Agenda items to be covered include: (1) Review and approve the May 14, 2002 meeting notes; (2) Discuss new business of the RAC if applicable; (3) Discuss the status of the 2001 projects' funds; (4) Discuss the Board of Supervisors meeting of June 4th; (5) Consideration of Title II Project proposals from the public and/or the RAC members; (6) Determine the date and location of the next meeting; (7) Public comment. The meeting is open to the public. Public input opportunity will be provided and individuals will have the opportunity to address the Committee at that time.

Agenda items for the meeting include: (1) Review applicable sections of the Secure Rural Schools and Community Self-Determination Act of 2000, regarding project recommendations; (2) Discuss & approve project selection process, (3) Discuss & select projects to recommend to the Forest Supervisor for funding; (4) Discuss & confirm logistics for forwarding recommended projects to Forest Supervisor (FS) and to project proponents following FS approval; and (5) Future meeting schedule/logistics/agenda.

The meeting is open to the public and individuals may address the Committee after being recognized by the Chair.

Background

The Department has received timely requests, in accordance with 19 CFR 351.213(b)(2001), for administrative reviews of various antidumping and countervailing duty orders and findings with April anniversary dates. The Department also received a timely request to revoke in part the antidumping duty order on Certain Steel Concrete Reinforcing Bars from Turkey.

Initiation of Reviews: In accordance with section 19 CFR 351.221(c)(1)(i), we are initiating administrative reviews of the following antidumping and countervailing duty orders and findings. We intend to issue the final results of these reviews not later than April 30, 2003.

Unless otherwise indicated, all citations to the Tariff Act of 1930, as amended (“Act”), are references to the provisions effective January 1, 1995, the effective date of the amendments made to the Act by the Uruguay Round Agreements Act. In addition, unless otherwise indicated, all citations to the Department's regulations are to the regulations at 19 C.F.R. part 351 (2001).

On April 2, 2002, the Department published its final determinations in the antidumping duty investigations of silicomanganese from Kazakhstan, India, and Venezuela. See Notice of Final Determination of Sales at Less than Fair Value and Final Negative Critical Circumstances Determination: Silicomanganese from India , 67 FR 15531 (April 2, 2002); Notice of Final Determination of Sales at Less than Fair Value: Silicomanganese from Kazakhstan , 67 FR 15535 (April 2, 2002); and Notice of Final Determination of Sales at Less than Fair Value: Silicomanganese from Venezuela , 67 FR 15533 (April 2, 2002).

On May 16, 2002, the International Trade Commission (“ITC”) notified the Department of its final determination pursuant to section 735(b)(1)(A)(i) of the Act that an industry in the United States is materially injured by reason of less-than-fair-value imports of subject merchandise from India, Kazakhstan, and Venezuela.

For purposes of these orders, the products covered are all forms, sizes and compositions of silicomanganese, except low-carbon silicomanganese, including silicomanganese briquettes, fines and slag. Silicomanganese is a ferroalloy composed principally of manganese, silicon and iron, and normally contains much smaller proportions of minor elements, such as carbon, phosphorous and sulfur. Silicomanganese is sometimes referred to as ferrosilicon manganese. Silicomanganese is used primarily in steel production as a source of both silicon and manganese. Silicomanganese generally contains by weight not less than 4 percent iron, more than 30 percent manganese, more than 8 percent silicon and not more than 3 percent phosphorous. Silicomanganese is properly classifiable under subheading 7202.30.0000 of the Harmonized Tariff Schedule of the United States (HTSUS). Some silicomanganese may also be classified under HTSUS subheading 7202.99.5040. This scope covers all silicomanganese, regardless of its tariff classification. Although the HTSUS subheadings are provided for convenience and U.S. Customs Service (Customs) purposes, our written description of the scope remains dispositive.

The low-carbon silicomanganese excluded from this scope is a ferroalloy with the following chemical specifications: minimum 55 percent manganese, minimum 27 percent silicon, minimum 4 percent iron, maximum 0.10 percent phosphorus, maximum 0.10 percent carbon and maximum 0.05 percent sulfur. Low-carbon silicomanganese is used in the manufacture of stainless steel and special carbon steel grades, such as motor lamination grade steel, requiring a very low carbon content. It is sometimes referred to as ferromanganese-silicon. Low-carbon silicomanganese is classifiable under HTSUS subheading 7202.99.5040.

On April 8, 2002, we received a submission from Eramet Marietta Inc. (Eramet) and the Paper, Allied-Industrial, Chemical and Energy Workers International Union, Local 5-0639 (collectively, petitioners) alleging two ministerial errors in the final determination calculations in the investigation of imports from India. The allegations concerned the Department's calculations for one respondent, Universal Ferro and Allied Chemicals, Ltd (Universal). See Analysis for Universal Ferro & Allied Chemicals, Ltd. (Universal) for the Final Determination in the Investigation of Silicomanganese from India for the Period April 1, 2000 Through March 31, 2001 , ( India Final Analysis ) (March 25, 2002). The allegations were timely filed pursuant to section 351.224(c)(2) of the Department's regulations. On April 16, 2002, we received a rebuttal submission from Universal. These two allegations are addressed below.

We did not receive any timely submissions alleging ministerial errors in the India investigation with respect to the other respondent, Nava Bharat. See Memorandum on Disclosure of Final Determination Documents in the Antidumping Investigation of Silicomanganese from India: Nava Bharat Ferro Alloys, Ltd. (Nava Bharat) , from Javier Barrientos, through Sally C. Gannon, to the File (April 26, 2002). No ministerial allegations were received concerning the final determinations for Kazakhstan or Venezuela.

Petitioners contend that the Department made a ministerial error in calculating the cost of slag included in Universal's total cost of manufacture (COM). Petitioners argue that the Department claimed that, for the final calculations, it was assuming that all slag was used for non-conversion products. See India Final Analysis , at 3 (“For these final calculations we are assuming that all slag was used for non-conversion products.”). Petitioners argue that the Department's calculation of the amount of slag costs to be included in COM is inconsistent with its statement that all slag costs were presumed to be consumed in the production of non-conversion silicomanganese. Specifically, petitioners maintain that the Department allocated only a portion of the total cost of slag to non-conversion silicomanganese. As per the Department's stated presumption that all slag was used for non-conversion products, petitioners claim that no allocation between conversion and non-conversion products was necessary.

Accordingly, petitioners request that the Department amend its final calculations to include all slag costs in Universal's COM.

In regard to the above allegation, the respondent maintains that petitioners selectively extracted parts of the Department's India Final Analysis to substantiate their ministerial error claim regarding the calculation of slag costs. Specifically, the respondent argues that the petitioners disregarded Department references in which the Department explicitly stated its intention to use a ratio of silicomanganese production in order to allocate slag costs. See India Final Analysis , at 2 (“We then multiplied this amount by the ratio of silicomanganese production quantity ... to total production quantity ... to derive an amount attributable to subject merchandise.”) Thus, according to the respondent, the Department's calculation method was intentional, and, therefore, there is no ministerial error.

According to the respondent, these statements by the Department regarding the use of an allocation ratio are contradicted by other statements made by the Department presuming that all slag was used for non-conversion products. According to the respondent, the Department only made this assumption as a result of its inability to locate the amount of slag used in the conversion products in Exhibit 5 of the verification exhibits. The respondent contends that it could have directed the Department to the subject information, if asked. Under these conditions, the respondent contends that there is no ministerial error, and that the Department would likely end up “confessing error before the Court of International Trade and seeking a remand.”

We agree with petitioners that the Department's objective was to assume slag was used only for non-conversion silicomanganese products. We made this assumption in applying adverse facts available, given our conclusion that the respondent had not provided the proper information. However, as the respondent has verified information on the record confirming its use of slag in conversion products (Verification Exhibit 5), the application of adverse facts available is no longer warranted. Therefore, the existing allocation of slag costs used in our calculations, which is between non-conversion and conversion silicomanganese products, is correct and no correction to the final determination calculations in this regard is necessary.

Petitioners argue that the Department committed a ministerial error in its calculation of the ratio used to calculate the interest expense component of Universal's cost of production (COP). According to petitioners, based on the data in the India Final Analysis , the Department incorrectly calculated the revised interest expense ratio. As a result, they state that the Department should amend its final calculations to incorporate the correct interest expense ratio in the calculation of Universal's total COP. Respondent did not comment on this allegation.

The Department agrees with petitioners in that, based on the data in the India Final Analysis , the ratio used to calculate the interest expense component of Universal's COP was calculated inaccurately as a result of an arithmetic error. The Department is revising its final calculations to incorporate the correct interest expense ratio in Universal's total COP for this amended final determination. See Analysis for Universal Ferro & Allied Chemicals, Ltd. (Universal) for the Amended Final Determination in the Investigation of Silicomanganese from India for the Period April 1, 2000 Through March 31, 2001 (May 17, 2002). As a result of this modification to the interest expense ratio, the margin for Universal has changed along with the “all others” rate, which was based on the average of the rates for Nava Bharat and Universal. Universal's margin has increased from 20.42 percent to 20.53 percent, and the “all others” rate has increased from 17.69 percent to 17.74 percent.

In accordance with section 736(a)(1) of the Act, the Department will direct the Customs Service to assess, upon further advice by the Department, antidumping duties equal to the amount by which the normal value of the merchandise exceeds the export price or constructed export price of the merchandise for all relevant entries of silicomanganese from India, Kazakhstan, and Venezuela. The antidumping duties will be assessed on all unliquidated entries of silicomanganese from India, Kazakhstan, and Venezuela entered, or withdrawn from warehouse, for consumption on or after November 9, 2001, the date on which the Department published its notices of preliminary determination in the Federal Register. Customs must require, at the same time as importers would normally deposit estimated duties on this merchandise, a cash deposit equal to the estimated weighted-average antidumping duty margins as noted below. The “all others” and “Kazakhstan-wide” rates apply to all exporters of subject merchandise not specifically listed. The weighted-average dumping margins are as follows:

This notice constitutes the antidumping duty orders with respect to silicomanganese from India, Kazakhstan, and Venezuela, pursuant to section 736(a) of the Act. Interested parties may contact the Department's Central Records Unit, Room B-099 of the Main Commerce Building, for copies of an updated list of antidumping duty orders currently in effect.

These orders are published in accordance with section 736(a) of Act and 19 C.F.R. 351.211.

Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq. ) direct the Secretary of Commerce to allow, upon request, the incidental, but not intentional taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are issued or, if the taking is limited to harassment, notice of a proposed authorization is provided to the public for review.

Permission for incidental takings may be granted if NMFS finds that the taking will have no more than a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses and that the permissible methods of taking and requirements pertaining to the monitoring and reporting of such taking are set forth.

NMFS has defined “negligible impact” in 50 CFR 216.103 as “an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.”

Subsection 101(a)(5)(D) of the MMPA established an expedited process by which citizens of the United States can apply for an authorization to incidentally take small numbers of marine mammals by harassment. The MMPA defines “harassment” as:

Subsection 101(a)(5)(D) establishes a 45-day time limit for NMFS review of an application followed by a 30-day public notice and comment period on any proposed authorizations for the incidental harassment of small numbers of marine mammals. Within 45 days of the close of the comment period, NMFS must either issue or deny issuance of the authorization.

On January 28, 2001, NMFS received an application from the 30 th Space Wing on behalf of Boeing requesting an authorization for the harassment of small numbers of Pacific harbor seals, and other marine mammal species, incidental to harbor activities related to the Delta IV/EELV, including: wharf modification, transport vessel operations, cargo movement activities, and harbor maintenance dredging. The harbor where activities will take place is on south VAFB approximately 4 kilometers (km) (2.5 miles, mi) south of Point Arguello, CA, and approximately 1.6 km (1 mi) north of the nearest marine mammal pupping site (i.e., Rocky Point).

Modifications to the existing wharf are needed to accommodate the specially designed transport vessel, the Delta Mariner, that will be used for delivering the Delta IV/EELV's common booster core (CBC). These modifications involve removing portions of the wharf surface, re-surfacing the wharf with concrete and stainless steel rub-rails, and construction of a ramp on the seaward portion of the wharf. Equipment to be used includes: a skip-loader, concrete saw, concrete ready-mix truck, and dump truck. Measured noise levels of equivalent heavy equipment ranged from 61 dB A-weighted (quietest measurement from clamshell dredge measurement) to 81 dB A-weighted (loudest measurement from roll-off truck transporter) at a distance of 76.2 meters (m) (250 feet, ft). (Acentech, 1998). These wharf modifications will take approximately 6 weeks.

Delta Mariner CBC off-loading operations and associated cargo movement activities will occur a maximum of 6 times per year, with the first Mariner visit scheduled for spring of 2002 and the first off-load operation for August 2002. The Delta Mariner is a 95.1 m (312 ft) long, 25.6 m (84 ft) wide steel hull ocean-going vessel capable of operating at a 2.4 m (8 ft) draft. For the first few visits to the south VAFB harbor, tug boats will accompany the Mariner. Sources of noise from the Delta Mariner vessel include ventilating propellers used for maneuvering into position and the cargo bay door when it becomes disengaged. Removal of the CBC from the Mariner requires use of an Elevating Platform Transporter (EPT). The EPT is an additional source of noise, with sound levels measured at a maximum of 82 dB A-weighted 6.1 m (20 ft) from the engine exhaust (Acentech, 1998). EPT operation procedures require 2 short (approximately 1/3 seconds) beeps of the horn prior to starting the ignition. At 60.9 m (200 ft) away, the sound level of the EPT horn ranged from 62-70 dB A-weighted. Containers containing flight hardware items will be towed off the Mariner by a tractor tug that generates a sound level of approximately 87 dB A-weighted at 15.2 m (50 ft) while in operational mode. Total time of Mariner docking and cargo movement activities is estimated at between 14 and 18 hours in good weather.

To accommodate the Delta Mariner, the harbor will need to be dredged to a working depth of approximately 3.0 m (10 ft) mean lower low water level plus a 0.61 m (2 ft) over-dredge. Dredging of the harbor will involve the use of heavy equipment, including a clamshell dredge, dredging crane, a small tug, dredging barge, dump trucks, and a skip loader. Measured sound levels from this equipment are roughly equivalent to those estimated for the wharf modification equipment: 61-81 dB A-weighted at 76.2 m (250 ft). Dredge operations, from set-up to tear-down, would continue 24-hours a day for 3-5 weeks. The frequency of maintenance dredging will be based on fill rate surveys conducted periodically during the first year following the initial dredge to determine the sedimentation rate. Boeing expects maintenance dredging would likely be required every 2-3 years.

A more detailed description of the work proposed for 2002 is contained in the application which is available upon request (see ADDRESSES) and in the Final US Air Force Environmental Assessment for Harbor Activities Associated with the Delta IV Program at Vandenberg Air Force Base (ENSRI, 2001).

On March 4, 2002 (67 FR 9702), NMFS published a notice of receipt and a 30-day public comment period was provided on the application and proposed authorization. Comments were received from the Marine Mammal Commission (MMC), Boeing, The Otter Project, and two private citizens. NMFS has not addressed in this document those comments and/or information that are contained in, and not in disagreement with, statements made in either the Boeing application or the notice of proposed authorization (67 FR 9702, March 4, 2002).

Comment 1 : Has any work actually begun on this application (meaning physical work at the harbor) without NMFS benefit of public comment?

Response : None of the actions covered in the permit application have begun.

Comment 2 : Why hasn’t the noise from the jackhammer been included in Boeing's application?

Response : Boeing's application includes an initial list of equipment required for the wharf modification that was requested from the construction contractor. A jackhammer was not listed on this initial list. The contractor has since informed Boeing that a jackhammer will be required for approximately a week. National Institute for Occupational Safety and Health (NIOSH) data shows that a jackhammer will generate between 102-111 dB measured at the operator’s ear.

Comment 3 : Where was the EPT noise level of 85 dB measured from? What is the noise level when the EPT engine is under a load condition? Is the EPT engine diesel, gasoline, or powered by some other source?

On August 31, 2001, notice was published in the Federal Register (66 FR 45971) that a request for a scientific research permit to take species listed above had been submitted by the above-named individual. The requested permit has been issued under the authority of the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq. ), the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR parts 222-226).

The Holder was issued five-year permit to maintain captively bred white abalone for scientific research and enhancement at the CIMRI Hatchery. Research Activities include feeding studies, propagation studies and studies identified as goals for the long term recovery of the white abalone. The action only covers the propagation of animals collected before June 28, 2001.

Issuance of this permit, as required by the ESA, was based on a finding that such permit (1) was applied for in good faith, (2) will not operate to the disadvantage of the endangered species which is the subject of this permit, and (3) is consistent with the purposes and policies set forth in section 2 of the ESA.

NTIA serves as the principal adviser to the President on telecommunications policies as they pertain to the Nation's technological and economic advancement. NTIA is the primary Executive Branch agency responsible for developing and articulating domestic and international telecommunications policies. NTIA also manages use of the radio frequency spectrum by all federal agencies. PSWN is a jointly sponsored initiative which is comprised of the Department of Justice and Department of the Treasury to specifically addresses public safety wireless communications interoperability. Federal, State and local government agencies are working to improve their ability to share information and to use current and emerging technology to ensure that they are better prepared for emergency response, regardless of the type of incident. Furthermore, government leaders are being challenged to better understand their current security and emergency response capabilities and, to implement services and technologies to improve emergency response, ensuring citizen safety during a time of increased national threat.

The Interoperability Summit will provide the platform for attendees to share information addressing current and emerging technology solutions, implementation, lessons learned, and current funding activities. The information will focus on technical solutions, but will be presented in an easy to understand format for attendees. Manufacturers of land mobile radio equipment and commercial providers of other wireless communications technologies will also have an opportunity to brief attendees of their interoperability products, the status of their research and development activities, and compliance with published standards. A Federal Business Opportunities Notice will be published and vendors will be accepted on a first-come, first-served basis. Vendors desiring to send a representative to participate in the presentations and/or the tabletop exhibits should review the Federal Business Opportunities Notice or make their request via electronic mail (preferred), by fax, or in writing to: Mrs. Carole Kirsch, PSWN Program, P.O. Box 3926, Fairfax, VA 22038, (electronic mail: <cakirsch@earthlink.net> , telephone: (703) 279-2006, facsimile: (703) 279-2032).

The audio of the Interoperability Summit will be webcast over the Internet and made available from NTIA's webpage ( <http://www.ntia.doc.gov> ) during the two-day event.

These meetings will be open to the public and will be physically accessible to people with disabilities. Any member of the public wishing to attend and requiring special services, such as sign language interpretation or other ancillary aids, should contact Derrick Owens or Richard Orsulak at least three (3) days prior to the meeting via the contact information provided above. All persons entering the Ronald Reagan International Trade Center must go through the security screening, therefore, please have photo identification available and/or a U.S. Government building pass, if applicable.

Research has shown that what principals do on a daily basis makes a difference in how well students learn. Principals influence teaching and classroom practice through such activities as formulating school goals, setting and communicating high achievement expectations, organizing resources for instruction, supervising and evaluating teachers' performance, and monitoring student progress. The primary responsibility of the principal is to create an environment that will enable all students to achieve.

It is clear that strong leadership is essential for effective school reform. However, fewer and fewer eligible candidates appear willing to accept the role of school administrator. Two hundred superintendents surveyed by Education Research Service in 1998 reported difficulties filling principal vacancies in their districts. The challenge does not rest with recruiting and training future principals. Attention must also focus on providing professional development to current administrators who, according to a 1997 report by the National Center for Education Statistics, are on average 48 years old and nearly a decade past their original training.

In this regard, section 2151(b) of Title II, Part A of the Elementary and Secondary Education Act (ESEA), as amended by the No Child Left Behind Act of 2001, authorizes a new competitive grant program to assist high-need LEAs in recruiting, training and retaining principals (including assistant principals). The School Leadership program will fund applicants that effectively address the competitive priority and selection criteria while demonstrating to the satisfaction of reviewers that receipt of a grant award will enable them to do one or both of the following:

(1) Hire, train, and mentor highly qualified individuals to become principals (and assistant principals) in high-need schools.

(2) Provide current principals (and assistant principals) who serve in high-need school districts with sustained professional development that is standards-focused and job-embedded.

It is the Secretary's practice, in accordance with the Administrative Procedure Act (5 U.S.C. 553), to offer interested parties the opportunity to comment on proposed rules, including competitive preferences. Section 437(d)(1) of the General Education Provisions Act (GEPA), however, allows the Secretary to exempt from rulemaking requirements rules governing the first grant competition under a new or substantially revised program authority (20 U.S.C. 1232(d)(1)). The Secretary, in accordance with section 437(d)(1) of GEPA, has decided to forego public comment in order to ensure timely grant awards. These requirements will apply to the FY 2002 grant competition only.

Selection Criteria. The Secretary uses the following criteria to evaluate an application. The maximum score for each criterion is indicated in parenthesis.

(a) Need for project. (15 points)

In determining the need for the proposed project, the Secretary considers:

(i) The magnitude of the need for recruiting and training highly qualified principals by the proposed project.

(ii) The extent to which the proposed project will prepare personnel to be highly qualified principals in which shortages have been demonstrated.

(b) Quality of project design. (25 points)

In determining the quality of project design of the proposed project, the Secretary considers:

(i) The extent to which the goals, objectives, and outcomes to be achieved by the proposed project are clearly specified and measurable.

(ii) The extent to which the design of the proposed project is appropriate to, and will successfully address the need to improve student achievement through effective school leadership.

(iii) The extent to which the proposed activities constitute a coherent, sustained program of training for principals in instructional leadership, community leadership, and systems management.

(iv) The extent to which the proposed project is designed to build capacity and yield results that will extend beyond the period of Federal financial assistance.

(c) Quality of project services. (25 points)

In determining the quality of the services to be provided by the proposed project, the Secretary considers the quality and sufficiency of strategies for ensuring equal access and treatment for eligible project participants who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability.

In addition, the Secretary considers:

(i) The extent to which the services to be provided by the proposed project are appropriate to the needs of the principal candidates or current principals to be served or both.

(ii) The extent to which the training or professional development services to be provided by the proposed project are of sufficient quality, intensity, and duration to lead to improvements in school leadership.

(iii) The extent to which the services to be provided by the proposed project involve the collaboration of appropriate partners for maximizing the effectiveness of project services.

(iv) The extent to which the services to be provided by the proposed project are focused on high-need schools.

(d) Quality of project personnel. (10 points)

In determining the quality of project personnel, the Secretary considers the extent to which the applicant encourages applications for employment from persons who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability.

In addition, the Secretary considers:

(i) The qualifications, including relevant training and experience, of the project director or principal investigator.

(ii) The qualifications, including relevant training and experience, of key project personnel.

(e) Adequacy of resources. (5 points) In determining the adequacy of resources for the proposed project, the Secretary considers the following:

(i) The adequacy of support, including facilities, equipment, supplies, and other resources, from the applicant organization or the lead applicant organization.

(ii) The extent to which the costs are reasonable in relation to the number of persons to be served and to the anticipated results and benefits.

(f) Quality of the management plan. (10 points)

In determining the quality of the management plan for the proposed project, the Secretary considers:

(i) The adequacy of the management plan to achieve the objectives of the proposed project on time and within budget, including clearly defined responsibilities, timelines, and milestones for accomplishing project tasks.

(ii) The adequacy of procedures for ensuring feedback and continuous improvement in the operation of the proposed project.

(iii) The extent to which the time commitments of the project director and principal investigator and other key project personnel are appropriate and adequate to meet the objectives of the proposed project.

(g) Quality of the project evaluation. (10 points) In determining the quality of the evaluation, the Secretary considers:

(i) The extent to which the methods of evaluation are thorough, feasible, and appropriate to the goals, objectives, and outcomes of the proposed project.

(ii) The extent to which the methods of evaluation include the use of objective performance measures that are clearly related to the intended outcomes of the project and will produce quantitative and qualitative data to the extent possible.

(iii) The extent to which the evaluation will provide guidance about effective strategies suitable for replication or testing in other settings.

Competitive Preference. Under 34 CFR 75.105(c)(2)(i) we award up to an additional 10 points to an application, depending on how well the application meets this competitive preference. The priority points are in addition to any points an application earns under the selection criteria for the program.

To promote sustained gains in student achievement, principals today need to be strong leaders and managers. Principals must effectively serve as leaders of the instructional school staff; leaders of the school, family, and business communities; and managers of the human, financial, and material resources of the school. In addition, the very purpose of this program is to help those schools and LEAs most in need of improved school leadership.

Therefore, a competitive preference is awarded to applications whose projects would both—

(1) Provide comprehensive and sustained training or professional development to current or prospective principals or assistant principals in each of the following three key areas: Instructional leadership, community leadership, and systems management; and,

(2) Support a district-wide effort to improve the academic achievement of students attending schools that are most in need of strong school leaders. For purposes of this program, schools most in need of strong leaders are “high-need schools” as defined in section 2312(3) of the ESEA, i.e., a school that—

(A) Is either located in an area in which the percentage of students from families with incomes below the poverty line is 30 percent or more; or

(B)(i) Is located in an area with a high percentage of out-of-field teachers, as defined in section 2102 of the ESEA;

(ii) Is within the top quartile of elementary schools and secondary schools statewide, as ranked by the number of unfilled, available teacher positions at the school;

(iii) Is located in an area in which there is a high teacher turnover rate; or

(iv) Is located in an area in which there is a high percentage of teachers who are not certified or licensed. Eligibility. An eligible application must propose a project directly benefits one or more named “high-need LEA(s)”. If the applicant is not the LEA(s), the application must contain a letter of support from the LEA(s). As this term is defined in section 2102 (3) of the ESEA, a high-need LEA is an LEA—

1. (a) That serves not fewer than 10,000 children from families with incomes below the poverty line, or (b) for which not less than 20 percent of the children in the area served by the LEA are from families with incomes below the poverty line; and

2. For which there is (a) a high percentage of teachers not teaching in the academic subjects or grade levels the teachers were trained to teach, or (b) a high percentage of teachers with emergency, provisional, or temporary certification or licensing.

Applicants will need to include information in their applications that demonstrates that they, or the LEA(s) with which they will work, meet this definition.

The uniform provisions in Title IX, Part E of the ESEA apply to this program. Among other things, this means that an LEA receiving financial assistance under the School Leadership Program must, after timely and meaningful consultation with private school officials, provide to private school staff professional development that is equitable to professional development provided with program funds to public school principals and assistant principals (or other public school staff whom the project serves). See section 9501 of the ESEA.

The success of the School Leadership Program will depend upon how well grantees produce highly qualified principals and assistant principals who will work and stay in high-need schools. If the program is to achieve its purposes, we need to ensure that the $10 million appropriation is used as effectively as possible. To do so, it is necessary to place a reasonable limitation on the amount of program funds that grant recipients may use to reimburse themselves for the “indirect costs” of program activities. Therefore, the Secretary has decided to establish a reasonable limit of eight percent on the indirect cost rate that all program recipients may charge to funds provided under this program.

The School Leadership Program does not fund activities that are strictly “educational training projects” within the meaning of section 75.562 of EDGAR, to which this eight-percent limitation already expressly applies. However, for reasons we have provided in a limited number of other competitive grant programs that focus on improving teacher quality or helping students in high-need schools achieve academically, we believe that a similar limitation on a recipient's indirect costs is necessary here to ensure that program funds are used to secure the school leaders that Congress had intended. See, e.g., (1) the analysis of EDGAR for proposed 34 CFR 611.61 that governs the Teacher Quality Enhancement Grant programs, authorized by Title II, Part A of the Higher Education Act (65 FR 6936, 6940 (February 11, 2000)); and (2) requirements for the FY 2001 grants competition under the Transition to Teaching program authorized in the FY 2001 Department of Education Appropriations Act, Pub. L. 106-554 (66 FR 19673, 19676-77(April 16, 2002)).

For Applications Contact: Education Publications Center (ED Pubs), PO Box 1398, Jessup, MD 20794-1398. Telephone (toll free): 1-877-433-7827. FAX: (301) 470-1244. If you use a telecommunications device for the deaf (TDD) you may call (toll free): 1-877-576-7734.

You may also contact ED Pubs at its Web site: http://www.ed.gov/about/ordering.jsp.

Or you may contact ED Pubs at its e-mail address: edpubs@inet.ed.gov.

If you request an application from ED Pubs, be sure to identify this competition as follows: CFDA number 84.363A.

For Technical Assistance Contact: Susan Toy, U.S. Department of Education, 400 Maryland Avenue, SW, Room 3E224, Washington, DC 20202-6140. Telephone: (202) 260-0995 or via Internet: Susan.Toy@ed.gov.

You may view this document, as well as all other Department of Education documents published in the Federal Register , in text or Adobe Portable Document Format (PDF) on the Internet at the following site: http://www.ed.gov/legislation/FedRegister/.

To use PDF you must have Adobe Acrobat Reader, which is available free at this site. If you have questions about using PDF, call the U.S. Government Printing Office (GPO), toll free, at 1-888-293-6498; or in the Washington, DC area at (202) 512-1530.

Individuals with disabilities may obtain this document in an alternative format (e.g., Braille, large print, audiotape, or computer diskette) on request using the contact information provided under For Applications Contact.

The API program promotes greater access to, and participation in, advanced placement courses and tests for low-income and other disadvantaged students. The API program is an important component of the Department's commitment to ensuring that “no child is left behind.” In order to improve academic achievement for all students, the expectations for low-income children must be raised. Therefore, in addition to improving reading and mathematics achievement for all children in the early grades, the Secretary supports more rigorous middle and high school curricula in English, mathematics, science, and other core subjects. The development, enhancement, and expansion of advanced placement courses in all core subjects are key strategies for enabling low-income students to achieve to high academic standards.

Since the original authorization of the Advanced Placement program in 1998, funding for the program has increased from $3 million to the current appropriation of $22 million. In May 2001, low-income students took 114,112 advanced placement tests administered by the College Board, an 11 percent increase compared to 2000. Nevertheless, there is still a significant gap between the level of participation of low-income students in advanced placement courses and tests and the level of participation of students from more affluent backgrounds. Further, recent data released by the College Board indicate a continued under-representation of minority students taking advanced placement exams generally, and of female students taking calculus and physics advanced placement exams.

The API program supports activities that enable greater numbers of low-income and other disadvantaged students to benefit from advanced placement courses and exams (ultimately increasing the likelihood that these students will receive college degrees) through increased access to, and participation in, pre-advanced placement and advanced placement courses. These courses will be developed, enhanced, and expanded in high-poverty schools, which are least likely to offer advanced placement courses. In addition, pre-advanced placement and advanced placement teachers in the schools served will participate in sustained, high-quality professional development activities designed to: (1) Improve teacher content area knowledge; (2) increase utilization of research-based classroom practices that foster student achievement for low-income students; and (3) strengthen the alignment of pre-advanced placement and advanced placement curricula through vertical team training and other strategies. Applicants approved for funding under this program will be required to submit disaggregated data (by race, ethnicity, sex, English proficiency status, and socio-economic status) on individuals taking advanced placement courses and tests.

Allowable Activities: Under the API program, eligible entities implement programs designed to expand access for low-income individuals to advanced placement incentive programs through:

(1) Teacher training; (2) pre-advanced placement course development; (3) coordination and articulation between grade levels to prepare students for academic achievement in advanced placement courses; (4) providing books and supplies; (5) activities to increase the availability of, and participation in, on-line advanced placement courses; and (6) any other activity directly related to expanding access to and participation in advanced placement programs, particularly for low-income individuals.

Waiver of Proposed Rulemaking: In accordance with the Administrative Procedure Act (5 U.S.C. 553), it is the practice of the Secretary to offer interested parties the opportunity to comment on proposed rules. Ordinarily, this practice might have applied to one or more of the priorities in this notice. Section 437(d)(1) of the General Education Administrative Provisions Act (GEPA), however, exempts rules that apply to the first competition under a new or substantially revised program from this requirement. As this competition is the first API program competition under the newly reauthorized ESEA, it qualifies as a new competitive grants program and is exempt from notice and comment rulemaking. The Secretary, in accordance with section 437(d)(1) of GEPA, to ensure timely awards, has decided to forgo public comment. These rules will apply to the FY 2002 competition only.

Absolute Priorities: Under 34 CFR 75.105(c)(3), the Secretary is establishing three separate absolute priorities as described below. We have chosen these priorities from the authorized activities and priorities specified in the authorizing statute for this program (see sections 1705(c) and (d) of Title 1, Part G of the ESEA). To implement the priorities, the Secretary will fund under this competition only applications that meet all three absolute priorities, except that priority (b) below applies only to eligible applicants that are LEAs.

(a) The Secretary gives an absolute priority to applications that demonstrate an intent to carry out activities that target schools, or LEAs serving schools, with a high concentration of low-income students. For a definition of high concentration of low-income students, see the Definitions section of this notice.

(b) For eligible applicants that are LEAs, the Secretary gives an absolute priority to applications that assure that the LEA serves schools with a high concentration of low-income students. For a definition of high concentration of low-income students, see the Definitions section of this notice.

(c) The Secretary gives an absolute priority to applications that propose to develop, enhance, or expand pre-advanced placement courses in English, mathematics, science, and other core academic areas at the middle or high school level. Proposals may include activities designed to develop, enhance, or expand advanced placement courses in conjunction with pre-advanced placement courses. Effective projects must be designed to enable low-income students to enroll and succeed in advanced placement courses and taking tests in core academic areas, and must include activities for coordination of curriculum design and development between middle and high school teachers as well as teacher training activities necessary for effective implementation of such programs.

Selection Criteria: The Secretary will use the following selection criteria in 34 CFR 75.210 to evaluate applications under this competition. The maximum score for all of the selection criteria is 100 points. The maximum score for each criterion is indicated in parenthesis with the criterion. The criteria are as follows:

(a) Significance (20 points). The Secretary considers the significance of the proposed project. In determining the significance of the proposed project, the Secretary considers one or more of the following factors:

(1) The potential contribution of the proposed project to increased knowledge or understanding of educational problems, issues, or effective strategies.

(2) The extent to which the proposed project involves the development or demonstration of promising new strategies that build on, or are alternatives to, existing strategies.

(3) The importance or magnitude of the results or outcomes likely to be attained by the proposed project, especially improvements in teaching and student achievement.

(b) Quality of the Project Design (20 points). The Secretary considers the quality of the project design of the proposed project. In determining the quality of the project design, the Secretary considers the following factors:

(1) The extent to which the proposed project represents an exceptional approach for meeting the priority or priorities established for the competition.

(2) The extent to which the goals, objectives, and outcomes to be achieved by the proposed project are clearly specified and measurable.

(3) The extent to which the design of the proposed project is appropriate to, and will successfully address, the needs of the target population or other identified needs.

(c) Quality of Project Services (20 points). The Secretary considers the quality of project services to be provided by the proposed project. In determining the quality of the services to be provided by the proposed project, the Secretary considers the quality and sufficiency of strategies for ensuring equal access and treatment for eligible project participants who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability. In addition, the Secretary considers the following factors:

(1) The extent to which the services to be provided by the proposed project reflect up-to-date knowledge from research and effective practices.

(2) The extent to which the training or professional development services to be provided by the proposed project are of sufficient quality, intensity, and duration to lead to improvements in practice among the recipients of those services.

(d) Quality of Project Personnel (10 points). The Secretary considers the quality of the personnel who will carry out the proposed project. In determining the quality of project personnel, the Secretary considers the extent to which the applicant encourages applications for employment from persons who are members of groups that have traditionally been under represented based on race, color, national origin, gender, age, or disability. In addition, the Secretary considers the following factors:

(1) The qualifications, including relevant training and experience, of the project director;

(2) The qualifications, including relevant training and experience, of key project personnel.

(3) The qualification, including relevant training and experience, of project consultants or subcontractors.

(e) Adequacy of Resources (10 points). The Secretary considers the adequacy of resources for the proposed project. In determining the adequacy of resources for the proposed project, the Secretary considers the following factors:

(1) The adequacy of support, including facilities, equipment, supplies, and other resources, from the applicant organization or the lead applicant organization.

(2) The extent to which the costs are reasonable in relation to the number of persons to be served and to the anticipated results and benefits.

(3) The potential for incorporation of project purposes, activities or benefits into the ongoing program of the agency or organization at the end of Federal funding.

(f) Quality of the Management Plan (10 points). The Secretary considers the quality of the management plan for the proposed project. In determining the quality of the management plan for the proposed project, the Secretary considers the following factors:

(1) The adequacy of the management plan to achieve the objectives of the proposed project on time and within budget, including clearly defined responsibilities, time lines, and milestones for accomplishing project tasks.

(2) The extent to which the time commitments of the project director and principal investigator and other key project personnel are appropriate and adequate to meet the objectives of the proposed project.

(g) Quality of the Project Evaluation (10 points). The Secretary considers the quality of the project evaluation. In determining the quality of the project evaluation, the Secretary considers the following factors:

(1) The extent to which the methods of evaluation include objective performance measures that are clearly related to the intended outcomes of the project and will produce quantitative and qualitative data to the extent possible.

(2) The extent to which the methods of evaluation will performance feedback and permit periodic assessment of progress toward achieving intended outcomes.

Priority Points : In accordance with statutory and regulatory requirements, the Secretary will award a total of twenty (20) additional priority points for applications based on the following criteria: (a) Pervasive need for access to API programs, including a focus on serving or otherwise addressing the needs of disadvantaged individuals—two (2) points;

(b) involvement of business and community organizations in the activities assisted—two (2) points; (c) availability of matching funds from State, local, or other sources to pay for the cost of activities to be assisted—two (2) points; (d) focus on developing or expanding advanced placement programs in the core academic areas of English, mathematics, or science—two (2) points; (e) intent to carry out activities to increase the availability of, and participation in, on-line advanced placement courses—two (2); and (f) serve schools where 75 percent or more of the students enrolled are from low-income families—ten (10) points.

These priorities are specified in the authorizing statute for the API Program. The priority points are in addition to any points the applicant earns under the selection criteria listed below. The Secretary may select an application that meets a priority over an application of comparable merit that does not meet the priority.

Applicable Regulations and Statute : The Education Department General Administrative Regulations (EDGAR) in 34 CFR parts 74, 75, 77, 79, 80, 81, 82, 85, 86, and 99. Title I, Part G of the Elementary and Secondary Education Act of 1965, as amended by the No Child Left Behind Act of 2001, Pub. L. 107-110.

General Requirements : The following requirements must be met for any application submitted under this program: (a) The program narrative is limited to no more than 50 pages; (b) each “page” is 8.5″ x 11″ (on one side only) with one inch margins (top, bottom, and sides); and (c) all text in the application narrative is double-spaced (no more than three lines per vertical inch), including titles, headings, footnotes, quotations, captions, as well as all text in charts, tables, figures, and graphs. The page limit applies to the narrative section only. However, all of the application narrative must be included in the narrative section. If the narrative section of an application exceeds the page limit, the application will not be reviewed.

The following definitions and other provisions are taken from the API program authorizing statute, in Title I, Part G of the ESEA. They are repeated in this application notice for the convenience of the applicant.

As used in this section:

(a) The term advanced placement test means an advanced placement test administered by the College Board or approved by the Secretary.

(b) The term high concentration of low-income students , used with respect to a school, means a school that serves a student population at least 40 percent or more of whom are low-income individuals.

(c) The term low-income individual means an individual who is determined by a State educational agency or local educational agency to be a child, ages 5 through 17, from a low-income family, on the basis of data used by the Secretary to determine allocations under section 1124 of the ESEA, data on children eligible for free or reduced lunches under the National School Lunch Act, data on children in families receiving assistance under part A of title IV of the Social Security Act, or data on children eligible to receive medical assistance under the Medicaid program under title XIX of the Social Security Act, or through an alternate method that combines or extrapolates from those data.

Funds provided under this program must be used to supplement and not supplant other non-Federal funds that are available to assist low-income individuals in paying advanced placement test fees.

For Applications or Information Contact: Madeline E. Baggett, U.S. Department of Education, School Improvement Programs, 400 Maryland Avenue, SW., Room 3C153, Washington, DC 20202-6140. Telephone (202) 260-2669. Internet address: Madeline.Baggett@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.

Individuals with disabilities may obtain this document in an alternative format ( e.g. , Braille, large print, audiotape, or computer diskette) upon request to the contact person listed in the preceding paragraph. Individuals with disabilities may obtain a copy of the application package in an alternative format, also, by contacting that person. However, the Department is not able to reproduce in an alternative format the standard forms included in the application package.

You may view this document, as well as all other Department of Education documents published in the Federal Register , in text or Adobe Portable Document Format (PDF) on the Internet at the following site: www.ed.gov/legislation/FedRegister .

To use PDF, you must have Adobe Acrobat Reader, which is available free at this site. If you have questions about using PDF, call the U.S. Government Printing Office (GPO) toll free at 1-888-293-6498; or in the Washington, DC area at (202) 512-1530.

This package contains: (1) OMB No. 1910-New; (2) Package Title: End-User Certificate; (3) Type of Request: New Collection; (4) Purpose: When acquiring High Risk Property from the Department of Energy, the End-Use Certificate (EUC) will be used to check respondents to determine if they are responsible, not debarred bidders, Specially Designated Nationals or Blocked Persons, or have not violated U.S. export laws and to advise recipients that when property is to be exported, they must comply with the International Traffic in Arms Regulations (ITAR), 22 CFR 120 et seq. ; Export Administration Regulations (EAR), 15 CFR 730 et seq. ; Office of Foreign Asset Controls (OFAC), 31 CFR 500 et seq. ; and the United States Customs Service rules and regulations; (5) Respondents: 5,000 perspective purchasers; (6) Estimated Number of Burden Hours: 1,650.

EPA ICR No. 1847.02; Federal Plan Recordkeeping and Reporting Requirements for Large Municipal Waste Combustors Constructed on or Before September 20, 1994; in 40 CFR part 62, subpart FFF; was approved 03/04/2002; OMB No. 2060-0390; expires 03/31/2003.

EPA ICR No. 1363.11; Toxic Chemical Release Reporting Recordkeeping, Supplier Notification and Petitions Under Section 313 of the Emergency Planning and Community Right-to-know Act (EPCRA); in 40 CFR part 372; was approved 03/07/2002; OMB No. 2070-0093; expires 01/31/2003.

EPA ICR No. 2067.01; Laboratory Quality Assurance Evaluation Program for Analysis of Cryptosporidium Under the Safe Drinking Water Act; was approved 04/11/2002; OMB No. 2040-0246; expires 07/31/2002.

EPA ICR No. 1506.09; NSPS Municipal Waste Combustors (MWC) for subpart Ea and subpart Eb; was approved 04/09/2002; OMB No. 2060-0210; expires 04/20/2005.

EPA ICR No. 1750.03; National Volatile Organic Compound Emission Standards for Architectural Coatings; was approved 04/16/2002; OMB No. 2060-0393; expires 04/20/2005.

EPA ICR No. 1637.05; General Conformity of Federal Actions to State Implementation Plan; in 40 CFR part 51, subpart W, and part 93, subpart B; was approved on 04/09/2002; OMB No. 2060-0279; expires 04/30/2005.

EPA ICR No. 1573.08; Part B Permit Application, Permit Modifications and Special Permits (Corrective Action Management Final Rule); was approved 03/18/2002; OMB No. 2050-0184; expires 03/31/2005.

EPA ICR No. 2013.01; Protection of Stratospheric Ozone: Request for Applications for Critical Use Exemptions from the Phaseout of Methyl Bromide; was approved 05/02/2002; OMB No. 2060-0482; expires 05/31/2005.

EPA ICR No. 0959.11; Facility Ground-water Monitoring Requirements; was approved 01/28/2002; OMB No. 2050-0033; expires 01/31/2005.

EPA ICR No. 0229.15; NPDES and Sewage Sludge Monitoring Reports; was approved 02/04/2002; OMB No. 2040-0004; expires 02/28/2005.

EPA ICR No. 1759.03; Worker Protection Standard Training and Notification; was approved 02/25/2002; OMB No. 2070-0148; expires 02/28/2005.

EPA ICR No. 1601.04; Air Pollution Regulations for Outer Continental Shelf Activities; OMB No. 2060-0249; on 03/13/2002 OMB extended the expiration date through 05/31/2002.

EPA ICR No. 1755.05; Regulatory Reinvention Pilot Projects Under Project XL; Pre-Treatment Program; OMB No. 2010-0026; on 02/26/2002 OMB extended the expiration date through 05/31/2002.

EPA ICR No. 0277.11; Application for New or Amended Pesticide Registration; OMB No. 2070-0060; on 04/20/2002 OMB extended the expiration date through 05/31/2002.

EPA ICR No. 1888.01; National Roster for Environmental Dispute Resolution and Consensus-Building Professionals; OMB No. 2010-0030; on 03/11/2002 OMB changed the expiration date to 03/31/2002.

EPA ICR No. 2029.01; National Emission Standards for Hazardous Air Pollutants: Asphalt Processing and Asphalt Rooting Manufacturing (40 CFR Part 63, Subpart LLLLL) Proposed Rule; on 01/03/2002 OMB filed comment.

You may be interested in this notice if you are involved in water quality, aquatic habitat, and sustainable land management issues at the Regional, State, Tribal, local, or community level. This notice is intended to solicit ideas and comments from an array of organizations and individuals across the country who have an interest in achieving clean and healthy watersheds. Interested individuals and organizations may include farmers, private landowners, commercial businesses, watershed and environmental interest groups, academicians, community leaders, county/city planners, commissioners, engineers, recreational water users, and members of the general public. This list is not intended to be exhaustive, nor is it intended to exclude entities that may be ineligible for Watershed grants, but rather provides a guide for readers. To determine whether you, your company or organization may be interested in responding to this notice, you should carefully examine its contents. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the FOR FURTHER INFORMATION CONTACT section.

1. Electronically. You may obtain electronic copies of this document and various support documents from the EPA home page at the Federal Register http://www.epa.gov/fedrgstr/, or on EPA's watershed homepage at http://www.epa.gov/owow/watershed.

2. In person. The complete administrative record for this action has been established under docket number W-02-05 and includes supporting documentation as well as printed, paper versions of electronic comments. Copies of information in the record are available upon request. A reasonable fee may be charged for copying. The records are available for inspection and copying from 9 a.m. to 4 p.m., Monday through Friday, excluding legal holidays, at the Water Docket, EPA, East Tower Basement, 401 M Street, SW, Washington, DC. For access to docket materials, please call (202) 260-3027 to schedule an appointment.

EPA invites you to provide your views on those items outlined in Section IV, Design of the Watershed Initiative, approaches it has not considered, the potential impacts of the various options (including possible unintended consequences), and any other information that you would like the Agency to consider. You may submit comments by mail, in person, or electronically:

1. By mail. Submit written comments on this notice to: Comment Clerk for the Watershed Initiative Competitive Grant program, Water Docket (W-02-05), Environmental Protection Agency, Ariel Rios Bldg. 1200 Pennsylvania Ave. NW, Washington, DC 20460. The Document Control Office telephone number is 202-260-3027. To ensure proper identification of your comments, include in the subject line the docket control number, together with the name, date and Federal Register citation of this notice.

2. In person. Deliver written comments to EPA's Water Docket located in Room EB-57 (East Tower Basement), 401 M Street, SW, Washington, DC 20460.

3. Electronically. Submit your comments electronically to: ow-docket@epa.gov. Electronic comments must be submitted as an ASCII or WordPerfect file avoiding the use of special characters and any form of encryption. Comments will also be accepted on disks in WordPerfect or ASCII file format sent or delivered to the addresses above. All comments and data in electronic form must be identified by the docket control number W-02-05. Electronic comments on this notice may also be filed online at many Federal Depository Libraries. No confidential business information should be sent via e-mail.

EPA expects to award these grants under the authority of section 104(b)(3) of the Clean Water Act (CWA) which authorizes grants to conduct and promote the coordination and acceleration of research, investigations, experiments, training, education, demonstrations, surveys, and studies relating to the causes, effect, extent, prevention, reduction, and elimination of water pollution. EPA is also considering awarding grants under the authority in the Clean Water Act for Wet Weather Watershed Pilot Projects (33 U.S.C. 1274) or National Estuary Program projects (33 U.S.C. 1330).

Americans depend on clean water to drink, manufacture their products, irrigate their crops, and support a healthy habitat for wildlife. Water resources also provide opportunities for recreation, such as fishing, boating and swimming. Wetlands afford protection from floods, filter pollutants, and are home to a wide diversity of plants and animals. Estuaries serve as both birthplace and nursery for many species of fish and shellfish. Today, a majority of watersheds have water quality problems such as habitat loss, nutrient enrichment, pathogens, toxic chemicals, and invasive species. These problems continue to impair watersheds nationwide and prohibit the attainment of State/Tribal water quality standards and other water quality goals. The problems are complex and vary from region to region. Governments working alone can not solve all of them.

State and Federal water protection programs along with volunteer and private sector efforts, have been successful in reversing or preventing damage to the nation's waters over the past 30 years. Nevertheless, nearly 40 percent of the nation's waters that have been assessed are still not considered safe for swimming and fishing, or are impaired in other ways. Further, many lakes, rivers, streams, wetlands, and estuaries have yet to be adequately assessed. The nation remains far from realizing the goals of the Clean Water Act.

To address water resource problems more effectively, water resource managers at all levels have been adopting a more comprehensive approach—one that considers all threats to a watershed. A watershed can be large or small. It can encompass the entire Mississippi River basin or a small stream in western Georgia. The “watershed approach” addresses natural resource issues that cross geographic, jurisdictional and political boundaries. This approach recognizes needs for water supply, water quality, flood control, navigation, hydropower generation, fisheries, biodiversity, habitat preservation and recreation—and it recognizes that these needs often compete. It establishes local priorities in the context of national goals, coordinates public and private actions, encourages partnerships to affect change, and enlists the support and knowledge base of the public at the local level.

Effective solutions to restoring water quality across the country will typically require cooperative efforts. Over the years, many communities around the country have joined forces to protect their watersheds, often using innovative and novel approaches that are geared toward solving the problems that make sense for their locality. In recent years, governments, non-profit organizations, businesses, and citizens have employed watershed based approaches to refocus their efforts to protect and restore the nation's waters. These refocused efforts have brought positive results and attainment of State/Tribal water quality standards in some areas.

The Watershed Initiative, if approved by Congress, would build on the watershed approach, encouraging innovative approaches for attaining water quality standards and improving water resource protection and restoration. It would also further EPA's goal to meet the mandate of the Clean Water Act. The Initiative will focus on highly valued watershed resources such as those that support human health, wildlife diversity, ecosystem integrity, economic stability, recreational opportunity, and natural or cultural significance.

The Administration has requested an additional $21 million in EPA's 2003 budget to spearhead this effort. The investment will capitalize on lessons learned from current protection efforts and build upon proven successful approaches to protect valued watershed resources. The Initiative will have several kinds of assistance. One part would direct cooperative agreements and demonstration funds to up to 20 watersheds. The grants would range from $300,000 to $1,300,000, depending on the amount requested and the overall size and need of the project.

A smaller portion of the funds could be used to respond to the recommendations of last year's National Watershed Forum ( http://www.epa.gov/owow/forum ), by supporting the development of tools, training, data and information, and technical assistance that can be provided to all watershed activities across the country, including projects which are nominated for selection under this Initiative but are not selected. The Initiative will also establish ten Federal liaison positions in EPA's Regional Offices. These watershed liaisons will serve as a vital link between the Federal government and the groups funded under the Initiative. This liaison will work to support cooperation and communication among all affected stakeholders of the project.

This notice only focuses on the competitive grant component of the Watershed Initiative described in section IV below.

If EPA awards these grants under section 104(b)(3) of the Clean Water Act, the funds may be used to conduct and promote the coordination and acceleration of research, investigations, experiments, training, demonstrations, surveys, and studies relating to the causes, effect, extent, prevention, reduction, and elimination of water pollution. Eligible activities under Wet Weather Watershed Pilot Project grants include pilot projects relating to watershed management of wet weather discharges and storm water best management practices. If EPA awards Watershed Initiative grants under the authority for National Estuary Program grants (section 320 of the Clean Water Act), the funds may be used for the development and implementation of a comprehensive management plan that has been developed under section 320.

EPA has begun the process of devising a strategy to implement the Initiative. Work is underway both within EPA and with outside parties to solicit ideas. Over the next few months, the Agency will consult with Congress, Governors, States, Tribes, local governments, and community groups to seek their help in developing the program.

Plans are to complete the design of the program this summer and to call for nominations of projects soon thereafter. The Agency wants to make its selections as soon as possible after the fiscal year 2003 appropriation act is enacted. Project selections could be made as early as December 2002 and implementation could be underway by next summer.

The Agency is interested in the public's views on several key aspects of the Initiative.

EPA will award grants through a competitive process. Under section 104(b)(3) of the CWA, the following entities are eligible to receive grants: State and Tribal water pollution control agencies, interstate or intertribal agencies, other public or non-profit private agencies, institutions, organizations, and individuals. Grants authorized under section 320 of the CWA (National Estuary Program Grants) may be awarded to State, interstate, and regional water pollution control agencies and entities, State coastal zone management agencies, interstate agencies, other public or nonprofit private agencies, institutions, organizations, and individuals. For-profit entities are not eligible for grants under either section 104(b)(3) or 320 of the CWA. There is no limitation on the types of entities eligible for Wet Weather Watershed Pilot Project grants. The Agency invites the public to address whether the Initiative should be limited to certain groups and why.

The Agency is interested in the views of interested parties on the selection process. One option is for the Governors or Tribal Leaders to nominate watershed projects to EPA. Under this option candidates representing a watershed that is wholly within a State's or Tribe's boundaries submit their proposals to the Governor or Tribal Leader of that State or Tribe, who in turn, would formally nominate selected watersheds to the EPA Administrator. This process is used by the Agency's National Estuary Program (NEP). Nominations for NEP funding can only be made by a Governor or by the EPA Administrator, on her own initiative. The Governor /Tribal Leader could serve as a screening step to the selection process and nominate only those watersheds in its State/Tribal land that most merit Federal funding. If the Governors or Tribal Leaders make the nominations, should they be restricted to a limited number of nominations?

Other programs take somewhat different approaches. For instance, to receive funding under EPA's Brownfields Showcase Communities Program, nominations are solicited through a notice in the Federal Register and are accepted from any party but must be submitted in partnership with a government entity. Other government granting programs, such as the Large-scale Watershed Restoration Program (LWRP), and the Community-Based Restoration Program (CBRP), do not require a State role per se. Nominations for these programs are submitted directly to the U.S. Forest Service and the National Marine Fisheries Service, respectively.

Some of the most significant management and environmental challenges the nation faces involve water bodies that straddle State and Tribal boundaries. If Governors and Tribal Leaders nominate watershed projects that are wholly within their jurisdiction as described above, should interstate or inter-tribal watershed projects go through a different nomination process? EPA could require that nominations for these trans-boundary watershed projects be screened by EPA's Regional Administrators or be submitted directly to the Administrator. In light of limited time to prepare nominations, and the increased difficulty of developing the proposal for multi-jurisdictional projects, would requiring Governor or Tribal Leader level nomination put these larger projects at a disadvantage?

EPA is requesting comment on the criteria it should use to select watershed projects for funding. Below is a list of criteria that are utilized in various other Federal programs. EPA would like comments on the appropriateness of each criterion to this Initiative, and which criteria (and/or others not on the list) should be used in the selection process.

1. Value of the Resource at Risk and Extent of Impairment or Threat. The cornerstone of the Watershed Initiative is to foster the protection, preservation, and restoration of the country's water bodies. To what degree should successful candidates demonstrate that the watershed provides a high value of services to human health, economic stability, ecosystem integrity, recreational opportunity, natural or cultural significance or any other important services? For water bodies which are impaired, how should the nature, extent, and severity of the impairment be weighed? Are there other aspects of resource value that should be considered, and if so, what are they?

2. Focus on Success. To what extent should selections be based on readiness to proceed and the likelihood of achieving positive environmental outcomes? EPA is considering giving preference to nominations that (1) demonstrate a knowledge of priority water resource problems, (2) have substantially completed planning for the project, and (3) are ready to begin. The reasoning behind this is that these types of projects would have the greatest likelihood of attaining tangible environmental results in the near, rather than distant, future.

EPA is considering establishing a requirement that nominations be supported by a clearly articulated set of success or progress measures and a description of how these measures would be tracked. The Agency is also considering criteria which would address the capability of nominees to manage the project. Should each project be required to have a coordinator and a developed infrastructure for carrying out the project? While a grant may be awarded to an individual watershed group, an institution, or to a consortium of groups, it seems likely that a project leader would be needed to oversee the plan and take fiscal and practical responsibility for implementing the project. For example, should candidates be required to submit a detailed business plan? Should there be a cost-share requirement to demonstrate a real commitment to the project? And if so, how much? Should applicants that commit to provide a larger share of the project's cost be given preference?

Finally, one additional aspect of this category of potential criteria is the ability to transfer the experience gained from a project selected for the Initiative to other watersheds across the country. The goal of this criterion would be to develop and document restoration models that can be applied nationally. For this criterion, EPA would consider whether the success of the particular project could be repeated in other impaired or threatened watersheds.

3. Innovation. To what extent does the project test novel or unique approaches, concepts, or techniques? A key objective of the Initiative is to foster innovative and novel approaches to achieving environmental results. The designated watersheds are expected to serve as models of the most creative, economically successful and ecologically sustainable approaches to restoration and protection. A wide array of progressive and forward-thinking actions, such as pollutant trading, third-party total maximum daily loads (TMDLs), National Pollutant Discharge Elimination System (NPDES) watershed permits under the Clean Water Act, enforcement programs, and demonstration projects could be advanced. The public is invited to comment on this criterion and how it should be applied in the selection process.

4. Broad Support. The most successful watershed communities have attained a local commitment, established stakeholder partnerships, and forged effective working relationships among State and local authorities. EPA is seeking comment on the extent to which partnerships should be demonstrated by the nominees for this Initiative. Should EPA have nominees submit letters of support, or affidavits, attesting to the establishment of partnerships and collaboration efforts? And, should one or more of the entities have a proven track record with respect to implementing environmental protection and restoration projects?

Another aspect to consider is what role, if any, should the Interagency Regional Coordination Teams play? These teams of representatives of Federal agencies that share common concerns about water quality are spread around the country to strengthen cross-agency communications and implementation activities. These regional teams were created to link the Federal government with on-the-ground water protection, restoration, and conservation efforts. As a result, they could be helpful in enhancing partnerships and leveraging resource possibilities.

5. Accountability. Performance expectations and attaining measurable results are a fundamental part of the Initiative. The progress of each watershed project must be measurable by scientifically sound ways that can also be understood and appreciated by the general public. Monitoring should be designed to show progress in the short term. Questions arising from this criterion are: should the nominee be required to provide a “Watershed Plan” as part of the nomination package and if so, what should be the key elements of that plan? What are the most appropriate measures of success for this Initiative? How could EPA and other affected stakeholders monitor the progress of each selected project and report on the results?

6. Integrated Application of EPA Programs. The Agency is also considering linking the goals of the Watershed Initiative with its programmatic goals and solicits comments on whether and how to apply such a criterion. For example, the Agency could give priority consideration to those watershed projects that incorporate an integrated approach to using regulatory and nonregulatory tools ( e.g., water quality standards, source water protection, TMDLs, permits, financial incentives) to address a diversity of aquatic resources ( e.g., rivers, streams, lakes, wetlands, riparian areas, and/or estuaries). A linkage could be applied to national goals as well. In this case, special consideration could be given to watershed projects with national prominence, such as the Gulf Hypoxia Action Plan or the Pacific Northwest Salmon Recovery Program. The Agency is specifically seeking comment on whether, and if so how, watersheds that include estuaries should be linked to the National Estuary Program.

Once the nomination materials have been submitted, EPA must determine how it will make its selections. EPA must decide whether any particular criterion should be “checked off” if met, or given more weight in the selection process than the others. For example, those nominations addressing the aquatic resources of greatest ecological or human health value could be considered first, or be scored higher by being assigned more “points.” EPA is exploring these and other questions regarding how much information will be needed to select the best projects.

EPA is inclined to support a variety of watershed scales and geographic locations. The appropriate size and location of the watershed and/or project area may depend on the local circumstances, the level of impairment, and other factors. Funds may be awarded based on the scale of the project, the anticipated need, and the amount requested. While EPA is leaning toward not specifying the scale or location of the watershed, it invites additional thoughts and comments on this issue.

This Federal Register notice is meant to solicit public participation in an initiative designed to encourage the building of partnerships in an effort to protect, preserve, and restore watersheds across the country. The goal of the Watershed Initiative is to provide funding and other types of assistance to communities with a broad spectrum of affected interests in attaining clean and healthy waterways. EPA invites constructive and insightful comments on the subject of this notice. The Agency is especially seeking the public's input and suggestions on the qualifying and selection criteria and other topics outlined in section IV. Commentors should feel free to deviate from the scope of this notice and provide comments on other possible innovative approaches to designing the Watershed Initiative.

You may be affected by this action if you are an agricultural producer, food manufacturer or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under 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/.

2. In person . The Agency has established an official record for this action under docket control number OPP-2002-0034. 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 Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

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 OPP-2002-0034 in the subject line on the first page of your response.

1. By mail . Submit your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

2. In person or by courier . Deliver your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

3. Electronically . You may submit your comments electronically by e-mail to: opp-docket@epa.gov, or you can submit a computer disk as described above. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in Wordperfect 6.1/8.0 or ASCII file format. All comments in electronic form must be identified by docket control number OPP-2002-0034. Electronic comments may also be filed online at many Federal Depository Libraries.

Do not submit any information electronically that you consider to be 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 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. Make sure to submit your comments by the deadline in this notice.

7. 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.

EPA has received a pesticide petition as follows proposing the establishment and/or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. EPA has determined that this petition contains data or information regarding the elements set forth in section 408(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.

The petitioner summary of the pesticide petition is printed below as required by section 408(d)(3) of the FFDCA. The summary of the petition was prepared by MeadWestaco Corporation, and represents the view of MeadWestaco. EPA is publishing the petition summary verbatim without editing it in any way. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed.

EPA has received a pesticide petition (2E6411) from MeadWestaco Corporation, 3950 Faber Place Drive, N. Charleston, SC 29405 proposing, pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish an exemption from the requirement of a tolerance for 2-propenoic acid, 2-methyl-, polymer with ethyl 2-propenoate and methyl 2-methyl-2-propenoate, ammonium salt (CAS Reg. No. 55989-05-4) when used as an inert ingredient (encapsulating agent, dispensers, resins, fibers and beads) in pesticide formulations applied to growing crops or raw agricultural commodities after harvest, under 40 CFR 180.1001(c) and applied to animals under 40 CFR 180.1001(e). EPA has determined that the petition contains data or information regarding the elements set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.

Analytical method . MeadWestvaco is petitioning that 2-Propenoic acid, 2-methyl-, polymer with ethyl 2-propenoate and methyl 2-methyl-2-propenoate, ammonium salt be exempt from the requirement of a tolerance based upon the definition of a low risk polymer under 40 CFR 723.250(e). Therefore, an analytical method to determine residues of 2-Propenoic acid, 2-methyl-, polymer with ethyl 2-propenoate and methyl 2-methyl-2-propenoate, ammonium salt in raw agricultural commodities (RACs) is not required.

Acute toxicity. As part of the EPA policy statement on inert ingredients published in the Federal Register of April 22, 1987 (52 FR 13305), the Agency set forth a list of studies that would generally be used to evaluate the risks posed by the presence of an inert ingredient in a pesticide formulation. However, where it can be determined without the data that the inert ingredient will present minimal or no risk, the Agency generally does not require some or all of the listed studies to rule on the proposed tolerance or exemption from the requirement of a tolerance for an inert ingredient. MeadWestvaco believes that the data and information described below is adequate to ascertain the toxicology and characterize the risk associated with the use of 2-propenoic acid, 2-methyl-, polymer with ethyl 2-propenoate and methyl 2-methyl-2-propenoate, ammonium salt (CAS Reg. No. 55989-05-4) as an inert ingredient in pesticide formulations applied to growing crops and raw agricultural commodities after harvest, and animals.

In the case of certain chemical substances that are defined as “polymers,” EPA has established a set of criteria that identify categories of polymers that present low risk. These criteria (described in 40 CFR 723.250) identify polymers that are relatively unreactive and stable compared to other chemical substances as well as polymers that typically are not readily absorbed. These properties generally limit a polymer's ability to cause adverse effects. In addition, these criteria exclude polymers about which little is known. EPA believes that polymers meeting the criteria noted below will present minimal or no risk.

2-Propenoic acid, 2-methyl-, polymer with ethyl 2-propenoate and methyl 2-methyl-2-propenoate, ammonium salt (CAS Reg. No. 55989-05-4) conforms to the definition of polymer given in 40 CFR 723.250(b) and meets the following criteria that are used to identify low risk polymers:

1. 2-Propenoic acid, 2-methyl-, polymer with ethyl 2-propenoate and methyl 2-methyl-2-propenoate, ammonium salt is not a cationic polymer, nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment.

2. 2-Propenoic acid, 2-methyl-, polymer with ethyl 2-propenoate and methyl 2-methyl-2-propenoate, ammonium salt contains as an integral part of its composition the atomic elements carbon, hydrogen, oxygen, and nitrogen.

3. 2-Propenoic acid, 2-methyl-, polymer with ethyl 2-propenoate and methyl 2-methyl-2-propenoate, ammonium salt does not contain as an integral part of its composition, except as impurities, any elements other than those listed in 40 CFR 723.250(d)(2)(ii).

4. 2-Propenoic acid, 2-methyl-, polymer with ethyl 2-propenoate and methyl 2-methyl-2-propenoate, ammonium salt copolymer is not designed, nor is it reasonably anticipated to substantially degrade, decompose, or depolymerize.

5. 2-Propenoic acid, 2-methyl-, polymer with ethyl 2-propenoate and methyl 2-methyl-2-propenoate, ammonium salt is not manufactured or imported from monomers and/or other reactants that are not already included on the Toxic Substance Control Act (TSCA) Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption.

6. 2-Propenoic acid, 2-methyl-, polymer with ethyl 2-propenoate and methyl 2-methyl-2-propenoate, ammonium salt is not a water-absorbing polymer.

7. 2-Propenoic acid, 2-methyl-, polymer with ethyl 2-propenoate and methyl 2-methyl-2-propenoate, ammonium salt does not contain any group as reactive functional groups.

8. The minimum number-average molecular weight of the 2-propenoic acid, 2-methyl-, polymer with ethyl 2-propenoate and methyl 2-methyl-2-propenoate is listed as 18,914 daltons. Substances with molecular weights greater than 400 generally are not absorbed through the intact skin, and substances with molecular weights greater than 1,000 generally are not absorbed through the intact gastrointestinal (GI) tract. Chemicals not absorbed through the skin or GI tract generally are incapable of eliciting a toxic response.

9. The 2-propenoic acid, 2-methyl-, polymer with ethyl 2-propenoate and methyl 2-methyl-2-propenoate has a number-average molecular weight of 18,914 and contains less than 10% oligomeric material below molecular weight 500 and less than 25% oligomeric material below 1,000 molecular weight.

In addition, 2-propenoic acid, 2-methyl-, polymer with ethyl 2-propenoate and methyl 2-methyl-2-propenoate is acceptable for use, with limitations, under 21 CFR for contact with food as a component in adhesives (21 CFR 175.105), coatings (21 CFR 175.300), and paper and paperboard (21 CFR 176.170). The ammonium hydroxide utilized to form the ammonium salt is listed in 21 CFR 184.1139 under the section, “Direct food substances affirmed as generally recognized as safe.”

1. Dietary exposure. Exposure to 2-propenoic acid, 2-methyl-, polymer with ethyl 2-propenoate and methyl 2-methyl-2-propenoate, ammonium salt may occur through dietary (e.g., food wrapping containing copolymer) and non-occupational (e.g., printed articles) sources. The chemical characteristics of 2-propenoic acid, 2-methyl-, polymer with ethyl 2-propenoate and methyl 2-methyl-2-propenoate, ammonium salt lead to the conclusion that there is a reasonable certainty of no harm from aggregate exposure to the polymer.

2. Non-dietary exposure. 2-propenoic acid, 2-methyl-, polymer with ethyl 2-propenoate and methyl 2-methyl-2-propenoate, ammonium salt formulations have been in commerce since the mid 1970's. The copolymer is ubiquitous in our every day environment and as it is commonly used in flexographic printing inks and coatings, such as on newspapers, corrugated boxes (e.g., pizza boxes), and disposable drinking cups.

Given the existing widespread and historic use of 2-propenoic acid, 2-methyl-, polymer with ethyl 2-propenoate and methyl 2-methyl-2-propenoate, ammonium salt, any additional exposure resulting from the approval of the copolymer as an inert ingredient in pesticide formulations for use on growing crops or to raw agricultural commodities after harvest should not be of concern.

At this time there is no information to indicate that any toxic effects produced by 2-propenoic acid, 2-methyl-, polymer with ethyl 2-propenoate and methyl 2-methyl-2-propenoate, ammonium salt would be cumulative with those of any other chemical. Given the compound's categorization as a “low risk polymer” (40 CFR 723.250) and its proposed use as an inert ingredient in pesticide formulations, there is no reasonable expectation of increased risk due to cumulative exposure.

1. U.S. population. 2-Propenoic acid, 2-methyl-, polymer with ethyl 2-propenoate and methyl 2-methyl-2-propenoate, ammonium salt formulations have been in commerce since the mid 1970's. The copolymer is ubiquitous in our every day environment and as it is commonly used in flexographic printing inks and coatings, with no known adverse effects.

There are no CODEX Maximum Residue Limits established for 2-Propenoic acid, 2-methyl-,polymer with ethyl 2-propenoate and methyl 2-methyl-2-propenoate, ammonium salt in/on any crop commodities at this time.

You may be affected by this action if you are an agricultural producer, food manufacturer or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under 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”, “Regulations and Proposed Rules”, 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/.

2. In person . The Agency has established an official record for this action under docket control number OPP2002-0038. 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 Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

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 OPP-2002-0038 in the subject line on the first page of your response.

1. By mail . Submit your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

2. In person or by courier . Deliver your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

3. Electronically . You may submit your comments electronically by e-mail to: opp-docket@epa.gov, or you can submit a computer disk as described above. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in Wordperfect 6.1/8.0 or ASCII file format. All comments in electronic form must be identified by docket control number OPP-2002-0038. Electronic comments may also be filed online at many Federal Depository Libraries.

Do not submit any information electronically that you consider to be 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 person listed 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. Make sure to submit your comments by the deadline in this notice.

7. 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.

EPA has received pesticide petitions as follows proposing the establishment and/or amendment of regulations for residues of certain pesticide chemicals in or on various food commodities under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. EPA has determined that these petitions contain data or information regarding the elements set forth in section 408(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.

Petitioner summaries of the pesticide petitions are printed below as required by section 408(d)(3) of the Federal Food, Drug, and Cosmetic Act (FFDCA). The summaries of the petitions were prepared by Sankyo Company, Ltd., and represent the views of the Sankyo Company. EPA is publishing the petition summaries verbatim without editing them in any way. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed.

EPA has received pesticide petitions (0F6134 and 1F6317) from Sankyo Company, Ltd., c/o Rockwell Enterprises, Inc., 1720 Savannah Drive NE, Rio Rancho, NM 87124-5700 proposing, pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing a tolerance for residues of milbemectin (a mixture of milbemycins containing greater than or equal to 70% milbemycin A 4 [(6R, 25R)- 5-O-demethyl-28-deoxy-6, 28-epoxy-25-ethyl-milbemycin B] and less than or equal to 30% milbemycin A 3 [(6R, 25R)-5-O-demethyl-28-deoxy-6, 28-epoxy-25-methyl-milbemycin B]) in or on the raw agricultural commodities citrus crop group at 0.02 parts per million (ppm); citrus pulp, dried at 0.2 ppm; citrus oil at 0.1 ppm; cotton, undelinted seed at 0.02 ppm (CA only); cotton gin by-products at 0.08 ppm (CA only); pome fruit crop group at 0.02 ppm; apple pomace, wet at 0.15 ppm; stone fruit crop group at 0.03 ppm (CA only); strawberry at 0.04 ppm; tree nut crop group at 0.02 ppm; and almond hulls at 0.2 ppm. EPA has determined that the petition contains data or information regarding the elements set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.

1. Plant metabolism. The metabolism of milbemectin in apples, oranges and strawberries has been studied. The parent molecules (Milbemycin A 3 and Milbemycin A 4 ) are the only metabolites found at significant levels in plant metabolism studies or in field residue studies under conditions of use, and are the only expected metabolites of toxicological concern in plants. The photolytic metabolites of milbemectin (8,9Z-M.A 3 and 8,9Z-M.A 4 ) were not found at toxicologically significant levels in these metabolism studies or in field residue studies limit of quantitation (LOQ) (Method LOQ = 0.01 ppm), but were included as part of the tolerance expression at the request of EPA.

2. Analytical method. An adequate analytical method high performance liquid chromotography using ultra-violet detection (HPLC with UV fluorescence detection at 460 nm) is available for enforcement purposes. The parent compounds, milbemycin A 3 and milbemycin A 4 , and their respective 8,9Z metabolites are converted to common moieties by derivatization before analysis. A successful Independent Laboratory Validation has been submitted.

3. Magnitude of residues —i Cotton. A total of 3 individual trials were conducted in California during the 1999 and 2000 crop season. Due to the limited geographical distribution of the crop residue trials for this crop grouping, a geographical restriction of California only is being requested. Applications were made at 1X the maximum labeled rate of 2 applications of 0.0192 lb. active ingredient/acre (a.i./acre) per crop season. Analyzed samples of undelinted cotton seed were < 0.01 ppm for both total M.A 3 (M.A 3 + 8,9Z-M.A 3 ) and total M.A 4 (M.A 4 + 8,9Z-M.A 4 ). Based on analysis of the findings, the expected maximum residue levels in undelinted cotton seed is 0.02 ppm (0.01 ppm total M.A 3 (M.A 3 + 8,9Z-M.A 3 ) + 0.01 ppm total M.A 4 (M.A 4 + 8,9Z-M.A 4 )). Analyzed samples of cotton gin by-products were < 10 to 22.8 μg a.i./kg (0.023 ppm) of total M.A 3 (M.A 3 + 8,9Z- M.A 3 ) and < 10 to 54.9 μg a.i./kg (0.055 ppm) of total M.A 4 (M.A 4 + 8,9Z-M.A 4 ). Based on analysis of the findings, the expected maximum residue levels in cotton gin by-products is 0.08 ppm total milbemectin (M.A 3 + 8,9Z-M.A 3 ) + (M.A 4 + 8,9Z-M.A 4 ).

ii. Strawberries. A total of 8 individual field trials were conducted over a period of two crop seasons (1997, 1998) in 6 states. Number, type and location of trials were in accordance with those specified by Guideline OPPTS 860.1500, Table 1. Applications were made at 1X (3 trials), 1.5X (1 trial) and 2X (4 trials) the maximum labeled rate of 4 applications of 0.019 lb. ai/acre, or 0.076 lb. ai/acre per crop season. After applying a correction factor of 0.5X to 0.75X where appropriate to the mean residue levels found in the samples, total residues of milbemectin (total M.A 3 + total M.A 4 ) in strawberries fell within a range of 0.012 ppm to 0.035 ppm. The method LOQ was 0.01 ppm each for total M.A 3 (M.A 3 + 8,9Z-M.A 3 ) and total M.A 4 (M.A 4 + 8,9Z-M.A 4 ). The photolytic metabolites of milbemectin (8,9Z-M.A 3 and 8,9Z-M.A 4 ) were not present in any samples where a separate analysis was conducted (LOQ = 0.01 ppm). Based on these findings, the expected maximum residue levels in strawberries is 0.04 ppm total milbemectin (M.A 3 + 8,9Z-M.A 3 ) + (M.A 4 + 8,9Z-M.A 4 ).

iii. Citrus Crop Group: The representative crops for this grouping as specified by 40 CFR 180.41 are sweet oranges, lemons and grapefruit.

a. Oranges. A total of 12 individual field trials were conducted over a period of two crop seasons (1997, 1998) in the states of California, Florida and Texas. Number, type and location of trials were in accordance with those specified by Guideline OPPTS 860.1500, Table 2. Applications were made at 1X (5 trials), 1.3X (3 trials) and 2X (4 trials) the maximum labeled rate of 3 applications of 0.024 lb. ai/acre, or 0.072 lb. ai/acre per crop season. All analyzed samples of the raw agricultural commodities (RAC) were less than the method LOQ of 0.01 ppm each for total M.A 3 (M.A 3 + 8,9Z-M.A 3 ) and total M.A 4 (M.A 4 + 8,9Z-M.A 4 ). Based on these findings, the expected maximum residue levels in oranges is 0.02 ppm ((0.01 ppm total M.A 3 (M.A 3 + 8,9Z-M.A 3 ) + 0.01 ppm total M.A 4 (M.A 4 + 8,9Z-M.A 4 )).

b. Grapefruit. A total of 6 individual field trials were conducted over a period of two crop seasons (1997, 1998) in the states of California, Florida and Texas. Number, type and location of trials were in accordance with those specified by Guideline OPPTS 860.1500, Table 2. Applications were made at 1X (3 trials), 1.3X (2 trials) and 2X (1 trial) the maximum labeled rate of 3 applications of 0.024 lb. ai/acre, or 0.072 lb. ai/acre per crop season. All analyzed samples of the RAC were less than the method LOQ of 0.01 ppm each for total M.A 3 (M.A 3 + 8,9Z-M.A 3 ) and total M.A 4 (M.A 4 + 8,9Z-M.A 4 ). Based on these findings, the expected maximum residue levels in grapefruit is 0.02 ppm ((0.01 ppm total M.A 3 (M.A 3 + 8,9Z-M.A 3 ) + 0.01 ppm total M.A 4 (M.A 4 + 8,9Z-M.A 4 )).

c. Lemons A total of 5 individual field trials were conducted over a period of two crop seasons (1997, 1998) in the states of Arizona, California and Florida. Number, type and location of trials were in accordance with those specified by Guideline OPPTS 860.1500, Table 2. Applications were made at 1X (2 trials) and 2X (3 trials) the maximum labeled rate of 3 applications of 0.024 lb. ai/acre, or 0.072 lb. ai/acre per crop season. After applying a correction factor of 0.5X where appropriate to residue levels found in the samples, all analyzed samples of the RAC were less than the method LOQ of 0.01 ppm each for total M.A 3 (M.A 3 + 8,9Z-M.A 3 ) and total M.A 4 (M.A 4 + 8,9Z-M.A 4 ). Based on these findings, the expected maximum residue levels in lemons is 0.02 ppm ((0.01 ppm total M.A 3 (M.A 3 + 8,9Z-M.A 3 ) + 0.01 ppm total M.A 4 (M.A 4 + 8,9Z-M.A 4 )).

d. Processed oranges. The study was comprised of a single trial located in east central Florida. The test substance was applied to the treated plot once at 60 days prior to normal maturity at 0.120 lb. ai/acre and an additional two times at 30 and 7 days prior to normal maturity at 0.240 lb. ai/acre, or 8.33X the maximum labeled rate. After processing, samples of orange juice, dried pulp and orange oil were analyzed for total M.A 3 and total M.A 4 . Reported mean values for total milbemectin (total M.A 3 + total M.A 4 ) were as follows: RAC - 0.011 ppm, dry pulp - 0.107, juice - < 0.01 ppm and oil - 0.0541 ppm. The method LOQ in each commodity was 0.01 ppm each for total M.A 3 (M.A 3 + 8,9Z-M.A 3 ) and total M.A 4 (M.A 4 + 8,9Z-M.A 4 ). The concentration factors were determined to be 9.7X for dry pulp and 4.9X for oil. Based on these findings, the expected maximum residue levels in dry citrus pulp is 0.20 ppm and in citrus oil is 0.10 ppm.

iv. Pome Fruit Crop Group. The representative crops for this grouping as specified by 40 CFR 180.41 are apples and pears.

a. Apples. A total of 12 validated individual field trials were conducted over a period of two crop seasons (1997, 1998) in the states of California, Colorado, Michigan, North Carolina, New York, Pennsylvania, and Washington. Number, type and location of trials were in accordance with those specified by Guideline OPPTS 860.1500, Table 2. Applications were made at 1X (2 trials) and 2X (10 trials) the maximum labeled rate of 2 applications of 0.024 lb. ai/acre, or 0.048 lb. ai/acre per crop season. After applying a correction factor of 0.5X where appropriate to residue levels found in the validated samples, all residues were less than or equal to the method LOQ of 0.01 ppm each for total M.A 3 (M.A 3 + 8,9Z-M.A 3 , and total M.A 4 (M.A 4 + 8,9Z-M.A 4 ). Based on these findings, the expected maximum residue levels in apples is 0.02 ppm ((0.01 ppm total M.A 3 (M.A 3 + 8,9Z-M.A 3 ) + 0.01 ppm total M.A 4 (M.A4 + 8,9Z-M.A 4 )).

b. Pears. A total of 6 individual field trials were conducted over a period of two crop seasons (1997, 1998) in the states of California, New York, Oregon and Washington. Number, type and location of trials were in accordance with those specified by Guideline OPPTS 860.1500, Table 2. Applications were made at 1X (3 trials) and 2X (3 trials) the maximum labeled rate of 2 applications of 0.024 lb. ai/acre, or 0.048 lb. ai/acre per crop season. After applying a correction factor of 0.5X where appropriate to residue levels found in the samples, all residues were less than or equal to the method LOQ of 0.01 ppm each for total M.A 3 (M.A 3 + 8,9Z- M.A 3 ) and total M.A 4 (M.A 4 + 8,9Z-M.A 4 ). Based on these findings, the expected maximum residue levels in pears is 0.02 ppm ((0.01 ppm total M.A 3 (M.A 3 + 8,9Z-M.A 3 ) + 0.01 ppm total M.A 4 (M.A 4 + 8,9Z-M.A 4 )).

c. Processed apples. The study was comprised of a single trial located in eastern Washington. The test substance was applied to the treated plot twice at 28 and 7 days prior to normal maturity at 0.240 lb. ai/acre, or 10X the maximum labeled rate. After processing, samples of apple juice and wet pomace were analyzed for total M.A 3 and total M.A 4 . Reported mean values for total milbemectin (total M.A 3 + total M.A 4 ) were as follows: RAC - 0.168 ppm, juice - < 0.01 ppm and wet pomace - 1.067 ppm. The method LOQ in each commodity was 0.01 ppm each for total M.A 3 (M.A 3 + 8,9Z-M.A 3 ) and total M.A 4 (M.A 4 + 8,9Z-M.A 4 ). The concentration factors were determined to be 6.4X for wet pomace and 0.06X for juice. Based on these findings, the expected maximum residue levels in wet apple pomace is 0.15 ppm. No residues in excess of the established tolerances in pome fruit juice, including apple juice, are expected.

v. Stone Fruit Crop Group. The representative crops for this grouping as specified by 40 CFR 180.41 are cherries, peaches and plums. Due to the limited geographical distribution of the crop residue trials for this crop grouping, a geographical restriction of California only is being requested.

a. Cherries. A total of 2 individual field trials were conducted during the 1999 crop season in the state of California. Applications were made at 1X the maximum labeled rate of 2 applications of 0.024 lb. ai/acre per crop season. Analyzed samples of the RAC were < 0.01 ppm for total M.A 3 (M.A 3 + 8,9Z-M.A 3 ) and < 0.01 to 0.0117 ppm total M.A 4 (M.A 4 + 8,9Z-M.A 4 ). Based on analysis of the findings, the expected maximum residue levels in cherries is 0.03 ppm ((0.01 ppm total M.A 3 (M.A 3 + 8,9Z-M.A 3 ) + 0.02 ppm total M.A 4 (M.A 4 + 8,9Z-M.A 4 )).

b. Peaches. A total of 3 individual field trials were conducted during the 1999 crop season in the state of California. Applications were made at 1X the maximum labeled rate of 2 applications of 0.024 lb. ai/acre per crop season. All analyzed samples of the RAC were < 0.01 ppm for total M.A 3 (M.A 3 + 8,9Z-M.A 3 ) and < 0.01 to 0.0145 ppm total M.A 4 (M.A 4 + 8,9Z-M.A 4 ). Based on analysis of the findings, the expected maximum residue levels in peaches is 0.03 ppm ((0.01 ppm total M.A 3 (M.A 3 + 8,9Z-M.A 3 ) + 0.02 ppm total M.A 4 (M.A 4 + 8,9Z-M.A 4 )).

c. Plums. A total of 5 individual field trials were conducted during the 1999 crop season in the state of California. Applications were made at 1X the maximum labeled rate of 2 applications of 0.024 lb. ai/acre per crop season. All analyzed samples of the RAC were < 0.01 ppm for both total M.A 3 (M.A 3 + 8,9Z-M.A 3 ) and total M.A 4 (M.A 4 + 8,9Z-M.A 4 ). Based on analysis of the findings, the expected maximum residue levels in plums is 0.02 ppm (0.01 ppm total M.A 3 ((M.A 3 + 8,9Z-M.A 3 ) + 0.01 ppm total M.A 4 (M.A 4 + 8,9Z-M.A 4 )).

d. Prunes. The study was comprised of a single trial located in California. Applications were made at 5X the maximum labeled rate as 2 applications of 0.12 lb. ai/acre, 21 and 14 days respectively before crop harvest. After processing, samples of prunes were analyzed for total M.A 3 and total M.A 4 . The mean residue levels in plums were < 0.01 ppm of total M.A 3 (M.A 3 + 8,9Z-M.A 3 ) and 0.0193 ppm total M.A 4 (M.A 4 + 8,9Z-M.A 4 ). The mean residue levels in the prunes were < 0.01 ppm of total M.A 3 (M.A 3 + 8,9Z-M.A 3 ) and 0.0179 ppm total M.A 4 (M.A 4 + 8,9Z-M.A 4 ). Based on analysis of the findings, no concentration of residues is expected in the processed commodity, prunes.

vi. Tree Nut Crop Group. The representative crops for this grouping as specified by 40 CFR 180.41 are almonds and pecans.

a. Almonds. A total of 5 individual field trials were conducted during the 1999 crop season in the state of California. Number, type and location of trials were in accordance with those specified by Guideline OPPTS 860.1500, Table 2. Applications were made at 1X the maximum labeled rate of 2 applications of 0.024 lb. ai/acre per crop season. Analyzed samples of the almond nut meat samples were < 0.01 ppm for both total M.A 3 (M.A 3 + 8,9Z-M.A 3 ) and total M.A 4 (M.A 4 + 8,9Z-M.A 4 ). In almond hull samples the residue levels were < 0.01 to 0.0388 ppm of total M.A 3 (M.A 3 + 8,9Z-M.A 3 ) and < 0.01 to 0.0911 ppm total M.A 4 (M.A 4 + 8,9Z-M.A 4 ). Based on analysis of the findings, the expected maximum residue level in almonds is 0.02 ppm ((0.01 ppm total M.A 3 (M.A 3 + 8,9Z-M.A 3 ) + 0.01 ppm total M.A 4 (M.A 4 + 8,9Z-M.A 4 )) and the expected maximum residue level in almond hulls is 0.2 ppm ((0.05 ppm total M.A 3 (M.A 3 + 8,9Z-M.A 3 ) + 0.15 ppm total M.A 4 (M.A 4 + 8,9Z-M.A 4 )).

b. Pecans. A total of 5 individual field trials were conducted during the 1999 crop season in the states of Arkansas, Georgia and Texas. Number, type and location of trials were in accordance with those specified by Guideline OPPTS 860.1500, Table 2. Applications were made at 1X the maximum labeled rate of 2 applications of 0.024 lb. ai/acre per crop season. Analyzed samples of the pecan meat samples were < 0.01 ppm for both total M.A 3 (M.A 3 + 8,9Z-M.A 3 ) and total M.A 4 (M.A 4 + 8,9Z-M.A 4 ). Based on analysis of the findings, the expected maximum residue levels in pecans is 0.02 ppm ((0.01 ppm total M.A 3 (M.A 3 + 8,9Z-M.A 3 ) + 0.01 ppm total M.A 4 (M.A 4 + 8,9Z-M.A 4 )).

A metabolism study in goats was conducted using 14C-labeled milbemycin A 4 . In this study it was determined that the primary route of elimination of milbemectin in the goat was the feces and urine. Only very low levels of total radioactive residues were found in meat or meat by-products, fat, and milk. Based on the total radioactive residue levels in meat, meat by- products and milk found in the goat metabolism study and analysis of the expected feeding levels from consumption of the feed commodities, the registrant has determined that finite residues in fed ruminants are not expected, therefore, no tolerances in meat or meat by-products, fat, and milk are required in accordance with 40 CFR 180.6.

The feed commodities, dried citrus pulp, wet apple pomace and almond hulls, are not utilized as a poultry feed stuff. The feed commodity, cotton meal, is utilized as a poultry feed stuff at 20% of the diet. Since applications of milbemectin at 5X the labeled rate resulted in no detectable residues in cotton seed of total M.A 3 or M.A 4 at the LOQ of 0.01 ppm, no detectable residues are expected to occur in poultry tissues including meat, fat, meat by-products and eggs. Therefore, no tolerances are required under the provisions of 40CFR 180.6.

1. Acute toxicity. The acute oral LD 50 in rats was 762 mg/kg for males and 456 milligrams/kilogram (mg/kg) for females, the dermal LD 50 of technical milbemectin is greater than 5,000 mg/kg, and the 4-hour acute inhalation LC 50 in rats is 1.9 milligrams per liter (mg/L) in males and 2.8 mg/L in females. It is not a dermal irritant or sensitizer and is a mild eye irritant. In a 28-day dermal study in rabbits, the no observed effect level (NOEL) was 1,000 mg/kg/day, the highest dose tested. No effects on mortality, general or specific toxic effects, gross pathology, clinical signs or other measured parameters at 1,000 milligrams/kilogram/day (mg/kg/day). The gross necropsy and histopathological evaluation revealed no apparent compound-related effects.

2. Genotoxicty. The following genotoxicity tests were all negative: Ames gene mutation, CHL chromosome aberration, mouse lymphoma cell mutation and in vivo mouse bone marrow micronucleus.

3. Reproductive and developmental toxicity. No reproductive or teratologic effects were observed in any study with milbemectin. Maternal NOEL's of 20 and 50 milligrams/kilogram/day (mg/kg/day) were observed in rat and rabbit teratogenicity studies but no teratogenic effects were observed at the highest doses tested, 60 and 1,000 mg/kg/day respectively. In a rat reproduction study the NOEL for both parents and offspring was observed to be 200 ppm, equivalent to consumption up to 26.4 mg/kg/day for males and 27.0 mg/kg/day for females. There were no reproductive effects at the highest dose tested, 800 ppm.

4. Subchronic toxicity. A NOEL of 3 mg/kg/day was derived from the dog 90-day feeding study. The NOEL derived from the rat 90-day study was 375 ppm for males. No NOEL was determined for females, however the NOEL from the chronic rat study for females was 150 ppm, equivalent to 8.77 mg/kg/day. The NOEL derived from the dog subchronic study is therefore the lowest of those derived from the studies.

5. Chronic toxicity. A NOEL of 3 mg/kg/day was derived from the dog 12-month feeding study. The NOEL derived from the rat 24-month chronic and oncogenicity study was 150 ppm, equivalent to 6.81 mg/kg/day for males and 8.77 mg/kg/day for females. The NOEL derived from the 96-week mouse oncogenicity study was 200 ppm, equivalent to 18.9 mg/kg/day for males and 19.6 mg/kg/day for females. The NOEL derived from the dog chronic study is, therefore, the lowest of those derived from the chronic studies. Milbemectin did not produce an oncogenic effect in either the rat or mouse study.

6. Neurotoxicity. The NOEL for acute neurotoxicity is 20 mg/kg with no neuropathological effects were noted at a dose levels of 100 mg/kg/day in female and 500 mg/kg/day in males. No histopathological evidence of central or peripheral neuropathology was associated with a single oral gavage dose at 500 mg/kg/day (males) or 100 mg/kg/day (females). The NOEL for subchronic neurotoxicity is the highest dose tested, 750 ppm (equivalent to 59.357 mg/kg/day for males and 72.416 mg/kg/day for females), based on a 13-week rat dietary neurotoxicity study. None of the observations noted during the functional observation battery (FOB) were considered to be related to exposure to the test substance. There were no statistically significant or otherwise notable differences between the mean motor activity counts of the control and treated rats during weeks 4, 8, and 13. There was no macroscopic or microscopic evidence central or peripheral neurotoxicity associated with 13 weeks of dietary administration to rats.

7. Animal metabolism. In a rat metabolism study conducted in Japan, more than 98% of the applied dose was excreted within 7 days, mostly in the feces. Radioactivity in blood reached maximum levels within 3 hours, with a half-life of 7-8 hours. In tissues, maximum levels were reached in 6 hours in the intestines, followed by the liver, fat and stomach. Residues in rats underwent extensive oxidation. Metabolites identified were hydroxy-, epoxy- and dehydrogenated milbemectins, followed by a number of polar metabolites. No metabolite exceeded 5% of the dose. Excretion, tissue distribution and metabolic profile after multiple day dosing was essentially the same as the single dose suggesting that none of the residues accumulate in any tissue.

In a more recent US study, no overt signs of toxicity were associated with 14C-M.A 4 following oral administration to male and female rats at 2.5 and 25 mg/kg. No significant gender-related differences were noted in the excretion, adsorption or distribution of 14C-M.A 4 . In analysis of tissues other than the gastroentestinal (GI) tract, the highest concentrations of total radioactive residue (TRR) was found in the liver for both genders at all time points. The lowest concentrations were found in the brain, eyes, uterus and testes of males and/or females. Excretion of TRR was rapid with most excreted within 24 hours post dose. Total recovery of radioactivity in feces through 168 hours post dose was from 84.8% to 100% for the low dose, and 81.5% to 92.8% for the high dose. Biliary excretion played a significant role in elimination of 14C-M.A 4 in rats. Based on TRR in bile and urine, ca 47% of the dose was absorbed in both sexes at the low dose level, and 40% and 30% were absorbed in males and females respectively at the high dose. Based on pharmacokinetic parameters of TRR in plasma, 14C-M.A 4 reaches maximum concentrations at 2 to 3 hours post dose and is eliminated slowly in the high dose groups. The metabolic pathway of 14C-M.A 4 in rats consists mainly of primary metabolism by hydroxylation, with the major metabolite, 13-hydroxy-M.A 4 , found in all plasma, liver and kidney samples. The unchanged parent compound was detected in the high dose group in all liver samples, except the 24-hour liver samples, all analyzed kidney samples and in the early time points of the plasma samples. It was also found in the 2-hour liver samples of the low dose group. A minor glucuronidation pathway was identified in the bile. Excretion, tissue distribution, and metabolic profiles were the same for single and multiple dosing suggesting that residues do not accumulate.

8. Metabolite toxicology. There is no evidence that the metabolites of milbemectin as identified in either the plant, or animal metabolism studies are of any toxicological significance.

9. Endocrine disruption. There is no evidence from the developmental/chronic studies that milbemectin induces any estrogenic or other endocrine effects.

1. Dietary exposure. Milbemectin is not currently registered as a pesticide in the U.S. and no tolerances have been previously established for food or feed commodities. Analysis of dietary exposure for proposed tolerances was made using Novigen Sciences DEEM software Version 7.62 using the USDA Continuing Survey of Food Intakes by Individuals.

i. Food. Tolerances are proposed for the combined residues of the miticide/ insecticide milbemectin (a mixture of milbemectins containing greater than or equal to 70% milbemycin A 4 [(6R, 25R)-5-O-demethyl-28-deoxy-6, 28-epoxy-25-ethyl-milbemycin B] and less than or equal to 30% milbemycin A 3 [(6R, 25R)-5-O-demethyl-28-deoxy-6, 28-epoxy-25-methyl- milbemycin B] and their 8,9-Z isomers (expressed as parts per million of the parent compound) in or on the following agricultural commodities: citrus crop group - 0.02 ppm, citrus pulp, dried - 0.20 ppm, citrus oil - 0.10 ppm, cotton, undelinted seed (CA only) - 0.02 ppm, cotton gin by-products (CA only) - 0.08 ppm, pome fruit crop group - 0.02 ppm, apple pomace, wet - 0.15 ppm, stone fruit crop group (CA only) - 0.03 ppm, strawberries - 0.04 ppm, tree nut crop group - 0.02 ppm and almond hulls - 0.20 ppm.

a. Acute dietary risk analysis. An acute reference dose (aRfD) of 0.20 mg/kg/day was used in a acute dietary risk analysis. The aRfD is based on oral no observed adverse effects levels (NOAEL's) of 20 mg/kg/day in the acute neurotoxicity and teratology studies in rats, divided by an uncertainty factor of 100 (interspecies safety factor = 10, intraspecies safety factor = 10). There was no evidence from the developmental or chronic studies that milbemectin induces any estrogenic or other endocrine effects. Therefore, the Food Quality Protection Act (FQPA) additional 10X uncertainty factor was not used. In the Tier 1 analysis it was assumed that all residues would be equal to the pending tolerances on cotton seed of 0.02 ppm, strawberries of 0.04 ppm, citrus, pome fruit, tree nuts of 0.02 ppm, and stone fruit of 0.03 ppm. It was assumed that 100% of the nation's acreage would be treated. Based on the review of data from the reproduction and teratology studies, no additional FQPA safety factor was applied to infants, since no additional toxicity to or sensitivity of the fetal or nursing infant test animals was seen during exposure to the test material. Based on this tier 1 analysis, the acute dietary exposure of all infants and nursing infants ( < 1 yr. old) would be only 0.58% at the 99.9 th percentile of the proposed aRfD. The percentage of the proposed aRfD for the U.S. population and all other subgroups are below this amount.

b. Chronic dietary risk analysis. A reference dose(RfD) of 0.03 mg/kg/day was used in a chronic dietary risk analysis. The RfD is based on a NOEL of 3 mg/kg/day derived from the dog 90-day and 12-month feeding studies, the lowest of those derived from the chronic feeding studies. In view of the fact that no special sensitivity in offspring were observed in any test and that no reproductive or teratogenic effects were observed, an uncertainty factor of 100 (interspecies safety factor = 10, intraspecies safety factor = 10) was used for milbemectin. In the Tier 1 analysis it was assumed that all residues would be equal to the pending tolerances on cotton seed of 0.02 ppm, strawberries of 0.04 ppm, citrus, pome fruit, tree nuts of 0.02 ppm, and stone fruit of 0.03 ppm. It was assumed that 100% of the nation's acreage would be treated. Based on the review of data from the reproduction and teratology studies, no additional FQPA safety factor was applied to infants, since no additional toxicity to or sensitivity of the fetal or nursing infant test animals was seen during exposure to the test material. Based on this tier 1 analysis, the dietary exposure of non-nursing infants would be only 0.4% of the proposed RfD. The percentage of the proposed RfD for the U.S. population and all other subgroups are below this amount.

c. Carcinogenic risk analysis. Not applicable. Milbemectin did not produce an oncogenic effect in two animal feeding studies.

ii. Drinking water. A screening level drinking water assessment for milbemectin was conducted using a maximum use scenario. Potential drinking water concentrations were estimated using models generated by GENEEC (surface water) and SCIGROW (ground water). Input parameters for the use models were those which maximized concentrations in water.

Dietary exposures were modeled with DEEM version 7.62 using the USDA Continuing Survey of Food Intakes by Individuals. It was assumed that all residues would be equal to the pending tolerances on cotton seed of 0.02 ppm, strawberries of 0.04 ppm, citrus, pome fruit, tree nuts of 0.02 ppm, and stone fruit of 0.03 ppm. It was assumed that 100% of the nation's acreage would be treated. Both acute and chronic exposures were modeled. For the acute assessment, the 99.9 th percentile of exposure was used. The most highly exposed subpopulations representing children, adult males, and adult females were evaluated. There are no residential exposures to consider at this time.

a. Acute exposure and risk. An aRfD of 0.20 mg/kg/day was used in an acute dietary risk analysis. The aRfD is based on oral NOAEL's of 20 mg/kg/day in the acute neurotoxicity and teratology studies in rats, divided by an uncertainty factor of 100 (interspecies safety factor = 10, intraspecies safety factor = 10). There was no evidence from the developmental or chronic studies that milbemectin induces any estrogenic or other endocrine effects. Therefore, the FQPA additional 10X uncertainty factor was not used.

The estimated screening level water concentrations of milbemectin in surface and ground water are 0.813 μg/L (peak EEC from GENEEC) and 0.005 μg/L (from SCIGROW), respectively. The acute DWLOCs for milbemectin for the most susceptible populations were calculated to be 6,990.83 μg/L, 5,985.45 μg/L and 1,987.55 μg/L for males, 13-19 years; females, 13+ years, nursing; and all infants, respectively.

Since the screening level water concentrations were orders of magnitude less than the acute drinking water levels of concerns (DWLOC's), the Agency should have no concern about exposures from drinking water.

b. Chronic exposure and risk. A RfD of 0.03 mg/kg/day was used in a chronic dietary risk analysis. The RfD is based on NOAEL of 3 mg/kg/day derived from the dog 90-day and 12-month feeding studies, the lowest of those derived from the chronic feeding studies. In view of the fact that no special sensitivity in offspring were observed in any test and that no reproductive or teratogenic effects were observed, an uncertainty factor of 100 (interspecies safety factor = 10, intraspecies safety factor = 10) was used for milbemectin. Based on the review of data from the reproduction and teratology studies, no additional FQPA safety factor was applied to infants, since no additional toxicity to or sensitivity of the fetal or nursing infant test animals was seen during exposure to the test material.

The estimated screening level water concentrations of milbemectin in surface and ground water are 0.434 μg/L (56 day average EEC from GENEEC) and 0.005 μg/L (from SCIGROW), respectively. The chronic DWLOCs for milbemectin for the most susceptible populations were calculated to be 1,049.30 μg/L, 899.13 μg/L and 299.08 μg/L for males, 13-19 years; females, 13+ years, nursing; and non-nursing infants, respectively.

Since the screening level water concentrations were orders of magnitude less than the chronic DWLOC's, the Agency should have no concern about exposures from drinking water.

2. Non-dietary exposure. There are no current non-food uses for milbemectin registered under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), as amended. No non-dietary exposures are expected for the general public. Secondary exposure would not be expected since milbemectin is not expected to be taken up by plants from the soil. The low application rates and short soil half-life are not conductive to buildup in the environment.

At this time, the Agency has not reviewed available information concerning the potentially cumulative effects of milbemectin and other substances that may have a common mechanism of toxicity. For purposes of this petition only, the Agency is considering only the potential risks of milbemectin in its aggregate exposure.

1. U.S. population. . As pointed out above in dietary exposure-food, the acute dietary exposure of all infants and non-nursing infants ( < 1 yr. old) would be only 0.58% at the 99.9 th percentile of the proposed aRfD and the chronic dietary exposure of non-nursing infants would be only 0.4% of the proposed RfD. The percentages of aRfD and chronic RfD for the U.S. population and all other subgroups are below these amounts.

2. Infants and children. In assessing the potential for additional sensitivity of infants and children to residues of milbemectin, EPA considered data from developmental toxicity studies in the rat and rabbit and a 2-generation study in the rat. The developmental toxicity studies are designed to evaluate adverse effects on the developing organism resulting from pesticide exposure during prenatal development to one or both parents. Reproduction studies provide information relating to effects from exposure to the pesticide on the reproductive capability of mating animals and data on systemic toxicity. No developmental or reproductive effects have been observed in any study with milbemectin. The calculation of safety margins with respect to these segments of the population were taken into consideration in the tolerance method validation (TMRC) estimates with respect to the risk associated with the percentage of the reference dose being consumed. It is concluded that there is a reasonable certainty of no harm to infants and children from aggregate exposure to milbemectin residues.

No Codex maximum residue levels have been established for residues of milbemectin. Milbemectin is not yet registered for use on any crop in Canada or Mexico. National maximum residue levels (MRL's) for milbemectin in Japan are as follows: Apple, Pear, Peach, Citrus, Melon, Watermelon, Cucumber, Eggplant, Adzuki-bean - 0.2 ppm, Strawberry, Cherry, Grape - 0.5 ppm, and Tea - 2 ppm. National MRL's for milbemectin in Taiwan are as follows: Small berry (Grape, Strawberry, Star fruit, etc.), Tree fruit (Pear, Apple, Cherry, Peach, Plum, etc.), Vegetables (Eggplant, Cucumber, Tomato, etc.), Melon (Watermelon, Muskmelon, etc.) - 0.2 ppm; Tea - 2 ppm. In general, where national MRL's differ from those proposed to EPA, they are associated with agricultural and regulatory practices that differ from those common in the U.S.

This is a summary of the Commission's Memorandum Opinion and Order (MO&O) in CC Docket No. 02-35, FCC 02-147, adopted May 15, 2002, and released May 15, 2002. This full text may be purchased from the Commission's duplicating contractor, Qualex International, Portals II, 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone 202-863-2893, facsimile 202-863-2898, or via e-mail qualexint@aol.com. It is also available on the Commission's website at http://www.fcc.gov/Bureaus/Common_Carrier/ in-region_applications/bellsouth_gala/welcome.html.

1. History of the Application. On February 14, 2002, BellSouth filed a joint application, pursuant to section 271 of the Telecommunications Act of 1996, with the Commission to provide in-region, interLATA service in Georgia and Louisiana.

2. The Georgia and Louisiana Public Service Commissions' Evaluations. Both the Georgia Public Service Commission (Georgia Commission) and the Louisiana Public Service Commission (Louisiana Commission) advised the Commission, following an extensive review process, that BellSouth met the checklist requirements of section 271 and has taken the statutorily required steps to open its local markets to competition. Consequently, the Georgia Commission and the Louisiana Commission recommended that the Commission approve BellSouth's in-region, interLATA entry in its March 4, 2002 evaluation of the Georgia and Louisiana Application.

3. The Department of Justice's Evaluation. The Department of Justice filed its evaluation of BellSouth's Georgia/Louisiana Application on March 19, 2002. It recommended approval of the application subject to the Commission's review of improvements in BellSouth's operations support systems (OSS).

4. Checklist Item 2—Unbundled Network Elements. Based on the record, the Commission finds that BellSouth has provided “nondiscriminatory access to network elements in accordance with the requirements of sections 251(c)(3) and 252(d)(1)” of the Act in compliance with checklist item 2.

5. The Commission finds that BellSouth UNE rates in Georgia and Louisiana are just, reasonable, and nondiscriminatory, and are based on cost plus a reasonable profit as required by section 252(d)(1). Thus, BellSouth UNE rates in Georgia and Louisiana satisfy checklist item 2. Because the Commission has not previously approved a section 271 application of BellSouth, it conducts a stand-alone analysis of BellSouth's rates, in which it reviews the rates from the “bottom up” to ensure they comply with our TELRIC standards rather than engaging in any benchmarking or other state comparisons. The Commission has previously noted that different states may reach different results that are each within the range of what a reasonable application of TELRIC would produce. After reviewing commenters' criticism of loop rate issues (including use of Universal Digital Loop Carrier and Integrated Digital Loop Carrier, loading factors and fill factors), switching rate issues and Daily Usage File (DUF) rates, the Commission concludes that the Georgia and Louisiana Commissions followed basic TELRIC principles and there is insufficient evidence to demonstrate that the state commissions committed clear error.

6. The Commission also concludes that BellSouth meets it obligation to provide access to its OSS—the systems, databases, and personnel necessary to support the network elements or services. Nondiscriminatory access to OSS ensures that new entrants have the ability to order service for their customers and communicate effectively with BellSouth regarding basic activities such as placing orders and providing maintenance and repair services for customers. The Commission finds that, for each of the primary OSS functions (pre-ordering, ordering, provisioning, maintenance and repair, and billing, as well as change management and technical assistance), BellSouth provides access that enables competing carriers to perform the functions in substantially the same time and manner as BellSouth or, if there is not an appropriate retail analogue in BellSouth's systems, in a manner that permits an efficient competitor a meaningful opportunity to compete.

7. Pursuant to this checklist item, BellSouth must also provide nondiscriminatory access to network elements in a manner that allows other carriers to combine such elements. Based on the evidence in the record, and upon BellSouth's legal obligations under interconnection agreements, BellSouth demonstrates that it provides to competitors combinations of already-combined network element as well as nondiscriminatory access to unbundled network elements in a manner that allows competing carriers to combine those elements themselves.

8. Checklist Item 1—Interconnection. Based on the evidence in the record, the Commission concludes that BellSouth demonstrates that it provides interconnection in accordance with the requirements of section 251(c)(2) and as specified in section 271 and applied in the Commission's prior orders. Pursuant to this checklist item, BellSouth must allow other carriers to interconnect their networks to its network for the mutual exchange of traffic, using any available method of interconnection at any available point in BellSouth's network.

9. BellSouth also demonstrates that its collocation offerings in Georgia and Louisiana satisfy the requirements of sections 251 and 271 of the Act and are in compliance with the Commission's recent Collocation Remand Order. BellSouth demonstrates that it offers interconnection in Georgia and Louisiana to other telecommunications carriers at just, reasonable, and nondiscriminatory rates, in compliance with checklist item 1.

10. Checklist Item 4—Unbundled Local Loops. BellSouth has adequately demonstrated that it provides unbundled local loops as required by section 271. More specifically, BellSouth establishes that it provides access to loop make-up information in compliance with the UNE Remand Order and nondiscriminatory access to stand alone xDSL-capable loops and high-capacity loops. Also, BellSouth provides voice grade loops, both as new loops and through hot-cut conversions, in a nondiscriminatory manner. Finally, BellSouth has demonstrated that it has a line-sharing and line-splitting provisioning process that affords competitors nondiscriminatory access to these facilities.

11. Checklist Item 5—Unbundled Local Transport. Section 271(c)(2)(B)(v) of the competitive checklist requires a BOC to provide “local transport from the trunk side of a wireline local exchange carrier switch unbundled from switching or other services.” The Commission concludes, based upon the evidence in the record, that BellSouth demonstrates that it provides unbundled local transport, in compliance with the requirements of checklist item 5.

12. Checklist Item 6—Unbundled Local Switching. Based on the Commission's review of the record, it concludes that BellSouth provides (1) line-side and trunk side facilities; (2) basic switching function; (3) vertical features; (4) customized routing; (5) shared trunk ports; (6) unbundled tandem switching; (7) usage information for billing exchange access; and (8) usage information for billing for reciprocal compensation in compliance with checklist item 6.

13. Checklist Item 7—911/E911 Access and Directory Assistance/Operation Services. Based on the Commission's review of the record, it finds that BellSouth provides non-discriminatory access to 911 and E911 services and access to directory assistance services to allow the other carrier's customers to obtain telephone numbers and operator call completion services in compliance with checklist item 7.

14. Checklist Item 8—White Pages. Based on the record, the Commission finds that BellSouth provides white page directory listings for customers of the other carrier's telephone exchange service and permits competitive providers of telephone exchange service and toll service to have access to directory listings in compliance with checklist item 8.

15. Checklist Item 11—Number Portability. The Commission finds that BellSouth complies with checklist item 11 in that it provides, to the extent technically feasible, number portability.

16. Checklist Item 12—Local Dialing Parity. Based on the evidence in the record, the Commission concludes that BellSouth provides nondiscriminatory access to such services or information as are necessary to allow the requesting carrier to implement local dialing parity in accordance with the requirements of section 251(b)(3) of the Act in compliance with checklist item 12.

17. Checklist Item 13—Reciprocal Compensation. The Commission finds that BellSouth demonstrates that it provides reciprocal compensation as required by checklist item 13.

18. Checklist Item 14—Resale. Based on the evidence in the record, the Commission concludes that BellSouth demonstrates that it makes telecommunications services, including DSL resale, available in Georgia and Louisiana for resale, in accordance with sections 251(c)(4) and 252(d)(3), and thus satisfies the requirements for checklist item 14.

19. Checklist Items 3, 9 and 10. An applicant under section 271 must demonstrate that it complies with checklist item 3 (poles, ducts, conduits, and rights of way), item 9 (numbering administration), and item 10 (databases and associated signaling). Based on the evidence in the record, and in accordance with Commission rules and orders concerning compliance with section 271 of the Act, the Commission concludes that BellSouth demonstrates that it is in compliance with checklist items 3, 9, and 10 in Georgia and Louisiana. Both the Georgia Commission and the Louisiana Commission also conclude that BellSouth complies with the requirements of each of these checklist items.

20. Compliance with Section 271(c)(1)(A). The Commission concludes that BellSouth demonstrates that it satisfies the requirements of section 271(c)(1)(A) based on the interconnection agreements it has implemented with competing carriers in Georgia and Louisiana. The record demonstrates that competitive LECs serve some business and residential customers using predominantly their own facilities.

21. Section 272 Compliance. BellSouth has demonstrated that it complies with the requirements of section 272.

22. Public Interest Analysis. The Commission concludes that approval of this application is consistent with the public interest. It views the public interest requirement as an opportunity to review the circumstances presented by the applications to ensure that no other relevant factors exist that would frustrate the congressional intent that markets be open, as required by the competitive checklist, and that entry will therefore serve the public interest as Congress expected. While no one factor is dispositive in this analysis, the Commission's overriding goal is to ensure that nothing undermines its conclusion that markets are open to competition.

23. The Commission finds that, consistent with its extensive review of the competitive checklist, barriers to competitive entry in the local market have been removed and the local exchange market today is open to competition. The Commission also finds that the record confirms our view that a BOC's entry into the long distance market will benefit consumers and competition if the relevant local exchange market is open to competition consistent with the competitive checklist.

24. The Commission also finds that the performance monitoring and enforcement mechanisms developed in Georgia and Louisiana, in combination with other factors, provide meaningful assurance that BellSouth will continue to satisfy the requirements of section 271 after entering the long distance market.

25. Section 271(d)(6) Enforcement Authority. Working with the Georgia and Louisiana Commissions, the Commission intends to monitor closely post-entry compliance and to enforce the provisions of section 271 using the various enforcement tools Congress provided us in the Communications Act.

Pursuant to section 6(f) of the Federal Trade Commission Act. 38 Stat. 15 U.S.C. 46(f), and § 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 home page (for May 13, 2002), on the World Wide Web, at “ http://www.ftc.gov/os/2002/05/index.htm. ” A paper copy can be obtained from the FTC Public Reference Room, Room 130-H, 600 Pennsylvania Avenue, NW., Washington, DC 20580, either in person or by calling (202) 326-2222.

Public comments are invited, and may be filed with the Commission in either paper or electronic form. Comments filed in paper form should be directed to: FTC/Office of the Secretary, Room 159-H, 600 Pennsylvania Avenue, NW., Washington, DC 20580. If a comment contains nonpublic information, it must be filed in paper form, and the first page of the document must be clearly labeled “confidential.” Comments that do not contain any nonpublic information may instead be filed in electronic form (in ASCII format, WordPrefect, or Microsoft Word) as part of or as an attachment to email messages directed to the following email box: consentagreement@ftc.gov. Such comments will be considered by the Commission and will be available for inspection and copying at its principal office in accordance with § 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 proposed consent order with Aurora Associated Primary Care Physicians, L.L.C. (“AAPCP”), Richard A. Patt, M.D., Gary L. Gaede, M.D., and Marcia L. Brauchler (“Respondents”). The agreement settles charges that Respondents violated section 5 of the Federal Trade Commission Act. 15 U.S.C. 45, by facilitating and implementing agreements among AAPCP's members to fix prices and other terms of dealing with health insurance firms and other third-party payors (hereinafter, “payors”), and to refuse to deal with payors except on collectively determined terms. The proposed consent order has been placed on the public record for 30 days to receive comments from interested persons. Comments received during this period will become part of the public record. After 30 days, the Commission will review the agreement and the comments received, and will decide whether it should withdraw from the agreement or make the proposed order final.

The purpose of this analysis is to facilitate public comment on the proposed order. The analysis is not intended to constitute an official interpretation of the agreement and proposed order, or to modify their terms in any way. Further, the proposed consent order has been entered into for settlement purposes only and does not constitute an admission by any Respondent that said Respondent violated the law or that the facts alleged in the complaint (other than jurisdictional facts) are true.

The allegations in the Commission's proposed complaint are summarized below.

AACP has approximately 45 primary care physicians in its membership. A board of managers operates AAPCP, and Dr. Patt is the board's chairman. Except to the extent that competition has been restrained as alleged in the proposed complaint, AAPCP's members compete with each other as internists, pediatricians, family physicians, or general practitioners, in offices located in the Aurora, Colorado, area. To be competitively marketable to employers and other purchasers in the Aurora areas, a payor's health insurance plan must include in its network of participating physician a large number of primary care physicians who practice in the Aurora area.

The physicians formed AAPCP as a vehicle collectively to negotiate contracts with payors, and thereby to achieve contracts containing higher fees and other, more advantageous terms than the individual physicians could obtain unilaterally. AAPCP members authorized AAPCP to negotiate for this purpose. Members also agreed to accept “non-risk” contracts, which are contracts that do not involve sharing among physicians of financial risk, through arrangements such as capitation or fee withholds. Further, before the entire organization could accept a proposed payor contract, AAPCP's board had to approve it.

In or about May 2000, AAPCP retained Ms. Brauchler, a non-physician consultant, after she had made a board presentation showing how AAPCP could collect fee information from members and use that information to reach a consensus on an initial fee level to demand from payors on the collective membership's behalf.

Sometimes a network of competing physicians uses an agent to convey to payors information obtained individually from the physicians about fees or other significant contract terms that they are willing to accept. The agent may also convey to the physicians all payor contract offers, which the physicians then unilaterally decide whether to accept or reject. Such a “messenger model” arrangement, which is described in the 1996 Statements of Antitrust Enforcement Policy in Health Care jointly issued by the Federal Trade Commission and U.S. Department of Justice ( see http://www.ftc.gov/reports/hlth3s.htm. ), can facilitate and minimize the costs involved in contracting between physicians and payors, without fostering an agreement among competing physicians on fees or fee-related terms.

AAPCP purported to operate as a messenger, but, in practice, it did not do so. Rather, in 2000 and 2001, Dr. Patt and Ms. Brauchler, together with Dr. Gaede, who is an ex-officio member of the board, and other physicians designated by Respondent AAPCP, on behalf of Respondent AAPCP's members, used the information gathered from members to negotiate fees and other competitively significant terms collectively on behalf of AAPCP's members. Only if a payor offered a contract containing sufficiently high fees did Drs. Patt and Gaede and Ms. Brauchler recommend that the board approve the contract and that the members accept it. The Respondent's refused to recommend to the board, or convey to AAPCP's members, contract offers containing price and other terms that they deemed to be deficient. Instead, they demanded, and received, contract terms that were more economically advantageous, from the physicians' perspective, than the physicians themselves could have obtained by negotiating individually rather than collectively.

AAPCP functioned as its members' de facto exclusive representative. Drs. Patt and Gaede and Ms. Brauchler told payors that AAPCP had the authority to negotiate and sign contracts on behalf of all of its members, and AAPCP's members themselves sent letters to payors, asserting that they would deal with payors only through AAPCP and not unilaterally. Respondents also successfully applied coercive tactics. For example, they advised AAPCP members to terminate, or threaten to terminate, their pre-existing, individual contracts with payors. Many AAPCP members complied, to pressure payors into offering a new contract to AAPCP that paid fees at or above the level that the physicians, through AAPCP, collectively demanded. The terminations and threats of termination left payors in the untenable position of having to pay higher fees to AAPCP members, or being denied such members' inclusion in the payors' respective provider networks. As a consequence of this conduct, AAPCP or its members contracted with various payors for fees that were higher than the fees such payors had agreed to pay other primary care physicians in the area.

Respondents' joint negotiation of fees and other competitively significant terms has not been reasonably related to any efficiency-enhancing integration. AAPCP members have not financially or clinically integrated their practices to create sufficiently substantial potential efficiencies. Respondents' actions have restrained price and other forms of competition among the members, caused fees for physician services to rise, and harmed consumers, including health plans, employers, and individual patients.

The proposed order is designed to prevent recurrence of these illegal concerted actions, while allowing Respondents to engage in legitimate conduct that does not impair competition. The proposed order's core prohibitions are contained in Paragraph II and III.

Paragraph II is intended to prevent the Respondents from participating in, or creating, future unlawful physician agreements.

Paragraph II.A prohibits, AAPCP, Drs. Patt and Gaede, and Ms. Brauchler from entering into or facilitating any agreement between or among any physicians: (1) To negotiate with payors on any physician's behalf; (2) to deal, not to deal, or threaten not to deal with payors; (3) on what terms to deal with any payor; or (4) not to deal individually with any payor, or not to deal with any payor through an arrangement other than AAPCP.

Paragraph II.B prohibits these Respondents from facilitating exchanges of information between physicians concerning whether, or on what terms, to contract with a payor. Paragraph II.C prohibits them from attempting to engage in any action prohibited by Paragraph II.A or II.B. Paragraph II.D prohibits them from inducing anyone to engage in any action prohibited by Paragraphs II.A through II.C.

Paragraph II also contains three provisos intended to clarify certain types of agreements that Paragraph II does not prohibit. The first proviso applies to Ms. Brauchler, the second to Drs. Patt and Gaede, and the third to AAPCP. Each provides that nothing in Paragraph II prohibits the applicable Respondent from engaging in conduct that is reasonably necessary to form, participate in, or act in furtherance of, a “qualified risk-sharing joint arrangement” or a “qualified clinically-integrated joint arrangement.” The proviso applies to AAPCP only if the physicians who participate in the arrangement are available to enter into payor contracts outside the arrangement, i.e., the arrangement is not exclusive.

As defined in the proposed order, a “qualified risk-sharing joint arrangement” must satisfy two conditions. First, all physician participants must share substantial financial risk through the arrangement and thereby create incentives for the physician participants jointly to control costs and improve quality by managing the provision of services. Second, any agreement concerning reimbursement or other terms or conditions of dealing must be reasonably necessary to obtain significant efficiencies through the joint arrangement. The definition of financial risk-sharing tracks the discussion of that term contained in the Health Care Statements.

As defined in the proposed order, a “qualified clinically-integrated joint arrangement” also must satisfy two conditions. First, all physician participants must participate in active and ongoing programs to evaluate and modify their clinical practice patterns, creating a high degree of interdependence and cooperation among physicians, in order to control costs and ensure the quality of services provided. Second, any agreement concerning reimbursement or other terms or conditions of dealing must be reasonably necessary to obtain significant efficiencies through the joint arrangement. This definition also reflects the analysis contained in the Health Care Statements.

Paragraph II's provisos, as they apply to Drs. Patt and Gaede and Ms. Brauchler, also provide that Paragraph II does not prohibit them from facilitating an agreement solely between physicians who are part of the same medical group practice. The proposed order defines such a practice as a bona fide, integrated firm in which physicians practice medicine together as partners, shareholders, owners, members, or employees, or in which only one physician practices medicine.

Paragraph III prohibits Ms. Brauchler, for a period of three years, from negotiating with any payor on behalf of any current or past member of AAPCP, and from advising any current or past member of AAPCP to accept or reject any term, condition, or requirement of dealing with any payor.

Ms. Brauchler is not prohibited from performing legitimate “messenger” services, including with respect to AAPCP. As noted above, a properly constituted messenger can efficiently facilitate the establishment of physician-payor contracts and avoid fostering unlawful agreements among the participating physicians. As set forth in the proposed complaint, however, while Ms. Brauchler purported to operate as a legitimate messenger, in practice she fostered anticompetitive physician agreements by negotiating directly with payors for higher fees on behalf of AAPCP's entire membership, and by advising AAPCP's members collectively to reject various payor offers and to engage in concerted refusals to deal. For this reason, Paragraph III is a necessary and appropriate supplement to Paragraph II's provisions. Under the proposed order, Ms. Brauchler may serve as AAPCP's messenger, but, pursuant to Paragraph III, may not negotiate for or advise any AAPCP member with respect to payor contracts.

Paragraph IV.C requires AAPCP to terminate, without penalty at any payor's request, current contracts with payors with respect to providing physician services. This provision is intended to eliminate the effects of Respondents' anticompetitive concerted actions. The remaining provisions of Paragraph IV and Paragraphs V through VIII of the proposed order impose obligations on Respondents with respect to distributing the proposed complaint and order to AAPCP's members and to other specified persons, and reporting information to the Commission.

The proposed order will expire in 20 years.

Pursuant to section 6(f) of the Federal Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46(f), and § 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 Home Page (for May 13, 2002), on the World Wide Web, at “ http://www.ftc.gov/os/2002/05/index.htm. ” A paper copy can be obtained from the FTC Public Reference Room, Room 130-H, 600 Pennsylvania Avenue, NW., Washington, DC 20580, either in person or by calling (202) 326-2222.

Public comments are invited, and may be filed with the Commission in either paper or electronic form. Comments filed in paper form should be directed to: FTC/Office of the Secretary, Room 159-H, 600 Pennsylvania Avenue, NW., Washington, DC 20580. If a comment contains nonpublic information, it must be filed in paper form, and the first page of the document must be clearly labeled “confidential.” Comments that do not contain any nonpublic information may instead be filed in electronic form (in ASCII format, WordPerfect, or Microsoft Word) as part of or as an attachment to email messages directed to the following email box: consentagreement@ftc.gov. Such comments will be considered by the Commission and will be available for inspection and copying at its principal office in accordance with § 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 proposed consent order with Physician Integrated Services of Denver, Inc. (“PISD”), Michael J. Guese, M.D., and Marcia A. Brauchler (“Respondents”). The agreement settles charges that Respondents violated section 5 of the Federal Trade Commission Act, 15 U.S.C. 45, by facilitating and implementing agreements among PISD's members to fix prices and other terms of dealing with health insurance firms and other third-party payors (hereinafter, “payors”), and to refuse to deal with payors except on collectively determined terms. The proposed consent order has been placed on the public record for 30 days to receive comments from interested persons. Comments received during this period will become part of the public record. After 30 days, the Commission will review the agreement and the comments received, and will decide whether it should withdraw from the agreement or make the proposed order final.

The purpose of this analysis is to facilitate public comment on the proposed order. The analysis is not intended to constitute an official interpretation of the agreement and proposed order, or to modify their terms in any way. Further, the proposed consent order has been entered into for settlement purposes only and does not constitute an admission by any Respondent that said Respondents violated the law or that the facts alleged in the complaint (other than jurisdictional facts) are true.

The allegations in the Commission's proposed complaint are summarized below.

PISD has approximately 41 primary care physicians in its membership. Dr. Guese is PISD's president and sole director. Ms. Branchler is a consultant and advisor to PISD. Except to the extent that competition has been restrained in the manner set forth in the proposed complaint, PISD's members compete with each other as internists, pediatricians, family physicians, or general practitioners, in offices located in the southern part of the Denver, Colorado, metropolitan area (“South Denver area”). To be competitively marketable to employers and other purchasers in the South Denver area, a payor's health insurance plan must include in its network of participating physicians a large number of primary care physicians who practice in the South Denver area.

The physicians formed PISD as a vehicle collectively to negotiate contracts with payors, and thereby to achieve contracts containing higher fees and other, more advantageous terms than the individual physicians could obtain unilaterally. PISD members authorized PISD to negotiate for this purpose. They also authorize PISD to negotiate “non-risk” contracts, which are contracts that do not involve sharing among physicians of financial risk, through arrangements such as capitation or fee withholds. Further, before the entire organization can accept a proposed mayor contract, a majority of PISD's members must approve it.

Sometimes a network of competing physicians uses an agent to convey to payors information obtained individually from the physicians about fees or other significant contract terms that they are willing to accept. The agent may also convey to the physicians all payor contract offers, which the physicians then unilaterally decide whether to accept or reject. Such a “messenger model” arrangement, which is described in the 1996 Statements of Antitrust Enforcement Policy in Health Care jointly issued by the Federal Trade Commission and U.S. Department of Justice (see http://www.ftc.gov/reports/hlth3s.htm. ), can failitate and minimize the costs involved in contracting between physicians and payors, without fostering an agreement amont competing physicians on fees or fee-related terms.

PISD purported to operate as a messenger, but, in practice, it did not do so. Rather, from 1999 through 2001, Dr. Guese and Ms. Brauchler negotiated fees and other competitively significant terms collectively on behalf of PISD's members. Only if a payor offered a contract containing sufficiently high fees did Dr. Guese and Ms. Brauchler recommend to the members that they accept the contract. Dr. Guese and Ms. Brauchler refused to convey to PISD's members contract offers containing price and other terms that Dr. Guese and Ms. Brauchler deemed to be deficient. Instead, they demanded, and received, contract terms that were more economically advantageous, from the physicians' perspective, than the physicians themselves could have obtained by negotiating individually rather than collectively.

PISD functioned as its members' de facto exclusive representative. Respondents told payors that PISD had the authority to negotiate and sign contracts on behalf of all of its members, and members themselves sent letters to payors, asserting that they would deal with payors only through PISD, Dr. Guese, or Ms. Brauchler, and not unilaterally. Respondents also successfully applied coercive tactics. For example, they advised PISD members to terminate, or threaten to terminate, their pre-existing, individual contracts with payors. Many PISD members complied, to pressure payors into offering a new contract to PISD that paid fees at or above the level that the physicians, through PISD, collectively demanded. The terminations and threats of termination left payors in the untenable position of having to pay higher fees to PISD members, or being denied such members' inclusion in the payors' respective provider networks. As a consequence of this conduct, PISD or its members contracted with various payors for fees that were higher than the fees such payors had agreed to pay other primary care physicians in the area.

Respondents' joint negotiation of fees and other competitively significant terms has not been reasonably related to any efficiency-enhancing integration. PISD refused to consider any form of financial risk-sharing, and its members have not clinically integrated their practices to create sufficiently substantial potential efficiencies. Respondents' actions have restrained price and other forms of competition among the members, caused fees for physician services to rise, and harmed consumers, including health plans, employers, and individual patients.

The proposed order is designed to prevent recurrence of these illegal concerted actions, while allowing Respondents to engage in legitimate conduct that does not impair competition. The proposed order's core prohibitions are contained in Paragraphs II and III.

Paragraph II is intended to prevent the Respondents from participating in, or creating, future unlawful physician agreements.

Paragraph II.A prohibits PISD, Dr. Guese, and Ms. Brauchler from entering into or facilitating any agreement between or among any physicians: (1) To negotiate with payors on any physician's behalf; (2) to deal, not to deal, or threaten not to deal with payors; (3) on what terms to deal with any payor; or (4) not to deal individually with any payor, or not to deal with any payor through an arrangement other than PISD.

Paragraph II.B prohibits these Respondents from facilitating exchanges of information between physicians concerning whether, or on what terms, to contract with a payor. Paragraph II.C prohibits them from attempting to engage in any action prohibited by Paragraph II.A or II.B. Paragraph II.D prohibits them from inducing anyone to engage in any action prohibited by Paragraphs II.A through II.C.

Paragraph II also contains three provisos intended to clarify certain types of agreements that Paragraph II does not prohibit. The first proviso applies to Ms. Brauchler, the second to Dr. Guese, and the third to PISD. Each provides that nothing in Paragraph II prohibits the applicable Respondent from engaging in conduct that is reasonably necessary to form, participate in, or act in furtherance of, a “qualified risk-sharing joint arrangement” or a “qualified clinically-integrated joint arrangement.” The proviso applies to PISD only if the physicians who participate in the arrangement are available to enter into payor contracts outside the arrangement, i.e. , the arrangement is not exclusive.

As defined in the proposed order, a “qualified risk-sharing joint arrangement” must satisfy two conditions. First, all physician participants must share substantial financial risk through the arrangement and thereby create incentives for the physician participants jointly to control costs and improve quality by managing the provision of services. Second, any agreement concerning reimbursement or other terms of conditions of dealing must be reasonably necessary to obtain significant efficiencies through the joint arrangement. The definition of financial risk-sharing tracks the discussion of that term contained in the Health Care Statements.

As defined in the proposed order, a “qualified clinically-integrated joint arrangement” also must satisfy two conditions. First, all physician participants must participate in active and ongoing programs to evaluate and modify their clinical practice patterns, creating a high degree of interdependence and cooperation among physicians, in order to control costs and ensure the quality of services provided. Second, any agreement concerning reimbursement or other terms or conditions of dealing must be reasonably necessary to obtain significant efficiencies through the joint arrangement. This definition also reflects the analysis contained in the Health Care Statements.

Paragraph II's provisos, as they apply to Dr. Guese and Ms. Brauchler, also provide that Paragraph II does not prohibit them from facilitating an agreement solely between physicians who are part of the same medical group practice. The proposed order defines such a practice as a bona fide, integrated firm in which physicians practice medicine together as partners, shareholders, owners, members, or employees, or in which only one physician practices medicine.

Paragraph III prohibits Ms. Brauchler, for a period of three years, from negotiating with any payor on behalf of any current or past member of PISD, and from advising any current or past member of PISD to accept or reject any term, condition, or requirement of dealing with any payor.

Ms. Brauchler is not prohibited from performing legitimate “messenger” services, including with respect to PISD. As noted above, a properly constituted messenger can efficiently facilitate the establishment of physician-payor contracts and avoid fostering unlawful agreements among the participating physicians. As set forth in the proposed complaint, however, while Ms. Brauchler purported to operate as a legitimate messenger, in practice she fostered anticompetitive physician agreements by negotiating directly with payors for higher fees on behalf of PISD's entire membership, and by advising PISD's members collectively to reject various payor offers and to engage in concerted refusals to deal. For this reason, Paragraph III is a necessary and appropriate supplement to Paragraph II's provisions. Under the proposed order, Ms. Brauchler may serve as PISD's messenger, but, pursuant to Paragraph III, may not negotiate for or advise any PISD member with respect to payor contracts.

Paragraph IV.C requires PISD to terminate, without penalty at any payor's request, current contracts with payors with respect to providing physician services. This provision is intended to eliminate the effects of Respondent's anticompetitive concerted actions. The remaining provisions of Paragraph IV and Paragraphs V through VIII of the proposed order impose obligations on Respondents with respect to distributing the proposed complaint and order to PISD's members and to offer specified persons, and reporting information to the Commission.

The proposed order will expire in 20 years.

Item 1300 inadvertently was omitted when the currently effective version of the STOS was implemented upon publication in the Federal Register (66 FR 63061, December 4, 2001). This Federal Register publication of Item 1300 serves to correct omission of Item 1300 from the December 4, 2001, version of the STOS, and to incorporate this item in the STOS in amended version that provides TSP's a means of compensating for operating expenses changes due to sudden and unforeseen fuel cost increases or decreases.

The provisions of subsections A through E of this section govern a Fuel Related General Rate Adjustment (FRGRA) that a Transportation Service Provider (TSP) participating in this STOS (including revisions to or reissues thereof) makes to its line-haul charge.

A. General. The FRGRA provides a TSP flexibility to obtain reasonable relief from sudden and unforeseen increases in diesel fuel prices. Additionally, the FRGRA requires a TSP to correspondingly discount its line-haul charge when there are sudden and unforeseen decreases in diesel fuel prices. Since fuel related rate adjustments for gradual changes in a TSP's fuel related costs over a longer period of time are beyond the purpose of this provision, a TSP should consider gradual fuel price changes when it submits or supplements its STOS rates during a rate filing open window if such changes significantly affect the TSP's operating costs.

B. Application. The FRGRA is applicable to all GSA negotiated/accepted rate offers as well as rate offers negotiated/accepted by a Federal agency that participates in the STOS. The FRGRA may be waived or altered only by the Freight Program Management Office (FPMO) or appropriate Federal agency that negotiated/accepted the rate offer.

C. Setting Baseline. Diesel fuel price ranges and corresponding applicable percent rate adjustment levels were collaboratively established with the motor TSP industry as of November 2000. The levels specified in this section reflect current standard industry practice and will be reviewed and revised on an as-needed basis.

D. Computation.

1. Determination of Adjustment. Each Monday, or first working day thereafter if the Monday falls on a Federal Holiday (hereinafter referred to as “Monday”), the Department of Energy, Energy Information Administration (EIA), posts the National U.S. Average diesel fuel price. If a FRGRA is justified under subsection D of this section based on each Monday's posting, the FRGRA applies to shipments picked up the ensuing Wednesday through the following Tuesday (Note: shipment pickup date is controlling for FRGRA purposes). A TSP is responsible for monitoring diesel fuel prices each Monday using one of the sources identified below to determine whether a FRGRA will apply for the one-week period beginning the upcoming Wednesday through Tuesday of the following week.

• EIA Web site: http://www.eia.doe.gov/

• EIA Weekly Petroleum Status Report

• EIA Hotline: (202) 586-6966

2. Amount of Adjustment. If on any given Monday National U.S. Average disease fuel prices, as published in one of the sources identified in subsection D1, exceed or fall below the neutral range specified in the table under subsection D2c, a TSP will compute its FRGRA under subsection D2a or b, as appropriate.

a. If the National U.S. Average diesel fuel prices exceed the neutral range, the TSP may increase its line-haul charge by the appropriate percentage specified in the table under subsection D2c; or

b. If the National U.S. Average diesel fuel prices fall below the neutral range, the TSP must decrease its line-haul charge by the percentage specified in the table under subsection D2c.

c. Increase/Decrease Schedule: The following table specifies the percentage FRGRA to be applied based on diesel fuel cost per gallon:

E. Billing Procedures. A TSP must clearly show the amount of any diesel fuel rate adjustment, either an increase or a decrease (discount), as a separate line item on all affected freight bills, Transportation Service Orders (TSO's), or bills of lading.

In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA sponsors must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved under a new drug application (NDA). Sponsors of ANDAs do not have to repeat the extensive clinical testing otherwise necessary to gain approval of an NDA. The only clinical data required in an ANDA are data to show that the drug that is the subject of the ANDA is bioequivalent to the listed drug.

The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products with Therapeutic Equivalence Evaluations,” which is generally known as the “Orange Book.” Under FDA regulations, drugs are withdrawn from the list if the agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).

Under § 314.161(a)(1) (21 CFR 314.161(a)(1)), the agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness before an ANDA that refers to that listed drug may be approved. FDA may not approve an ANDA that does not refer to a listed drug.

Ardeparin sodium injection (Normiflo) was the subject of approved NDA 20-227, formerly held by Wyeth-Ayerst and then by Pharmacia & Upjohn. Normiflo is a low molecular weight heparin indicated for the prevention of deep vein thrombosis which may lead to pulmonary embolism following knee replacement surgery. FDA received a request from Pharmacia & Upjohn, dated May 22, 2001, to withdraw approval of NDA 20-227 for Normiflo injection in accordance with 21 CFR 314.150(c). Following Pharmacia & Upjohn's request, Normiflo was moved from the prescription drug product list to the “Discontinued Drug Product List” section of the Orange Book. Approval of the application was withdrawn on February 11, 2002 (67 FR 6264).

In a citizen petition dated September 19, 2001 (Docket No. 01P-0447/CP1), submitted under 21 CFR 10.30, John W. Herr requested that the agency determine whether ardeparin sodium injection was withdrawn from sale for reasons of safety or effectiveness.

The agency has determined that Normiflo was not withdrawn from sale for reasons of safety or effectiveness. The petitioner identified no data or other information suggesting that Normiflo was withdrawn from sale as a result of safety or effectiveness concerns. FDA has independently evaluated relevant literature and data for possible postmarketing adverse event reports, but has found no information that would indicate this product was withdrawn for reasons of safety or effectiveness.

After considering the citizen petition and reviewing its records, FDA determines that, for the reasons outlined in this notice, ardeparin sodium injection approved under NDA 20-227 was not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will continue to list Normiflo (ardeparin sodium injection) in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to Normiflo (ardeparin sodium injection) may be approved by the agency.

FDA is announcing the availability of a guidance for industry entitled “Carcinogenicity Study Protocol Submissions.” In conjunction with the reauthorization of the Prescription Drug User Fee Act of 1992 (PDUFA), FDA agreed to specific performance goals (PDUFA goals) for activities associated with the development and review of products in human drug applications. The PDUFA goals related to special protocol assessment and agreement provide that, upon request, FDA will evaluate within 45 calendar days certain protocols and issues relating to the protocols to assess whether they are adequate to meet scientific and regulatory requirements identified by the sponsor. Protocols for animal carcinogenicity studies are eligible for this special protocol assessment. This guidance is intended to facilitate the agency's review of protocols for animal carcinogenicity studies by informing sponsors of the types of information the agency relies on during its evaluation of such protocols. A draft guidance of the same name was made available for public comment in a notice published in the Federal Register of November 7, 2000 (65 FR 66757). This guidance contains only minor changes for clarification.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on carcinogenicity study protocol submissions. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

Interested persons may, at any time, submit written or electronic comments on the guidance to the Dockets Management Branch (address above). Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The guidance and received comments are available for public examination in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

Persons with access to the Internet may obtain the document at http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

Rural Access to Emergency Devices Act, 42 U.S.C. 254c note, authorizes grants to community partnerships to provide for the purchase, placement, and training in the use of automated external defibrillators (AEDs) and related activities in eligible rural areas. An applicant must be a multi-county, regional or Statewide consortium of rural community organizations applying as a community partnership. Each community partnership must have a designated lead applicant to apply as the grantee of record and act as a fiscal agent for the partnership. Funding preference  1 will be granted to applications that are Statewide in scope. Additional funding priority  2 will be given to Statewide community partnerships that identify their State Office of Emergency Medical Services as the lead applicant and/or include emergency first response entities ( e.g., EMS, law enforcement and fire departments) that are currently operating without AEDs. In order to qualify as a Statewide community partnership, not every eligible county within a State need apply but must have a State Office as the lead applicant. Selected locations around the State should be identified by the lead applicant to achieve fair geographical, organizational ( e.g., first response verses public access placement) and resource allocation.

The State Office of Emergency Medical Services is a logical lead applicant to disseminate funding to individual entities within the partnership given their statutory role in medical direction and regulation. Other State Offices eligible to accept these Federal grant funds include the State Office of Rural Health or a division within the Department of Health. The State Office of Rural Health is a valuable resource for consulting in public access AED placement for those areas that lack EMS services, or are located too far away to be of practical benefit to a community. Community partnerships that apply without their State Office of Emergency Medical Services as the lead applicant must work with the State Office of Emergency Medical Services on issues related to medical direction and integration and placement of AEDs into existing EMS systems.

Applicants must apply in the form of a community partnership. Interested eligible entities are encouraged to collaborate with a wide range of other providers in developing a broad-based consortium that will make up their community partnerships. These partnerships will include local first response entities ( e.g., EMS, law enforcement and fire departments). In addition, local for- and non-profit entities may be included (that have a demonstrated concern about cardiac arrest survival rates) such as, but are not limited to, community hospitals or clinics, nursing homes and senior citizen day care facilities, governmental facilities, athletic facilities, faith based organizations and schools.

All services provided by the community partnership must be provided in an eligible rural county or Rural-Urban Commuting Area zip code. All State Offices, acting on behalf of the community partnerships within their State, will be required to demonstrate how its services will be directed to the eligible rural areas. A complete listing of these eligible rural areas is available on the Web. Eligible rural counties can be found at (http://www.ruralhealth.hrsa.gov/ruralcoI.htm) and Rural-Urban Commuting Area zip codes can be found at (http://www.ruralhealth.hrsa.gov/ruralcoZIPII.htm). Each is sorted by State.

The HRSA Grants Application Center will screen applications for completeness and responsiveness to the program guidance. Applications that are complete and responsive to the guidance will be evaluated for technical merit by a peer review group convened specifically for this solicitation and in accordance with HRSA grants management policies and procedures. As part of the initial merit review, all applications will receive a written critique. Applications recommended for funding will be discussed fully by the ad hoc peer review group and assigned a priority score for funding. Technical merit will be assessed using the following criteria:

(a) Need for AED equipment and training with documentation using any local standard enumerating average response  3 and transport times (noting mileage to stabilizing and/or definitive care) for the response area and cardiovascular mortality prevalence rates;

(b) Plan for a need-based placement of AEDs and accessibility plan to those AEDs;

(c) Estimated AED purchasing, training, and maintenance costs (include maintenance schedule);

(d) How the grant award will be distributed within the community partnership, with identified names of who will receive funding for each entity within the partnership;

(e) An identified and approved CPR and AED training entity;

(f) Who will use the AEDs, and reference State laws regulating AED usage;

(g) Integration into local EMS systems ensuring medical direction for documented protocols of care and legal oversight; and

(h) A well-defined data collection and reporting mechanism via their State Office of Emergency Medical Services or the State Office of Rural Health should the former be unable to participate.

A further explanation of these criteria will be included in the grant guidance.

The application for the Rural Access to Emergency Devices Grant Program has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act. The OMB clearance number is 0920-0428.

This program is subject to the Public Health System Reporting Requirements (approved under OMB No. 0937-0195). Under these requirements, the community-based non-governmental applicant must prepare and submit a Public Health System Impact Statement (PHSIS). The PHSIS is intended to provide information to State and local health officials to keep them apprized of proposed health services grant applications submitted by community-based organizations within their jurisdictions.

Community-based non-governmental applicants are required to submit the following information to their State Office of Emergency Medical Services no later than the Federal application receipt due date of July 15, 2002:

(a) A copy of the face page of the application (SF 424)

(b) An abstract of the project not to exceed one page, which provides:

(1) A description of the population to be served,

(2) The proposed number of AEDs to be purchased and how many people will be trained within the community partnership,

(3) A description of the coordination planned with the appropriate State agencies (ranging from required notification of AED placement to such agency agreeing to being the lead applicant and/or fiscal agent of a Statewide community partnership should they choose to).

This grant program is subject to the provisions of Executive Order 12372 concerning intergovernmental review of Federal programs by appropriate State and local officials as implemented by 45 CFR part 100. Executive Order 12372 allows States the option of setting up a system for reviewing applications from within their States for assistance under certain Federal programs. Applicants (other than Federally-recognized Indian tribal governments) should contact their State Single Point of Contact (SPOC), a list of which will be included in the application kit, as early as possible to alert them to the prospective applications and receive any necessary instructions on the State process. All SPOC recommendations should be submitted to Larry Poole, Office of Grants Management, Bureau of Primary Health Care, 4350 East West Highway, 11th Floor, Bethesda, Maryland 20814, (301) 594-4260. The due date for State process recommendations is 60 days after the application deadline of July 15, 2002, for competing applications for the Rural Access to Emergency Devices Grant Program. The granting agency does not guarantee to “accommodate or explain” State process recommendations it receives after that date. See part 148 of the PHS Grants Administration Manual, Intergovernmental Review of PHS Programs under Executive Order 12372, and 45 CFR part 100 for a description of the review process and requirements.

Current cancer treatment with chemotherapy or radiation is often accompanied by serious side effects related to cytotoxicity at non-cancerous tissue sites. Depression of bone marrow function is one of the most serious side effects in terms of patient morbidity and mortality. CanFite discovered that Adenosine A3 agonists had both a protective action in preventing neutropenia after cancer therapy and in mobilizing bone marrow stem cells for harvest. They found that these agonists also appear to have direct anti-cancer actions.

The prospective exclusive license will be royalty-bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless, within 60 days from the date of this published Notice, NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.

Properly filed competing applications for a license filed in response to this notice will be treated as objections to the contemplated license. Comments and objections submitted in response to this notice will not be made available for public inspection, and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.

A significant number of patients suffering from schizophrenia prove resistant to treatment with typical neuroleptics. Scientists at the NIH discovered that the administration of an alpha 2 -adrenergic receptor antagonist unexpectedly enhances the therapeutic effect of typical antipsychotic neuroleptics. The present invention provides an improved treatment for patients suffering from serious psychotic mental illness who have proven resistant to treatments with known typical antipsychotic neuroleptics alone.

The prospective exclusive license will be royalty-bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless, within 60 days from the date of this published Notice, NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.

Properly filed competing applications for a license filed in response to this notice will be treated as objections to the contemplated license. Comments and objections submitted in response to this notice will not be made available for public inspection, and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.