Russian knapweed ( Acroptilon repens ) is an aggressive, long-lived perennial in the Asteraceae or sunflower family that thrives in both irrigated and arid environments, and in cropland, pastures, rangeland, shrubland, and wasteland. It is difficult to control in alfalfa, clover, other forage crops, and pastures. It reduces wildlife habitat and suppresses the growth of other plants.

Russian knapweed has no known beneficial qualities. It is not utilized for forage because of its bitter taste, and may cause neurological disorders in horses if consumed. The quality of flour or other grain products that have been contaminated by Russian knapweed is reduced due to the bitter taste it imparts. Studies indicate that the spread of Russian knapweed may have a significant economic impact.

Russian knapweed reproduces primarily vegetatively from a primary vertical root with numerous lateral roots. It is a strong competitor and produces compounds that exclude other plant species. Russian knapweed seeds may be spread through infested hay or crop seeds or through the movement of cattle, as the seeds are able to survive the digestive system of these animals.

Estimated Russian knapweed acreage for the Western United States and Canada for the year 2000 totaled over 1,561,714 acres, with 80 percent of the affected acreage located in the States of Washington, Idaho, Colorado, and Wyoming.

Aulacidea acroptilonica is a small gall-forming wasp that has been demonstrated through specificity testing and field observations reported in scientific literature to attack only Russian knapweed. Gall induction diverts nutrients from flower formation, seed production, and the normal growth of plant tissues, thus reducing the plant's competitive ability and seed production.

On April 24, 2008, we published in the Federal Register (73 FR 22127-22128, Docket No. APHIS-2008-0042) a notice  1 in which we announced the availability, for public review and comment, of an environmental assessment entitled “Field Release of Aulacidea acroptilonica (Hymenoptera: Cynipidae), an Insect for Biological Control of Russian Knapweed ( Acroptilon repens ), in the Continental United States” (January 22, 2008) that examined the potential environmental impacts associated with the proposed use of A. acroptilonica as an agent for the biological control of Russian knapweed.

We solicited comments on the environmental assessment for 30 days ending May 27, 2008. We did not receive any comments by that date.

In this document, we are advising the public of our decision and finding of no significant impact regarding the release of the gall wasp Aulacidea acroptilonica as an agent for the biological control of Russian knapweed. This decision is based upon the updated environmental assessment, entitled “Field Release of Aulacidea acroptilonica (Hymenoptera: Cynipidae), an Insect for Biological Control of Russian Knapweed ( Acroptilon repens ), in the Continental United States” (June 2008). This version of the environmental assessment contains minor editorial changes and addresses our compliance with Executive Order 13175, which requires APHIS to consult with Indian Tribal governments regarding the proposed release of Aulacidea acroptilonica.

The updated environmental assessment and finding of no significant impact may be viewed on the Regulations.gov Web site (see footnote 1). Copies of the updated environmental assessment and finding of no significant impact are also available for public inspection at USDA, room 1141, South Building, 14th Street and Independence Avenue SW., Washington, DC, between 8 a.m. and 4:30 p.m., Monday through Friday, except holidays. Persons wishing to inspect copies are requested to call ahead at (202) 690-2817 to facilitate entry into the reading room. You may request paper copies of the updated environmental assessment and finding of no significant impact by calling or writing to the person listed under FOR FURTHER INFORMATION CONTACT . Please refer to the title of the environmental assessment when requesting copies.

The environmental assessment has been prepared in accordance with: (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq. ), (2) regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA regulations implementing NEPA (7 CFR part 1), and (4) APHIS's NEPA Implementing Procedures (7 CFR part 372).

Title: Special Milk Program.

OMB Number: 0584-0005.

Expiration Date: March 31, 2009.

Type of Request: Extension of a currently approved collection.

Abstract: Section 3 of the Child Nutrition Act (CNA) of 1966, (42 U.S.C. 1772) authorizes the Special Milk Program (SMP). It provides for the appropriation of such sums as may be necessary to enable the Secretary of Agriculture to encourage the consumption of fluid milk by children in the United States in (1) nonprofit schools of high school grade and under, and (2) nonprofit nursery schools, child care centers, settlement houses, summer camps, and similar nonprofit institutions devoted to the care and training of children, which do not participate in a food service program authorized under the CNA or the National School Lunch Act.

Section 10 of the CNA (42 U.S.C. 1779) requires the Secretary of Agriculture to prescribe such regulations as deemed necessary to carry out this Act and the National School Lunch Act. Pursuant to that provision, the Secretary has issued 7 CFR Part 215, which sets forth policies and procedures for the administration and operation of the SMP. State and local operators of the SMP are required to meet Federal reporting and accountability requirements. The vast majority of reporting relates to information regarding eligibility determinations of the children, the number of milk servings, and revenues received from milk sales. State and local operators are also required to maintain records regarding eligibility to operate the program, review results, and accounts of revenues and expenditures.

Affected Public: 55 State agencies, 4,150 School food authorities/Sponsors, 4,910 schools, 533 child care institutions and 853 camps.

Estimated Number of Respondents: 10,501.

Estimated Number of Responses per Respondent: 14.

Estimated Total Annual Responses: 147,014.

Estimated Time per Response: .29.

Estimated Total Reporting Annual Burden hours: 42,634.06.

Number of Recordkeepers: 10,501.

Estimated Number of Responses per Respondent: 39.

Estimated Total Annual Responses: 409,539.

Estimated Time per Response: .17.

Estimated Total Annual Recordkeeping Burden Hours: 69,621.63.

Total Request Annual Reporting and Recordkeeping Burden Hours: 112,255.69.

The Federal Recreation Lands Enhancement Act (Title VII, Pub. L. 108-447) directed the Secretary of Agriculture to publish a six month advance notice in the Federal Register whenever new recreation fee areas are established. Once public involvement is complete, new fee proposals will he reviewed by the Pacific Northwest Recreation Resource Advisory Committee (RRAC). The RRAC will discuss and forward their recommendation to the Regional Forester who makes the final decision on behalf of the Secretary of Agriculture. Information about the Pacific Northwest Recreation Resource Advisory Committee, RRAC meeting dates and location can be found on the Region 6 (Oregon/Washington) Forest Service Web site at: http://www.fs.fed.us/r6/passespermits/rrac.shtml. A tentative meeting is scheduled for the end of October of 2008.

A limited number of copies of the Environmental Assessment and the Supplemental Environmental Assessment are available to fill single copy requests at the above address. Copies of the environmental documents are also available for review at the above address.

The National Environmental Policy Act of 1969 (NEPA) requires Federal agencies to examine the environmental impacts of all Federal actions affecting the quality of the human environment. I have determined, based upon the evaluation of impacts in the Environmental Assessment (EA) prepared in 2003 and the Supplemental Environmental Assessment (SEA) prepared in 2007, that there would be no significant individual or cumulative impacts on the quality of the human environment as a result of implementing the North Forest Acres Levee/Road Project in Seward, Alaska. The EA and SEA are attached hereto and made a part hereof. Based on the documented findings, I have determined that an Environmental Impact Statement is not required.

The city of Seward, Alaska, has experienced flood damage from the Resurrection River and Japanese Creek several times in the past. Damages from the 1995 flood alone totaled 9.8 million dollars. A multi-agency task force recommended five complementary actions to minimize the risk of future damage. Three of these actions (a levee on Japanese Creek, dredging at the mouth of the Resurrection River and widening of the highway bridges) have been completed. The North Forest Levee/Road Project, along with widening of the railroad bridges are the final components of the flood control strategy. Congress has authorized funding for this project in the Natural Resources Conservation Service (NRCS) budget.

An Environmental Assessment was completed for this project in 2003. Based on the findings of the EA a preferred alternative was selected (West 2b and East 3) as the best viable option of the eight considered, including the no-action. This decision was based on an analysis of the environmental impacts for each alternative, public comment, and State and Federal agency comments. A Finding of No Significant Impact (FONSI) was issued based on the preferred alternative and published in the Federal Register (69 FR 2110-2111). The Seward City Council and the residents of the effected areas raised objections to the FONSI and the preferred alternative. The objections were based primarily on the close proximity of the dyke and road to the residential subdivision. A decision was made to rescind the original FONSI and prepare a Supplemental Environmental Analysis to address these concerns.

The SEA assessed the impacts of an additional alignment further to the north of the original alternatives addressed in the EA. This alternative had the support of the City and the nearby residents. This alternative also had greater adverse impacts (than the original routes) on the floodplain, wetlands, and Japanese Creek. Based on comments received from State and Federal agencies it was clear that the northerly route would require a more in-depth study and in all probability would create the need for the preparation of an Environmental Impact Statement (EIS) with no guarantee of support for the City's preferred alternative. For the purpose of furthering the project, the Seward City Council has dropped their objections to the preferred alternative identified in the 2003 EA.

The current preferred alternative is the same as the preferred alternative identified in the 2003 EA with a slight modification. The eastern half of the alignment has been moved slightly further south so as to further reduce any impacts to those wetlands. The western half of the route remains as identified in the 2003 preferred alternative. This alternative minimizes impact to the wetlands, minimizes encroachment on the floodplain, and results in no significant rise of floodwaters in Resurrection River. There are no stream crossings of Japanese Creek and no culverts or flood gates to operate and maintain.

Based on the information presented in the attached North Forest Levee/Road Project EA and SEA, I find that the proposed action is not a major Federal action significantly affecting the quality of the human environment. Therefore, an EIS is not required.

Paperwork Reduction Act

Under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. , OMB must approve all “collections of information” by USDA Rural Development. The Act defines “collection of information” as a requirement for “answers to * * * identical reporting or recordkeeping requirements imposed on ten or more persons * * *.” (44 U.S.C. 3502(3)(A)). Because the RFP is expected to receive less than 10 respondents, the Paperwork Reduction Act does not apply.

Federal Agency: Rural Business-Cooperative Service.

Funding Opportunity Title: Research on the Economic Impact of Cooperatives.

Announcement Type: Initial announcement.

Catalog of Federal Domestic Assistance Number: 10.778

Dates: You may submit completed applications for the cooperative agreement on paper or electronically according to the following deadlines:

Paper copies must be received by September 19, 2008, to be eligible for FY 2008 funding. Late applications are not eligible for FY 2008 funding.

Electronic copies must be received by September 19, 2008, to be eligible for FY 2008 funding. Late applications are not eligible for FY 2008 funding.

This solicitation is issued pursuant to the Consolidated Appropriations Act, 2008 (Pub. L. 110-161) directing funds “for a cooperative research agreement with a qualified academic institution to conduct research on the national economic impact of all types of cooperatives.” The Secretary of Agriculture has delegated the program's administration to USDA Rural Development.

The primary objective of this cooperative research agreement program is to facilitate university research on the national economic impact of cooperatives. This cooperative research agreement is a continuation of research conducted in USDA Rural Development cooperative research agreements RD-06-01 and RBS-07-31. As further described below, data generated and results produced in cooperative research agreements RD-06-01 and RBS-07-31 will be accessible to the institution awarded this cooperative research agreement. To the extent that this research program will generate further data, existing Web-based methodologies will be used to enable cooperatives to enter financial and other impact data on a periodic basis; apply the methodology to collect data updates estimates of economic impact of cooperatives; analyze the impact of cooperatives on local wealth creation and retention, and analyze the total returns to investment in cooperatives. Methodologies will need to account for cooperative organizational complexity, such as a single organization's several local, regional, and national locations, as well as sector differences.

The cooperative agreement proposal must address specifically, and in detail sufficient to assess the effectiveness of proposed work, how the following deliverables will be provided:

1. An analysis of how and the extent to which cooperatives facilitate the creation and retention of wealth within the local communities they serve. The analysis should include the identification of cooperative models and practices that could enhance cooperative contribution to local wealth creation. An estimate of cooperative wealth creation should be made for the U.S. and for each of the following four categories or classes of cooperatives:

i. Commercial sales or marketing—includes farm supply and marketing, grocery and consumer goods, business-to-business, the emerging ethanol and biofuels related industry, and manufacturing.

ii. Social and public services—includes housing, health care, day care/elder care, transportation, and educational services.

iii. Financial services—includes credit unions, banks, and mutual insurance.

iv. Utilities—includes electric, telephone, water, waste, and other regulated utilities.

2. An analysis of the total returns to investment in cooperatives, including returns to the cooperative businesses at the enterprise level as well as the impact of cooperative returns and services to the cooperatives' members at their enterprise levels. Total returns to investment should be analyzed using the same classification scheme as describe in Deliverable 1 above.

3. Development of sound methodologies to utilize available and newly-generated data to identify and measure the economic impacts of cooperatives as to the following:

i. Local and regional significance and impact analysis using appropriate input-output, social accounting matrix, and multiplier tools;

ii. Differential economic impacts of cooperatives as compared to other types of organizations performing the same general functions, including but not limited to (a) the differential impacts of local ownership versus ownership from outside the region and (b) any special economic impacts generated by the patron-oriented characteristics of cooperative businesses;

iii. Whether a non-cooperative business enterprise would exist in the local or regional economy if the cooperative did not exist;

iv. Displacement or replacement of other businesses by cooperatives;

v. Departure of a cooperative including a cooperative's replacement by another type of business; and

vi. Impact on local, regional, and national tax generation and on infrastructure.

4. Because output of the FY 2006 research will likely not be available before January 2009, USDA Rural Development will arrange for the winner of this competition to obtain updates and preliminary data from the University of Wisconsin, the FY 2006 and FY 2007 award recipient, as progress is being made on the FY 2006 and FY 2007 research. Data available to the FY 2008 award recipient will include:

i. number and headquarters location of cooperatives,

ii. volume measures appropriate for each sector (revenues, dollar value, and other appropriate size indicators),

iii. number of persons impacted by the cooperative (members, patrons, or investors), and

iv. number of full-time equivalent jobs and other economic impact variables.

v. Cooperative data will be identified using the North American Industry Classification System (NAICS).

5. Economic impact analyses as described in deliverables 3 and 4 above to be conducted on a sector basis. Sectors to be analyzed include:

i. Housing,

ii. health care,

iii. daycare/elder care,

iv. financial services,

v. grocery/consumer retail,

vi. business-to-business (wholesaling, manufacturing),

vii. agricultural marketing (including organic and conventional),

viii. agricultural supplies and services,

ix. public services (including transportation and education),

x. renewable energy, and

xi. utilities.

6. The population of a database for individual cooperative and summary data collected and additional data generated as necessary to obtain economic impacts as described in deliverables 3 and 4 above. The database is to be delivered to USDA Rural Development. USDA Rural Development will work with the grantee to integrate data from this deliverable into existing database applications.

7. The performance of subcontracting services, oversight, and financial controls for the overall project.

8. The submission of quarterly progress reports and quarterly financial reports to USDA Rural Development; and

9. The preparation and submission of publishable quality written reports for Deliverables 1 through 5 to USDA Rural Development.

USDA Rural Development will competitively award one cooperative agreement to fund the collection and analysis of data to determine the national economic impact of cooperatives. An institution of higher education may subcontract or collaborate with others on the research and data collection. A formal consortium of academic institutions is allowed.

The definitions at 7 CFR 3019.2 are incorporated by reference.

Type of Award: Cooperative Agreement.

Fiscal Year Funds: FY 2008.

Approximate Total Funding: $491,535.

Approximate Number of Awards: 1.

Approximate Average Award: $491,535.

Floor of Award Range: None.

Ceiling of Award Range: $491,535.

Anticipated Award Date: September 25, 2008.

Budget Period Length: 24 months.

Project Period Length: 24 months.

Applicants must be institutions of higher education. Proposals may be submitted by public or private colleges or universities, research foundations maintained by a college or university, or private nonprofit organizations funded by a group of colleges or universities.

Matching funds are not required but are highly encouraged. Applicants must verify in their applications that matching funds are available for the time period of the agreement if the matching funds are required to complete the project. Matching funds must be provided by either the applicant or by a third party in the form of cash or in-kind contributions. Matching funds must be spent on eligible expenses and must be from eligible sources.

Indirect Cost Eligibility: Public Law 110-161, “Consolidated Appropriations Act, 2008” continues the provision which states “No funds appropriated by this Act may be used to pay negotiated indirect cost rates on cooperative agreements or similar arrangements between the United States Department of Agriculture and nonprofit institutions in excess of 10 percent of the total direct cost of the agreement when the purpose of such cooperative arrangements is to carry out programs of mutual interest between the two parties.” Indirect costs in excess of 10 percent of the direct cost, therefore, will be ineligible for funding.

Activity Eligibility: A cooperative agreement reflects a relationship between the United States Government and an eligible recipient where the principal purpose of the relationship is the transfer of money, property, services, or anything of value to the eligible recipient to carry out the desired research; and substantial involvement is anticipated between USDA Rural Development acting for the United States Government and the eligible recipient during the performance of the research in the agreement. A cooperative agreement is not a grant. Therefore, the project proposed must include a description of USDA Rural Development's substantial participation. USDA Rural Development may subsequently negotiate the nature of its participation before the cooperative agreement is executed.

Applicants that propose budgets that include more than 10 percent of total project costs that are ineligible for the program will be ineligible, and the application will not be considered for funding. However, if an application with 10 percent or less of ineligible costs is selected for funding, all ineligible costs must be removed from the project and replaced with eligible activities or the amount of the award will be reduced accordingly.

Cooperative Agreement Period Eligibility: Applications that have a timeframe of more than 24 months will be considered ineligible and will not be considered for funding. Applications that request funds for a time period ending after September 30, 2010, will not be considered for funding.

Completeness Eligibility: Applications without sufficient information to determine eligibility will not be considered for funding. Applications that are missing any required elements (in whole or in part) will not be considered for funding.

If you plan to apply using a paper application, you can obtain the application package for this funding opportunity at http://www.rurdev.usda.gov/rbs/coops/reic.htm. If you plan to apply electronically, you must visit http://www.grants.gov and follow the instructions.

You may submit your application in paper or in an electronic format. You may view the Application Guide at http://www.rurdev.usda.gov/rbs/coops/reic.htm.

If you submit your application in paper form, you must submit one signed original of your complete application along with two additional copies.

If you submit your application electronically, you must follow the instructions given at http://www.grants.gov. Applicants are advised to visit the site well in advance of the application deadline if they plan to apply electronically to insure that they have obtained the proper authentication and have sufficient computer resources to complete the application.

An application must contain all of the following elements. Any application that is missing any element or contains an incomplete element will not be considered for funding:

1. Form SF-424, “Application for Federal Assistance.” In order for this form to be considered complete, it must contain the legal name of the applicant, the applicant's Dun and Bradstreet Data Universal Numbering System (DUNS) number, the applicant's complete mailing address, the name and telephone number of a contact person, the employer identification number (EIN), the start and end dates of the project, the Federal funds requested, other funds that will be used as matching funds, an answer to the question, “Is applicant delinquent on any Federal debt?”, the name and signature of an authorized representative, the telephone number of the authorized representative, and the date the form was signed. Other information requested on the form may be applicable, but the above-listed information is required for an application to be considered complete.

The DUNS number is a nine-digit identification number, which uniquely identifies business entities. Applicants can receive a DUNS number at no cost by accessing http://www.dnb.com/us/ or calling (866) 705-5711.

2. Form SF-424A, “Budget Information—Non-Construction Programs.” In order for this form to be considered complete, the applicant must fill out Sections A, B, C, and D. The applicant must include both Federal and any matching funds to be included.

3. Form SF-424B, “Assurances—Non-Construction Programs.” In order for this form to be considered complete, the form must be signed by an authorized official and include the title, name of applicant, and date.

4. Title Page. The title page must include the title of the project as well as any other relevant identifying information. The length should not exceed one page.

5. Table of Contents. For ease of locating information, each proposal must contain a detailed Table of Contents immediately following the title page.

6. Executive Summary. A summary of the proposal, not to exceed one page, must briefly describe the project, including goals, tasks to be completed, and other relevant information that provides a general overview of the project. In the event an applicant submits more than one page for this element, only the first page submitted will be considered.

7. Eligibility Discussion. A detailed discussion, not to exceed four pages, will describe how the applicant meets the eligibility requirements. In the event that more than four pages are submitted, only the first four pages will be considered.

i. Applicant Eligibility. The applicant must first describe how it meets the definition of an institution of higher education.

ii. Purpose Eligibility. The applicant must describe how the project purpose is eligible for funding. The project purpose is comprised of two components. First, the applicant must describe how the proposed project consists of activities needed to determine the national economic impact of all types of cooperatives. Second, the applicant must demonstrate that the combined activities are sufficient to estimate the national economic impact of all types of cooperatives.

8. Proposal Narrative. The narrative must include the following information:

i. Project Title. The title of the proposed project must be brief, not to exceed 75 characters, yet describe the essentials of the project. It should match the project title submitted on the SF-424. The project title does not need to appear on a separate page. It can be included on the title page and/or on the information sheet.

ii. Information Sheet. A separate one-page information sheet listing each of the evaluation criteria referenced in this funding announcement followed by the page numbers of all relevant material contained in the proposal that address or support each criterion.

iii. Goals of the Project. A clear statement of the ultimate goals of the project must be included. There must be an explanation of how economic benefit will be measured.

iv. Workplan. The narrative must contain a description of the project and set forth the tasks involved in reasonable detail. The description should specify the activity, who will perform the activity, during what timeframe the activity will take place, and the cost of the activity. Please note that one of the proposal evaluation criteria evaluates the workplan and budget. Applicants should only submit the workplan and budget once, either in this section or as part of the workplan/budget evaluation criterion discussion.

v. Proposal Evaluation Criteria. Each of the proposal evaluation criteria referenced in this funding announcement must be addressed, specifically and individually, in narrative form.

9. Certification of Judgment. Applicants must certify that the United States has not obtained a judgment against them. No Federal funds shall be used to pay a judgment obtained by the United States. It is suggested that applicants use the following language for the certification. “[INSERT NAME OF APPLICANT] certifies that the United States has not obtained a judgment against it.” A separate signature is not required.

10. Verification of Matching Funds. Applicants must provide a budget to support the workplan showing all sources and uses of funds during the project period. Applicants will be required to verify any and all matching funds, both cash and in-kind. All proposed matching funds must be specifically documented in the application. If the matching funds are to be provided by an in-kind contribution from the applicant, the application must include a signed letter from an authorized representative of the applicant verifying the goods or services to be donated, when the goods and services will be donated, and the value of the goods or services. Applicants should note that only goods or services for which no expenditure is made can be considered in-kind. If the applicant is paying for goods and services as part of the matching funds contribution, the expenditure is considered a cash match, and should be verified as such. If the matching funds are to be provided by a third party in cash, the application must include a signed letter from that third party verifying how much cash will be donated and when it will be donated. Verification of funds donated outside the proposed time period of the cooperative agreement will not be accepted. If the matching funds are to be provided by a third party in-kind donation, the application must include a signed letter from the third party verifying the goods or services to be donated, when the goods and services will be donated, and the value of the goods or services. Verification of in-kind contributions donated outside the proposed time period of the cooperative agreement will not be accepted. Verification of in-kind contributions that are over-valued will not be accepted. The valuation process for the in-kind funds does not need to be included in the application, especially if it is lengthy, but the applicant must be able to demonstrate how the valuation was achieved at the time of notification of tentative selection for the award. If the applicant cannot satisfactorily demonstrate how the valuation was determined, the award may not be made.

If matching funds are in cash, they must be spent on goods and services that are eligible expenditures for this cooperative agreement program. If matching funds are in-kind contributions, the donated goods or services must be considered eligible expenditures for this program. The matching funds must be spent or donated during the agreement period. (See 7 CFR parts 3015 and 3019 for funds use eligibility rules.)

If acceptable verification for all proposed matching funds is missing from the application by the application deadline, the application will receive zero points for the Funding Match part of the evaluation criteria.

Application Deadline Date: September 19, 2008.

Explanation of Deadlines: Paper applications must be RECEIVED by the deadline date (see Section IV.F. for the address). Final electronic applications must be RECEIVED by http://www.grants.gov by the deadline date. If your application does not meet the deadline above, it will not be considered for funding. You will be notified whether or not your application was received on time.

Executive Order 12372, Intergovernmental Review of Federal Programs, does not apply to this program.

Funding restrictions apply to both Federal funds and matching funds. Funds may only be used for activities related to determining the economic impact of cooperatives.

No funds made available under this solicitation shall be used to:

1. Pay for the preparation of the cooperative agreement application;

2. Pay expenses not directly related to the funded project;

3. Fund political or lobbying activities;

4. Fund any activities prohibited by 7 CFR parts 3015 or 3019;

5. Duplicate current services or replace or substitute support previously provided;

6. Pay costs of the project incurred prior to the date of agreement approval; or

7. Pay any judgment or debt owed to the United States.

You may submit your paper application for a cooperative agreement to USDA Rural Development's Cooperative Programs, Attn: Cooperative Research, Mail STOP 3250, Room 4016-South, 1400 Independence Ave., SW., Washington, DC 20250-3250. The phone number that should be used for FedEx packages is (202) 720-7558. You may also choose to submit your application electronically at http://www.grants.gov. Final applications may not be submitted by electronic mail, facsimile, or by hand-delivery. Any application submission in a non-electronic format must contain all required documents in one envelope.

All eligible and complete applications will be evaluated based on the following criteria and maximum point allowances. Failure to address any one of the following criteria by the application deadline will result in a determination of incomplete and the application will not be considered for funding. The total points available for the set of criteria are 100.

1. Relevance of the project proposal (30 points). Proposals will be evaluated on how directly they address the stated objective of demonstrating economic impact of all types of cooperatives in the United States. Factors to be weighed by evaluators in scoring a proposal's relevance will include the:

• Definition of clear and objective measures of impact;

• Definition of specific measurement strategies for obtaining impact measures from each major cooperative sector and each category of persons impacted by cooperatives; and

• Description of sound data collection and analysis methodology.

2. Quality of Workplan (30 points). The quality evaluation criterion will be based on whether the proposal outlines a sound plan of work that will meet the objectives in a timely and cost-efficient manner. Factors to be weighed by evaluators in scoring a proposal's workplan will include:

• How well the steps for carrying out the work are defined;

• The logic of the sequence of proposed steps and the likelihood they will achieve their intended result;

• The establishment of clear benchmarks and timetables to measure the progress of the project;

• The detail, accuracy, and reasonableness of the project's proposed budget; and

• The ability to replicate measures from the FY 2006 and FY 2007 funding cycles.

3. Quality of personnel and management plan (20 points). The quality of the management plan and the personnel involved in carrying out the proposed project will evaluate the capabilities of the individuals and institutions to implement the work plan in an effective manner. Factors to be weighed by evaluators in scoring a proposal's personnel and management plan will include the:

• Experience of project leaders and the lead institution in managing complex research projects;

• Demonstration of a clear understanding of business models and general economic development;

• Management controls, progress measurements, and reporting systems within a structured project management plan; and

• Experience and relevant skills of researchers, consultants, and subcontractors assigned to carry out specific roles in the project.

4. Funding match and cooperative community support (20 points). Points will be awarded on the basis of the percentage match provided by the applicant and the level of support for the proposal from the cooperative community as evidenced by contribution of resources to the match and other indications of support.

• Up to 20 points will be awarded for matching funds provided by or arranged for by the applicant. Two points will be awarded for each 5 percent match, up to a maximum of 20 points for a 50 percent match.

Each application will be initially reviewed by Rural Development personnel for eligibility and to determine whether all required elements are complete. A list of required elements follows:

• SF-424

• SF-424A

• SF-424B

• Title Page

• Table of Contents

• Executive Summary

• Applicant Eligibility Discussion

• Purpose Eligibility Discussion

• Project Title

• Information Sheet

• Goals of the Project

• Work Plan

• Proposal Evaluation Criterion 1

• Proposal Evaluation Criterion 2

• Proposal Evaluation Criterion 3

• Proposal Evaluation Criterion 4

• Certification of Judgment

• Verification of any Matching Funds

Any incomplete or ineligible applications will not be further evaluated or considered for funding.

All eligible and complete proposals will be evaluated by a team of at least three reviewers based on criteria 1 through 4 described in paragraph A of this section. Reviewers will represent the Rural Development broad mission area, and will include at least three employees of USDA.

Once the scores for criteria 1 through 4 have been independently completed by the three reviewers, the scores will be used to rank the proposals. If the three reviewers rank the best proposal differently then, with the aid of a facilitator, the three reviewers will develop a consensus ranking. If the three reviewers cannot reach a consensus, two additional reviewers will review the proposals and be added to the rankings. A final ranking will be obtained based on the consensus rankings of the three member review panel, or, if appointed, the average of the five reviewers' rankings. Final award recommendation will be sent to the Under Secretary for Rural Development for final selection concurrence.

After the award selection is made, all applicants will be notified of the status of their applications by mail. The awardee must meet all statutory and regulatory program requirements in order to receive the award. In the event that an awardee cannot meet the requirements, the award will be withdrawn.

Award Date: The announcement of award selection is expected to occur on or about September 25, 2008.

The successful applicant will receive a notification of tentative selection for funding from USDA Rural Development. The applicant must sign a mutually agreed to cooperative agreement and comply with all applicable statutes, regulations, and this notice before the award will receive final approval.

Unsuccessful applicants will receive notification, including mediation procedures and appeal rights, by mail.

This award is subject to 7 CFR parts 3015 and 3019. These regulations may be accessed at http://www.access.gpo.gov/nara/cfr/cfr-table-search.html#page1 .

The following additional documentation requirements apply to the awardee selected for this program:

• Agency Approved Cooperative Agreement

• Form RD 1940-1, “Request for Obligation of Funds”

• Form AD-1047, “Certification Regarding Debarment, Suspension, and Other Responsibility Matters-Primary Covered Transactions”

• Form AD-1048, “Certification Regarding Debarment, Suspension, Ineligibility and Voluntary Exclusion-Lower Tier Covered Transactions”

• Form AD-1049, “Certification Regarding a Drug-Free Workplace Requirements (Grants)”

• Form RD 400-1, “Equal Opportunity Agreement”

• Form RD 400-4, “Assurance Agreement”

Additional information on these requirements can be found at http://www.rurdev.usda.gov/rbs/coops/reic.htm .

Reporting Requirements: You must provide USDA Rural Development with an original or an electronic copy that includes all required signatures of the following reports. The reports should be submitted to the Agency contact listed on your Cooperative Agreement. Failure to submit satisfactory reports on time may result in suspension or termination of your award.

1. Form SF-269 or SF-269A. A “Financial Status Report,” listing expenditures according to agreed upon budget categories, on a quarterly basis. Reporting periods end each December 31, March 31, June 30, and September 30. Reports are due 30 days after the reporting period ends.

2. Quarterly performance reports that compare accomplishments to the objectives stated in the proposal. Identify all tasks completed to date and provide documentation supporting the reported results. If the original schedule provided in the workplan is not being met, the report should discuss the problems or delays that may affect completion of the project. Objectives for the next reporting period should be listed. Compliance with any special condition on the use of award funds should be discussed. Reporting periods end each December 31, March 31, June 30, and September 30. Reports are due 30 days after the reporting period ends. Supporting documentation must also be submitted for completed tasks. The supporting documentation for completed tasks include, but are not limited to, questionnaire or interview guides, publications of research findings, summaries of data collected, and any other documentation related to how funds were spent.

3. Final Project performance reports that compare accomplishments to the objectives stated in the proposal. Identify all tasks completed and provide documentation supporting the reported results. If the original schedule provided in the workplan was not met, the report must discuss the problems or delays that affected completion of the project. Compliance with any special condition on the use of award funds should be discussed. Supporting documentation for completed tasks must also be submitted. The supporting documentation for completed tasks include, but are not limited to, publications of research findings, summaries of data collected, documentation of data and software delivered to USDA Rural Development, and any other documentation related to how funds were spent. The final performance report is due within 90 days of the completion of the project.

For general questions about this announcement and for program technical assistance, please contact the USDA Rural Development's Cooperative Programs, Mail STOP 3250, Room 4016-South, 1400 Independence Avenue, SW., Washington, DC 20250-3250, Telephone: (202) 720-8460 (TDD: (800) 877-8339 Federal Information Relay Service), e-mail: cpgrants@wdc.usda.gov .

USDA prohibits discrimination in all its programs and activities on the basis of race, color, national origin, age, disability, and where applicable, sex, marital status, familial status, parental status, religion, sexual orientation, genetic information, political beliefs, reprisal, or because all or part of an individual's income is derived from any public assistance program. (Not all prohibited bases apply to all programs.) Persons with disabilities who require alternative means for communication of program information (Braille, large print, audiotape, etc.) should contact USDA's TARGET Center at (202) 720-2600 (voice and TDD). To file a complaint of discrimination, write to USDA, Director, Office of Civil Rights, 1400 Independence Avenue, SW., Washington, DC 20250-9410, or call (800) 795-3272 (voice), or (202) 720-6382 (TDD). “USDA is an equal opportunity provider, employer, and lender.”

On January 4, 2005, the Department published in the Federal Register the antidumping duty order on wooden bedroom furniture from the PRC. See Notice of Amended Final Determination of Sales at Less Than Fair Value and Antidumping Duty Order: Wooden Bedroom Furniture from the People's Republic of China , 70 FR 329 (January 4, 2005). On January 2, 2008, the Department published a notice of opportunity to request an administrative review of the antidumping duty order on wooden bedroom furniture from the PRC for the period January 1, 2007, through December 31, 2007. See Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation: Opportunity to Request Administrative Review , 73 FR 158 (January 2, 2008).

The Department received multiple timely requests for review and on March 7, 2008, in accordance with section 751(a) of Tariff Act of 1930, as amended (“the Act”), published in the Federal Register a notice of the initiation of the antidumping duty administrative review of wooden bedroom furniture from the PRC for the 2007 period of review. See Initiation Notice .

Pursuant to 19 CFR 351.213(d)(1), the Department will rescind an administrative review, in whole or in part, if a party that requested a review withdraws the request within 90 days of the date of publication of the notice of initiation. Because all requesting parties withdrew their respective requests for review of the following entities within 90 days of the date of publication of the notice of initiation, the Department is rescinding this review with respect to these entities, in accordance with 19 CFR 351.213(d)(1):

• Ace Furniture & Crafts Ltd., Deqing Ace Furniture & Crafts Ltd.

• Alexandre International Corp., Southern Art Development Ltd., Alexandre Furniture (Shenzhen) Co. Ltd., Southern Art Furniture Factory

• Art Heritage International Ltd., Super Art Furniture Co. Ltd., Artwork Metal & Plastic Co., Ltd., Jibson Industries Ltd., Always Loyal International

• Baigou Crafts Factory of Fengkai

• Beijing New Building Materials Co., Ltd. (BNBM Co. Ltd.)

• Best King International Ltd.

• Billy Wood Industrial (Dong Guan), Great Union Industrial (Dongguan) Co., Ltd., Time Faith Ltd.

• Changshu HTC Import & Export Co. Ltd.

• Chen Meng Furniture (PTE) Co., Ltd., Cheng Meng Decoration & Furniture (Suzhou) Co., Ltd.

• Chuan Fa Furniture Factory

• Classic Furniture Global Co., Ltd.

• Clearwise Co., Ltd.

• Dalian Guangming Furniture Co., Ltd.

• Dalian Huafeng Furniture Co., Ltd.

• Dalian Pretty Home Furniture Co., Ltd.

• Der Cheng Wooden Works of Factory

• Dong Guan Golden Fortune Houseware Co., Ltd.

• Dongguan Cambridge Furniture Co., Ltd., Glory Oceanic Co., Ltd.

• Dongguan Chunsan Wood Products Co., Ltd, Trendex Industries Limited

• Dongguan Creation Furniture Co., Ltd., Creation Industries Co., Ltd.

• Dongguan Dihao Furniture Co., Ltd.

• Dongguan Fortune Furniture Ltd.

• Dongguan Grand Style Furniture Co., Ltd., Hong Kong DaZhi Furniture Company Ltd.

• Dongguan Great Reputation Furniture Co., Ltd.

• Dongguan Hero Way Woodwork Co., Ltd., Hero Way Enterprises, Ltd., Dongguan Da Zhong Woodwork Co., Ltd., Well Earth International Ltd.

• Dong Guan Hua Ban Furniture Co., Ltd.

• Dongguan Hung Sheng Artware Products Co., Ltd., Coronal Enterprise Co., Ltd.

• Dongguan Kin Feng Furniture Co., Ltd.

• Dongguan Kingstone Furniture Co., Ltd., Kingstone Furniture Co., Ltd.

• Dongguan Liaobushangdun Huada Furniture Factory, Great Rich (HK) Enterprises Co., Ltd.

• Dongguan Lung Dong Furniture Co., Ltd., Dongguan Dong He Furniture Co., Ltd.

• Dongguan New Technology Import & Export Co., Ltd.

• Dongguan Singways Furniture Co., Ltd.

• Dongguan Sunpower Enterprise Co., Ltd.

• Dongguan Sunrise Furniture Co., Taicang Sunrise Wood Industry Co., Ltd, Shanghai Sunrise Furniture Co., Ltd., Fairmont Designs

• Dongying Huanghekou Furniture Industry Co., Ltd.

• Dorbest Ltd., Rui Feng Woodwork Co., Ltd., Rui Feng Lumber Development Co., Ltd., aka, Dorbest Ltd., Rui Feng Woodwork (Dongguan) Co., Ltd., Rui Feng Lumber Development (Shenzhen) Co., Ltd.

• Eurosa (Kunshan) Co., Ltd., Eurosa Furniture Co., (PTE) Ltd.

• Ever Spring Furniture Co., Ltd. S.Y.C. Family Enterprise Co., Ltd.

• Fine Furniture (Shanghai) Ltd.

• Fortune Furniture Ltd.

• Foshan Guanqiu Furniture Co., Ltd.

• Furnmart Ltd.

• Gaomi Yatai Wooden Ware Co., Ltd., Team Prospect International Ltd., Money Gain International Co.

• Garri Furniture (Dong Guan) Co., Ltd., Molabile International, Inc. Weei Geo Enterprise Co., Ltd.

• Green River Wood (Dongguan) Ltd.

• Guangdong New Four Seas Furniture Manufacturing, Ltd.

• Guangming Group Wumahe Furniture Co., Ltd.

• Guangzhou Lucky Furniture Co., Ltd.

• Guangzhou Maria Yee Furnishings, Ltd., Pyla HK Ltd., Maria Yee, Inc.

• Hainan Jong Bao Lumber Co., Ltd. Jibbon Enterprise Co., Ltd.

• Hang Hai Woodcrafts Art Factory Co. Ltd.

• Hong Yu Furniture (Shenzhen) Co., Ltd.

• Hualing Furniture (China) Co., Ltd., Tony House Manufacture (China) Co., Ltd., Buysell Investments Ltd., Tony House Industries Co., Ltd.

• Hung Fai Wood Products Factory Ltd.

• Inni Furniture

• Jardine Enterprise, Ltd.

• Jiangmen Kinwai Furniture Decoration Co., Ltd.

• Jiangmen Kinwai International Furniture Co., Ltd.

• Jiangsu Weifu Group Company Fullhouse Furniture Manufacturing Corp

• Jiangsu Xiangsheng Bedtime Furniture Co., Ltd., aka Xiangsheng Jiangsu Bedtime Furniture Co., Ltd.

• Jiangsu Yuexing Furniture Group Co., Ltd.

• Jiedong Lehouse Furniture Co., Ltd.

• Kalanter (Hong Kong) Furniture Company Limited

• King Kei Trading Co. Ltd., King Kei Furniture Factory, Jiu Ching Trading Co., Ltd.

• King Wood Furniture Co., Ltd.

• King's Way Furniture Industries Co., Ltd., Kingsyear, Ltd.

• Kuan Lin Furniture (Dong Guan) Co., Ltd., Kuan Lin Furniture Factory, Kuan Lin Furniture Co., Ltd.

• Kunshan Lee Wood Product Co., Ltd.

• Kunshan Summit Furniture Co. Ltd.

• Kunwa Enterprise Company

• Langfang TianCheng Furniture Co., Ltd.

• Leefu Wood (Dongguan) Co., Ltd. King Rich International, Ltd.

• Link Silver Ltd. (V.I.B.), Forward Win Enterprises Co. Ltd., Dongguan Haoshun Furniture Ltd.

• Locke Furniture Factory, Kai Chan Furniture Co. Ltd., Kai Chan (Hong Kong) Enterprise Ltd., Taiwan Kai Chan Co. Ltd.

• Longrange Furniture Co. Ltd.

• Mei Jia Ju Furniture Industrial Shenzhen Co., Ltd.

• Nanhai Baiyi Woodwork Co. Ltd.

• Nanhai Jiantai Woodwork Co. Ltd., Fortune Glory Industrial, Ltd. (HK Ltd.)

• Nanjing Nanmu Furniture Co., Ltd.

• Nantong Yangzi Furniture Co., Ltd.

• Nantong Yushi Furniture Co., Ltd.

• Nathan International Ltd., Nathan Rattan Factory

• Ningbo Furniture Industries Limited, Techniwood Industries Ltd., Ningbo Hengrun Furniture Co., Ltd.

• Passwell Corporation, Pleasant Wave Ltd.

• Perfect Line Furniture Co., Ltd.

• Po Ying Industrial Co.

• Primewood International Co., Ltd., Prime Best International Co., Ltd., Prime Best Factory, Liang Huang (Jiaxing) Enterprise Co., Ltd.

• Profit Force Limited

• PuTian JingGong Furniture Co., Ltd.

• Qingdao Beiyuan Industry Trading Co. Ltd.

• Qingdao Beiyuan-Shengli Furniture Co., Ltd.

• Qingdao Liangmu Co., Ltd.

• Red Apple Trading Co., Ltd.

• Restonic (Dongguan) Furniture Ltd., Restonic Far East (Samoa) Ltd.

• Season Furniture Manufacturing Co., Season Industrial Development Co.

• Sen Yeong International Co. Ltd., Sheh Hau International Trading Ltd.

• Shanghai Jian Pu Export & Import Co., Ltd.

• Shanghai Maoji Imp. & Exp. Co. Ltd.

• Sheng Jing Wood Products (Beijing) Co., Ltd., Telstar Enterprises Ltd.

• Shenyang Kunyu Wood Industry Co., Ltd.

• Shenyang Shining Dongxing Furniture Co., Ltd.

• Shenzhen Dafuhao Industrial Development Co., Ltd.

• Shenzhen Forest Furniture Co., Ltd.

• Shenzhen Jiafa High Grade Furniture Co., Ltd., Golden Lion International Trading Ltd.

• Shenzhen New Fudu Furniture Co., Ltd.

• Shenzhen Tiancheng Furniture Co., Ltd., Winbuild Industrial Ltd., Red Apple Furniture Co., Ltd.

• Shenzhen Wonderful Furniture Co., Ltd.

• Shenzhen Xiande Furniture Factory

• Shenzhen Xingli Furniture Co., Ltd.

• Shing Mark Enterprise Co., Ltd., Carven Industries Ltd. (BVI), Carven Industries Limited (HK), Dongguan Zhenxin Furniture Co., Ltd., Dongguan Yongpeng Furniture Co., Ltd.

• Shun Feng Furniture Co., Ltd.

• Sino Concord International Corporation

• Songgang Jasonwood Furniture Factory, Jasonwood Industrial Co., Ltd. S.A.

• Starwood Furniture Manufacturing Co., Ltd.

• Starwood Industries Ltd.

• Strongson Furniture (Shenzhen) Co., Ltd., Strongson Furniture Co., Ltd., Strongson (HK) Co.

• Sunforce Furniture (Hui-Yang) Co., Ltd., SunFung Wooden Factory, Sun Fung Co., Shin Feng Furniture Co. Ltd., Stupendous International Co. Ltd.

• Superwood Co. Ltd., Lianjiang Zongyu Art Products Co., Ltd.

• T.J. Maxx International Co., Ltd.

• Tarzan Furniture Industries, Ltd., Samso Industries Ltd.

• Teamway Furniture (Dong Guan) Co. Ltd., Brittomart Inc.

• Tianjin First Wood Co., Ltd.

• Tianjin Fortune Furniture Co. Ltd.

• Tianjin Master Home Furniture

• Tianjin Phu Shing Woodwork Enterprise Co., Ltd.

• Top Art Furniture Factory/Sanxiang Top Art Furniture/Ngai Kun Trading

• Top Goal Development Co.

• Tradewinds Furniture Ltd.

• Tube-Smith Enterprises (ZhangZhou) Co., Ltd., Tube-Smith Enterprise (Haimen) Co., Ltd., Billionworth Enterprise, Ltd.

• Union Friend International Trade Co., Ltd.

• U-Rich Furniture (ZhangZhou) Co., Ltd., U-Rich Furniture, Ltd.

• Wan Bao Cheng Group Hong Kong Co., Ltd.

• Wanhengtong Nueevder (Furniture) Manufacture Co., Ltd., Dongguan Wanhengtong Industry Co., Ltd.

• Winmost Enterprises Limited

• Woodworth Wooden Industries (Dong Guan) Co., Ltd.

• Xiamen Yongquan Sci-Tech Development Co., Ltd.

• Xilinmen Group Co., Ltd.

• Yangchun Hengli Co., Ltd.

• Yichun Guangming Furniture Co., Ltd.

• Yongxin Industrial (Holdings) Limited

• Zhang Zhou Sanlong Wood Product Co., Ltd.

• Zhangjiagang Daye Hotel Furniture Co., Ltd.

• Zhangjiagang Zheng Yan Decoration Co. Ltd.

• Zhangzhou Guohui Industrial & Trade Co. Ltd.

• Zhanjiang Sunwin Arts & Crafts Co., Ltd.

• Zhong Cheng Furniture Co., Ltd.

• Zhong Shan Fullwin Furniture Co., Ltd.

• Zhongshan Fookyik Furniture Co., Ltd.

• Zhongshan Golden King Furniture Industrial Co., Ltd.

• Zhoushan For-Strong Wood Co., Ltd.

The Department will instruct U.S. Customs and Border Protection (“CBP”) to assess antidumping duties on all appropriate entries for the above-named entities. For those companies for which this review has been rescinded, antidumping duties shall be assessed at rates equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(1)(i). The Department will issue appropriate assessment instructions directly to CBP 15 days after the publication of this notice in the Federal Register .

In addition, the Department is rescinding this review with respect to the following entities which did not receive a separate rate in any completed prior segment of this proceeding. For purposes of initiation of this administrative review, the Department accepted requests for review of these entities based upon the premise that such entities would seek to demonstrate in this review that they were, in law and in fact, separate from the PRC-wide entity, and therefore, entitled to a rate separate from the rate established for the PRC-wide entity. However, as the requests for review of these entities have been withdrawn, these entities may be subject to this review as part of the single PRC-wide entity. 1 Therefore, the Department will provide assessment instructions to CBP for the PRC-wide entity, which includes the following companies, after the final results of this administrative review.

• Bao An Guan Lan Winmost Furniture Factory

• Beijing MingYaFeng Furniture Co., Ltd.

• Best King International Ltd., Bouvrie International Limited

• C.F. Kent Co., Inc., C.F. Kent Hospitality, Inc. Shanghai Kent Furniture Co., Ltd., and Shanghai Hospitality Product Mfg., Co., Ltd.

• Conghua J.L. George Timber & Co., Ltd.

• Contact Co., Ltd.

• Denny's Furniture Associates Corp.

• Der Cheng Furniture Co., Ltd.

• Dongguan Huada Furniture Co., Ltd.

• Dongguan Mu Si Furniture Co., Ltd.

• Dongguan Sea Eagle Furniture Co., Ltd.

• Dongguan Wanhengtong Furniture Co. Ltd.

• Engmost Investments Limited

• Evershine Enterprise, Ltd.

• Four Seas Furniture Manufacturing Ltd.

• Gainwell Industries Limited

• Grand Style Furniture Co., Ltd.

• Guangdong Gainwell Industrial Furniture Co., Ltd.

• Hainan Rulai Furniture Co., Ltd.

• Hong Kong Boliya Industry Development Co., Ltd.

• Hong Kong Jingbi Group

• Huizhou Jadom Furniture Co., Ltd., Jadom Furniture Co., Ltd.

• Hwangho New Century Furniture (Dongguan) Corp. Ltd., Trade Rich Furniture (Dongguan) Corp., Ltd.

• Kong Fong Furniture, Kong Fong Mao Iek Hong

• Kunshan Junsen Furniture Co., Ltd.

• Nanjing Jardine Enterprise Ltd.

• Nantong Dongfang Orient Furniture Co., Ltd.

• Nathan China Group

• Ningbo Fubang Furniture Industries Limited

• Ningbo Techniwood Furniture Industries Limited

• Ningbo Furniture Industries Company Limited

• Northeast Lumber Co., Ltd.

• Passwell Wood Corporation

• Putian Ou Dian Furniture Co., Ltd.

• Shanghai Season Industry & Commerce Co., Ltd.

• Sino Concord (Zhangzhou) Furniture Co., Ltd.

• Speedy International Ltd.

• Starcorp Furniture Co., Ltd., Starcorp Furniture (Shanghai) Co., Ltd., Orin Furniture (Shanghai) Co., Ltd., Shanghai Star Furniture Co., Ltd., Shanghai XingDing Furniture Industrial Co., Ltd.

• Techniwood (Macao Commercial Offshore) Limited,

• Time Crown (U.K.) International Ltd., China United International Company

• Top Goal Furniture Co., Ltd. (Shenzhen)

• Tradewinds International Enterprise Ltd.

• Trendex Industries Limited (BVI)

• Triple J Furniture Enterprises Co., Mandarin Furniture (Shenzhen) Co., Ltd.

• Winky Top Ltd.

• Zhejiang NiannianHong Industrial Co., Ltd.

• Zhongshan Fengheng Furniture Co., Ltd.

• Zhongshan Yiming Furniture Co. Ltd.

• Zhongshan Youcheng Wooden Arts & Crafts Co., Ltd.

This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's assumption that reimbursement of antidumping duties occurred and subsequent assessment of double antidumping duties.

This notice also serves as a reminder to parties subject to APOs of their responsibility concerning the return or destruction of proprietary information disclosed under an APO in accordance with 19 CFR 351.305, which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.

This notice is in accordance with section 777(i)(1) of the Act, and 19 CFR 351.213(d)(4).

On January 28, 2008, the Department published a notice of initiation of administrative review of the antidumping duty order on certain cased pencils from the People's Republic of China, covering the period December 1, 2006 through November 30, 2007. See Initiation of Antidumping and Countervailing Duty Administrative Reviews and Request for Revocation in Part , 73 FR 4829 (January 28, 2008). The current deadline for the preliminary results of this administrative review is September 2, 2008. 1

Section 751(a)(3)(A) of the Tariff Act of 1930, as amended (“the Act”), requires the Department of Commerce (“the Department”) to issue the preliminary results of an administrative review within 245 days after the last day of the anniversary month of an order for which a review is requested and the final results of review within 120 days after the date on which the preliminary results are published. If it is not practicable to complete the review within the time period, section 751(a)(3)(A) of the Act allows the Department to extend these deadlines to a maximum of 365 days and 180 days, respectively.

The Department requires additional time to review and analyze the sales and cost responses in this administrative review. Moreover, the Department requires additional time to analyze complex issues related to surrogate value selections. Because the Department requires additional time to analyze the information, issue supplemental questionnaires, and possibly verify the information, it is not practicable to complete this review within the originally anticipated time limit ( i.e. , by September 2, 2008). Therefore, the Department is extending the time limit for completion of the preliminary results by 112 days to not later than December 22, 2008, in accordance with section 751(a)(3)(A) of the Act.

We are issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act.

On February 15, 2008, TCA filed notice of an appeal with the Secretary of Commerce (Secretary), pursuant to the Coastal Zone Management Act of 1972 (CZMA), 16 U.S.C. 1451 et seq. , and implementing regulations found at 15 C.F.R. Part 930, Subpart H. TCA appealed an objection to its construction of an extension to California State Route 241 in northern San Diego and southern Orange Counties, California.

Under the CZMA, the Secretary must close the decision record in an appeal 160 days after the notice of appeal is published in the Federal Register . 16 U.S.C. 1465. However, the CZMA authorizes the Secretary to stay closing the decision record for up to 60 days when the Secretary determines it necessary to receive, on an expedited basis, any supplemental information specifically requested by the Secretary to complete a consistency review or any clarifying information submitted by a party to the proceeding related to information in the consolidated record compiled by the lead Federal permitting agency. 16 U.S.C. 1465(b)(3).

The decision record is currently scheduled to close on August 25, 2008. After reviewing the decision record developed to date, the Secretary has decided to solicit supplemental and clarifying information. In order to allow receipt of this information, the Secretary hereby stays closure of the decision record until October 24, 2008.

Additional information about the TCA Consistency Appeal and the CZMA appeals process is available from the Department of Commerce CZMA appeals Web site http://www.ogc.doc.gov/czma.htm .

Pursuant to sections 304(e)(2) and (e)(7) of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), 16 U.S.C. 1854(e)(2) and (e)(7), and implementing regulations at 50 CFR 600.310(e)(2), NMFS, on behalf of the Secretary, notifies fishery management councils when overfishing is occurring, a stock is approaching overfishing, a stock is overfished, a stock is approaching an overfished condition, or existing action taken to end previously identified overfishing or rebuilding a previously identified overfished stock or stock complex has not resulted in adequate progress.

On June 20, 2008, the NMFS approved Amendment 30A to the Fishery Management Plan for the Reef Fish Resources of the Gulf of Mexico and implemented it with a final rule published in the Federal Register (73 FR 38139; July 3, 2008). Amendment 30A established management targets and thresholds for Gulf of Mexico gray triggerfish that were previously undefined. Based on these new status determination criteria the NMFS found that the Gulf of Mexico gray triggerfish is overfished using an earlier stock assessment (SEDAR 9, 2006). Amendment 30A includes a rebuilding plan for Gulf of Mexico gray triggerfish.

On July 8, 2008, the NMFS Southeast Regional Administrator sent a letter notifying the South Atlantic Fishery Management Council (South Atlantic Council) that South Atlantic red snapper is overfished. The South Atlantic Council must submit a rebuilding plan for red snapper within one year of that notification.

On July 21, 2008, the NMFS Northeast Regional Administrator sent a letter notifying the New England Fishery Management Council (New England Council) that smooth skate is overfished and that thorny skate is undergoing overfishing. Thorny skate is currently under a rebuilding plan. The New England Council must therefore ensure that overfishing is ended and that the stock rebuilds on schedule. Copies of the notification letters sent to the fishery management councils for the aforementioned determinations are available at http://www.nmfs.noaa.gov/sfa/statusoffisheries/SOSmain.htm .

NMFS previously published the Secretary's determination that blacknose shark is overfished and subject to overfishing (73 FR 25665; May 7, 2008). It is included in this notice to provide complete documentation of the overfished and overfishing determinations made between April 1, 2008 and June 30, 2008.

Within 1 year of a notification under Magnuson-Stevens Act sections 304(e)(2) or (e)(7), the respective Council must take remedial action in response to the notification, to end overfishing if overfishing is occurring; rebuild an overfished stock or stock complex to the abundance that can produce maximum sustainable yield within an appropriate time frame; prevent overfishing from occurring if a stock is approaching overfishing; and/or prevent a stock from becoming overfished if it is approaching an overfished condition (see implementing regulations at 50 CFR 600.310(e)(3)). Such action must be submitted to NMFS within 1 year of notification and may be in the form of a new fishery management plan (FMP), an FMP amendment, or proposed regulations.

The FAR requires certain information to be provided by contractors which would enable the Government to make payments under the contract by electronic funds transfer (EFT). The information necessary to make the EFT transaction is specified in clause 52.232-33, Payment by Electronic Funds Transfer—Central Contractor Registration, which the contractor is required to provide prior to award, and clause 52.232-34, Payment by Electronic Funds Transfer—Other than Central Contractor Registration, which requires EFT information to be provided as specified by the agency to enable payment by EFT.

Respondents: 14,000.

Responses Per Respondent: 10.

Annual Responses: 140,000.

Hours Per Response: .5.

Total Burden Hours: 70,000.

Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, FAR Secretariat (VPR), Room 4041, 1800 F Street, NW, Washington, DC 20405, telephone (202) 501-4755. Please cite OMB Control No. 9000-0144, Payment by Electronic Funds Transfer, in all correspondence.

Background and Need for Agency Action: The Energy Policy Act of 2005 (EPAct 2005), Section 932, directs the Secretary of Energy to conduct a program of research, development, demonstration, and commercial application for bioenergy, including, integrated biorefineries that may produce biopower, biofuels, and bioproducts. Section 932 provides that “the goals of the biofuels and bioproducts programs shall be to develop, in partnership with industry and institutes of higher education—

(1) Advanced biochemical and thermochemical conversion technologies capable of making fuels from lignocellulosic feedstocks that are price-competitive with gasoline or diesel in either internal combustion engines or fuel cell-powered vehicles;

(2) Advanced biotechnology processes capable of making biofuels and bioproducts with emphasis on development of biorefinery technologies using enzyme-based processing systems;

(3) Advanced biotechnology processes capable of increasing energy production from lignocellulosic feedstocks, with emphasis on reducing the dependence of industry on fossil fuels in manufacturing facilities; and

(4) Other advanced processes that will enable the development of cost-effective bioproducts, including biofuels.”

Section 932(d) provides that “the Secretary shall carry out a program to demonstrate the commercial application of integrated biorefineries. The Secretary shall ensure geographical distribution of biorefinery demonstration under this subsection. The Secretary shall not provide more than $100,000,000 under this subsection for any single biorefinery demonstration. In making awards under this subsection, the Secretary shall encourage—

(A) The demonstration of a wide variety of lignocellulosic feedstocks;

(B) The commercial application of biomass technologies for a variety of uses, including—

i. Liquid transportation fuels;

ii. High-value biobased chemicals;

iii. Substitutes for petroleum-based feedstocks and products; and

iv. Energy in the form of electricity or useful heat; and

(C) The demonstration of the collection of treatment of a variety of biomass feedstocks.”

Section 932(d) further directs the Secretary to solicit proposals for demonstration of advanced biorefineries and to select only proposals that demonstrate economic viability without Federal subsidy after initial construction costs are paid and for projects that are replicable.

In implementing section 932, DOE's goal is to demonstrate that commercial-scale integrated biorefineries that use a wide variety of lignocellulosic feedstocks (biomass), can operate profitably once constructed, and can be replicated. Lignocellulosic feedstock includes energy crops, corn fiber, wood wastes, agricultural wastes such as corn stover, and certain municipal solid wastes. DOE notes that, while the refining process for ethanol from biomass is more complex than the refining process for ethanol derived from grain, cellulosic ethanol can yield a greater net energy benefit and result in lower greenhouse gas emissions.

Accordingly, DOE issued a funding opportunity announcement for the construction and operation of commercial-scale integrated biorefineries intended to demonstrate the use of a wide variety of cellulosic feedstocks. On February 28, 2007, DOE announced the selection of six biorefinery projects for negotiation of financial assistance awards. In that announcement, DOE proposes to invest up to $385 million in the six projects over the next four years.

Abengoa Bioenergy Biomass of Kansas, LLC (ABBK) of Chesterfield, Missouri, was one of the six applicants competitively selected for negotiation of award under DOE's funding opportunity announcement. Abengoa proposed an innovative approach to biorefinery operations that involves production of a biofuel and of energy in the form of steam that can be used to meet energy needs and displace fossil fuels such as coal and natural gas. In addition, siting the facility in Kansas would qualify Abengoa for state tax credits for biofuels, which would make the biorefinery a more viable commercial operation.

DOE granted an initial award to ABBK to advance the conceptual design; to initiate the permitting process; and to support an environmental review under NEPA for ABBK's proposed biomass-to-ethanol-and-energy facility near Hugoton, KS. DOE requires that ABBK fulfill these design, permitting, and environmental review obligations prior to deciding whether to cofund the construction and operation phase of the project. The total anticipated cost of this initial work is $37.5 million of which DOE is funding 40% ($15 million) and ABBK is providing 60% ($22.5 million).

As described below, DOE is now proposing to negotiate a second financial assistance agreement for approximately $61 million for the construction and operation of the biomass to ethanol facility, whose anticipated total cost is approximately $190.5 million.

ABBK is also planning to construct and operate a traditional grain-to-ethanol production facility at the same site that would integrate the biomass-to-ethanol facility into the overall facility. This grain-to-ethanol facility would use a traditional starch conversion process to produce ethanol from grain feedstocks (sorghum or corn) along with distillers grains with solubles, which is a product. While the traditional grain-to-ethanol facility would be constructed and operated with private funds, DOE plans to analyze the traditional grain-to-ethanol facility as a connected action in the EIS.

Proposed Action: DOE is proposing to provide approximately $61 million in Federal funding to ABBK for the construction and operation of a commercial-scale biomass-to-ethanol and energy facility near Hugoton, KS. The total estimated cost (beyond the initial award) for construction and operation of the biomass-to-ethanol portion of the project is approximately $190.5 million.

The biomass-to-ethanol facility would process 400 dry metric tons per day of biomass to produce approximately 12 million gallons per year (MGPY) of denatured ethanol. The biomass-to-ethanol facility would utilize an enzymatic hydrolysis process for converting biomass feedstocks to ethanol and co-products, and a gasification technology to convert biomass to synthesis gas. Biomass feedstock would be supplied from waste products from the production of crops produced within a 30 mile radius of the facility, and may include sorghum stubble, corn stover, switchgrass, and other opportunity feedstocks that are available in the area.

The traditional grain-to-ethanol process would use 32 million bushels of grain (sorghum and corn) to produce approximately 88 MGPY of denatured ethanol annually, two-thirds of which (i.e. that derived from sorghum) would qualify as Advanced Biofuels under Section 207 of the Energy Independence and Security Act of 2007 (EISA) (Per EISA, Advanced Biofuels includes all biofuels except corn-based ethanol). Solids from the process will be converted to animal feed, resulting in the production of up to 781,800 tons per year wet distillers grain with solubles (WDGS). The facility will have the capability to dry up to 50 percent of the WDGS, producing a maximum of 152,000 tons per year of dried distiller's grains with solubles (DDGS). The difference between the two sources of animal feed is moisture; DDGS contains approximately 10 percent moisture while WDGS contains approximately 65 percent moisture.

The overall integrated biorefinery, comprising both the proposed biomass-to-ethanol facility and the grain-to-ethanol facility, would be capable of producing about 100 MGPY of denatured ethanol and would be located on approximately 800 acres, which includes the combined facility footprint of about 385 acres and a buffer area between the proposed biorefinery and the City of Hugoton to the east. Hugoton has a population of about 3,700 and is located in Stevens County in southwest KS. Land use in the area is primarily agricultural in nature with cropland being the dominant use and grassland being the secondary use. The area has diverse biomass feedstocks, numerous large cattle feedlots, and a variety of grains grown locally.

The project site itself currently consists of row-cropped agricultural land and is adjoined by grain elevators, an asphalt plant, industrial park, and airport to the south; golf course and agricultural land to the west; two residences to the northwest; and agricultural cropland to the north. About 65 % of the site would qualify as prime farmland if it were irrigated. The proposed biorefinery site and additional buffer area to the east are currently zoned Agricultural, but the biorefinery location is proposed for a change to Heavy Industrial zoning.

Infrastructure required to operate the proposed biorefinery would include the following:

• Water, which would be supplied from wells on-site and near the project site utilizing water rights acquired from local owners;

• Electricity, which would be brought to the project site by Pioneer Electric from an existing substation located a few miles to the north of the project site;

• Natural gas, which would be brought through a lateral connection to one of the nearby interstate pipelines or through the local distribution company;

• Wastewater treatment—wastewater would be treated on-site, non-contact cooling water will be used for irrigation;

• Railroad service would be provided by the Cimarron Valley Short Line which runs adjacent to the project site; and

• Road access would be via a truck bypass route that the City of Hugoton intends to construct prior to the completion of the project.

During construction, truck traffic to the site would be expected to average about 30 shipments a day. During operations, truck traffic would be expected to increase to about 470 shipments a day. Most of the grain and biomass would be obtained from growers located near the proposed facility, but about 8 million tons of grain would be shipped to the facility from non-local sources each year.

Alternatives: NEPA requires that agencies evaluate reasonable alternatives to the proposed action in an EIS. To implement the requirements of EPAct 2005, Section 932(d), in a separate, earlier proceeding DOE conducted a competitive solicitation. DOE received 24 applications in the response to the solicitation. Of these, nine did not comply with statutory requirements for eligibility under Section 932. DOE reviewed the remaining 15 applications on their merits and, having considered the objectives set forth in Section 932, selected six proposals, including ABBK's proposal for appropriate NEPA review. DOE selected ABBK's proposal for negotiation of a funding agreement in part because of its particular scale, location, and technology.

DOE will consider reasonable only alternatives to the proposed action that meet its purpose and need. Accordinly, DOE proposes to analyze the following alternatives in detail in the EIS: (1) To provide federal funding for the Abengoa Biorefinery Project as proposed by ABBK (the Proposed Action); (2) to provide federal funding for the Abengoa Biorefinery Project contingent on implementation of environmental mitigation measures, which would be determined based on the environmental impact analysis in the EIS; and (3) to not provide federal funding for the proposed project (the No Action alternative).

Preliminary Identification of Environmental Issues: The purpose of this Notice is to solicit comments and suggestions for consideration in the preparation of the EIS. As background for public comment, this Notice contains a list of potential environmental issues that DOE has tentatively identified for analysis. This list identifies resource areas that may be affected by construction and operation of the proposed Project and that DOE plans to analyze in the EIS. This list is not intended to be all-inclusive or to imply any predetermination of impacts. DOE welcomes comments on this list and other suggestions on the scope of the EIS.

1. Water Resources: Potential impacts on surface and groundwater resources and water quality, including effects of water usage, wastewater management, storm water management.

2. Potential impacts on apparent isolated wetlands at the project site.

3. Utility and transportation infrastructure requirements for delivery of feedstocks and process chemicals to the facility and distribution of products from the facility to the marketplace.

4. Land Use: Changes in land use, including the proposed site and the geographical area that will provide feedstock to the proposed facility.

5. Local and Regional Air Quality.

6. Cultural Resources: Including potential effects on historic and archaeological resources and Native American tribal resources.

7. Ecological Resources: Terrestrial and aquatic plants and animals including state and Federally listed threatened and endangered species and other protected resources.

8. Health and safety impacts: Including construction-related safety and process-related safety associated with handling and management of process chemicals.

9. Noise: Potential impacts resulting from construction and operation of the proposed plant and from transportation of feedstocks, process materials, and plant byproducts.

10. Socioeconomic impacts: Potential socioeconomic impacts of plant construction and operation, including effects on public services and infrastructure resulting from the influx of construction personnel and plant operating staff, and environmental justice issues.

11. Aesthetic and scenic resources: Potential visual effects associated with plant structures and operations.

12. Cumulative impacts that result from the incremental impacts of the proposed plant when added to the other past, present, and reasonably foreseeable future activities within the regions of influence. This may include potential impacts resulting from widespread replication of this type of technology.

13. Global Climate Change: Potential greenhouse gas emissions and impacts on global climate change that may result from this project.

Public Scoping Process: Interested agencies, organizations, Native American tribes, and members of the public are encouraged to submit comments or suggestions concerning the content of the EIS, including the range of reasonable alternatives and the potential environmental impacts to be analyzed. DOE invites oral comments and suggestions at the public scoping meeting. The public scoping period will be open until October 9, 2008.

Written comments should be sent to Kristin Kerwin as described in the ADDRESSES section of this Notice. The public scoping meeting will be held at the location, date, and time listed in the DATES and ADDRESSES sections of this notice. This meeting will be informal. A presiding officer designated by DOE will establish procedures governing the conduct of the meeting and an overview of the proposed Project will be provided. The meeting will not be conducted as an evidentiary hearing, and those who choose to make statements will not be cross-examined by other speakers. However, DOE representatives may ask speakers questions to help ensure that DOE fully understands their comments or suggestions. To request time to speak at the meeting, please contact Kristin Kerwin via telephone, mail, fax or e-mail as listed in the ADDRESSES section of this Notice. Persons may also sign up to speak before the meeting at the reception desk at the entrance to the meeting and will be provided opportunities to speak after previously scheduled speakers have spoken, as time allows. To ensure that everyone who wishes to speak has a chance to do so, five minutes will be allotted to each speaker. Depending on the number of persons requesting to speak, DOE may allow longer times for representatives of organizations. Persons wishing to speak on behalf of an organization should identify that organization when they sign up to speak.

A complete transcript of the public scoping meeting will be retained by DOE and made available to the public for review via the Golden Field Office Online Public Reading Room at: http://www.eere.energy.gov/golden/Reading_Room.aspx and during business hours at the Department of Energy, Freedom of Information Reading Room, Forrestal Building, Room 1E-90, 1000 Independence Avenue, SW., Washington, DC 20585-0001. Additional copies of the public scoping meeting transcripts will be made available during business hours at the following location: Stevens County Library, 500 S. Monroe Street, Hugoton, Kansas 67951.

Draft EIS Schedule and Availability: The draft EIS is scheduled to be issued in late 2008. The availability of the draft EIS will be announced in the Federal Register and local media. The draft EIS will be made available for public inspection at the location listed above and on the Internet. Comments on the Draft EIS will be considered in preparing the Final EIS.

Interested parties who do not wish to submit comments at this time, but who would like to receive a copy of the draft EIS should contact Kristin Kerwin as provided in the ADDRESSES section of this notice.

Purpose of the Board: The purpose of the Board is to make recommendations to DOE in the areas of environmental restoration, waste management, and related activities.

○ Engineering and Technology Panel and Roundtable Discussion

○ Communications and External Affairs Presentation and Roundtable Discussion

○ Waste and Materials Disposition Panel and Roundtable Discussion

○ EM Update Presentation and Roundtable Discussion

○ Round Robin: Top Three Site-Specific Issues and EM SSAB Accomplishments

○ Strategic Planning and Transition Panel and Roundtable Discussion

○ EM SSAB Roundtable Discussion

• Public Outreach and Recruitment Strategies

• Annual Reports and Member Surveys

• Product Development

Public Participation: The meeting is open to the public. Written statements may be filed either before or after the meeting with the Designated Federal Officer, E. Douglas Frost, at the address or telephone listed above. Individuals who wish to make oral statements pertaining to agenda items should also contact E. Douglas Frost. Requests must be received five days prior to the meeting and reasonable provision will be made to include the presentation in the agenda. The Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Individuals wishing to make public comment will be provided a maximum of five minutes to present their comments.

Minutes: Minutes will be available by writing or calling E. Douglas Frost at the address or phone number listed above. Minutes will also be available at the following Web site: http://www.em.doe.gov/stakepages/ssabchairs.aspx.

The Nuclear Energy Advisory Committee (NEAC), formerly the Nuclear Energy Research Advisory Committee (NERAC), was established in 1998 by the U.S. Department of Energy (DOE) to provide expert advice on complex scientific, technical, and policy issues that arise in the planning, managing, and implementation of DOE's civilian nuclear energy research programs. The committee is composed of 12 individuals of diverse backgrounds selected for their technical expertise and experience, established records of distinguished professional service, and their knowledge of issues that pertain to nuclear energy.

Purpose of the Meeting: To inform the committee of recent developments and current status of research programs and projects pursued by the Department of Energy's Office of Nuclear Energy and receive advice and comments in return from the committee.

Tentative Agenda: The meeting is expected to include presentations that cover such topics as the current status of the Global Nuclear Energy Partnership (GNEP), Next Generation of Nuclear Power, Nuclear Power 2010, and Idaho National Laboratory. The agenda may change to accommodate committee business. For updates, one is directed the NEAC Web site: http://www.ne.doe.gov/neac/neNeacOverview.html.

Public Participation: Individuals and representatives of organizations who would like to offer comments and suggestions may do so on the day of the meeting, Tuesday, September 23, 2008. Approximately one-half hour will be reserved for public comments. Time allotted per speaker will depend on the number who wish to speak but is not expected to exceed 5 minutes. Anyone who is not able to make the meeting or has had insufficient time to address the committee is invited to send a written statement to Dr. John Boger, 19901 Germantown Rd, Germantown, MD 20874, or e-mail john.boger@hq.doe.gov.

Minutes: The minutes of the meeting will be available by contacting Dr. John Boger at the address above or on the Department of Energy, Office of Nuclear Energy Web site at http://www.ne.doe.gov/neac/neNeacOverview.html.

DOE, with the Department of State as a cooperating agency, issued the Environmental Impact Statement on a Proposed Nuclear Weapons Nonproliferation Policy Concerning Foreign Research Reactor Spent Nuclear Fuel (FRR SNF EIS, DOE/EIS-218) in February 1996. The Record of Decision was issued on May 13, 1996, and was published in the Federal Register on May 17, 1996 (61 FR 25092). In the FRR SNF EIS, DOE and the Department of State considered the potential impacts of a proposed policy to manage U.S.-origin spent nuclear fuel and target material from foreign research reactors. After consideration of public comments submitted on the Draft and Final EIS, DOE, in consultation with the Department of State, decided to implement the proposed policy as identified in the Preferred Alternative contained in the Final EIS, subject to additional stipulations specified in Section VII of the Record of Decision. The Record of Decision stated, “DOE would take title to the foreign research reactor spent nuclear fuel and target material that is shipped by sea after it is unloaded from the ship at the port of entry * * * ” In its initial decision, DOE announced that eligible spent fuel that is irradiated and discharged from reactors before May 13, 2006, is eligible for acceptance through May 12, 2009. DOE later extended the program for an additional 10 years, until May 12, 2016, for irradiation of eligible fuel, and until May 12, 2019, for fuel acceptance (69 FR 69901; December 1, 2004).

DOE subsequently determined that the need may arise during implementation of the policy for the United States to take title to spent nuclear fuel and target material from foreign research reactors located in countries with other-than-high-income economies at locations other than the port of entry into the United States. Foreign governments had raised a concern in cases where transportation casks from multiple countries were on a single vessel regarding who would be liable for any potential damage when spent fuel from one country is in the territory of another during the shipment. DOE was informed that shipowners willing to transport spent nuclear fuel from these countries without coverage under the Price-Anderson Act had not been identified. After determining that the point at which title to the spent nuclear fuel and target material transfers from the reactor operator to the United States had no effect on the physical processes that would take place under the acceptance policy, and thus would not have any effect on the potential impacts to the environment, workers, or the public, DOE issued its Revision to the Record of Decision (61 FR 38720; July 25, 1996) to allow DOE to take title to spent nuclear fuel and target material from foreign research reactors located in countries with other-than-high-income economies, as defined in the Final EIS, at locations other than the port of entry into the United States. This revised policy did not extend to reactors in countries with high-income economies, since reactor operators in these countries, at that time, were able to provide sufficient liability insurance for transporting their own spent nuclear fuel to the United States.

Recently, the need has arisen during implementation of the policy for the United States also to take title to spent nuclear fuel and target material from foreign research reactors located in countries with high-income economies at locations other than the port of entry into the United States.

Nuclear insurance pools covering individual reactor operators in countries with high-income economies have begun to require additional coverage. This rise in premiums affects, in particular, some smaller foreign research reactors in high-income economy countries that are in many cases operated by educational and research institutions that do not have the funding to pay for additional coverage, estimated to cost approximately $50,000 per shipping participant. Since some smaller foreign research reactors would have significant difficulties obtaining additional funding, they could decide not to participate at all in future shipments. One reactor in a high-income economy country recently refused to participate in a shipment without reimbursement of additional insurance costs.

DOE anticipates that liability insurance costs will continue to increase in the coming years for reactors in countries of all incomes. If research reactors in high-income economy countries are increasingly unable to participate in shipments due to lack of liability insurance, the program's nonproliferation goal of repatriating U.S.-origin highly enriched uranium would be jeopardized.

DOE's experience since 1996 in taking title to material from reactors in other-than-high-income economy countries has confirmed that the point at which title to the spent nuclear fuel and target material transfers from the reactor operator to the United States has no effect on the physical processes that take place under the acceptance policy. There are, for example, no changes in the applicable requirements or handling practices that ensure worker and public safety and environmental protection. Thus, the location of title change does not have any effect on the potential impacts to the environment.

Therefore, in place of the current policy that allows DOE to take title to spent nuclear fuel or target material at a location other than the U.S. port of entry only from foreign research reactors in other-than-high-income-economy countries, DOE is herein revising the Record of Decision to allow the title transfer location for spent nuclear fuel or target material from reactors located in countries of any income to be determined on a case-by-case basis by DOE, and the terms and conditions of the title transfer to be specified in DOE's individual contracts with the reactor operators. As with the policy in the prior Revised Record of Decision (61 FR 38720; July 25, 1996), title could transfer as early as the departure of the loaded cask from the reactor site or at the foreign port-of-origin, or as late as entry into the United States.

For the reasons set forth above, Section VII (“Decision”) of the Record of Decision (61 FR 25092; May 17, 1996) as previously revised (61 FR 38720; July 25, 1996) is further revised by replacing the current Paragraph E with a new Paragraph E to read as follows:

In addition, Section IX (“Basis for the Decision”), Paragraph G (“Title Transfer Location”) of the Record of Decision is revised to read as follows:

Under United States law, the Price-Anderson Act would provide indemnification coverage for spent nuclear fuel and target material shipments from foreign research reactors upon entry of material into the United States regardless of when title is transferred to the United States. However, Price-Anderson coverage outside U.S. territory is provided only if the material is owned by, and used by, or under contract with the United States. For countries with other-than-high-income economies, DOE has provided Price-Anderson Act coverage on a case-by-case basis per the Revised Record of Decision issued in 1996 (61 FR 38720; July 25, 1996). Recently, reactor operators in countries with high-income economies have been unable to afford nuclear liability insurance due to increasing costs.

The approach for transfer of title discussed in Section VII.E. permits DOE to take title to spent fuel at locations other than the U.S. port of entry, regardless of the income status of the country repatriating the spent fuel or target material to the United States. This policy revision allows DOE, on a case-by-case basis, to extend Price-Anderson Act coverage and assume financial responsibility for shipments from the point at which DOE takes title. This removes the need for reactors for whom sufficient liability insurance is unaffordable to purchase such insurance for shipment to the U.S. port of entry. This provision will provide a mechanism whereby liability coverage can be provided for segments of the transportation process that the reactor operators are unable themselves to provide. In implementing this policy, the Administrator for the National Nuclear Security Administration must make, on a case-by-case basis, any decision to accept title to foreign research reactor spent nuclear fuel outside the United States. The authority to make this decision cannot be delegated.

The revision of the Record of Decision set forth in this Notice complies with the requirements of the National Environmental Policy Act (42 U.S.C. 4321 et seq. ) and its implementing regulations at 40 CFR Parts 1500-1508 and 10 CFR Part 1021. Because there are no environmental impacts associated with changing the title transfer location, no further environmental review is required under the National Environmental Policy Act or Executive Order 12114 (January 4, 1979) in order to effectuate the revision.

In notice document E8-16381 beginning on page 42798 in the issue of Wednesday, July 23, 2008, make the following correction:

On page 42798, in the third column, under the DATES heading, in the second line “August 18, 2008” should read “August 22, 2008”.

Parts of this meeting of the Board will be open to the public (limited space available), and parts will be closed to the public. 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:

OMB Control No. : 3060-0695.

Title: Section 87.219, Automatic Operations.

Form No. : N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit.

Number of Respondents: 60 respondents; 60 responses.

Estimated Time Per Response: .7 hours.

Frequency of Response: On occasion reporting requirement, recordkeeping requirement, and third party disclosure requirement.

Obligation to Respond: Required to obtain or retain benefits.

Total Annual Burden: 42 hours.

Annual Cost Burden: $6,468.

Privacy Act Impact Assessment: N/A.

Nature and Extent of Confidentiality: There is no need for confidentiality.

Needs and Uses: This collection will be submitted as an extension (no change in reporting requirements, recordkeeping and/or third party disclosure requirements) after this 60 day comment period to Office of Management and Budget (OMB) in order to obtain the full three year clearance.

The Commission has adjusted the number of respondents and responses due to an increase in the number of respondents for this information collection. Therefore, we are reporting a +7 hour adjustment in the total annual burden.

Section 87.219 requires that if airports have control towers or Federal Aviation Administration (FAA) flight service stations, and more than one licensee wants to have an automated aeronautical advisory station (Unicom), they must write an agreement outlining who will be responsible for the Unicom's operation, sign the agreement and keep a copy of the agreement with each licensee's station authorization.

Specifically, only one automated Unicom may be operated at an uncontrolled airport. Prior to the operation of an automated Unicom at an airport with more than one Unicom licensee, all of the licensees at that airport must sign a letter of agreement stating which licensee(s) control the automated Unicom operations, and, if control is to be shared among several operators, how that control will be divided or scheduled. The original or a copy of the letter of agreement must be kept with each licensee's station records. Within 90 days of the date upon which a new Unicom operator is licensed at an airport where more than one Unicom is authorized, and an automated Unicom is being operated, an amended letter of agreement that includes the new licensee's signature must be sign or automated Unicom operations must cease.

The information will be used by compliance personnel for enforcement purposes and by licensees to clarify responsibility in operating Unicom.

OMB Control No. : 3060-0740.

Title: Section 95.1015, Disclosure Policies.

Form No. : N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit.

Number of Respondents: 26 respondents; 26 responses.

Estimated Time Per Response: 1 hour.

Frequency of Response: On occasion reporting requirement, recordkeeping requirement, and third party disclosure requirement.

Obligation to Respond: Required to obtain or retain benefits.

Total Annual Burden: 26 hours.

Annual Cost Burden: $1,300.

Privacy Act Impact Assessment: N/A.

Nature and Extent of Confidentiality: There is no need for confidentiality.

Needs and Uses: This collection will be submitted as an extension (no change in reporting requirements, recordkeeping and/or third party disclosure requirements) after this 60 day comment period to Office of Management and Budget (OMB) in order to obtain the full three year clearance.

Manufacturers of Low Power Radio Service (LPRS) transmitters used for auditory assistance, health care assistance, and law enforcement tracking purposes must include with each transmitting device the following statement: “This transmitter is authorized by rule under the Low Power Radio Service (47 CFR Part 95) and must not cause harmful interference to TV reception or United States Navy SPASUR installations. You do not need an FCC license to operate this transmitter. This transmitter may only be used to provide: auditory assistance to persons with disabilities, persons who require language translation, or persons in educational settings; health care services to the ill; law enforcement tracking services under agreement with a law enforcement agency; or automated maritime telecommunications system (AMTS) network control communications. Two-way voice communications and all other types of uses not mentioned above are expressly prohibited.”

Prior to operating a LPRS transmitter for AMTS purposes, an AMTS licensee must notify, in writing, each television station that may be affected by such operations, as defined in 47 CFR 80.215(h) of the Commission's rules. The notification provided with the station's license application is sufficient to satisfy this requirement if no new television stations would be affected.

The information is used by Commission staff and affected television stations to be aware of the location of potential harmful interference from AMTS operations. If this information was not available, the location of potential harmful interference from AMTS operations would be negatively affected.

OMB Control No.: 3060-0223.

Title: Section 90.129, Supplemental Information to be Routinely Submitted with Applications, Non-type Accepted Equipment.

Form No.: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Individuals or households, business or other for-profit, not-for-profit institutions, and State, local or tribal governments.

Number of Respondents: 10 respondents; 10 responses.

Estimated Time per Response: .33 hours.

Frequency of Response: On occasion reporting requirement.

Obligation To Respond: Required to obtain or retain benefits.

Total Annual Burden: 4 hours.

Annual Cost Burden: N/A.

Privacy Act Impact Assessment: Yes.

Nature and Extent of Confidentiality: There is no need for confidentiality. This information collection does contain personally identifiable information (PII) on individuals. The FCC maintains a system of records notice (SORN), FCC/WTB-1, “Wireless Services Licensing Records,” that covers the collection, purpose(s), storage, safeguards, and disposal of the PII that individual private land mobile radio licensees maintain under 47 CFR 90.129.

Needs and Uses: This collection will be submitted as an extension (no change in reporting requirements) after this 60 day comment period to Office of Management and Budget (OMB) in order to obtain the full three year clearance.

Section 90.129 requires that applicants proposing to use transmitting equipment that is not type-certified by FCC laboratory personnel to provide a description of the proposed equipment. This assures that the equipment is capable of performing within certain tolerances that limit the interference potential of the device.

Additionally, this rule section requires that each application under this part that is received by the Commission, through the application process outlined in 47 CFR part 1, subpart F, must be accompanied by the applicable supplementary information described in the paragraphs in 47 CFR 90.129. The information is used by FCC engineers to determine the interference potential of the proposed equipment.

OMB Control No.: 3060-0770.

Title: Sections 61.49 and 69.4, Price Cap Performance Review for Local Exchange Carriers, FCC 99-206 (New Services).

Form No.: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit.

Number of Respondents: 21 respondents; 21 responses.

Estimated Time per Response: 10 hours.

Frequency of Response: On occasion reporting requirement.

Obligation To Respond: Required to obtain or retain benefits.

Total Annual Burden: 210 hours.

Annual Cost Burden: $16,275.

Privacy Act Impact Assessment: N/A.

Nature and Extent of Confidentiality: There is no need for confidentiality. The Commission is not requesting that the respondents submit confidential information to the FCC. However, respondents who wish to request confidential treatment of the information they believe to be confidential, may do so under 47 CFR 0.459 of the Commission's rules.

Needs and Uses: This collection will be submitted as an extension (no change in reporting requirements) after this 60 day comment period to Office of Management and Budget (OMB) in order to obtain the full three year clearance.

In the Fifth Report and Order in FCC 99-206, the Commission permitted price cap local exchange carriers (LECs) to introduce new services on a streamlined basis, without prior approval. The Commission adopted rules to eliminate the public interest showing required by section 69.4(g) and eliminated the new services test (except in the case of loop-based new services) required under sections 69.49(f) and (g). These modifications eliminated delays that existed for the introduction of new services as well as encouraging efficient investment and innovation.

The information is used by the Commission to determine whether this is in the public interest for the incumbent LEC to offer a proposed new switched access service.

OMB Control No.: 3060-0989.

Title: Sections 63.01, 63.03, 63.04, Procedures for Applicants Requiring Section 214 Authorization for Domestic Interstate Transmission Lines Acquired Through Corporate Control.

Form No.: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit.

Number of Respondents: 86 respondents; 86 responses.

Estimated Time Per Response: 1.5-12 hours.

Frequency of Response: On occasion reporting requirement.

Obligation to Respond: Mandatory.

Total Annual Burden: 959 hours.

Annual Cost Burden: $76,235.

Privacy Act Impact Assessment: N/A.

Nature and Extent of Confidentiality: There is no need for confidentiality. The FCC is not requiring applicants to submit confidential information to the Commission. If applicants want to request confidential treatment of the documents they submit to Commission, they may do so under 47 CFR 0.459 of the Commission's rules.

Needs and Uses: This collection will be submitted as an extension (no change in reporting requirements) after this 60 day comment period to Office of Management and Budget (OMB) in order to obtain the full three year clearance.

A Report and Order, FCC 02-78, adopted and released in March 2002 (Order), set forth the procedures for common carriers requiring authorization under section 214 of the Communications Act of 1934, as amended, to acquire domestic interstate transmission lines through a transfer of control. Under section 214 of the Act, carriers must obtain FCC approval before constructing, acquiring, or operating an interstate transmission line. Acquisitions involving interstate common carriers require affirmative action by the Commission before the acquisition can occur.

This information collection contains filing procedures for domestic transfer of control applications under sections 63.03 and 63.04.

(a) Section 63.03 and 63.04 requires domestic section 214 applications involving domestic transfers of control, at a minimum, should specify: (1) The name, address and telephone number of each applicant; (2) the government, state, or territory under the laws of which each corporate or partnership applicant is organized; (3) the name, title, post office address, and telephone number of the officer or contact point, such as legal counsel, to whom correspondence concerning the application is to be addressed; (4) the name, address, citizenship and principal business of any person or entity that directly or indirectly owns at least ten percent of the equity of the applicant, and the percentage of equity owned by each of those entities (to the nearest one percent); (5) certification pursuant to 47 CFR 1.2001 through 1.2003 that no party to the application is subject to a denial of Federal benefits pursuant to section 5301 of the Anti-Drug Abuse Act of 1988; (6) a description of the transaction; (7) a description of the geographic areas in which the transferor and transferee (and their affiliates) offer domestic telecommunications services, and what services are provided in each area; (8) a statement as to how the application fits into one or more of the presumptive streamlined categories in section 63.03 or why it is otherwise appropriate for streamlined treatment; (9) identification of all other Commission applications related to the same transaction; (10) a statement of whether the applicants are requesting special consideration because either party to the transaction is facing imminent business failure; (11) identification of any separately filed waiver request being sought in conjunction with the transaction; and (12) a statement showing how grant of the application will serve the public interest, convenience, and necessity, including any additional information that may be necessary to show the effect of the proposed transaction on competition in domestic markets. Where an applicant wishes to file a joint international section 214 transfer of control application and domestic section 214 transfer of control application, the applicant must submit information that satisfies the requirements of 47 CFR section 63.18. In the attachment to the international application, the applicant must submit information described in 47 CFR section 63.04(a)(6)-(a)(12).

When the Commission, acting through the Wireline Competition Bureau, determines that applicants have submitted a complete application qualifying for streamlined treatment, it shall issue a public notice commencing a 30-day review period to consider whether the transaction serves the public interest, convenience and necessity. Parties will have 14 days to file any comments on the proposed transaction, and applicants will be given 7 days to respond.

(b) Applicants are not required to file post-consummation notices of pro forma transactions, except that a post transaction notice must be filed with the Commission within 30 days of a pro forma transfer to a bankruptcy trustee or a debtor-in-possession. The notification can be in the form of a letter (in duplicate to the Secretary, Federal Communications Commission). The letter or other form of notification must also contain the information listed in sections (a)(1) through (a)(4) of section 63.04. A single letter may be filed for more than one such transfer of control. The information will be used by the Commission to ensure that applicants comply with the requirements of 47 U.S.C. 214.

OMB Control Number: 3060-1119.

OMB Approval Date: August 12, 2008.

Expiration Date: August 31, 2011.

Title: Information Collection regarding Redundancy, Resiliency and Reliability of 911 and E911 Networks and/or Systems as set forth in the Commission's Rules (47 CFR 12.3).

Form No.: Not applicable.

Estimated Annual Burden: 74 responses; 120 hours for local exchange carriers, 72 hours for commercial mobile radio service providers, and 40 hours for interconnected Voice over Internet Protocol service providers per response; 7,792 hours total per year.

Obligation to Respond: Mandatory.

Nature and Extent of Confidentiality: These reports will contain sensitive data and, for reasons of national security and the prevention of competitive injury to reporting entities, Section 12.3 of the Commission's rules specifically states that all reports will be afforded confidential treatment. Data in these reports will be considered confidential information that is exempt from routine public disclosure under the Freedom of Information Act (FOIA) Exemption 4. See 47 CFR 0.457 and 5 U.S.C. 552(b)(4); see also Homeland Security Presidential Directive 7, Part 10. These reports will be shared pursuant to a protective order with only the following three entities, if the entities file a request for the information: The National Emergency Number Association, The Association of Public Safety Communications Officials, and The National Association of State 9-1-1 Administrators. All other access to these reports must be sought pursuant to procedures set forth in 47 CFR 0.461. Notice of any requests for inspection of these reports will be provided to the filers of the reports pursuant to 47 CFR 0.461(d)(3).

Needs and Uses: The Commission, in order to help fulfill its statutory obligation to make wire and radio communications services available to all people in the United States for the purpose of the national defense and promoting safety of life and property, released an Order (FCC 07-107) that adopted a rule requiring analysis of 911 and E911 networks and/or systems and reports to the Commission on the redundancy, resiliency and reliability of those networks and/or systems (47 CFR 12.3). It is critical that Americans have access to a resilient and reliable 911 system irrespective of the technology used to provide the service. These analyses and reports on the redundancy, resiliency, and dependability of 911 and E911 networks and systems will further this goal. This requirement will serve the public interest and further the Commission's statutory mandate to promote the safety of life and property through the use of wire and radio communication. See 47 U.S.C. 151.

This rule obligates local exchange carriers (LECs), commercial mobile radio service (CMRS) providers that are required to comply with the wireless 911 rules set forth in Section 20.18 of the Commission's rules, and interconnected Voice over Internet Protocol (VoIP) service providers to analyze their 911 and E911 networks and/or systems and file a detailed report to the Commission on the redundancy, resiliency and reliability of those networks and/or systems. LECs that meet the definition of a Class B company set forth in Section 32.11(b)(2) of the Commission's rules, non-nationwide commercial mobile radio service providers with no more than 500,000 subscribers at the end of 2001, and interconnected VoIP service providers with annual revenues below the revenue threshold established pursuant to Section 32.11 of the Commission's rules are exempt from this rule. The reports are due 120 days from the date that the Commission or its staff announces activation of the 911/E911 network and system reporting process.

OMB Control Number: 3060-0805.

OMB Approval Date: July 2, 2008.

Expiration Date: July 31, 2011.

Title: 700 MHz Eligibility, Regional Planning Requirements, Interference Protection Criteria and 4.9 GHz Guidelines (47 CFR 90.523, 90.527, 90.545, and 90.1211).

Form No.: Not applicable.

Estimated Annual Burden: 21,116 responses; 2.89236 hours per response; 61,075 hours total per year.

Obligation to Respond: Mandatory (47 CFR 90.523); required to obtain or retain benefits (47 CFR 90.523, 90,527, and 90.545); and voluntary.

Nature and Extent of Confidentiality: There is no need for confidentiality.

Needs and Uses: Section 90.523 requires that nongovernmental organizations that provide services which protect the safety of life or property obtain a written statement from an authorizing state or local government entity to support the nongovernmental organization's application for assignment of 700 MHz frequencies. Section 90.527 requires 700 MHz regional planning committees to submit a plan for use of the 700 MHz general use spectrum in the consolidated narrowband segment 763-775 MHz and 793-805 MHz. It advocates a fair and open process in developing allocation assignments by requiring input from eligible entities in the allocation decisions and the application technical review/approval process. Entities that seek inclusion in the plan to obtain future licenses are considered third party respondents. Section 90.545 TV/DTV interference protection criteria, provides that public safety base, control and mobile transmitters in the 763-775 MHz and 793-805 MHz band applicants select one of three ways to meet the TV/DTV interference protection requirements: (1) By utilizing geographic separation in the rule; (2) submitting an engineering study to justify other separations, or (3) obtain concurrence from applicable TV/DTV station(s). Section 90.1211 authorizes the fifty-five 700 MHz regional planning committees to develop and submit on a voluntary basis a plan on guidelines for coordination procedures to facilitate the shared use of 4940-4990 MHz (4.9 GHz) band. Applicants are granted a geographic area license for the entire fifty MHz of 4.9 GHz spectrum over a geographical area defined by the boundaries of their jurisdiction—city, county or state. Accordingly, licensees are required to coordinate their operations in the shared band to avoid interference, a common practice when joint operations are conducted.

Commission staff will use the information to assign licenses, determine regional spectrum requirements and to develop technical standards. The information will also be used to determine whether prospective licensees operate in compliance with the Commission's rules. Without such information, the Commission could not accommodate regional requirements or provide for the efficient use of the available frequencies. Information provided to, or exchanged among, third parties will be used to establish eligibility and to prevent harmful interference. This information collection request includes rules to govern the operation and licensing of the 700 MHz and 4.9 GHz bands to ensure that licensees continue to fulfill their statutory responsibilities in accordance with the Communications Act of 1934, as amended. Such information will continue to be used to minimize interference, verify that applicants are legally and technically qualified to hold licenses, and to determine compliance with Commission rules.

OMB Control Number: 3060-0742.

Title: Sections 52.21 through 52.33, Telephone Number Portability (47 CFR Part 52, Subpart C), CC Docket No. 95-116.

Form No.: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit.

Number of Respondents: 1,990 respondents; 1,990 responses.

Estimated Time Per Response: 2 hours-50 hours.

Frequency of Response: On occasion and one-time reporting requirements, recordkeeping requirement, and third party disclosure requirement.

Obligation to Respond: Required to obtain or retain benefits.

Total Annual Burden: 5,850 hours.

Total Annual Cost: $91,000.

Privacy Act Impact Assessment: N/A.

Nature and Extent of Confidentiality: There is no need for confidentiality. The Commission is not requesting respondents to submit confidential information to the Commission. If the Commission requests respondents to submit information which the respondent believes is confidential, they may request confidential treatment of such information pursuant to Section 0.459 of the Commission's rules ( see 47 CFR 0.459).

Needs and Uses: The Commission will submit this information collection to the Office of Management and Budget (OMB) as an extension after this 60 day comment period to obtain the full three year clearance from them. There is no change to the reporting, recordkeeping and/or third party disclosure requirements. However, the Commission is reporting an adjusted increase in the number of respondents filing information with the Commission, and the tariff and cost support estimate has been reduced from 149 hours per response to 50 hours per response.

Thereby, reducing the total annual burden by 8,483 hours. There are four information collection requirements in this information collection subject to OMB review and approval under the Paperwork Reduction Act. They are: (1) Requests for long-term number portability; (2) petitions to extend implementation deadlines; (3) tariffs and cost support; and (4) recordkeeping requirement. The reporting requirements and recordkeeping requirement are as follows:

(a) Requests for long-term number portability—Long-term number portability (LNP) must be provide by Local Exchange Carriers (LECs) and Commercial Mobile Radio Service (CMRS) providers in switches for which another carrier has made a specific request for number portability, according to the Commission's deployment schedule. Wireline carriers began providing LNP in 1998. CMRS providers began offering LNP in 2003.

(b) Petitions to extend implementation deadline—Carriers that are unable to meet the deadlines for implementing a long-term number portability solution are required to file with the Commission at least 60 days in advance of the deadline a petition to extend the time by which implementation in its network will be completed.

(c) Tariffs and cost support—Incumbent LECs may recover their carrier-specific costs directly related to providing long-term number portability by establishing in tariffs filed with the Commission certain number portability charges. Incumbent LECs are required to include many details in their cost support that are unique to the number portability proceeding pursuant to the Cost Classification Order. For instance, incumbent LECs must demonstrate that any incremental overhead costs claimed in their cost support are actually new costs incremental to and resulting from the provision of long-term number portability.

(d) Recordkeeping requirement—Incumbent LECs are required to maintain records that detail both the nature and specific amount of these carrier-specific costs that are directly related to number portability, and those carrier-specific costs that are not directly related to number portability.

The information collected and used by the Commission to determine compliance with Section 251 of the Communications Act, as amended, and the Commission's LNP orders and rules.

OMB Control Number: 3060-0854.

Title: Truth-in-Billing Format, CC Docket No. 98-170 and CG Docket No. 04-208.

Form Number: Not applicable.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit entities.

Number of Respondents and Responses: 5,588 respondents; 41,858 responses.

Estimated Time per Response: 2 to 243 hours.

Frequency of Response: On occasion reporting requirement; Third party disclosure requirement.

Total Annual Burden: 3,872,876 hours.

Total Annual Cost: $15,418,200.

Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this information collection is found at section 201(b) of the Communications Act of 1934, as amended, 47 U.S.C. 201(b), and section 258, 47 U.S.C. 258, Public Law No. 104-104, 110 Stat. 56. The Commission's implementing rules are codified at 47 CFR 64.2400-01.

Nature and Extent of Confidentiality: An assurance of confidentiality is not offered because this information collection does not require the collection of personally identifiable information from individuals.

Privacy Impact Assessment: No impact(s).

Needs and Uses: On March 18, 2005, the Commission released Truth-in-Billing and Billing Format ; National Association of State Utility Consumer Advocates' Petition for Declaratory Ruling Regarding Truth-in-Billing , Second Report and Order, Declaratory Ruling, and Second Further Notice of Proposed Rulemaking, CC Docket No. 98-170, CG Docket No. 04-208, 20 FCC Rcd 6448 (2005) ( 2005 Second Report and Order and Second Further Notice ); published at 70 FR 29979 and 70 FR 30044, May 25, 2005, which determined, inter alia, that Commercial Mobile Radio Service providers no longer should be exempted from 47 CFR 64.2401(b), which requires billing descriptions to be brief, clear, non-misleading and in plain language. The 2005 Second Further Notice proposed and sought comment on measures to enhance the ability of consumers to make informed choices among competitive telecommunications service providers.

The full text of these applications is available for inspection and copying during normal business hours in the Commission's Reference Center, 445 12th Street, SW., Washington, DC 20554 or electronically via the Media Bureau's Consolidated Data Base System, http://svartifoss2.fcc.gov/prod/cdbs/pubacc/prod/cdbs_pa.htm . A copy of this application may also be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC, 20554, telephone 1-800-378-3160 or http://www.BCPIWEB.com.

FRTIB-2, Personnel Security Files, updates Agency systems of records so that they are compliant with both HSPD-12 and the Privacy Act and conform to the Privacy Act notices on the standard forms which are used to initiate the HSPD-12 process. FRTIB-10, Identity Management Systems, covers the HSPD-12 process after adjudication determines the individual can receive an identification card. FRTIB-10 includes both mandatory and optional information necessary to the request for a card, registration, verification, and issuance procedures, the index/database of active and invalid cards, and the information stored on the cards. FRTIB-10 may include records maintained by agencies of individuals who entered and exited facilities or accessed systems.

The proposed system reports, as required by 5 U.S.C. 552a(r), of the Privacy Act of 1974, as amended, were submitted to the House Committee on Government Reform, the Senate Committee on Homeland Security and Government Affairs, and the Office of Management and Budget (OMB) pursuant to paragraph 4c of Appendix I to OMB Circular No. A-130, “Federal Agency Responsibilities for Maintaining Records About Individuals,” dated February 8, 1996 (February 20, 1996, 61 FR 6427).

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

The information required under section 402(j)(5)(B) of the Public Health Service Act (PHS Act) (42 U.S.C. 282(j)(5)(B)) will be submitted in the form of a certification to accompany applications and submissions currently submitted to FDA under part 312 (21 CFR part 312) and 21 CFR part 314 (human drugs) and approved under OMB control numbers 0910-0014 (expires May 31, 2009) and 0910-0001 (expires May 31, 2011), respectively; submitted to FDA under part 312 and 21 CFR part 601 (biological products) and approved under OMB control numbers 0910-0014 and 0910-0338 (expires June 30, 2010); and submitted to FDA under 21 CFR parts 807 and 814 (devices) and approved under OMB control numbers 0910-0120 (expires August 31, 2010) and 0910-0231 (expires November 30, 2010), respectively.

Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Public Law 110-85) amended the PHS Act by adding section 402(j) (42 U.S.C. 282(j)). The new provisions require additional information to be submitted to the clinical trials data bank (ClinicalTrials.gov) 1 previously established by the National Institutes of Health/National Library of Medicine, including expanded information on clinical trials and information on the results of clinical trials. The provisions include new responsibilities for FDA as well as several amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act).

One new provision, section 402(j)(5)(B) of the PHS Act, requires that a certification accompany human drug, biological, and device product submissions made to FDA. Specifically, at the time of submission of an application under sections 505, 515, or 520(m) of the FD&C Act (21 U.S.C. 355, 360e, or 360j(m)), or under section 351 of the PHS Act (42 U.S.C. 262), or submission of a report under section 510(k) of the FD&C Act (21 U.S.C. 360(k)), such application or submission must be accompanied by a certification that all applicable requirements of section 402(j) of the PHS Act have been met. Where available, such certification must include the appropriate National Clinical Trial (NCT) numbers.

The proposed collection of information is necessary to satisfy the previously mentioned statutory requirement.

The importance of obtaining these data relates to adherence to the legal requirements for submissions to the clinical trials registry and results data bank and ensuring that individuals and organizations submitting applications or reports to FDA under the listed provisions of the FD&C Act or the PHS Act adhere to the appropriate legal and regulatory requirements for certifying to having complied with those requirements. The failure to submit the certification required by section 402(j)(5)(B) of the PHS Act, and the knowing submission of a false certification are both prohibited acts under section 301 of the FD&C Act (21 U.S.C. 331). Violations are subject to civil money penalties.

FDA's Center for Drug Evaluation and Research (CDER) received 1,837 investigational new drug applications (INDs) and 20,969 new IND amendments in Fiscal Year (FY) 2004. CDER received 4,764 annual reports in FY 2004. CDER anticipates that IND, amendment, and annual report submission rates will remain at or near this level in the near future.

FDA's Center for Biologics Evaluation and Research (CBER) received 206 new INDs and 826 new IND amendments in FY 2004. CBER received 878 annual reports in FY 2004. CBER anticipates that IND, amendment, and annual report submission rates will remain at or near this level in the near future.

The estimated total number of submissions (new INDs, new submissions, and annual reports) subject to mandatory certification requirements under 42 U.S.C. 282(j)(5)(B), section 402(j)(5)(B) of the PHS Act, is 27,570 for CDER plus 1,910 for CBER, or 29,480 submissions per year. The minutes per response is the estimated number of minutes that a respondent would spend preparing the information to be submitted to FDA under 42 U.S.C. 282(j)(5)(B), section 402(j)(5)(B) of the PHS Act, including the time it takes to type the necessary information.

Based on its experience reviewing INDs and consideration of the previous information, FDA estimated that approximately 15.0 minutes on average would be needed per response for certifications which accompany IND applications and submissions. It is assumed that most submissions to investigational applications will reference only a few protocols for which the sponsor/applicant/submitter has obtained a National Clinical Trial (NCT) number from ClinicalTrials.gov prior to making the submission to FDA. It is also assumed that the sponsor/applicant/submitter has electronic capabilities allowing them to retrieve the information necessary to complete the form in an efficient manner.

In 2004, CDER and CBER received 214 new drug applications (NDA)/biologics license applications (BLA)/resubmissions and 4,451 NDA/BLA amendments for which certifications are needed. CDER and CBER received 259 efficacy supplements/resubmissions to previously approved NDAs/BLAs, and 1,273 labeling submissions in FY 2004. CDER received 7,753 annual reports and CBER received 629 annual reports in FY 2004. CDER and CBER anticipate that new drug/biologic, efficacy supplement, and annual report submission rates will remain at or near this level in the near future.

FDA's Center for Devices and Radiological Health (CDRH) received 51 new applications for premarket approvals (PMA), 364 510(k) submissions containing clinical information, and 9 applications for humanitarian device exemptions (HDE), for a total of 424 new applications/submissions in FY 2004. CDRH received 2,267 PMA/510(k)/HDE amendments in FY 2004. CDRH received 2,526 PMA/510(k)/HDE supplements in FY 2004. CDRH received 433 annual reports in FY 2004. CDRH anticipates that application, amendment, supplement, and annual report submission rates will remain at or near this level in the near future.

FDA's Office of Generic Drugs (OGD) received 563 abbreviated new drug applications (ANDAs) in FY 2004. OGD received 477 bioequivalence amendments/supplements and 723 labeling supplements in FY 2004. OGD received 5,173 annual reports in FY 2004. OGD anticipates that application, amendment, supplement, and annual report submission rates will remain at or near this level in the near future.

The estimated total number of new submissions (new marketing applications/submissions, amendments, supplements, and annual reports) subject to the mandatory certification requirements under 42 U.S.C. 282(j)(5)(B), section 402(j)(5)(B) of the PHS Act, is 14,579 for CDER and CBER, 5,650 for CDRH, plus 6,936 for OGD or 27,165 new submissions per year. The minutes per response is the estimated number of minutes that a respondent would spend preparing the information to be submitted to FDA under 42 U.S.C. 282(j)(5)(B), section 402(j)(5)(B) of the PHS Act, including the time it takes to type the necessary information and compile a list of relevant NCT numbers.

Based on its experience reviewing NDAs, BLAs, PMAs, HDEs, 510(k)s, and ANDAs and consideration of the previous information, FDA estimated that approximately 45.0 minutes on average would be needed per response for certifications which accompany NDA, BLA, PMA, HDE, 510(k), and ANDA applications and submissions. It is assumed that the sponsor/applicant/submitter has electronic capabilities allowing them to retrieve the information necessary to complete the form in an efficient manner.

In the Federal Register of March 5, 2008 (73 FR 11926), FDA published a 60-day notice requesting public comment on the information collection provisions. FDA received a number of comments concerning such issues as FDA's legal interpretation of the statutory language, clarification of the instructions to the form, concerns with FDA's estimates of the amount of time required to fill out the form, and suggestions for technical formatting changes to the form.

(Comment 1) A number of respondents maintained that, because section 402(j)(5)(B) of the PHS Act does not apply to INDs submitted to FDA under section 505(i) of the FD&C Act, a certification form need not accompany INDs submitted to FDA. As previously stated, section 402(j)(5)(B) of the PHS Act, requires that, at the time of submission of an application under sections 505, 515, or 520(m) of the FD&C Act (21 U.S.C. 355, 360e, or 360j(m)), or under section 351 of the PHS Act (42 U.S.C. 262), or submission of a report under section 510(k) of the FD&C Act (21 U.S.C. 360(k)), such application or submission must be accompanied by a certification that all applicable requirements of section 402(j) of the PHS Act have been met. The comments challenge the agency's interpretation of Section 402(j)(5)(B) of the PHS Act on several fronts. The respondents maintain that IND submissions are not “applications” in the terminology of the FD&C Act. Some comments rely upon language found in HR 2900, an earlier version of the legislation that was eventually enacted as FDAAA, to support their assertion that Congress both understood the distinction between “applications” on the one hand, and “submissions” and “exemptions” on the other, and that Congress explicitly omitted exemptions from the scope of the certification requirement. The language in HR 2900 would have required the FDA to verify that the requirements of section 402(j) were met for each applicable clinical trial submitted when considering a drug for an exemption under section 505(i). Section 402(j) no longer includes this verification requirement, and the explicit reference to section 505(i) in HR 2900 was omitted from section 402(j)(5)(B) of the PHS Act. Commenters further stated that submitting a certification of compliance when submitting an IND is illogical because an IND must be submitted to FDA prior to enrolling subjects in the clinical trials, yet registration in the clinical trials data bank is not generally required until 21 days after the first subject is enrolled in the clinical trial. In addition, some of the comments noted that the conforming amendment to section 505(i) of the FD&C Act relates only to informed consent documentation and includes no reference to the certification requirement.

(Response) FDA does not agree with these conclusions. FDA agrees that the word “application” is not used in section 505(i) of the FD&C Act in reference to an IND. However, section 505(i)(1) directed the Secretary of Health and Human Services to issue regulations exempting from the requirements of section 505 of the FD&C Act drugs intended solely for investigational use. The regulations issued by FDA under this authority define an IND as “an investigational new drug application.” 21 CFR 312.3 (emphasis added). Furthermore, these regulations repeatedly use the term “application” in reference to an IND. Therefore, FDA considers an IND to be an application under section 505 of the FD&C Act . Congress is familiar with FDA regulations and could have specifically exempted INDs from the certification process by directly excluding 505(i) from the scope of section 402(j)(5)(B) of the PHS Act.

FDA disagrees with the commenters' conclusions that the precursor language in HR 2900 demonstrates that Congress intended to exclude INDs from the certification requirement and that Congress understood the difference between marketing applications and IND submissions and exemptions. FDA has concluded that the reference to section 505 of the FD&C Act was simply a streamlined reference to all applications and submissions possible under section 505 of the FD&C Act. The scope of Title VIII of FDAAA, the numerous requirements for updating the clinical trials registry information, the inclusion of a new clinical trials results data bank, and the new enforcement provisions (including making failure to file a certification a prohibited act) indicate that Congress intended that the clinical trials data bank include information about clinical trials throughout the product development life cycle. Clearly, the IND phase is an extremely important phase of this process. The certification required by section 402(j)(5)(B) of the PHS Act is one means of ensuring that the clinical trial registry information is submitted when required. This information is required to be submitted to the registry data bank well before an NDA is ever filed with FDA. If the certification did not accompany INDs, there would be no means of ensuring that information is submitted to the registry data bank during the investigational stage, which would be inconsistent with the statute's intent to have such information available.

Further, submission of the certification with INDs helps to ensure that the clinical trial information is submitted to the registry data bank for trials that are never submitted in an NDA or a BLA. Many trials are never submitted in an NDA or a BLA. Requiring that the certification accompany INDs helps ensure that applicable clinical trials that are not included in an NDA or BLA are registered as required. The fact that an original IND application is filed with FDA before the responsible party is required to register a trial does not require the conclusion that certifications were intended to be inapplicable to INDs. Throughout the life of an IND, there are numerous opportunities for filing IND amendments, many of which will be filed after the trial is required to be registered. Submission of the certification with these IND amendments helps to ensure that the requirements of section 402(j) of the PHS Act are met.

The lack of a conforming amendment for INDs is not an indicator that certifications are not required to be submitted with INDs. There is also no conforming amendment for BLAs, but it is clear from the wording of section 402(j)(5)(B) of the PHS Act that the certification is required to be submitted with applications under section 351 of the PHS Act. The statute must be considered in its entirety; in light of the other provisions of the statute discussed in the previous paragraph, and the language of section 402(j)(5)(B), FDA has concluded that the absence of those two conforming amendments does not detract from the statutory language requiring submission of a certification when submitting an application under section 505 of the FD&C Act (or when submitting a BLA under section 351 of the PHS Act). Accordingly, FDA concludes that the certification form should accompany INDs.

(Comment 2) A number of comments challenged FDA's conclusion that the term “application” refers to supplements, annual reports, or adverse event reports.

(Response) The term “application” is used in the context of many filings made with FDA, particularly with products handled by CDER and CBER. Supplements, annual reports, and other submissions are all characterized as “applications” by FDA and are identified as such throughout parts 312 and 314 of FDA's regulations. For example, the form with which sponsors submit most IND, NDA, and BLA-related submissions is the Form FDA 356h, which is titled “Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use,” includes check boxes for submitting, among other things, annual reports, efficacy supplement, labeling supplement and chemistry manufacturing and controls supplement. As stated previously, FDA assumes that Congress was familiar with FDA regulations when it drafted section 402(j) of the PHS Act.

FDA appreciates that there are many routine filings that fall under this broader definition of application; however, the relevant statutory language is itself written very broadly. FDA recognizes the burden associated with submitting certifications with all of these filings, and FDA continues to work to identify filings which may not need to be accompanied by a certification. In April 2008, FDA issued a draft guidance describing FDA's current thinking on the types of information and documents that need not be accompanied by a certification. (See, Guidance For Sponsors, Industry, Researchers, Investigators, and Food And Drug Administration Staff: Certifications To Accompany Drug, Biological Product, And Device Applications/Submissions: Compliance With Section 402(J) of The Public Health Service Act, Added By Title VIII of The Food And Drug Administration Amendments Act of 2007, April 2008, available at http://www.fda.gov/oc/initiatives/fdaaa/guidance_certifications.html ).

FDA will address any suggestions made by the respondents that are relevant to the issues contained in the draft guidance when FDA finalizes that draft guidance.

(Comment 3) A number of comments concerned the burden estimate and stated that FDA underestimated the amount of time needed to prepare the form. Related to these comments were comments that requested the form be PDF fillable; that it be able to be electronically saved in order to be used repeatedly; and/or that the form be combined with other existing forms.

(Response) In evaluating the burden, FDA considered the fact that multiple certifications relating to a single IND or NDA may be filed with FDA. FDA anticipated that many submitters would pre-fill and save electronic versions of the forms necessary for existing applications. When an NCT number becomes available or a new one is issued related to a particular application, it then can simply be added to the previously completed form. Although the draft certification form was not PDF fillable and was not able to be saved electronically, the form currently is PDF fillable and is able to be saved electronically, which means it can be amended by submitters as necessary. FDA further determined that, over time, familiarity with the form and the requirements of section 402(j) of the PHS Act would significantly reduce the amount of time needed to prepare the form for filing.

With regard to the suggestion that the certification be incorporated into existing forms, section 402(j)(5) of the PHS Act requires that the certification “accompany” an application or submission, and we infer from this wording that the certification is not intended to be part of that application or submission. Because the existing forms are considered to be part of the application or submission, it is not appropriate to add the certification to those forms. FDA notes, however, that it is possible that, as FDA's information technology systems continue to evolve, more forms and submissions will be filed electronically, and there will be a means to transfer information from an application onto the certification form.

(Comment 4) One comment requested that the form be modified to remove the second sentence above the signature block. The second sentence currently reads: “Warning: A willfully and knowingly false statement is a criminal offense, U.S. Code, title 18, section 1001.” The rationale for requesting removal of the sentence was that “FDAAA does not authorize FDA to bring a perjury action for failure to certify accurately.”

(Response) The sentence requested to be removed does not entail a perjury charge. In the draft certification form circulated for comment in December 2007, FDA did include a sentence that indicated a charge of perjury could be brought. After further consideration of the statute and the certification form, FDA concluded that this sentence should be removed. However, the knowing and willful inclusion of a materially false statement in any government document is subject to 18 U.S.C. 1001, which allows a criminal charge to be brought for violations of that section. Accordingly, this reference to 18 U.S.C. 1001 will not be removed from the form.

(Comment 5) A number of respondents commented that the certification should apply only to clinical trials sponsored by the applicant and the form should not require certification with regard to trials over which the manufacturer/sponsor had no control.

(Response) The certification provision, section 402(j)(5)(B) of the PHS Act, does not make a distinction between trials conducted by the sponsor and trials relied upon in the application but conducted by entities other than the sponsor. FDA is aware that sponsors or applicants will be required to certify as to trials they did not conduct or register in the clinical trials data bank. FDA has addressed this concern by requiring the submitter to declare that the information submitted is accurate, true, and complete “to the best of her/his knowledge.”

(Comment 6) Respondents made a number of miscellaneous suggestions related to the certification form such as changing the FDA Form 3674 to eliminate sections 9.A and 9.B.; clarifying the certification form's instructions; and updating the eCTD (electronic common technical document) specifications to account for the certification form.

(Response) At the current time, the form will remain the same. The boxes 9.A and 9.B in the certification form will not be removed. These boxes provide information allowing FDA to determine if there are clinical trials referenced in the application /submission to which the requirements of section 402(j) of the PHS Act apply without having to review each clinical trial included in the application or submission. However, we have updated the instructions to provide additional clarity for sponsors in filling out the information required. Lastly, as the eCTD specifications are updated, FDA intends to consider adding an appropriate leaf module for the certification form.

Estimated Annual Reporting Burden

Table 1 of this document provides an estimate of the annual reporting burden for the submission of information to satisfy the requirements of section 402(j)(5)(B) of the PHS Act. The annual reporting burden reflects changes made based on certain applications/submissions either removed from the burden calculations made in the original estimates or new applications/submissions added to the burden calculations. Those applications/submissions removed include those we currently have determined do not typically require that a certification form accompany the application/submission, as described in our April 2008 Draft Guidance. Added to the burden were generic applications/submissions, which were originally not included in the burden calculations, but have since been determined to require a certification form accompany the application/submission.

We believe the estimate of 27,746 hours per year accurately reflects the burden. We recognize that individuals or entities less familiar with FDA forms and the clinical trials data bank (ClinicalTrials.gov) may require greater than 15 and 45 minutes (depending on the type of application/submission) per response.

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Section 112(a) of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) amended the Federal Food, Drug, and Cosmetic Act (the act) by adding section 506 (21 U.S.C. 356). The section authorizes FDA to take appropriate action to facilitate the development and expedite the review of new drugs, including biological products, intended to treat a serious or life-threatening condition and that demonstrate a potential to address an unmet medical need. Under FDAMA section 112(b), FDA issued guidance to industry on fast track policies and procedures outlined in section 506 of the act. The guidance discusses collections of information that are specified under section 506 of the act, other sections of the Public Health Service Act (the PHS Act), or implementing regulations. The guidance describes three general areas involving collection of information: (1) Fast track designation requests, (2) premeeting packages, and (3) requests to submit portions of an application. Of these, fast track designation requests and premeeting packages, in support of receiving a fast track program benefit, provide for additional collections of information not covered elsewhere in statute or regulation. Information in support of fast track designation or fast track program benefits that has previously been submitted to the agency, may, in some cases, be incorporated into the request by referring to the information rather than resubmitting it.

Under section 506(a)(1) of the act, an applicant who seeks fast track designation is required to submit a request to the agency showing that the product: (1) Is intended for a serious or life-threatening condition; and (2) the product has the potential to address an unmet medical need. Mostly, the agency expects that information to support a designation request will have been gathered under existing provisions of the act, the PHS Act, or the implementing regulations. If such information has already been submitted to the agency, the information may be summarized in the fast track designation request. The guidance recommends that a designation request include, where applicable, additional information not specified elsewhere by statute or regulation. For example, additional information may be needed to show that a product has the potential to address an unmet medical need where an approved therapy exists for the serious or life-threatening condition to be treated. Such information may include clinical data, published reports, summaries of data and reports, and a list of references. The amount of information and discussion in a designation request need not be voluminous, but it should be sufficient to permit a reviewer to assess whether the criteria for fast track designation have been met.

After the agency makes a fast track designation, a sponsor or applicant may submit a premeeting package which may include additional information supporting a request to participate in certain fast track programs. The premeeting package serves as background information for the meeting and should support the intended objectives of the meeting. As with the request for fast track designation, the agency expects that most sponsors or applicants will have gathered such information to meet existing requirements under the act, the PHS Act, or implementing regulations. These may include descriptions of clinical safety and efficacy trials not conducted under an investigational new drug application (i.e., foreign studies), and information to support a request for accelerated approval. If such information has already been submitted to FDA, the information may be summarized in the premeeting package. Consequently, FDA anticipates that the additional collection of information attributed solely to the guidance will be minimal.

Under section 506(c) of the act, a sponsor must submit sufficient clinical data for the agency to determine, after preliminary evaluation, that a fast track product may be effective. Section 506(c) of the act also requires that an applicant provide a schedule for the submission of information necessary to make the application complete before FDA can commence its review. The guidance does not provide for any new collection of information regarding the submission of portions of an application that is not required under section 506(c) of the act or any other provision of the act. All forms referred to in the guidance have a current OMB approval: FDA Forms 1571 (OMB Control No. 0910-0014); 356h (OMB Control No. 0910-0338); and 3397 (OMB Control No. 0910-0297).

Respondents to this information collection are sponsors and applicants who seek fast track designation under section 506 of the act. The agency estimates the total annual number of respondents submitting requests for fast track designation to the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research is approximately 64, and the number of requests received is approximately 77 annually. FDA estimates that the number of hours needed to prepare a request for fast track designation is approximately 60 hours per request.

Not all requests for fast track designation may meet the statutory standard. Of the requests for fast track designation made per year, the agency granted 60 from 54 respondents, and for each of these granted requests a pre-meeting package was submitted to the agency. FDA estimates that the preparation hours are approximately 100 hours per pre-meeting package.

In the Federal Register of May 6, 2008 (73 FR 25016), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received.

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

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

The authority for FDA to collect the information derives from the FDA Commissioner's authority, as specified in section 903(d)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)).

The proposed information collection will help FDA advance public health by identifying misperceptions and knowledge gaps about how health care providers use information to make decisions about the use of prescription drugs for the targeted patient groups. Knowledge of these misperceptions and gaps provides opportunities for FDA to target its communications more precisely to such gaps and areas of misperception in health care providers' mental models regarding treatment decisions.

FDA engages in various communication activities to ensure that patients and health care providers have the information they need to make informed decisions about treatment options, including the use of prescription drugs. FDA regulations (21 CFR 201.57) describe the content of required product labeling, and FDA reviewers ensure that labeling contains accurate and complete information about the known risks and benefits of each drug. This data collection and analysis is designed to identify knowledge gaps that FDA could then address, which would ultimately improve decision making and potentially improve health outcomes.

The project will use “mental modeling,” a qualitative research method that compares a model of the decision-making processes of a group or groups to an “expert model” of the same decision-making processes developed from expert knowledge and experience. In this study, the decision models of certain health care providers concerning treatment options for pregnant and nursing women will be compared to an expert model concerning such treatment options that was derived from the knowledge and experience of FDA reviewers responsible for product labeling. FDA will use telephone interviews to determine from the health care providers the factors that influence their treatment decisions for pregnant and nursing women with chronic conditions. A comparison between expert and health care provider models based on the collected information may identify consequential knowledge gaps that can be redressed through messages or information campaigns designed by FDA.

Using a protocol derived from the research that resulted in the “expert model,” trained interviewers will conduct one-on-one telephone discussions with 24 to 30 members of each of 2 categories of health care providers (described in the following paragraph) who provide health care services to pregnant and nursing women.

The two categories of health care providers are:

(1) Those who directly care for pregnant and nursing women, including obstetricians, OB/GYNs (obstetrician/gynecologists), nurse midwives, and primary care practitioners.

(2) Selected specialties of healthcare providers who directly care for women of reproductive age who have chronic health conditions (allergists, psychiatrists, neurologists, and cardiologists).

In the Federal Register of December 11, 2007 (72 FR 70328), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received.

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

The study will involve about 60 respondents and take approximately 1 hour each to complete. These estimates are based on the contractor's extensive experience with mental models research. FDA conducted pretests of the mental models protocol with six health care providers. These resulted in the current protocol.

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 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 these topics: (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.

Under FIMA (21 U.S.C. 141-149), milk or cream may be imported into the United States only by the holder of a valid import milk permit (21 U.S.C. 141). Before such permit is issued: (1) All cows from which import milk or cream is produced must be physically examined and found healthy; (2) if the milk or cream is imported raw, all such cows must pass a tuberculin test; (3) the dairy farm and each plant in which the milk or cream is processed or handled must be inspected and found to meet certain sanitary requirements; (4) bacterial counts of the milk at the time of importation must not exceed specified limits; and (5) the temperature of the milk or cream at time of importation must not exceed 50° F (21 U.S.C. 142).

FDA's regulations in part 1210 (21 CFR part 1210) implement the provisions of FIMA. Sections 1210.11 and 1210.14 require reports on the sanitary conditions of, respectively, dairy farms and plants producing milk and/or cream to be shipped to the United States. Section 1210.12 requires reports on the physical examination of herds, while § 1210.13 requires the reporting of tuberculin testing of the herds. In addition, the regulations in part 1210 require that dairy farmers and plants maintain pasteurization records (§ 1210.15) and that each container of milk or cream imported into the United States bear a tag with the product type, permit number, and shipper's name and address (§ 1210.22). Section 1210.20 requires that an application for a permit to ship or transport milk or cream into the United States be made by the actual shipper. Section 1210.23 allows permits to be granted based on certificates from accredited officials.

The estimated number of respondents and hours per response are based on FDA's experience with the import milk permit program and the average number of import milk permit holders over the past 3 years. FDA estimates that eight respondents will submit approximately 200 Form FDA 1996 reports annually, for a total of 1,600 responses. FDA estimates the reporting burden to be 1.5 hours per response, for a total burden of 2,400 hours.

The Secretary of Health and Human Services has the discretion to allow Form FDA 1815, a duly certified statement signed by an accredited official of a foreign government, to be submitted in lieu of Forms FDA 1994 and 1995. To date, Form FDA 1815 has been submitted in lieu of these forms. Because FDA has not received any Forms FDA 1994 and 1995 in the last 3 years, the agency estimates no more than one will be submitted annually. FDA estimates the reporting burden for each to be 0.5 hours per response for a total burden reporting burden of 0.5 hours each.

FDA estimates that eight respondents will submit one Form FDA 1997 report annually, for a total of eight responses. FDA estimates the reporting burden to be 2.0 hours per response, for a total burden of 16 hours. FDA estimates that eight respondents will submit one Form FDA 1993 report annually, for a total of eight responses. FDA estimates the reporting burden to be 0.5 hours per response, for a total burden of 4 hours. FDA estimates that eight respondents will submit one Form FDA 1815 report annually, for a total of eight responses. FDA estimates the reporting burden to be 0.5 hours per response, for a total burden of 4 hours.

With regard to records maintenance, FDA estimates that approximately eight recordkeepers will spend 0.05 hours annually maintaining the additional pasteurization records required by § 1210.15, for a total of 0.40 hours annually.

No burden has been estimated for the tagging requirement in § 1210.22 because the information on the tag is either supplied by FDA (permit number) or is disclosed to third parties as a usual and customary part of the shipper's normal business activities (type of product, shipper's name and address). Under 5 CFR 1320.3(c)(2), the public disclosure of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public is not a collection of information. Under 5 CFR 1320.3(b)(2)), the time, effort, and financial resources necessary to comply with a collection of information are excluded from the burden estimate if the reporting, recordkeeping, or disclosure activities needed to comply are usual and customary because they would occur in the normal course of activities.

Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at http://www.regulations.gov .

On March 1, 2007, FDA received a citizen petition submitted by a number of pediatric health care practitioners that raised concerns about the safety and efficacy of OTC cough and cold products in children less than 6 years old. The petition requested that FDA, among other actions, amend the OTC drug monograph for Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products (CCABADP) in 21 CFR part 341 to revise the labeling for OTC antitussive, expectorant, nasal decongestant, antihistamine, and combination cough and cold products. The petition requested that revised labeling state that these products should not be used in children under 6 years of age for the treatment of cough and cold because the products have not been found to be safe or effective. In addition, the petition requested that the agency notify manufacturers of products whose labeling either uses such terms as “infant” or “baby,” or displays images of children under the age of 6, that such marketing is not supported by scientific evidence and that manufacturers will be subject to enforcement action at any time. The petition and additional information can be found at the following Web site: http://www.fda.gov/ohrms/dockets/dockets/07p0074/07p0074.htm .

Many of today's OTC cough and cold medicines are marketed under monographs established through the OTC Drug Review and published in the Code of Federal Regulations. FDA initiated the OTC Drug Review in 1972, after amendments to the Federal Food, Drug, and Cosmetic Act in 1962 required that drugs be shown to be effective as well as safe. Using expert advisory panels to review data, the OTC Drug Review examined drug ingredients marketed OTC in the United States to verify which of these ingredients can be generally recognized among qualified experts as safe and effective for their intended uses (GRAS/E). After review by the panel, FDA published advance notices of proposed rulemaking for active ingredients in various therapeutic categories to establish monographs describing the conditions under which the products could be considered GRAS/E and marketed under the monograph without an approved new drug application. Based on the recommendations in the panel reports and additional public comments and data, FDA published a proposed rule, also known as a tentative final monograph (TFM), which set forth the FDA's views on the conditions of use for the monograph. Finally, based on additional comments and information submitted in response to the TFM, FDA published final monographs. The final monographs, codified in the Code of Federal Regulations, specify the active ingredients that are GRAS/E for each indication, and for each such active ingredient, the permitted dosages, claims, and warnings. Products that comply with all specified monograph conditions may be marketed without prior FDA approval.

Through the OTC Drug Review, FDA has established numerous monographs for classes of OTC drug ingredients. Each completed OTC drug monograph considers a particular therapeutic class of drugs (e.g., antacids, topical antifungal drugs, nighttime sleep aids) and describes the active ingredients that have been determined to be GRAS/E through the OTC Drug Review process, with specifications for the amount of drug per dose, labeling, and other general requirements. As long as a manufacturer uses ingredients (or combinations of ingredients) that are included in the monograph, and follows the monograph specifications in manufacturing and marketing, these “OTC Monograph” products may be sold over the counter without FDA pre-clearance. Drugs that are not covered under the OTC Drug Review may be marketed OTC under the terms of an approved NDA.

In the Federal Register of September 9, 1976 (41 FR 38312), FDA published an advance notice of proposed rulemaking (ANPRM) to establish a monograph under § 330.10(a)(6) (21 CFR 330.10(a)(6)), for OTC cold, cough, allergy, bronchodilator, and antiasthmatic drug products. At the same time, FDA published the recommendations of the Advisory Review Panel on OTC Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products (the Panel), which was the advisory review panel that evaluated these products.

The final CCABADP monograph includes GRAS/E active ingredients in five separate categories: Antihistamines (13 active ingredients), decongestants (13 active ingredients), antitussives (10 active ingredients), bronchodilator (7 active ingredients), and expectorants (1 active ingredient). 1

Dosing for each active ingredient was largely based on the advisory panel recommendations, made in consultation with the Special Panel on Pediatric Dosage. The following statements appear in the ANPRM:

We estimate that there are approximately 10,000 products being marketed for cold, cough, or combined indications under the OTC Drug Review. (See 67 FR 78158 at 78166.) Depending on the dosage form and strength of these products, many of them are labeled for pediatric use, including some that are labeled for use in both adults and children. There are approximately 38 active ingredients in the final CCABADP monograph. Some combination cough and cold products contain as many as four of these active ingredients in a single dosage form, meaning that patients may be exposed to four different active ingredients when using a single product. From 2002 to 2006, there were approximately 36 billion units of combination cough and cold products sold each year in the United States. For liquid formulations used for the youngest children, there were approximately 190 million units sold each year in the combined cough and cold categories during this period. 2

During the past decade, there have been several important new developments in the evaluation of safety and efficacy of drugs for pediatric use. First, the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) (Nov. 21, 1997) was enacted, and included a provision to create voluntary incentives to develop medications for use in the pediatric population. This program was reauthorized and expanded first in the Best Pharmaceuticals for Children Act of 2002 (Public Law 107-109) (January 4, 2002), and then again in Title V of the FDA Amendments Act of 2007 (FDAAA) (Public Law 110-85) (September 27, 2007). The Pediatric Research Equity Act (PREA) of 2003 required that drugs be studied in pediatric patients in certain circumstances. The PREA requirements were reauthorized and expanded by Title IV of FDAAA in 2007. Collectively, these laws recognize that differences in metabolism between adults and children, as well as differences between pediatric age groups, may require individualized dosing. They also recognize that there are often differences in effects of drugs and in adverse events observed in pediatric patients when compared to adult patients. Although these laws do not apply to products marketed under an OTC monograph, data from studies performed under these provisions suggest that children are not small adults, but rather may have a response to medication, both beneficial and adverse, that is different from adults.

Given the evolution in our thinking about the use of drugs in children, the passage of more than 30 years since the recommendations from the advisory review panels were made, and the concerns about pediatric cough and cold products that have been presented to FDA, including those raised by the March 1, 2007, citizen petition, the agency has taken a new look at the assumptions that were used to create the pediatric conditions for cough and cold medicines contained in the CCABADP monograph. As part of this review, FDA convened a joint meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee on October 18 and 19, 2007, to discuss the safety and efficacy of these OTC cough and cold products marketed for pediatric use. The discussion at the Advisory Committee meeting addressed a variety of issues including the extrapolation of efficacy data from adults to children of any age for cough and cold products; the safety profile of these products in children; the basis for dosing recommendations in the CCABADP monograph and the use of pharmacokinetic data to determine appropriate dosing in children; the basis of dosing recommendations for various age intervals of less than 2 years, 2 to 5 years of age, and 6 to 11 years of age; the use of the products in children less than 2 years of age; the potential for misuse, unintentional overdose, and excessive dosing; the ability of parents or caregivers to correctly dose and administer cough and cold products to their children; and the labeling changes recommended by the petitioner and the effects they would have on the use of these products in children and the recommendations of health care providers. The 22 person Advisory Committee was nearly unanimous in agreeing that new studies were necessary because extrapolation of efficacy data for the common cold indication from adults to children was not acceptable for children less than 2 years old or for children 2 years to less than 12 years. The vote was 22 to 0 and 21 to 1, respectively, for the two age groups. The committee understood that changing the OTC drug monographs required rulemaking that would take several years to complete. The Advisory Committee also voted 13 to 9 to recommend that pediatric cough and cold drugs should not be used for children under 6 years of age while rulemaking proceeded, and voted 15 to 7 to recommend that the products should continue, for the time being, to be sold for use in children ages 6 to under 12 while new studies are conducted.

On January 17, 2008, FDA issued a Public Health Advisory (PHA) available at: http://www.fda.gov/cder/drug/advisory/cough_cold_2008.htm . The PHA recommended that these drugs not be used to treat infants and children under 2 years of age because serious and potentially life-threatening side effects can occur. The PHA also indicated that FDA had not yet completed its review of the safety of these medicines in children 2 through 11, and the agency committed to completing the review as quickly as possible. Pending completion of this review, the PHA recommended a number of precautions for parents and caregivers using OTC cough and cold medicines in children 2 years of age and older, including carefully following the directions in the Drug Facts label; using appropriate measuring spoons or instruments made for measuring medicines; choosing products with safety caps; avoiding concurrent use of different OTC cough and cold medications to avoid unintentional overdose; not using these products to sedate children; and consulting a physician, pharmacist, or other health care professional with any questions about using these products in children.

In the PHA, we also announced strong support for the voluntary action taken by many pharmaceutical manufacturers to withdraw cough and cold medicines that were being sold for use in children under 2 years of age.

Since we issued the Public Health Advisory, we have continued our review of available data concerning the use of cough and cold medications in children, including information from the Advisory Committee meeting about the efficacy of the products, information from FDA's drug Adverse Event Reporting (AERS) database, and a published report in the medical literature from the Centers for Disease Control and Prevention (CDC) about children who ingested cough and cold medicines and had side effects that were serious enough to require an emergency room visit. 3 While many of the observed adverse events were due to overdoses associated with accidental ingestions or dosing errors, allergic and non-allergic adverse events occurred with the labeled dose in children. FDA reviewed the CDC study and underlying data, particularly looking at the type of events that occurred with the labeled dose of OTC cough and cold medications, and noted that children under 4 years of age are more likely to experience non-allergic adverse events than older children.

Cough and cold products are commonly used in children. A recent report suggested that 1 in 10 children uses one or more cough and cold products during a given week with exposure being highest among 2 to 5 year olds, and high in children under 2. 4 Based on the number of cases of serious adverse events reported to FDA and the number of serious adverse events in the CDC emergency room study, we believe that serious adverse events are relatively rare given the extensive use of the drug products.

Despite the fact that serious adverse events are relatively rare in children using cough and cold drugs, we have determined that the collection of additional data using modern standards is warranted to support the current dosing or to establish new dosing regimens for children, given the concerns that have been raised about the safety and efficacy of these products, particularly in younger age groups. Lack of safety and efficacy data for specific pediatric age groups also inhibits the conduct of a meaningful risk benefit analysis under 21 CFR 330.10(a)(4)(iii).

We recognize that many scientific issues must be addressed and resolved to support the development and review of data that, in the long term, will provide increased confidence in the safe and effective pediatric use of these OTC cough and cold products, either under the monograph or approved NDAs. FDA has decided to hold a Part 15 hearing to hear from the public, including parents, health care practitioners, manufacturers of cough and cold products, retailers, and other interested persons, about these issues. FDA will consider this public input in developing a proposed rule to amend the CCABADP monograph to reflect the new data and any appropriate changes to the conditions necessary to ensure that these medications can be considered GRAS/E.

FDA is interested in obtaining public comment on the following issues relating to the use of pediatric cough and cold medicines:

1. What types of studies, if any, should be conducted to assess effectiveness and/or safety, and determine appropriate dosing of cough and cold ingredients in the pediatric population? How should these studies be designed and powered?

2. Should cough and cold products for the pediatric population continue to be available OTC, or should they be made available only by prescription?

3. If the pediatric indications and dosing for cough and cold products were no longer available OTC, would the public use the adult formulations of the OTC monograph products for children, and thus create a greater risk of misuse or overdose?

4. Do the answers to the previous questions depend on the age of the pediatric patients? If so, how should age be considered in making regulatory decisions for these products?

5. At the time the monograph was established, FDA routinely extrapolated safety and efficacy data from adults to children age 12 and over. Current PREA standards permit extrapolation of pediatric efficacy -- but not safety-- based upon sufficient adult data. Does it remain appropriate to recommend in the cough and cold monograph that children 12 and over should receive the same dose of medication as adults, without requiring any additional studies in children in this age group? What additional safety and/or efficacy studies should be required in this age group?

6. What is the most appropriate method for determining pediatric doses that could be used as an alternative to the quarter- and half-dose assumptions used in the monograph? Should products be dosed by age, by weight, or both?

7. There are monographs for topical and intranasal ingredients to treat the common cold. Should these monographs be considered in a similar fashion to the oral cough and cold products? Are the answers to the previous questions different for any subcategories of cough and cold medicines (e.g., topical or intranasal products)?

8. The CCABADP monograph allows for the combination of ingredients to treat colds and/or coughs. Should combination products be permitted for all pediatric age groups? Should data be provided to support each unique combination?

9. Can measurement errors in dosing be reduced using more standardized measuring devices or alternative dosage forms and, if so, what is the best way to effect this change?

The Commissioner is announcing that the public hearing will be held in accordance with part 15 (21 CFR part 15). The hearing will be conducted by a presiding officer, accompanied by FDA senior management from the Office of the Commissioner and the Center for Drug Evaluation and Research.

Under § 15.30(f), the hearing is informal, and the rules of evidence do not apply. No participant may interrupt the presentation of another participant. Only the presiding officer and panel members may question any person during or at the conclusion of each presentation. Public hearings under part 15 are subject to FDA's policy and procedures for electronic media coverage of FDA's public administrative proceedings (part 10 (21 CFR part 10), subpart C)). Under § 10.205, representatives of the electronic media may be permitted, subject to certain limitations, to videotape, film, or otherwise record FDA's public administrative proceedings, including presentations by participants. The hearing will be transcribed as stipulated in § 15.30(b). To the extent that the conditions for the hearing, as described in this document, conflict with any provisions set out in part 15, this document acts as a waiver of those provisions as specified in 21 CFR 15.30(h).

Regardless of attendance at the public hearing, interested persons may submit written or electronic comments to the Division of Dockets Management (see ADDRESSES ). Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments should be identified with the docket number found in brackets in the heading of this document. To ensure consideration, submit comments by (see DATES ). Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA through FDMS only.

Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov . It may be viewed at the Division of Dockets Management (see ADDRESSES). A transcript will also be available in either hard copy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to Division of Freedom of Information (HFI-35), Office of Management Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857. Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic notices of participation and comments for consideration.

IHS initiated a national workgroup consisting of IHS Chief Medical Officers (CMOs) and the IHS National Pharmacy Council (NPC) to assist the IHS in systematically addressing the issue of prescription drug abuse. Currently, approximately 35 States have controlled substances prescription reporting systems that allow providers to monitor their patient's prescriptions and access to controlled substances.