A new process-based cotton model, CPM, has been developed to simulate the growth and development of upland cotton (Gossypium hirsutum L.) throughout the growing season with minimal data input. CPM predicts final cotton yield for any combination of soil, weather, cultivar, and sequence of management actions. The executable code, source code, and supporting documentation for the model are available on the webpage of the Office of Technology Transfer, USDA-ARS (http://ott.ars.usda.gov/). The personal computer system requirements to run CPM are minimal, requiring IBM-compatability, Windows 95+, 64K RAM, and 4Mb hard disk space.

The model draws upon the latest scientific knowledge available, and is intended to be used with a wide variety of cotton types across the entire U.S. Cotton Belt. CPM is written in C++ using a new modular structure that allows flexibility and adaptability. This object-oriented structure should allow modules to be incorporated into process-based models of other crop species (see Acock, B. and V. R. Reddy. 1977. Designing an object-oriented structure for crop models. Ecological Modeling 94: 33-44). In addition to being modular and generic, CPM has other advantages over earlier models. Compared to previous cotton models, CPM is more robust, more user-friendly, more easily maintained, and more easily updated with future advances in science. The algorithms that simulate crop growth are derived in part from the best of each of the previous models, and they incorporate new physiological information as well. A new feature of CPM is that it incorporates 2DSOIL, an excellent up-to-date soil and root process model (see Timlin, D. J., Y. Pachepsky, and B. Acock. 1996. A design for a modular, generic soil simulator to interface with plant models. Agronomy Journal 88:162-169). 2DSOIL tracks water movement through the soil-plant-atmosphere continuum with hourly time-steps. It also incorporates a new model of plant water relations that responds realistically to water stress. CPM has updated treatments of carbon and nitrogen stresses compared to previous models, and it is designed for easy addition of responses to phosphorus and potassium. Because the growth of each leaf, internode and fruit is simulated separately, CPM should be easily linked to pest or disease models.

CPM requires fewer and simpler data inputs from users than do previous models. Required inputs at the start of each run include data on weather, soil, cultivar characteristics, and management actions. No prior knowledge of cotton growth is required and no soil or plant measurements are required during the season. Mid-season correction of simulated plant growth is unnecessary. Weather data are best obtained from a weather station near the field, though use of readily available county weather data produces acceptable results. Soils data from the database of the U.S. Department of Agriculture, Natural Resources Conservation Service (NRCS), generally are sufficient to run CPM. These data are maintained and updated by NRCS, and can be accessed if one knows the soil type in which the crop is grown. Data on management actions are entered by the user, and are similar to those of other modern models.

In 1998, CPM underwent limited testing and revision using data from several locations across the U.S. Cotton Belt. In 1999, the evaluation was much more extensive, using data from about 20 locations across the Cotton Belt in a cooperative effort involving ARS scientists, University scientists, and Cooperative Extension Specialists and Agents. The testing utilized the most current cultivars and management practices, including genetically engineered cultivars and ultra-narrow row spacings. Evaluation testing was an independent process from model development and calibration (parameterization). In one test, the model was calibrated using data obtained in 1997 for the variety DPL 5415 RR in Starkville, Mississippi, on a Marietta soil. Calibration of the model involved determining cultivar-specific values of 11 parameters to provide a best fit between model output and measured crop characteristics (e.g., plant height, number of nodes, stem weight, fruit count, fruit weight). The calibrated model accurately predicted plant growth from the same cultivar grown in Stoneville, Mississippi, on a Bosket loam in 1998. Notably, 1997 was a cool wet year, whereas 1998 was a hot dry year. The model's success in simulating responses to these environmental and soils differences indicates its robustness and utility.

CPM has the potential to be useful as a decision aid for cotton farmers and crop production consultants. If fully developed, it would be a valuable tool to optimize management inputs such as irrigation, fertilization, plant growth regulators, and defoliant application prior to harvest. In its current version, however, CPM has not yet been fully validated to be useful as a decision aid. The released version of CPM should be considered an advanced model suitable for research purposes. ARS does not endorse its use for any other purpose at this time. Of particular importance to a decision aid model is the user interface. The interface under which CPM has been developed and tested is one that was earlier developed for the soybean model, GLYCIM, and has been documented elsewhere (Acock, B., Pachepsky, Y. A., Mironenko, E. V., Whisler, F. D., and Reddy, V. R. 1999. GUICS: A Generic User Interface for On-Farm Crop Simulations. Agronomy Journal. 91:657-665). However, this interface is not part of the current release, and the user will need to develop or adapt one for his or her own needs.

The CPM Development Team was an ad hoc group drawn from numerous ARS laboratories across the Cotton Belt. Dr. Basil Acock, ARS, Beltsville, Maryland, led the team that developed CPM to its present stage. Drs. Rick Olson and Yakov Pachepsky were the other central members of the development team. The other team members included, Drs. Eugene Marenenko, Avi Marani, Ron Sequeira, and Hal Lemmon. The CPM Validation Team was led by Dr. Gretchen F. Sassenrath-Cole, ARS, Stoneville, MS, with a very large team of cooperators.

ARS is releasing the source code and documentation of CPM at this time, under the Authority: 35 U.S.C. 207, so that interested parties can continue to develop the model for their own needs and purposes. ARS does not foresee providing monetary or technical support for the efforts of others to refine, adapt, or use this model, and provides no warranty for its use for any purpose. ARS does not reserve any rights or interests in the work that may be performed by others to refine or adapt it. ARS does reserve the right to continue its own refinement of the current version of the model at a later date, should program needs require it.

The Federal Meat Inspection Act (21 U.S.C. 601 et seq. ) and the Poultry Products Inspection Act (21 U.S.C. 451 et seq. ) provide that the statutory provisions requiring inspection of the slaughter of livestock or poultry and the preparation or processing of products thereof do not apply to operations of types traditionally and usually conducted at retail stores and restaurants, when conducted at any retail store or restaurant or similar retail-type establishment for sale in normal retail quantities or service to consumers at such establishments (21 U.S.C. 454(c)(2)and 661 (c)(2)). In §§ 303.1(d) and 381.10(d), respectively (9 CFR 303.1(d) and 381.10(d)), FSIS regulations address the conditions under which requirements for inspection do not apply to retail operations.

Under these regulations, sales to hotels, restaurants, and similar institutions disqualify a store for exemption if they exceed either of two maximum limits: 25 percent of the dollar value of total product sales or the calendar year dollar limitation set by the Administrator. The dollar limitation is adjusted automatically during the first quarter of the year if the CPI, published by the Bureau of Labor Statistics, indicates an increase or decrease of more than $500 in the price of the same volume of product for the previous year. FSIS publishes a notice of the adjusted dollar limitations in the Federal Register . (See paragraphs (d)(2)(iii)(b) and (d)(2)(vi) of §§ 303.1 and 381.10.)

The CPI for 2001 reveals an average annual price increase for meat and meat food products of 4.6 percent and for poultry products of 4.4 percent. When rounded off to the nearest $100.00, the price increase for meat and meat food products is $2,100.00 and for poultry products is $1,800.00. Because the price of meat and meat food products and the price of poultry products have increased by more than $500, in accordance with §§ 300.1 (d)(2)(iii)(b) and 381.10 (d)(2)(iii)( b ) of the regulations FSIS has increased the dollar limitation on sales to hotels, restaurants, and similar institutions from $44,900 to $47,000 for meat and meat food products and from $39,800 to $41,000 for poultry products for calendar year 2002.

Public awareness of all segments of rulemaking and policy development is important. Consequently, in an effort to better ensure that minorities, women, and persons with disabilities are aware of this final rule, FSIS will announce and provide copies of this Federal Register notice in the FSIS Constituent Update . FSIS provides a weekly FSIS Constituent Update via fax to over 300 organizations and individuals. In addition, the update is available on line through the FSIS web page located at http://www.fsis.usda.gov . The update is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, recalls, and any other types of information that could affect or would be of interest to our constituents/stakeholders. The constituent fax list consists of industry, trade, and farm groups, consumer interest groups, allied health professionals, scientific professionals, and other individuals that have requested to be included. Through these various channels, FSIS is able to provide information to a much broader, more diverse audience than would be otherwise possible.

For more information or to be added to the constituent fax list, fax your request to the Congressional and Public Affairs Office, at (202) 720-5704.

Plan revisions are warranted in light of the combined effects of multiple needs for change. The preliminary revision issues have been developed from discussions with Kootenai and Idaho Panhandle National Forests employees, our Monitoring and Evaluation Reports, current science and assessments, and our daily contact with our public. The preliminary issues have been divided into two categories:

Revision Topics—This category includes topics for which resource conditions, technical knowledge, or public perception of resource management have created a “need for change” in the Forest Plans. These topics generally would be significant amendments because their resolution could result in changes to management direction over large areas of the Forests, changes in the mix of goods and services that the Forests provide, and changes to other decisions made in the Forest Plans. They involve choices in management direction where there is no clear public consensus on the best course of action.

Other Revision Items—A number of items were identified that need to be addressed in the Forest Plans, but do not meet the above criteria for Revision Topics. In general, these items represent inadequate or out-of-date Forest Plan direction and addressing these items would not require a significant amendment to the Forest Plans. There appears to be general consensus on how to resolve the issue by rewriting and updating the Forest Plans Standards and Guidelines during Forest Plan Revision. Following are the Revision Topics/Preliminary Issues that have been identified to date:

National Forest System lands are capable of contributing essential elements in managing for sustainability. Sustainability is widely recognized as the overarching objective of land and resource management. Sustainability in land management has three components: ecological, economic, and social. These different components of sustainability are interrelated. The sustainability of ecological systems is a necessary prerequisite for strong, productive economies and enduring human communities. At the same time, we compromise human welfare if we fail to sustain vital, functioning ecological systems. In addition, strong economies and communities are often a prerequisite to societies possessing the will and patience needed to sustain ecological systems.

The revision topics have been developed around the ecological, economic, and social components of sustainability. The planning questions for each revision topic provide information that further defines the topic and how we intend to address it in plan revision.

Ecological sustainability is defined as: “The ability to maintain diversity, productivity, resilience to stress, health, and yields of desired values, resource uses, products, or services over time in an ecosystem while maintaining its integrity.” (cited from Sustaining Ecosystems: A Conceptual Approach, USDA Forest Service, Pacific Southwest Research Station, R5-EM-TP-001, p. 212).

Forest plan monitoring, geographic area assessments, the Northern Region Overview, and the Interior Columbia River Basin Ecosystem Management Project have identified problems in maintaining terrestrial sustainability on our national forest lands. Examples of findings in these assessments indicate we are lacking in early seral tree species and have an increasing amount of shade-tolerant, fire intolerant, and insect and disease prone tree species dominating the landscape. Decades of fire suppression have resulted in higher fuel loading and landscapes that may pose risk to terrestrial sustainability. There is a reduction in large snags on portions of the landscape. Past timber harvest has resulted in a decrease in interior habitat in late successional stands.

What structure, composition, and function of vegetation components are needed to contribute to long-term terrestrial sustainability?

What species are at risk and which are not and what strategies are needed to contribute to sustaining all native and desired non-native species?

Based on monitoring results, preliminary analyses, and public input, the following actions may be proposed in one or more EIS alternative:

• Define the desired conditions for contribution of national forest system lands to terrestrial ecosystem sustainability for appropriate temporal and spatial scales.

• Base management practices on understanding and consideration of natural disturbance processes, including the intensity, frequency, and magnitude of those disturbance regimes.

• Develop a strategy for aggressively treating noxious weed populations through various means, including mechanical, biological and chemical control.

• Develop a monitoring strategy that will measure appropriate indicators of ecological sustainability at multiple scales, and will serve to facilitate adaptive management.

Forest Plan monitoring, geographic area assessments, the Northern Region Overview, and Interior Columbia River Basin Ecosystem Management Project have identified problems with the hydrologic condition of many of our watersheds and aquatic life in our national forest lands. Approximately 165 stream segments or water bodies have been listed by the States as impaired water quality under section 303(d) of the Clean Water Act. Landscape assessments have found that approximately 20 percent of our wastersheds are “not properly functioning,” and 30-50 percent may be “functioning at risk.” In recent years under the Endangered Species Act, two fish species have been listed as “threatened” or “endangered,” and three additional species are being studies for possible future listing.

What are the conditions and trends of the Forests' watersheds, riparian areas, and aquatic biota? How well do the aquatic systems' condition, status and trend contribute to aquatic sustainability?

What management strategies are needed to effectively contribute to the maintance or restoration of aquatic sustainability?

Based on monitoring results, preliminary analyses, and public input, the following actions may be proposed in one or more EIS alternative:

• Provide strategies that maintain the conditions and water quality of watersheds that are “properly functioning” and are fully supporting beneficial uses.

• Provide strageties that will restore watershed conditions and water quality in “not properly functioning,” and “functioning-at risk” watersheds adequately to fully support beneficial uses.

• Facilitate Total Maximum Daily Load (TMDL) implementation plans and schedules coordinated with the States' restoration priorities in watersheds that contain water quality limited (303d) segments and waterbodies.

• Develop strategies that will protect, and where feasible, recover native aquatic and riparian dependent species and prevent the introduction and spread of undesirable non-native aquatic species.

• Develop strategies that will restore aquatic resources, including water quality, watershed systems, streams, lakes and other water bodies, wetlands, riparian areas, and floodplains.

• Prioritize watershed systems for restoration by designing and applying effective Best Management Practices and watershed-scale restoration projects cooperatively with States, Tribes, adjacent land interests, and the public.

The inherent capability of soil to support vegetative growth is central to forest management and is rooted in our land ethic and resource laws. Soil physical and chemical status, within acceptable ranges, is an indicator of maintaining or improving soil productivity. Some soil nutrients are derived from parent materials (geological types); others from organic debris (woody or vegetative materials), wind or water deposits, climate and other factors.

Management practices, such as logging or prescribed fire, may disturb the natural balance of soil nutrients and physical condition, and, particularly with potassium-limited soils, contribute to regeneration problems, slowing growth, and thereby increasing susceptibility to insects and disease. Current research by the Intermountain Forest Tree Nutrition Cooperative is showing that potassium is inherently very low within portions of the Precambrian meta-sedimentary rocks known as the Belt Super-group. Approximately 80% of the KIPZ is located on this Belt Super-group formation. This research indicates that 20-30% of this area may be inherently deficient in potassium. Limited potassium nutrition has been shown to significantly affect Douglas-fir root biochemistry, making these trees much more susceptible to insects and disease.

Other key soil elements that address sustainability of forest soil productivity are detrimental disturbances (compaction, displacement, erosion, and severe burns) and nutrient cycling (residual organics debris). These elements are adequately addressed in the current Forest Plans, FSH direction and best management practices, and will not be part of the plan revision topics.

Does the soil nutrient conditions, and trends support long-term soil productivity on nutrient limited (i.e., potassium-limited) sites?

Based on monitoring results, preliminary analyses, and public input, the following actions may be proposed in one or more EIS alternative:

• Develop criteria to maintain and restore soil productivity on potassium and other nutrient limited soils.

Social and economic components of sustainability include meeting the economic, social, aesthetic, and cultural needs and desires of local communities without reducing the capacity of the environment to provide for the needs and desires of future generations.

National Forest System lands contribute many values, services, outputs, and uses that allow economies and communities to persist, prosper, and evolve.

Recreation, the production of wood fiber, grazing of livestock, and mining are important historic and current uses of the Forest. The level of production of these commodities and recreation uses affects the social and economic environment of local communities. These production and use levels must be sustainable in order to contribute to sustainable economies and communities. Monitoring indicates that wood fiber production levels are far below those estimated to occur in the current Forest Plans. Timber harvest levels for the past 13 years are less than 50% of those projected in the current Forest Plans. Recent assessments indicate that motorized and non-motorized recreation use has increased above levels projected in the current Forest Plans.

What are the jobs, income, costs and values associated with the Forest production and use levels?

How are the lifestyles, values, and beliefs of local communities affected?

Based on monitoring results, preliminary analyses, and public input, the following actions may be proposed in one or more EIS alternative;

• Identify acres suitable for timber production, suitable for grazing, and areas to be withdrawn from mineral entry.

• Identify timber sale volume, grazing levels, mineral development potential, and recreation use associated with each alternative. Estimate the jobs and income generated by these levels of production and use, and their contribution to local communities.

• Identify how scenery management may be used in conjunction with ecosystem management objectives.

• Incorporate the social and cultural values into the alternative development and desired future conditions.

Access to national forest lands is one of the most controversial elements in forest management. Since the 1987 Forest Plans were developed, motorized and non-motorized forms of travel have increased and become more diversified. The advent of mountain bikes and all-terrain vehicles, the growing popularity of four-wheel-drive vehicles and snowmobiles, and increasing non-motorized uses such as hiking, backcountry skiing, and snowshoeing, are all competing for the same land base.

What are the types, quantities, and distribution of access and recreation opportunities?

What are the desired future conditions related to access and recreation?

Based on monitoring results, preliminary analyses, and public input, the following actions may be proposed in one or more EIS alternative:

• Identify a road and trail transportation network that provides an environmentally sound and socially responsive travel management system.

• Specify criteria for developing access strategies by appropriate modes and season of use.

• The Forests may be zoned into various classifications of “recreation opportunity spectrum” for summer and winter uses.

Decades of active fire suppression have altered some ecosystems by increasing fuel levels beyond an acceptable range. In addition, increasing numbers of people are moving from urban areas toward more rural near public lands. This has resulted in more homes and other structures being built near and around national forests. As people, homes, and structures increasingly occupy the wildland/urban interface and as hazard fuels continue to accumulate, a high risk and volatile situation needs to be addressed. Geographic area assessments, the Northern Region Overview, and Interior Columbia River Basin Ecosystem Management Project have identified an increase in fuel loading, duff depth, stand density, and a fuel ladder that can carry fire from the surface into the tree crowns. As a result, wildfire intensity has increased.

Where and when will we manage fire? Where and when will we manage fuels to reduce risks to communities and the environment? How do we balance risks posed by fire and the benefits to the ecosystem that fire provides?

Based on monitoring results, preliminary analyses, and public input, the following actions may be proposed in one or more EIS alternative:

• Develop fire management units (FMU's) consistent with Land and Resource Management Plans that identify appropriate management response strategies for each unit.

• Identify FMU's where wildland fire use, fire protection, and limited or modified wildland fire use is an appropriate tool.

• Identify lands by condition class or risk category.

• Establish monitoring and evaluation programs and measures in Land and Resource Management Plan revisions for restoration activities in fire-adapted ecosystems.

Inventoried Roadless Areas (IRAs) continue to be a topic of interest and controversy to many people in north Idaho and northwest Montana. The IPNF has 47 IRAs totaling 823,000 acres. The KNF has 43 IRAs totaling 638,000 acres. Recent efforts to resolve this issue at the national level have been unsuccessful, leaving the issue to be addressed at the local level during Forest Plan Revision. The 1982 Planning Regulations require that we inventory, evaluate and consider all roadless areas for possible inclusion in the National Wilderness Preservation System.

Which IRAs have potential for Wilderness? Which of the IRAs should be recommended for Wilderness? How should the IRAs not recommended for wilderness be managed?

Based on monitoring results, preliminary analyses, and public input, the following actions may be proposed in one or more EIS alternative:

• Identify and recommend roadless areas for wilderness designation.

• Provide management direction for those roadless areas not recommended for wilderness designation.

Preliminary topics discussed in this section are also important issues to be addressed during Plan revision. However, they are likely not substantial or widespread enough to be major drivers in the EIS alternative themes or forest-wide management area prescriptions and standards.

The planning area includes several unique or outstanding areas and resources of outstanding physical, biological, or social interest. Collectively these are known as “special areas.” Potential formal designations of special areas may include Wilderness (see Revision Topic 7, above); Wild and Scenic Rivers; Research Natural Areas (RNAs); and Special Interest Areas (SIAs) with scenic, historical, geological, botanical, zoological, paleontological, archaeological, or other special characteristics. Research Natural Areas have been established on both Forests. The Plan revision will address establishment of RNAs and SIAs, including an assessment of the needs for additions to the RNA and SIA network.

• Which rivers, or river segments, on the Forests are potentially eligible for addition to the Wild and Scenic Rivers System?

• Are there sufficient RNAs and SIAs designated within the Planning Zone to meet the intent of the national and regional RNA Program and intent of SIA objectives?

• Do designated RNA's need management plans?

• Do designated SIAs need reviews and objectives assigned?

• Which portions of the Forest qualify for other special area designations?

There are currently several historic properties representing the historic period (50-200 years ago) and the prehistoric period (8,000 to 200 years ago) on the Forests. Many of these properties have been evaluated and are eligible to the National Register of Historic Place. Many other properties have not been evaluated. Historic properties are protected by law. Portions of the Forests are part of the traditional homeland of the Kootenai and Salish, Kalispel, Coeur d' Alene, Colville, Pend Oreille, Nez Perce, and Spokane Tribes. The prehistoric properties on the Forest are considered by the Tribes as part of their heritage and they attach traditional cultural significance to these sites.

• Should landscapes containing concentrations of cultural or historic resource properties that are potentially eligible for, or eligible to the National Register of Historic Places, receive special land management prescriptions?

• What kinds of cooperation are needed between the Forest Service, the Tribes, other agencies, and private individuals to protect these areas?

Landownership adjustment is generally considered a tool to accomplish resources or socieconomic objectives, rather than a driving issue in and of itself. Plan revision offers an opportunity to develop agreements about desired future patterns of land ownership that could be achieved through exchanges or purchases. Access to public land is often a related concern where private land development is happening, or likely will occur, adjacent to the Forests.

• Which areas of the Forests need strengthened programmatic direction to guide land ownership pattern adjustments?

• How can goals, objectives, standards, and guidelines for lands adjustment be improved to prioritize agency action, enhance management efficiency, and assist local communities?

The existing Forest Plans were approved in 1987, which indicates it's been approximately 15 years since they were approved. Experience and monitoring have shown the need for changes in management direction for some resources or programs. Several sources have highlighted needed changes in the current Forest Plans. These sources include:

• Public involvement, which has identified new information and public values;

• Monitoring and scientific research, which have identified new information and knowledge gained;

• Forest plan implementation, which has identified management concerns to find better ways for achieving desired conditions; and

• Changes in laws, regulations, and policies.

In addition, direction specific to restoration strategies are not in place to guide management under our current Forest Plans. Changing public views and changes in information and scientific understanding of these ecosystems has also occurred. Some new information is a product of research, while other information has resulted from changes in technology.

Proposed Action: See specific Proposed Actions under each Revision Topic/Preliminary Issue in the Supplementary Information section above.

Responsible Official: The Responsible Official is Brad Powell, Regional Forester, Northern Region, 200 East Broadway, PO Box 7669, Missoula, Montana 59807.

Pursuant to Part 36 Code of Federal Regulations (CFR) 219.10(g), the Regional Forester for the Northern Rockies Region gives notice of the agency's intent to prepare an environmental impact statement for the revision effort described above. The Forests are beginning an environmental analysis and decision-making process for this proposed action so that interested or affected people can participate in the analysis and contribute to the final decision. The Forest Plans describe the intended management of National Forests. According to 36 CFR 219.10(g), Land and Resource Management Plans are ordinarily revised on a 10 to 15 year cycle. Key decisions made in the Forest Plan for long-term management of National Forests are:

• Establishment of forest-wide multiple use goals and objectives, 36 CFR 219.11(b);

• Establishment of forest-wide management requirements (forest-wide standards and guidelines), 36 CFR 219.13-219.17;

• Establishment of management area direction, 36 CFR 219.11;

• Designation of suitable timber land and establishment of allowable sale quantity. Designation of land suitable for grazing and browsing. Identification of lands suitable and available for oil and gas leasing. Provision for a broad spectrum of forest and outdoor recreation opportunities. 36 CFR 219.14-219.16, 219.20-219.21;

• Establishment of requirements for monitoring and evaluating the implementation of the revised plan to meet the requirements of 36 CFR 219.11(d);

• Documentation that we will/will not recommend any further additions to the wilderness preservation system.

A range of alternatives will be considered when revising the Forest Plans. The alternatives will present different options to address the revision topics. A reasonable range of alternatives will be evaluated and reasons given for eliminating some alternatives from detailed study. A “no-action alternative” is required, meaning that management would continue under the existing Plan. Alternatives will provide different ways to address and respond to public issues, management concerns, and resource opportunities identified during the scoping process. In describing alternatives, desired vegetation and resource conditions will be defined. Resource outputs will be estimated in the Forest Plan based on achieving desired conditions.

Opportunities will be provided to discuss the Forest Plan revision. The public is invited to help identify issues and define the range of alternatives to be considered in the environmental impact statement. Forest Service officials will lead these discussions, helping to describe issues and preliminary alternatives. These officials will also explain the environmental analysis process and the disclosures of that analysis, which will be available for public review. Comments identifying issues for analysis and the range of alternatives are encouraged. Issue identification (scoping) meetings will be scheduled for early summer through November 2002. Alternative development meetings will be held in the fall of 2002 and early 2003. Public notice of dates, times, and locations for specific meetings will be provided in local newspapers and posted on the Forest's web sites: http://www.fs.fed.us/rl/kootenai/ or http://www.fs./fed./us/rl/ipnf. Additionally, we will send notices/newsletters to those on the forest plan revision mailing list. Requests to be placed on this mailing list should be sent to the comment address stated above.

The United States has a unique legal relationship with Indian tribal governments as set forth in the Constitution of the United States, treaties, statutes, Executive orders, and court decisions. In fulfillment of our Government-to-Government responsibilities, the Forest Service will be working with Tribal governments in order to address natural and cultural resource issues, treaty rights, and any issues that significantly or uniquely affect Tribes. Meaningful consultation will assure that tribal issues will be addressed within the most critical context of current and projected interests, values, objectives for and uses of national forest lands.

This notice of intent initiates the scoping process, which guides that development of the environmental impact statement. This revision effort is being undertaken to develop management direction that may help contribute to basic agency goals of ecological, social and economic sustainability.

Early public participation will identify the topics to be addressed during Forest Plan revision. The preceding discussion of preliminary revision topics is based upon our assessment of a Plan monitoring and evaluation results; public and agency input during project planning and Plan amendment efforts; and socioeconomic, demographic and political changes. We expect this list to change as people engage in the planning process.

An atmosphere of openness is one of the objectives of the public involvement process, in which all members of the public feel free to share information with the Forest Service regularly. All parts of this process will be structured to maintain this openness.

The Forest Service is seeking information, comments, and assistance from individuals, organizations, tribal governments, and federal, state, and local agencies who are interested in or may be affected by the proposed action (36 CFR 219.6). The Forest Service is also looking for collaborative approaches with members of the public who are interested in forest management. Federal and state agencies and some private organizations have been cooperating in the development of assessments of current biological, physical, and economic conditions. This information will be used to prepare the Draft Environmental Impact Statement (DEIS). The range of alternatives to be considered in the DEIS will be based on public issues, management concerns, resource management opportunities, and specific decisions to be made. Public participation will be solicited from known interested and affected public. News releases will be used to give the public general notice, and public scoping opportunities will be offered in numerous locations. Public participation activities will include (but will not be limited to) requests for written comments, open houses, focus groups, field trips, and collaborative forums.

Public participation will be especially important at several points along the way. The first formal opportunity to comment is during the scoping process (40 CFR 1501.7). Scoping includes (1) Identifying potential issues, (2) from these, identifying significant issues or those that have been covered by prior environmental review, (3) exploring alternatives in addition to No Action, and (4) identifying the potential environmental effects of the proposed action and alternatives.

A draft environmental impact statement will be prepared for comment by the winter of 2003. The comment period on the draft environmental impact statement will be 90 days from the date the Environmental Protection Agency publishes the notice of availability in the Federal Register .

The Forest Service believes, at this early stage, it is important to give reviewers notice of several court rulings related to public participation in the environmental review process. First, reviewers of draft environmental impact statements must structure their participation in the environmental review of the proposal so that it is meaningful and alerts an agency to the reviewer's position and contentions. Vermont Yankee Nuclear Power Corp. v. NRDC, 435 U.S. 519, 553 (1978). Also, environmental objections that could be raised at the draft environmental impact statement stage but that are not raised until after completion of the final environmental impact statement may be waived or dismissed by the courts. City of Angoon v. Hodel, 803 F.2d 1016, 1022 (9th Cir. 1986) and Wisconsin Heritages, Inc. v. Harris, 490 F. Supp. 1334, 1338 (E.D. Wis. 1980). Because of these court rulings, it is very important that those interested in this proposed action participate by the close of the comment period so that substantive comments and objections are made available to the Forest Service at a time when it can meaningfully consider them and respond to them in the final environmental impact statement.

To assist the Forest Service in identifying and considering issues and concerns on the proposed action, comments on the draft environmental impact statement should be as specific as possible. It is also helpful if comments refer to specific pages or chapters of the draft statement. Comments may also address the adequacy of the draft environmental impact statement or the merits of the alternatives formulated and discussed in the statement. Reviewers may wish to refer to the Council on Environmental Quality Regulations for implementing the procedural provisions of the National Environmental Policy Act at 40 CFR 1503.3 in addressing these points.

After the comment period on the DEIS ends, comments will be analyzed, considered, and responded to by the Forest Service in preparing the Final EIS. The FEIS is scheduled to be completed in 2005. The responsible official will consider the comments, responses, environmental consequences discussed in the FEIS, and applicable laws, regulations, and policies in making decisions regarding these revised Forest Plans. The responsible official will document the discussions and reasons for the decisions in Record of Decisions for the revised Plans. The decisions will be subject to appeal in accordance with 36 CFR 217.

The business meeting on May 17, begins at 10:00 AM, at Richard A. Halfmoon Tribal Council Chambers, Main Street and Beavers Grade, Lapwai, Idaho. Agenda topics will include review of proposed projects and project selections. A public forum will begin at 2:30 PM (PST).

The environmental assessment of this federally assisted action indicates that the project will not cause significant local, regional, or national impacts on the environment. As a result of these findings, M. Darrel Dominick, State Conservationist, has determined that the preparation and review of an environmental impact statement is not needed for this project.

The project purposes are flood control and watershed protection. The planned works of improvement include the rehabilitation of two aging floodwater retarding structures and associated land treatment for sediment control.

The Notice of a Finding of No Significant Impact (FONSI) has been forwarded to the Environmental Protection Agency and to various Federal, State, and local agencies and interested parties. A limited number of copies of the FONSI are available to fill single copy requests at the above address. Basic data developed during the environmental assessment are on file and may be reviewed by contacting M. Darrel Dominick.

No administrative action on implementation of the proposal will be taken until 30 days after the date of this publication in the Federal Register .

On December 21, 2000, the “Launching Our Communities” Access to Local Television Act of 2000,” was signed into law as Public Law 106-553. The Act provides for the establishment of the Local Television Loan Guarantee Board (the “Board”), which consists of the Secretaries of Agriculture, Treasury, and Commerce, and the Chair of the Board of Governors of the Federal Reserve System, or their designees. The Board may approve loan guarantees up to 80 percent of $1.25 billion in loans, to facilitate access, on a technologically neutral basis, to signals of local television stations for households located in nonserved areas and underserved areas. The Act stipulates that, among other provisions, the Administrator of RUS shall prescribe regulations to implement the Act and shall issue and otherwise administer loan guarantees approved by the Board. No funds were appropriated for the Act for fiscal year (FY) 2001; hence, RUS was not authorized to draft and implement regulations until program funds were appropriated. The Agriculture FY 2002 Appropriations bill, signed into law on November 28, 2001, included $20,000,000 for the cost of guaranteed loans and $2,000,000 for salaries and administrative expenses to implement the Act. Under the provisions of the Appropriations Act, $258 million in loan guarantee authority is available for FY 2002.

As noted above, regulations must be prescribed on a “technologically neutral” basis. However, the $258 million appropriated for loan guarantees may limit the type of technology that can be financed. As the Act also contains several specialized technical and business provisions, RUS encourages interested parties to review the Act in its entirety on the RUS website at: http://www.usda.gov/rus/telecom/initiatives/initiatives.htm.

RUS is requesting comment and discussion on the following topics:

(1) RUS seeks comment on recent changes in the industry that could affect the delivery of local TV signals to households located in nonserved areas and underserved areas. These changes include, among others, the mergers and acquisitions of cable, telephony, and Internet service providers. One developing factor that may have a significant impact on the provision of local TV signals to markets is the recently proposed merger of the two major direct broadcast satellite (DBS) providers. The Act could be noticeably affected, and its goal virtually fulfilled, if certain requirements are imposed on the survivor. In a February 26, 2002, joint press release, the companies involved in the merger proposed to offer every consumer in the continental United States, Alaska, and Hawaii access to satellite-delivered local television signals, thus covering all designated market areas in the United States.

(2) RUS is aware that new technologies have emerged and continue to develop that could provide local TV signals. RUS is seeking additional information on those technologies and, specifically, technologies that would be the most cost effective method of delivering local TV signals to the largest number of nonserved and underserved rural residences not located in the top 40 designated market areas (as that term is defined in 17 U.S.C. 1226(j)).

(3) In addition to the information solicited by the preceding question, RUS also seeks comments regarding what kinds of technology, if not the same, may be utilized to deliver, and the extent to which rural households located in nonserved and underserved areas could receive, local TV signals using the $258 million authorized for this program this fiscal year only.

(4) RUS is interested in comments from rural TV subscribers, who do not reside in major market TV station areas, concerning what affect, if any, recent Satellite Home Viewer Improvement Act (SHVIA) “carry one, carry all” provisions, effective January 1, 2002, and any other regulatory provisions or new products in the marketplace are having on their local TV viewing.

RUS invites interested parties including, but are not limited to, financial and lending institutions, equipment providers, facility and other TV broadcast providers, cable and satellite providers, trade associations, consumer groups, and individuals to provide RUS, in writing, any information or analyses they believe to be relevant to the issues discussed in this Notice and to the implementation of the loan guarantee program.

At the Board meeting, the Access Board will consider the following agenda items.

• Executive Director's report

• Approval of the minutes of the March 13, 2002 board meeting

• Committee Reports

• Ad Hoc Committee on Water Passenger Vessels

• ADA and ABA Accessibility Guidelines

All meetings are accessible to persons with disabilities. Sign language interpreters and an assistive listening system are available at all meetings. Persons attending Board meetings are requested to refrain from using perfume, cologne, and other fragrances for the comfort of other participants.

Unless otherwise indicated, all citations to the statute are references to the Tariff Act of 1930, as amended (the Act). In addition, unless otherwise indicated, all citations to the Department's regulations are to the current regulations, codified at 19 CFR Part 351 (2002).

On March 29, 2002, the Department received a timely request from Zhenyu, in accordance with section 751(a)(2)(B) of the Act and 19 CFR 351.214(c), for a new shipper review of this antidumping duty order on freshwater crawfish tail meat from the People's Republic of China (“PRC”), which has a September anniversary date.

As required by 19 CFR 351.214(b)(2)(i), (ii), and (iii)(A), Zhenyu, an exporter and producer of crawfish tail meat, has certified that it did not export freshwater crawfish tail meat to the United States during the period of investigation (“POI”), and that it has never been affiliated with any exporter or producer which exported freshwater crawfish tail meat to the United States during the POI. Zhenyu has further certified that its export activities are not controlled by the central government of the PRC, pursuant to the requirements of 19 CFR 351.214(b)(2)(iii)(B). Pursuant to the Department's regulations at 19 CFR 351.214(b)(2)(iv)(A), Zhenyu submitted documentation establishing the date on which it first shipped the subject merchandise to the United States, the date of entry of that first shipment, the volume of that shipment and the date of the first sale to an unaffiliated customer in the United States. After reviewing submissions with respect to the new shipper review request filed on behalf of Zhenyu, the Department has decided that it will initiate this request in accordance with section 351.214(b) of the Department's regulations. See Memo from Barbara E. Tillman to the File , dated April XX, 2002, discussing Zhenyu's request for new shipper review.

In accordance with section 751(a)(2)(B)(ii) of the Act and 19 CFR 351.214(d)(1), we are initiating a new shipper review of the antidumping duty order on freshwater crawfish tail meat from the PRC.

In accordance with 19 CFR 351.214(g)(1)(i)(B) of the Department's regulations, the period of review (POR) for a new shipper review, initiated in the month immediately following the semiannual anniversary month, will be the six-month period immediately preceding the semiannual anniversary month. Therefore, the POR for this new shipper review is:

We will instruct the Customs Service to allow, at the option of the importer, the posting, until the completion of the review, of a bond or security in lieu of a cash deposit for each entry of the merchandise exported by Zhenyu. This action is in accordance with 19 CFR 351.214(e).

The interested parties that need access to proprietary information in this new shipper review should submit applications for disclosure under administrative protective order in accordance with 19 CFR 351.305 and 351.306.

This initiation and notice are in accordance with section 751(a) of the Act (19 U.S.C. 1675(a)) and 19 CFR 351.214(d).

Unless otherwise indicated, all citations are to the Tariff Act of 1930, as amended (the Act). In addition, unless otherwise indicated, all citations to the Department's regulations are to 19 CFR part 351 (2001).

On September 20, 2001, the Department of Commerce received a request from Shouzhou Huaxiang Foodstuffs, Co., Ltd. to conduct a new shipper review of the antidumping duty order on freshwater crawfish tail meat from the People's Republic of China. On September 28, 2001, the Department received a similar request from North Supreme Seafood (Zhejiang) Co., Ltd. On November 8, 2001, the Department found that the requests for review met all of the regulatory requirements set forth in section 351.214(b) of the Department's regulations and initiated these new shipper antidumping reviews covering the period September 1, 2001, through August 31, 2001. See Freshwater Crawfish Tail Meat From the People's Republic of China: Initiation of New Shipper Antidumping Review, 66 FR 56536 (November 8, 2001). The preliminary results are currently due no later than April 30, 2002.

Pursuant to section 751(a)(2)(B) of the Act, the Department may extend the deadline for completion of the preliminary results of a new shipper review if it determines that the case is extraordinarily complicated. The Department has determined that this case is extraordinarily complicated, and the preliminary results of this new shipper review cannot be completed within the statutory time limit of 180 days. The Department has issued supplemental questionnaires on the respondents' claims concerning affiliation and date of sale. In addition, we requested information on entry documentation. Given the issues in this case, the Department finds that this case is extraordinarily complicated. Accordingly, the Department is extending the time limit for the completion of the preliminary results by 97 days, to August 5, 2002, in accordance with section 751(a)(2)(B)(iv) of the Act and 351.214(i)(2) of the Department's regulations. The final results will in turn be due 90 days after the date of issuance of the preliminary results, unless extended.

The NIST Center for Neutron Research (NCNR) is part of the Materials Science and Engineering Laboratory in Gaithersburg, MD. The NCNR is a national center for research using thermal and cold neutrons, offering advanced measurement capabilities for use by all qualified applicants. Many instruments rely on intense beams of cold neutrons emanating from a recently upgraded liquid hydrogen moderator. The application process collects information which is an integral part of the operation of NCNR as a National User Facility. It is comprised of several stages: a competitive, peer-reviewed proposal process, required by the NCNR charter; required site access procedures for successful applicants; and post-visit customer feedback collection.

Web forms and paper forms as a backup method.

OMB Number: None.

Form Number: None.

Type of Review: Regular submission.

Affected Public: Individuals or households, business or for-profit.

Estimated Number of Respondents: 400.

Estimated Time Per Response: 2 hours.

Estimated Total Annual Burden Hours: 800 hours.

Estimated Total Annual Cost to the Public: $0.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

The workgroup will continue its efforts to develop alternatives for rationalizing the Gulf of Alaska Groundfish Fisheries.

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

This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Helen Allen, 907-271-2809, at least 5 working days prior to the meeting date.

On April 24, 2002, under Section 204 of the Agricultural Act of 1956, the Government of the United States requested consultations with the Government of Belarus with respect to women’s and girls’ wool coats in Category 435 and women’s and girls wool slacks, breeches and shorts in Category 448, produced or manufactured in Belarus.

The purpose of this notice is to advise the public that, if no solution is agreed upon in consultations with the Government of Belarus, the Government of the United States reserves its right to establish a twelve-month limit for the period beginning on April 24, 2002, and extending through April 23, 2003, of not less than 55,021 dozen for Category 435 and not less than 23,595 dozen for Category 448 for the entry and withdrawal from warehouse for consumption of textile products in these categories, produced or manufactured in Belarus.

Anyone wishing to comment or provide data or information on imports from Belarus in Categories 435 and 448 is invited to submit 10 copies of such comments or information to James C. Leonard III, Chairman, Committee for the Implementation of Textile Agreements, U.S. Department of Commerce, Washington, DC 20230; ATTN: Becky Geiger. The comments received will be considered in the context of the consultations with the Government of Belarus.

Because the exact timing of the consultations is not yet certain, comments should be submitted promptly. Comments or information submitted in response to this notice will be available for public inspection in the Office of Textiles and Apparel, room H3100, U.S. Department of Commerce, 14th and Constitution Avenue, NW., Washington, DC.

Further comments may be invited regarding particular commentary or information received from the public which the Committee for the Implementation of Textile Agreements considers appropriate for further consideration.

This solicitation of comments is not a waiver in any respect of the exemption contained in 5 U.S.C. 553(a)(1) relating to matters which constitute “a foreign affairs function of the United States.”

The United States remains committed to finding a solution concerning these categories. Should such a solution be reached in consultations with the Government of Belarus, further notice will be published in the Federal Register .

A description of the textile and apparel categories in terms of HTS numbers is available in the CORRELATION: Textile and Apparel Categories with the Harmonized Tariff Schedule of the United States (see Federal Register notice 66 FR 65178, published on December 18, 2001). Also see 66 FR 53783, published on October 24, 2001.

Category 435 imports from Belarus are undermining the implementation of the World Trade Organization (WTO) Agreement on Textiles and Clothing (ATC). The introduction of a limit on Category 435 imports from Belarus is necessary and appropriate to carry out the ATC, and is relevant to the enforcement of the ATC. Current imports from Belarus exceed imports from a number of WTO countries, imports that are limited by agreed levels (see Table I). In fact, calendar year 2001 Category 435 imports from Belarus exceed the agreed levels of 15 countries (see Table II). The orderly flow of trade into the U.S. women’s and girls’ wool coat market is being disrupted and, if Category 435 imports from Belarus are not limited, the orderly integration process called for by the ATC will be impossible.

U.S. imports of women’s and girls’ wool coats, Category 435, from Belarus during calendar year 2001 reached 55,021 dozens, over seven times Belarus’ 1994 level, and 42 percent above the 38,743 dozens imported during the calendar year 2000. Belarus started shipping women’s and girls’ wool coats to the U.S. in 1994, shipping only 7,144 dozens. Belarus is now the 9th largest supplier in Category 435 accounting for 3.5 percent of calendar year 2001 world imports.

Total U.S. imports of women’s and girls’ wool coats, Category 435, reached 1,560,294 dozens in the calendar year 2001 and represent nearly one and a half times the level of U.S. production.

Thailand is a WTO member with whom the United States has negotiated a specific limit. Belarus’ calendar year 2001 import level is higher than Thailand’s calendar year 2001 import level. Moreover, Belarus’ import level for calendar year 2001 exceeds the negotiated specific limits of Uruguay, Indonesia, Korea, Hungary, Taiwan, Bulgaria, China, Slovak Republic, Sri Lanka, Malaysia, Poland, Romania, Singapore, and the Czech Republic, all of which are WTO member countries, and the negotiated specific limit of Macedonia, which is not a WTO member.

The sharp and substantial increase of Category 435 imports from Belarus is disrupting the orderly flow of trade into the U.S. women’s and girls’ wool coat market. The increasing share of unrestrained women’s and girls’ wool coat imports from Belarus is creating an inequitable situation in Category 435. Belarus, by shipping in excess of many WTO member countries that have negotiated quota agreements with the United States under the ATC, is disrupting the orderly flow of trade and creating an inequitable situation.

After undertaking a comparative assessment of Belarus’ Category 435 imports and imports from other sources, the United States has determined that a request for consultations is necessary to correct the inequity between controlled and uncontrolled suppliers in the flow of trade into the U.S. women’s and girls’ wool coat market and to implement and maintain the integrity of the ATC.

Category 448 imports from Belarus are undermining the implementation of the World Trade Organization (WTO) Agreement on Textiles and Clothing (ATC), and the introduction of a limit on Category 448 imports from Belarus is necessary and appropriate to carry out the ATC, and is relevant to the enforcement of the ATC. Current imports from Belarus exceed imports from a number of WTO countries, imports that are limited by agreed levels (see Table I). In fact, calendar year Category 448 imports from Belarus exceed the agreed levels of four countries (see Table II). The orderly flow of trade into the U.S. women’s and girls’ wool slacks, breeches and shorts market is being disrupted and, if Category 448 imports from Belarus are not limited, the orderly integration process called for by the ATC will be impossible.

U.S. imports of women’s and girls’ wool slacks, breeches and shorts, Category 448, from Belarus during calendar year 2001 reached 23,595 dozens, over thirteen times Belarus’ 1995 level, and 29 percent above the 18,328 dozens imported during the calendar year 2000. Belarus started shipping women’s and girls’ wool slacks, breeches and shorts to the U.S. in 1995, shipping only 1,791 dozens. Belarus is now the 14th largest supplier in Category 448 accounting for 2.3 percent of calendar year 2001 world imports.

Total U.S. imports of women’s and girls’ wool slacks, breeches and shorts, Category 448, reached 1,019,208 dozens in the calendar year 2001 and represent nearly two and one half times the level of U.S. production.

Romania and Hungary are WTO members with whom the United States has negotiated specific limits. Belarus’ calendar year 2001 import level is higher than the calendar year 2001 import levels of Romania and Hungary. Moreover, Belarus’ import level for calendar year 2001 exceeds the negotiated specific limits of China, Indonesia, Taiwan, Egypt, and the unilateral restraint of Burma, all of which are WTO member countries.

The sharp and substantial increase of Category 448 imports from Belarus is disrupting the orderly flow of trade into the U.S. women’s and girls’ wool slacks, breeches and shorts market. The increasing share of unrestrained women’s and girls’ wool slacks, breeches and shorts imports from Belarus is creating an inequitable situation in Category 448. Belarus, by shipping in excess of many WTO member countries that have negotiated quota agreements with the United States under the ATC, is disrupting the orderly flow of trade and creating an inequitable situation.

After undertaking a comparative assessment of Belarus’ Category 448 imports and imports from other sources, the United States has determined that a request for consultations is necessary to correct the inequity between controlled and uncontrolled suppliers in the flow of trade into the U.S. women’s and girls’ wool slacks, breeches and shorts market and to implement and maintain the integrity of the ATC.

The Commission has received correspondence from Snow Glow® Inc. requesting that the Commission issue a rule prescribing performance standards for auxiliary hazard lighting systems on snowmobiles. The petitioner asserts that snowmobiles without such auxiliary hazard lighting systems pose an increased risk of collision between snowmobiles and serious injury or death to the operator of either snowmobile involved.

The petitioner maintains that auxiliary hazard lighting systems to reduce or eliminate this risk must exhibit the following characteristics: (1) Have an energy power source separate from the main power source of the snowmobile; (2) operate for a minimum of 40 hours at 0 degrees Fahrenheit and function in temperatures of minus 30 degrees Fahrenheit or colder; (3) have an on-off switch that is separate from the main electrical system; (4) emit yellow light from the front of the snowmobile and red from the rear; and (5) have a flashing display visible in unobstructed darkness from at least one half mile distance, from the front and rear of the snowmobile

The Commission is docketing the correspondence as a petition under provisions of the Consumer Product Safety Act (CPSA), 15 U.S.C. 2051-2084.

Interested parties may obtain a copy of the petition by writing or calling the Office of the Secretary, Consumer Product Safety Commission, Washington, DC 20207; telephone (301) 504-0800. The petition is available on the CPSC website at www.cpsc.gov . A copy of the petition is also available for inspection from 8:30 a.m. to 5 p.m., Monday through Friday, in the Commission's Public Reading Room, Room 419, 4330 East-West Highway, Bethesda, Maryland.

These draft guidelines and supporting documents are available on the Internet at http://www.cpsc.gov/library/infoguides.pdf and are issued pursuant to section 515 of the Treasury and General Government Appropriations Act for Fiscal Year 2001, Public Law 106-554, which mandated that the Office of Management and Budget (OMB) issue government-wide guidelines that “provide policy and procedural guidance to Federal agencies for ensuring and maximizing the quality, objectivity, utility, and integrity of information (including statistical information) disseminated by Federal agencies.” The statute further requires OMB to require each Federal agency to issue its own guidelines. OMB's amended final guidance appears at 67 FR 8452, February 22, 2002, and at http://www.whitehouse.gov/omb/fedreg/final_information_quality.htm . The OMB guidelines, as further revised at 67 FR 9797, March 4, 2002, require each Federal agency to post its own draft guidelines on the Internet by May 1, 2002. Based on comments from the public and OMB, final agency guidelines will be issued by October 1, 2002. Thereafter, starting on January 1, 2004, agencies must file annual fiscal year reports to OMB on the number, nature and resolution of complaints about alleged noncompliance with the agency guidelines.

A paper copy of the guidelines may also be obtained by telephoning Mary Kelsey at 301-504-0000.

The text of the Agreement and Order appears below.

Exports of electricity from the United States to a foreign country are regulated and require authorization under section 202(e) of the Federal Power Act (FPA) (16 U.S.C. 824a(e)).

On April 11, 2002, the Office of Fossil Energy (FE) of the Department of Energy (DOE) received separate applications from UBS for authorization to transmit electric energy from the United States to Mexico and to Canada. UBS, a Swiss corporation formed in 1998 by the merger of Union Bank of Switzerland and Swiss Bank Corporation, is a power marketer that does not own or control any electric generation or transmission facilities nor does it have any franchised service territory in the United States. The designation “London Branch” indicates the principal booking location of the company's energy trading business; UBS AG London Branch and UBS AG are legally the same entity.

In FE Docket No. EA-261, UBS proposes to export electric energy to Mexico and to arrange for the delivery of those exports to Mexico over the international transmission facilities owned by San Diego Gas and Electric Company, El Paso Electric Company, Central Power and Light Company, and Comision Federal de Electricidad, the national electric utility of Mexico. UBS seeks expeditious approval of this application in order to participate in a solicitation for electric power by CFE during the summer of 2002. In FE Docket No. EA-263, UBS proposes to export electric energy to Canada and to arrange for the delivery of those exports over the international transmission facilities owned by Basin Electric Power Cooperative, Bonneville Power Administration, Citizens Utilities, Eastern Maine Electric Cooperative, International Transmission Company, Joint Owners of the Highgate Project, Long Sault, Inc., Maine Electric Power Company, Maine Public Service Company, Minnesota Power, Inc., Minnkota Power Cooperative, New York Power Authority, Niagara Mohawk Power Corporation, Northern States Power, and Vermont Electric Transmission Company.

The construction of each of the international transmission facilities to be utilized by UBS, as more fully described in the applications, has previously been authorized by a Presidential permit issued pursuant to Executive Order 10485, as amended.

Procedural Matters: Any person desiring to become a party to these proceedings or to be heard by filing comments or protests to these applications should file a petition to intervene, comment or protest at the address provided above in accordance with §§ 385.211 or 385.214 of the FERC's Rules of Practice and Procedures (18 CFR 385.211, 385.214). Fifteen copies of each petition and protest should be filed with the DOE on or before the date listed above.

Comments on the UBS applications to export electric energy to Mexico and/or Canada should be clearly marked with Docket EA-261 and/or Docket EA-263, respectively. Additional copies are to be filed directly with Sarah G. Novosel, Bracewell & Patterson, L.L.P., 2000 K Street, NW., Suite 500, Washington, DC 20006-1872 and Robert Frank, Director, Regulatory Affairs, UBS Warburg Energy, LLC, 1500 Louisiana Street, Houston, TX 77010.

A final decision will be made on these applications after the environmental impacts have been evaluated pursuant to the National Environmental Policy Act of 1969, and a determination is made by the DOE that the proposed actions will not adversely impact on the reliability of the U.S. electric power supply system.

Copies of these applications will be made available, upon request, for public inspection and copying at the address provided above or by accessing the Fossil Energy Home Page at http://www.fe.doe.gov. Upon reaching the Fossil Energy Home page, select “Electricity Regulation,” and then “Pending Proceedings” from the options menus.

Title II of the Powerplant and Industrial Fuel Use Act of 1978 (FUA), as amended (42 U.S.C. 8301 et seq. ), provides that no new baseload electric powerplant may be constructed or operated without the capability to use coal or another alternate fuel as a primary energy source. In order to meet the requirement of coal capability, the owner or operator of such facilities proposing to use natural gas or petroleum as its primary energy source shall certify, pursuant to FUA section 201(d), to the Secretary of Energy prior to construction, or prior to operation as a base load electric powerplant, that such powerplant has the capability to use coal or another alternate fuel. Such certification establishes compliance with section 201(a) as of the date filed with the Department of Energy (DOE). The Secretary is required to publish a notice in the Federal Register that a certification has been filed. The following owners/operators of proposed new baseload electric powerplants have filed self-certifications pursuant to section 201(d) and in accordance with DOE regulations in 10 C.F.R. 501.60, 61.

Title: State Program Adequacy Determination—Municipal Solid Waste Landfills (MSWLFs) and Non-municipal, Non-hazardous Waste Disposal Units that Receive Conditionally Exempt Small Quantity Generator (CESQG) Hazardous Waste, OMB Control No. 2050-0152; EPA ICR No. 1608.03, expiring April 30, 2002. This is a request for extension of a currently approved collection.

Abstract: Section 4010(c) of the Resource Conservation and Recovery Act (RCRA) of 1976 requires that EPA revise the landfill criteria promulgated under paragraph (1) of section 4004(a) and section 1008(a)(3). Section 4005(c) of RCRA, as amended by the Hazardous Solid Waste Amendments (HSWA) of 1984, requires states to develop and implement permit programs to ensure that MSWLFs and non-municipal, non-hazardous waste disposal units that receive household hazardous waste or CESQG hazardous waste are in compliance with the revised criteria for the design and operation of non-municipal, non-hazardous waste disposal units under 40 CFR part 257, subpart B and MSWLFs under 40 CFR part 258. (40 CFR part 257, subpart B and 40 CFR part 258 are henceforth referred to as the “revised federal criteria”.) Section 4005(c) of RCRA further mandates the EPA Administrator to determine the adequacy of state permit programs to ensure owner and/or operator compliance with the revised federal criteria. A state program that is deemed adequate to ensure compliance may afford flexibility to owners or operators in the approaches they use to meet federal requirements, significantly reducing the burden associated with compliance.

In response to the statutory requirement in section 4005(c), EPA developed 40 CFR part 239, commonly referred to as the State Implementation Rule (SIR). The SIR describes the state application and EPA review procedures and defines the elements of an adequate state permit program.

The purpose of the ICR is to allow EPA to continue its evaluation of state permit program applications to determine whether they satisfy the statutory test reflected in the requirements of 40 CFR part 239. In all cases, the information will be analyzed to determine the adequacy of the states permit program for ensuring compliance with the federal revised criteria. The analysis will also assist EPA in complying with the Government Performance and Results Act (GPRA) of 1993. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15. The Federal Register document required under 5 CFR 1320.8(d), soliciting comments on this collection of information was published on October 11, 2001 (66 FR 51949); no comments were received.

Burden Statement: The annual public reporting and record keeping burden for this collection of information is estimated to average 177 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

Respondents/Affected Entities: States that seek approval of new or modified permit programs for MSWLFs and for non-municipal, non-hazardous waste disposal units that receive CESQG waste.

Estimated Number of Respondents: 18.

Frequency of Response: One-time only.

Estimated Total Annual Hour Burden: 3,189 hours.

Estimated Total Annualized Capital, O&M Cost Burden: $0.

Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the addresses listed above. Please refer to EPA ICR No. 1608.03 and OMB Control No. 2050-0152 in any correspondence.

This action is directed to the public in general. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the 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/.

The proposed consent decree and other relevant documents are available electronically on EPA's web site http://www.epa.gov/pesticides under both headings, “What's New?” and “Open Comment Periods.”

2. In person. The Agency has established an official record for this action under docket ID number OPP-2002-0056. 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. 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, 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 Hwy., 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 ID number OPP-2002-0056 in the subject line on the first page of your response. The submission of a comment is construed as a waiver of any CBI claim as to that comment. (See Unit I.D.)

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 Hwy., 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 ID number OPP-2002-0056. Electronic comments may also be filed online at many Federal Depository Libraries.

Should EPA determine as a result of any comments received during this public comment period that all or part of the proposed consent decree merits reconsideration, EPA will provide the Plaintiffs with a written request for further negotiations and a copy of all comments related to EPA's basis for such negotiations. Therefore, EPA will construe the submission of a comment as a waiver of any CBI claim as to that comment. If you have any questions about 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. Offer alternative ways to improve the notice or collection activity.

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

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

a. On August 31, 2000, Plaintiffs filed a lawsuit in U.S. District Court for the Northern District of California alleging that EPA failed to comply with ESA sections 7(a)(1) and 7(a)(2), 16 U.S.C. 1536(a)(1)-(2), and with the Fish and Wildlife Act, 16 U.S.C. 742d-1. CATs v. EPA , Case No. C00-3150 CW (N.D. Calif.). The Plaintiffs filed an amended complaint on November 13, 2000.

b. In March of 2001, the parties participated in a court-ordered mediation. For several months following the mediation, the parties engaged in extensive discussions in hopes of settling this litigation.

c. On April 19, 2002, EPA reached an agreement with the Plaintiffs. The agreement is embodied in a proposed consent decree. The proposed Consent Decree sets a series of deadlines for initiating a number of consultations with the FWS and the NMFS relative to certain pesticide uses and their potential effects on certain plants and fish, including:

1. Consultation on the effects of certain forest operation uses of registered pesticide products containing the active ingredients atrazine, imazapyr, glyphosate, hexazinone, sulfometuron-methyl, triclopyr butoxyethyl ester, triclopyr triethylammonium, and 2,4-D-2 ethylhexyl ester on 33 listed plants associated with forests in California;

2. Consultation on the effects of certain forest operation uses of registered pesticide products containing the active ingredients imazapyr, sulfometuron-methyl, and triclopyr triethylammonium on six species of listed salmon and steelhead and their designated critical habitat (hereinafter collectively referred to as “salmonids”);

3. Consultation on the effects of certain pesticide uses of registered pesticide products containing the active ingredients acrolein, carbaryl, chlorpyrifos, and diazinon on salmonids;

4. Consultation on the effects of certain pesticide uses of registered pesticide products containing the active ingredients atrazine, bromacil, diuron, and simazine on salmonids;

5. Consultation on the effects of certain pesticide uses of registered pesticide products containing the active ingredients 2,4-D-2 ethylhexyl ester, molinate, oryzalin, and triclopyr butoxyethyl ester on salmonids; and

6. Consultation on the effects of certain pesticide uses of registered pesticide products containing the active ingredients glyphosate, hexazinone, and oxyfluorfen on salmonids.

d. In addition, the proposed consent decree provides that EPA will evaluate, during its ongoing ESA section 7(a)(1) Proactive Conservation Review with FWS and NMFS, how to consider the following topics:

1. Chronic and sublethal effects of pesticides on all life stages of endangered and threatened species;

2. Effects of complete pesticide product formulations, effects of diluents, and adjuvants, and effects of the products of pesticide degradation;

3. How direct and indirect effects of pesticides added to the environmental baseline impact endangered and threatened species;

4. The use of systematic field monitoring in a variety of site conditions, runoff patterns, and application methods to validate transport and persistence models; and

5. Best available scientific evidence.

e. The proposed consent decree also provides that the Plaintiffs may develop a position paper on any or all of the five topics identified in Unit II.d. EPA is offering this same opportunity to the public. EPA will consider any position papers it receives from the Plaintiffs and/or the public within 90 days from the date that a final consent decree is entered by the Court.

f. Beginning on April 29, 2002, EPA opened a 30-day comment period on the proposed consent decree. EPA will use the comments to determine whether all or part of the proposed consent decree warrants reconsideration. If EPA determines that any part of the proposed consent decree warrants reconsideration, EPA will provide the Plaintiffs with a written request for further negotiations and with copies of all comments received in response to this notice. The proposed consent decree shall not be entered with the Court unless the parties can reach agreement on needed changes. If EPA determines that the proposed consent decree does not need to be reconsidered, the terms of the proposed consent decree shall become effective upon entry by the U.S. District Court for the Northern District of California. Once the Consent Decree is entered by the U.S. District Court for the Northern District of California, EPA will publish another Federal Register notice notifying the public of the opportunity to submit position papers on the five topics described in Unit II.d.

EPA drafted Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by the Environmental Protection Agency to comply with a new Office of Management and Budget (OMB) guideline (67 FR 8451, February 22, 2002). Section 515 of the “Treasury and General Government Appropriations Act for FY2001 (Pub. L. 106-554)” directed OMB to issue government-wide guidelines that “provide policy and procedural guidance to Federal agencies for ensuring and maximizing the quality, objectivity, utility, and integrity of information, including statistical information, disseminated by Federal agencies.” EPA's “Information Quality Guidelines” will build upon on-going efforts to improve the quality of the data and analyses that are used to support Agency policy and regulatory decisions and programs.

EPA is seeking comments on many key areas of the “Information Quality Guidelines” developed thus far. Specific areas have been highlighted in a Request for Comments section of the “Information Quality Guidelines”. After the comment period closes on May 31, 2002, EPA plans to submit the Agency's revised “Information Quality Guidelines” to OMB by July 1, 2002.

EPA has established a public docket for these draft “Information Quality Guidelines” under Docket ID No. OEI-10014. The docket contains background information and supporting materials available for public viewing at: Northeast Mall, Room B607, 401 M Street SW., Washington, DC, 20460. This docket consists of a copy of the “Information Quality Guidelines”, public comments received during the public comment period on the “Information Quality Guidelines”, and other information related to the “Information Quality Guidelines”. The docket is open from 12:00 pm to 4:00 pm EST, Monday through Friday, excluding legal holidays.

You may also access EPA's draft “Information Quality Guidelines” and other information related to this notice electronically at this web page: www.epa.gov/oei/qualityguidelines. To obtain a written copy of the draft “Information Quality Guidelines”, you may contact: Ms. Evangeline Tsibris Cummings, U.S. Environmental Protection Agency, Office of Environmental Information, Mail Code 2842T, 1200 Pennsylvania Avenue NW., Washington, DC, 20460; Telephone: 202-566-0621; or e-mail: cummings.evangeline@epa.gov.

EPA intends to make public comments and supplemental information that are received during the comment period available for public viewing via EPA's Web site at www.epa.gov/oei/qualityguidelines , as the Agency receives them and without change, unless the comments contain copyrighted material, Confidential Business Information (CBI), or other information whose disclosure is restricted by statute. Paper comments (with their attachments) will be scanned and placed on the web page. To the extent feasible, other supporting information for these guidelines may be placed on the web page as well. EPA will maintain a docket list of the materials that are available in the public docket, and will include this docket list with the other materials on the Web site.

You may submit comments via EPA's Web site, electronic mail (e-mail), mail, facsimile, or in person. To ensure proper receipt of your comments by EPA, identify Docket ID No. OEI-10014 in the subject line on the first page of your comments.

Submitting comments via EPA's web page ( www.epa.gov/oei/qualityguidelines ) is the Agency's preferred method for receiving comments on the draft “Information Quality Guidelines” in order to ensure timely receipt. The Web site is an “anonymous access” system, which means EPA will not know your identity, e-mail address, or other contact information unless you provide it. Please note, that EPA asks commenters to provide their names in order to comment via the Web site. These commenters' names will be included with their comments when they are placed on the EPA Web site for public viewing.

Comments may also be sent by e-mail to: quality.guidelines@epa.gov , Attention: Docket ID No. OEI-10014. In contrast to the Web site, EPA's e-mail system is not an “anonymous access” system. If you send an e-mail comment, EPA's e-mail system automatically captures your e-mail address. E-mail addresses that are automatically captured by EPA's e-mail system will be posted on the Web site with comments received.

If you submit any type of electronic comment EPA recommends that you include your name, mailing address, and an e-mail address or other contact information with your comment. This ensures that you can be identified as the submitter of the comment and it allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or seeks further information on the substance of your comment. EPA's policy is to post comments, as they are submitted. Any identifying or contact information provided in the comment will be made available to the public via the Web site.

If you submit comments by U.S. mail, send two copies of your comments to: Evangeline Tsibris Cummings, Environmental Protection Agency, Office of Environmental Information, Mail Code 2842T, 1200 Pennsylvania Avenue, N.W., Washington, DC Attention: Docket ID No. OEI-10014.

If you submit comments in person, by courier, or other shipping method, deliver your comments to: U.S. EPA, 401 M Street SW., Washington, DC, 20460 Northeast Mall, Room B607, Attention: Docket ID No. OEI-10014. The docket is open from 12:00PM—4:00 PM EST Monday through Friday, excluding legal holidays. Send comments by fax to: 202-566-0706, Attention: Docket ID No. OEI-10014 and Attention: Ms. Evangeline Tsibris Cummings.

EPA will convene a public meeting on May 15, 2002 in Washington, DC, for the purpose of receiving public comments on the draft Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by the Environmental Protection Agency . This meeting is open to the public. Please check the EPA Web site to confirm the location of the public meeting. EPA encourages you to register for the public meeting at: www.epa.gov/oei/qualityguidelines by May 3, 2002, to ensure timely receipt of your registration and to ensure that adequate space is provided and adequate time is allotted for those who wish to present comments. You may also register by contacting Ms. Evangeline Tsibris Cummings, U.S. Environmental Protection Agency, Office of Environmental Information, Mail Code 2842T, 1200 Pennsylvania Avenue, NW., Washington, DC 20460. Telephone: 202-566-0621; e-mail: cummings.evangeline@epa.gov.

EPA will not be recording or transcribing the public meeting. To facilitate EPA's consideration of your planned comments, EPA recommends that you provide EPA with a written record of those comments you want EPA to consider, either at the public meeting or shortly thereafter via the methods described in this notice.

EPA will consider all comments received during the comment period as the Agency develops the final “Information Quality Guidelines.” Comments received after the close of the comment period may be considered as time permits. As appropriate, EPA intends to summarize or respond to significant comments when the Agency issues the final “Information Quality Guidelines”. However, due to the limited time available, EPA does not expect to be able to respond to individual comments.

Parts of this meeting of the Board will be open to the public (limited space available), and parts of this meeting will be closed. In order to increase the accessibility to Board meetings, persons requiring assistance should make arrangements in advance.

The matters to be considered at the meeting are:

• April 11, 2002 (Open)

• Corporate Approvals

• Preview of Capital Issues

• Conditions and Trends in the Bloomington Field Office Portfolio

• Early Warning System

• OSMO Report

The notice of a major disaster declaration for the Commonwealth of Kentucky is hereby amended to include the following areas among those areas determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of April 4, 2002:

The notice of a major disaster declaration for the State of Tennessee is hereby amended to include the following area among those areas determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of April 5, 2002:

The notice of a major disaster declaration for the State of Tennessee is hereby amended to include the following areas among those areas determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of April 5, 2002:

The notice of a major disaster declaration for the Commonwealth of Virginia is hereby amended to include Public Assistance for the following areas among those areas determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of April 2, 2002:

FEMA administers the National Flood Insurance Program (NFIP) and, under the authority of section 1360 of the National Flood Insurance Act of 1968 (42 U.S.C. 4101) establishes and updates flood-risk zone data in floodplain areas. In the identification of floodprone areas, we may consult with, receive information from and enter into agreements or other arrangements with the head of any State, regional, or local agency in order to identify these floodprone areas.

We are implementing the Cooperating Technical Partners (CTP) program as part of our Flood Map Modernization Program. The plan document for our Map Modernization Program and progress reports concerning the Program are available at http://www.fema.gov/library/mapmod.pdf. The program, previously known as the Cooperating Technical Communities program, formally recognizes and encourages the contributions that our Flood Hazard Mapping Partners (State agencies, regional agencies, tribal governments, and communities) make in developing timely and accurate flood hazard information. FEMA anticipates publishing regulations for this program by the end of fiscal year 2002. We strongly encourage partner contributions to flood hazard data development, which are a key part of the program.

Establishing formal partnerships with State, regional, and local organizations to produce NFIP maps is beneficial for the following reasons:

• The data used for local permitting and planning will also be the basis for the NFIP map, facilitating more efficient floodplain management;

• The CTP program provides the opportunity to interject a tailored, local focus into a national program; thus, where unique conditions may exist, we can take needed special approaches to flood hazard identification; and

• The partnership mechanism provides the opportunity to pool resources and extend the productivity of limited public funds.

Under this program, the partners will enter into a general overall agreement that recognizes the fundamental importance of flood hazard identification, flood insurance, and floodplain management. Then, through a collaborative process, the partners will identify the specific flood mapping activities to be undertaken. If this process results in CTP activities that we will support with FEMA funds, the partners will enter into a Cooperative Agreement and define the roles and responsibilities for each Flood Map Project through agreements termed Mapping Activity Statements. The intent of any Cooperative Agreement and accompanying funds that we award is to supplement and not to supplant ongoing mapping efforts by the community, regional agency, or State agency. Further, we envision that this collaborative process will maximize the extent, accuracy, and utility of flood studies to best meet local and Federal needs, while minimizing costs for all parties.

Additional guidance on the program is available at http://www.fema.gov/mit/tsd/ctp_main.htm.

We have set aside approximately $15 million nationwide for use by all FEMA Regional Offices to fund CTP mapping activities in fiscal year 2002 (October 1, 2001 through September 30, 2002). We base the selection of CTP participants on floodplain mapping needs and capability to perform the types of eligible activities that we identified for the CTP program. A significant factor in the selection process will be the partner contribution to the project. We will provide funding to eligible CTP applicants through the Cooperative Agreement process in accordance with 44 CFR part 13, Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments, which we will allocate as part of our flood study prioritization process. Upon publication of this notice, our Regional Offices will mail Request for Federal Assistance (RFA) packages to potential applicants.

Our Regional Offices will select partners based on the following criteria:

(1) The CTP applicant must be a community participating in the NFIP and be in good standing in the program as determined by FEMA, or be a State or regional agency that serves communities that participate in the NFIP.

(2) The CTP applicant must have existing processes or systems in place that support mapping or data collection activities that contribute to flood hazard identification. Non-federal funding must support these ongoing processes or systems.

(3) The CTP applicant must have the capability and commitment to perform the mapping activities for which it is applying. We require a demonstration of this capability, which an applicant may demonstrate through (but not limited to) a Regional Office review of both previously prepared map products and the applicant's existing processes or systems for the production of map products that the applicant intends to use for CTP activities.

(4) The CTP applicant that will receive funds under a Cooperative Agreement must be able to perform the financial management activities required as part of the Cooperative Agreement (i.e., account for Federal funds, prepare required performance and financial reports). Our Regional Offices can assist the communities with these financial management activities, if questions arise. FEMA-funded activities must meet the requirements of 44 CFR part 13. Part 13 sets forth requirements for proper grant administration and management including record-keeping, allowable costs, and the processes for use of contractors.

(5) The CTP applicant must have in-house staff capabilities in the appropriate technical area for the given activity. If the applicant contracts out a portion of the activities, the CTP applicant must have in-house staff capability to monitor the contractor as well as review and approve the resulting products. For these purposes, “capability” means “demonstrated experience in the performance, or management of, similar activities.”

(6) CTP applicants that use contactors to perform FEMA-funded activities must ensure that those contractors meet the requirements of 44 CFR Part 13. Within Part 13, section 13.36 covers procurement standards that must be followed for any mapping-related activities for which the CTP applicant wishes to contract with another party. Items in this part include contract administration and record-keeping, notification requirements, review procedures, competition, methods of procurement, and cost and pricing analysis. If desired, our Regional Offices will provide assistance on developing selection criteria for contracted tasks. All work must meet the standards and certification requirements described in Subsections Standards and Certification below.

As stated previously, Mapping Activity Statements will define the roles and responsibilities of the all partners, including contractors to the CTP applicant and FEMA, in the production or maintenance of flood hazard maps. FEMA support may include technical assistance, data, and funding.

(1) Funded Activities: In Fiscal Year 2002, the following mapping activities are eligible for funding:

(2) Other Activities: While we will provide no funding to CTPs for the following mapping activities, we may provide technical assistance, support, and data to the CTP:

Unless otherwise indicated in specific Mapping Activity Statements, all flood hazard identification activities will be accomplished according to the relevant portions of 44 CFR parts 59 through 77, as well as the technical standards contained in the most recent version of FEMA's Guidelines and Specifications for Flood Mapping Partners, which are set out at www.fema.gov/mit/tsd/dl_cgs.htm.

All data generated under CTP Mapping Activity Statements must meet the applicable certification requirements for the identification and publication of flood hazard information in Flood Insurance Rate Map (FIRM) form as indicated in 44 CFR 65, Identification and Mapping of Special Hazard Areas. For those States that have adopted more stringent mapping requirements that have been sanctioned by FEMA, all Mapping Activity Statements must be reviewed, coordinated with, and concurred upon by the State and all map products must meet State certification requirements.

Evaluation will be based on the following criteria:

(1) The continued maintenance (funded/supported by the CTP) for existing and/or future processes or systems in place to support mapping or data collection activities that contribute to flood hazard identification, e.g., continued data collection for changing flood hazards and related development, continued upgrades to data collection or mapping capabilities to incorporate new technologies, preparation of multi-year mapping or data collection plans, etc.;

(2) The demonstrated commitment by the CTP for existing and continued support of flood hazard identification and mapping activities conducted with and by FEMA;

(3) Adherence to timeliness and completeness of performance and to financial report submittals to the Regional Office;

(4) Adherence to timeliness and completeness of mapping product submittals to the Regional Office;

(5) Quality of product(s) submitted to the Regional Office; and

(6) Ability to cooperate and coordinate with the Regional Office, FEMA Hazard Mapping Division of the Federal Insurance and Mitigation Administration in Washington, and/or the FEMA Flood Map Production Coordination Contractor during all phases of the mapping activity as needed.

We will evaluate the performance of each CTP upon completion of the period of performance for each Mapping Activity Statement. This evaluation will determine the adequacy of the performance by the CTP and the eligibility for future Mapping Activity Statements to be initiated. Insufficient performance by the CTP may result in cancellation of FEMA funding at any point during the period of performance for a Mapping Activity Statement.

The FEMA Regional Office contacts for the CTP programs are:

Region 1: (Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont), Dean Savramis, 442 J.W. McCormack POCH, Boston, MA 02109, (telephone) (617) 223-9564, (e-mail) dean.savramis@fema.gov.

Region 2: (New Jersey, New York, Puerto Rico, Virgin Islands), Paul Weberg, 26 Federal Plaza, Room 1337, New York, NY 10278, (telephone) (212) 680-3638, (e-mail) paul.weberg@fema.gov.

Region 3: (Delaware, Maryland, Pennsylvania, Virginia, West Virginia, District of of Columbia), Martin Frengs, 615 Chestnut Street, 6th Floor, Philadelphia, PA 19106, (telephone) (215) 931-5532, (e-mail) marty.frengs@fema.gov.

Region 4: (Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina, South Carolina, Tennessee), Laura Algeo, 3003 Chamblee Tucker Rd., Atlanta, GA 30341, (telephone) (770) 220-5515, (e-mail) laura.algeo@fema.gov.

Region 5: (Illinois, Indiana, Michigan, Minnesota, Ohio, and Wisconsin), Ken Hinterlong, 536 S. Clark Street, 6th Floor, Chicago, IL 60605, (telephone) (312) 408-5529, (e-mail) ken.hinterlong@fema.gov.

Region 6: (Arkansas, Louisiana, New Mexico, Oklahoma, and Texas), Jack Quarles, FRC 800 North Loop 288, Denton, TX 76210, (telephone) (817) 898-5156, (email) jack.quarles@fema.gov.

Region 7: (Iowa, Kansas, Missouri, and Nebraska), Bob Franke, 2323 Grand Avenue, Suite 900, Kansas City, MO 64108, (telephone) (816) 283-7073, (e-mail) bob.franke@fema.gov.

Region 8: (Colorado, Montana, North Dakota, South Dakota, Utah, Wyoming), John Liou, Denver Federal Center, Bldg. 710, Box 25267, Denver, CO 80225, (telephone) (303) 235-4836, (e-mail) john.liou@fema.gov.

Region 9: (Arizona, California, Hawaii, Nevada, American Samoa, Guam), Les Sakumoto, Bldg. 105, Presidio of San Francisco, San Francisco, CA 94129, (telephone)(415) 923-7183, (e-mail) leslie.sakumoto@fema.gov.

Region 10: (Alaska, Idaho, and Oregon, Washington), Larry Basich, Federal Regional Center, 130-228th Street, Bothell, WA 98021, (telephone) (425) 487-4703, (e-mail) lawrence.basich@fema.gov.

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

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from OMB for each collection of information they conduct or sponsor. “Collection of information” means agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. 44 U.S.C. 3502(3), 5 CFR 1320.3(c). As required by section 3506(c)(2)(A) of the PRA, the FTC is providing this opportunity for public comment before requesting that OMB extend the existing paperwork clearance for the regulations noted herein.

The FTC invites comments on: (1) Whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimates of the burden of the proposed collections of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

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: pra@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 Section 4.9(b)(6)(ii) of the Commission's Rules of Practice, 16 CFR 4.9(b)(6)(ii)).

The relevant information collection requirements are as follows:

The Negative Option Rule governs the operation of prenotification subscription plans. Under these plans, sellers ship merchandise such as books, compact discs or tapes automatically to their subscribers, and bill them for the merchandise if consumers do not expressly reject the merchandise within a prescribed time. The Rule protects consumers by: (a) Requiring that promotional materials disclose the terms of membership clearly and conspicuously; and (b) establishing procedures for the administration of such “negative option” plans.

Estimated annual hours burden: 14,000 total burden hours, rounded to the nearest thousand (all disclosure-related).

Staff estimates that approximately 179 existing clubs require annually about 75 hours each to comply with the Rule's disclosure requirements, for a total of 13,425 hours (179 clubs × 75 hours). These clubs should be familiar with the Rule, which has been in effect since 1974. Thus, the “burden” of compliance has declined over time. Moreover, comments provided to the FTC indicate that a substantial portion of the existing clubs likely would make these disclosures absent the Rule because they have helped foster long-term relationships with consumers.

Approximately 5 new clubs come into being each year. These clubs require approximately 120 hours to comply with the Rule, including start up-time. Thus, cumulative PRA burden for new clubs is about 600 hours. Combined with the estimated burden for established clubs, total burden is 14,025 hours or 14,000, rounded to the nearest thousand.

Estimated annual cost burden: $385,000, rounded to the nearest thousand (solely related to labor costs).

Based on recent Bureau of Labor Statistics, the average compensation for advertising managers is approximately $30 per hour. Compensation for clerical personnel is approximately $10 per hour. Assuming that managers perform the bulk of the work, while clerical personnel perform associated tasks (e.g., placing advertisements and responding to inquiries about offerings or prices), the total cost to the industry for the Rule's paperwork requirements would be approximately $384,700. [(65 hours managerial time × 179 existing negative option plans × $30 per hour) + (10 hours clerical time × 179 existing negative option plans × $10 per hour) + (115 hours managerial time × 5 new negative option plans × $30 per hour) + (10 hours clerical time × 5 new negative option plans × $10).]

Because the Rule has been in effect since 1974, the vast majority of the negative option clubs have no current start-up costs. For the few new clubs that enter the market each year, the costs associated with the Rule's disclosure requirements, beyond the additional labor costs discussed above, are de minimis. Negative option clubs already have access to the ordinary office equipment necessary to achieve compliance with the Rule. Similarly, the Rule imposes few, if any, printing and distribution costs. The required disclosures generally constitute only a small addition to the materials that a prospective subscriber sends to the seller to solicit enrollment in a negative option plan. Because printing and distribution expenditures are incurred regardless of the Rule to market the product, adding the required disclosures to them would result in marginal incremental expense.

The Amplifier Rule assists consumers by standardizing the measurement and disclosure of power output and other performance characteristics of amplifiers in stereos and other home entertainment equipment. The Rule specifies the test conditions necessary to make the disclosures that the Rule requires.

Estimated annual hours burden: 600 hours (30 disclosure-related hours; 300 testing-related hours).

The annual burden is approximately 600 hours. The Rule's provisions require affected entities to test the power output of amplifiers in accordance with specified FTC protocol. Approximately 300 new amplifiers and receivers come on the market each year. Since high fidelity manufacturers routinely conduct performance tests as part of any new product development, the Rule imposes incremental costs only to the extent that the FTC protocol is more time-consuming than alternative testing procedures. Specifically, a warm up (“precondition”) period that the Rule requires before measurements are taken may add approximately one hour to the time testing entails. Thus, staff estimates that the Rule imposes approximately 300 hours (1 hour × 300 new products) of added testing burden annually.

The Rule requires disclosures if an advertisement makes a power output claim. Assuming that ten advertisements per magazine are placed each month in ten existing magazines featuring audio equipment advertisements, staff estimates that approximately 1,200 magazine advertisements annually would be required to carry the FTC disclosures. The cost of these disclosures is limited to the time needed to draft and review the language pertaining to power output specifications. Because this rule became effective in 1974, and because members of the industry are familiar with its requirements, compliance is less burdensome today. Accordingly, staff estimates the time involved for this task to be a maximum of 1/4 hour per advertisement, for a total burden of 300 hours. 1 The total annual burden impose by the Rule is therefore approximately 600 burden hours for disclosures and testing.

Estimated annual cost burden: $19,000, rounded to the nearest thousand (solely relating to labor costs).

Based on recent Bureau of Labor Statistics, the average hourly compensation for electronics engineers is about $32, and the average hourly compensation for marketing, advertising and public relations managers is about $30. Generally, electronics engineers perform the testing of amplifiers and receivers (300 hours × $32 = $9,600), and marketing, advertising or public relations managers prepare advertisements (including required disclosures) (300 hours × $30 = $9,000). Based on this information, staff estimates the cost to the industry per year for the Rule's paperwork requirements to be approximately $19,000 per year.

The Rule imposes no capital or other non labor costs because its requirements are incidental to testing and advertising done in the ordinary course of business.

The Franchise Rule requires franchisors and franchise brokers to furnish to prospective investors a disclosure document that provides information relating to the franchisor, the franchisor's business, and the nature of the proposed franchise relationship, as well as additional information about any claims concerning actual or potential sales, income, or profits for a prospective franchisee (“earnings claims”). Franchisors must also preserve the information that forms a reasonable basis for such claims. The Rule is designed to help potential investors from fraudulent claims.

The Rule's required disclosure document provides franchisees with information on twenty broad-ranging subjects that affect franchisors and the nature of the proposed franchise relationship. This includes not only generally available information, such as the official name and address and principal place of business of the franchisor, but also less commonly available information such as, among other things, the previous 5 years business experience of each of a franchisor's current directors and executive officers and whether any of these individuals has been convicted of a felony or embezzlement, or has filed in bankruptcy or been adjudged bankrupt during the previous 7 years. All information in the disclosure statement must be updated and revised according to the express time requirements set forth in the Rule.

Based on a review of the trade publications and information from state regulatory authorities, staff believes that, on average, from year to year, there are approximately 5,000 American franchise systems, consisting of 2,500 business format franchises and 2,500 business opportunity sellers, with perhaps about 10% of that total reflecting an equal amount of a new and departing business entrants.

Staff has calculated burden based on the above estimates and corollary assumption. Some franchisors, however, for various reasons, are not covered by the Rule in certain situations (e.g., when a franchisee buys bona fide inventory but pays no franchisor fees). Moreover, fifteen states have franchise disclosure laws similar to the Rule. These states use a disclosure document format known as the Uniform Franchise Offering Circular (“UFOC”). In order to ease compliance burdens on the franchisor, the Commission has authorized use of the UFOC in lieu of its own disclosure format to satisfy the Rule's disclosure requirements. Staff estimates that about 95 percent of all franchisors use the UFOC format. When that format is used, the franchisor is not required to prepare an additional federal disclosure document. The burden hours stated below reflects staff's estimate of the incremental burden that the Franchise Rule may impose beyond information requirements imposed by states and/or followed by franchisors who use the UFOC.

Estimated annual hours burden: 34,000 hours, rounded up to the next thousand (28,500 disclosure hours + 5,000 recordkeeping hours).

Staff estimates that the 500 or so new franchisors require approximately 30 hours each to develop a Rule-compliant disclosure document. Staff additionally estimates that the remaining 4,500 established franchisors require no more than approximately 3 hours each to update the disclosure document. The combined cumulative burden is 28,500 hours.

The franchisor may require additional recordkeeping of information pertaining to the sale of franchises in non-registration states. At most, franchisors would require an additional hour of recordkeeping per year. This yields a cumulative total of 5,000 hours per year for affected entities.

Estimated annual cost burden: $19,952,000 ($7,175,000 in labor costs; $12,777,000 in capital or other non-labor costs).

Labor costs are determined by applying applicable wage rates to associated burden hours. Staff assumes that an attorney likely would prepare or update the disclosure document. Accordingly, staff's estimate of the labor costs attributed to those tasks are as follow: (500 new franchisors × $250 per hour × 30 hours per franchisor) + (4,500 established franchisors × $250 per hour × 3 hours per franchisor) = &7,125,000.

Staff anticipates that recordkeeping would be performed by clerical staff at approximately $10 per hour. At 5,000 hours per year for all affected entities, this would amount to a total cost of $50,000. Thus, combined labor costs for recordkeeping and disclosure is approximately $7,175,000.

To comply specifically with the Rule, franchisors must incur costs to print and distribute the disclosure document. These costs vary based upon the length of the disclosures and the number of copies produced to meet the expected demand. Staff estimates that 2,500 business format and product franchisors print and mail 100 disclosure documents per year at a cost of $35 per document. Staff further estimates that another 2,500 business opportunity sellers print and mail 100 documents per year at a cost of $15 per document, for a total cost of $12,500,000.

The franchisor also must provide and disseminate an FTC cover sheet that identifies the franchisor, the date the document is issued, a table of contents, and a notice that tracks the language specifically provided in the Rule. Although some of the language in the cover sheet is supplied by the government for the purpose of disclosure to the public, and is thus excluded from the definition of “collection of information” under the PRA, see 5 CFR 1320.3(c)(2), there are residual costs to print and mail these cover sheets, including within them the presentation of related information beyond the supplied text. Staff estimates that 5,000 francisors complete and disseminate 100 cover sheets per year at a cost of approximately $.55 per cover sheet, or a total cost of approximately $277,000.

The R-value Rule establishes uniform standards for the substantiation and disclosure of accurate, material product information about the thermal performance characteristics of home insulation products. The R-value of an insulation signifies the insulation's degree of resistance to the flow of heat. This information tells consumers how well a product is likely to perform as an insulator and allows consumers to determine whether the cost of the insulation is justified.

Estimated annual hours burden: 366,000 hours, rounded to the nearest thousand (366,095 disclosure hours and 305 hours for testing and recordkeeping).

The Rule's requirements include product testing, recordkeeping, and third-party disclosures on labels, fact sheet, advertisements, and other promotional materials. Based on information provided by members of the insulation industry, staff estimates that the Rule affects: (1) 150 insulation manufacturers and their testing laboratories; (2) 1,500 installers who sell home insulation; (3) 130,000 new home builders/sellers of site-built homes and approximately 7,000 dealers who sell manufactured housing; and (4) 25,000 retail sellers who sell home insulation for installation by consumers.

Under the Rule's testing requirements, manufacturers must test each insulation product for its R-value. The test takes approximately 2 hours. Approximately 15 of the 150 insulation manufacturers in existence introduce one new product each year. The total annual testing burden is therefore approximately 30 hours (15 manufacturers × 2 hours per test).

Staff further estimates that most manufacturers require an average of approximately 20 hours per year with regard to third-party disclosure requirements in advertising and other promotional materials. Only the five or six largest manufacturers require additional time, approximately 80 hours each. Thus, the annual third-party disclosure burden for manufacturers is approximately 3,360 hours. [(144 manufacturers × 20 hours) + (6 manufacturers × 80 hours)].

While the Rule imposes recordkeeping requirements, most manufacturers and their testing laboratories keep their testing-related records in the ordinary course of business. Staff estimates that no more than one additional hour per year per manufacturer is necessary top comply with this requirement, for an annual recordkeeping burden of approximately 150 hours (150 manufacturers × 1 hour).

Installers are required to show the manufacturer's insulation fact sheet to retail consumers before purchase. They must also disclose information in contracts or receipts concerning the R-value and the amount of insulation to install. Staff estimates that two minutes per sales transaction is sufficient to comply with these requirements. Approximately 835,000 retrofit insulations are installed by approximately 1,500 installers per year and, thus, the related annual burden total is approximately 27,833 hours (835,000 sales transactions × 2 minutes). Staff anticipates that one hour per year per installer is sufficient to cover required disclosures in advertisements and other promotional materials. Thus, the burden for this requirement is approximately 1,500 hours per year (1,500 installers × 1 hour). In addition, installers must keep records that indicate the substantiation relied upon for savings claims. The additional time to comply with this requirement is minimal—approximately 5 minutes per year per installer—for a total of approximately 125 hours (1,500 installers × 5 minutes).

New home sellers must make contract disclosures concerning the type, thickness, and R-value of the insulation they install in each part of a new home. Staff estimates that no more than one minute per sales transaction is required to comply with this requirement, for a total annual burden of approximately 283,333 hours (1.7 million new home sales × 1 minute). New Home sellers who make energy savings claims must also keep records regarding the substantiation relied upon for those claims. Because few new home sellers make these claims, and the ones that do would likely keep these records regardless of the R-value Rule, staff believes that the one minute covering disclosures would also encompass this recordkeeping element.

The Rule requires that the approximately 25,000 retailers who sell home insulation make fact sheets available to consumers before purchase. This can be accomplished by, for example, placing copies in a display rack or keeping copies in a binder on a service desk with an appropriate notice. Replenishing or replacing fact sheets should require no more than approximately one hour per year per retailer, for a total of 25,000 annual hours, industry-wide.

The Rule also requires specific disclosures in advertisements or other promotional materials to ensure that the claims are fair and not deceptive. This burden is very minimal because retailers typically use advertising copy provided by the insulation manufacturer, and even when retailers prepare their own advertising copy, the Rule provides some of the language to be used. Accordingly, approximately one hour per year per retailer should suffice to meet this requirement, for a total annual burden of approximately 25,000 hours.

Retailers who make energy savings claims in advertisements or other promotional materials must keep records that indicate the substantiation they are relying upon. Because few retailers make these types of promotional claims, and because the Rule permits retailers to rely on the insulation manufacturer's substantiation data for any claims that are made, the additional recordkeeping burden is de minimis . The time calculated for disclosures, above, would be more than adequate to cover any burden imposed by this recordkeeping requirement.

To summarize, staff estimates that the Rule imposes a total of 366,331 burden hours, as follows: 150 recordkeeping and 3,390 testing and disclosure hours for manufacturer; 125 recordkeeping and 29,333 disclosure hours for installers; 283,333 disclosure hours for new home sellers; and 50,000 disclosure hours for retailers. Rounded to the nearest thousand, the total burden is 366,000 burden hours.

Estimated annual cost burden: $7,290,030 (solely related to labor costs).

The total annual labor costs for the Rule's information collection requirements is $7,290,030, derived as follows: $600 for testing, based on 30 hours for manufacturers (30 hours × $20 per hour for skilled technical personnel); $2,750 for complying with the recordkeeping requirements of the rule, based on 275 hours (275 hours × $10 per hour for clerical personnel); $33,360 for manufacturers' compliance with third-party disclosure requirements, based on 3,360 hours (3,360 hours × $10 per hour for clerical personnel); and $7,253,320 for compliance by installers, new home (362,666 hours × $20 per hour for sales persons).

There are no significant current capital or other non-labor costs associated with this Rule. Because the Rule has been in effect since 1980, members of the industry are familiar with its requirements and already have in place the equipment for conducting tests and storing records. New products are introduced infrequently. because the required disclosures are placed on packaging or on the product itself, the Rule's additional disclosure requirements do not cause industry members to incur any significant additional non-labor associated costs.

This category consists of: (a) applications to the Commission, including applications and notices contained in the Commission's Rules of Practice (primarily parts I, II, and IV); and (b) the FTC's Consumer Response Center.

Estimated annual hours burden: 78,000 hours, rounded to the nearest thousand.

Most applications to the Commission generally fall within the “law enforcement exception” to the PRA  2 ; any burden associated with those that do not is de minimis. For example, over the last decade, the Commission has received only one application for an exemption under the Fair Debt Collection Practices Act provisions. Staff has estimated that such a submission can be completed well within 50 hours. Applications and notices to the Commission contained in other rules (generally in Parts I, II, and IV of the Commission's Rule of Practice) are also infrequent and difficult to quantify. Nonetheless, in order to cover any potential “collections of information” for which separate clearance has not been sought, staff is projecting 125 hours as its estimate of the time needed to submit any applicable responses. 3

Pursuant to Section 6(f) of the Federal Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46(f), and Section 2.34 of the Commission's Rules of Practice, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC home page (for April 23, 2002), on the World Wide Web, at “ http://www.ftc.gov/os/2002/04/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 e-mail 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 Section 4.9(b)(6)(ii) of the Commission's Rules of Practice, 16 CFR 4.9(b)(6)(ii)).

The Federal Trade Commission has accepted for public comment an agreement and proposed consent order with Biovail Corporation, settling charges that Biovail illegally acquired an exclusive patent license and wrongfully listed that patent with the U.S. Food and Drug Administration. The Commission has placed the proposed consent order on the public record for thirty days in order to receive comments by interested persons. The proposed consent order has been entered into for settlement purposes only and does not constitute an admission by Biovail Corporation that it violated the law or that the facts alleged in the complaint, other than the jurisdictional facts, are true.

Biovail Corporation is a Canadian manufacturer of branded and generic pharmaceutical products, including Tiazac. Tiazac, a once-a-day diltiazem-based prescription drug that is at issue in this case, is used to treat high blood pressure and to decrease the occurrence of chronic chest pain. In 2000, Tiazac's sales reached almost $200 million, accounting for 38 percent of Biovail's gross sales.

Andrx Pharmaceuticals, Inc., a Florida-based company that develops generic versions of branded pharmaceuticals, was the first company to submit an application to the U.S. Food and Drug Administration (“FDA”) to make and sell a generic version of Tiazac. Andrx's application to the FDA included a certification asserting that its generic product would not infringe any patent claiming Tiazac. At that time, the only patent known to claim Tiazac was U.S. Patent Number 5,529,791 (“the “791 patent”), which covers aspects of Tiazac's once-a-day formulation.

As in several recent Commission matters, the facts of this case are set against the backdrop of the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as “the Hatch-Waxman Act.” Congress enacted the Hatch-Waxman Act to facilitate the entry of lower priced generic drugs, while maintaining incentives for pharmaceutical companies to invest in developing new drugs. In particular, the Hatch-Waxman Act established certain rights and procedures in situations where a company seeks approval from the FDA to market a generic product prior to the expiration of a patent or patents relating to the branded drug upon which the generic is based.

A generic drug is a pharmaceutical product that the FDA has determined to be bioequivalent to a branded drug. Generic drugs are chemically identical to their branded counterparts, but they typically are sold at substantial discounts from the branded drug's price. A Congressional Budget Office Report estimates that U.S. consumers saved an estimated $8-10 billion on prescriptions at retail pharmacies in 1994 by purchasing generic drugs instead of the branded product. 1

Under the provisions of the Hatch-Waxman Act, a company seeking approval from the FDA to market a new drug must file a New Drug Application (“NDA”) demonstrating the safety and efficacy of its product. As part of this process, the NDA applicant also is required to submit to the FDA information on any patent claiming the approved drug and for which a claim of patent infringement could reasonably be asserted against another party. The FDA then lists the approved drug and its related patents in a publication entitled “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the “Orange Book.”

The Hatch-Waxman Act also allows the listing of patents that are issued by the U.S. Patent and Trademark Office after an NDA has been approved. 2

In order to receive FDA approval to market a generic version of a branded drug, a company must file an Abbreviated New Drug Application (“ANDA”) demonstrating that its product is bioequivalent to its branded counterpart. As part of the ANDA application process, the ANDA applicant also must provide a certification to the FDA regarding its generic product and any patents listed in the Orange Book that claim the reference branded drug. Under one form of certification, known as a “Paragraph IV certification,” the ANDA applicant certifies that the patents listed in the Orange Book either are invalid or will not be infringed by the manufacture, use, or sale of the drug products for which the ANDA is submitted.

The Hatch-Waxman Act further provides that notice of the Paragraph IV certification must be provided to each patent owner and the NDA holder for the listed drug. After receiving notice of a Paragraph IV certification, if the branded drug owner does not initiate a patent infringement suit within forty-five days, then the FDA's review and generic approval process may proceed according to the FDA's schedule. If, however, a patent infringement suit is filed within the forty-five day window, the FDA's approval of the ANDA is automatically stayed until the earliest of: (1) The date the patents expire; (2) a final determination of non-infringement or patent invalidity by a court in the patent litigation; or (3) the expiration of thirty months from the receipt of notice of the Paragraph IV certification (the “30-month stay”).

Andrx filed the first ANDA for a generic version of Tiazac in June 1998. At that time, it provided a Paragraph IV certification to the FDA regarding the only patent then claiming Tiazac, the ‘791 patent. Within forty-five days of receiving Andrx's notice of certification, Biovail filed a patent infringement lawsuit, alleging that Andrx's generic Tiazac product would infringe the ‘791 patent. This lawsuit triggered a 30-month stay of final regulatory approval of Andrx's ANDA, which was to expire on February 26, 2001 (or earlier, if an appellate court decision was granted in Andrx's favor before that date).

On March 6, 2000, the U.S. District Court presiding over the patent infringement suit found that Andrx's product did not infringe the ‘791 patent. 3 Biovail appealed this decision to the U.S. Court of Appeals for the Federal Circuit. On September 29, 2000, while the appeal was still pending, the FDA tentatively approved Andrx's ANDA and informed Andrx that it would be eligible to receive final FDA approval upon expiration of the 30-month stay. This stay would have expired on February 13, 2001, the day the Federal Circuit affirmed the district court's ruling that Andrx's product did not infringe Biovail's ‘791 patent.

Before the Federal Circuit issued its decision, however, Biovail, on January 8, 2001, listed a second patent in the Orange Book as claiming Tiazac. Biovail acquired this patent, U.S. Patent No. 6,162,463 (“the ‘463 patent”), from DOV Pharmaceuticals, Inc., of New Jersey, through an exclusive licensing arrangement that also included plans to jointly develop new diltiazem products using the ‘463 patent. Because of this listing, Andrx was required to submit a second Paragraph IV certification asserting non-infringement of the ‘463 patent. After receiving Andrx's certification, Biovail filed a second patent infringement suit, triggering a second 30-month stay of the final approval of Andrx's ANDA, and further delaying the potential entry of Andrx's generic Tiazac product.

The Commission's complaint alleges that Biovail acquired exclusive rights to the ‘463 patent from DOV Pharmaceuticals, Inc., for the purpose of listing it in the FDA's Orange Book and thereby blocking Andrx's entry into the Tiazac market.

Two days after the U.S. Patent and Trademark Office issued the ‘463 patent, Biovail met with DOV to discuss a potential licensing agreement. Biovail sought to complete an exclusive licensing agreement with DOV by no later than January 19, 2001, the last date on which it could list the patent in the Orange Book and still be eligible to trigger Hatch-Waxman provisions that could result in a 30-month stay. Biovail listed the ‘463 patent in the Orange Book on January 8, four days before it actually completed the exclusive license agreement with DOV.

In its certification to the FDA supporting the listing of the patent, Biovail attested that the ‘463 patent claimed FDA-approved Tiazac. According to the complaint, however, Biovail was aware that the ‘463 patent did not claim the formulation of Tiazac that it had been marketing. The product described in the ‘463 patent contains at least 1 percent of uncoated or “free” immediate-release diltiazem, in addition to extended-release diltiazem in the form of coated beads. By contrast, the only form of Tiazac that Biovail has ever sold contains only negligible amounts—that is, well below 1 percent—of uncoated immediate-release diltiazem. Accordingly, Biovail did not need the ‘463 patent in order to make or sell its existing FDA-approved formulation of Tiazac, and it could have continued to do so without infringing the ‘463 patent. Moreover, in prosecuting the patent before the U.S. Patent and Trademark Office, Dr. Lippa of DOV was required to distinguish the ‘463 patent from the prior art—including Biovail's Tiazac—before the patent examiner approved the patent. This suggests that the ‘463 patent could not simultaneously be valid and properly listed in the Orange Book for Tiazac.

After learning that DOV was unable to give it a license to the ‘463 patent because of Biovail's exclusive license, Andrx petitioned the FDA to require Biovail to de-list the ‘463 patent from the Orange Book. Although the FDA has publicly stated that it lacks the resources and the expertise to review patents submitted with NDAs and that it has only a limited “ministerial role” in listing patents, 4 a party may dispute the propriety of a patent listing, as Andrx did, by notifying the FDA. The FDA will then request that the NDA holder confirm that the listed patent information is correct. Unless the NDA holder voluntarily withdraws or amends its listing, however, the FDA will not change the patent information in the Orange Book. As one court has observed, the FDA's listing of a patent does “not create any presumption that [a] patent was correctly listed” in the Orange Book. 5

On February 7, 2001, and again on February 22, 2001, the FDA, consistent with its limited “ministerial role” in listing patents in the Orange Book, sought confirmation from Biovail that the ‘463 patent was properly listed. The complaint alleges that on February 26, 2001, as a result of a court filing by Biovail in a federal lawsuit brought by Andrx to force Biovail to de-list the ‘463 patent, 6 the FDA learned that Biovail's position was that the ‘463 patent covered a new formulation of Tiazac that Biovail had developed only after it acquired and listed the ‘463 patent, rather than the version of Tiazac that the FDA had approved and that Biovail had been marketing. The FDA notified Biovail on March 20, 2001, that its new formulation of Tiazac was not approved by the FDA under the Tiazac NDA. Accordingly, the FDA would de-list the ‘463 patent from the Orange Book unless Biovail amended its certification to indicate that the patent claimed the version of Tiazac the FDA had approved.

In response to the FDA's inquiries, Biovail submitted a signed declaration stating that the ‘463 patent was eligible for listing in the FDA's Orange Book as claiming Tiazac. The complaint alleges that this declaration was misleading because it did not clarify whether the term “Tiazac” as used by Biovail meant the form of Tiazac the FDA had approved for marketing (as the FDA intended) or Biovail's revised form of the product. The FDA understood Biovail's March 26, 2001, declaration as affirming that the ‘463 patent covers the currently approved Tiazac product. On that basis, the FDA decided not to de-list the ‘463 patent from the Orange Book. According to the complaint, however, Biovail continued to assert that listing the ‘463 patent in the Orange Book was justified because it covers a revised form of Tiazac that Biovail believed fell within the Tiazac NDA, but which the FDA did not.

The complaint concludes that as a result of Biovail's conduct, consumers of Tiazac have been deprived of the benefits of lower-priced generic competition that might have been possible had Biovail not acquired exclusive rights to, and then listed, the ‘463 patent, thereby precluding the FDA from granting final approval to Andrx's generic Tiazac in February 2001.

The complaint alleges that the relevant product market in which to assess the anticompetitive effects of Biovail's conduct is Tiazac and generic bioequivalent versions of Tiazac. Although other therapeutic agents can be used to treat high blood pressure and chronic chest pain, including several other branded and generic formulations of once-a-day diltiazem, these other therapeutic agents do not significantly constrain Tiazac's pricing. In contrast, entry of a generic bioequivalent version of Tiazac likely would result in a significant, immediate decrease in the sales of branded Tiazac, and lead to a significant reduction in the average market price paid for Tiazac and its generic bioequivalents. In fact, Biovail's own sales forecasts projected that generic Tiazac would have captured 40 percent of branded Tiazac sales within the first year alone.

The relevant geographic market in which to assess the competitive effects of Biovail's conduct is the United States, given the FDA's elaborate regulatory process for approving drugs for sale in the United States, and the fact that the marketing, sales, and distribution of pharmaceuticals, like Tiazac, occur on a nationwide basis.

The complaint thus alleges that, at all times relevant to this case, Biovail's market share of the relevant antitrust market has been 100 percent.

Biovail's conduct as described above, and as alleged in the complaint, violated the antitrust laws in two ways. First, Biovail's acquisition of an exclusive license to the ‘463 patent substantially lessened competition in the U.S. market for Tiazac and its generic equivalents. As stated in the complaint, Biovail's acquisition of the exclusive license to the ‘463 patent raised substantial barriers to Andrx's entry into the relevant market and gave Biovail the power to exclude competition, thereby protecting Biovail's monopoly in the Tiazac market, in violation of section 7 of the Clayton Act, 15 U.S.C. 18, and section 5 of the FTC Act, 15 U.S.C. 45.

The complaint also alleges that Biovail violated Section 5 of the FTC Act by engaging in acts that willfully maintained its Tiazac monopoly. These acts included: (a) acquiring an exclusive license to the ‘463 patent for the purpose of listing it in the Orange Book; (b) wrongfully listing the ‘463 patent in the Orange Book as claiming Tiazac, in order to be eligible for an automatic 30-month stay of FDA approval for any generic Tiazac product; and (c) giving non-responsive answers to questions raised by the FDA about the propriety of listing the ‘463 patent in the Orange Book, so as to avoid the possibility of de-listing. As the complaint states, Biovail's illegal monopolization raised substantial barriers to entry into the relevant market and gave Biovail the power to exclude competition. Biovail thereby deprived consumers of the benefits of lower-priced generic competition that might have been possible had the FDA not been precluded from granting final approval to Andrx's generic Tiazac. These acts and practices are anticompetitive in nature and tendency, and constitute an unfair method of competition in violation of section 5 of the FTC Act, 15 U.S.C. 45.

The proposed order is designed to address the anticompetitive effects of Biovail's illegal conduct charged above, by requiring Biovail to divest part of its exclusive rights to the ‘463 patent and by providing other relief, on a prospective basis, to prevent or discourage recurrence of such conduct in the future. In essence, the proposed order:

• Requires that Biovail divest to DOV the exclusive rights to the ‘463 patent, as it applies for use in making any form of the currently marketed and FDA-approved Tiazac product.

• Prevents Biovail from taking any actions that would result in an additional 30-month stay of final FDA approval for a generic form of Tiazac.

• Prohibits Biovail from wrongfully listing any patents in the Orange Book in violation of applicable law.

• Requires that Biovail give the Commission prior written notice before it acquires an exclusive license to any patent that it plans to list in the Orange Book for a product for which Biovail already has an FDA-approved NDA.

By requiring that Biovail divest its exclusive rights in the “463 patent in the “Tiazac Field,” that is, for use in making any form of the currently FDA-approved Tiazac, Paragraph II returns the market for Tiazac products to the status quo as it existed before the patent acquisition occurred. Paragraph II.A requires that Biovail divest to DOV its exclusive interest in the “463 patent as it relates to the Tiazac Field. Paragraph II.B prevents Biovail from structuring the divestiture in such a way that it would be able to continue reaping the benefits of its acquisition of the patent. Paragraph II.C proscribes the creation of a confidentiality agreement that could hinder future Commission enforcement actions against Biovail under the order or the antitrust laws. Paragraph II.D prohibits Biovail from having any input into the future utilization of the patent in the Tiazac Field. Paragraph II.E prevents Biovail from participating in any lawsuits to enforce the “463 patent in the Tiazac Field. Paragraph II.F requires Biovail to dismiss its patent infringement claim against Andrx.

Taken as a whole, Paragraph II removes Biovail's possession of exclusive rights in the “463 patent (through which it was able to erect barriers to Andrx's potential entry), while preserving Biovail's and DOV's ability to innovate and develop new products using that same patent. Paragraph II allows Biovail to continue to use the “463 patent, on an exclusive basis, to develop new diltiazem products that may result in the filing of an NDA with the FDA. Moreover, nothing in the paragraph prevents Biovail from holding non-exclusive rights to the “463 patent to develop improved forms of the currently marketed Tiazac product.

If Biovail fails to complete the divestiture required in Paragraph II.A within ninety days of signing the Agreement Containing Consent Order in this matter, Paragraph III of the Proposed Order requires Biovail to enter into a trust agreement and transfer the assets set forth in Paragraph II.A to a trustee appointed by the Commission. The trustee will then have the sole and exclusive power to divest the assets required in Paragraph II.A, subject to the prior approval of the Commission. The trustee will have twelve months to accomplish the divestiture, at no minimum price, to a buyer or buyers approved by the Commission.

Paragraph IV is intended to remedy Biovail's allegedly illegal monopolization. By preventing Biovail from engaging in strategies that pharmaceutical companies have used to exploit the Hatch-Waxman Act to thwart generic entry, Paragraph IV seeks to ensure the entry of a generic Tiazac product at the earliest possible moment.

Paragraph V is intended to deter Biovail from listing patents in the Orange Book that do not actually claim the drug product at issue, and thus prevent the triggering of procedures under the Hatch-Waxman Act that could improperly block generic entry. The Commission is concerned that improper patent listings may be a recurring problem in the pharmaceutical industry, and that such listings have a significant potential to affect competition and harm consumers. NDA holders have the ability unilaterally to list patents in the Orange Book—and thus exclude potential generic competitors from entering the market and competing for up to thirty months—whether or not the patent they list actually claims the product approved under the NDA. Because the FDA views its role in listing patents as “purely ministerial,” and because there is no private right of action to challenge a patent listing under the Food, Drug, and Cosmetic Act, 7 or NDA holders, such as Biovail in this case, to obtain an additional thirty months free from generic competition by listing inappropriate patents in the Orange Book.

The Commission believes that the operative provisions in Paragraphs II through V of the proposed order strike an appropriate balance between Biovail's interests in acquiring patents for legitimate business purposes, such as developing new products using that intellectual property, and the Commission's intention to remedy an NDA holder's creation of barriers to generic competition through strategic patent acquisitions and the misuse of the Hatch-Waxman regulatory framework. By not imposing broad prohibitions on Biovail's ability to develop new products based on the “463 patent, and by not preventing Biovail from legitimately acquiring and listing patents for other NDAs it may hold, the order maintains Biovail's incentive to develop and sell new drug products, while curbing the potential for Hatch-Waxman Act abuse.

Paragraph VI requires that Biovail submit written notification to the Commission before acquiring any patent or exclusive license on a patent, if Biovail also intends to seek the patent's listing in the Orange Book. Biovail will thus be free to continue acquiring intellectual property for legitimate business purposes, but the Commission will be notified in situations where there is a possibility that the acquisition of an exclusive license may serve to protect Biovail's dominant position in a relevant pharmaceutical market.

Paragraph VII sets forth the form of notice that Biovail must provide to the Commission under Paragraph VI of the order. In addition to supplying a copy of the patents to be acquired, Paragraph VII requires Biovail to provide certain other information to assist the Commission in assessing the potential competitive effect of the patent acquisition. Accordingly, the order requires Biovail to identify, among other things, the parties participating in the acquisition, the approved NDA(s) with respect to which the acquired patent will be submitted for listing in the Orange Book, and all persons who have filed an ANDA referencing the identified NDAs. In addition, Biovail must provide the Commission with copies of all transactional documents and other documents that evaluate the proposed licensing agreement.

Paragraphs VIII, IX, and X of the proposed order contain certain reporting and other standard Commission order provisions designed to assist the Commission in monitoring compliance with the order.

The order will expire in ten years.

The proposed order has been placed on the public record for thirty days in order to receive comments from interested persons. Comments received during this period will become part of the public record. After thirty days, the Commission will again review the proposed order and the comments received and will decide whether it should withdraw from the agreement containing the proposed order or make the proposed order final.

By accepting the proposed order subject to final approval, the Commission anticipates that the competitive issues alleged in the complaint will be addressed. The purpose of this analysis is to facilitate public comment on the agreement. It is not intended to constitute an official interpretation of the agreement, the complaint, or the proposed consent order, or to modify their terms in any way.

The Draft Guideline for Disinfection and Sterilization in Healthcare Facilities, 2003 presents a pragmatic approach to the judicious selection and proper use of disinfection and sterilization processes in healthcare settings. The guideline is intended to assist healthcare personnel in preventing infections associated with contaminated medical devices or surgical instruments and is targeted to infection control professionals, infectious disease clinicians, physicians who perform endoscopic procedures (e.g., gastroenterologists, pulmonologists), central processing technicians, sterile processing technicians, operating room nurses and technicians, manufacturers of disinfection and sterilization equipment, and manufacturers of reusable medical devices.

Part 1 of the two-part document provides information on chemical disinfectants recommended for patient-care equipment; these disinfectants include alcohol, glutaraldehyde, hydrogen peroxide, iodophors, ortho-phthalaldehyde, peracetic acid, phenolics, quaternary ammonium compounds, and sodium hypochlorite. Sterilization methods discussed include steam sterilization, ethylene oxide, hydrogen peroxide gas plasma, and liquid peracetic acid. Part 2 of the document provides consensus recommendations of the Healthcare Infection Control Practices Advisory Committee (HICPAC) for the practice of disinfection and sterilization in healthcare settings. Most recommendations are pertinent for the inpatient, outpatient, and home care setting, unless otherwise noted.

HICPAC was established in 1991 to provide advice and guidance to the Secretary and the Assistant Secretary for Health, DHHS; the Director, CDC; and the Director, National Center for Infectious Diseases, regarding the practice of infection control and strategies for surveillance, prevention, and control of healthcare-associated infections in U.S. healthcare facilities. The committee advises CDC on guidelines and other policy statements regarding prevention of healthcare-associated infections and related adverse events.

Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Upon passage of the Animal Drug Availability Act, Congress enacted legislation establishing a new class of restricted feed use drugs called VFD, which can be distributed without involving State pharmacy laws. Although controls on the distribution and use of VFD drugs are similar to those for prescription drugs regulated under section 503(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353), the implementing VFD regulation under 21 CFR 558.6 is tailored to the unique circumstances relating to the distribution of medicated feeds. The content of the VFD is spelled out in the regulation. All distributors of medicated feeds containing VFD drugs must notify FDA of their intent to distribute, and records must be maintained of the distribution of all medicated feeds containing VFD drugs. The VFD regulation ensures the protection of public health while enabling animal producers to obtain and use needed drugs as efficiently and cost-effectively as possible. The respondents for VFD drugs are veterinarians, distributors of animal feeds containing VFD drugs, and clients utilizing medicated feeds containing VFD drugs.

FDA estimates the burden of this collection of information as follows:

Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355), requires that important safety information relating to all human prescription drug products be made available to FDA so that it can take appropriate action to protect the public health when necessary. Section 702 of the act (21 U.S.C. 372) authorizes investigational powers to FDA for enforcement of the act.

Under section 519 of the act (21 U.S.C. 360i), FDA is authorized to require manufacturers to report medical device-related deaths, serious injuries, and malfunctions to FDA and to require user facilities to report device-related deaths directly to FDA and to manufacturers, and to report serious injuries to the manufacturer. Section 522 of the act (21 U.S.C. 360l) authorizes FDA to require manufacturers to conduct postmarket surveillance of medical devices. Section 705(b) of the act (21 U.S.C. 375(b)) authorizes FDA to collect and disseminate information regarding medical products or cosmetics in situations involving imminent danger to health or gross deception of the consumer. Section 903(d)(2) of the act (21 U.S.C. 393(d)(2)) authorizes the Commissioner of Food and Drugs (the Commissioner) to implement general powers (including conducting research) to carry out effectively the mission of FDA. These sections of the act enable FDA to enhance consumer protection from risks associated with medical products usage that are not foreseen or apparent during the premarket notification and review process.

FDA's regulations governing application for agency approval to market a new drug (21 CFR part 314) and regulations governing biological products (21 CFR part 600) implement these statutory provisions.

Currently FDA monitors medical product related postmarket adverse events via both the mandatory and voluntary MedWatch reporting systems using FDA Forms 3500 and 3500A (OMB Control No. 0910-0291) and the vaccine adverse event reporting system.

FDA is seeking OMB clearance to collect vital information via a series of rapid response surveys. Participation in these surveys will be voluntary. This request covers rapid response surveys for community based health care professionals, general type medical facilities, specialized medical facilities (those known for cardiac surgery, obstetrics/gynecology services, pediatric services, etc.), other health care professionals, patients, consumers, and risk managers working in medical facilities.

FDA will use the information gathered from these surveys to obtain quickly vital information about medical product risks and interventions to reduce risks so the agency may take appropriate public health or regulatory action including dissemination of this information as necessary and appropriate.

FDA estimates the burden of this collection of information as follows:

FDA projects 30 emergency risk related surveys per year with a sample of between 50 and 200 respondents per survey. FDA also projects a response time of 0.5 hours per response.

These estimates are based on the maximum sample size per questionnaire that FDA can analyze in a timely manner. The annual frequency of response was determined by the maximum number of questionnaires that will be sent to any individual respondent. Some respondents may be contacted only one time per year, while other respondents may be contacted several times annually, depending on the human drug, biologic, or medical device under evaluation. It is estimated that, given the expected type of issues that will be addressed by the surveys, it will take 0.5 hours for a respondent to gather the requested information and fill in the answers.

In the Federal Register of May 29, 2001 (66 FR 29143), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0001. The approval expires on March 31, 20005. A copy of the supporting statement for this information collection is available on the Internet at http://www.fda.gov/ohrms/dockets.

On January 19, 2001, the U.S. District Court for the Central District of California accepted a plea of guilty and entered a judgment against Mr. Petrik for one count of making a false statement to a government agency, a Federal felony under 18 U.S.C. 1001. As a result of this conviction, FDA sent a letter dated August 31, 2001, to Mr. Petrik proposing to issue an order to permanently debar him from providing services in any capacity to a person that has an approved or pending drug product application including, but not limited to, a biologics license application, and offering him an opportunity for a hearing on the proposal. The proposal was based on a finding, under section 306(a)(2)(B) and (c)(2)(A)(ii) of the act (21 U.S.C. 355a(a)(2)(B) and (c)(2)(A)(ii)), that he was convicted of a felony under Federal law for conduct relating to the regulation of a drug product. Mr. Petrik was provided 30 days to file objections and request a hearing. Mr. Petrik did not request a hearing. His failure to request a hearing constitutes a waiver of his right to a hearing concerning the proposed order.

Therefore, the Director, Center for Biologics Evaluation and Research, under section 306(a)(2)(B) of the act, and under authority delegated to her (21 CFR 5.99), finds that Mr. Craig H. Petrik has been convicted of a felony under Federal law for conduct relating to the regulation of a drug product.

As a result of the foregoing finding, Mr. Craig H. Petrik is permanently debarred from providing services in any capacity to a person with an approved or pending drug product application. A drug product means a drug, including a biological product, subject to regulation under sections 505, 512, or 802 of the act (21 U.S.C. 355, 360b, or 382), or section 351 of the Public Health Service Act (42 U.S.C. 262), effective April 30, 2002 (21 U.S.C. 335a(a)(2), (c)(1)(B), and (c)(2)(A)(ii), and 321(dd)). Any person with an approved or pending drug product application including, but not limited to, a biologics license application, who knowingly uses the services of Mr. Petrik, in any capacity, during his period of debarment, will be subject to civil money penalties (21 U.S.C. 335a(a)(6)). If Mr. Petrik, during his period of debarment, provides services in any capacity to a person with an approved or pending drug product application including, but not limited to, a biologics license application, he will be subject to civil money penalties (21 U.S.C. 335a(a)(7)).

Any application by Mr. Petrik for termination of debarment under section 306(d)(4) of the act should be identified with Docket No. 01N-0359 and sent to the Dockets Management Branch (see ADDRESSES ). All such submissions are to be filed in four copies (§ 10.20(a) (21 CFR 10.20(a))). The public availability of information in these submissions is governed by § 10.20(j). Publicly available submissions may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday (§ 10.20(j)(1)).

In the Federal Register of September 6, 2001 (66 FR 46641), FDA published a proposed rule to reclassify the hip joint metal/polymer constrained cemented or uncemented prosthesis from class III (premarket approval) to class II (special controls) based on new information regarding this device contained in a reclassification petition submitted by the Orthopedic Surgical Manufacturers Association. FDA also identified the document “Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis” as the special control capable of providing reasonable assurance of safety and effectiveness for this device.

Interested persons were invited to comment on the draft guidance by December 5, 2001. FDA received three comments. Two comments commended FDA's proposal to reclassify these devices and agreed that the guidance proposed as the special control was adequate to provide reasonable assurance of the safety and effectiveness of the device. One comment stated that FDA's proposed special control was inadequate to protect against certain types of device failure, specifically shell-bone interface failure that may occur after implantation of this highly constrained device.

FDA agrees that shell-bone interface failure may occur after implantation of the device. FDA has revised the precaution section in the guidance document to clarify that it addresses device failure at the shell-bone interface.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). This guidance represents the agency's current thinking on special controls for the hip joint metal/polymer constrained cemented or uncemented prosthesis. 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 applicable statutes and regulations.

In order to receive the guidance entitled “Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis” via your fax machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt press 1 to order a document. Enter the document number (1393) followed by the pound sign ( # ). Follow the remaining voice prompts to complete your request.

Persons interested in obtaining a copy of the draft guidance may also do so using the Internet. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer. Updated on a regular basis, the CDRH home page includes device safety alerts, Federal Register reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturers' assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH home page may be accessed at http://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also available at http://www.fda.gov/ohrms/dockets.

Interested persons may, at any time, submit written comments on the guidance to the Dockets Management Branch (see ADDRESSES ). 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.

HIV prevention efforts to date have focused primarily on reducing the risk of infection among persons who are not infected with HIV. The programs of the Centers for Disease Control and Prevention (CDC) have generally focused on individuals not infected who engage in “high risk” sexual and drug using activities. However, recent research suggests that HIV-infected individuals also engage in risky activities.

These behaviors are frequent and appear to be increasing among HIV-infected populations. Several factors may be contributing to this trend. People using risk reduction behaviors may be tiring of doing so after more than 15 years of hearing prevention messages. Furthermore, treatment advances that have dramatically improved the health and quality of life for people infected with HIV may be leading persons to believe that transmission risk is low or HIV disease is easily managed.

Interventions targeting HIV-infected men and women are therefore needed. SPNS wants to know how HIV providers in primary care settings can contribute to the prevention of treatment resistant re-infection among persons who are already infected as well as the prevention of infections among those not infected who engage in “high risk” activities. Studies have shown that clinician-delivered prevention interventions can be effective with an array of other health issues. Furthermore, clinicians can often link patients needing intensive or ongoing behavioral interventions to other prevention services in the community. Recommendations for clinicians on how to incorporate risk screening and brief intervention messages into regular office visits are currently under development by the joint efforts of CDC, HRSA, the National Institutes of Health, and the Infectious Disease Society of America.

Availability of Funds: The SPNS program is authorized by Section 2691 of the PHS Act. Grants may be awarded directly to public and non-profit private entities, including community-based organizations. The program has $1.5 million dollars available for this Center initiative, at $300,000 per year for 5 years. The budget and project periods for approved and funded projects will begin on or about September 1, 2002. Funds must be requested for all 5 years of the initiative.

All applicants funded should recognize that this initiative is not designed to provide continuous support once the initiative is complete and evaluated. Applicants are strongly encouraged to secure non-SPNS funding support during their initiative if the evaluation suggests that the Center is effective and merits continuation.

Eligible Applicants: The statute, Section 2691(a) specifies that grants may be awarded to public and non-profit private entities to fund special programs for the care and treatment of people with HIV disease. Eligible applicants may include, but are not limited to, State, local, or tribal public health, mental health, housing, or substance abuse departments; public or non-profit hospitals and medical facilities; faith-based and community-based service organizations (e.g., AIDS service organizations, federally-qualified health centers, family planning centers, AIDS anti-discrimination and advocacy organizations, homeless assistance providers, hemophilia centers, community mental health centers, substance abuse treatment centers, urban and tribal Indian health centers or facilities, migrant health centers, etc.), institutions of higher education (e.g., Historically Black Colleges and Universities, Hispanic Serving Institutions, and Tribal Colleges and Universities), and national service provider and/or policy development associations and organizations.

Allowable Costs: The basis for determining allocable and allowable costs to be charged to PHS grants is set forth in 45 CFR Part 74 and 45 CFR Part 92 for State, local, or tribal governments. The four separate sets of cost principles prescribed for public and private non-profit recipients are: Office of Management and Budget (OMB) Circular A-87 for State, local or tribal governments; OMB Circular A-21 for institutions of higher education; 45 CFR Part 74, Appendix E for hospitals; and OMB Circular A-122 for non-profit organizations. Further information on allowable costs is contained in the Guidance.

Reporting and Other Requirements: In addition to deliverables described in guidance materials, the successful applicant under this notice must submit two semi-annual activity summary reports, in accordance with provisions of the general regulations which apply under 45 CFR Part 74.51 “Monitoring and Reporting of Program Performance” (with the exception of State and local governments to which 45 CFR Part 40 reporting requirements apply), and comply with audit requirements of OMB Circular A-133. Further, the PHS also strongly encourages all award recipients to provide a smoke-free workplace and to promote the non-use of all tobacco products. In particular, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children.

Public Health System Reporting Requirements: This program is also subject to the PHS Reporting Requirements which have been approved by the OMB under No. 0937-0195. Under these requirements, any community-based, non-governmental applicant must prepare and submit a Public Health System Impact Statement (PHSIS). The PHSIS is intended to keep State and local health officials appraised of proposed health services grant applications submitted from within their jurisdictions. Instructions on this matter are contained in the Guidance for this initiative, available from the GAC, previously cited.

Executive Order 12372: The SPNS Grant Program is subject to the provisions of Executive Order 12372, concerning intergovernmental review of Federal Programs, 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. The application packages to be made available under this notice will contain a listing of States which have chosen to set up a review system and will provide a State Single Point of Contact (SPOC) for the review. Applicants (other than federally recognized Indian tribes) should contact their SPOCs as early as possible to alert them to the prospective applications and receive any necessary instructions on the State process. For proposed projects serving more than one State, the applicant is advised to contact the SPOC of each affected State. The due date for State process recommendations under E.O. 12372 is 60 days after the application due date. HRSA does not guarantee that it will accommodate or explain its responses to State process recommendations received after that date. (See “Intergovernmental Review of Federal Programs,” Executive Order 12372, and CFR part 100, for a description of the review process and requirements.)

Audit Requirements: Applicants are required to comply with requirements of OMB Circular A-133. For additional information on this topic, contact the Grants Management Specialist at 301-443-1262.

HUD has the authority to address deficiencies in the performance of lenders' loans as provided in the HUD mortgagee approval regulations at 24 CFR 202.3. On May 17, 1999 (64 FR 26769), HUD published a notice on its procedures for terminating origination approval agreements with FHA lenders and placement of FHA lenders on Credit Watch status (an evaluation period). In the May 17, 1999 notice, HUD advised that it would publish in the Federal Register a list of mortgagees which have had their Origination Approval Agreements terminated.

Termination of Origination Approval Agreement: Approval of a mortgagee by HUD/FHA to participate in FHA mortgage insurance programs includes an Agreement between HUD and the mortgagee. Under the Agreement, the mortgagee is authorized to originate single family mortgage loans and submit them to FHA for insurance endorsement. The Agreement may be terminated on the basis of poor performance of FHA-insured mortgage loans originated by the mortgagee. The Termination of a mortgagee's Agreement is separate and apart from any action taken by HUD's Mortgagee Review Board under HUD's regulations at 24 CFR part 25.

Cause: HUD's regulations permit HUD to terminate the Agreement with any mortgagee having a default and claim rate for loans endorsed within the preceding 24 months that exceeds 200 percent of the default and claim rate within the geographic area served by a HUD field office, and also exceeds the national default and claim rate. For the eighth review period, HUD is only terminating the Agreement of mortgagees whose default and claim rate exceeds both the national rate and 300 percent of the field office rate.

Effect: Termination of the Agreement precludes that branch(s) of the mortgagee from originating FHA-insured single family mortgages within the area of the HUD field office(s) listed in this notice. Mortgagees authorized to purchase, hold, or service FHA insured mortgages may continue to do so.

Loans that closed or were approved before the Termination became effective may be submitted for insurance endorsement. Approved loans are (1) those already underwritten and approved by a Direct Endorsement (DE) underwriter employed by an unconditionally approved DE lender and (2) cases covered by a firm commitment issued by HUD. Cases at earlier stages of processing cannot be submitted for insurance by the terminated branch; however, they may be transferred for completion of processing and underwriting to another mortgagee or branch authorized to originate FHA insured mortgages in that area. Mortgagees are obligated to continue to pay existing insurance premiums and meet all other obligations associated with insured mortgages.

A terminated mortgagee may apply for a new Origination Approval Agreement if the mortgagee continues to be an approved mortgagee meeting the requirements of 24 CFR 202.5, 202.6, 202.7, 202.8 or 202.10 and 202.12, if there has been no Origination Approval Agreement for at least six months, and if the Secretary determines that the underlying causes for termination have been remedied. To enable the Secretary to ascertain whether the underlying causes for termination have been remedied, a mortgagee applying for a new Origination Approval Agreement must obtain an independent review of the terminated office's operations as well as its mortgage production, specifically including the FHA-insured mortgages cited in its termination notice. This independent analysis shall identify the underlying cause for the mortgagee's high default and claim rate. The review must be conducted and issued by an independent Certified Public Accountant (CPA) qualified to perform audits under Government Auditing Standards as set forth by the General Accounting Office. The mortgagee must also submit a written corrective action plan to address each of the issues identified in the CPA's report, along with evidence that the plan has been implemented. The application for a new Agreement should be in the form of a letter, accompanied by the CPA's report and corrective action plan. The request should be sent to the Director, Office of Lender Activities and Program Compliance, 451 Seventh Street, SW., Room B133-P3214, Washington, DC 20410 or by courier to 490 L'Enfant Plaza, East, SW., Suite 3214, Washington, DC 20024.

Action: The following mortgagees have had their Agreements terminated by HUD:

HUD has the authority to address deficiencies in the performance of lenders' loans as provided in the HUD mortgagee approval regulations at 24 CFR 202.3. On May 17, 1999 (64 FR 26769), HUD published a notice on its procedures for terminating origination approval agreements with FHA lenders and placement of FHA lenders on Credit Watch status (an evaluation period). In the May 17, 1999 notice, HUD advised that it would publish in the Federal Register a list of mortgagees which have had their Origination Approval Agreements terminated.

Termination of Origination Approval Agreement : Approval of a mortgagee by HUD/FHA to participate in FHA mortgage insurance programs includes an Agreement between HUD and the mortgagee. Under the Agreement, the mortgagee is authorized to originate single family mortgage loans and submit them to FHA for insurance endorsement. The Agreement may be terminated on the basis of poor performance of FHA-insured mortgage loans originated by the mortgagee. The Termination of a mortgagee's Agreement is separate and apart from any action taken by HUD's Mortgagee Review Board under HUD's regulations at 24 CFR part 25.

Cause: HUD's regulations permit HUD to terminate the Agreement with any mortgagee having a default and claim rate for loans endorsed within the preceding 24 months that exceeds 200 percent of the default and claim rate within the geographic area served by a HUD field office, and also exceeds the national default and claim rate. For the ninth review period, HUD is only terminating the Agreement of mortgagees whose default and claim rate exceeds both the national rate and 300 percent of the field office rate.

Effect: Termination of the Agreement precludes that branch(s) of the mortgagee from originating FHA-insured single family mortgages within the area of the HUD field office(s) listed in this notice. Mortgagees authorized to purchase, hold, or service FHA insured mortgages may continue to do so.

Loans that closed or were approved before the Termination became effective may be submitted for insurance endorsement. Approved loans are (1) those already underwritten and approved by a Direct Endorsement (DE) underwriter employed by an unconditionally approved DE lender and (2) cases covered by a firm commitment issued by HUD. Cases at earlier stages of processing cannot be submitted for insurance by the terminated branch; however, they may be transferred for completion of processing and underwriting to another mortgagee or branch authorized to originate FHA insured mortgages in that area. Mortgagees are obligated to continue to pay existing insurance premiums and meet all other obligations associated with insured mortgages.

A terminated mortgagee may apply for a new Origination Approval Agreement if the mortgagee continues to be an approved mortgagee meeting the requirements of 24 CFR 202.5, 202.6, 202.7, 202.8 or 202.10 and 202.12, if there has been no Origination Approval Agreement for at least six months, and if the Secretary determines that the underlying causes for termination have been remedied. To enable the Secretary to ascertain whether the underlying causes for termination have been remedied, a mortgagee applying for a new Origination Approval Agreement must obtain an independent review of the terminated office's operations as well as its mortgage production, specifically including the FHA-insured mortgages cited in its termination notice. This independent analysis shall identify the underlying cause for the mortgagee's high default and claim rate. The review must be conducted and issued by an independent Certified Public Accountant (CPA) qualified to perform audits under Government Auditing Standards as set forth by the General Accounting Office. The mortgagee must also submit a written corrective action plan to address each of the issues identified in the CPA's report, along with evidence that the plan has been implemented. The application for a new Agreement should be in the form of a letter, accompanied by the CPA's report and corrective action plan. The request should be sent to the Director, Office of Lender Activities and Program Compliance, 451 Seventh Street, SW., Room B133-P3214, Washington, DC 20410 or by courier to 490 L'Enfant Plaza, East, SW., Suite 3214, Washington, DC 20024.

Action: The following mortgagees have had their Agreements terminated by HUD:

The OMB regulations at 5 CFR part 1320, which implement provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13), require that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities (see 5 CFR 1320.8(d)). On Friday, December 21, 2001, the U.S. Fish and Wildlife Service (Service) was given emergency approval by OMB for collection of information in order to quickly implement the grant program to be conducted under the Neotropical Migratory Bird Conservation Act (Pub. L. 106-247). The assigned OMB information collection control number is 1018-0113, and temporary approval expires June 30, 2002. The Service is requesting a three year term of approval for this information collection activity. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

Comments are invited on: (1) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the collection of information; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents.

Title: Information Collection In Support of Grant Programs Authorized by the Neotropical Migratory Bird Conservation Act of 2000 (NMBCA).

Approval Number: 1018-0113.

Service Form Number(s): N/A.

Description and Use: The purposes of the Neotropical Migratory Bird Conservation Act (Act) are to: (1) Perpetuate healthy populations of neotropical migratory birds; (2) assist in the conservation of these birds by supporting conservation initiatives in the United States, Latin America, and the Caribbean; and (3) provide financial resources and foster international cooperation for those initiatives.

The Act authorizes $5 million for this program, and Congress appropriated $3 million for Fiscal Year 2002. At a minimum, 75% of this money will be available for projects outside the United States. No maximum request has been established. The match ratio is 3:1, calculated in U.S. dollars. That is, every grant dollar requested under the Act must be matched by 3 partner dollars. U.S.-Federal funds may be used to support projects, but may not be used as match. Partner funds for U.S. projects must be in cash, whereas funds for projects in Latin America and the Caribbean may be cash or in-kind contribution.

Projects may be located in the United States and in all countries of Latin America and the Caribbean, with the exception of Cuba. Projects in Canada are not eligible for this funding. An applicant may be an individual, corporation, partnership, trust, association, other private entity, government agency in the U.S. or a foreign country, or an international organization.

The Act describes activities which may be carried out under the Act, including: protection and management of neotropical migratory bird populations; maintenance, management, protection, and restoration of neotropical migratory bird habitat; research and monitoring; law enforcement; and community outreach and education.

The Act authorizes the Secretary of the Interior, who has principal responsibility for implementation, to convene an advisory group consisting of individuals representing public and private organizations actively involved in the conservation of neotropical migratory birds to assist with and provide advice on proposal funding. The Federal Advisory Committee Act provisions do not apply to this advisory group.

Competing for grant funds involves applications from partnerships that describe in substantial detail project locations and other characteristics. The grant program, i.e., competition for funds, for this Act is currently being implemented by the Division of Bird Habitat Conservation, U.S. Fish and Wildlife Service, which is publishing and distributing instructional materials that assist the applicants in formulating project proposals for advisory group consideration. The instructional booklets and other instruments, e.g., Federal Register notices on request for proposals, are the basis for this information collection request for OMB clearance. Information collected under this program is used to respond to such needs as: Audits, program planning and management, program evaluation, Government Performance and Results Act reporting, Standard Form 424 (Application for Federal Assistance), grant agreements, budget reports and justifications, public and private requests for information, data provided to other programs for database on similar programs, Congressional inquiries and reports required by NMBCA, etc.

In summary, information collection under these programs is required to obtain a benefit, i.e., a cash reimbursable grant that is given competitively to some applicants based on eligibility and relative scale of resource values involved in the projects. The information collection is subject to the Paperwork Reduction Act requirements for such activity, which includes soliciting comments from the general public regarding the nature and burden imposed by the collection.

Frequency of Collection: Occasional. The Neotropical Migratory Bird Conservation Act grant program currently has one project proposal submissions window per year.

Description of Respondents: Households and/or individuals; business and/or other for-profit; not-for-profit institutions; farms; Federal Government; and State, local and/or Tribal governments.

Estimated Completion Time: The reporting burden, or time involved in writing project proposals, is estimated to be 40 hours.

Number of Respondents: It is estimated that approximately 200 proposals will be submitted each year for the Neotropical Migratory Bird Conservation Act grant program.

Authority for this program is found at 43 USC 36c, and 43 USC 50c. The Office of Management and Budget Catalog of Federal Domestic Assistance Number is 15.808.

Under the RIK pilot undertaken jointly by the State of Texas General Land Office and the Department of the Interior's Minerals Management Service, gas was sold beginning in June 1999. The pilot included thirteen of the forty leases offshore Texas subject to section 8(g) of the OCS Lands Act. These leases were split into two packages “ the “Blessing” and the “MOPS” “ for purposes of gas sales. The Report summarizes and analyzes the results of the sales for the first 19 months “ June 1999 through December 2000.

MMS and the State of Texas initiated the 8(g) gas pilot as part of the continuing effort to follow through on the recommendations of the Royalty-In-Kind Feasibility Study published by MMS in 1997. Many of the lessons learned during the 8(g) pilot period and subsequent sales have been carried over to the expansion of the gas RIK pilots to the entire Gulf of Mexico (GOM). MMS's intent in making the Report available for comment prior to finalization is to continue an iterative improvement process by receiving comments from individuals and groups with expertise in the GOM gas market.

The internet posting and availability of the Report in hard copy are being announced by a press release as well as in this Federal Register notice.

Our practice is to make comments, including names and home addresses of respondents, available for public review. Individual respondents may request that we withhold their home address from public disclosure, which we will honor to the extent allowable by law. There also may be circumstances in which we would withhold a respondent's identity from public disclosure, as allowable by law. If you wish us to withhold your name and/or address, you must state this prominently at the beginning of your comment. We will make all submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, available for public disclosure in their entirety.

Reclamation has undertaken this study as one potential means to augment instream flow in the lower Yakima River and benefit anadromous fish under the authority of Title XII, Phase 2 of the Yakima River Basin Water Enhancement Project, in Public Law 103-434 (Title XII), which was passed by the Congress on October 31, 1994. Public Law 106-372, which amended Title XII, authorized an engineering feasibility report of the Chandler Pump Exchange, as well as electrifying the pumps at the Chandler Pumping Plant at Prosser Diversion Dam, Washington. Alternatives being considered include either a partial or full Yakima-Columbia River water exchange, or the electrification of the Chandler Pumping Plant.

Water exchange would entail pumping water from the Columbia River near the mouth of the Yakima River into the Kennewick Irrigation District (KID) and Columbia Irrigation District (CID) canals and reducing the amount of water diverted from the Yakima River at the current points of diversion. One of the alternatives being considered is a partial exchange of KID's full Yakima River diversion. It would involve diverting about 2/3 of KID's total 333 cfs diversion from the Columbia River and continuing to divert the remainder at Prosser Dam on the Yakima River. Another alternative is a full exchange which would totally eliminate the diversion of water from the Yakima River to the KID canal. Both alternatives would involve pumping approximately 116 cfs of CID's total existing Yakima River diversion from the Columbia River.

The alternative of electrification of the Chandler Pumping Plant would involve replacing the existing hydraulic pumps in the pumping plant with electric pumps to pump Yakima River water into KID's main canal at the current point of diversion. The Chandler Pumping Plant is located at the end of the Chandler Canal into which water is diverted at Prosser Dam. Replacing the hydraulic pumps with electric pumps would eliminate the need to divert water at Prosser Dam to drive the hydraulic pumps leaving up to 450 cfs in the 11 mile reach of the Yakima River from Prosser Dam to the Chandler Pumping Plant. No exchange with CID would take place under this alternative.

Reclamation plans to conduct public scoping meetings to solicit input on the alternatives developed to address stream flows in the lower Yakima River between Prosser Dam and the mouth of the river, and impacts associated with those alternatives. Reclamation will summarize comments received during the scoping meetings and written comments received during the scoping period, identified under DATES , into a scoping summary document which will be made available to the public.