are the subjects of this inquiry. See Decision Memo at 8.

In addition, respondents have often referred to the boron-added grader blade steel as an “alloy steel” and have discussed general differences between “alloy steel” and carbon steel. However, we believe that this reference is misleading. Although the carbon steel to which a small amount of boron has been added is technically an “other alloy” steel for the purposes of the HTSUS classification, a true alloy steel as recognized by the industry is markedly different from the product at issue. The ITC Staff Report describes a true alloy steel as a significantly higher priced product with distinct characteristics and uses, containing much higher levels of alloys. Staff Report, Certain Flat-Rolled Carbon Steel Products from Various Countries, USITC Pub. 2664, Vol. 2 (August 1993), at I-37. The “alloy” steel produced by respondents has, with the exception of its boron content, exactly the same physical and metallurgical properties of its carbon steel counterpart.

Based on the record evidence, the Department finds that there is no substantial difference in the physical characteristics between boron-added and carbon steel—indeed the differences are “minor”. Both kinds of steel are produced to the same specifications with the exception of boron content. Although respondents claim that differences exist in terms of toughness and through hardening, neither respondent has made any effort to confirm and quantify any improvement that would indicate a difference in physical characteristics. The record evidence indicates that respondents are not primarily concerned with the steel's purported improvement.

The petitioner maintains that carbon steel users purchase high carbon steel with the expectation that the product be especially hard and durable, and that these characteristics are imparted by the presence of sufficient levels of carbon. Petitioner states that consumers of this product are fully aware that carbon steel of the sort at issue does not rely on or benefit from the presence of boron, and thus “do not expect, seek, or desire” its presence.

Typical uses for grader blade steel are blades for snowplows and bulldozers. Draft key steel is used to make locking devices for railroad car couplings. Because of their application, customers require and expect that the steel they buy will be hard. The primary characteristic of high carbon steel is its hardness, due to the level of carbon. Although CSL and MRM claim to have improved the steel, no evidence has been presented to significantly distinguish boron-added steel from the in-scope high carbon steel in terms of use or performance. CSL reports that there is no application that restricts customers to using boron-added steel versus a carbon steel. MRM presented no evidence for the record that customers could use the boron-added steel in applications where they could not use the carbon steel.

Respondent CSL reports that the decision to use boron was not the result of customer dissatisfaction, specific requests, or problems with the process of production. CSL reported at verification that customers did not request boron, and have to date made no comment regarding its addition, or any purported improvement. In addition, CSL did not indicate to its customers that the boron-added product was significantly better than the carbon product, nor did the company charge more for the product. CSL reported that it only told its customers that boron was being added to the steel as a grain refiner, and that its addition “wouldn't hurt the steel.” Record evidence offers other indications that CSL has sold both boron-added and carbon grader blade steel to its customers, and that none of CSL's customers made any distinction between the two products. For a further discussion of this issue, see Decision Memo.

MRM has not presented any corroborated evidence that the ultimate users of its products have any expectations with regard to any improvement in the increased surface and through hardness of the boron-added grader blade and draft key steel vis-a-vis an ordinary carbon grader blade and draft key steel. For a further discussion of this issue, see Decision Memo.

The petitioner maintains that, with or without boron, high carbon grader blade and draft key steel have the same uses: making blades on grading equipment and locking devices on railroad couplings. The petitioner states that knowledgeable purchasers would be aware that there are no uses of high carbon steel containing small amounts of boron that cannot fully be met without boron, and that the addition of boron neither responds to a new need in the market, nor improves the way existing technical needs are met.

CSL reports that there is no difference in the use of the boron-added product versus the carbon product, both in its responses and at verification. As noted above in “Expectations of End-Users,” CSL has sold both boron-added and carbon steel to the same customer, and has not received any comments concerning any differences in application or performance.

MRM claims that it “cannot state with certainty what their customers “intended use” was or is with alloy steel or carbon steel.” See MRM response, October 6, 1998, at 15. However, the sales-related documentation MRM submitted in its responses indicate that MRM did have knowledge of its customers' use of the merchandise. Every sample sale presented by MRM in its October 6 and December 7, 1998 responses include descriptions of products that are either clearly grader blade products, or clearly not grader blade products. This evidence, coupled with the sales and marketing process of direct contact with customers, indicates that MRM is fully aware of customers' use of the merchandise. MRM has not presented any evidence that indicates that boron-added steel is used in a manner different from that of ordinary carbon steel. For a further discussion of this issue, see Decision Memo.

The petitioner states that steel producers, with few exceptions, sell directly to manufacturers of grader blades and draft keys through company sales forces. Petitioner claims that, because carbon grader blade and draft key steels are used for precisely the same products as are the boron-added versions of the products, boron-added steel is sold in precisely the same sales channels as carbon steel.

The grader blade and draft key steel market has been reported to be mature, with few customers and a limited number of suppliers. Record evidence indicates that CSL and MRM have sold their products to the same U.S. customers before and after the investigation in 1993. Both CSL and MRM have stated that their products are marketed by direct contact with the customer, and have made no distinction between the sales and marketing process for either the boron-added or carbon steel.

Petitioner alleges that, by adding boron to high carbon steels, Canadian producers have been able to avoid dumping duties ranging from 1.47 percent to 68.7 percent, and that the cost of avoiding these duties, relative to the total value of the product itself, is negligible. Based on records examined at verification of CSL, the additional cost of making a boron-added steel is wholly insignificant. For a further discussion of this issue, see Decision Memo.

MRM claims that “it has no basis for a comparison between carbon steel and high-carbon/boron alloy steel.” See MRM response, dated December 7, 1998, at 4. MRM's only reference to a price difference between carbon steel and “high-carbon/boron alloy steel” is a comparison of all carbon steels (not just grader blade and draft key steels) in unadjusted dollars over a four year period. Id. However, MRM has not made any claim regarding additional cost in the cost of producing a boron-added steel vis-a-vis a carbon steel without boron. If the only additional cost is the cost of the boron, it may be assumed that CSL's boron costs and MRM's costs are similar, and therefore, the price differential would also be similar.

In addition to the criteria above, we note that the Department has in a prior anticircumvention proceeding considered other factors as relevant to the circumvention allegation. These factors are: (i) the circumstances under which the subject products entered the United States, (ii) the timing of these entries during the circumvention review period, and (iii) the total quantity of the merchandise entered during this period. See Brass Sheet and Strip from Germany; Negative Preliminary Determination of Circumvention of Antidumping Duty Order, 55 FR 32655 (August 10, 1990).

The Department is not required to determine intent during a circumvention inquiry. Nevertheless, the facts surrounding CSL's production and importation of boron-added steel tend to indicate a deliberate attempt to modify carbon steel so as to avoid the effects of the antidumping duty order.

Record evidence indicates that CSL clearly distinguishes its boron-added grader blade and carbon grader blade. CSL's own metallurgical specification records indicate a deliberate effort to avoid antidumping duties on products shipped to the United States. Boron-added grader blade steel is almost exclusively, and seemingly by design, produced for U.S. customers, while grader blade steel without boron represents the vast majority of products sold to Canadian customers. If the addition of boron served any purpose other than circumvention, we would expect to see boron added to steel regardless of whether the customer was located in the United States or Canada. For a further discussion of this issue, see Decision Memo.

Generally speaking, a preliminary affirmative determination by the Department in an antidumping investigation is seen by foreign manufacturers/exporters as the first reliable indication that antidumping duties will most likely be imposed. This is because it is the first formal determination by the Department, and the first time the Department directs the Customs Service to suspend liquidation and collect a cash deposit of estimated dumping duties. In the antidumping investigation of cut-to-length carbon steel plate from Canada, a preliminary affirmative determination was published on February 4, 1993. See Notice of Preliminary Determinations of Sales at Less Than Fair Value: Certain Hot-Rolled Carbon Steel Flat Products, Certain Cold-Rolled Carbon Steel Flat Products, Certain Corrosion-Resistant Carbon Steel Flat Products, and Certain Cut-to-Length Carbon Steel Plate from Canada, 58 FR 7085 (February 4, 1998).

CSL's records indicate that boron-added steel, technically out of the scope of the order, was first produced shortly after the publication of the preliminary affirmative determination. This suggests that the addition of boron may have been in response to the preliminary determination.

Each “batch” of steel, called a heat, has a specific chemistry, namely, the content levels of certain elements and alloys in the heat. On one occasion, CSL appears to have modified a heat to contain boron levels above the HTSUS threshold. This could indicate a deliberate attempt to exceed the 0.0008 percent threshold. For a further discussion of this issue, see Decision Memo.

The facts surrounding MRM's production and importation of boron-added steel also indicates circumvention. According to MRM's July 17, 1998 response, boron-added grader blade and draft key steels were not sold to either Canadian or U.S. customers prior to 1993, but were sold exclusively to U.S. customers after 1993, the year of the investigation. In contrast, with the exception of a negligible amount, all of MRM's sales to its Canadian customers, before and after 1993, involved grades that did not include boron. For a further discussion of this issue, see Decision Memo.

Record evidence indicates that, after the investigation in 1993, both CSL and MRM shifted all of their production for U.S. customers to boron-added steel. Sales data submitted by both respondents indicate that all grader blade and draft key steel sold in the United States has boron added, while steel sold in Canada is, for the most part, produced without boron. Neither respondent has presented any evidence that explains why only U.S. customers are sold the allegedly “improved” boron-added steel.

As a result of our inquiry, we preliminarily determine that exports of boron-added grader blade and draft key steel from Canada are circumventing the antidumping order on certain cut-to-length carbon steel plate from Canada. While carbon steel plate products containing over 0.0008 percent boron by weight are, by definition, technically outside the literal scope of the antidumping duty order, we have preliminarily determined that, pursuant to “minor alterations” provision of the statue, it is appropriate to include the putatively out-of-scope boron-added steel, which is the subject of this inquiry, in the class or kind of merchandise subject to the order on cut-to-length carbon steel plate. See Section 781(c) of the Act.

Boron-added steel is made by slightly altering carbon steel during its production process. With the exception of the presence of boron, boron-added steel has the same physical characteristics as carbon steel. There are no differences in the expectations of the ultimate users, uses of the merchandise, and channels of marketing between boron-added steel and the subject merchandise. Furthermore, the cost of adding boron in the course of production is negligible. Since the original investigation, respondents have shifted their entire production for U.S. customers away from in-scope carbon steel to out-of-scope carbon steel to out-of-scope boron-added steel. No similar shift has occurred in the home market, where the majority, if not all, of both respondents' production is devoted to carbon grader blade and draft key steel without boron. The timing of this shift further indicates circumvention of the order by making a minor alteration. Taken as a whole, this evidence leads to our determination that boron-added grader blade and draft key steel is being produced in circumvention of the antidumping law, undermining its intent, and eviscerating its effectiveness.

After a thorough analysis of the physical characteristics of the merchandise subject to this inquiry, the expectations of the ultimate users, the ultimate use of the merchandise, the cost of modification, and the additional factors listed above, we have determined that Canadian manufacturers/exporters of grader blade and draft key steel have made minor alterations in their in-scope merchandise within the meaning of section 781(c) of the Act, resulting in circumvention of the antidumping order covering certain cut-to-length carbon steel plate from Canada. This preliminary determination extends only to those products manufactured by Co-Steel Lasco and Gerdau MRM Steel.

In accordance with section 351.225(1) of the Department's regulations, we are directing the U.S. Customs Service to suspend liquidation of all imports of high carbon (minimum 0.55 percent by weight) cut-to-length carbon steel plate with boron (minimum 0.0008 percent by weight), falling within the physical parameters outlined in the scope of this order, manufactured or exported by Co-Steel Lasco or Gerdau MRM Steel that are entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the Federal Register . We will also instruct the U.S. Customs Service to require a cash deposit of estimated duties for each unliquidated entry of the product entered, or withdrawn from warehouse, on or after the date of initiation of this inquiry, in accordance with section 351.225(1)(2) of our regulations. We will instruct the U.S. Customs Service to require a cash deposit at the applicable rates for MRM and CSL listed below. These suspension-of-liquidation instructions will remain in effect until further notice.

As a result of this preliminary determination, the merchandise subject to the scope of this order includes merchandise entered under the following additional HTSUS number: 7211.14.0030.

Case briefs or other written comments in at least ten copies must be submitted to the Assistant Secretary for Import Administration no later than 30 days after the publication of the preliminary determination, and rebuttal briefs, limited to issues raised in case briefs, no later than 35 days after the publication of the preliminary determination. A list of authorities used and an executive summary of issues should accompany any briefs submitted to the Department. Such summary should be limited to five pages total, including footnotes. We will hold a public hearing, if requested, to afford interested parties an opportunity to comment on arguments raised in case or rebuttal briefs. Tentatively, the hearing will be held 37 days after the publication of the preliminary determination, time and room to be determined, at the U.S. Department of Commerce, 14th Street and Constitution Avenue, N.W., Washington, D.C. 20230. Parties should confirm by telephone the time, date, and place of the hearing 48 hours before the scheduled time.

Interested parties who wish to request a hearing, or to participate if one is requested, must submit a written request to the Assistant Secretary for Import Administration, U.S. Department of Commerce, Room 1870, within 30 days of the publication of this notice. Requests should contain: (1) The party's name, address, and telephone number; (2) the number of participants; and (3) a list of the issues to be discussed. Oral presentations will be limited to issues raised in the briefs. If this investigation proceeds normally, we will make our final determination no later than January 10, 2001.

This determination is issued and published in accordance with section 777(i)(1) of the Act.

This will be the sixth meeting of the RFDTF and will discuss the following topics: the implementation of the NMFS Marine Recreational Fisheries Statistical Survey (MRFSS), Pelagic Environmental Impact Statement & recreational fisheries, outcome of the seventh Multilateral High Level Conference for tuna management in the Central-West Pacific, the pros and cons for a marine recreational fishery license in Hawaii, recreational bag limits and minimum sizes for sale, effectiveness of bottomfish closed areas in the Main Hawaiian Islands, new Council Advisory Panels and the future of the RFDTF.

Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council’s intent to take final action to address the emergency.

This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kitty M. Simonds, 808-522-8220 (voice) or 808-522-8226 (fax), at least 5 days prior to meeting date.

The subject amendment to Permit No. 633-1483, issued on March 3, 1999 (64 FR 10276), is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361 et seq.), the Regulations Governing the Taking and Importing of Marine Mammals (50 CFR part 216), the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq.), and the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR 222-227).

Permit No. 633-1483 authorizes the permit holder to (Project I): (1) conduct behavioral observations of, and photo-identify northern right whales during aerial and vessel surveys; (2) place VHF tags on right whales during the course of vessel surveys; (3) collect skin and blubber biopsy samples and sloughed skin; and (4) export skin samples for genetic analysis. And, under Project II (humpback whales), to: (1) develop a genealogy of the Gulf of Maine humpback whale population; (2) determine paternity and evaluate male reproductive success; (3) evaluate the influence of relatedness on feeding distribution, behavior and social organization; (4) determine individual movement and habitat preferences; (5) evaluate rates and severity of entanglement; (6) monitor trends in abundance, reproductive rates, recruitment, and mortality; and (7) opportunistically photo-identify and biopsy sample various Balaenopterid species.

With this application for amendment, the permit holder requests authorization (Project III) to attach a non-invasive optical device (“critter cam”) to seven North Atlantic right whales in Cape Cod Bay for collecting video documentation in order to better assess prey selectivity and movements of the whales during foraging and the quality of the food layer supporting the whales. This documentation will provide a subsurface tool for supplementing CCS' on-going oceanographic surveys and for “ground-truthing” current estimates of prey patch density and area in Cape Cod Bay.

In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.), an initial determination has been made that the activity proposed is categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement.

Concurrent with the publication of this notice in the Federal Register , NMFS is forwarding copies of this application to the Marine Mammal Commission and its Committee of Scientific Advisors.

Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that the Office of Management and Budget (OMB) provide interested Federal agencies and the public an early opportunity to comment on information collection requests. OMB may amend or waive the requirement for public consultation to the extent that public participation in the approval process would defeat the purpose of the information collection, violate State or Federal law, or substantially interfere with any agency's ability to perform its statutory obligations. The Leader, Regulatory Information Management Group, Office of the Chief Information Officer, publishes that notice containing proposed information collection requests prior to submission of these requests to OMB. Each proposed information collection, grouped by office, contains the following (1) Type of review requested, e.g. new, revision, extension, existing or reinstatement; (2) Title; (3) Summary of the collection; (4) Description of the need for and proposed use of, the information; (5) Respondents and frequency of collection; and (6) Reporting and/or Recordkeeping burden. OMB invites public comment. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology.

Type of Review: New.

Title: Evaluation of the Partnership Grants Program of Title II of the Higher Education Act.

Frequency: Annually; Weekly.

Affected Public: Not-for-profit initiations; State, Local, or Tribal Gov't, SEAs or Leas.

Reporting and Recordkeeping Hour Burden:

Responses: 453.

Burden Hours: 963.

Abstract: The purpose of this evaluation is to assess the impact, strengths and weaknesses of the Partnership Grants Program, one of the three programs authorized in Title II of the Higher Education Amendments of 1998. This program is designed primarly to increase collaboration between schools of arts and sciences and schools of education, increase the rule of K-12 educators in the design and implementation of effective teacher education programs, and increase the intensity and quality of clinical experiences for prospective teachers. The evaluation will measure the impact of grants in helping colleges of education, colleges of arts and sciences, school districts and other partners to work more closely together to improve the content and structure of the professional education offered to prospective teachers.

Requests for copies of the proposed information collection request may be accessed from http://edicsweb.ed.gov, or should be addressed to Vivian Reese, Department of Education, 400 Maryland Avenue, SW, Room 4050, Regional Office Building 3, Washington, D.C. 20202-4651. Requests may also be electronically mailed to the internet address OCIO-IMG-Issues@ed.gov or faxed to 202-708-9346. Please specify the complete title of the information collection when making your request. Comments regarding burden and/or the collection activity requirements should be directed to Joseph Schubart at (202) 708-9266 or via his internet address Joe_Schubart@ed.gov. Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339.

Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that the Office of Management and Budget (OMB) provide interested Federal agencies and the public an early opportunity to comment on information collection requests. OMB may amend or waive the requirement for public consultation to the extent that public participation in the approval process would defeat the purpose of the information collection, violate State or Federal law, or substantially interfere with any agency's ability to perform its statutory obligations. The Leader, Regulatory Information Management Group, Office of the Chief Information Officer, publishes that notice containing proposed information collection requests prior to submission of these requests to OMB. Each proposed information collection, grouped by office, contains the following: (1) Type of review requested, e.g. new, revision, extension, existing or reinstatement; (2) Title; (3) Summary of the collection; (4) Description of the need for, and proposed use of, the information; (5) Respondents and frequency of collection; and (6) Reporting and/or Recordkeeping burden. OMB invites public comment.

Type of Review: Reinstatement.

Title: Public Libraries Survey.

Frequency: Annually.

Affected Public: State, Local, or Tribal Gov't, SEAs or LEAs; Federal Government.

Reporting and Recordkeeping Hour Burden:

Responses: 56.

Burden Hours: 1,680.

Abstract: The Public Libraries Survey is an annual survey of public libraries in the 50 States, D.C. and the Outlying Areas. Data for local public libraries are aggregated at the State and national levels. Federal, state, and local officials use the data for planning, evaluation, monitoring, budgeting, administration, and policy. Other users include librarians, educators, and researchers. The respondents are the 50 States, D.C. and the Outlying Areas.

Requests for copies of the proposed information collection request may be accessed from http://edicsweb.ed.gov , or should be addressed to Vivian Reese, Department of Education, 400 Maryland Avenue, SW, Room 4050, Regional Office Building 3, Washington, DC 20202-4651. Requests may also be electronically mailed to the internet address OCIO_IMG_Issues@ed.gov or faxed to 202-708-9346. Please specify the complete title of the information collection when making your request. Comments regarding burden and/or the collection activity requirements should be directed to Kathy Axt at her internet address Kathy_Axt@ed.gov. Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339.

DOE has prepared the Draft Study on the possible consequences of long-term stewardship according to the terms of a 1998 settlement agreement that resolved a lawsuit brought against DOE by the Natural Resources Defense Council and 38 other plaintiffs [ Natural Resources Defense Council, et al. v. Richardson, et al., Civ. No. 97-936 (SS) (D.D.C. Dec. 12, 1998)]. The Draft Study incorporates input received during a public scoping process and examines the institutional and programmatic issues currently facing DOE as it completes the environmental cleanup program at its sites. Long-term stewardship, under the agreement, refers to:

The goal of the Draft Study is to inform decision-makers and the public about the long-term stewardship issues and challenges facing DOE and potential options for addressing such issues.

The Draft Study does:

• Describe DOE's long-term stewardship responsibilities, the status of current and ongoing stewardship obligations, activities and initiatives, and the plans for future activities;

• Analyze the national issues that DOE needs to address in planning for and conducting long-term stewardship activities; and

• Promote information exchange on long-term stewardship among DOE, Tribal nations, state and local governments, and private citizens.

The Draft Study does not:

• Serve as a National Environmental Policy Act (NEPA) document or its functional equivalent;

• Identify or address site-specific issues, except as examples in the context of presenting national issues; or

• Address issues specific to nuclear stockpile stewardship, other activities related to national security, or the Central Internet Database required by the settlement agreement.

The terms of the settlement agreement stipulate that DOE follow the President's Council on Environmental Quality (CEQ) procedures for public scoping, 40 CFR 1501.7(a)(1)-(2) for this study, even though it is not a NEPA document or its functional equivalent. Therefore, DOE conducted a scoping process during October 1999—February 2000 to gather comments on the scope of the Draft Study. The scoping period was initially intended to run from October 1999 to January 2000, but was extended by request to February 2000. The scoping process provided DOE with input about the topics and issues that should be included in the Draft Study, within the general parameters established by the settlement agreement. DOE developed the overall scope and issues that are addressed in the Draft Study based on comments received through the scoping process, ongoing work on long-term stewardship being conducted by DOE and non-DOE organizations, and requirements of the settlement agreement. DOE is soliciting comments on the Draft Study during a public comment period that begins on the date of publication of this notice and ends on December 15, 2000. Similarly, a public hearing will be held to receive oral and written comments from the public on the Draft Study. Comments received during the public comment period will be used by DOE to complete the final study. DOE's responses to comments received during the public comment period will be presented in a public comment summary document to be issued as part of the final study.

DOE released a background document, From Cleanup to Stewardship, a Companion Report to “Paths to Closure” and Background Information to Support the Scoping Process Required for the 1998 PEIS Settlement Study in October 1999. In producing the background document and the Draft Study, DOE used the same data set used to develop the 1998 Accelerating Cleanup: Paths to Closure report. DOE used this information to identify sites where contaminated facilities, water, soil, and/or engineered units would likely remain after cleanup is complete to estimate the scope of long-term stewardship activities. Both the Draft Study on long-term stewardship and the background document are the best available information sources to date on the issue of DOE's long-term stewardship responsibilities. Copies of the Draft Study and the background document or other related information can be obtained by contacting:

• The Internet Web Site at www.em.doe.gov/lts, which contains information on long-term stewardship related issues produced by DOE and outside sources.

• The Center for Environmental Management Information, 955 L'Enfant Plaza, North, SW, Suite 8200, Washington, D.C. 20024, 1-800-736-3282 (“1-800-7EM-DATA”).

• DOE Reading Rooms (for locations of the DOE Reading Rooms or other public information repositories containing background information, please contact the Center for Environmental Management Information at the above address and telephone).

You may be affected by this document if you are, or may in the future be, a manufacturer or importer of a monomer acid derivative that requires submission of a Premanufacture Notice (PMN) or Significant New Use Notice (SNUN) under the Toxic Substances Control Act (TSCA). Special rules apply to persons who manufactured (or processed) these chemicals between August 2, 1985, and 12 months following the date of publication of the final nomenclature correction notice in the Federal Register . Potentially affected entities may include, but are not limited to the following:

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 technical person listed under FOR FURTHER INFORMATION CONTACT.

1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select ``Laws and Regulations'' and then look up the entry for this document under the `` Federal Register _Environmental Documents.'' You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/. To access information about EPA's New Chemicals Program, go directly to the Home Page at http://www.epa.gov/oppt/newchems/.

2. In person . The Agency has established an official record for this action under docket control number OPPTS-50040. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as confidential business information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the TSCA Nonconfidential Information Center, North East Mall, Rm. B-607, Waterside Mall, 401 M St., SW., Washington, DC. The Center is open from noon to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Center is (202) 260-7099.

You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPPTS-50040 in the subject line on the first page of your response.

1. By mail . Submit your comments to: Document Control Office (7407), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

2. In person or by courier . Deliver your comments to: OPPT Document Control Office (DCO) in East Tower Rm. G-099, Waterside Mall, 401 M St., SW., Washington, DC. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is (202) 260-7093.

3. Electronically . You may submit your comments electronically by e-mail to: ``oppt.ncic@epa.gov,'' or mail your computer disk to the address identified above. Do not submit any information electronically that you consider to be CBI. Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Comments and data will also be accepted on standard disks in WordPerfect 6.1/8.1 or ASCII file format. All comments in electronic form must be identified by docket control number OPPTS-50040. Electronic comments may also be filed online at many Federal Depository Libraries

Do not submit any information electronically that you consider to be confidential business information (CBI). You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the technical person identified under FOR FURTHER INFORMATION CONTACT.

You may find the following suggestions helpful for preparing your comments:

1. Explain your views as clearly as possible.

2. Describe any assumptions that you used.

3. Provide copies of any technical information and/or data you used that support your views.

4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.

5. Provide specific examples to illustrate your concerns.

6. Offer alternative ways to improve the notice or collection activity.

7. Make sure to submit your comments by the deadline in this notice.

8. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

An August 2, 1985 letter from EPA erroneously equates monomer acid and its derivatives with Tall Oil Fatty Acid (TOFA) and its corresponding derivatives for TSCA Inventory purposes when, in fact, they are chemically distinct. As a result, many manufacturers of monomer acid derivatives have not submitted PMNs under TSCA section 5, because the letter incorrectly indicated that monomer acid derivatives were covered by TOFA derivatives already on the Inventory. This notice proposes a correction to the 1985 letter on nomenclature of monomer acid and derivatives. With this proposed correction, monomer acid derivatives that are not on the Inventory would be considered new chemical substances under section 5 of TSCA.

Section 5 of TSCA requires any person who intends to manufacture (defined by statute to include import) a new chemical (i.e., a chemical not on the TSCA Inventory) to notify EPA and comply with the statutory provisions pertaining to the manufacture of new chemicals. Section 8(b) of TSCA requires EPA to compile, keep current, and publish a list of each chemical substance which is manufactured or processed in the United States (the TSCA Inventory). This requirement includes defining the scope of the listings on the Inventory.

The August 2, 1985 EPA letter to an industry representative on the nomenclature for monomer acids states:

Tall oil is a source for natural fatty acids, commonly referred to as Tall Oil Fatty Acids (TOFA). TOFA may be reacted with other substances to create TOFA derivatives. TOFA that is heated in the presence of an acid clay catalyst forms a “dimer acid” together with small amounts of “trimer acid” and higher oligomers. The “dimer acid” process also produces “monomer acid” as a co-product. The monomer acid is often used as an inexpensive fatty acid source to make monomer acid derivatives or other downstream products for use in lubricants, greases, hot melt adhesives, printing ink resins, ore flotation agents, corrosion inhibitors, etc.

It is clear that the TOFA dimerization process yields distinct chemical substances that may be separated by distillation: Dimer acid, trimer acid, and monomer acid. Whereas the natural source-derived TOFA largely consists of linear C18-unsaturated carboxylic acids, principally oleic and linoleic acids, monomer acid contains relatively small amounts of oleic and linoleic acids, and instead contains significant amounts of branched and cyclic C18 acids, both saturated and unsaturated, as well as elaidic acid. The more diverse and significantly branched composition of monomer acid results from the thermal catalytic processing carried out on TOFA or analogous feedstocks.

Further, the reaction of monomer acid with other chemical substances also yields unique, identifiable derivative substances which are chemically different from corresponding TOFA derivatives. Therefore, it is incorrect to equate monomer acid to TOFA, or a monomer acid derivative to a TOFA derivative.

Oleic acid and octadecenoic acid are also unique, identifiable substances that are distinguished from monomer acid because of their essentially linear, unsaturated acid composition. Thus, the derivatives of oleic and octadecenoic acid are also unique, identifiable, and different from monomer acid derivatives.

Through dialogue over the last 6 years, EPA and industry have worked toward a mutual understanding of the correct nomenclature for these chemical substances that previously were believed to be on the Inventory, and have mutually developed procedures to implement the nomenclature change. In 1994, the Pine Chemicals Association (PCA, then known as the Pulp Chemicals Association) asked EPA to clarify the Agency's chemical nomenclature policy for dimer acids. At that time several alternative listings for dimer acid were present in the Inventory, and PCA and EPA agreed that one description, “Fatty Acids, C18 unsaturated, dimers (CASRN 61788-89-4),” would describe dimer acids irrespective of the fatty acid source (except for the crude form of dimer acid that is not made from oleic acid or linoleic acid, and is used directly as a crude chemical intermediate, which is instead named “Fatty acids, C16-18 and C18-unsatd., dimerized (CASRN 71808-39-4)”). Subsequently, over 100 Inventory corrections were filed and the dimer acid issue successfully resolved. During this program it was also realized that a similar issue existed for a co-product, monomer acid, as there were four separate ways in which it was identified in the Inventory. As a consequence, different types of chemical names exist on the Inventory for derivatives and other downstream products based on monomer acids. EPA and PCA agreed that it would be necessary to correct the existing Inventory listings under a uniform nomenclature.

EPA also acknowledged that the August 2, 1985 Agency letter had erroneously equated monomer acid derivatives with TOFA derivatives and derivatives of oleic acid or octadecenoic acid, when in fact they are chemically distinct. Because the guidance found in the 1985 letter led the manufacturers to believe that the products they manufactured were already on the Inventory under a name based on TOFA, oleic acid, or octadecenoic acid, since 1985 a number of manufacturers of monomer acid products have not submitted PMNs required under section 5 of TSCA.

Today's proposed nomenclature correction constitutes official notice that EPA's August 2, 1985 letter was erroneous and that monomer acids are not equivalent to TOFA, oleic acid, or octadecenoic acid for Inventory purposes. Under this proposed notice PMNs are required for monomer acid derivatives that are not on the TSCA Inventory and which are manufactured on or after the effective date of the final notice. In accordance with Inventory correction guidelines (45 FR 50544; July 29, 1980), because these monomer acid derivatives were not manufactured during the Initial Inventory reporting period and were never reported for the Initial TSCA Inventory, they are not eligible for Inventory correction as an alternative to PMN submission.

EPA no longer considers as valid the nomenclature interpretation in the August 2, 1985 EPA letter which stated:

The proposed nomenclature correction affects anyone who manufactures or imports, or who plans to manufacture or import, a monomer acid derivative or other “downstream” substance based on monomer acid for a non-exempt commercial purpose. The correct nomenclature now required for monomer acid is “Fatty acids, C16-18 and C18-unsatd., branched and linear” (CAS Registry Number 68955-98-6). For TSCA Inventory purposes, derivatives and other downstream products made from monomer acids must be named consistently with this nomenclature for monomer acid.

The proposed effective date for this new nomenclature interpretation, described in Unit III.A., will be 12 months following the date of publication of the final nomenclature correction notice in the Federal Register . Prior to this effective date, EPA will allow manufacturers to continue commercial production of existing monomer acid derivatives and downstream products under the old nomenclature. After the effective date, companies that manufacture monomer acid derivatives and downstream products under the old nomenclature will no longer be in compliance with TSCA section 5. Therefore, companies would need to submit PMNs at least 90 days before the effective date to ensure that Agency review is completed before this nomenclature correction takes effect.

EPA will work closely with chemical manufacturers and importers to resolve chemical nomenclature of specific monomer acid derivatives whose Inventory status is uncertain. EPA is taking two specific steps to facilitate the Premanufacture Notice process for chemical substances currently using the incorrect nomenclature. For the purposes of this proposed nomenclature correction only, EPA is suspending its TSCA new chemicals program policy of a limit of six chemical substances per consolidation notice and waiving PMN fees for any PMN submissions required as a result of the proposed nomenclature correction. However, consistent with the Agency's chemical nomenclature requirements for consolidated notices, submitters must use the Chemical Abstract Service (CAS) Inventory Expert Service to develop correct Chemical Abstracts (CA) names for all of their reported substances, in accordance with Method 1 as described in the Revision of Premanufacture Notification Regulations (60 FR 16298; March 29, 1995) (FRL-4921-8), 40 CFR 720.45(a). EPA encourages conversion to the new nomenclature immediately instead of delaying the correction to the effective date of this proposed notice.

EPA expects that there will be at least several consolidated PMNs submitted as a result of this proposed nomenclature correction, and there may also be individual PMNs filed. It may be possible that only one consolidated PMN is necessary for each chemical class of product based on monomer acid. These notices can be submitted by individual companies or as part of an organized effort to submit consolidated PMNs. It is expected that the affected manufacturers and importers of monomer acid and its derivatives or other downstream products, supported by PCA, will prepare consolidated PMNs. In such cases, PMN Standard Form pages 8 through 11 of each consolidated PMN may be filled out by PCA or another organization (this information is expected to be more generally applicable to a given class of monomer acid derivative). Pages 1 through 7, however, pertain to information that is specific to individual submitters, and will need to be filled out by the individual manufacturers and importers. The individual manufacturers and importers of monomer acid derivatives will be the submitter of record for each PMN chemical substance. Other information, such as toxicity data on the PMN chemical substance that are in the possession or control of the PMN submitter, or known to or reasonably ascertainable by the PMN submitter, must also be submitted or described by each individual manufacturer or importer, as specified in 40 CFR 720.50. There may be some manufacturers that do not wish to participate in a consolidated PMN; these manufacturers can submit individual notices separately for their corrected nomenclature.

If a person intends to manufacture a monomer acid derivative or monomer acid-based downstream product for the first time before the effective date, and there is no corresponding Inventory listing using the old nomenclature for that particular substance, this person must submit a regular PMN, using the correct nomenclature, at least 90 days before manufacture of that substance. The special consolidated PMN reporting process involving PCA, as described in this section, cannot be used to report such new derivatives or downstream products.

On the effective date of the final nomenclature correction notice, TOFA, oleic acid, or octadecenoic acid will no longer be considered equivalent to monomer acid. Starting on the effective date, anyone manufacturing a chemical substance based on monomer acid that is not specifically listed on the TSCA Inventory using the correct nomenclature for the monomer acid component of the chemical substance name will be in violation of TSCA. A person may, of course, continue to manufacture TOFA derivatives and derivatives of oleic acid or octadecenoic acid listed on the Inventory without submitting a PMN.

A PMN must be submitted by those persons who intend to manufacture monomer acid and its derivatives and other downstream products not on the TSCA Inventory on or after the effective date of the final nomenclature correction notice. For example, if you manufactured such a monomer acid derivative in 1986 but are not currently manufacturing or intending to resume manufacture, you are not required to submit a PMN now. However, if you later plan to manufacture the monomer acid derivative after the effective date of the final nomenclature correction notice, you will need to submit a PMN 90 days before commencing manufacture.

Consistent with current law, policy and practice in the New Chemicals Program, multiple persons submitting information required in a specific consolidated PMN may make separate submissions to EPA so as to not disclose CBI to one another. For example, a customer of a PMN submitter of record who also is a manufacturer of monomer acid derivatives may submit a letter of support, confidential from the supplier, directly to EPA for TSCA section 5 notification, giving complete chemical identity, health and safety, use, production volume, or process information, etc. This enables the customer to disclose any specific CBI to EPA but not to the other parties in the consolidated PMN.

No. This document is not a rule. It only seeks comment on a proposed correction to TSCA Inventory nomenclature. As such, this action does not require review by the Office of Management and Budget (OMB) under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997).

Because this action is not economically significant as defined by section 3(f) of Executive Order 12866, this action is not subject to Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997).

This action will not result in environmental justice related issues and does not, therefore, require special consideration under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

This action is not subject to notice-and-comment requirements under the Administrative Procedure Act or any other statute, and is not subject to the provisions of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ), or to sections 202 and 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pubic Law 104-4). In addition, this action does not significantly or uniquely affect small governments or impose a significant intergovernmental mandate, as described in sections 203 and 204 of UMRA. Nor does this action significantly or uniquely affect the communities of tribal governments as specified by Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 10, 1998). This action will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999).

This action does not involve any technical standards that require the Agency's consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

In issuing this action, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct, as required by section 3 of Executive Order 12988, entitled Civil Justice Reform (61 FR 4729, February 7, 1996).

EPA has complied with Executive Order 12630, entitled Governmental Actions and Interference with Constitutionally Protected Property Rights (53 FR 8859, March 15, 1988), by examining the takings implications of this action in accordance with the ``Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings'' issued under the Executive Order.

This document does not contain any new information collection requirements that would require additional OMB review and approval. The information collection activities related to the submission of information pursuant to TSCA section 5 has been already approved by OMB under OMB control number 2070-00012 (EPA ICR No.574). The annual respondent burden for this information collection activity is estimated to average 100 hours per respondent, including time for reading the regulations, processing, compiling and reviewing the requested data, generating the request, storing, filing, and maintaining the data. The additional reporting requirement is estimated to be six additional PMNs over and above the current annual projections of PMN submissions. The renewal ICR projects about 875 PMNs and 185,000+ burden hours annually. An additional six PMNs at 100 hours each would be covered by these current estimates.

As defined by the Paperwork Reduction Act and 5 CFR 1320.3(b), ``burden'' means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

Comments regarding 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, should be submitted as described in Unit I.C.

The Council was established by the Federal Communications Commission to provide a means by which a diverse array of recognized technical experts from a variety of interests such as industry, academia, government, citizens groups, etc., can provide advice to the FCC on innovation in the communications industry.

The purpose of this seventh meeting will be to hear and discuss the progress of the three focus groups established by the Council to consider the issues the FCC presented to it at its April 30, 1999 meeting. These issues include: (1) The current state of the art for software defined radios, cognitive radios, and similar devices, future developments for these technologies, and ways that the availability of such technologies might affect the FCC's traditional approaches to spectrum management; and the current state of knowledge of electromagnetic noise levels and the effects of such noise on the reliability of existing and future communications systems; (2) the current technical trends in telecommunications services, changes that might decrease, rather than increase, the accessibility of telecommunications services by persons with disabilities and ways the FCC might best communicate to designers of emerging telecommunications network architectures, the requirements for accessibility; and (3) the telecommunications common carrier network interconnection scenarios that are likely to develop, including the technical aspects of cross network ( i.e., end-to-end) interconnection, quality of service, network management, reliability, and operations issues, as well as the deployment of new technologies such as dense wave division multiplexing and high speed packet/cell switching. The Council may also consider such other issues as come before the Council at the meeting.

Members of the general public may attend the meeting. The Federal Communications Commission will attempt to accommodate as many persons as possible. However, admittance will be limited to the seating available. Depending on the Council's progress at this meeting, public participation may be permitted at the discretion of the Council's Chairman. Interested persons may submit written comments to David Farber, the Council's Designated Federal Officer, before the meeting either by e-mail (dfarber@fcc.gov) or by U.S. mail to David Farber, Chief Technologist, Room 7-C161, Office of Engineering & Technology, Federal Communications Commission, 445 12th Street, SW., Washington, DC 20554.

You may call 202-452-3206 beginning at approximately 5 p.m. two business days before the meeting for a recorded announcement of bank and bank holding company applications scheduled for the meeting; or you may contact the Board's Web site at http://www.federalreserve.gov for an electronic announcement that not only lists applications, but also indicates procedural and other information about the meeting.

Notice is hereby given, pursuant to Reorganization Plan No. 4 of 1961, 26 FR 6191, that the Commission has delegated to the Associate Director for Planning and Information the authority to disclose: (1) To Canadian law enforcement agencies, information regarding consumer protection investigations involving Canadian businesses or consumers; and (2) to the Australian Competition and Consumer Commission, information regarding consumer protection investigations involving Australian businesses or consumers. With respect to Canada, the Associate Director can redelegate this authority to individual Regional Directors on specific cases and projects as appropriate.

This delegation does not apply to competition-related investigations. When exercising its authority under this delegation, staff will require from the relevant foreign law enforcement agency assurances of confidentiality. Disclosures shall be made only to the extent consistent with limitations on disclosure, including section 6(f) of the FTC Act, 15 U.S.C. 46(f), section 21 of the Act, 15 U.S.C. 57b-2, and Commission Rule 4.10(d), 16 CFR 4.10(d), and with the Commission's enforcement policies and other important interests. Where the subject matter of the information to be shared raises significant policy concerns, staff shall consult with the Commission before disclosing such information.

Pursuant to Section 6(f) of the Federal Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46 and Section 2.34 of the Commission's Rules of Practice (16 CFR 2.34), notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Homes Page (for October 25, 2000), on the World Wide Web, at “http://www.ftc.gov/os/2000/10/index.htm.” A paper copy can be obtained from the FTC Public Reference Room, Room H-130, 600 Pennsylvania Avenue, NW, Washington, D.C. 20580, either in person or by calling (202) 326-3627.

Public comment is invited. Comments should be directed to: FTC/Office of the Secretary, Room 159, 600 Pennsylvania Ave., NW, Washington, D.C. 20580. Two paper copies of each comment should be filed, and should be accompanied, if possible, by a 3 1/2 inch diskette containing an electronic copy of the comment. Such comments or views will be considered by the Commission and will be available for inspection and copying at its principal office in accordance with Section 4.9(b)(6)(ii) of the Commission's Rules of Practice (16 CFR 4.9(b)(6)(ii)).

The Federal Trade Commission has accepted, subject to final approval, an agreement containing a consent order from WebTV Networks, Inc. (“WNI”).

The proposed consent order has been placed on the public record for thirty (30) days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty (30) days, the Commission will again review the agreement and the comments received, and will decide whether it should withdraw from the agreement or make final the agreement's proposed order.

WNI advertises and promotes the WebTV system, consisting of a set-top box and an Internet service which, together, allows users to connect to the Internet through a telephone line and a television. WNI licenses the set-top box technology to various companies, including Sony, Philips Electronics, and Mitsubishi, which manufacture and sell the boxes. WNI sells the Internet service for a flat monthly fee.

This matter concerns allegedly false and deceptive advertising for the WebTV system. The Commission's proposed complaint alleges that WNI falsely claimed that:

• The WebTV system provides access to all of the Internet's content, including all of the entertainment and information available on the Internet. In fact, WebTV users are unable, for example, to access files on Web sites that use popular formats or programming languages, including technologies for Web site audio, video, interactivity, and multimedia used for online entertainment and information communication.

• The WebTV set-top box is equivalent to a personal computer with respect to its Internet-related performance. In fact, in contrast to a computer, WebTV users are unable, for example, to download, store, or run software available on the Internet; display certain Web pages or play certain Web pages or play certain Web files; or open email attachments in certain common formats.

• WNI's upgrades to the WebTV system keep users current with the latest Internet technology. In fact, those upgrades have failed to provide certain commonly used Internet technologies for audio, video, interactivity, and multimedia.

The complaint also alleges that, in advertising the total cost of using the WebTV system, WNI failed to disclose adequately that a significant percentage of U.S. consumers will incur long distance telephone toll charges while connected to the Internet through the WebTV Internet service. The complaint alleges that this is a deceptive practice.

The proposed consent order contains provisions designed to prevent WNI from engaging in similar acts and practices in the future.

Part I of the proposed order prohibits the three alleged false representations, as well as any false representation related to access to Internet content or functionality of any Internet access product or service.

Part II of the proposed order prohibits WNI from making any representation about the cost of any Internet access product or service unless it discloses certain material information. If using such product or service to access the Internet may result in telephone toll charges, this fact must be disclosed, clearly and conspicuously, along with how consumers can determine whether they would be subject to these charges.

Part III of the proposed order requires that WNI make clear and conspicuous disclosures about long distance charges on a log-on screen, dialog box, or other similar device that appears prior to any Internet access product dialing a telephone number for which there is a toll charge. The disclosures must state the following: (a) That the user will or will likely incur such a charge while connected to the Internet access service; (b) how the user can determine whether in fact (s)he will incur such a charge, and the amount of the charge; and (c) a source of information about means, if any, of avoiding the charge. Under this provision, WNI must use a procedure designed to ensure that the user expressly consents to connecting on a toll basis, before a toll charge is incurred.

Part IV of the proposed order requires that WNI clearly and conspicuously disclose in its Terms of Service and introductory kit, or the equivalent documents it provides to new subscribers, that users may incur toll charges while using the Internet service, if that is the case, and how users can determine whether they would incur these charges.

Part V of the proposed order requires that WNI offer reimbursement to certain former subscribers to its Internet service for toll charges they incurred. Subscribers eligible for reimbursement are those who: (a) Incurred toll charges before March 1, 1999, and within sixty days of subscribing to the service; (b) have not been previously reimbursed; (c) canceled their subscription before April 1, 1999, and within ninety days of subscribing to the service; (d) identified toll charges as a reason for canceling; and (e) provide proof of the charges. Eligible subscribers may receive reimbursement for toll charges incurred in the first two months of their subscription. subscribers who cannot provide phone bills as proof of the charges would receive reimbursement up to a maximum dollar amount, which depends on the type of proof submitted.

Part VI of the proposed order requires WNI to notify its advertising agencies, manufacturers, and retailers to discontinue making any of the advertising claims prohibited by the order. WNI must also set up, staff, and refer consumers to a toll-free customer service telephone number (or a similar mechanism that is free to consumers) that would handle inquiries regarding telephone toll charges.

Part VII describes a consumer education campaign that WNI must undertake to inform consumers about the limitations of Internet access devices as compared to computers. The campaign will include one-half page advertisements in three national magazines, as well as a brochure that WNI will (a) distribute to retailers selling WebTV set-top boxes for posting in the stores and (b) post on its Web site.

Parts VIII through XI of the proposed order are reporting and compliance provisions. Part XII is a provision “sunsetting” the order after twenty years, with certain exceptions.

The purpose of this analysis is to facilitate public comment on the proposed order. It is not intended to constitute an official interpretation of the agreement and proposed order or to modify in any way their terms.

The following are approved uses for fluoroquinolones in poultry:

NADA 141-017, SaraFlox® WSP, approved August 18, 1995, for the control of mortality in growing turkeys and broiler chickens associated with Escherichia coli organisms, Abbott Laboratories, 1401 Sheridan Rd., North Chicago, IL 60064.

NADA 141-018, SaraFlox® Injection, approved October 12, 1995, for the control of early chick mortality associated with E . coli organisms in chickens and turkeys, Abbott Laboratories, 1401 Sheridan Rd., North Chicago, IL 60064.

NADA 140-828, Baytril® 3.23% Concentrate Antimicrobial Solution, approved October 4, 1996, for the control of mortality in chickens associated with E . coli organisms and control of mortality in turkeys associated with E . coli and Pasteurella multocida organisms, Bayer Corp., Agriculture Division, Animal Health, Shawnee Mission, KS 66201.

Abbott Laboratories has requested withdrawal of NADA's 141-017 and 141-018 for use of sarafloxacin hydrochloride in poultry. By doing so, the company has waived its right to a hearing. Therefore, only NADA 140-828 is covered by this notice.

CVM is providing notice of an opportunity for a hearing on a proposal to withdraw approval of the NADA for enrofloxacin for use in poultry and to revoke the new animal drug regulations reflecting the approval of the NADA (21 CFR 520.813). Enrofloxacin belongs to the class of antimicrobial drugs called fluoroquinolones. Fluoroquinolones also are approved for use in humans. Fluoroquinolones are considered to be one of the most valuable antimicrobial drug classes available to treat human infections because of their spectrum of activity, pharmacodynamics, safety and ease of administration. This class of drugs is effective against a wide range of human diseases and is used both in treatment and prophylaxis of bacterial infections in the community and in hospitals. Fluoroquinolones are essential to the treatment of foodborne diseases. These diseases have a major public health impact in the United States.

Enrofloxacin oral solution for each of its uses in poultry is a new animal drug as defined in section 201(v) of the act (21 U.S.C. 321(v)). As such, the drug cannot be legally marketed in interstate commerce in the absence of an approved NADA (sections 301, 501, and 512 of the act (21 U.S.C. 331, 351, and 360b)). The requirements for approval of NADA's are set out in section 512 of the act. Section 512 of the act requires that a new animal drug must be shown to be safe and effective for its intended uses. Section 201(u) of the act provides that “safe” as used in section 512 “has reference to the health of man or animal.” The determination of safety requires CVM to consider, among other relevant factors, “the probable consumption of such drug and of any substance formed in or on food because of the use of such drug” (section 512(d)(2)(A)). Accordingly, CVM must consider not only safety of the new animal drug to the target animal but also safety to humans of substances formed in or on food as a result of the use of the new animal drug.

FDA approved the NADA's for fluoroquinolones for use in poultry in 1995 and 1996 (see section V.A.3 of this document). After the approvals, CVM instituted several strategies intended to prevent or mitigate the development of resistance (see section V.A.4 of this document). However, resistance still quickly developed to the fluoroquinolones among the human foodborne pathogen, Campylobacter (see section V.B of this document). The resistance developed from use of fluoroquinolones in poultry under the approved, labeled conditions of use (see section V.B.1 of this document).

By 1998, Centers for Disease Control and Prevention (CDC) testing found that 13.6 percent of Campylobacter human isolates were resistant to fluoroquinolones. Fluoroquinolone resistance rose to 17.6 percent among Campylobacter jejuni and 30 percent among Campylobacter coli isolated from ill humans in 1999. In 1998, testing established that approximately 9.4 percent of the C . jejuni isolated from chicken carcasses at federally inspected slaughter plants in the United States were fluoroquinolone resistant. Higher levels of fluoroquinolone resistance are observed in retail chicken (see section V.B of this document).

After thoroughly analyzing all the data and evidence, CVM has determined the following: The primary cause of the emergence of domestically-acquired fluoroquinolone-resistant Campylobacter infections in humans is the consumption of or contact with contaminated food (see section IV.B of this document). Moreover, poultry is the most likely source of campylobacteriosis in humans (see section V.C.2 of this document), poultry is also a source of fluroquinolone-resistant Campylobacter (see sections V.B.3 and V.B.4 of this document), and administration of fluoroquinolones to chickens leads to development of fluoroquinolone-resistant Campylobacter in chickens.

CVM has concluded, based on data from surveillance programs, published literature and other sources, that the use of fluoroquinolones in poultry is a significant cause of fluoroquinolone-resistant Campylobacter on poultry carcasses, and therefore a significant cause of fluoroquinolone-resistant Campylobacter infections in humans. CVM's conclusion is supported by data establishing a temporal association between the approvals of these drugs for use in poultry in the United States and the increase in resistant Campylobacter infections in humans. Fluoroquinolones have been available for human use since 1986 and are commonly prescribed for persons with gastrointestinal illness. Yet resistance to fluoroquinolones did not increase among Campylobacter organisms above a very low level until 1996 or 1997, or soon after the approval and use of these drugs in poultry (see section V.B.5 of this document).

CVM's conclusion is also supported by comparison of fluoroquinolone use in poultry with the two most likely other possible causes of fluoroquinolone-resistant human infections—exposure to resistant Campylobacter during foreign travel, and direct use of fluoroquinolones in humans. People are exposed to fluoroquinolone-resistant Campylobacter during travel to developing countries (Ref. 1). However, a risk assessment conducted by CVM (see section V.C.3 of this document) demonstrates an unacceptable human health impact from domestically-acquired Campylobacter infections from use of fluoroquinolones in chickens (Ref. 2). These domestically acquired infections are much more likely to come from exposure to resistant Campylobacter through food than as a result of direct treatment with fluoroquinolones in humans (see section IV.B of this document). This is due in part to the fact that even if fluoroquinolone treatment results in resistant Campylobacter in an individual, the resistant organisms are unlikely to be transmitted to other people in the United States because generally the numbers of organisms present are low and fecal-oral transmission is required (Ref. 3). Therefore, the level of fluoroquinolone-resistant Campylobacter now seen in human isolates in the United States is not plausibly due to fluoroquinolone use in humans or the spread of resistant Campylobacter from one human to another.

Development of resistance to fluoroquinolones among Campylobacter has important consequences for human health (see section V.C of this document). Foodborne diseases have a major public health impact in the United States, and Campylobacter is the most common known cause of foodborne illness in the United States (Ref. 3). Fluoroquinolones are considered to be one of the most valuable antimicrobial drug classes available to treat a wide variety of human infections, including infections resistant to other drugs, and have been particularly important in the treatment of foodborne infections.

Patients with severe enteric disease such as campylobacteriosis are usually treated empirically. Therefore, Campylobacter resistance presents a dilemma for the physician. If fluoroquinolone treatment is given based on symptoms, and the patient is infected with resistant Campylobacter , there is a risk that the treatment will not be effective or will be less effective and valuable time will be lost. If treatment is delayed until the causative organism and susceptibility are confirmed by a medical laboratory, again valuable time will be lost. That is, the disease may be prolonged or result in complications, especially in vulnerable patients with underlying health problems (Refs. 1 and 4). Use of an alternative drug to treat the patient empirically may be less desirable because that drug may have a narrower spectrum of activity or greater or more toxic side effects.

Isolation of fluoroquinolone-resistant Campylobacter organisms from humans means that fluoroquinolone therapy—if administered—would be ineffective or less effective in these humans. The current level of resistance to fluoroquinolones among human Campylobacter isolates attributed to the use of fluoroquinolones in poultry represents a harm to human health.

Furthermore, a risk assessment conducted by CVM demonstrated the magnitude of the adverse impact that the use of fluoroquinolones in chickens has on human health. The risk assessment determined that in 1999 a mean estimate of 11,477 persons (5th and 95th percentiles: 6,412 and 18,978) infected with campylobacteriosis and prescribed a fluoroquinolone would have had a fluoroquinolone-resistant illness due to the use of fluoroquinolones in chickens. These people are likely to have had prolonged illnesses or complications. Furthermore, CVM believes that the adverse human health effects were underestimated due to limitations in study methods and data.

Finally, CVM is concerned that the harm from fluoroquinolone-resistant Campylobacter infections will continue to increase such that more people will be unable to be effectively treated with fluoroquinolones when those drugs are needed for foodborne illness. With respect to the harm presented by resistant foodborne pathogens, it is especially important to take action as soon as a problem is detected since the nature of the problem is dynamic and relatively large shifts in the prevalence of resistance can occur within short timeframes (Refs. 5 and 6).

Section 512(e)(1)(B) of the act, requires withdrawal of approval of an NADA if:

* * * new evidence not contained in [an approved] application or not available to the Secretary until after such application was approved, or tests by new methods, or tests by methods not deemed reasonably applicable when such application was approved, evaluated together with the evidence available to the Secretary when the application was approved, shows that such drug is not shown to be safe for use under the conditions of use upon the basis of which the application was approved * * *.

Under this clause, to meet its initial burden to support withdrawal of an approval CVM must provide “a reasonable basis from which serious questions about the ultimate safety of [the drug] may be inferred.” See Diethylstilbestrol: Withdrawal of Approval of New Animal Drug Applications; Commissioner's Decision (Commissioner's DES Decision), 44 FR 54852 at 54861, September 21, 1979, aff'd Rhone-Poulenc, Inc ., Hess & Clark Div . v. FDA , 636 F.2d 750 (D.C. Cir 1980). See also Nitrofurans: Withdrawal of Approval of New Animal Drug Applications; Final Rule; Final Decision Following a Formal Evidentiary Public Hearing, 56 FR 41902, August 23, 1991. “‘Serious questions’ can be raised where the evidence is not conclusive, but merely suggestive of an adverse effect” (44 FR 54861). Once this threshold burden has been satisfied, the burden passes to the sponsor to demonstrate safety. Id .

Section 201(u) of the act provides that for purposes of section 512 of the act, “safe” has “reference to the health of man or animals.” In determining whether a drug is “safe,” section 512(d)(2)(A) of the act requires FDA to consider “the probable consumption of such drug and any substance formed in or on food because of the use of such drug.”

“Safe,” in the context of human food safety, can be defined as “reasonable certainty of no harm.” The definition is derived from language in H. Rept. 2284, 85th Cong., 2d. sess. 4095, 1958, defining the term “safe” as it appears in section 409 of the act (21 U.S.C. 348), which governs food additives. Substances formed in or on food due to the use of animal drugs were regulated under the food additive provisions in section 409 of the act until passage of the Animal Drug Amendments in 1968 (the 1968 amendments). The 1968 amendments merely consolidated all of the existing statutory authorities related to animal drugs into section 512 of the act, and the legislative history shows that the consolidation in no way changed the authorities with respect to the regulation of new animal drugs (S. Rept. 1308, 90th Cong., 2d. sess. 1, 1968). CVM has applied the “reasonable certainty of no harm” standard in determining the safety of substances formed in or on food as a result of the use of a new animal drug during the new animal drug application review process. CVM has done so by determining the level at which a substance formed in or on food as a result of the use of a new animal drug has no effect on humans (Ref. 75).

Antimicrobial drugs are products that affect bacteria by inhibiting their growth or by killing them outright. Antimicrobial drugs are used to treat bacterial disease in humans and since their discovery have prevented countless deaths worldwide. In animals, these drugs are used to control, prevent, and treat infection, and to enhance animal growth and feed efficiency.

That antimicrobial agents could select for resistant bacterial populations became apparent soon after the first antimicrobial drug, penicillin, was discovered. Antimicrobial use promotes antimicrobial resistance by selecting for resistant bacteria (Refs. 7 and 8). When an antimicrobial drug is used to treat an infection, the bacteria most sensitive to the drug die or are inhibited. Those bacteria that have, or acquire, the ability to resist the antimicrobial persist and replace the sensitive bacteria. If these bacteria that have developed resistance are disease causing (pathogenic) in humans, they may cause disease resistant to treatment (Refs. 7 and 9).

Selective pressure resulting from the use of antimicrobial drugs is the underlying force in the development and spread of resistant bacterial populations. The association between antimicrobial use and resistance has been documented in various settings (Ref. 7), for nosocomial infections (Ref. 10) as well as for community-acquired infections (Ref. 11).

In industrialized countries, the major foodborne pathogens, Campylobacter and Salmonella , are infrequently transferred from person to person (Refs. 3 and 12). In these countries, epidemiological data have demonstrated that the primary source of antibiotic resistant foodborne infections in humans is the acquisition of resistant bacteria from animals via food (Refs. 3, 13, and 14). This has been demonstrated through several different types of foodborne disease followup investigations, including laboratory surveillance, molecular subtyping, outbreak investigations, and studies on infectious dose and carriage rates (Refs. 15, 16, 17, and 18).

CDC published an extensive review of epidemiological studies that focused on human foodborne infections caused by drug-resistant Salmonella and concluded that the resistant infections were acquired through contaminated foods of animal origin (Refs. 12 and 19). Transfer of Campylobacter from poultry to humans through food was demonstrated as early as 1984 (Ref. 15).

Recent emergence of a resistant foodborne pathogen that has a food-producing animal reservoir is illustrated by Salmonella enterica serotype Typhimurium Definitive Type 104 (DT104). DT104 is a multidrug resistant pathogen that is currently epidemic in human and food-producing animal populations in the United Kingdom and has been isolated in several countries in Europe (Refs. 20, 21, and 22). This organism has also been identified in livestock and poultry in the United States (Refs. 23, 24, and 25). Also, a report from the United Kingdom suggests that infections caused by DT104 may be associated with greater morbidity and mortality than infections by less resistant serotypes of Salmonella (Ref. 26).

Scientific evidence demonstrates that the use of antimicrobials in food-producing animals can select for resistant bacteria of human health concern. Repeated dosing of food-producing animals can also contribute to the selection of resistant bacteria (Refs. 27 and 28). When an antimicrobial drug is administered to an animal, the most susceptible bacteria will be eliminated, while the least susceptible organisms will survive. These surviving bacteria will proliferate and become the predominant population. With additional exposure to the drug, the resistant populations of bacteria will expand and have an increasing probability of survival and dissemination.

The resistant bacteria that develop as a result of antimicrobial drug use in food-producing animals can then be transferred to humans via food. The contaminated food may cause disease in persons handling or consuming the food or in persons consuming food contaminated from the animal-derived food.

When antimicrobial drugs are administered to food-producing animals, they promote the emergence of resistance in bacteria that may not be pathogenic to the animal, but are pathogenic to humans (Refs. 15, 29, 30, 31, and 32). For example, Salmonella and Campylobacter are ubiquitous and can exist in the intestinal flora of various food-producing animals without causing disease in the animals. However, these bacteria can cause severe, even fatal, foodborne illness in humans. If using an antimicrobial in a food-producing animal causes resistance to occur in such bacteria, and the resistant bacteria cause an illness in a consumer who needs treatment, that treatment may be compromised (Ref.9).

The link between antimicrobial resistance in foodborne pathogenic bacteria and use of antimicrobials in food-producing animals has been demonstrated in a number of studies (Refs. 25, 33, 34, and 35). For example, an association has been noted between loss of susceptibility to fluoroquinolones among Salmonella enterica Typhimurium DT104 isolates (see section IV.B of this document) and the approval and use of a fluoroquinolone for veterinary therapeutic use in the United Kingdom (Refs. 14, 30, and 36). Moreover, fluoroquinolone administration to chickens infected with fluoqouinolone-sensitive C . jejuni has been shown to result in the development of fluoroquinolone-resistant C . jejuni in those chickens (Ref. 35).

Epidemiological evidence shows that resistant foodborne pathogens are present on or within animals as a result of antimicrobial drug use in food-producing animals and can result in drug-resistant infections in humans (Refs. 1, 16, 37, 38, and 39). Holmberg et al. were the first to establish this by documenting an outbreak of salmonellosis in people caused by multi-drug-resistant Salmonella from eating hamburger originating from South Dakota beef cattle fed the antibiotic chlortetracycline for growth promotion (Ref. 16). As explained more fully in section V.B of this document, researchers in Minnesota recently reported on fluoroquinolone-resistant Campylobacter infections in humans acquired from poultry treated with fluoroquinolones (Ref. 1).

As discussed below, during its evaluation of the NADA's for use of fluoroquinolones in poultry, CVM carefully considered the issue of potential resistance development due to the use of the drugs in poultry. When CVM approved the NADA's for use of fluoroquinolones in poultry, it believed that the fluoroquinolones could be used safely in poultry and that resistance development could be limited by certain restrictions placed on the use of the drugs. Resistance, however, has developed such that CVM now believes that its only option to protect human health is withdrawal of the approval of the NADA's for use of fluoroquinolones in poultry.

Prior to FDA's approval of fluoroquinolones for use in food-producing animals, several scientific organizations and individual scientists expressed concern that the use of fluoroquinolones in food-producing animals would result in the selection of fluoroquinolone-resistant foodborne bacterial pathogens in humans (Refs. 7, 33, and 40). There were several reasons for these concerns.

First, as explained more fully in section V.C of this document, fluoroquinolones are very important for human therapy. Bacteria resistant to veterinary fluoroquinolones exhibit resistance to other compounds within the class. Thus, resistance to a fluoroquinolone used only in animals, such as enrofloxacin, confers resistance to all other fluoroquinolones, including ciprofloxacin and other fluoroquinolones used only in humans. The veterinary fluoroquinolone enrofloxacin is structurally similar to ciprofloxacin and a portion of it is metabolized to ciprofloxacin in the animal (Ref. 41).

Second, reports of studies conducted after approvals of fluoroquinolones for poultry in other countries had shown a relationship between the approval of fluoroquinolones for therapeutic use in food-producing animals and the development of fluoroquinolone resistance in Campylobacter in animals and humans. For example, the approval and use of these drugs in poultry in the Netherlands (Refs. 33, 35, and 42), and Spain (Refs. 43 and 44) preceded increases in fluoroquinolone resistance in Campylobacter isolates from treated animals and ill humans. In the Netherlands, Campylobacter isolates from humans and poultry were examined for resistance to the human fluoroquinolone ciprofloxacin between the years 1982 and 1989 to determine the influence of licensing of enrofloxacin for veterinary use in 1987 (Ref. 33). In 1982, none of the Campylobacter isolates from either human or poultry sources was resistant to ciprofloxacin. In 1989, fluoroquinolone resistance among the Campylobacter isolates was 11 percent in humans and 14 percent in poultry (Ref. 33).

Third, there was a concern about use of fluoroquinolones as water-soluble products. This use raised the possibility of development of resistant organisms in greater numbers than if the drugs were to be administered in an individually administered injectable dosage form. Due to the nature of animal production, the most efficient way to treat herds or flocks is to administer drugs through the water supply or the feed. When disease is detected in a herd of animals or a flock of poultry, the product is put into the animals' water supply, thereby exposing greater numbers of animals than just the few with clinical signs of the disease. The practice of treating an entire herd or flock is more likely to result in resistant pathogens than individual animal treatment due to the inability to control each animal's dose and the widespread contamination by water leakage and animal waste that occurs when large numbers of animals are treated, which result in untreated animals being exposed to the drug.

Selective pressure exerted by fluoroquinolone use is the driving force for the development and spread of the genetic mutations in Campylobacter that lead to fluoroquinolone resistance. Administering fluoroquinolones to large numbers of animals through water or feed could substantially increase the selective pressure on the organisms and facilitate the spread of resistant pathogens. An additional problem arises when the dose administered to each bird is variable, which is the case when the antimicrobial is administered ad libitum in the water. This practice may result in ineffective dosing in some animals and increase the probability of selecting for resistant zoonotic bacteria in both healthy and diseased animals.

Because of the concerns surrounding the use of fluoroquinolones in food-producing animals, CVM consulted with a panel of experts comprised of its Veterinary Medicine Advisory Committee and FDA's [Human] Anti-Infective Drug Advisory Committee in May 1994 to address the issue of use of fluoroquinolones in food-producing animals in light of concerns about antimicrobial resistance. The panel supported several restrictions on the use of the drugs in food-producing animals in order to minimize the human health risks related to the development of resistant bacteria in animals (Ref. 45). Frequently expressed recommendations of committee members included approval for therapeutic use by veterinary prescription only, prohibition of extra-label use, and establishment of a nationally representative surveillance system to prospectively monitor resistance trends of selected enteric bacteria of animals that can cause disease in humans (Ref. 45).

The NADA for Baytril® 3.23% Concentrate Antimicrobial Solution (enrofloxacin) was approved October 4, 1996, for broiler chickens and growing turkeys. The approval is for therapeutic use: Enrofloxacin is approved for the control of mortality in chickens associated with E . coli organisms and control of mortality in turkeys associated with E . coli and P . multocida organisms.

At the time this drug was approved, microbial safety studies were not required for therapeutic uses of antimicrobial new animal drugs in food-producing animals. Thus, no studies were required of the drug sponsor, and none was performed, demonstrating the safety of the use of fluoroquinolones in poultry with respect to antimicrobial resistance and the potential for resistant pathogens to be transferred from poultry to humans. At that time, the agency believed that such studies were necessary only for certain subtherapeutic feed uses in food-producing animals (21 CFR 558.15). However, increasing evidence that therapeutic as well as subtherapeutic use of antimicrobials in food-producing animals may select for resistant bacteria of human health concern led the agency to issue final guidance addressing this concern in December 1999 (Ref. 46). The guidance addresses how FDA intends to consider the potential human health impact of all uses, therapeutic as well as subtherapeutic, of all classes of antimicrobial new animal drugs intended for use in food-producing animals. The guidance states that preapproval studies to answer questions regarding the human health impact of the microbiological effects of an antimicrobial product may be needed for therapeutic as well as subtherapeutic products (Ref. 46).

Certain actions were taken at or near the time of approval of the fluoroquinolones to help ensure that resistance to fluoroquinolones did not develop in bacteria that are transferred from poultry to humans, and to detect any trend towards the development of resistance at an early stage. First, CVM imposed two restrictions on the use of the fluoroquinolones. CVM limited the drugs to use by or on the order of a licensed veterinarian. Also, FDA issued an order to prohibit all extra-label uses of fluoroquinolones in animals, which became effective in August 1997 (21 CFR 530.41).

Second, the agency took steps to gather surveillance data on the development of antimicrobial resistance among foodborne pathogens, including resistance to fluoroquinolones. In 1996, FDA, CDC, and the U.S. Department of Agriculture (USDA) established the National Antimicrobial Resistance Monitoring System: Enteric Bacteria (NARMS) to prospectively monitor changes in antimicrobial susceptibilities of selected zoonotic enteric pathogens from human and animal clinical specimens, from healthy farm animals, and from carcasses of food-producing animals at slaughter (Ref. 47). Nontyphoid Salmonella was initially selected as the sentinel organism and the program has been expanded each year since its inception. NARMS is currently monitoring susceptibilities of human and animal isolates of Salmonella , E . coli , Campylobacter , and Enterococcus . NARMS is set up as two equal parts, human and animal, that use the same methodology for isolating and testing the organisms.

Animal isolate testing is conducted at the USDA Agricultural Research Service Russell Research Center. Human isolate testing is conducted at the CDC National Center for Infectious Diseases Foodborne Disease Laboratory. Goals and objectives of the monitoring program include: Providing descriptive data on the extent and temporal trends of antimicrobial susceptibility in enteric organisms from the human and animal populations; providing information to veterinarians, physicians, and public health authorities so that timely action can be taken; prolonging the life span of approved drugs by promoting the prudent use of antimicrobials; identifying areas for more detailed investigation; and guiding research on antimicrobial resistance.

Third, CVM has supported efforts by the American Veterinary Medical Association (AVMA) and several practitioner and producer groups to define and promote the appropriate use of antimicrobial drugs in food-producing animals to try to minimize the occurrence of resistant foodborne pathogens that may be transferred to humans through food. CVM is supporting the development of printed material and videotapes based on the prudent use guidelines developed by the AVMA to educate producers and veterinarians about food-producing animal drug use. CVM is also committed to help develop other educational strategies to be disseminated to veterinarians and food-producing animal producers via symposia and exhibits at scientific meetings. Veterinary medical schools may also use these educational materials as part of a food safety curriculum.

Despite the previously described restrictions placed by FDA on the use of the approved poultry fluoroquinolone products, fluoroquinolone resistance among Campylobacter developed and increased after the 1996 approvals. CVM believes, based on research, that prior to 1995, there was very little, if any, fluoroquinolone-resistant Campylobacter in the United States among domestically acquired foodborne disease (see section V.B.5 of this document). After the approval, however, fluoroquinolone resistance was observed in Campylobacter from human clinical cases, and in poultry isolates taken from slaughter plants and retail establishments. The results were obtained from NARMS and a key study by the Minnesota Department of Health. In the 4 years since approval of the fluoroquinolones, CVM has found very little evidence of extra-label use of these drugs in food-producing animals, based on information derived from regulatory inspections. Nor has CVM found evidence of over-the-counter sales of the poultry fluoroquinolones. Therefore, the agency's attempts to prevent the development of fluoroquinolone-resistant human pathogens through limiting these drugs to prescription use and by prohibiting extra-label use have not been sufficient.

CDC began routinely testing human Campylobacter isolates for resistance to fluoroquinolones in 1998, 2 years after approval of enrofloxacin for use in poultry. In 1998, CDC tested 346 human Campylobacter isolates and found 13.6 percent of the Campylobacter isolates were resistant to fluoroquinolones (Ref. 48). In 1999, CDC tested 315 human isolates of Campylobacter ; fluoroquinolone resistance had risen to 17.6 percent among C . jejuni and 30 percent among C. coli, a statistically significant increase (Ref. 49).

Approximately 9.4 percent of the C . jejuni isolated from chicken carcasses at federally inspected slaughter plants in 1998 were fluoroquinolone resistant (Ref. 50). The Campylobacter isolates were collected in a pilot study during the latter 3 months of the year. The 1999 data set, collected for the entire year, shows that approximately 9.3 percent of the C . jejuni were resistant to fluoroquinolones (Ref. 51). However, the 1999 data when segregated by State show that several areas of the country had significantly higher than the 9.3 percent average level (Ref. 2). When the isolate test results are weighted by the level of chicken production in each State, the level of resistance among C . jejuni is approximately 12 percent for 1999 (Ref. 2).

Campylobacter isolates from retail chicken products show even higher levels of fluoroquinolone resistance. In January-June 1999, public health laboratories in Georgia, Maryland, and Minnesota, under the direction of the CDC, tested 180 chickens with 23 distinct brand names that were purchased from 25 grocery stores (Ref. 52). Campylobacter were isolated from 80 (44 percent) of the chickens. Nineteen (24 percent) of the samples had Campylobacter isolates resistant to fluoroquinolones and 25 (32 percent) were resistant to nalidixic acid, a quinolone antimicrobial drug that serves as a precursor to fluoroquinolone resistance development (Ref. 52). These retail chicken findings are consistent with those from an earlier, independent study by the Minnesota Department of Health, described in the next subsection.

Researchers at the Minnesota Department of Health studied quinolone and fluoroquinolone resistance among Minnesota residents, and evaluated chicken as the source of the resistance. They found that the proportion of fluoroquinolone-resistant C . jejuni isolates from humans increased from 1.3 percent in 1992 to 10.2 percent in 1998 (Ref. 1).

The proportion of resistant C . jejuni collected from all reported cases of illness increased only slightly from 1992 to 1994. Although researchers found that increases between 1996 and 1998 were predominantly associated with foreign travel, the percentage of resistant infections that were acquired domestically also increased from 0.3 percent to 3 percent between 1996 and 1998 (Ref. 1).

As part of the study, the Minnesota Department of Health in cooperation with the Minnesota Department of Agriculture collected 20 different brands of retail chicken products from 18 markets in the Twin Cities metro area in 1997. Campylobacter were isolated from 88 percent (80/91) of the samples; 20 percent of these were Campylobacter resistant to fluoroquinolones. The products with resistant strains had been processed in five States (Ref. 1).

Molecular subtyping revealed a strong association between resistant C . jejuni strains from the retail chicken products and C . jejuni strains from the domestically acquired human cases of campylobacteriosis. The study used polymerase chain reaction with restriction length polymorphism flagellin gene typing to identify strains of fluoroquinolone-resistant C . jejuni among isolates from the domestically acquired human cases and locally available retail chicken products. The investigators attributed the 1996 to 1998 increase in resistant domestic cases among humans to poultry treated with fluoroquinolones (Ref. 1). The investigators concluded that “the use of fluoroquinolones in poultry, which began in the United States in 1995, has created a reservoir of resistant C . jejuni ” (Ref. 1).

The most recent data on fluoroquinolone resistance among Campylobacter isolates (1999) show 17.6 percent resistance among C . jejuni in humans, and 9.3 percent resistance among C . jejuni on chickens sampled at slaughter plants. Retail samples taken in 1999 indicate even higher levels of fluoroquinolone-resistant Campylobacter on chickens (Ref. 52).

After thoroughly analyzing all the data and evidence, CVM has determined that a significant cause of the emergence of domestically-acquired fluoroquinolone-resistant Campylobacter infections in humans is the consumption of, or contact with, contaminated food (see section IV.B of this document), that poultry is the most likely source of campylobacteriosis in humans (see section V.C.2 of this document), and that poultry is also a source of resistant Campylobacter (see section V.B.3 and V.B.4 of this document). CVM has also concluded that the administration of fluoroquinolones to chickens leads to development of fluoroquinolone-resistant Campylobacter in the chickens (see section IV.C of this document). Fluoroquinolone-resistant Campylobacter have been found in broiler chicks that had been administered fluoroquinolone drugs (Ref. 35). Further, resistant Campylobacter found on chicken carcasses would not have resulted from use of a nonfluoroquinolone drug because fluoroquinolone resistance in Campylobacter arises exclusively from clonal expansion, rather than by the transfer of plasmids or resistance determinants (Ref. 53). Also, the fluoroquinolone resistance results only from drug use; that is, the resistance could not have developed naturally since fluoroquinolones are totally synthetic antimicrobials with no known natural analogues. (See also discussion in section IV.A of this document.) Consequently, CVM has concluded, based on a careful study of all relevant data and information, that use of fluoroquinolones in poultry is a significant cause of domestically acquired resistant Campylobacter infections in humans.

CVM's conclusion is supported by the establishment of a temporal association between the approval of the fluoroquinolones for poultry and the emergence of fluoroquinolone-resistant Campylobacter in humans. Although most of the data cited above were collected after the approval, CVM believes that there was very little, if any, fluoroquinolone-resistant Campylobacter in the United States among domestically acquired foodborne disease cases before the approvals. Fluoroquinolones have been available for human use since 1986 when ciprofloxacin was approved in the United States (Refs. 1 and 54). Ciprofloxacin soon was one of the most commonly used antimicrobials to treat infections caused by a variety of bacterial infections in humans, including Campylobacter infections. However, emergence of domestically acquired fluoroquinolone-resistant human foodborne infections in numbers large enough to be detected by national surveillance systems did not occur until sometime between 1996 and 1998

Only rare, sporadic, and isolated incidents of fluoroquinolone-resistant Campylobacter infections were reported in humans prior to 1995. 1 (NARMS was not initiated until January 1996 and Campylobacter were not tested until 1998.) In addition, as shown in section V.B.4 of this document, only very low levels of resistance were detected among isolates from human Campylobacter cases collected by the Minnesota Department of Health from 1992 to 1994 (Ref. 1). Additional data from Minnesota demonstrated an increase in fluoroquinolone resistance among Campylobacter collected from domestically-acquired cases of human illness after the approval of the poultry fluoroquinolones (Refs. 1 and 54). The researchers were able to conclude that the 1996 to 1998 increases in domestic cases were due to the use of fluoroquinolones in poultry. That conclusion is supported by the association found between molecular subtypes of resistant C . jejuni strains that were acquired domestically in humans and those found in chicken products (Ref. 1). (See section V.B.4 of this document.)

Because there was no food-producing animal fluoroquinolone use other than use in poultry until late 1998 (when CVM approved fluoroquinolones for use in cattle), CVM believes that the data presented in this section V.B of the document) provide strong evidence that the increase in domestically acquired fluoroquinolone resistance observed in people since 1996 (Ref. 1) is largely associated with the use of fluoroquinolones in poultry. Data from other countries, which showed increases in Campylobacter resistance following approval of fluoroquinolones for use in poultry, support this conclusion as to temporal association (Refs. 33, 43, and 55). (See section V.A.1 of this document.)

CVM's conclusion is also supported by an examination of the two most likely other possible causes of fluoroquinolone-resistant Campylobacter in humans. One possible cause is the direct use of fluoroquinolones in humans. Although fluoroquinolone-resistant Campylobacter may develop in the intestinal tract of persons with these infections who are treated with fluoroquinolones, spread of the organisms to other persons is uncommon because person-to-person transmission of these organisms is rare in developed countries (Ref. 3). As a result, the resistance due to direct human use is likely to be limited (Refs. 12 and 19). (See section IV.B of this document.) The lack of an increase in fluoroquinolone-resistant human cases from the time when fluoroquinolones were first used in human medicine, the high level of human use since their approval, and the emergence of fluoroquinolone resistance in human cases of Campylobacter infections soon after the approval of fluoroquinolones for poultry, all support the conclusion that the resistance observed in humans is due to the use of fluoroquinolones in poultry.

Exposure to Campylobacter -contaminated food can occur during foreign travel and, indeed, some of the fluoroquinolone resistance identified among humans is due to acquiring an illness while traveling outside the United States. However, a risk assessment conducted by CVM demonstrates a significant human health impact from domestically acquired fluoroquinolone-resistant Campylobacter infections due to the use of fluoroquinolones in chickens (Ref. 2). (See section V.C.3 of this document.)

CVM therefore believes that a significant cause of the emergence of fluoroquinolone-resistant Campylobacter infections in humans is the consumption of, or contact with, contaminated poultry that had been administered fluoroquinolones, had contact with other poultry treated with this drug, or had contact with the environment contaminated directly or indirectly with this drug.

Fluoroquinolones are considered to be one of the most valuable antimicrobial drug classes available to treat human infections because of their broad spectrum of activity, pharmacokinetics, safety, and ease of administration (Ref. 56). This class of drugs is effective against a wide range of human diseases and is widely used both in treatment and prophylaxis of bacterial infections in the community and in hospitals (Ref. 56). Fluoroquinolones are important because they are active against a variety of organisms resistant to most other classes of antibiotics or for which alternative agents are more toxic and/or not available for oral administration. They have been very effective in treating or preventing serious, often life-threatening, infections in a number of major areas of human medicine, both in the hospital and in the community. In the hospital setting, the fluoroquinolones are very often life-saving drugs of choice for a wide variety of common resistant and serious infections because of both their activity and their favorable safety profiles.

Fluoroquinolones are particularly important in the treatment of gram negative infections, including those caused by Campylobacter , but also including Shigella , Salmonella , E . coli , Klebsiella and other Enterobactericiae. These type of enteric bacteria cause a wide variety of infections and are frequently resistant to agents such as ampicillin, tetracycline, trimethoprim-sulfa and many cephalosporins (Ref. 56). In addition, the fluoroquinolones are often less toxic and more convenient to administer than alternative treatments that may be available for resistant organisms.

Fluoroquinolones are the agents most frequently used as the drugs of choice in the empiric treatment of patients presenting to a physician with serious gastrointestinal symptoms such as acute diarrhea or possible enteric fever (e.g., typhoid fever) because they traditionally have exhibited a very high level of clinical effectiveness against most enteric pathogens (Refs. 4 and 57). Severity of illness is one of the most important criteria physicians use in determining which patients require immediate treatment for a presumed infectious enteric illness. Other criteria include having a complicating medical condition and belonging to a high-risk group such as persons who are immunocompromised. Upon presentation to the physician, the patient is examined and if treatment is deemed necessary, treatment is usually prescribed empirically, that is, without having the results of culture and sensitivity testing available prior to the selection of the treatment. Culture and sensitivity testing of Campylobacter can take 48 to 96 hours before results are available to provide guidance to the physician in selection of a treatment regimen. Thus, the physician needs to be able to confidently prescribe an agent likely to be immediately effective against the array of organisms most likely to be causing the patient's severe symptoms.

Treatment of serious susceptible enteric infections with an effective fluoroquinolone (e.g., ciprofloxacin) can reduce the duration of illness and most likely prevent complications and adverse outcomes, including hospitalization (Refs. 19 and 58). The magnitude of the benefit of antibiotic treatment is directly related to the early initiation of therapy (Refs. 19 and 58). For example, effective treatment of campylobacteriosis with fluoroquinolones has been shown to decrease the duration of illness from 10 days to 5 days and the mean duration of diarrhea from 5 to 1.3 days (Refs. 7, 19, and 58).

a. Introduction . Foodborne diseases have a major public health impact in the United States. Recent estimates describe 5,000 deaths and 76 million foodborne illnesses annually (Ref. 59). The causes of foodborne illness are varied and include bacteria, parasites, viruses, toxins and novel agents. Clinical severity of foodborne disease also varies and ranges from mild gastroenteritis to life-threatening neurologic, hepatic, and renal syndromes as well as septicemia (Ref. 59). Development of resistance in foodborne bacterial pathogens to safe and effective antimicrobials complicates the medical and public health concern as important treatment options are compromised or lost (Refs. 7, 19, 61, and 62).

b. Campylobacteriosis . The three primary causes of bacterial foodborne disease in the United States are Campylobacter , Salmonella , and some pathogenic strains of E . coli . Campylobacter infections are predominantly foodborne infections associated with animal-derived food products (Refs. 59, 63, and 64). Campylobacter is the most common known cause of foodborne illness in the United States (Ref. 3), causing an estimated 2 million cases every year (Ref. 60). Compared to patients with typical noninvasive salmonellosis, patients with C . jejuni or Campylobacter coli gastroenteritis often experience more severe illness and are ill longer. Gastroenteritis caused by Campylobacter commonly causes severe diarrhea, often bloody, fever, severe abdominal pain, and can mimic acute appendicitis, which may result in unnecessary surgery (Ref. 65). While these symptoms usually improve within several days, they persist or recur in 15 to 25 percent of patients and can be confused with chronic bowel diseases (Ref. 65). For example, among 460 sporadic (not associated with an epidemic) cases of campylobacteriosis recently reported in 19 representative U.S. counties, the mean duration of illness was 10 days, with 7 lost workdays, and one-half hospitalization day. Five patients (1 percent) died (Ref. 66). Effective treatment of campylobacteriosis with fluoroquinolones within the first 2 days of illness decreased the duration of illness from 10 days to 5 days (Refs. 7, 19, and 58).

Campylobacter species are often found as commensal bacteria, which are bacteria that exist in an animal without causing harm to that animal. These bacteria are carried in the intestinal tract of food-producing animals and can contaminate food during slaughter and processing (Ref. 67). The USDA Food Safety Inspection Service has recently conducted surveys of recovery rates and estimated the mean number per unit (gram, cm 3 ) of product for some of the major foodborne pathogens found on raw animal products at slaughter and processing. Raw product isolation rates vary by species, with turkeys and chickens appearing to have the highest rates of Campylobacter recovery (Refs. 68, 69, 70, and 71).

Broiler chickens carry the highest carcass and ground product load of Campylobacter when compared to other food-producing animals at slaughter (Refs. 70 and 71). These data are consistent with the repeated observations in epidemiological studies of the increased risk of campylobacteriosis associated with exposure to poultry. In surveys of retail food products conducted by other organizations, Campylobacter was isolated from: 2 to 20 percent of raw beef, 40 percent of veal; up to 98 percent of chicken meat; low proportions of pork, mutton, and shellfish; 2 percent of fresh produce from outdoor markets and 1.5 percent of mushrooms (Refs. 15 and 72).

The symptoms exhibited by persons with an enteric foodborne illness include vomiting, diarrhea, abdominal pain, cramping, and fever. The causal agent of an enteric illness is not easily determined based upon symptoms alone. Empiric treatment of patients with serious enteric disease of presumed bacterial etiology is usual medical practice because when treatment is delayed (e.g., until the Campylobacter infection or another etiologic agent is confirmed by a medical laboratory), the therapy may be ineffective or less effective, and the illness is more likely to be prolonged or result in complications (Ref. 4). Also, the clinical signs of patients with campylobacteriosis are indistinguishable from enteric disease caused by Salmonella , which also is treated with fluoroquinolones. Relapses occur in approximately 5 to 10 percent of untreated patients with campylobacteriosis (Ref. 4) and have been associated with fluoroquinolone resistance (Ref. 74).

Antibiotic therapy is always indicated for patients who demonstrate symptoms of high fever, bloody diarrhea, or more than eight stools in 24 hours; who are immunosuppressed; who have bloodstream infections; or whose symptoms worsen or persist for more than 1 week (Ref. 4). More invasive disease such as blood-borne infections occur in less than 1 percent of patients with C . jejuni infections and are more common in the elderly or very young individuals as well as those with impaired immune systems (Ref. 65). Rare manifestations of campylobacteriosis can include meningitis, endocarditis, and septic abortion (Ref. 4).

Campylobacteriosis also carries the potential for serious sequelae as a result of immunologic reactions to the infection. The disease has been linked to reactive arthritis and Reiter's Syndrome as well as Guillain-Barre Syndrome (Ref. 65). Guillain-Barre Syndrome is an autoimmune-mediated disorder of the peripheral nervous system. Since the elimination of polio, this syndrome is now the most common cause of acute flaccid paralysis (Ref. 73). Many studies have shown a link between campylobacteriosis and Guillain-Barre Syndrome. Culture and serologic data indicate that 30 to 40 percent of patients with the syndrome have evidence of a preceding Campylobacter infection, but this may be an underestimate (Ref. 73). C . jejuni is the most common species identified from patients with Guillain-Barre Syndrome, but other species of Campylobacter may be involved (Ref. 73). It is not known whether resistant Campylobacter infections are more susceptible to developing sequelae such as Guillain-Barre Syndrome. There is also evidence suggesting that Guillain-Barre Syndrome may be more severe following infection with Campylobacter than other precipitating infections (Ref. 73).

The data on fluoroquinolone resistance levels, and the evidence leading to the conclusion that the use of fluoroquinolones in chickens is a significant cause of fluoroquinolone resistance in humans, establish an adverse effect on human health by fluoroquinolones. To assist in establishing the extent of the adverse human health impact of fluoroquinolone use in poultry, CVM developed a risk assessment model. The risk assessment estimates the extent of the risk to human health from resistant Campylobacter pathogens attributed to the use of fluoroquinolones in chickens in the United States. Specifically, the risk assessment model relates the prevalence of fluoroquinolone-resistant Campylobacter infections in humans associated with the consumption of chicken to the prevalence of fluoroquinolone-resistant Campylobacter in chickens (Ref. 2). The risk assessment addressed that portion of the risk that was quantifiable, which is the risk related to consumption of chicken. The unquantifiable portion, that portion due to spread of the pathogen from chicken to other foods through contamination during food preparation or from secondary spread to other animals, was not considered in the risk assessment.

As explained in section V.B.5 of this document, the presence of fluoroquinolone-resistant Campylobacter on chicken carcasses results from the use of fluoroquinolones in chickens. This conclusion was used as a parameter in the risk assessment. This does not mean, for purposes of the risk assessment, that every chicken carrying resistant Campylobacter had to have been treated with a fluoroquinolone. Resistant organisms could have been acquired from a contaminated environment due to fluoroquinolone drug use in a previous flock, through contact with other chickens during transportation to the slaughter plant and antemortem processing, or through contamination in the slaughter plant by other infected chicken carcasses.

The number of Campylobacter culture confirmed human cases in the U.S. population was used to estimate the total burden of campylobacteriosis. These data are collected from State public health laboratories that participate in FoodNet, the CDC's Foodborne Disease Active Surveillance Network. FoodNet monitors the incidence of foodborne disease in humans and conducts studies to identify the sources and consequences of infection. Using the data on human Campylobacter cases reported in FoodNet, the risk assessment calculated a mean estimate of 1.7 million cases of campylobacteriosis (5th and 95th percentiles: 1.1 million and 2.7 million) for 1999 (Ref. 2).

The model also estimates the number of fluoroquinolone-resistant Campylobacter cases in humans attributable to chickens. This estimate excludes travelers to countries outside the United States, those patients who were prescribed a fluoroquinolone prior to stool culture, and those patients who were unsure of the timing of their treatment in relation to stool culture. For 1999, the mean estimate of the domestically-acquired fluoroquinolone-resistant Campylobacter cases in humans attributable to chickens is 190,421 (5th and 95th percentiles: 103,471 and 318,321) (Ref. 2). The model also estimated the number of humans with fluoroquinolone-resistant campylobacteriosis due to chickens who actually received a fluoroquinolone drug for therapy.

For 1999, the estimated mean number of people infected with fluoroquinolone-resistant Campylobacter from consuming or handling chicken and who subsequently received a fluoroquinolone as therapy is 11,477 (5th and 95th percentiles: 6,412 and 18,978) (Ref. 2). These people received less effective or ineffective therapy for their infections. Because their therapy was less effective or ineffective, these people would have had adverse health effects. Since the risk assessment was limited to resistance development due to use of fluoroquinolones in chickens only and the impact is a mean estimate, the actual risk to humans from fluoroquinolone-resistant Campylobacter infections from all foodborne sources is likely to be higher.

Foodborne diseases have a major public health impact in the United States, and Campylobacter is the most common known cause of foodborne illness. Fluoroquinolones are especially important in the treatment of foodborne diseases. Selection of Campylobacter resistance to fluoroquinolones is therefore a particular human health concern. Fluoroquinolones used in treating patients with enteritis are typically prescribed empirically because when treatment is delayed pending the results of culture and sensitivity, the illness may be extended or therapy may be ineffective. Moreover, fluoroquinolone resistance in Campylobacter infections has been associated with relapses (Ref. 74).

Campylobacter resistance therefore presents a dilemma for the physician. If fluoroquinolone treatment is given based on symptoms, there is a risk that the treatment will not be effective or will be less effective and valuable time will be lost. If the physician waits for a culture to determine the organism and its susceptibility to antimicrobials, again valuable time will be lost. In either case, the illness may be prolonged and result in complications, including hospitalization and deaths. The physician could turn to another drug for empiric treatment, but alternatives with the spectrum of activity shown by the fluoroquinolones are not available or may be less desirable than the fluoroquinolone due to greater side effects associated with therapy or increased cost of treatment. Even if an acceptable alternative is available at the time, the public health is diminished by the loss of an effective drug from the physician's armamentarium. The Campylobacter risk assessment provides evidence of the extent of the adverse impact of fluoroquinolone use in poultry on human health. The risk assessment determined in 1999 a mean estimate of 11,477 people (5th and 95th percentiles: 6,412 and 18,978) infected with fluoroquinolone-resistant Campylobacter from consuming or handling chicken and who subsequently received a fluoroquinolone as therapy. The fact that fluoroquinolone use in poultry has resulted in increased resistance of Campylobacter infecting humans is clear, as is the risk to human health. Continued use will likely lead to even higher levels of resistance and additional adverse health effects.

Before issuing this notice of opportunity for a hearing on the withdrawal of the approval for use of fluoroquinolones in poultry, CVM considered requiring revisions to the labeling of the fluoroquinolones to exert more control over their use. Limiting use to individual bird treatment and requiring that the drugs not be used more than once in any individual animal in order to minimize the initial development of resistant enteric organisms were options considered. CVM determined, however, that these use limitations would be impractical for both the veterinary practitioners and poultry producers. The limitations would necessitate mandatory animal identification and maintenance of extensive treatment records. Even if feasible, due to poultry production and processing practices, this approach would not prevent untreated poultry from picking up the resistant organism from treated poultry or from the environment, exposures that may be substantial during transportation to slaughter and antemortem containment.

CVM also considered establishing a drug registry requiring that veterinarians demonstrate the need for a fluoroquinolone through culture and antimicrobial susceptibility testing and request permission to use the drug in chickens or turkeys from CVM before doing so. This approach would greatly diminish the exposure of poultry to fluoroquinolones and could also be used to enforce a “single use” labeling provision. The treated animals could be tagged for followup testing at the slaughter plant and if resistant organisms were identified, the contaminated carcasses could be diverted to nonfood uses. CVM also determined that this alternative was impractical due to the cost of sampling, process control problems with accumulation of carcasses due to the prohibitive amount of time required for current resistance testing techniques, and the public health risk associated with the handling of contaminated carcasses.

Therefore, notice is given to Bayer Corp., Agriculture Division, Animal Health, that CVM proposes to withdraw the approval of the fluoroquinolone enrofloxacin for use in poultry. This action is based on section 512(e)(1)(B) of the act in that new evidence not contained in the NADA or not available until after the application was approved, evaluated together with the evidence available when the application was approved, shows that enrofloxacin is not shown to be safe under the conditions of use upon the basis of which the application was approved.

In accordance with section 512 of the act and part 514 (21 CFR part 514) and under the authority delegated to the Director of the Center for Veterinary Medicine (21 CFR 5.84), CVM hereby provides an opportunity for a hearing to show why approval of the new animal drug application for enrofloxacin for use in poultry, NADA 141-828, should not be withdrawn. Any hearing would be subject to part 12 (21 CFR part 12).

If a sponsor decides to seek a hearing, the sponsor must file: (1) On or before November 30, 2000, a written notice of appearance and request for a hearing, and (2) on or before January 2, 2001, the data, information, and analyses relied on to demonstrate that there is a genuine and substantial issue of fact to justify a hearing as specified in § 514.200.

Any other person may also submit comment on this notice. Procedures and requirements governing this notice of opportunity for a hearing, a notice of appearance and request for a hearing, submission of data, information, and analyses to justify a hearing, other comments, and a grant or denial of a hearing, are contained in § 514.200 and part 12.

The failure of a holder of an approval to file timely a written appearance and request for hearing as required by § 514.200 constitutes an election not to avail himself or herself of the opportunity for a hearing, and the Director of the Center for Veterinary Medicine will summarily enter a final order withdrawing the approvals.

A request for a hearing may not rest upon mere allegations of denials, but must set forth specific facts showing that there is a genuine and substantial issue of fact that requires a hearing. If it conclusively appears from the face of the data, information, and factual analyses in the request for hearing that there is no genuine and substantial issue of fact that precludes the withdrawal of approval of the applications, or when a request for hearing is not made in the required format or with the required analyses, the Commissioner of Food and Drugs will enter summary judgment against the person who requests a hearing, making findings and conclusions, and denying a hearing.

If a hearing is requested and is justified by the sponsor's response to this notice of opportunity for a hearing, the issues will be defined, an administrative law judge will be assigned, and a written notice of the time and place at which the hearing will commence will be issued as soon as practicable.

All submissions under this notice must be filed in four copies. Except for data and information prohibited from public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 1905, the submissions may be seen in the Dockets Management Branch (address above) between 9 a.m. and 4 p.m. Monday through Friday.

This notice is issued under the Federal Food, Drug, and Cosmetic Act (section 512 (21 U.S.C. 360b)) and under the authority delegated to the Director of the Center for Veterinary Medicine (21 CFR 5.84).

The agency has determined under 21 CFR 25.33(g) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

The following references have been placed on display in the Dockets Management Branch (address above) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

On July 31, 1992, HCFA issued a final rule (57 FR 33992). Under section 353(e)(2) of the Public Health Service Act (PHSA), HCFA may approve a private, nonprofit organization to accredit clinical laboratories (an “approved accreditation organization”) under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program if the organization meets certain requirements. An organization's requirements for accredited laboratories must be equal to, or more stringent than, the applicable CLIA program requirements in 42 Code of Federal Regulations (CFR), part 493 (Laboratory Requirements). Therefore, a laboratory accredited by an approved accreditation organization that meets and continues to meet all of the accreditation organization's requirements would be considered to meet CLIA condition level requirements if it were inspected against CLIA regulations. The regulations listed in subpart E (Accreditation by a Private, Nonprofit Accreditation Organization or Exemption Under an Approved State Laboratory Program) of part 493 specify the requirements an accreditation organization must meet to be an approved accreditation organization. HCFA approves an accreditation organization for a period not to exceed 6 years.

In general, the approved accreditation organization must among other conditions and requirements:

• Use inspectors qualified to evaluate laboratory performance and agree to inspect laboratories with the frequency determined by HCFA.

• Apply standards and criteria that are equal to or more stringent than those condition level requirements established by HCFA when taken as a whole.

• Provide reasonable assurance that these standards and criteria are continually met by its accredited laboratories;

• Provide HCFA with the name of any laboratory that has had its accreditation denied, suspended, withdrawn, limited, or revoked within 30 days of the action taken.

• Notify HCFA in writing at least 30 days before the effective date of any proposed changes in its standards.

• If HCFA withdraws its approval, notify the accredited laboratories of the withdrawal within 10 days of the withdrawal. A laboratory can be accredited if, among other things, it meets the standards of an approved accreditation organization and authorizes the accreditation body to submit to HCFA records and other information HCFA may require.

Along with requiring the promulgation of criteria for approving the accreditation body and for withdrawing this approval, CLIA requires HCFA to perform an annual evaluation by inspecting a sufficient number of laboratories accredited by an approved accreditation organization as well as by any other means that HCFA determines appropriate.

In this notice, we approve COLA as an organization that may continue to accredit laboratories for purposes of establishing their compliance with CLIA requirements. HCFA and Centers for Disease Control and Prevention (CDC) have examined the COLA application and all subsequent submissions to determine equivalency with HCFA requirements under subpart E of part 493 that an accreditation organization must meet to be granted approved status under CLIA. We have determined that COLA has complied with the applicable CLIA requirements as of October 31, 2000, and grant COLA approval as an accreditation organization under subpart E, through August 31, 2002, for the following specialty/subspecialty areas:

As a result of this determination, any laboratory that is accredited by COLA during this time period for an approved specialty/subspecialty (listed above) is deemed to meet the applicable CLIA condition level requirements for the laboratories found in part 493 and, therefore, is not subject to routine inspection by a State survey agency to determine its compliance with CLIA requirements. The accredited laboratory, however, is subject to validation and complaint investigation surveys performed by HCFA, or by any other Federal or State or local public agency or nonprofit private organization under an agreement with the Secretary.

The following describes the process used to determine that COLA, as a private, nonprofit organization, provides reasonable assurance that laboratories it accredits will meet the applicable requirements of the CLIA and applicable regulations.

To determine whether we should grant approved status to COLA as a private, nonprofit organization for accrediting laboratories under CLIA for the specific specialty or subspecialty areas of human specimen testing it requested, we conducted a detailed and in-depth comparison of COLA's requirements for its laboratories to those of CLIA. In summary, we evaluated whether COLA meets the following requirements:

• Provides reasonable assurance to us that it requires the laboratories it accredits to meet requirements that are equal to or more stringent than the CLIA condition level requirements (for the requested specialties/subspecialties) and would, therefore, meet the condition level requirements of CLIA if those laboratories had not been granted deemed status and had been inspected against condition level requirements.

• Meets the applicable requirements of Subpart E.

As specified in the regulations of subpart E, HCFA review of a private, nonprofit accreditation organization seeking approved status under CLIA includes, but is not limited to, an evaluation of the following:

• Whether the organization's requirements for its accredited laboratories are equal to or more stringent than the condition level requirements of the CLIA regulations.

• The organization's inspection process to determine:

• The organization's agreement with HCFA that requires it, among other things, to meet the following requirements:

Laboratories that are accredited by an approved accreditation organization must, among other things, meet the following requirements:

• Authorize the organization to release to HCFA all records and information required.

• Permit inspections as required by the CLIA regulations in part 493, subpart Q (Inspection).

• Obtain a certificate of accreditation as required by § 493.55 (Application for registration certificate and certificate of accreditation).

HCFA has verified COLA's assurance that it requires the laboratories it accredits to be, and that the organization is, in compliance with the following subparts of part 493 as explained below:

COLA has submitted a list of the specialties and subspecialties that it would continue to accredit, a description of its inspection process and guidelines, PT monitoring process, and its data management and analysis system, a listing of the size, composition, education and experience of its inspection teams, its investigative and complaint response procedures, its notification agreements with HCFA, its removal or withdrawal of laboratory accreditation procedures, its current list of accredited laboratories, and its announced or unannounced inspection process. We have determined that COLA has complied with the requirements under CLIA for approval as an accreditation organization under this subpart.

COLA's requirements for PT are equivalent to those of CLIA.

COLA has revised its requirements to equal the CLIA requirements at §§ 493.1101 through 493.1111 on an overall basis.

The quality control (QC) requirements of COLA have been evaluated against the applicable requirements of CLIA and its implementing regulations. We have determined that COLA's requirements, when taken as a whole, are equal to or more stringent than the CLIA requirements.

We have found the COLA personnel requirements to be equal to the CLIA personnel requirements.

We have determined that COLA's requirements are equal to the CLIA requirements of this subpart.

We have determined that COLA's inspection requirements are equal to the requirements of this subpart.

COLA meets the requirements of subpart R to the extent it applies to accreditation organizations. COLA policy stipulates the action it takes when laboratories it accredits do not comply with its requirements. COLA shall suspend, withdraw, revoke, or limit accreditation of a laboratory as appropriate and report the action to HCFA within 30 days. COLA also provides an appeals process for laboratories that have had accreditation denied.

We have determined that COLA's laboratory enforcement and appeal policies are essentially equivalent to the requirements of this subpart as they apply to accreditation organizations.

The Federal validation inspections of COLA accredited laboratories may be conducted on a representative sample basis or in response to substantial allegations of noncompliance (complaint inspections). The outcome of those validation inspections, performed by HCFA or our agent, or the State survey agency, will be HCFA's principal means for verifying that the laboratories accredited by COLA remain in compliance with CLIA requirements. This Federal monitoring is an ongoing process.

Our regulations provide that we may remove the approval of an accreditation organization, such as that of COLA, for cause, before the end of the effective date of approval. If validation inspection outcomes and the comparability or validation review produce findings as described in § 493.573 (Continuing Federal oversight of private nonprofit accreditation organizations and approved State licensure program), HCFA will conduct a review of an approved accreditation organization's program. We also conduct a review when the validation review findings, irrespective of the rate of disparity (as defined in § 493.2), indicate systemic problems in the organization's processes that provide evidence that the organization's requirements, taken as a whole, are no longer equivalent to the CLIA requirements, taken as a whole.

If HCFA determines that COLA has failed to adopt or maintain requirements that are equal to or more stringent than the CLIA requirements, or systemic problems exist in its inspection process, a probationary period, not to exceed 1 year, may be given to COLA to adopt equal or more stringent requirements. HCFA will make a determination as to whether or not COLA retains its approved status as an accreditation organization under CLIA. If approved status is withdrawn, an accreditation organization such as COLA may resubmit its application if it revises its program to address the rationale for the denial, demonstrates that it can reasonably assure that its accredited laboratories meet CLIA condition level requirements, and resubmits its application for approval as an accreditation organization in its entirety. If, however, an approved accreditation organization requests reconsideration of an adverse determination in accordance with subpart D (Reconsideration of Adverse Determinations—Deeming Authority for Accreditation Organizations and CLIA Exemption of Laboratories Under State Programs) of part 488 (Survey, Certification, and Enforcement Procedures) of our regulations, it may not submit a new application until HCFA issues a final reconsideration determination.

Should circumstances result in COLA having its approval withdrawn, HCFA will publish a notice in the Federal Register explaining the basis for removing its approval.

Under section 1816 of the Social Security Act (the Act), public or private organizations and agencies participate in the administration of Part A (Hospital Insurance) of the Medicare program under agreements with us. These agencies or organizations, known as fiscal intermediaries, determine whether medical services are covered under Medicare, determine correct payment amounts and then make payments to the health care providers (for example, hospitals, skilled nursing facilities (SNFs), community mental health centers, etc.) on behalf of the beneficiaries. Section 1816(f) of the Act requires us to develop criteria, standards, and procedures to evaluate an intermediary's performance of its functions under its agreement. Evaluations of Medicare fee-for-service performance need not be limited to the current fiscal year (FY), other fixed term basis, or agreement term. We may evaluate performance using a time frame that does not mirror the FY or other fixed term. The evaluation of intermediary performance is part of our contract management process.

Under section 1842 of the Act, we are authorized to enter into contracts with carriers to fulfill various functions in the administration of Part B (Supplementary Medical Insurance) of the Medicare program. Beneficiaries, physicians, and suppliers of services submit claims to these carriers. The carriers determine whether the services are covered under Medicare and the payable amount for the services or supplies, and then make payment to the appropriate party. Under section 1842(b)(2) of the Act, we are required to develop criteria, standards, and procedures to evaluate a carrier's performance of its functions under its contract. Evaluations of Medicare fee-for-service performance need not be limited to the current FY, other fixed term basis, or contract term. We may evaluate performance using a timeframe that does not mirror the FY. The evaluation of carrier performance is part of our contract management process.

In addition to the statutory requirements, 42 CFR 421.120 and 421.122 provide for publication of a Federal Register notice to announce criteria and standards for intermediaries prior to implementation. Section 421.201 provides for publication of a Federal Register notice to announce criteria and standards for carriers prior to implementation. The current criteria and standards were published in the Federal Register on December 3, 1999 at 64 FR 67920.

To the extent possible, we make every effort to publish the criteria and standards before the beginning of the Federal FY, which is October 1. If we do not publish a Federal Register notice before the new FY begins, readers may presume that until and unless notified otherwise, the criteria and standards that were in effect for the previous FY remain in effect. In those instances in which we are unable to meet our goal of publishing the subject Federal Register notice before the beginning of the FY, we may publish the criteria and standards notice at any subsequent time during the year. If we choose to publish a notice in this manner, the evaluation period for any such criteria and standards that are the subject of the notice will be revised to be effective on the first day of the first month following publication. Any revised criteria and standards will measure performance prospectively; that is, we will not apply new measurements to assess performance on a retroactive basis.

It is not our intention to revise the criteria and standards that will be used during the evaluation period once this information has been published in a Federal Register notice. However, on occasion, either because of administrative action or congressional mandate, there may be a need for changes that have direct impact upon the criteria and standards previously published, or that require the addition of new criteria or standards, or that cause the deletion of previously published criteria and standards. If we must make these changes, we will publish a Federal Register notice prior to implementation of the changes. In all instances, necessary manual issuances will be published to ensure that the criteria and standards are applied uniformly and accurately. Also, as in previous years, this Federal Register notice will be republished and the effective date revised if changes are warranted as a result of the public comments received on the criteria and standards.

We received a total of 19 comments in response to the Federal Register notice published on December 3, 1999. All comments were reviewed, but none necessitated our reissuance of the FY 2000 Criteria and Standards. Medicare program components were advised of the concerns as appropriate. When warranted, revisions have been incorporated in this Federal Register notice. We are responding to the following performance evaluation issues:

Comment: We were advised that the Blue Cross and Blue Shield Medicare contractors have a different scope of work for fraud and abuse (F&A) activities than the commercial contractors. As a result, Blue Cross and Blue Shield Plans' performance would need to be evaluated against the negotiated scope of work, not our manuals, since not all of our manual requirements are addressed in the contract amendment.

Response: While it is true that there are some differences between performance expectations for Blue Cross and Blue Shield Plans as opposed to commercial contractors, the protocols used for evaluation of F&A activities in FY 2000 did not contain performance expectations that were not already contained in the Blue Cross and Blue Shield Medicare contract.

Comment: We were advised that references under the Fiscal Responsibility Criterion relating to the evaluation of a contractor's adherence to the Chief Financial Officers' Act (CFO), 31 USC 503, et seq. are incorrect. The expectation to comply with this law is applicable to us, not the contractors. The expectation should be reworded to reflect that contractors assist the Secretary with being compliant with the CFO Act.

Response: We agree that the requirement referenced in the above comment is applicable to us and not to the contractors. The FY 2001 Federal Register notice has been revised to correctly reflect language as contained in the contract. Language in the Federal Register notice now specifically references the Federal Managers' Financial Integrity Act (FMFIA), 31 U.S.C. 1105, et seq; rather than the CFO Act and also states that contractors must cooperate with us in complying with the FMFIA.

Comment: We were advised that the Agency issued a moratorium on the review of all demand bills because of the SNF prospective payment system (PPS). It was suggested that we acknowledge that the standard would not be evaluated until the Agency issued instructions and intermediaries had a chance to train staff on such.

Response: The moratorium on the review of all demand bills was lifted, and we issued appropriate instructions in March 2000.

Comment: HCFA was advised that the carrier Customer Service criterion states that carriers are to achieve a monthly All Trunks Busy (ATB) Rate of not more than 5 percent. For callers choosing to speak with a customer service representative, 97.5 percent or more of the calls are to be answered within 120 seconds; no less than 85 percent are to be answered within the first 60 seconds. A question was raised as to whether this requirement applies only to call centers servicing beneficiaries (and providers, if the call centers are not separate).

Response: The telephone service requirement referenced in the above comment is applicable to call centers servicing beneficiaries (and providers if the centers are not separate). The requirement is not applicable to call centers that specifically service providers.

Basic principles of the Medicare program are to pay claims promptly and accurately and to foster good beneficiary and provider relations. Contractors must administer the Medicare program efficiently and economically. The goal of performance evaluation is to ensure that contractors meet their contractual obligations. We measure contractor performance to ensure that contractors do what is required of them by law, regulation, contract and our directives. We have developed a contractor management program for FY 2001 that outlines expectations of the contractor; measures the performance of the contractor; evaluates the performance against the expectations; and, takes appropriate contract action based upon the evaluation of the contractor's performance. We work to develop and refine measurable performance standards in key areas in order to better evaluate contractor performance. In addition to evaluating performance based upon expectations for FY 2001, we may conduct follow-up evaluations in areas when contractor performance was out of compliance with laws, regulations, and our performance expectations during FY 2000, thus having required the contractor to submit a Performance Improvement Plan (PIP).

We have structured the FY 2001 Contractor Performance Evaluation into five criteria designed to meet those objectives. The first criterion is “Claims Processing,” which measures contractual performance against claims processing accuracy and timeliness requirements. Within the Claims Processing criterion, we have identified those performance standards that are mandated by either legislation, regulation, or judicial decision. These standards include claims processing timeliness, the accuracy of Explanations of Medicare Benefits (EOMBs) or Medicare Summary Notices (MSNs), the rate of cases reversed by the Administrative Law Judge (ALJ), the timeliness of intermediary reconsideration cases and the timeliness of carrier reviews and hearings. Further evaluation in the Claims Processing criterion may include, but is not limited to, the accuracy of bill and claims processing, the level of electronic claims payment, the percent of bills and claims paid with interest, and the accuracy of reconsiderations, reviews, and hearings.

The second criterion is “Customer Service,” which assesses the completeness of the service provided to customers by the contractor in its administration of the Medicare program. Mandated standards in the Customer Service criterion include timeliness of carrier replies to beneficiary telephone inquiries and the accuracy and clarity of responses to written inquiries. In FY 2001, customer feedback may be used to collect comparable data on customer satisfaction and identify areas in need of improvement. Further evaluation of services under this criterion may include, but is not limited to, a review of beneficiary relations; provider education; appropriateness of telephone inquiry responses; and walk-in service.

The third criterion is “Payment Safeguards,” which evaluates whether the Medicare Trust Fund is safeguarded against inappropriate program expenditures. Intermediary and carrier performance may be evaluated in the areas of medical review (MR), Medicare secondary payer (MSP), F&A (also referred to as benefits integrity (BI)), overpayments (OP) , provider enrollment (PE), and audit and reimbursement (A&R). Mandated performance standards in the Payment Safeguards criterion are the accuracy of decisions on SNF demand bills, and the timeliness of processing Tax Equity and Fiscal Responsibility Act (TEFRA) target rate adjustments, exceptions, and exemptions. Further evaluation in this criterion may include, but is not limited to, review of the efficient and effective compilation and analysis of data to bring about continuous improvement in a contractor's efforts to safeguard Medicare program dollars. Intermediaries and carriers may also be evaluated on any Medicare Integrity Program (MIP) activities if performed under their Part A agreement or Part B contract.

The fourth criterion is “Fiscal Responsibility,” which evaluates the contractor's efforts to protect the Medicare program and the public interest. Contractors must effectively manage Federal funds for both the payment of benefits and costs of administration under the Medicare program. Proper financial and budgetary controls, including internal controls, must be in place to ensure contractor compliance with its agreement with HHS and HCFA. Additional functions reviewed under this criterion may include, but are not limited to, adherence to approved budget, compliance with the BPRs, and financial reporting requirements.

The fifth and final criterion is “Administrative Activities,” which measures a contractor's administrative management of the Medicare program. A contractor must efficiently and effectively manage its operations to ensure constant improvement in the way it does business. Proper systems security (general and application controls), Automated Data Processing (ADP) maintenance, and disaster recovery plans must be in place. A contractor's evaluation under the Administrative Activities criterion may include, but is not limited to, establishment, application, documentation, and effectiveness of internal controls, which are essential in all aspects of a contractor's operation and the degree to which the contractor cooperates with us in complying with the FMFIA. Administrative Activities evaluations may also include reviews related to implementation of change management instructions and data and reporting requirements.

We have also developed separate measures for evaluating unique activities of Regional Home Health Intermediaries (RHHIs). Section 1816(e)(4) of the Act requires us to designate regional agencies or organizations, which are already Medicare intermediaries under section 1816, to perform bill processing functions with respect to freestanding home health agency (HHA) bills. The law requires that we limit the number of these regional intermediaries (RHHIs) to not more than 10; see 42 CFR 421.117 and the final rule published in the Federal Register on May 19, 1988 at 53 FR 17936 for more details about the RHHIs.

We have developed separate measures for RHHIs in order to evaluate the distinct RHHI functions. These functions include the processing of bills from freestanding HHAs, hospital affiliated HHAs, and hospices. Through an evaluation using these criteria and standards, we may determine whether the RHHI functions should be moved from one intermediary to another in order to ensure effective and efficient administration of the program benefit.

Below, we list the criteria and standards to be used for evaluating the performance of intermediaries and carriers. In several instances, we identify a Medicare manual as a source of more detailed requirements. Intermediaries and carriers have copies of various Medicare manuals referenced in this notice. Members of the public also have access to our manualized instructions.

Medicare manuals are available for review at local Federal Depository Libraries (FDLs). Under the FDL Program, government publications are sent to approximately 1,400 designated public libraries throughout the United States. Interested parties may examine the documents at any one of the FDLs. Some may have arrangements to transfer material to a local library not designated as a FDL. To locate the nearest FDL, individuals should contact any public library.

In addition, individuals may contact regional depository libraries, which receive and retain at least one copy of nearly every Federal government publication, either in printed or microfilm form, for use by the general public. These libraries provide reference services and interlibrary loans; however, they are not sales outlets. Individuals may obtain information about the location of the nearest regional depository library from any library. Information may also be obtained from the following web site: www.hcfa.gov/pubforms/progman.htm. Some manuals may be obtained from the following web site: www.hcfa.gov/pubforms/p2192toc.htm. Finally, all of our Regional Offices (RO) maintain all Medicare manuals for public inspection. To find the location of the nearest available HCFA RO, you may call the individual listed at the beginning of this notice. That individual can also provide information about purchasing or subscribing to the various Medicare manuals.

The Claims Processing criterion contains 4 mandated standards. Standard 1: 95 percent of clean electronically submitted non-Periodic Interim Payment (PIP) bills paid within statutorily specified time frames. Clean bills are defined as bills that do not require Medicare intermediaries and/or carriers to investigate or develop external to their Medicare operations on a prepayment basis. Specifically, clean, non-PIP electronic claims can be paid as early as the 14th day (13 days after the date of receipt) and must be paid by the 31st day (30 days after the date of receipt).

Standard 2: 95 percent of clean paper non-PIP bills paid within specified time frames. Specifically, clean, non-PIP paper claims can be paid as early as the 27th day (26 days after the date of receipt) and must be paid by the 31st day (30 days after the date of receipt).

Standard 3: Reversal rate by Administrative Law Judge (ALJ) is acceptable. We have defined an acceptable reversal rate by an ALJ as one that is at or below 5.0 percent.

Standard 4: 75 percent of reconsiderations are processed within 60 days and 90 percent are processed within 90 days.

Additional functions may be evaluated under this criterion. These functions include, but are not limited to, the—

• Bill processing accuracy;

• Establishment and maintenance of relationship with Common Working File (CWF) Host;

• Management of shared processing sub-contract;

• Analysis and validation of data; and

• Accuracy of processing reconsideration cases with clear responses and appropriate customer-friendly tone and clarity.

We may review the intermediary's efforts to enhance customer satisfaction through the use of customer feedback. Results of the feedback may be used to establish comparable data on customer satisfaction and to identify areas in need of improvement. The results may be summarized for publication in the Report of Contractor Performance (RCP) and shared with individual contractors.

Functions that may be evaluated under this criterion include, but are not limited to—

• Accuracy, timeliness and appropriateness of responses to telephone inquiries;

• Accuracy and timeliness of responses to written inquiries with appropriate customer-friendly tone and clarity;

• Establishment and maintenance of relationships with professional and beneficiary organizations;

• Use of focus groups; and

• Conduct of educational and outreach efforts.

The Payment Safeguard criterion contains two mandated standards.

Standard 1—Decisions on SNF demand bills are accurate.

Standard 2—TEFRA target rate adjustments, exceptions, and exemptions are processed within mandated time frames. Specifically, applications must be processed to completion within 75 days after receipt by the contractor or returned to the hospitals as incomplete within 60 days of receipt.

Intermediaries may also be evaluated on any MIP activities if performed under their Part A agreement. These functions and activities include, but are not limited to—

• Medical Review.

• Applying analytical skills and focusing resources on particular providers or claim types that represent unnecessary or inappropriate care.

• Developing local and national data that identify aberrancies and form the basis of corrective actions, such as educating the provider, or become the basis of medical review policies or review screens as directed by Medicare program manuals and BPR requirements.

• Making decisions that comply with current coverage guidelines.

• Developing means of addressing aberrancies identified during the analysis of all local and national data.

• Medicare Secondary Payer.

• Identifying and recovering mistaken Medicare payments in accordance with appropriate Medicare Intermediary Manual instructions and other pertinent HCFA general instructions.

• Accurately reporting savings and following claim development procedures.

• Prioritizing and processing recoveries in compliance with instructions.

• Fraud and Abuse (also known as BI).

• Identifying fraud cases that exist within the intermediary's service area and taking appropriate actions to dispose of these cases.

• Investigating allegations of fraud made by beneficiaries, providers, HCFA, Office of Inspector General (OIG), and other sources.

• Putting in place effective fraud detection and deterrence programs.

• Overpayments.

• Collecting Medicare debts timely.

• Accurately reporting overpayments to HCFA.

• Adhering to our instructions for management of Medicare Trust Fund debts.

• Provider Enrollment.

• Complying with assignment of staff to the provider enrollment function and training the staff in procedures and verification techniques.

• Complying with the operational standards relevant to the process for enrolling providers.

• Audit and Reimbursement.

• Performing the activities specified in our general instructions for conducting audit and settlement of Medicare cost reports.

• Settling Medicare cost reports timely and accurately in establishing interim provider payments.

We may review the intermediary's efforts to establish and maintain appropriate financial and budgetary internal controls over benefit payments and administrative costs. Proper internal controls must be in place to ensure that contractors comply with their agreements with us.

Additional matters to be reviewed under the Fiscal Responsibility criterion may include, but are not limited to—

• Adherence to approved program management and MIP budgets;

• Compliance with the BPRs;

• Compliance with financial reporting requirements and;

• Control of administrative cost and benefit payments.

We may measure an intermediary's administrative ability to manage the Medicare program. We may evaluate the efficiency and effectiveness of its operations, its system of internal controls, and its compliance with our directives and initiatives.

We may measure an intermediary's efficiency and effectiveness in managing its operations to ensure constant improvement in the way it does business. Proper systems security (general and application controls), ADP maintenance, and disaster recovery plans must be in place. An intermediary must also test system changes to ensure the accurate implementation of our instructions.

Our evaluation of an intermediary under the Administrative Activities criterion may include, but is not limited to, reviews of its—

• Systems security;

• ADP maintenance (configuration management, testing, change management, security, etc.);

• Disaster recovery plan;

• Change management plan implementation;

• Data and reporting requirements implementation; and

• Internal controls establishment and use, including the degree to which the contractor cooperates with the Secretary in complying with the FMFIA.

The Claims Processing criterion contains five mandated standards.

Standard 1: 95 percent of clean electronically submitted claims processed within statutorily specified time frames. Specifically, clean electronic claims can be paid as early as the 14th day (13 days after the date of receipt) and must be paid by the 31st day (30 days after the date of receipt).

Standard 2: 95 percent of clean paper claims processed within specified time frames. Specifically, clean paper claims can be paid as early as the 27th day (26 days after the date of receipt) and must be paid by the 31st day (30 days after the date of receipt).

Standard 3: 98 percent of EOMBs and MSNs are properly generated.

Standard 4: 95 percent of review determinations are accurate and clear with appropriate customer-friendly tone and clarity, and are completed within 45 days.

Standard 5: 90 percent of carrier hearing decisions are accurate and clear with appropriate customer-friendly tone and clarity, and are completed within 120 days.

Additional functions may be evaluated under this criterion. These functions include, but are not limited to, the—

• Claims Processing accuracy;

• Management of shared processing sub-contract;

• Establishment and maintenance of relationship with the CWF Host; and

• Analysis and validation of data.

The Customer Service criterion contains two mandated standards.

Standard 1— Telephone inquiries are answered timely.

Carriers are to achieve a monthly ATB Rate of not more than 10%. For callers choosing to speak with a customer service representative, 97.5% or more of telephone calls are to be answered within 120 seconds; no less than 85% are to be answered within the first 60 seconds.

Standard 2— Accuracy and timeliness of responses to written inquiries with appropriate customer-friendly tone and clarity. Responses to beneficiary written inquiries are written at an appropriate reading level.

We may review the carrier's efforts to enhance customer satisfaction through the use of customer feedback. Results of the feedback may be used to establish comparable data on customer satisfaction and to identify areas in need of improvement. The results may be summarized for publication in the RCP and shared with individual contractors.

Additional functions may be evaluated under this criterion. These functions include, but are not limited to, the carrier's—

• Accuracy and appropriateness of responses to telephone inquiries;

• Establishment and maintenance of relationships with professional and beneficiary organizations;

• Use of focus groups;

• Conduct of educational and outreach efforts; and

• Walk-in services.

Carriers may be evaluated on any MIP activities if performed under their Part B contracts. In addition other carrier functions and activities that may be reviewed under this criterion include, but are not limited to—

• Medical Review.

• Applying their analytical skills and focusing resources on particular providers or claim types that represent unnecessary or inappropriate care.

• Developing effective means of addressing aberrancies identified through analyzing data to target prepay and postpay review.

• Using medical coverage guidelines to determine if each medical review screen is supported by sufficient documentation.

• Developing means of addressing aberrancies identified during the analysis of all local and national data.

• Medicare Secondary Payer.

• Identifying and recovering mistaken Medicare payments in accordance with the appropriate Medicare Carriers Manual instructions, and other pertinent HCFA general instructions.

• Accurately reporting savings and following claim development procedures.

• Prioritizing and processing recoveries in compliance with instructions.

• Fraud and Abuse (also known as BI).

• Identifying fraud and abuse cases that exist within the carrier's service area and taking appropriate actions to dispose of these cases.

• Investigating allegations of fraud and/or abuse made by beneficiaries, providers, HCFA, OIG, and other sources.

• Putting in place effective fraud and abuse detection and deterrence programs.

• Overpayments.

• Collecting Medicare debts timely.

• Accurately reporting overpayments to HCFA.

• Adhering to our instructions for management of Medicare Trust Fund debts.

• Provider Enrollment

• Complying with assignment of staff to the provider enrollment function and training staff in procedures and verification techniques.

• Complying with the operational standards relevant to the process for enrolling providers.

We may review the carrier's efforts to establish and maintain appropriate financial and budgetary internal controls over benefit payments and administrative costs. Proper internal controls must be in place to ensure that contractors comply with their agreements with us.

Additional matters to be reviewed under the Fiscal Responsibility criterion may include, but are not limited to—

• Adherence to approved program management and MIP budgets;

• Compliance with the BPRs;

• Compliance with financial reporting requirements; and

• Control of administrative cost and benefit payments.

We may measure a carrier's administrative ability to manage the Medicare program. We may evaluate the efficiency and effectiveness of its operations, its system of internal controls, and its compliance with our directives and initiatives.

A carrier must efficiently and effectively manage its operations to assure constant improvement in the way it does business. Proper systems security (general and application controls), ADP maintenance, and disaster recovery plans must be in place. Also, a carrier must test system changes to ensure accurate implementation of our instructions.

Our evaluation of a carrier under this criterion may include, but is not limited to, reviews of its—

• Systems security;

• ADP maintenance (configuration management, testing, change management, security, etc.);

• Disaster recovery plan;

• Change management plan implementation;

• Data and reporting requirements implementation; and

• Internal controls establishment and use including the degree to which the contractor cooperates with the Secretary in complying with the FMFIA.

The following standards are mandated for the RHHI criterion:

Standard 1: 95 percent of clean electronically submitted non-PIP HHA/hospice bills are paid within statutorily specified time frames. Specifically, clean, non-PIP electronic claims can be paid as early as the 14th day (13 pays after the date of receipt) and must be paid by the 31st day (30 days after the date of receipt).

Standard 2: 95 percent of clean paper non-PIP HHA/hospice bills are paid within specified time frames. Specifically, clean, non-PIP paper claims can be paid as early as the 27th day (26 days after the date of receipt) and must be paid by the 31st day (30 days after the date of receipt).

Standard 3: 75 percent of HHA/hospice reconsiderations are processed within 60 days and 90 percent are processed within 90 days.

We may use this criterion to review a RHHI's performance with respect to handling the HHA/hospice workload. This includes processing HHA/hospice bills timely and accurately; properly paying and settling HHA cost reports; and timely and accurately processing reconsiderations from beneficiaries, HHAs, and hospices, interim rate setting, and accuracy of MR coverage decisions.

We evaluate a contractor's performance against applicable program requirements for each criterion. Each contractor must certify that all information submitted to us relating to the contract management process, including, without limitation, all files, records, documents and data, whether in written, electronic, or other form, is accurate and complete to the best of the contractor's knowledge and belief. A contractor will also be required to certify that its files, records, documents, and data have not been manipulated or falsified in an effort to receive a more favorable performance evaluation. A contractor must further certify that, to the best of its knowledge and belief, the contractor has submitted, without withholding any relevant information, all information required to be submitted with respect to the contract management process under the authority of applicable law(s), regulation(s), contracts, or HCFA manual provision(s). Any contractor that makes a false, fictitious, or fraudulent certification may be subject to criminal and/or civil prosecution, as well as appropriate administrative action. This administrative action may include debarment or suspension of the contractor, as well as the termination or nonrenewal of a contract.

If a contractor meets the level of performance required by operational instructions, it meets the requirements of that criterion. Any performance measured below basic operational requirements constitutes a program deficiency. The contractor will be required to develop and implement a PIP for each program deficiency identified. The contractor will be monitored to ensure effective and efficient compliance with the PIP, and to ensure improved performance when requirements are not met. The contractor will also be monitored when a program vulnerability in any performance area is identified. A program vulnerability exists when a contractor's performance complies with basic program requirements, but one or more weaknesses are present that could result in deficient performance if left ignored.

The results of performance evaluations and assessments under all five criteria will be used for contract management activities and will be published in the contractor's annual performance report. We may initiate administrative actions as a result of the evaluation of contractor performance based on these performance criteria. Under sections 1816 and 1842 of the Act, we consider the results of the evaluation in our determinations when—

• Entering into, renewing, or terminating agreements or contracts with contractors;

• Deciding other contract actions for intermediaries and carriers (such as deletion of an automatic renewal clause). These decisions are made on a case-by-case basis and depend primarily on the nature and degree of performance. More specifically, they depend on the—

• Relative overall performance compared to other contractors;

• Number of criteria in which deficient performance occurs;

• Extent of each deficiency;

• Relative significance of the requirement for which deficient performance occurs within the overall evaluation program; and

• Efforts to improve program quality, service, and efficiency.

• Deciding the assignment or reassignment of providers and designation of regional or national intermediaries for classes of providers.

We make individual contract action decisions after considering these factors in terms of their relative significance and impact on the effective and efficient administration of the Medicare program.

In addition, if the cost incurred by the intermediary or carrier to meet its contractual requirements exceeds the amount that we find to be reasonable and adequate to meet the cost that must be incurred by an efficiently and economically operated intermediary or carrier, these high costs may also be grounds for adverse action.

Because of the large number of items of correspondence we normally receive on Federal Register documents published for comment, we are unable to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the Dates section of this preamble, and, if we proceed with a subsequent document, we will respond to the comments in the preamble of that document.

In accordance with the provisions of Executive Order 12866, this notice was reviewed by the Office of Management and Budget.

We have reviewed this notice under the threshold criteria of Executive Order 13132, Federalism. We have determined that the notice does not significantly affect the rights, roles, and responsibilities of States.

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 performance of the functions of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

This Notice also lists the following information:

Title of Proposal: Updating the Low Income Housing Tax Credit Database.

Description of the need for the information and proposed use:

Section 42 of the I.R.C. provides for Low-Income Housing Tax Credits (LIHTC) that encourage the production of qualified low-income housing units. Due to the decentralized nature of the LIHTC program, there are few data available on the units that are currently being developed with this federal tax subsidy. The Department of Housing and Urban Development, while not responsible for administering tax credits, has special responsibilities in understanding and evaluating credit usage, both because the LIHTC helps provide for the housing needs of low-income persons and because credits work in conjunction with HUD subsidies in some units.

Absent this data collection, HUD will not have at its disposal the most current, comprehensive LIHTC data, rendering HUD unable to determine the types of areas in which the units are located, the concentration of such units geographically and with respect to other subsidized housing types, or whether incentives to develop LIHTC units in a set of HUD designed Difficult Development Areas has been effective. In addition, without these data, both HUD and private researchers will be unable to conduct sample-based studies on the LIHTC due to the difficulty of constructing a valid sample without a complete data set on the universe of LIHTC projects.

Members of affected public: Information will be solicited from the 57 agencies (predominantly state-level) that allocate credits under section 42 of the I.R.C.

Estimation of the total numbers of hours needed to prepare the information collection including number of respondents, frequency of response, and hours of response:

Number of respondents: 58.

Number of responses per respondent: 01.

Total number of responses per annum: 54.

Hours per response: 24.

Total Hours: 1,392.

Status of the proposed information collection: Pending OMB approval.

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 needed 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:

Title of Proposal: Request voucher for Grant Payment & LOCCS Voice Response System Access Authorization.

OMB Approval Number: 2535-0102.

Form Numbers: HUD-27053; HUD-27054.

Description of the Need for the Information and its Proposed Use: Request vouchers are used to prepare automated phone request for distribution of grant funds using the automated Voice Response System (VRS). Authorization form is submitted to establish access to voice activated payment system.

Frequency of Submission: on occasion.

Total Estimated Burden Hours: 41,133.

Status: Reinstatement, without change.

HUD regulations, at 24 CFR 30.45, permit the Assistant Secretary of Housing—Federal Housing Commissioner to initiate and resolve civil money penalty actions against participants in HUD multifamily insured housing programs. These participants include: a mortgagor of any property that includes five or more living units and is subject to a mortgage insured, coinsured or held by the Secretary. Section 30.45 identifies the violations for which the Assistant Secretary may impose a penalty. Among the referenced violations is the mortgagor's failure to timely file audited financial reports. See 12 U.S.C. 1735f-15(c)(1)(B)(x) and 12 U.S.C. 1701q-1(c)(1)(J). Mortgagors are required to file annual financial reports within 60 days of the end of the mortgagor's fiscal year. These reports must be examined and certified by an independent or certified public accountant, and certified by an officer of the mortgagor.

Section 30.45 also provides that the Assistant Secretary may delegate his authority under the regulations to a designee. This document would make that delegation to the Director of the Enforcement Center. This delegation does not affect the authority of the Mortgagee Review Board to initiate civil money penalties, as described in 24 CFR 30.35, or the authority of the Assistant Secretary to initiate civil money penalties for violations identified in 12 U.S.C. 1735f-15(c)(1)(B)(x) and 12 U.S.C. 1701q-1(c)(1)(J).

Wherefore, the Assistant Secretary for Housing—Federal Housing Commissioner delegates authority, as follows:

Section A. Authority Delegate: The Director of the HUD Enforcement Center, as designee, is authorized to take all actions permitted under 24 CFR Part 30, as they pertain to violations identified in 12 U.S.C. 1735f-15(c)(1)(B)(x) and 12 U.S.C. 1701q-1(c)(1)(J).

Section B. Authority to Redelegate: The Director of the Enforcement Center is not authorized to redelegate, to another designee, the authority delegated under Section A.

The purpose of this natural resource damage assessment is to confirm and quantify injuries to natural resources, resultant economic damages, and the natural resource restoration necessary to address those injuries in the Lower Fox River, Green Bay, and Lake Michigan environment resulting from exposure to polychlorinated biphenyls released by Fox River, Wisconsin paper mills. The injury and required restoration are assessed under the Comprehensive Environmental Response, Compensation, and Liability Act, as amended, and the Clean Water Act, as amended.

In accordance with Federal coal management regulations 43 CFR 4322 and 4325, a public hearing shall be held on the proposed sale to allow public comment on and discussion of the potential effects of mining and proposed lease. Not less than 30 days prior to the publication of the notice of sale, the Secretary shall solicit public comments on fair market value appraisal and maximum economic recovery and on factors that may affect these two determinations. Proprietary data marked as confidential may be submitted to the Bureau of Land Management in response to this solicitation of public comments. Data so marked shall be treated in accordance with the laws and regulations governing the confidentiality of such information. A copy of the comments submitted by the public on fair market value and maximum economic recovery, except those portions identified as proprietary by the author and meeting exemptions stated in the Freedom of Information Act, will be available for public inspection at the Bureau of Land Management, Utah State Office during regular business hours (8:00 a.m. to 4:00 p.m.) Monday through Friday. Comments on fair market value and maximum economic recovery should be sent to the Bureau of Land Management and should address, but not necessarily be limited to, the following information:

1. The quality and quantity of the coal resource.

2. The mining method or methods which would achieve maximum economic recovery of the coal, including specifications of seams to be mined and the most desirable timing and rate of production.

3. The quantity of coal.

4. If this tract is likely to be mined as part of an existing mine and therefore be evaluated on a realistic incremental basis, in relation to the existing mine to which it has the greatest value.

5. If this tract should be evaluated as part of a potential larger mining unit and evaluated as a portion of a new potential mine (i.e., a tract which does not in itself form a logical mining unit).

6. The configuration of any larger mining unit of which the tract may be a part.

7. Restrictions to mining which may affect coal recovery.

8. The price that the mined coal would bring when sold.

9. Costs, including mining and reclamation, of producing the coal and the time of production.

10. The percentage rate at which anticipated income streams should be discounted, either in the absence of inflation or with inflation, in which case the anticipated rate of inflation should be given.

11. Depreciation and other tax accounting factors.

12. The value of any surface estate where held privately.

13. Documented information on the terms and conditions of recent and similar coal land transactions in the lease sale area.

14. Any comparable sales data of similar coal lands.

Coal quantities and the FMV of the coal developed by BLM may or may not change as a result of comments received from the public and changes in market conditions between now and when final economic evaluations are completed.

Summary minutes for the Council meeting will be maintained in the Canon City Center and will be available for public inspection and reproduction during regular business hours within thirty (30) days following the meeting.

Title: 36 CFR Part 61, Procedures for State, Tribal, and Local Government Historic Preservation Programs.

OMB Number: 1024-0038.

Type of Request: Reinstatement, with change, of a previously approved collection for which approval has expired.

Abstract: This information collection has an impact on State, Tribal, and local governments that wish to participate formally in the national historic preservation program and who wish to apply for Historic Preservation Fund grant assistance. The National Park Service uses the information to ensure compliance with the National Historic Preservation Act and government-wide grant requirements.

Respondents/Record Keepers: State, Tribal, and Local Governments.

Estimate of Burden: NPS estimates that the public reporting burden for this collection of information will average 9.06 hours per response and 0.60 hours per record, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed and reviewing the collection of information.

Estimated Number of Respondents/Record Keepers: NPS estimates that there are 450 respondents and 83 record keepers. This is the gross number of respondents and record keepers for all of the documents included in this information collection. The net number of States, Tribal, and local governments participating in this information collection annually is 136. The frequency of response varies depending upon activity. States complete Grant application and end-of-year report documents once a year. NPS requires project documents at the beginning and end of each subgrant with a large Federal share. NPS reviews each State's program once every four years. NPS requires information from a local government when it applies for certification. NPS requires that each State maintain one record for each property in its inventory and one record per project for tracking its responses to Federal agency requests for State review. Pursuant to Section 101(d) of the National Historic Preservation Act, federally recognized Indian Tribes, after agreement with the National Park Service (NPS), may assume responsibilities specified in Section 101(b)(3) and therefore use related information collections.

Estimated Number of Responses per Respondent: 1.

Estimated Number of Records per Record Keeper: 350.

Estimated Total Annual Burden on Respondents: 4,078 hours.

Estimated Total Annual Burden on Record Keepers: 17,430 hours.

Estimated Total Annual Burden: 21,508 hours.

You may obtain copies of this information collection from Mr. John W. Renaud, Project Coordinator.

NPS is soliciting comments regarding:

(1) Whether the collection of information is necessary for the proper performance of the functions of NPS, including whether the information will have practical utility;

(2) The accuracy of the burden estimate including the validity of the method and assumptions used;

(3) The quality, utility, and clarity of the information to be collected;

(4) Ways to minimize the burden, including through the use of automated collection or other forms of information technology; or,

(5) Any other aspect of this collection of information.

All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

This document presents and analyzes 7 alternatives for winter use management in Yellowstone National Park (YNP), Grand Teton National Park (GTNP), and the John D. Rockefeller, Jr., Memorial Parkway (the Parkway).

Alternative G, the preferred alternative, emphasizes clean, quiet access to the parks using the technologies available today. It would allow over-snow access on all routes currently available via NPS-managed snowcoach only. Other key changes in recreation opportunities are: eliminating winter plowing on the Colter Bay to Flagg Ranch route, making Flagg Ranch a destination via over-snow transport, and eliminating all winter motorized use on Jackson Lake. This alternative addresses the full range of issues regarding safety, natural resource impacts, visitor experience and access. It addresses the issues in a way that would make it necessary for local economies to adapt, and for snowmobile users to access the parks using a different mode of transport. Under alternative A-No Action, current use and management practices in the parks and Parkway continue. The concept under alternative B provides a moderate range of affordable and appropriate winter visitor experiences. Air quality and oversnow motor vehicle sound would be addressed, and by the winter of 2008-2009, strict emission and sound requirements would be required by all oversnow vehicles entering the parks. This alternative also emphasizes an adaptive approach to park resource management, which would allow the results of new and ongoing research and monitoring to be incorporated. Alternative C maximizes winter visitor opportunities for a range of park experiences. Alternative D stresses visitor access to unique winter features in the parks. This alternative emphasizes clean, quiet modes of travel, visitor activities focused near destination areas, and a minimization of conflicts between nonmotorized and motorized users. Under alternative E the protection of wildlife and natural resources is emphasized while allowing park visitors access to a range of winter recreation experiences. Alternative E uses an adaptive planning approach that allows new information to be incorporated over time. Alternative F stresses the protection of wildlife resources by focusing winter visitor activities in YNP outside important winter range for large ungulate species, and closing north and west roads to winter use. For GTNP and the Parkway, this alternative emphasizes the protection of all resources by focusing developments, oversnow motorized trails and zones, and nonmotorized trails and zones in certain areas, while still allowing park visitors opportunities for a range of winter recreational experiences.

The details and impacts of the alternatives are described in this document. They include major long-term beneficial improvements to the protection of geothermal winter range and other park resources, some adverse effects from visitor use activities, and major beneficial improvements to the desired visitor experience for solitude, clean air, and natural quiet. These impacts vary by alternative.

The Bureau of Justice Assistance (BJA), 42 U.S.C. 3741, as required by the Council on Environmental Quality's regulations, 40 CFR parts 1500 through 1508, has prepared an Environmental Assessment for methamphetamine law enforcement programs, and with specific application for the Methamphetamine/Drug Hot Spots Program. The Methamphetamine/Drug Hot Spots Program addresses a broad array of law enforcement initiatives pertaining to the investigation of methamphetamine trafficking in many heavily impacted areas of the country. For the purposes of this program, law enforcement may include training of law enforcement officers in methamphetamine-related issues; collection and maintenance of intelligence and information relative to methamphetamine trafficking and traffickers; investigation, arrest and prosecution of producers, traffickers and users of methamphetamine; interdiction and removal of laboratories, finished products, and precursor chemicals and other elements necessary to produce methamphetamine; and preventive efforts to reduce the spread and use of methamphetamine. Individual projects will reflect a concentration on program areas consistent with the Congressional appropriations language.

Among the many challenges faced by law enforcement agencies in the Methamphetamine/Drug Hot Spots Program, will be discovery, interdiction, and dismantling of clandestine drug laboratories. These lab sites, as well as other methamphetamine crime venues must be comprehensively dealt with in compliance with a variety of health, safety and environmental regulations. The Bureau of Justice Assistance anticipates that law enforcement efforts funded under this program, when encountering illegal drug laboratories, will use grant funds to effect the proper removal and disposal of hazardous materials located at those laboratories and directly associated sites. Where grant funds are not used to effect clean-up of hazardous waste sites, grantees must document in their applications how they will remediate clandestine drug laboratories that are seized as a result of grant-related activities.

BJA will award 16 grants to State and local criminal justice agencies consistent with congressional earmarks for the FY 2000 COPS Methamphetamine/Drug Hot Spots Program. The Environmental Assessment concludes that the funding of this program will not have a significant impact on the quality of the human environment. Therefore, an Environmental Impact Statement will not be prepared for the funding of this program.

ETA is soliciting proposals on a competitive basis for the incumbent/dislocated workers' skill shortage II demonstration program. It is envisioned that the program will encompass the upgrading of current workers, designing or adapting training curricula in skills shortage occupational areas, or in regionally important business/industry areas including manufacturing and machining, and specialized industrial areas.

This announcement consists of five (5) parts:

• Part I—Background.

• Part II—Eligible Applicants and the Application Process.

• Part III—Statement of Work.

• Part IV—Rating Criteria and Award Selection Process.

• Part V—Monitoring, Reporting and Evaluation.

Section 171(d) of the Workforce Investment Act of 1998 (WIA) (29 U.S.C. 2916) authorizes the use of funds for demonstration projects from funds made available to the Secretary under Section 132(a)(2)(A) of WIA (29 U.S.C. 2862). In addition, the DOL FY 2000 Appropriations Act of November 17, 1999, authorizes dislocated worker demonstration projects that provide assistance to new entrants in the workforce and incumbent workers. Demonstration program grantees must comply with all applicable federal and state laws and regulations in setting up and carrying out their program.

The purpose of this demonstration program is to test the ability of the workforce development system to create projects or industry-led consortia for the purpose of upgrading current workers, designing or adapting training curricula in skills shortage occupational areas, or in regionally important business/industry areas including manufacturing and machining, and specialized industrial areas such as plastics, telecommunications and the environment, and to recruit/retrain workers in these occupations. The dislocated and/or incumbent workers who will be assisted by these efforts include specific groups such as agricultural workers, low skilled workers, and those needing assistance in overcoming barriers to employment. These barriers to employment may be caused by living in rural communities, having limited options for transportation to work, having inadequate or obsolete skills or having skills in declining occupations. The focus of these efforts will be on skills training in skills shortage occupations including welding and metals, new and growing occupations in technological fields such as information technology, telecommunications, and other fields in which technology skills are critical parts of the jobs emerging in their regional labor markets. Any consortia established as a result of this competition would also be expected to enhance the strategic planning efforts and policy efforts of local boards under the Workforce Investment Act in these areas.

This $8.2 million dislocated and incumbent worker demonstration program will support the creation of projects to respond to employer-identified skill shortages in regional labor markets with a focus on assisting the types of workers and types of occupational-industrial areas noted above. Such projects could encompass the creation of industry-led consortia which can design or adapt training curricula in skill shortage occupational areas or in key regional businesses. This program will build on two Departmental demonstration programs announced in June 2000—the $9.2 million comprehensive incumbent/dislocated worker retraining demonstration and the $10.3 million demonstration program for training in high skill jobs to meet critical labor shortages.

Any organization capable of fulfilling the terms and conditions of this solicitation may apply. Applicants should note that, prior to any selection as a grantee, ETA will review its agency records to assess the applicant organization's overall record in administering federal funds as provided in 20 CFR 667.170. Applicants also should know that this is a risk free federal program; therefore, all for profit organizations that apply will not be able to receive a fee if awarded a grant.

All participants who receive services in projects funded under this demonstration program must be either:

(a) Eligible dislocated workers as defined at Section 101(9) of the Workforce Investment Act. This section of the law may be viewed at http://usworkforce.org/asp/act.asp Proposed projects may target subgroups of the eligible population based on factors such as, but not limited to occupation, industry, nature of dislocation, and reason for unemployment; or

(b) Incumbent workers. These are currently-employed workers whose employers have determined that the workers require training in order to help keep their firms competitive and the subject workers employed, avert layoffs, upgrade workers' skills, increase wages earned by employees and/or keep workers' skills competitive. Such training would support further job retention and career development for improved economic self-sufficiency for employed workers, especially those most vulnerable to job loss, and increase the capability of the employing firm(s) to access and retain skilled workers.

Funds provided through this demonstration may be used only to provide services of the types described at Sections 134 (d)(2)(A-D)(J)(ii)(K), (d)(3)(C), (d)(4)(D), (e)(2), and (e)(3) of WIA. These encompass basic cores, more intensive, and training activities along with supportive services. The latter may be provided when they are necessary to enable an individual who is eligible for training, but cannot afford to pay for such supportive services, to participate in the training program. Supportive services are defined in Section 101(46) of WIA. (Use ETA's web site referenced above to view.)

Grant funds may be used to reimburse employers for extraordinary costs associated with on-the-job training of program participants, in accordance with the provisions of 20 CFR 663.710. In addition to those provisions, prospective applicants should be aware that grant funds may not be used for the following purposes:

(a) for training that an employer is in a position to provide and would have provided in the absence of the requested grant;

(b) to pay salaries for program participants; and

(c) for acquisition of production equipment.

Applicants may budget limited amounts of grant funds to work with technical experts or consultants to provide advice and develop more complete project plans after a grant award, however, the level of details in the project plan may affect the amount of funding provided.

Grant activities may include:

(a) development, testing and initial application of curricula focused on intensive, short-term training to get participants into productive, high demand employment as quickly as possible;

(b) working with employers to develop and apply worksite-based learning strategies that utilize cutting-edge technology and equipment;

(c) development of employer-based training programs that will take advantage of opportunities created by employers' needs for workers with new skills;

(d) development and initial application of contextual learning opportunities for participants to learn occupational theory in a classroom setting while applying that learning in an on-the-job setting;

(e) use of curriculum and skills training programs that are designed to impart learning to meet employer-specified or industry specific skill standards or certification requirements;

(f) convening of an Employer Advisory Board to identify skills gaps of job applicants and present workers which effect competitive production and to develop a strategy for retraining;

(g) innovative linkage and collaboration between employers and the local Workforce Investment Board (WIB) and/or One-Stop/Career Center system to ensure a steady supply of targeted workers.

The above are illustrative examples and are not intended to be an exhaustive listing of possible demonstration project designs or approaches which may achieve the purpose of this solicitation.

In order to maximize the use of public resources and avoid duplication of effort, applicants will coordinate the delivery of services under this demonstration with the delivery of services under other programs (public or private), available to all or part of the target group. Projects linking or collaborating with an existing WIA funded One-Stop/Career Center and/or local Workforce Investment Board located within a project area fulfill this requirement. The use of Pell Grants for eligible workers or the use of State training or education funds provided for dislocated workers or certain types of employers should also be addressed in the application. Where appropriate, partnerships should also include trade unions, manufacturing extension programs, economic development organizations, training institutions, and other local stakeholders. Any efforts proposed in isolation will not have the maximum impact on building capacity within that region or industry and are not likely to be funded.

Proposals must provide assurance that all participating firms which employ successful training completers have committed to pay wages to these completers at the wage level set by any collective bargaining agreement which covers positions to be filled by the project participants, or, if no such agreement exists, at a level at least equal to meeting the lower living standard income level as defined in Section 101(24) of WIA.

It is anticipated that $8.2 million will be available to fund these projects. DOL anticipates awarding 6 to 12 grants, with an estimated range of $200,000 to $3 million per grant, with no individual grant exceeding $3 million.

The period of performance shall be 24 months from the date of execution by the Government.

DOL may elect to exercise its option to extend these grants for an additional one (1) or two (2) years of operation, based on the availability of demonstration funding under the Workforce Investment Act, successful program operation, and the determination that a grantee's initial program findings could further inform the workforce development system through refinement of the present demonstration.

Applicants must submit four (4) copies of their proposal with original signatures. The proposal must consist of two (2) distinct parts, Part I and Part II. Part I of the proposal, the financial application, shall contain the Standard Form SF-424, “Application for Federal Assistance” (Appendix A) and the Budget Information Sheet (Appendix B). The Federal Domestic Assistance Catalog number is 17.246. Applicants shall indicate on the SF-424 the organization's IRS status, if applicable. According to the Lobbying Disclosure Act of 1995, section 18, an organization described in section 501(c)(4) of the Internal Revenue Code of 1986 which engages in lobbying activities shall not be eligible for the receipt of federal funds constituting an award, grant, or loan. The individual signing the SF-424 on behalf of the applicant must represent the responsible financial and administrative entity for a grant should that application result in an award.

The budget must include on separate pages detailed breakouts of each proposed budget line item found in the budget information sheet including detailed administrative costs. The Salaries line item shall be used to document the project staffing plan by providing a detailed listing of each staff position providing more than .05 FTE support to the project, by annual salary, number of months assigned to demonstration responsibilities, and FTE percentage to be charged to the grant. In addition, for the Contractual line item, each planned contract and the amount of the contract shall be listed. For each budget line item that includes funds or in-kind contributions from a source other than the requested grant funds, the source, the amount, and in-kind contributions, including any restrictions that may apply to these funds, shall be identified. Costs associated with the development of curriculum and other one-time costs should be noted separately in order for reviewers to identify costs associated with development and start-up as well as ongoing participant costs. In addition, the budget shall provide sufficient funds for four persons' trips to meetings in Washington, D.C. and other locations.

Part II, the technical proposal, shall demonstrate the offerors's capabilities in accordance with the Statement of Work in Part III of this solicitation. The technical proposal shall be limited to thirty (30) double-spaced, single-side, 8.5-inch x 11-inch pages with 1-inch margins. An Executive Summary not to exceed two pages must be included and will be counted within the 30 page limits. Attachments shall not exceed twenty (20) pages including the required Appendices A-D listed at the end of this SGA. Text type shall be 11 point or larger. No cost data or reference to price shall be included in the technical proposal.

Each technical proposal must follow the format outlined here. As noted in Part IV, each criterion on which proposals will be rated relates to specific sections of this Part against which the criterion will be applied. Failure to provide the information requested in the specific section prescribed in this Part will result in a reduced rating of the evaluation criterion(a) to which that section applies. For every section, A through F, the application should include: (1) Information that responds to the requirements in this Part; (2) information that indicates adherence to the provisions described in Parts I and II of this solicitation; and (3) other information the offerors believe will address the rating criteria identified in Part IV.

Information required under B and C below shall be provided separately for each labor market area where incumbent and dislocated workers will be served. To the extent that the project design differs for different geographic areas, information required under section D below shall be provided for each geographic area.

Describe the specific purpose or purposes of the proposed project.

Identify those skills/occupational/industrial shortage areas to be addressed by the project. Such areas must be one or more of those identified in Part I.B above. The identity and geographic locations of those firms which currently have these shortages and which will be targeted for assistance under this project must be provided. Corroborating evidence (footnote sources) also should be presented, based on local or regional data and information, of the current existence of the identified shortages in the given geographic area with respect to both job demand and the lack of qualified job applicants.

For each firm to be served, an authorizing letter should be included in the proposal's attachments indicating: (1) The skill area(s) of the firm's current shortage, (2) the duration of the shortage, (3) the magnitude of the shortage as reflected in the current and, if applicable, projected number of: (a) Unfilled job openings and/or (b) encumbered positions for which employees lack needed knowledge of the identified skill area, (4) plans for utilizing successful training completers, and (5) a commitment to adhere to the wage requirements for successful training completers as provided in Part II.D.

Identify the targeted workers who will receive the training and other services to be provided through this project. Indicate the number to be trained for each firm identified in section B above and whether they will be incumbent workers of the firm and/or recruited dislocated workers. For incumbent workers, discuss the types of positions these employees currently occupy, and, if training is voluntary, the availability of a sufficient number of workers. For dislocated workers, provide evidence that sufficient numbers of dislocated workers with appropriate backgrounds will be available for training and placement with participating firms. Describe the process to be used in documenting the incumbent or dislocated workers' status of the project participants consistent with the requirements in Part II.A.

Describe the strategy and service components to be applied in addressing the skill/occupational/ industrial shortages identified in section B above. (Note: the services to be provided must be consistent with the provisions of Part II.B.) Insert a brief chart of the sequencing of the services to be provided. Include in this discussion detail regarding the service components identified below and any additional components proposed:

• Recruitment/outreach—depending on which type(s) of workers will be assisted by this project, indicate how incumbent workers will be recruited within the participating firms and/or how dislocated workers in the local/regional area(s) served will be recruited. Briefly describe any recruitment materials to be developed.

• Training—its general content, duration, and methods of instruction. Indicate whether the curriculum to be used is ready for use, will need to be adapted from an existing version, or will be developed. If applicable, briefly discuss the development process to be utilized. Discuss the appropriateness of the curriculum in addressing the identified shortages in section B above with particular reference to any pertinent skill or industrial standards. Discuss the suitability of the training in regard to the backgrounds and experience of the targeted workers described in section C above.

• Supportive services—describe each and the circumstances under which they would be provided.

• Placement—describe the process to be used once training is completed for placing dislocated workers into the skill shortage jobs identified in participating firms and how a firm's incumbent workers will be placed in either new jobs or their new skills will be utilized in their existing positions.

• Post-placement services—if applicable, describe such services and the circumstances under which they would be provided.

With reference to the service components to be utilized, describe the coordination of services to be undertaken. This description must include the requirements referenced in Part II.C. In addition, if applicable, describe any parallel efforts by participating firms to address their skill shortages in conjunction with the training being provided.

Describe the performance goals to be met by this project, the justification of the goals set, and the performance measures to be used in assessing the attainment of those goals in regard to the following outcomes:

• The reduction of identified shortages in participating firms as a result of the training/services provided

• The effect of reduced shortages on one or more dimensions of the participating firms' performance, e.g., productivity, sales, profitability, on time deliveries

• The effect on participating workers including skill gains, utilization of the new skills learned, wages, wage gains, and job satisfaction.

Projects may also include other performance goals and measures for other outcomes as applicable.

Describe staffing for the project including the numbers and types of positions and associated full-time equivalents (FTE's), along with very brief (2-3 sentences) descriptions of duties. Include all positions for the project whether funded by federal grant funds or by other sources. This staffing description must be directly related to the proposal budget submitted in the financial application. Provide a project organizational chart identifying the positions and their relationships to each other. Include an explanation of this staffing in relation to the project's purpose, services, and performance goals.

Include, if applicable, a description of any industry-led consortium/Employer Advisory Board (existing or specially formed for this project) that will provide guidance to this project. Describe the consortium's role in this effort and its membership.

Describe the connection between this project and the local Workforce Investment Board(s) in the local areas in which the firms to be served are located with particular reference to: (1) The coordination of services to be provided worker participants (see Part II.C.) and (2) if applicable, the relationship of the industry-led consortium/Employer Advisory Board with the local WIB(s) in regard to strategy planning and policy efforts (see Part I.B.). Include as an attachment a letter(s) from the local WIB(s) indicating its commitments to working with this project, if funded.

A careful evaluation of applications will be made by a technical review panel who will evaluate the applications against the criteria listed in the SGA. The panel results will be advisory in nature and not binding on the Grant Officer. The Government may elect to award grants with or without discussions with the offerors. In situations without discussions, an award will be based on the offerors's signature on the Standard Form SF-424, which constitutes a binding offer. The Grant Officer will make final award decisions based upon what is most advantageous to the Federal Government in terms of technical quality, responsiveness to this solicitation (including goals of the Department to be accomplished by this solicitation), geographical balance, and other factors.

Panelists shall evaluate proposals for acceptability based upon overall responsiveness in accordance with the factors below.

Documentation is presented from those firms targeted for assistance attesting to their specific skill/occupational/industrial shortages in those shortage areas identified in the grant program purpose and the number of jobs affected. Sufficient corroborating information is provided demonstrating that the shortages identified by the firms also exist more generally in the local/ regional areas where the target firms are located. Credible information is presented to demonstrate that there are incumbent and dislocated workers who are available to participate in training in sufficient numbers and with appropriate backgrounds to alleviate the shortages identified in participating firms. (Relates to information requested in Part III, sections B and C.)

The services planned are appropriate, suitable, and responsive to: (1) The need for reducing the shortages identified through the successful recruitment, training, support, and placement of incumbent and dislocated workers and (2) the backgrounds and experience of those workers who are to be served. A high degree of coordination with other public and private programs will occur in order to maximize the use of other public services and resources and to avoid duplicative efforts. (Relates to information requested in Part III, section D.)

The justifications cited for the performance goals proposed show a clear and logical relationship between the goals and the solicitation's identified outcomes and any other outcomes proposed. The proposed performance measures to determine the extent to which the performance goals will be met are also appropriate for the task. (Relates to information requested in Part III, section E.)

The proposed staffing with regard to the number, types of positions, duties, associated full-time equivalents (FTE's), and staff relationships are clearly presented. The explanation provided of the staffing in regard to the project's purpose, services, and performance goals shows a clear, logical, and reasonable relationship. There is an explicit commitment by the local WIB(s) to participate in this project. (Relates to information requested in Part III, section F.)

The cost effectiveness of the project is reasonable and optimal as indicated by the relationship of proposed costs to the number of participants to be served, the range of services to be provided, and the planned performance goals. (Relates to information requested in Part II, section H (on the financial application) and Part III, sections C, D, and E.)

The Department shall be responsible for ensuring effective implementation of each competitive grant project in accordance with the Act, the Regulations, the provisions of this announcement and the negotiated grant agreement. Applicants should assume that at least one on-site project review will be conducted by Department staff, or their designees. This review will focus on the project's performance in meeting the grant's programmatic goals and participant outcomes, complying with the targeting requirements regarding participants who are served, expenditure of grant funds on allowable activities, collaboration with other organizations as required, and methods for assessment of the responsiveness and effectiveness of the services being provided. Grants may be subject to additional reviews at the discretion of the Department.

DOL will arrange for or provide technical assistance to grantees in establishing appropriate reporting and data collection methods and processes taking into account the applicant's project management plan. An effort will be made to accommodate and provide assistance to grantees to be able to complete all reporting electronically. Applicants selected as grantees will be required to provide the following reports:

1. Monthly progress reports, during initial start-up and implementation of the project, and Quarterly Progress Reports thereafter.

2. Standard Form 269, Financial Status Report Form, on a quarterly basis.

3. Final Project Report including an assessment of project performance. This report will be submitted in hard copy and on electronic disk utilizing a format and instructions to be provided by the Department. A draft of the final report is due to the Department 45 days prior to the termination of the grant.

DOL will arrange for or conduct an independent evaluation of the outcomes, impacts, and benefits of the demonstration projects. Grantees must agree to make available records on participants and employers as well as project financial and management data and to provide access to personnel, as specified by the evaluator(s) under the direction of the Department.

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 continuing information-collection requirements in accordance with the Paperwork Reduction Act of 1995 (PRA-95) (44 U.S.C. 3506(c)(2)(A)). This program ensures that information is in the desired format, reporting burden (time and costs) is minimal, collection instruments are clearly understood, and OSHA's estimate of the information burden is correct. The Occupational Safety and Health Act of 1970 (the “Act”) authorizes information collection by employers as necessary or appropriate for enforcement of the Act or for developing information regarding the causes and prevention of occupational injuries, illnesses, and accidents (29 U.S.C. 657).

The basic purpose of the information-collection requirements in the Standard is to provide employees with information necessary for them to determine that they are receiving the required protection from hazardous asbestos exposure. Asbestos exposure results in asbestosis, an emphysema-like condition; mesothelioma; and gastrointestinal cancer.

Several provisions of the Standard specify paperwork requirements, including: Implementing an exposure monitoring program that notifies employees of their exposure-monitoring results; establishing a written compliance program; and informing laundry personnel of the requirement to prevent release of airborne asbestos above the time-weighted average and excursion limit. Other provisions associated with paperwork requirements include: Maintaining records of information obtained concerning the presence, location, and quantity of asbestos-containing materials (ACMs) and/or presumed asbestos-containing materials (PACMs) in a building/facility; notifying housekeeping employees of the presence and location of ACMs and PACMs in areas they may contact during their work; posting warning signs demarcating regulated areas; posting signs in mechanical rooms/areas that employees may enter and that contain ACMs and PACMs, informing them of the identity and location of these materials and work practices that prevent disturbing the materials; and affixing warning labels to asbestos-containing products and to containers holding such products. Additional provisions that contain paperwork requirements include: Developing specific information and training programs for employees; using information, data, and analyses to demonstrate that PACM does not contain asbestos; providing medical surveillance for employees potentially exposed to ACMs and/or PACMs, including administering an employee medical questionnaire, providing information to the examining physician, and providing the physician's written opinion to the employee; maintaining exposure-monitoring records, objective data used for exposure determinations, and medical-surveillance; making specified records ( e.g., exposure-monitoring and medical-surveillance records) available to designated parties; and transferring exposure-monitoring and medical-surveillance records to the National Institute for Occupational Safety and Health on cessation of business.

These paperwork requirements permit employers, employees and their designated representatives, OSHA, and other specified parties to determine the effectiveness of an employer's asbestos-control program. Accordingly, the requirements ensure that employees exposed to asbestos receive all of the protection afforded by the Standard.

OSHA proposes to extend the Office of Management and Budget's (OMB) approval of the collection-of-information (paperwork) requirements contained in the Standard. The Agency will summarize the comments submitted in response to this notice, and will include this summary in its request to OMB to extend the approval of these information-collection requirements.

Type of Review: Extension of currently approved information-collection requirements.

Title: Asbestos in General Industry (29 CFR 1910.1001).

OMB Number: 1218-0133.

Affected Public: Business or other for-profit organizations; Federal, State, Local, or Tribal governments.

Number of Respondents: 233.

Frequency: On occasion.

Average Time per Response: Varies from 5 minutes to maintain records to 1.5 hours for employee training or medical evaluation.

Estimated Total Burden Hours: 35,523.

Estimated Cost (Operation and Maintenance): $1,625,143.

Charles N. Jeffress, Assistant Secretary of Labor for Occupational Safety and Health, directed the preparation of this notice. The authority for this notice is the Paperwork Reduction Act of 1995 (44 U.S.C. 3506) and Secretary of Labor's Order No. 3-2000 (65 FR 50017).

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 continuing information-collection requirements in accordance with the Paperwork Reduction Act of 1995 (PRA-95) (44 U.S.C. 3506(c)(2)(A)). This program ensures that information is in the desired format, reporting burden (time and costs) is minimal, collection instruments are clearly understood, and OSHA's estimate of the information burden is correct. The Occupational Safety and Health Act of 1970 (the “Act”) authorizes information collection by employers as necessary or appropriate for enforcement of the Act or for developing information regarding the causes and prevention of occupational injuries, illnesses, and accidents (29 U.S.C. 657).

The basic purpose of the information-collection requirements in the Standard is to provide employees with information necessary for them to determine that they are receiving the required protection from hazardous asbestos exposure. Asbestos exposure results in asbestosis, an emphysema-like condition; mesothelioma; and gastrointestinal cancer.

Several provisions of the Standard specify paperwork requirements, including: Implementing an exposure-monitoring program that informs employees of their exposure-monitoring results; and, at multi-employer worksites, notification of other onsite employers by employers establishing regulated areas of the type of work performed with asbestos-containing materials (ACMs) and/or presumed asbestos-containing materials (PACMs), the requirements that pertain to regulated areas, and the measures they can use to protect their employees from asbestos overexposure. Other provisions associated with paperwork requirements include: Evaluating and certifying alternative control methods for Class I and Class II asbestos work and, for Class I asbestos work, a requirement to send a copy of the evaluation and certification to the OSHA national office;  1 informing laundry personnel of the requirement to prevent release of airborne asbestos above the time-weighted average and excursion limit; notification by employers and building/facility owners of designated personnel and employees regarding the presence, location, and quantity of ACMs and/or PACMs; using information, data, and analyses to demonstrate that PACM does not contain asbestos; posting signs in mechanical rooms/areas that employees may enter and that contain ACMs and PACMs, informing them of the identity and location of these materials and work practices that prevent disturbing the materials; posting warning signs demarcating regulated areas; and affixing warning labels to asbestos-containing products and to containers holding such products. Additional provisions of the Standard that contain paperwork requirements include: Developing specific information and training programs for employees; providing medical surveillance for employees potentially exposed to ACMs and/or PACMs, including administering an employee medical questionnaire, providing information to the examining physician, and providing the physician's written opinion to the employee; maintaining records of objective data used for exposure determinations, employee exposure-monitoring and medical-surveillance records, training records, the record ( i.e., information, data, and analyses) used to demonstrate that PACM does not contain asbestos, and notifications made and received by building/facility owners regarding the content of ACMs and PACMs; making specified records ( e.g., exposure-monitoring and medical-surveillance records) available to designated parties; and transferring exposure-monitoring and medical-surveillance records to the National Institute for Occupational Safety and Health on cessation of business.

These paperwork requirements permit employers, employees and their designated representatives, OSHA, and other specified parties to determine the effectiveness of an employer's asbestos-control program. Accordingly, the requirements ensure that employees exposed to asbestos receive all of the protection afforded by the Standard.

OSHA proposes to extend the Office of Management and Budget's (OMB) approval of the collection-of-information (paperwork) requirements contained in the Standard. The Agency will summarize the comments submitted in response to this notice, and will include this summary in its request to OMB to extend the approval of these information-collection requirements.

Type of Review: Extension of currently approved information-collection requirements.

Title: Asbestos in Shipyards (29 CFR 1915.1001).

OMB Number: 1218-0195.

Affected Public: Business or other for-profit organizations; Federal, State, Local, or Tribal governments.

Number of Respondents: 89.

Frequency: On occasion.

Average Time per Response: Varies from 5 minutes to maintain records to 17.3 hours for training a competent person.

Estimated Total Burden Hours: 1,484.

Estimated Cost (Operation and Maintenance): $36,497.

Charles N. Jeffress, Assistant Secretary of Labor for Occupational Safety and Health, directed the preparation of this notice. The authority for this notice is the Paperwork Reduction Act of 1995 (44 U.S.C. 3506) and Secretary of Labor's Order No. 3-2000 (65 FR 50017).

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 continuing information-collection requirements in accordance with the Paperwork Reduction Act of 1995 (PRA-95) (44 U.S.C. 3506(c)(2)(A)). This program ensures that information is in the desired format, reporting burden (time and costs) is minimal, collection instruments are clearly understood, and OSHA's estimate of the information burden is correct. The Occupational Safety and Health Act of 1970 (the “Act”) authorizes information collection by employers as necessary or appropriate for enforcement of the Act or for developing information regarding the causes and prevention of occupational injuries, illnesses, and accidents (29 U.S.C. 657).

The basic purpose of the information-collection requirements in the Standard is to provide employees with information necessary for them to determine that they are receiving the required protection from hazardous asbestos exposure. Asbestos exposure results in asbestosis, an emphysema-like condition; mesothelioma; and gastrointestinal cancer.

Several provisions of the Standard specify paperwork requirements, including: Implementing an exposure-monitoring program that informs employees of their exposure-monitoring results; and, at multi-employer worksites, notification of other onsite employers by employers establishing regulated areas of the type of work performed with asbestos-containing materials (ACMs) and/or presumed asbestos-containing materials (PACMs), the requirements that pertain to regulated areas, and the measures they can use to protect their employees from asbestos overexposure. Other provisions associated with paperwork requirements include: Evaluating and certifying alternative control methods for Class I and Class II asbestos work and, for Class I asbestos work, a requirement to send a copy of the evaluation and certification to the OSHA national office;  1 informing laundry personnel of the requirement to prevent release of airborne asbestos above the time-weighted average and excursion limit; notification by employers and building/facility owners of designated personnel and employees regarding the presence, location, and quantity of ACMs and/or PACMs; using information, data, and analyses to demonstrate that PACM does not contain asbestos; posting signs in mechanical rooms/areas that employees may enter and that contain ACMs and PACMs, informing them of the identity and location of these materials and work practices that prevent disturbing the materials; posting warning signs demarcating regulated areas; and affixing warning labels to asbestos-containing products and to containers holding such products. Additional provisions of the Standard that contain paperwork requirements include: Developing specific information and training programs for employees; providing medical surveillance for employees potentially exposed to ACMs and/or PACMs, including administering an employee medical questionnaire, providing information to the examining physician, and providing the physician's written opinion to the employee; maintaining records of objective data used for exposure determinations, employee exposure-monitoring and medical-surveillance records, training records, the record ( i.e., information, data, and analyses) used to demonstrate that PACM does not contain asbestos, and notifications made and received by building/facility owners regarding the content of ACMs and PACMs; making specified records ( e.g., exposure-monitoring and medical-surveillance records) available to designated parties; and transferring exposure-monitoring and medical-surveillance records to the National Institute for Occupational Safety and Health on cessation of business.

These paperwork requirements permit employers, employees and their designated representatives, OSHA, and other specified parties to determine the effectiveness of an employer's asbestos-control program. Accordingly, the requirements ensure that employees exposed to asbestos receive all of the protection afforded by the Standard.

OSHA proposes to extend the Office of Management and Budget's (OMB) approval of the collection-of-information (paperwork) requirements contained in the Standard. The Agency will summarize the comments submitted in response to this notice, and will include this summary in its request to OMB to extend the approval of these information-collection requirements.

Type of Review: Extension of currently approved information-collection requirements.

Title: Asbestos in Construction (29 CFR 1926.1101).

OMB Number: 1218-0134.

Affected Public: Business or other for-profit organizations; Federal, State, Local, or Tribal governments.

Number of Respondents: 286,821.

Frequency: On occasion.

Average Time per Response: Varies from 5 minutes to maintain records to 17.3 hours for training a competent person.

Estimated Total Burden Hours: 5,817,388.

Estimated Cost (Operation and Maintenance): $42,774,491.

Charles N. Jeffress, Assistant Secretary of Labor for Occupational Safety and Health, directed the preparation of this notice. The authority for this notice is the Paperwork Reduction Act of 1995 (44 U.S.C. 3506) and Secretary of Labor's Order No 3-2000 (65 FR 50017).