Title: In-Depth Case Studies of Advanced SNAP Modernization Initiatives.

OMB Number: 0584-0547.

Form Number: N/A.

Expiration Date: April 30, 2011.

Type of Request: Revision of currently approved data collection.

Abstract: The Supplemental Nutrition Assistance Program (SNAP) (formerly known as the Food Stamp Program) is a critical source of support for many low-income families and individuals. In recent years, States have implemented new procedures and policies, commonly referred to as modernization, that focus on reducing SNAP administrative costs while maintaining or improving program access. Though State efforts vary, common initiatives include expanded use of technology, partnerships with community organizations, policy simplifications, and administrative restructuring.

In order to examine how modernization potentially affects key outcome measures—efficiency, access, and integrity—and establish if, and to what extent, the goals of States were met by their modernization efforts, six States have been selected for comprehensive case studies. The selection process employed a modernization index designed to identify States with the most advanced modernization initiatives. Florida, Georgia, Massachusetts, Utah, Washington, and Wisconsin were selected and have agreed to participate in this study. The study will ultimately yield a comprehensive picture of each State's experiences with modernization and assess the potential impacts of modernization. Specifically, the study will identify the steps States have taken to implement modernization changes, the challenges States experienced, and the perceptions of SNAP staff and participants regarding the changes. This information can be used by federal and State policymakers to identify important lessons. Project findings will help these policymakers understand the implications of modernization changes and identify effective modernization practices while avoiding implementation pitfalls.

The project has seven research objectives: (1) Update the existing State profiles of modernization efforts and identify the geographic and caseload coverage affected by modernization changes; (2) describe how key certification, recertification, and case management functions have changed; (3) describe the current roles and responsibilities of State and local SNAP staff, vendors, and partners and how they have changed; (4) document the relationship between SNAP modernization initiatives and stakeholder satisfaction; (5) describe the current performance of each State's modernization initiatives and the level of outcome variability within each State; (6) compare pre-, current, and post-modernization performance; and (7) document the main takeaway points for use by other States and for future study consideration.

Data collection strategies include multiple site visits, during which we will conduct interviews of SNAP staff at all levels, visit multiple local offices, hold focus groups with current participants and eligible nonparticipants, and meet with community-based partner organizations and vendors that contract with State SNAP agencies. Tailored protocols will be used for the interviews. Members for the SNAP participant focus groups will be selected using State SNAP administrative data for current participants. Members of the eligible nonparticipant focus groups will be recruited at local food banks. Potential focus group members will be offered $25 for their participation and $5 for transportation to and from the focus group location. Working parents will be offered an additional $15 for child care. To examine how within-State participation patterns vary with within-State differences in modernization, the study will also collect and analyze monthly State case record extant data. Each of the six States will receive remuneration of $75,000 to offset the costs of participating in the study.

Interview and focus group questions will be kept as simple and respondent-friendly as possible. Responses to all questions will be voluntary. The contractor will take the following steps to treat the data provided in a confidential manner: (1) No data will be released in a form that identifies individual respondents by name; and (2) information collected through interviews will be combined across other respondents in the same category and reported only in aggregate form. Respondents will be notified of these confidentiality measures during data collection.

Affected Public: State, local or tribal government; businesses or other for-profits; not-for-profit institutions; individuals or households. Respondent groups identified include: (1) SNAP staff at the State, regional, and local levels, including staff of call centers and other specialized units; (2) staff from community partners and vendors or businesses assisting with modernization efforts; and (3) current SNAP participants and eligible non-participants.

Estimated Number of Respondents: The study will collect data from a total of 606 respondents across all States. This number represents the sum of 33 State-level SNAP staff interviews; 84 district/county SNAP staff interviews; 21 interviews at SNAP call center staff or other centralized operation units staff; 154 local office SNAP staff interviews; 14 interviews with vendors; 60 interviews with staff members from community partners involved in modernization; and 120 SNAP participants and 120 eligible non-participants.

Estimated Number of Responses per Respondent: 1.

Estimated Time per Response: For all interviews of State SNAP staff, district/county SNAP staff, SNAP call center staff or centralized operation units staff, local office SNAP staff, vendor staff, and community partner staff, the burden estimate is 1.5 hours and includes respondents' time to prepare for and complete the interview. For all participating members in the focus groups, the burden estimate is 1.667 hours (100 minutes) and includes respondents' time to be screened, receive a reminder call, read a reminder letter, and to participate in the group. For all persons who decline to participate in the focus groups, the burden estimate is .0835 hours (5 minutes) and includes the respondents' time to be screened (see table below).

Estimated Total Annual Burden on Respondents and Non-Responders: Total of 1,009.1 hours, including: State SNAP staff, 49.5 hours; district/county SNAP staff, 126 hours; SNAP call center staff or centralized operation units staff, 31.5 hours; local office SNAP staff, 231 hours; vendor staff, 21 hours; community partner staff, 90 hours; SNAP participants, 200 hours; eligible non-participants, 200 hours. In addition, respondents who elect not to participate in the focus groups (refusers), the estimated total burden is 60.1 hours. The number of refusers is based on the assumption that in order to have 240 respondents ultimately attend the focus groups, 480 persons will need to be recruited. And in order for 480 persons to be recruited, twice as many persons, or 960, will need to be contacted initially.

The phytosanitary treatments regulations contained in 7 CFR part 305 (referred to below as the regulations) set out general requirements for conducting treatments indicated in the Plant Protection and Quarantine (PPQ) Treatment Manual1 for fruits, vegetables, and articles to prevent the introduction or dissemination of plant pests or noxious weeds into or through the United States.

On October 19, 2009, we published in the Federal Register (74 FR 53424-53430, Docket No. APHIS-2008-0140) a proposal2 to amend the regulations by adding new treatment schedules for sweet cherries and for certain species of citrus fruit imported from Australia into the United States.3 We also proposed to establish an approved irradiation dose for Mediterranean fruit fly (Medfly) of 100 gray. Our analysis of the efficacy of the proposed treatments was presented in a treatment evaluation document that was made available with the proposed rule.

We solicited comments concerning our proposal for 60 days ending December 18, 2009, and received five comments by that date. They were from a State plant protection official, a research entomologist, a foreign national plant protection organization representative, and two students. We have carefully considered the comments we received. One commenter simply pointed out a misspelling in a footnote. The issues raised by the remaining commenters are discussed below.

One commenter, while agreeing with the changes we proposed, expressed concern that the proposal mentioned no requirement for field monitoring of fruit flies or subsequent field treatment when fruit fly populations exceed a defined limit. The commenter added that even if the treatments we propose achieve a probit-9 level of efficacy, the possibility remains that heavy infestations of fruit flies could overwhelm the treatments.

The national plant protection organization (NPPO) of Australia is a signatory to the International Plant Protection Convention (IPPC) and therefore observes IPPC guidelines for pest surveillance, monitoring, and information collection in its production areas. Should fruit fly populations increase in these areas, the Animal and Plant Health Inspection Service (APHIS) would have the information and resources readily at hand to respond effectively.

Another commenter who agreed with our proposed treatment changes asked whether the reduced irradiation dose of 100 gray we proposed as a treatment for Medfly would result in improved fruit quality and longer shelf life for sweet cherries.

We have no evidence to suggest that a 100 gray dose would result in improved fruit quality or shelf life. In fact, our experience indicates that an irradiation dose of 150 gray has no discernible positive or negative effect on fruit quality, making it less likely that a dose of 100 gray will have any such effect.

The same commenter also wanted to know if the reduced irradiation dose we proposed for Medfly would be effective for other types of fruit flies.

We have established that the 100 gray dose is effective against certain species of Anastrepha and Bactrocera fruit flies and the approved irradiation doses listed for these species in the PPQ Treatment Manual are already 100 gray or lower. For all other fruit flies of the family Tephritidae, the approved dose is 150 gray. Additional testing would be necessary to confirm whether a 100 gray dose would serve as an efficacious treatment for other species of fruit fly.

One commenter stated that the proposed treatment changes would allow the Australian cherry industry to benefit unfairly from lower treatment costs, thereby putting emerging cherry-producing countries in the Middle East such as Turkey and Iran at an economic disadvantage in the world cherry market.

The treatments discussed in the proposed rule with respect to Australia are specific to the pests present there, Medfly and Queensland fruit fly, and were evaluated with respect to their efficacy, not their costs. Cherries from another region with the same pest complex could be treated in the same manner, so we disagree that Australian cherry producers are receiving any sort of unfair benefit.

Another commenter, a representative of the Australian NPPO, observed that the State of Tasmania is not included in the areas of Australia listed by APHIS as free of fruit flies. The commenter noted that the APHIS Fruits and Vegetables Import Requirements database specifically lists cherries, apples, and pears from Tasmania as being permitted access to the United States without the requirement for a phytosanitary treatment for fruit flies. The commenter asked that Tasmania be added to APHIS’ list of approved pest-free areas.

For a given plant pest, APHIS makes a distinction between pest-free areas and areas that have never been known to support that pest in sufficient numbers to be a threat to agriculture; Tasmania is an example of the latter with regard to fruit flies. If a particular quarantine pest has never been known to be associated with the regulated article in the country or region of origin, we do not usually include that country or region on the list of pest-free areas for that pest. Because the cooler climate and geographical isolation of Tasmania inhibit a resident fruit fly population from establishing itself there, we do not consider it necessary to include Tasmania on the list of approved pest-free areas.

Following the publication of our October 2009 proposed rule, we published a final rule that amended the regulations by removing all phytosanitary treatments and treatment schedules from 7 CFR part 305, while retaining general treatment requirements.4 The sections in part 305 we had proposed to amend no longer exist, so the modified treatments will instead be added to the appropriate sections of the PPQ Treatment Manual. The regulations now indicate that all approved treatments and treatment schedules are contained in the PPQ Treatment Manual.

Accordingly, the PPQ Treatment Manual has been amended to include the new treatments for sweet cherries from Australia and a specific irradiation dose of 100 gray for Medfly.

Done in Washington, DC, this 29th day of July 2010.

The meeting is open to the public. Committee discussion is limited to Forest Service staff and Committee members. However, public input opportunity will be provided and individuals will have the opportunity to address the Committee at that time.

The meeting is open to the public. The following business will be conducted: (1) Introductions of all committee members, replacement members and Forest Service personnel. (2) Selection of a chairperson by the committee members. (3) Receive materials explaining the process for considering and recommending Title II projects; and (4) Public Comment. Persons who wish to bring related matters to the attention of the Committee may file written statements with the Committee staff before or after the meeting.

The meeting is open to the public. Council discussion is limited to Forest Service, National Institute for Food and Agriculture staff and Council members. However, persons who wish to bring forestry research matters to the attention of the Council may file written statements with the Council staff before or after the meeting.

The amount of the proposed changes varies considerably for each of the Conservation Practice Standards addressed in this notice. To fully understand the proposed changes, individuals are encouraged to compare these changes with each standard's current version as shown at http://www.nrcs.usda.gov/technical/Standards/nhcp.html. To aid in this comparison, following are highlights of the proposed revisions to each standard:

Channel Bed Stabilization (Code 584)—Name changed for better description, plus minor edits.

Dust Control From Animal Activity on Open Lot Surfaces (Code 375)—This is a new Conservation Practice Standard.

Karst Sinkhole Treatment (Code 527)—Practice name changed from “Sinkhole and Sinkhole Area Treatment” to “Karst Sinkhole Treatment.” Practice specially does not apply to sinkholes with non-karst origins (structural failures due to piping, etc.), plus minor edits.

Lined Waterway or Outlet (Code 468)—Changes to the standard include: A revision in the range in Manning's roughness and references cited in the criteria section; an expansion of the considerations section to include fish and wildlife and soil bioengineering, etc.; and more comprehensive guidance on what should be included in the plans and specifications section.

Monitoring Well (Code 353)—Updated references to ASTM standards and minor edits.

On-Farm Equipment Efficiency Improvement (Code 374)—This is a new Conservation Practice Standard.

Pond Sealing or Lining—Bentonite Treatment (Code 521C)—The standard was revised to better match the changes to our technical guidance document National Engineering Handbook Series, Part 651, Agricultural Waste Management Field Handbook (AWMFH), Chapter 10, Appendix 10D.

Pond Sealing or Lining—Compacted Clay Treatment (Code 521D)—The standard was revised to better match the changes to our technical guidance document National Engineering Handbook Series, Part 651, AWMFH, Chapter 10, Appendix 10D.

Pond Sealing or Lining—Soil Dispersant Treatment (Code 521B)—The standard was revised to better match the changes to our technical guidance document National Engineering Handbook Series, Part 651, AWMFH, Chapter 10, Appendix 10D.

Salinity and Sodic Soil Management (Code 610)—Clarified the Conditions Where Practice Applies and General Criteria Applicable to All Purposes sections. Added separate sections for Criteria Applicable to Irrigated Lands and to Non-Irrigated Lands. Expanded the sections for Criteria To Reduce Problems of Crusting, Permeability or Soil Structure on Sodium-Affected Soils, and to Saline Seeps and Their Recharge Areas. Expanded the Considerations section. Added detailed requirements for Plans and Specifications. Deleted the Operation and Maintenance section. Reduced the References section.

Stream Habitat Improvement and Management (Code 395)—Changed “Stream Visual Assessment Protocol” to “Stream Visual Assessment Protocol, Version 2,” changed considerations, added monitoring guidelines for evaluating the effectiveness of the conservation actions, and added post-project monitoring to Operation and Maintenance.

Vertical Drain (Code 630)—Additional emphasis on water quality protection if practice is used.

Water Well (Code 642)—Purpose clarified to exclude human consumption. Screen entrance velocity criteria changed in accordance with AWWA standard.

Water Well Decommissioning (Code 351)—Name was changed to Water Well Decommissioning, distinguishing this practice from industry practices for closure of other purposed wells (oil, injection, etc.). Purpose was clarified. Additional clarification on plugging materials was added.

Well Water Testing (Code 355)—Conditions Where Practice Applies has been updated to exclude water wells not for agricultural use, plus minor edits.

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 “collection of information” requirement in 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 1, 2010, to be eligible for FY 2010 funding. Late applications are not eligible for FY 2010 funding.

Electronic copies must be received by September 1, 2010, to be eligible for FY 2010 funding. Late applications are not eligible for FY 2010 funding.

This solicitation is issued pursuant to the Appropriations Act, 2010 (Pub. L. 111-80) 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, RBS-07-31, RBS-08-00 and RBS-09-00, collectively known as “REIC Agreements”. As further described below, data generated and results produced in the REIC Agreements will be accessible to the institution awarded this cooperative research agreement.

These agreements have produced the first census data of U.S. cooperatives across economic sectors, reporting their financial variables and employment data. Based on this census, cooperatives' direct and indirect impacts on national revenue, income and employment were estimated. Standard estimation methods, as applied to all types of business organizations, were used to obtain the economic estimates. These estimation methods do not measure distinctive and deeper economic impacts of cooperatives, which is the overall objective of this research program.

Two research initiatives were launched in FY 2009 that will help increase public and academic awareness of cooperatives. First, a more detailed survey sample, called the Cooperative Business Study, was launched to address the elements of member governance that influence distinctive policies in the operations and impacts of cooperatives. Further surveys of these sample cooperatives will examine in comprehensive detail the subjects of finance and human resources. Second, a program for annual collection of cooperative data by the U.S. Census Bureau was initiated. Completing these initiatives launched in 2009, will be a part of the work plan for FY 2010.

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. Complete a proposal to the U.S. Census Bureau for annual collection of data on cooperatives, involving criteria for identifying businesses and organizations as cooperatives.

2. Complete the first phase of the Cooperative Business Study on governance.

3. Develop research proposals for further surveys of the sample of cooperatives on the topics of finance, human resources, and other avenues of inquiry that provide a basis for examining the distinctive and deeper impacts of cooperatives.

4. Initiate research projects in the following subjects:

a. Economic resiliency—comparing and contrasting cooperatives with other types of firms on various measures of sustaining their operations or maintaining services over time or during and after economic recessions.

b. Competitive yardstick—measure the impact of cooperatives in maintaining competitive prices for producers and consumers, or in terms of supporting services that would be provided to some diminished degree in the absence of cooperatives.

c. Local impact—identify the extent to which local communities or rural areas have developed and retained more wealth because of the operations of cooperatives.

5. 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, FY 2007, FY 2008 and FY 2009 award recipient, as further progress is made on the FY 2006, FY 2007, FY 2008 and FY 2009 research.

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

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

8. The preparation and submission of publishable quality written reports for Deliverables 1 through 4 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 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 2010.

Approximate Total Funding: $300,000.

Approximate Number of Awards: 1.

Approximate Average Award: $300,000.

Floor of Award Range: None.

Ceiling of Award Range: $300,000.

Anticipated Award Date: September 24, 2010.

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: Section 705 of Public Law 111-80, “Agriculture, rural development, food and drug administration and related agencies appropriations act, 2010” 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. This does not preclude appropriate payment of indirect costs on grants and contracts with such institutions when such indirect costs are computed on a similar basis for all agencies for which appropriations are provided in this Act.” 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, 2012, 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 work plan and budget. Applicants should only submit the work plan and budget once, either in this section or as part of the work plan/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. Matching funds are not required but are highly encouraged. If matching funds are provided, applicants must provide a budget to support the work plan 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 1, 2010.

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 general 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:

• Description of how research projects would measure differences of economic impacts of cooperatives as compared to other forms of business organization;

• Description of sound data collection and analysis methodology; and

• Description of a program of assisting the Census Bureau in identifying cooperatives for annual data collection.

2. Quality of work plan (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 work plan 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

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. Cooperative and academic community support (20 points). Points will be awarded for having support for the proposal from both cooperative and academic communities. This support should be evidenced by either contribution of resources or by statements from representatives about the value of the proposed research to their organizations or communities.

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:

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 24, 2010.

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-425 or SF-425A. 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 work plan 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 work plan 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.”

The National Institute of Food and Agriculture (NIFA), established in Section 7511 of the Food, Conservation, and Energy Act of 2008 (Pub. L. 110-246), serves the nation's needs by supporting exemplary research, education, and extension that address many challenges facing the nation. NIFA works with scientists at universities and colleges throughout the United States and around the world to find innovative solutions to critical issues facing rural communities and American consumers including global food security and hunger, climate change, sustainable energy, childhood obesity and food safety.

Section 724 of Title VII, General Provisions, in the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Programs Appropriations Act, 2010 (Pub. L. 111-80) provided $4 million to the Secretary of Agriculture to award grant(s) to develop and field test new food products designed to improve the nutritional delivery of humanitarian food assistance provided through the McGovern-Dole (section 3107 of the Farm Security and Rural Investment Act of 2002 (7 U.S.C. 1736o-1)) and the Food for Peace title II (7 U.S.C. 1691 et seq.) programs.

Senate Report 111-39, which accompanies Pub. L. 111-80, states in Title I, Agricultural Programs, Production, Processing, and Marketing, Office of the Secretary:

As one step in conducting the assessments on Improving Food Aid and Providing Safe Water, NIFA is soliciting input from interested stakeholders on the following questions. Comments received will be considered as the assessment reports are developed. NIFA will not endorse particular products or approaches, and will focus its assessments on the steps that are needed for improving existing methods and technologies, or for developing new methods and technologies.

Respondents may address as many of the following questions as they wish.

1. What methods and tools do non-governmental organizations and international agencies use to assess nutritional gaps in populations that are served by U.S. international food aid programs?

2. What are the strengths and weaknesses of those methods and tools?

3. How could such methods and tools be made more reliable, informative and cost-effective?

4. What additional laboratory or field-based research and development is needed to improve such methods and tools?

5. What innovations and/or studies could lead to significant future improvements in such methods and tools?

1. What are the most effective and cost-efficient, commercially available water purification and supply technologies for serving the safe water needs of vulnerable populations in developing countries?

2. What are the strengths and weaknesses of currently available water purification and supply technologies?

3. What improvements are needed to make currently available water purification and supply technologies more reliable and cost effective?

4. What additional laboratory or field-based research and development is needed to improve such technologies?

5. What significant innovations in water purification and supply technologies are underway?

In accordance with sections 735(d) and 777(i)(1) of the Tariff Act of 1930, as amended, (“the Act”), on July 2, 2010, the Department of Commerce (“Department”) published the final determination of sales at less than fair value (“LTFV”) in the antidumping investigation of certain woven electric blankets (“woven electric blankets”) from the People's Republic of China (“PRC”). See Certain Woven Electric Blankets From the People's Republic of China: Final Determination of Sales at Less Than Fair Value, 75 FR 38459 (July 2, 2010) (“Final Determination”).

On July 6, 2010, Jarden Consumer Solutions (“Petitioner”) filed a timely allegation that the Department made various ministerial errors in the Final Determination and requested, pursuant to 19 CFR 351.224, that the Department correct the alleged ministerial errors in the calculation of the margins for respondent, Hung Kuo Electronics (Shenzhen) Company Limited (“Hung Kuo”). No other parties in this proceeding submitted comments on the Department's final margin calculations or replies to Petitioner's submission.

A ministerial error is defined as an error “in addition, subtraction, or other arithmetic function, clerical error resulting from inaccurate copying, duplication, or the like, and any other type of unintentional error which the Department considers ministerial.” See section 735(e) of the Act; see also 19 CFR 351.224(f).

After analyzing Petitioner's comments, we have determined, in accordance with section 735(e) of the Act and 19 CFR 351.224(e), that we made certain inadvertent ministerial errors in our calculations for the final determination with respect to Hung Kuo. For a detailed discussion of these ministerial errors, as well as the Department's analysis of these errors, see Memorandum to Abdelali Elouaradia, Director, AD/CVD Operations, Office 4, through Howard Smith, Program Manager, AD/CVD Operations, Office 4, concerning, “Antidumping Duty Investigation of Certain Woven Electric Blankets from the People's Republic of China: Analysis of Ministerial Error Allegations,” dated July 28, 2010.

Additionally, in the Final Determination, we determined that Ningbo V.K. Industry & Trading Co., Ltd., and Ningbo Jifa Electrical Appliances Co., Ltd./Ningbo Jinchun Electric Appliances Co., Ltd. had demonstrated their eligibility to receive a separate rate. See Final Determination, 75 FR 38459-38461. In the Final Determination, we assigned Ningbo V.K. Industry & Trading Co., Ltd., and Ningbo Jifa Electrical Appliances Co., Ltd./Ningbo Jinchun Electric Appliances Co., Ltd. the dumping rate calculated for Hung Kuo. For this amended final determination, we have assigned these companies Hung Kuo's recalculated dumping rate.

We have made no changes to the margin selected for the PRC-wide entity.

Therefore, in accordance with section 735(e) of the Act, we are amending the final determination of sales at LTFV in the antidumping duty investigation of woven electric blankets from the PRC. After correcting these ministerial errors, the revised final weighted-average dumping margins are as follows:

We determine that the following weighted-average dumping margins exist for the period October 1, 2008, through March 31, 2009:

In accordance with section 735(c)(1)(B) of the Act, the Department will instruct CBP to continue to suspend liquidation of all entries of woven electric blankets from the PRC, as described in the “Scope of Investigation” section, entered, or withdrawn from warehouse, for consumption on or after, February 3, 2010, the date of publication of the Preliminary Determination in the Federal Register. See Certain Woven Electric Blankets From the People's Republic of China: Preliminary Determination of Sales at Less Than Fair Value and Postponement of Final Determination, 75 FR 5567 (February 3, 2010) (“Preliminary Determination”). The Department will instruct CBP to require a cash deposit or the posting of a bond equal to the weighted-average dumping margin amount by which the normal value exceeds U.S. price, as follows: (1) The rate for the exporter/producer combinations listed in the chart above will be the rate the Department has determined in this final determination; (2) for all PRC exporters of subject merchandise which have not received their own rate, the cash-deposit rate will be the PRC-wide entity rate; and (3) for all non-PRC exporters of subject merchandise which have not received their own rate, the cash-deposit rate will be the rate applicable to the PRC exporter/producer combination that supplied that non-PRC exporter. These suspension-of-liquidation instructions will remain in effect until further notice.

This determination is issued and published in accordance with sections 735(d) and 777(i)(1) of the Act, and 19 CFR 351.224(e).

Section 117 of the Marine Mammal Protection Act (MMPA) (16 U.S.C. 1361 et seq.) requires NMFS and the U.S. Fish and Wildlife Service (FWS) to prepare stock assessments for each stock of marine mammals occurring in waters under the jurisdiction of the United States. These reports must contain information regarding the distribution and abundance of the stock, population growth rates and trends, estimates of annual human-caused mortality and serious injury from all sources, descriptions of the fisheries with which the stock interacts, and the status of the stock. Initial reports were completed in 1995.

The MMPA requires NMFS and FWS to review the SARs at least annually for strategic stocks and stocks for which significant new information is available, and at least once every 3 years for non-strategic stocks. NMFS and the FWS are required to revise a SAR if the status of the stock has changed or can be more accurately determined. NMFS, in conjunction with the Alaska, Atlantic, and Pacific Scientific Review Groups (SRGs), reviewed the status of marine mammal stocks as required and revised reports in the Alaska, Atlantic, and Pacific regions to incorporate new information. NMFS solicits public comments on the draft 2010 SARs.

In the Alaska region, SARs for 23 stocks (14 strategic and 9 non-strategic) were updated; 13 SARs were not updated. Most revisions included updates of abundance and/or mortality estimates. None of the updates resulted in change of status of a stock. Estimates of mortality and serious injury incidental to observed Federally-managed fisheries remain based on information obtained during the period, 2002-2006. Preliminary results from 2007 and 2008 are discussed in the section related to fishery mortality; however, these preliminary estimates have not yet been fully reviewed and are not combined with the previous estimates to obtain a new 5-year average.

After receiving increasing reports of sightings of narwhal in waters under U.S. jurisdiction, a new SAR for narwhal has been added in the Alaska region. Narwhals observed in Alaskan waters likely belong to populations outside U.S. waters, and the stock of origin is unknown. Therefore, the SAR is for an unidentified stock of narwhal.

As recommended by the Alaska SRG, the draft 2010 SAR for Cook Inlet beluga whales alters the way that abundance and the minimum estimate of abundance (Nmin) are reported. The abundance reported in the 2010 draft SAR is the mean of estimates from 2007 (375), 2008 (375), and 2009 (321) and is 375. Nmin, which is a function of the abundance estimate and the coefficient of variation (CV) of that estimate, is 326. Nmin is used within the SAR only for calculating PBR, which remains undetermined for this stock.

A new abundance estimate for the 2006/2007 survey is reported in the eastern North Pacific gray whale SAR. After realizing that early estimates of abundance of this stock were calculated from models using different parameters, NMFS scientists re-analyzed the entire history of abundance estimates for this stock using consistent methods (Laake et al. 2009). Punt and Wade (2009) used the new abundance estimates to evaluate the status and trend of the stock. These new analyses are included in the SAR and reaffirm that the stock remains within its Optimum Sustainable Population limits.

NMFS scientists also considered guidance included in Taylor et al. (2003) to evaluate the potential to adjust recovery factors for stocks of endangered marine mammals in Alaska. This evaluation noted that for the central North Pacific (CNP) stock of humpback whales, Nmin exceeded 5,000 and the trend was increasing. For endangered stocks with such abundance and trend that have a CV of 0.5 or less, Taylor et al. (2003) suggest a recovery factor of 0.5; however, the CV reported in the CNP humpback whale SAR (0.3) is an assumed value. Accordingly, the recovery factor was increased from 0.1 to 0.3, which is the value recommended for those cases when CV of the abundance estimate is larger than 0.5. As has been reported in previous CNP humpback SARs, the PBR is reported for the entire stock as well as for feeding aggregations in AK, two of which retain 0.1 as the recovery factor in the PBR calculation.

The draft 2010 SARs for 17 Atlantic Stocks were updated (9 strategic and 8 non-strategic) and 4 Gulf of Mexico stocks (2 strategic and 2 non-strategic). The updates included revised abundance and/or mortality estimates for these stocks, and one update resulted in a modified status of a stock (long-fined pilot whale).

In a SAR prepared in 2008 seven stocks of Atlantic coastal bottlenose dolphins were grouped into a single report. For the draft 2010 SARs, each stock of coastal bottlenose dolphins is presented in a separate report. Stock structure was revised due to additional information into five stocks of coastal bottlenose dolphins in the Atlantic Ocean: Northern Migratory stock, Southern Migratory stock, South Carolina/Georgia Coastal stock, Northern Florida Coastal stock, and Central Florida Coastal stock. All of these stocks are strategic due to their origins of the previously identified, depleted coastal migratory stock.

Three stocks of coastal bottlenose dolphins had been included in a single SAR for Northern Gulf of Mexico Coastal stocks in 2007-2009. These stocks are each described in a separate report in 2010, and are identified as the Gulf of Mexico Eastern Coastal stock, Gulf of Mexico Northern Coastal stock, and Gulf of Mexico Western Coastal stock. From 2007-2009, each of these stocks was considered a strategic stock because the abundance estimate was outdated, PBR was undetermined, and human-caused mortality was occurring. Aerial surveys conducted in 2007 provided abundance estimates for the Eastern and Northern Coastal stocks, which in turn led to the status becoming non-strategic. The Western Coastal stock was not surveyed in 2007. PBR remains undetermined, and status remains strategic.

Among the Gulf of Mexico, Bay, Sound, and Estuary stocks of bottlenose dolphins, two previously separated stocks were combined into a single stock (Sarasota Bay/Little Sarasota Bay). Accordingly, this SAR describes the status of 32, rather than 33, stocks of bottlenose dolphins. The abundance estimate of one of these stocks (Barataria Bay) became outdated, and that stock's PBR was changed to undetermined.

Analysis of the geographical separation in summer of long and short-finned pilot whale stocks in the Atlantic has been completed, and preliminary abundance estimates for the two stocks are included in the revised pilot whale reports. Similar analyses have not been completed for mortality and serious injury estimates; therefore, each of these SARs reports the combined mortality and serious injury estimate. The short-finned pilot whale stock remains non-strategic, but the status of the long-finned pilot whale stock is now considered strategic.

A new SAR is included for a Puerto Rico and Virgin Islands stock of sperm whales in the Caribbean Sea. The abundance estimate for the Western North Atlantic stock of harbor seals became outdated in 2010, and PBR for the stock was changed to undetermined. The harbor seal stock remains non-strategic.

In the Pacific region, SARs were revised for 51 stocks, and 12 SARs were added for a total of 63 draft 2010 SARs, including 12 “strategic” stocks, 48 “non-strategic” stocks, and three stocks of unknown status. The remaining 12 Pacific region stocks were not revised. General updates are as follows. Abundance estimates were updated for 41 stocks, and these updates did not change the status of most stocks. The new abundance for short-finned pilot whales increased the PBR so that the status of this stock was changed from strategic to non-strategic. Information updates for longline fisheries in the Pacific Islands region are also included in a fishery description appendix. Where available, information on subspecies designations has been included in these reports to reflect local taxonomic and conservation issues (Perrin et al. 2009).

The former Hawaii stock of spinner dolphin was renamed as the Hawaii pelagic stock, and five new near-shore stocks of spinner dolphins were identified in the Hawaiian Exclusive Economic Zone (EEZ). These new spinner dolphin stocks are the Hawaii (Island) stock, Oahu, Four Islands (Maui, Molokai, Lanai, and Kahoolawe) stock, Niihau stock, Kure-Midway stock, and the Pearl and Hermes stock.

The SAR for the Hawaii stock of bottlenose dolphin was renamed the Hawaii pelagic stock, and four new near-shore stocks were identified. The new bottlenose dolphin stocks are the Kauai-Niihau stock, Oahu stock, Four Islands stock, and the Hawaii (Island) stock.

Three new reports are added for dolphin stocks incidentally taken in longline fisheries or identified during nearshore surveys around American Samoa. American Samoa stocks are added for spinner dolphins, false killer whales, and rough-tooth dolphins. Estimates of mortality and serious injury are provided for false killer whales and rough-toothed dolphins, but there are no abundance estimates for the new American Samoa stocks. Accordingly, the status of each of the three new American Samoa stocks is unknown.

There is a substantial revision of the SAR for the Pacific Islands Stock Complex of false killer whales. Key revisions include stock identity and range, a newly recognized fishery, proration of incidental mortality and serious injury among stocks and fisheries, and abundance estimates for animals south of the U.S. EEZ around Hawaii. Revisions related to stock identity and geographic range include evidence that there is overlap in the ranges of the HI insular and pelagic stocks, both of which are exposed to commercial fishing operations of the Hawaii-based longline fisheries. The identity of the pelagic stock was revised to clarify that the stock occupies international waters as well as the U.S. EEZ around Hawaii; however, the geographic limits of the stock's range are unknown. The SAR also describes a new commercial fishery, the HI shortline fishery, for which there are anecdotal reports of interactions with false killer whales. Mortality and serious injury of false killer whales incidental to longline fishing are allocated among false killer whale stocks and fisheries by a statistical algorithm, as recommended by the Pacific SRG. The revised SAR also includes an abundance estimate (and PBR) calculated from a 2005 survey south of the HI EEZ, including international waters and the U.S. EEZ surrounding Johnston Atoll.

On September 4, 2008, the Department published in the Federal Register an antidumping duty order on OTR tires from the PRC.2 As part of the Order, Shandong Jinyu received the amended separate-rate respondent rate of 12.91 percent.3 On September 14, 2009, Mai Shandong filed a submission requesting that the Department conduct a changed circumstances review of the Order to confirm that it is the successor-in-interest to Shandong Jinyu.4 As part of its September 14, 2009, submission, Mai Shandong requested that the Department conduct an expedited review.

In response to the request, the Department initiated a changed circumstances review of Mai Shandong on November 10, 2009.5 However, the Department found conclusive evidence lacking and, therefore, determined an expedited preliminary result was not appropriate.6 Subsequent to initiation, the Department issued, and Mai Shandong responded to, an original and several supplemental questionnaires requesting additional information.

On June 8, 2010, the Department published preliminary results of the changed circumstances review, finding Mai Shandong not to be the successor-in-interest to Shandong Jinyu, and invited interested parties to comment.7 We received no comments or requests for a hearing from interested parties.

The products covered by the order are new pneumatic tires designed for off-the-road and off-highway use, subject to exceptions identified below. Certain OTR tires are generally designed, manufactured and offered for sale for use on off-road or off-highway surfaces, including but not limited to, agricultural fields, forests, construction sites, factory and warehouse interiors, airport tarmacs, ports and harbors, mines, quarries, gravel yards, and steel mills. The vehicles and equipment for which certain OTR tires are designed for use include, but are not limited to: (1) Agricultural and forestry vehicles and equipment, including agricultural tractors,8 combine harvesters,9 agricultural high clearance sprayers,10 industrial tractors,11 log-skidders,12 agricultural implements, highway-towed implements, agricultural logging, and agricultural, industrial, skid-steers/mini-loaders; 13 (2) construction vehicles and equipment, including earthmover articulated dump products, rigid frame haul trucks,14 front end loaders,15 dozers,16 lift trucks, straddle carriers,17 graders,18 mobile cranes,19 compactors; and (3) industrial vehicles and equipment, including smooth floor, industrial, mining, counterbalanced lift trucks, industrial and mining vehicles other than smooth floor, skid-steers/mini-loaders, and smooth floor off-the-road counterbalanced lift trucks.20 The foregoing list of vehicles and equipment generally have in common that they are used for hauling, towing, lifting, and/or loading a wide variety of equipment and materials in agricultural, construction and industrial settings. Such vehicles and equipment, and the descriptions contained in the footnotes are illustrative of the types of vehicles and equipment that use certain OTR tires, but are not necessarily all-inclusive. While the physical characteristics of certain OTR tires will vary depending on the specific applications and conditions for which the tires are designed (e.g., tread pattern and depth), all of the tires within the scope have in common that they are designed for off-road and off-highway use. Except as discussed below, OTR tires included in the scope of the order range in size (rim diameter) generally but not exclusively from 8 inches to 54 inches. The tires may be either tube-type 21 or tubeless, radial or non-radial, and intended for sale either to original equipment manufacturers or the replacement market. The subject merchandise is currently classifiable under Harmonized Tariff Schedule of the United States (“HTSUS”) subheadings: 4011.20.10.25, 4011.20.10.35, 4011.20.50.30, 4011.20.50.50, 4011.61.00.00, 4011.62.00.00, 4011.63.00.00, 4011.69.00.00, 4011.92.00.00, 4011.93.40.00, 4011.93.80.00, 4011.94.40.00, and 4011.94.80.00. While HTSUS subheadings are provided for convenience and customs purposes, our written description of the scope is dispositive.

Specifically excluded from the scope are new pneumatic tires designed, manufactured and offered for sale primarily for on-highway or on-road use, including passenger cars, race cars, station wagons, sport utility vehicles, minivans, mobile homes, motorcycles, bicycles, on-road or on-highway trailers, light trucks, and trucks and buses. Such tires generally have in common that the symbol “DOT” must appear on the sidewall, certifying that the tire conforms to applicable motor vehicle safety standards. Such excluded tires may also have the following designations that are used by the Tire and Rim Association:

• P—Identifies a tire intended primarily for service on passenger cars;

• LT—Identifies a tire intended primarily for service on light trucks; and,

• ST—Identifies a special tire for trailers in highway service.

• TR—Identifies a tire for service on trucks, buses, and other vehicles with rims having specified rim diameter of nominal plus 0.156” or plus 0.250”;

• MH—Identifies tires for Mobile Homes;

• HC—Identifies a heavy duty tire designated for use on “HC” 15” tapered rims used on trucks, buses, and other vehicles. This suffix is intended to differentiate among tires for light trucks, and other vehicles or other services, which use a similar designation.

• Example: 8R17.5 LT, 8R17.5 HC

• LT—Identifies light truck tires for service on trucks, buses, trailers, and multipurpose passenger vehicles used in nominal highway service; and

• MC—Identifies tires and rims for motorcycles.

The following types of tires are also excluded from the scope: Pneumatic tires that are not new, including recycled or retreaded tires and used tires; non-pneumatic tires, including solid rubber tires; tires of a kind designed for use on aircraft, all-terrain vehicles, and vehicles for turf, lawn and garden, golf and trailer applications. Also excluded from the scope are radial and bias tires of a kind designed for use in mining and construction vehicles and equipment that have a rim diameter equal to or exceeding 39 inches. Such tires may be distinguished from other tires of similar size by the number of plies that the construction and mining tires contain (minimum of 16) and the weight of such tires (minimum 1500 pounds).

In the Preliminary Results, the Department found that Mai International's acquisition of approximately 90 percent equity in Shandong Jinyu's OTR tires business resulted in a joint venture that is majority owned and operated by a new, foreign entity, with a new corporate structure, changed management, and significantly altered sales and marketing operations.22 As a result, the Department preliminarily determined that Mai Shandong is a new entity that operates in a significantly different manner from Shandong Jinyu. The Department did not receive any comments on the preliminary results of this review. For the same reasons stated in the preliminary results, the Department continues to find that Mai Shandong is not the successor-in-interest to Shandong Jinyu for the purposes of the antidumping duty proceeding.23 Accordingly, Mai Shandong remains subject to the PRC-wide entity rate.

The Department will instruct U.S. Customs and Border Protection that the determination from this changed circumstances review will apply to all shipments of the subject merchandise produced and exported by Mai Shandong entered, or withdrawn from warehouse, for consumption on or after the date of publication of the final results of this changed circumstances review. This cash deposit rate shall remain in effect until publication of the final results of the next administrative review in which Mai Shandong participates.

This notice also serves as a final reminder to parties subject to administrative protective orders (“APOs”) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.306. 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 sanctionable violation.

This notice is published in accordance with sections 751(b)(1) and 777(i) of the Tariff Act of 1930, as amended, and 19 CFR 351.216.

On September 1, 2009, the Department of Commerce (“the Department”) published a notice of opportunity to request an administrative review of the antidumping duty order on new pneumatic off-the-road tires (“OTR tires”) from the People's Republic of China (“PRC”) for the period of review (“POR”) February 20, 2008, through August 31, 2009. See Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation: Opportunity to Request Administrative Review, 74 FR 45179 (September 1, 2009). On September 29, 2009, Qingdao Free Trade Zone Full World International Trading Co., Ltd. (“Full-World”), exporter of OTR tires, requested that the Department conduct an administrative review of its exports to the United States during the POR. The Department received timely requests for review for fourteen additional exporters: Aeolus Tyre Co., Ltd. (“Aeolus”); Guizhou Tire I&E Corporation, Guizhou Tyre Co., Ltd., and Guizhou Advanced Rubber Co., Ltd. (collectively “GTC”); Hanghzou Zhongce Rubber Co., Ltd.; Hebei Starbright Tire Co., Ltd. (“Starbright”); Innova Rubber Co., Ltd. (“Innova”); Jiangsu Feichi Co., Ltd. (“Feichi”); KS Holding Limited and KS Resources Limited (collectively “KS Ltd.”); Laizhou Xiongying Rubber Industry Co., Ltd.; Qingdao Taifa Group Co., Ltd.; Shangdong Huitong Tyre Co., Ltd. (“Huitong”); Triangle Tyre Co., Ltd. (“Triangle”); Tianjin Wanda Tyre Group (“Wanda”); Tianjin United Tire &Rubber International Co., Ltd. (“TUTRIC”); and Weihai Zhongwei Rubber Co., Ltd. The Department then published in the Federal Register the initiation notice for the antidumping duty administrative review of OTR tires from the PRC for the 2008 -2009 POR. See Initiation of Antidumping and Countervailing Duty Administrative Reviews, Request for Revocation in Part, 74 FR 54956 (October 26, 2009).

Pursuant to 19 CFR 351.213(d)(1), the Secretary will rescind an administrative review, in whole or in part, if the party that requested the review withdraws the request within 90 days of the date of publication of the notice of initiation of the requested review. The Secretary may also extend this time limit if the Secretary decides that it is reasonable to do so. On May 21, 2010, the Department rescinded the administrative reviews of OTR tires with respect to GTC's, TUTRIC's, Feichi's, Huitong's, Aeolus', Triangle's, Wanda's, and Innova's exports. See New Pneumatic Off-the-Road Tires From the People's Republic of China: Notice of Partial Rescission of Antidumping Duty Administrative Review, 75 FR 28567 (May 21, 2010). On May 26, 2010, Full-World withdrew its request for an administrative review of its exports. In spite of the fact that Full-World missed the 90-day deadline, we are extending the time limit and accepting the request because the Department has not invested significant resources into the analysis of Full-World's responses. In fact, Full-World had not submitted any questionnaire responses prior to its request to rescind the review with respect to its exports. Because no additional party requested a review of Full-World's exports, the Department hereby rescinds the administrative review of OTR tires with respect to this entity in accordance with 19 CFR 351.213(d)(1). This administrative review will continue with respect to Starbright, Hanghzou Zhongce Rubber Co., Ltd., KS Ltd., Laizhou Xiongying Rubber Industry Co., Ltd., Qingdao Taifa Group Co., Ltd. and Weihai Zhongwei Rubber Co., Ltd.

The Department will instruct U.S. Customs and Border Protection (“CBP”) to assess antidumping duties on all appropriate entries. For Full-World, which had previously established eligibility for a separate rate, 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)(2). The Department intends to issue appropriate assessment instructions directly to CBP 15 days after publication of this notice.

This notice serves as a final reminder to importers of their responsibility under section 351.402(f) of the Department's regulations 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 is issued and published in accordance with section 777(i) of the Tariff Act of 1930, as amended, and 19 CFR 351.213(d)(4).

This action is directed to the public in general. This action may, however, be of interest to persons who are or may be required to conduct testing of chemical substances under the Federal Food, Drug, and Cosmetic Act (FFDCA), FIFRA, and the Food Quality Protection Act of 1996 (FQPA). Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the DFO listed under FOR FURTHER INFORMATION CONTACT.

When submitting comments, remember to:

1. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number).

2. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

3. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

4. Describe any assumptions and provide any technical information and/or data that you used.

5. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

6. Provide specific examples to illustrate your concerns and suggest alternatives.

7. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

8. Make sure to submit your comments by the comment period deadline identified.

The FIFRA SAP serves as the primary scientific peer review mechanism of EPA's Office of Chemical Safety and Pollution Prevention (OCSPP) and is structured to provide scientific advice, information and recommendations to the EPA Administrator on pesticides and pesticide-related issues as to the impact of regulatory actions on health and the environment. The FIFRA SAP is a Federal advisory committee, established in 1975 under FIFRA, that operates in accordance with requirements of the Federal Advisory Committee Act (FACA). In accordance with the statute, the FIFRA SAP is composed of a permanent panel consisting of seven members who are appointed by the EPA Administrator from nominees provided by the National Institutes of Health (NIH) and the National Science Foundation (NSF). FIFRA, as amended by FQPA, established a Science Review Board consisting of at least 60 scientists who are available to the SAP on an ad hoc basis to assist in reviews conducted by the FIFRA SAP. As a peer review mechanism, the FIFRA SAP provides comments, evaluations and recommendations to improve the effectiveness and quality of analyses made by Agency scientists. Members of the FIFRA SAP are scientists who have sufficient professional qualifications, including training and experience, to provide expert advice and recommendation to the Agency. The statute further stipulates that the Agency publish the name, address and professional affiliation in the Federal Register.

The Agency, at this time, anticipates selecting two new members to serve on the panel as a result of membership terms that will expire this year. The Agency requested nominations of experts to be selected from the field of environmental risk assessment with experience and expertise in all phases of the risk assessment process including: Planning, scoping, and problem formulation, analysis, and interpretation and risk characterization (including the interpretation and communication of uncertainty). Nominees should be well published and current in their field of expertise.

A Charter for the FIFRA Scientific Advisory Panel dated October 24, 2008, was issued in accordance with the requirements of the Federal Advisory Committee Act, Public Law 92-463, 86 Stat. 770 (5 U.S.C. App. I).

Members are scientists who have sufficient professional qualifications, including training and experience, to be capable of providing expert comments as to the impact of pesticides on health and the environment. No persons shall be ineligible to serve on the Panel by reason of their membership on any other advisory committee to a Federal department or agency or their employment by a Federal department or agency (except EPA). The Administrator appoints individuals to serve on the Panel for staggered terms of 4 years. Panel members are subject to the provisions of 40 CFR part 3, subpart F, Standards of Conduct for Special Government Employees, which include rules regarding conflicts of interest. Each nominee selected by the Administrator, before being formally appointed, is required to submit a confidential statement of employment and financial interests, which shall fully disclose, among other financial interests, the nominee's sources of research support, if any.

In accordance with section 25(d)(1) of FIFRA, the Administrator shall require all nominees to the Panel to furnish information concerning their professional qualifications, educational background, employment history, and scientific publications.

With respect to the requirements of section 25(d) of FIFRA that the Administrator promulgate regulations regarding conflicts of interest, the Charter provides that EPA's existing regulations applicable to Special Government Employees, which include advisory committee members, will apply to the members of the Scientific Advisory Panel. These regulations appear in 40 CFR part 3, subpart F. In addition, the Charter provides for open meetings with opportunities for public participation.

In accordance with the provisions of section 25(d) of FIFRA, EPA, on March 11, 2010, requested that the National Institutes of Health (NIH) and the National Science Foundation (NSF) nominate scientists to fill vacancies occurring on the Panel. The Agency requested nominations of experts in the field of environmental risk assessment with experience and expertise in all phases of the risk assessment process. NIH and NSF responded by letter, providing the Agency with a total of 16 nominees. Eight of the 16 nominees are interested and available to actively participate in SAP meetings (see Unit IV. Nominees). The following eight nominees are not available:

1. Elizabeth Kelly, Ph.D., Los Alamos National Laboratory, Los Alamos, NM.

2. Riana Maier, Ph.D., Department of Soil, Water and Environmental Science, University of Arizona, Tucson, AZ.

3. Ronald Melnick, Ph.D., National Institute of Environmental Health Sciences, National Institutes of Health, Research Triangle Park, NC.

4. Eva Oberdorster, Ph.D., Department of Biological Sciences, Southern Methodist University, Dallas, TX.

5. Walter Piegorsch, Ph.D., Department of Mathematics, University of Arizona, Tucson, AZ.

6. Jim Riviere, Ph.D., Department of Population Health and Pathobiology, North Carolina State University, Raleigh, NC.

7. Theodore Slotkin, Ph.D., Department of Pharmacology and Cancer Biology, Duke University, Durham, NC.

8. Nigel Walker, Ph.D., National Institute of Environmental Health Sciences, National Institutes of Health, Research Triangle Park, NC.

The following are the names, addresses, professional affiliations, and selected biographical data of nominees being considered for membership on the FIFRA Scientific Advisory Panel. The Agency anticipates selecting two of the nominees to fill vacancies occurring this year.

1. Lawrence Barnthouse, Ph.D., President and Principle Scientist, LWB Environmental Services, Inc., Hamilton, OH.

i. Expertise. Population biology, ecological risk assessment.

ii. Education. B.A. in Biology, Kenyon College; Ph.D., in Biology with area of specialty of population biology, University of Chicago.

iii. Professional experience. Dr. Barnthouse is President and Principal Scientist of LWB Environmental Services, Inc. He has more than 30 years of experience in research and assessment projects involving impacts of energy technologies in freshwater, estuarine, and marine environments. Prior to founding LWB Environmental Services in 1998, he spent 19 years as a staff scientist at the U.S. Department of Energy's (DOE) Oak Ridge National Laboratory (ORNL). At ORNL, he led or participated in dozens of environmental research and assessment projects involving development of new methods for predicting and measuring the environmental risks of energy technologies. In 1981, he became co-principal investigator on EPA’s first research project on ecological risk assessment. Since that time, he has been active in the development and application of ecological risk assessment methods for EPA, other federal agencies, state agencies, and private industry. He has chaired workshops on ecological risk assessment for the National Academy of Sciences and the Society of Environmental Toxicology and Chemistry, and served on the peer review panels for the Framework for Ecological Risk Assessment and the Guidelines for Ecological Risk Assessment. He continues to support the development of improved methods for ecological risk assessment as the Hazard/Risk Assessment Editor of Environmental Toxicology and Chemistry and Associate Editor of Integrated Environmental Assessment and Management.

2. Deborah Cory-Slechta, Ph.D., Professor, Environmental Medicine and Pediatrics, University of Rochester Medical School, Rochester, NY.

i. Expertise. Neurotoxicology.

ii. Education. B.S. in Psychology and M.A. in Experimental Psychology, Western Michigan University; Ph.D. in Experimental Psychology, University of Minnesota.

iii. Professional experience. Dr. Cory-Slechta became a faculty member at the University of Rochester Medical School (URMC) in 1982. She became Chair of its Department of Environmental Medicine and Director of the NIEHS Environmental Health Sciences Center in 1998, and served as Dean for Research from 2000-2002. She then became Director of the Environmental and Occupational Health Sciences Institute (EOHSI) and Chair of the Department of Environmental and Community Medicine at the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School from 2003-2007, before returning to URMC as Professor in Environmental Medicine and Pediatrics. Dr. Cory-Slechta has served on national review and advisory panels of the National Institutes of Health, the National Institute of Environmental Health Sciences, the Food and Drug Administration, the National Center for Toxicological Research, the Environmental Protection Agency, the National Academy of Sciences, the Institute of Medicine, and the Agency for Toxic Substances and Disease Registry, Centers for Disease Control (CDC). She currently serves on the Science Advisory Board of EPA and on the Advisory Committee for Childhood Lead Poisoning Prevention of the CDC. In addition, Dr. Cory-Slechta has served on the editorial boards of the journals Neurotoxicology, Toxicology, Toxicological Sciences, Fundamental and Applied Toxicology, Neurotoxicology and Teratology, and American Journal of Mental Retardation. She has held the elected positions of President of the Neurotoxicology Specialty Section of the Society of Toxicology, President of the Behavioral Toxicology Society, and been named a Fellow of the American Psychological Association. Her research has focused largely on the relationships between brain neurotransmitter systems and behavior, and how such relationships are altered by exposures to environmental toxicants, particularly the role played by environmental neurotoxicant exposures in developmental disabilities and neurodegenerative diseases. These research efforts have resulted in over 120 papers and book chapters to date.

3. Timothy Gross, Ph.D., Consultant, Environmental Resource Consultants, Gainsville, FL.

i. Expertise. Environmental resource management, wildlife biology, ecotoxicology.

ii. Education. B.S. and M.S. in Biology, Indiana University of Pennsylvania; M.A. in Historical Preservation, Savannah College of Art and Design; Ph.D. in Toxicology/Animal Sciences, University of Maryland.

iii. Professional experience. Dr. Gross is a private environmental resource consultant with over 20 years of experience and expertise in ecotoxicology. Dr. Gross was previously employed at the University of Florida from 1992 through 2007 and simultaneously with the U.S. Department of Interior (U.S. Geological Survey) from 1997-2006, providing Dr. Gross with a unique background in academia, public service and industry. Dr. Gross’s research expertise has focused on the assessment of biological effects of environmental stressors across many levels of biological organization, from the biochemical and molecular levels to population and community effects. These efforts have examined the potential effects of single chemicals and complex mixtures in wildlife using both laboratory-based and field-based assessments. Efforts have evaluated effects of pesticides, wastewater, pharmaceuticals, pulp-and paper discharge and other assorted man-made and natural environmental stressors. Research projects have considered a wide array of taxonomic impacts, from planktonic and macro-invertebrate populations to fish, birds, amphibians, and reptiles. Dr. Gross’s research has had broad implication and contribution to the research area of “endocrine disruption” Indeed, Dr. Gross’s research efforts on Lake Apopka and similar sites nationally are among the first indicators of endocrine modulating effects of environmental contaminants in wildlife. Dr Gross has mentored many graduate students and post-docs since 1994 and continues to participate in graduate education.

4. Nominee. Mark Harwell, Ph.D., Harwell Gentile and Associates, L.C., Palm Coast, FL.

i. Expertise. Ecological risk assessment and ecosystem management.

ii. Education. B.S. in Biology, Emory University; Ph.D., in Systems Ecology from University of Miami, Institute of Marine Science.

iii. Professional experience. Dr. Harwell is an ecosystems ecologist and is currently a Partner in Harwell Gentile and Associates, L.C, following a 25-year career in academia at Cornell University, the University of Miami Rosenstiel School, and Florida A&M University. Dr. Harwell was a leader in the development of EPA ecological risk assessment framework and has led several large risk assessments, including comparative ecological risk assessments of oil spills in Tampa Bay and the Bay of Fundy; an ecological risk assessment of the effects of climate change and the South Florida ecosystem restoration on the Everglades and Biscayne Bay; an ecotoxicological risk assessment of the Coeur d'Alene River watershed; and an assessment of the current ecological significance of effects from the Exxon Valdez oil spill on Prince William Sound. He led a series of interdisciplinary studies on human interactions with the South Florida environment, including field, mesocosm, and modeling studies in Biscayne Bay and the Florida Keys National Marine Sanctuary. He coordinated interdisciplinary studies in five National Estuarine Research Reserves, developing conceptual models of coupled human environment systems, and contributing to ecological assessments using remote sensing and hyperspectral imagery. Dr. Harwell served for more than a decade as a member of the EPA Science Advisory Board (SAB), including two terms as Chair of the Ecological Processes and Effects Committee. He led the ecological risk component of the EPA Unfinished Business Project, and was a member of the EPA SAB Reducing Risk project. He chaired the U.S. Man and the Biosphere Human-Dominated Systems Directorate, and led its project on ecological sustainability, ecosystem management, and an ecosystem integrity report card framework. He led the Scientific Committee on Problems of the Environment (SCOPE) 5-year international study to assess the global environmental consequences of nuclear war (ENUWAR), with emphasis on ecological responses to climate change. He directed the PAN-EARTH Project, a series of national-level case studies on the ecological and agricultural effects of climate variability on Venezuela, India, Japan, China, and sub-Saharan Africa; he was a member of the U.S. Global Change Research Program's National Assessment working group on coastal resources effects; and he serves as an expert reviewer for the Intergovernmental Panel on Climate Change. He served on the National Academy of Sciences (NAS) panel on ecological risks in the U.S. and Poland, and was a member of the NAS panel on risk communications. Dr. Harwell also served as a member of the NAS Board on Environmental Studies and Toxicology, and was elected a Fellow of the American Association for the Advancement of Science.

5. Stephen J. Klaine, Ph.D., Professor in the Department of Biological Sciences and Director of the Institute of Environmental Toxicology (CU-ENTOX), Clemson University, Pendleton, SC.

i. Education. B.S. in Biology, University of Cincinnati; M.S. and Ph.D. in Environmental Science, Rice University.

ii. Expertise. Toxicity and risk assessment of pesticides and metals

iii. Professional experience. Dr. Klaine has spent over 25 years conducting environmental research and educating graduate students. He has 30 Ph.D. and over 40 MS graduates from his laboratory. He has served on the board of directors of the Society of Environmental Toxicology and Chemistry and has been an associate editor for the journal, Environmental Toxicology and Chemistry for 15 years. He has been on the editorial board of the journal, Nanotoxicology, since 2009. From 1995 to 2000 he was the only U.S. participant on a multi-national International Atomic Energy Agency Cooperative Research Program on Pesticides in Coastal Tropical Ecosystems. In addition to building capacity in tropical countries around the world, this group produced the first book to compile pesticide use and effects information in tropical countries of which Dr. Klaine was co-editor. He has served on several EPA Science Advisory Panels and workshops dealing with pesticide and metal fate, effects, and risk assessment. He has also served on the panel to review the National Nanotechnology Initiative Strategy on Environmental and Human Safety Needs for Nanomaterials. He has served on the National Institute of Environmental Health Sciences (NIEHS) review panel for the Superfund Basic Research Program since 1995 and chaired the panel in 2007 and 2008. He has served on several other proposal review panels for EPA, USDA, and NIEHS. He has been a Sigma Xi National Lecturer, won the Clemson University Sigma Xi researcher of the year in 2007, and won the Clemson University Alumni Award for Outstanding Research in 2009. He has over 110 peer-reviewed publications on research ranging from the bioavailability and toxicity of pesticides and metals to pesticide risk assessment, to the environmental behavior and toxicity of nanomaterials. Current research in his laboratory focuses on characterizing: (1) The bioavailablity of metals and pesticides in aquatic systems; (2) the comparative phytotoxicity of pesticides; (3) the response of aquatic organisms to episodic contaminant exposures; (4) the water quality consequences of land use; (5) the effects of pharmaceuticals on fish behavior; and (6) the bioavailability and toxicity of colloids and nanoparticles in aquatic systems.

6. Charlene McQueen, Ph.D., ATS., W.W. Walker Professor at the Harrison School of Pharmacy, Auburn University, Auburn, AL.

i. Education. M.S. in Pharmacology and Toxicology, University of Arizona; Ph.D. in Human Genetics, University of Michigan.

ii. Expertise. Pharmacology and toxicology.

iii. Professional experience. Prior to moving to Auburn in 2007, Dr. McQueen was a professor in the Department of Pharmacology and Toxicology at the University of Arizona. Her research in the areas of pharmacogenomics, toxicogenomics and chemical carcinogenesis investigates the role of genetic variation in response to chemicals. Dr. McQueen is particularly interested in the genes that code for N-acetyltransferases (NAT1 and NAT2), enzymes involved in the metabolism of aromatic amines and hydrazines. She is using model systems to understand the mechanisms of the adverse effects of such chemicals during development and in adults. Dr. McQueen is an American Association for the Advancement of Science (AAAS) Fellow and a Fellow in the Academy of Toxicological Sciences (ATS). She has been on numerous review panels for the National Institutes of Health (NIH) and served on the Board of Scientific Councillors of the National Toxicology Program. She is currently a member of the NIH Cancer Etiology Study Section.

7. Martha Sandy, Ph.D., Senior Toxicologist/Chief, Cancer Toxicology and Epidemiology Section, California Environmental Protection Agency, Oakland, CA.

i. Expertise. Risk assessment, children's health, carcinogen exposure.

ii. Education. M.P.H. and Ph.D., in Environmental Health Science, University of California; Berkeley School of Public Health.

iii. Professional experience. Dr. Sandy is a Senior Toxicologist and Chief of the Cancer Toxicology and Epidemiology Section within the California Environmental Protection Agency's (Cal/EPA) Office of Environmental Health Hazard Assessment (OEHHA). Dr. Sandy’s section conducts hazard identification, dose-response assessment, and exposure assessment of chemical carcinogens. Children's environmental health, and in particular, cancer risk associated with early life carcinogen exposures, has been a significant focus in recent years. Her group is comprised of individuals with expertise in toxicology, epidemiology, biostatistics and exposure assessment. She conducted research investigating biochemical and molecular mechanisms of toxicity and carcinogenicity, and biochemical and genetic susceptibility factors in Parkinson’s disease before joining OEHHA in 1994. Dr. Sandy currently serves on EPA’s Children’s Health Protection Advisory Committee and has served as an ad hoc member of two EPA Scientific Review panels, as a member of two National Academy committees, as a member of one Report on Carcinogens Expert panel, and as a peer reviewer for the National Research Council.

8. Coby Schal, Ph.D., Blanton J. Whitmire Distinguised Professor of Structural Pest Management, North Carolina State University, Raleigh, NC.

i. Education. B.S. in Biology, State University of New York at Albany; Ph.D. in Entomology, University of Kansas - Lawrence; post-doctoral training in chemical ecology, University of Massachusetts-Amherst.

ii. Expertise. Entomology, pest management.

iii. Professional experience. Dr. Schal is co-founder and member of the Executive Committee of the W. M. Keck Center for Behavioral Biology, on the Executive Committee of the Genetic Pest Management Program, and member of the Agromedicine Institute. Between 1984 and 1993, Dr. Schal was Assistant and Associate Professor and Extension Specialist of Urban Entomology at Rutgers University, New Jersey. He is a leading authority on cockroach and bed bug behavior, chemical ecology, physiology, toxicology, biochemistry and molecular biology. His research has resulted in publications, patents, and tools for pest management. Dr. Schal’s research on chemical ecology has delineated pheromone-mediated communication in cockroaches, oviposition attractants in mosquitoes and the evolution of pheromone communication in moths. His team also characterized the role that juvenile hormone plays in regulating sexual behavior and sexual maturation in insects and studies the function and regulation of cuticular waxes in various insects. Research in urban entomology in the last decade has concentrated on the biology of cockroach-produced allergens and intervention strategies to mitigate their pervasiveness in the indoor environment; profiles and mechanisms of insecticide resistance that form the basis for recommendations to the pest control industry; optimization of bait delivery systems, developing and testing repellents against urban pests, and assessing the impact of these approaches on pest behavior, humans, and the environment; and practical integrated solutions (IPM) to cockroach problems in livestock production facilities that emphasize reduced-risk approaches. Dr. Schal's research has been funded by EPA, NIH, NSF, USDA, private foundations and industry, and he has published over 200 refereed papers. He has served as subject editor of the Journal of Economic Entomology and Pest Management Science, and on the editorial boards of Archives of Insect Biochemistry and Physiology, Journal of Chemical Ecology, Journal of Insect Science, and Psyche. Dr. Schal also served on several EPA panels and as panelist and panel manager for USDA grants panels, and has been an active volunteer with the Entomological Society of America, the Entomological Foundation, and the International Society of Chemical Ecology. He has directed 24 graduate students and 26 post-doctoral researchers, and mentored high school and undergraduate students. Dr. Schal teaches a graduate course in Insect Behavior, graduate seminars in Urban Entomology and Chemical Ecology, and contributes to a team-taught Professional Development course. Recent honors include Lifetime Honorary Membership in the North Carolina Pest Management Association, Distinguished Achievement Award in Urban Entomology from the National Conference on Urban Entomology, Fellow of the Entomological Society of America, Fellow of the American Association for the Advancement of Science, and North Carolina State University’s Research Friend of Extension Award and Alumni Association Outstanding Research Award.

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When submitting comments, remember to:

i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number).

ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

iv. Describe any assumptions and provide any technical information and/or data that you used.

v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

vi. Provide specific examples to illustrate your concerns and suggest alternatives.

vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

viii. Make sure to submit your comments by the comment period deadline identified.

3. Environmental justice. EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of any group, including minority and/or low-income populations, in the development, implementation, and enforcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical or disproportionately high and adverse human health impacts or environmental effects from exposure to the pesticides discussed in this document, compared to the general population.

EPA is announcing its receipt of several pesticide petitions filed under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, proposing the establishment or modification of regulations in 40 CFR part 174 or part 180 for residues of pesticide chemicals in or on various food commodities. EPA has determined that the pesticide petitions described in this notice contain the data or information prescribed in FFDCA section 408(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the pesticide petitions. Additional data may be needed before EPA can make a final determination on these pesticide petitions.

Pursuant to 40 CFR 180.7(f), a summary of each of the petitions that are the subject of this notice, prepared by the petitioner, is included in a docket EPA has created for each rulemaking. The docket for each of the petitions is available on-line at http://www.regulations.gov.

As specified in FFDCA section 408(d)(3), (21 U.S.C. 346a(d)(3)), EPA is publishing notice of the petition so that the public has an opportunity to comment on this request for the establishment or modification of regulations for residues of pesticides in or on food commodities. Further information on the petition may be obtained through the petition summary referenced in this unit.

1. PP 0E7717. (EPA-HQ-OPP-2010-0472). IR-4 Project, Rutgers, The State University of NJ, 500 College Rd. East, Suite 201 W, Princeton, NJ 08540, proposes to establish a tolerance in 40 CFR part 180 for residues of the insecticide zeta-cypermethrin, in or on pistachio at 0.05 parts per million (ppm), artichoke, globe at 0.80 ppm; barley, grain at 1.7 ppm; barley, hay at 5.0 ppm; barley, straw at 19.0 ppm; buckwheat, grain at 1.7 ppm; buckwheat, hay at 5.0 ppm; buckwheat, straw at 19.0 ppm; oat, grain at 1.7 ppm; oat, hay at 5.0 ppm; oat, straw at 19.0 ppm; rye, grain at 1.7 ppm; rye, hay at 5.0 ppm; and rye, straw at 19.0 ppm. There is a practical analytical method for detecting and measuring levels of cypermethrin in or on food with a limit of detection that allows monitoring of food with residues at or above the levels set in these tolerances (Gas Chromatography with Electron Capture Detection) (GC/ECD). Contact: Andrew Ertman, (703) 308-9367, e-mail address: ertman.andrew@epa.gov.

2. PP 0F7719. (EPA-HQ-OPP-2010-0526). Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, NC 27419, proposes to establish a tolerance in 40 CFR part 180 for residues of the plant growth regulator, trinexapac-ethyl: 4-(cyclopropyl-α-hydroxy-methylene)-3,5-dioxo-cyclohexanecarboxylic acid ethyl ester expressed as its primary metabolite CGA-179500: 4-(cyclopropyl-α-hydroxy-methylene)-3,5-dioxo-cyclohexanecarboxylic acid, in or on grass, forage, grown for seed at 1.60 ppm; grass, hay, grown for seed at 3.5 ppm; grass, seed screenings, grown for seed at 45.0 ppm; grass, straw, grown for seed at 12 ppm; cattle, fat at 0.05 ppm; cattle, meat at 0.05 ppm; cattle, meat byproducts at 0.05 ppm; goat, fat at 0.05 ppm; goat, meat at 0.05 ppm; goat, meat byproducts at 0.05 ppm; horse, fat at 0.05 ppm; horse, meat at 0.05 ppm; horse, meat byproducts at 0.05 ppm; sheep, fat at 0.05 ppm; sheep, meat at 0.05 ppm; sheep, meat byproducts at 0.05 ppm. Syngenta Crop Protection is submitting Analytical Method GRM020.01A for the Determination of Residues of Trinexapac-ethyl as CGA-179500 in Crops by liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) for detecting and measuring levels of trinexapac-ethyl expressed as its major metabolite CGA-179500, in or on food with a limit of quantitation (LOQ) that allows monitoring of food with residues at or above the levels set in the proposed tolerances. The LOQ for CGA-179500 is 0.01 ppm for all matrices. Syngenta Crop Protection is also submitting Analytical Method REM 137.14 for the Determination of Residues of Trinexapac Acid (CGA 179500) in Animal Matrices. The LOQ has been set at 0.01 milligrams/kilogram (mg/kg) with final analysis by LC-MS/MS for egg, kidney, liver, muscle and fat. The LOQ has been set at 0.005 mg/kg for LC-MS/MS determination for milk. Contact: Bethany Benbow, (703) 347-8072, e-mail address: benbow.bethany@epa.gov.

3. PP 0F7720. (EPA-HQ-OPP-2010-0524). Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, NC 27419, proposes to establish a tolerance in 40 CFR part 180 for residues of the plant growth regulator, trinexapac-ethyl: 4-(cyclopropyl-α-hydroxy-methylene)-3,5-dioxo-cyclohexanecarboxylic acid ethyl ester expressed as its primary metabolite CGA-179500: 4-(cyclopropyl-α-hydroxy-methylene)-3,5-dioxo-cyclohexanecarboxylic acid, in or on barley, grain at 1.6 ppm; barley, hay at 0.7 ppm; barley, straw at 0.35 ppm; cattle, kidney at 0.05 ppm; hog, kidney at 0.05 ppm; sugarcane, cane at 0.8 ppm; oat, forage at 1.0 ppm; oat, grain at 4.1 ppm; oat, hay at 1.3 ppm; oat, straw at 0.7 ppm; wheat, forage at 1.0 ppm; wheat, grain at 4.1 ppm; wheat, hay at 1.3 ppm; and wheat, straw at 0.7 ppm. Syngenta Crop Protection is submitting Analytical Method GRM020.01A for the Determination of Residues of Trinexapac-ethyl as CGA-179500 in Crops by LC-MS/MS for detecting and measuring levels of trinexapac-ethyl expressed as its major metabolite CGA-179500, in or on food with a LOQ that allows monitoring of food with residues at or above the levels set in the proposed tolerances. Method validation data using this method on various crop commodities is presented in the validation study. The LOQ for CGA-179500 is 0.01 ppm for all matrices. Syngenta Crop Protection is also submitting Analytical Method REM 137.14 for the Determination of Residues of Trinexapac Acid (CGA 179500) in Animal Matrices. The LOQ has been set at 0.01 mg/kg with final analysis by LC-MS/MS for egg, kidney, liver, muscle, and fat. The limit of quantification has been set at 0.005 mg/kg for LC-MS/MS determination for milk. Contact: Bethany Benbow, (703) 347-8072, e-mail address: benbow.bethany@epa.gov.

4. PP 0F7725. (EPA-HQ-OPP-2010-0496). Monsanto Company, 1300 I St., NW., Suite 450 East, Washington DC 20052, proposes to establish tolerances in 40 CFR part 180 for residues of the herbicide dicamba (3,6-dichloro-o-anisic and its metabolites 3,6-dichloro-5-hydroxy-o-anisic acid (5-OH dicamba) and 3,6-dichloro-2-hydroxybenzoic acid (DCSA), in or on soybean, forage at 45 ppm and soybean, hay at 70 ppm. Adequate enforcement methods are available for the analysis of residues of dicamba and its relevant metabolites in or on plant and livestock commodities. Pesticide Analytical Manual (PAM) Vol. II lists appropriate analytical methods based on GC/ECD, that are sufficient to provide for the enforcement of proposed dicamba tolerances in soybean forage and hay. Contact: Michael Walsh, (703) 308-2972, e-mail address: walsh.michael@epa.gov.

5. PP 9F7666. (EPA-HQ-OPP-2010-0494). ISK Biosciences Corporation, 7470 Auburn Rd., Suite A, Concord, OH 44077, proposes to establish tolerances in 40 CFR part 180 for residues of the herbicide flazasulfuron, N-[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]-3-(trifluoromethyl)-2-pyridinesulfonamide, in or on fruit, citrus, group 10 at 0.01 ppm; grapes at 0.01 ppm; and sugarcane at 0.01 ppm. A practical analytical method for flazasulfuron and metabolite 1-(4,6-dimethoxypyridin-2-yl)-1-(3-trifluoromethyl-2-pyridyl)urea (DTPU) using LC-MS/MS is available for enforcement purposes. The limit of detection (LOD) is 0.003 ppm. Contact: Hope Johnson, (703) 305-5410, e-mail address: johnson.hope@epa.gov.

6. PP 9F7676. (EPA-HQ-OPP-2010-0296). Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, NC 27419, proposes to establish tolerances in 40 CFR part 180 for residues of the fungicide difenoconazole, (1-[2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4-triazole), in or on carrot at 0.45 ppm; chickpeas at 0.05 ppm; fruits, stone, group 12 at 2.5 ppm; soybean, seed at 0.2 ppm; soybean, aspirated grain fraction at 95 ppm; strawberry at 2.5 ppm; and turnip, greens at 35 ppm. Syngenta Crop Protection, Inc. has submitted a practical analytical method (AG-575B) for detecting and measuring levels of difenoconazole in or on food with a LOQ that allows monitoring of food residues at or above the levels set in the proposed tolerances. Residues are qualified by LC-MS/MS. Contact: Rose Mary Kearns, (703) 305-5611, e-mail address: kearns.rosemary@epa.gov.

PP 9F7676. (EPA-HQ-OPP-2010-0296). Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, NC 27419, proposes to amend the tolerance in 40 CFR 180.475 for residues of the fungicide difenoconazole, (1-[2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4-triazole) by increasing the existing tolerance in or on milk from 0.01 ppm to 0.08 ppm. Syngenta Crop Protection, Inc. has submitted a practical analytical method (AG-575B) for detecting and measuring levels of difenoconazole in or on food with a LOQ that allows monitoring of food residues at or above the levels set in the proposed tolerances. Residues are qualified by LC-MS/MS. Contact: Rose Mary Kearns, (703) 305-5611, e-mail address: kearns.rosemary@epa.gov.

This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. If you have any questions regarding the information in this notice, consult the person listed under FOR FURTHER INFORMATION CONTACT.

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When submitting comments, remember to:

i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number).

ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

iv. Describe any assumptions and provide any technical information and/or data that you used.

v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

vi. Provide specific examples to illustrate your concerns and suggest alternatives.

vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

viii. Make sure to submit your comments by the comment period deadline identified.

This notice announces receipt by the Agency of requests from registrants to cancel 76 pesticide products registered under FIFRA section 3 or 24(c). These registrations are listed in sequence by registration number (or company number and 24(c) number) in Table 1 of this unit.

Unless the Agency determines that there are substantive comments that warrant further review of the requests or the registrants withdraw their requests, EPA intends to issue an order in the Federal Register canceling all of the affected registrations.

Table 2 of this unit includes the names and addresses of record for all registrants of the products in Table 1 of this unit, in sequence by EPA company number. This number corresponds to the first part of the EPA registration numbers of the products listed in this unit.

Section 6(f)(1) of FIFRA provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be canceled. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any such request in the Federal Register.

Section 6(f)(1)(B) of FIFRA requires that before acting on a request for voluntary cancellation, EPA must provide a 30-day public comment period on the request for voluntary cancellation or use termination. In addition, FIFRA section 6(f)(1)(C) requires that EPA provide a 180-day comment period on a request for voluntary cancellation or termination of any minor agricultural use before granting the request, unless:

1. The registrants request a waiver of the comment period, or

2. The EPA Administrator determines that continued use of the pesticide would pose an unreasonable adverse effect on the environment.

The registrants in Table 2 of Unit II. have requested that EPA waive the 180-day comment period. Accordingly, EPA will provide a 30-day comment period on the proposed requests.

Registrants who choose to withdraw a request for cancellation should submit such withdrawal in writing to the person listed under FOR FURTHER INFORMATION CONTACT. If the products have been subject to a previous cancellation action, the effective date of cancellation and all other provisions of any earlier cancellation action are controlling.

Existing stocks are those stocks of registered pesticide products that are currently in the United States (U.S.) and that were packaged, labeled, and released for shipment prior to the effective date of the cancellation action.

Because the Agency has identified no significant potential risk concerns associated with these pesticide products, upon cancellation of the products identified in Table 1 of Unit II. (except EPA Reg. No. 524-478), EPA anticipates allowing registrants to sell and distribute existing stocks of these products for 1 year after publication of the Cancellation Order in the Federal Register. Thereafter, registrants will be prohibited from selling, formulating or distributing the pesticides identified in Table 1 of Unit II., except for export consistent with FIFRA section 17 or for proper disposal. Persons other than registrants will generally be allowed to sell, distribute, or use existing stocks until such stocks are exhausted, provided that such sale, distribution, or use is consistent with the terms of the previously approved labeling on, or that accompanied, the canceled products.

In accordance with a “phase-out” agreement negotiated with Monsanto Company in conjunction with an amendment request for EPA Reg. No. 524-478, all sale, distribution, and planting of Bollgard® Cotton (EPA Reg. No. 524-478) is prohibited after July 1, 2010. The terms of the negotiated U.S. phase-out strategy include:

1. Production of Bollgard® Cotton (EPA Reg. No. 524-478) by Monsanto Company after September 30, 2009, is prohibited.

2. All sales of Bollgard® Cotton after September 30, 2009, are prohibited.

3. Planting of Bollgard® Cotton seed after midnight of July 1, 2010, is prohibited.

4. All Bollgard® Cotton seed not planted on or before July 1, 2010, must be returned either to the retailer or to Monsanto Company. As a consequence of the U.S. phase-out strategy for Bollgard® Cotton, sale, distribution, and/or planting of Bollgard® Cotton is prohibited. All existing stocks must be returned to Monsanto Company or to an authorized retailer. These prohibitions will be reflected in the pending final order cancelling the registration for Bollgard® Cotton.

This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. If you have any questions regarding the information in this notice, consult the person listed under FOR FURTHER INFORMATION CONTACT.

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When submitting comments, remember to:

i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number).

ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

iv. Describe any assumptions and provide any technical information and/or data that you used.

v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

vi. Provide specific examples to illustrate your concerns and suggest alternatives.

vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

viii. Make sure to submit your comments by the comment period deadline identified.

This notice announces receipt by the Agency of requests from registrants to cancel 33 pesticide products registered under FIFRA section 3 or 24(c). These registrations are listed in sequence by registration number (or company number and 24(c) number) in Table 1 of this unit.

Unless the Agency determines that there are substantive comments that warrant further review of the requests or the registrants withdraw their requests, EPA intends to issue an order in the Federal Register canceling all of the affected registrations.

Table 2 of this unit includes the names and addresses of record for all registrants of the products in Table 1 of this unit, in sequence by EPA company number. This number corresponds to the first part of the EPA registration numbers of the products listed in this unit.

Section 6(f)(1) of FIFRA provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be canceled. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any such request in the Federal Register.

Section 6(f)(1)(B) of FIFRA requires that before acting on a request for voluntary cancellation, EPA must provide a 30-day public comment period on the request for voluntary cancellation or use termination. In addition, FIFRA section 6(f)(1)(C) requires that EPA provide a 180-day comment period on a request for voluntary cancellation or termination of any minor agricultural use before granting the request, unless:

1. The registrants request a waiver of the comment period, or

2. The EPA Administrator determines that continued use of the pesticide would pose an unreasonable adverse effect on the environment.

The registrants in Table 2 of Unit II. have not requested that EPA waive the 180-day comment period. Accordingly, EPA will provide a 180-day comment period on the proposed requests.

Registrants who choose to withdraw a request for cancellation should submit such withdrawal in writing to the person listed under FOR FURTHER INFORMATION CONTACT. If the products have been subject to a previous cancellation action, the effective date of cancellation and all other provisions of any earlier cancellation action are controlling.

Existing stocks are those stocks of registered pesticide products that are currently in the United States and that were packaged, labeled, and released for shipment prior to the effective date of the cancellation action. Because the Agency has identified no significant potential risk concerns associated with these pesticide products, upon cancellation of the products identified in Table 1 of Unit II., EPA anticipates allowing registrants to sell and distribute existing stocks of these products for 1 year after publication of the Cancellation Order in the Federal Register. Thereafter, registrants will be prohibited from selling or distributing the pesticides identified in Table 1 of Unit II., except for export consistent with FIFRA section 17 or for proper disposal. Persons other than registrants will generally be allowed to sell, distribute, or use existing stocks until such stocks are exhausted, provided that such sale, distribution, or use is consistent with the terms of the previously approved labeling on, or that accompanied, the canceled products.

OMB Control Number: 3060-1110.

Title: Sunset of the Cellular Radiotelephone Service Analog Service Requirement and Related Matters, FCC 07-103.

Form No.: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit, not-for-profit institutions, and state, local or tribal government.

Number of Respondents and Responses: 118 respondents; 118 responses.

Estimated Time Per Response: 24 hours.

Frequency of Response: Third party disclosure requirement.

Obligation to Respond: Mandatory. Statutory authority for this information collection is contained in 47 U.S.C. sections 154(i), 201, and 303(r) and 5 U.S.C. section 554 of the Administrative Procedures Act.

Total Annual Burden: 2,832 hours.

Total Annual Cost: N/A.

Privacy Act Impact Assessment: N/A.

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

Needs and Uses: The Commission will submit this expiring collection after this comment period to the Office of Management and Budget (OMB) to obtain the full three year clearance from them. The Commission is reporting an adjustment decrease in burden by 8,016 hours.

On June 15, 2007, the Federal Communications Commission (“Commission”) released a Memorandum Opinion and Order (MO&O), FCC 07-103, which denied a petition for rulemaking to extend the requirement that all cellular radiotelephone licensees provide analog service e to subscribers and roamers whose equipment conforms to the Advanced Mobile Phone Service (AMPS) standard. This requirement will sunset on February 18, 2008. In the MO&O, the Commission also directed cellular radiotelephone service licensees to notify their remaining analog subscribers of the sunset date and of their intention to discontinue AMPS-compatible analog service at least four months before such discontinuance, and a second time, at least 30 days before such discontinuance (the “consumer-notice requirement”).

The consumer-notice requirement will ensure that remaining analog cellular service subscribers, including persons with hearing disabilities, are fully apprised of the sunset of the analog cellular service requirement.

OMB Control Number: 3060-0179.

Title: Section 73.1590, Equipment Performance Measurements.

Form Number: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Businesses or other for-profit entities; Not-for-profit institutions.

Number of Respondents and Responses: 13,049 respondents and 13,049 responses.

Estimated Time per Response: 0.5 -18 hours.

Frequency of Response: Recordkeeping requirement.

Total Annual Burden: 12,335 hours.

Total Annual Cost: None.

Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection of information is contained in Section 154(i) of the Communications Act of 1934, as amended.

Nature and Extent of Confidentiality: No need for confidentiality required with this collection of information.

Privacy Impact Assessment: No impact(s).

Needs and Uses: 47 CFR 73.1590(d) states the data required by paragraphs (b) and (c) of this section, together with a description of the equipment and procedure used in making the measurements, signed and dated by the qualified person(s) making the measurements, must be kept on file at the transmitter or remote control point for a period of two years, and on request must be made available during that time to duly authorized representatives of the FCC.

Pursuant to section 6(f) of the Federal Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46(f), and § 2.34 the Commission Rules of Practice, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for July 28, 2010), on the World Wide Web, at (http://www.ftc.gov/os/actions.shtm). A paper copy can be obtained from the FTC Public Reference Room, Room 130-H, 600 Pennsylvania Avenue, NW, Washington, D.C. 20580, either in person or by calling (202) 326-2222.

Public comments are invited, and may be filed with the Commission in either paper or electronic form. All comments should be filed as prescribed in the ADDRESSES section above, and must be received on or before the date specified in the DATES section.

The Federal Trade Commission (“Commission”) has accepted, subject to final approval, an Agreement Containing Consent Order (“Consent Agreement”) from Nufarm Limited (“Nufarm” or “Respondent”) to remedy the anticompetitive effects stemming from Nufarm’s acquisition of A.H. Marks Holding Limited (“A. H. Marks”). Under the terms of the Consent Agreement, Nufarm is required to divest to Commission-approved buyers certain A. H. Marks assets, including regulatory permits and intellectual property, and take certain additional measures to restore competition in the markets for three phenoxy herbicide products: MCPA, MCPP-p, and 2,4DB.

On March 5, 2008, Nufarm acquired A. H. Marks. Both parties held, or had access to, regulatory approvals from the United States Environmental Protection Agency (“EPA”) to sell MCPA, MCPP-p, and 2,4DB in the United States. The Commission’s complaint alleges that the acquisition and acquisition agreement violated Section 7 of the Clayton Act, as amended, 15 U.S.C. § 18, and Section 5 of the Federal Trade Commission Act (“FTC Act”), as amended, 15 U.S.C. § 45, by lessening competition in the United States markets for the sale of the phenoxy herbicides: MCPA, MCPP-P, and 2,4DB.

The Consent Agreement has been placed on the public record for thirty (30) days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty (30) days, the Commission will review the Consent Agreement and comments received and decide whether to withdraw from the proposed Consent Agreement, modify it, or make final the Consent Agreement’s proposed Decision and Order.

With its acquisition of A.H. Marks, Nufarm obtained monopoly positions in the United States markets for two phenoxy herbicide markets (MCPA and MCPP-p) and reduced a third phenoxy herbicide market (2,4DB) to a duopoly. Phenoxy herbicides are post-emergent selective broadleaf herbicides which are designed to act on full or partially grown weeds without damaging surrounding plants. They are used widely in the turf, lawn care, and agriculture industries to eliminate existing broadleaf weeds safely and cheaply. Nufarm and A.H. Marks sold these herbicides to agricultural and turf and lawn care formulators in their raw form as “technical” ingredients for their formulated herbicide products. Agricultural formulators generally purchase MCPA for use on cereal crops, such as wheat and barley, and 2,4DB for peanut and alfalfa crops. Turf and lawn care formulators purchase MCPP-p for turf care products used by landscape professionals or consumers. Each of the three herbicides is a highly cost-effective herbicide for its intended use with no equivalent substitutes. More expensive herbicides are generally used as complements and combined with phenoxy herbicides such as MCPA, MCPP-p, or 2,4DB, to increase the effectiveness of formulated herbicide products.

Entry into the markets for MCPA, MCPP-p and 2,4DB would not be timely, likely, or sufficient to deter or counteract the anticompetitive effects of the acquisition. In order to obtain approval to sell herbicides for use on crops, turf, or lawns in the United States, the Environmental Protection Agency (“EPA”) requires manufacturers to submit extensive environmental and toxicology testing data. Herbicide manufacturers often generate such data by forming industry task forces to share the costs of testing. Later entrants are often required to compensate members of the task force to obtain intellectual property rights to existing testing data by either purchasing the rights to the data or obtaining a seat on the task force. The costs associated with obtaining either the testing data or a task force seat to enter the markets for MCPA, MCPP-p, and 2,4DB are high compared to the limited potential sales revenues available to an entrant in each of these markets. Additionally, obtaining EPA approval for the manufacture and sale of each of the relevant products can take several years due to the presence of regulatory barriers. As a result, entry into each relevant market would require substantial sunk costs that would make entry unattractive. In addition, prior to the acquisition, Nufarm had entered into contracts with several of its task force members which posed barriers to entry by these firms. Therefore, the prospect of entry into the relevant markets is very limited and does not alleviate the concerns about the adverse competitive effects of the acquisition.

The acquisition is likely to cause significant competitive harm to consumers in the relevant U.S. markets for MCPA, MCPP-p, and 2,4DB by eliminating the direct and substantial competition between Nufarm and A.H. Marks. There is evidence that Nufarm acquired A.H. Marks with the expectation that it would be able to increase prices as a result of the merger. In addition, the evidence indicated that in some instances Nufarm may have increased its prices for the three herbicides following the merger. As a result, the transaction increased the likelihood that Nufarm could unilaterally exercise market power and raise prices in each of the relevant markets.

The Consent Agreement preserves competition in each of the relevant markets alleged in the complaint by requiring that Nufarm divest certain A.H. Marks assets to new entrants and take additional measures to restore competition in the markets for MCPA, MCPP-p, and 2,4DB. Specifically, Nufarm has agreed to sell A.H. Marks’ EPA registration and task force seat for MCPA to Albaugh Inc., and A.H. Marks’ EPA registration and task force seat for MCPP-p to PBI Gordon Corp. Nufarm has also agreed to modify its contractual agreements with Dow and Aceto relating to MCPA and 2.4-DB, which restricted these firms’ competitive activities in the markets for MCPA and 2,4-DB. Staff has evaluated the proposed divestitures and modifications and concluded that these measures are sufficient to remedy the anticompetitive effects resulting from the transaction.

For both MCPA and MCPP-p, the purchase of a task force seat and EPA registration will permit each divestiture purchaser to enter and compete in these markets. By acquiring A.H. Mark’s task force seat and EPA registration, the divestiture purchasers will obtain EPA approval to distribute the herbicide in the United States and certify additional manufacturing sources of the herbicides. In addition to the task force seat and EPA registration, Nufarm is required to enter into supply agreements with each divestiture purchaser to permit these purchasers to compete with Nufarm as wholesale suppliers of the herbicides while new manufacturing sources are developed.

With respect to MCPA, Nufarm would divest AH Mark’s MCPA Task Force Seat and EPA registrations relating to MCPA to Albaugh. Albaugh is a qualified divestiture candidate that is uniquely situated to use the A.H. Marks assets and supply contract to compete with Nufarm in the market for MCPA. Albaugh is the largest privately-owned formulator of crop protection products. Albaugh is headquartered in Ankeny, Iowa and sells exclusively in the United States. Within the crop protection industry, Albaugh has extensive relationships with firms at every level of distribution. Given Albaugh’s position, commitment, and experience in the MCPA market, staff believes that divestiture of A.H. Marks’ MCPA assets will enable Albaugh to restore the competition lost as a result of the transaction.

With respect to MCPP-p, Nufarm would divest A.H. Mark’s MCPP-p Task Force Seat and EPA registrations relating to MCPP-p to PBI Gordon and enter a three-year supply arrangement. PBI Gordon, headquartered in Kansas City, Missouri, is a privately held company founded in 1947. PBI Gordon is a long-standing player in the turf care industry. Its primary business is the development, manufacture, and marketing of herbicides, pest management, and related products to the lawn, garden, professional turf, and specialty agricultural markets. It has an extensive distribution network and a wide customer base. PBI Gordon’s presence in the market, combined with its expertise with herbicides, will ensure it will use the assets to compete with Nufarm in the market for MCPP-p.

The Consent Agreement also addresses concerns regarding Nufarm’s agreements with Dow and Aceto by preventing Nufarm from enforcing agreements which may limit or restrict competitive entry in the MCPA and 2,4DB markets. Pursuant to Section V of the proposed Decision and Order, Nufarm agreed not to enforce any provision, or otherwise take any future action, restricting competition in the manufacture or sale of MCPA, 2,4DB or MCPP-p. Nufarm’s compliance with these provisions will enable Dow and Aceto to enter these respective markets, as manufacturers and/or wholesalers, and compete with Nufarm for sales. Equally important, Dow and Aceto will be able to use their task force seats and registrations to sponsor new entrants to the United States markets for these herbicides. The resulting entry, or threat of entry, is likely to serve as an additional competitive constraint in both the MCPA and 2,4DB markets. Lastly the Consent Agreement contains several other significant provisions. Section IV of the proposed Order permits Nufarm’s customers to terminate their contracts with Nufarm with respect to the products. Section VII requires Nufarm to notify the Commission if it: (a) acquires any task force seat or registration with respect to the products or (b) enters into any agreements with task force members or registrants that contain non-compete, joint-marketing or other provisions restricting competition. Section VIII requires Nufarm to divest the MCPA and MCPP-p assets to a trustee in the event Nufarm fails to comply with the divestiture obligations for these assets in the proposed Order.

The purpose of this analysis is to facilitate public comment on the proposed Decision and Order. This analysis is not intended to constitute an official interpretation of the Consent Agreement and the proposed Decision and Order.

By direction of the Commission, Commissioner Ramirez recused.

Sections 735 and 736 of the act (21 U.S.C. 379g and 379h, respectively), establish three different kinds of user fees. Fees are assessed on the following: (1) Certain types of applications and supplements for approval of drug and biological products, (2) certain establishments where such products are made, and (3) certain products (section 736(a) of the act). When certain conditions are met, FDA may waive or reduce fees (section 736(d) of the act).

For FY 2008 through FY 2012, the base revenue amounts for the total revenues from all PDUFA fees are established by PDUFA IV. The base revenue amount for FY 2008 is to be adjusted for workload, and that adjusted amount becomes the base amount for the remaining 4 fiscal years. That adjusted base revenue amount is increased for drug safety enhancements by $10,000,000 in each of the subsequent 4 fiscal years, and the increased total is further adjusted each year for inflation and workload. Fees for applications, establishments, and products are to be established each year by FDA so that revenues from each category will provide one-third of the total revenue to be collected each year.

This notice uses the fee base revenue amount for FY 2008 published in the Federal Register of October 12, 2007 (72 FR 58103), adjusts it for the FY 2010 and FY 2011 drug safety increases (see section 736(b)(4) of the act), for inflation, and for workload, and then establishes the application, establishment, and product fees for FY 2011. These fees are effective on October 1, 2010, and will remain in effect through September 30, 2011.

The total fee revenue amount for FY 2011 is $619,070,000, based on the fee revenue amount specified in the statute, including additional fee funding for drug safety and adjustments for inflation and changes in workload. The statutory amount and a one-time base adjustment are described in sections II.A and II.B of this document. The adjustment for inflation is described in section II.C of this document, and the adjustment for changes in workload in section II.D of this document.

PDUFA IV specifies that the fee revenue amount before adjustments for FY 2011 for all fees is $447,783,000 ($392,783,000 specified in section 736(b)(1) of the act plus an additional $55,000,000 for drug safety in FY 2011 specified in section 736(b)(4) of the act).

The statute also specifies that $354,893,000 of the base amount is to be further adjusted for workload increases through FY 2007 (see section 736(b)(1)(B) of the act). The workload adjustment on this amount is to be made in accordance with the workload adjustment provisions that were in effect for FY 2007, except that the adjustment for investigational new drug (IND) workload is based on the number of INDs with a submission in the previous 12 months rather than on the number of new commercial INDs submitted in the same 12-month period. This adjustment was explained in detail in the Federal Register of October 12, 2007 (72 FR 58103). Increasing the statutorily specified amount of $354,893,000 by the specified workload adjuster (11.73 percent) results in an increase of $41,629,000, rounded to the nearest thousand. Adding this amount to the $447,783,000 statutorily specified amount from section II.A of this document, results in a total adjusted PDUFA IV base revenue amount of $489,412,000, before further adjustment for inflation and changes in workload after FY 2007.

PDUFA IV provides that fee revenue amounts for each fiscal year after FY 2008 shall be adjusted for inflation. The adjustment must reflect the greater of the following amounts: (1) The total percentage change that occurred in the Consumer Price Index (CPI) (all items; U.S. city average) during the 12-month period ending June 30 preceding the fiscal year for which fees are being set; (2) the total percentage pay change for the previous fiscal year for Federal employees stationed in the Washington, DC metropolitan area; or (3) the average annual change in cost, per full time equivalent (FTE) FDA position, of all personnel compensation and benefits paid for the first 5 of the previous 6 fiscal years. PDUFA IV provides for this annual adjustment to be cumulative and compounded annually after FY 2008 (see section 736(c)(1) of the act).

The first factor is the CPI increase for the 12-month period ending in June 2010. The CPI for June 2010 was 217.965 and the CPI for June 2009 was 215.693. (These CPI figures are available on the Bureau of Labor Statistics Web site at http://data.bls.gov/cgi-bin/surveymost?bls by checking the first box under “Price Indexes” and then clicking “Retrieve Data” at the bottom of the page.) (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.) The CPI for June 2010 is 1.053 percent higher than the CPI for the previous 12-month period.

The second factor is the increase in pay for the previous fiscal year (FY 2010 in this case) for Federal employees stationed in the Washington, DC metropolitan area. This figure is published by the Office of Personnel Management, and found on their Web site at http://www.opm.gov/oca/10tables/html/dcb.asp above the salary table. (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.) For FY 2010 it was 2.42 percent.

The third factor is the average change in FDA cost for compensation and benefits per FTE over the previous 5 of the most recent 6 fiscal years (FY 2004 through 2009). The data on total compensation paid and numbers of FTE paid, from which the average cost per FTE can be derived, are published in FDA's Justification of Estimates for Appropriations Committees. Table 1 of this document summarizes that actual cost and FTE use data for the specified fiscal years, and provides the percent change from the previous fiscal year and the average percent change over the most 5 recent fiscal years, which is 4.53 percent.

The inflation increase for FY 2011 is 4.53 percent. This is the greater of the CPI change during the 12-month period ending June 30 preceding the fiscal year for which fees are being set (1.053 percent), the increase in pay for the previous fiscal year (FY 2010 in this case) for Federal employees stationed in the Washington, DC metropolitan area (2.42 percent), and the average annual change in cost, per FTE FDA position, of all personnel compensation and benefits paid for the first 5 of the previous 6 fiscal years (4.53 percent). Because the average change in pay per FTE (4.53 percent) is the highest of the three factors, it becomes the inflation adjustment for total fee revenue for FY 2011.

The inflation adjustment for FY 2009 was 5.64 percent. This is the greater of the CPI increase during the 12-month period ending June 30 preceding the fiscal year for which fees were being set (June 30, 2008, which was 5.05 percent), the increase in pay for FY 2008 for Federal employees stationed in Washington, DC (4.49 percent), or the average annual change in cost, per FTE FDA position, of all personnel compensation and benefits paid for the first 5 of the previous 6 fiscal years (5.64 percent).

The inflation adjustment for FY 2010 was 5.54 percent. This is the greater of the CPI increase during the 12-month period ending June 30 preceding the fiscal year for which fees were being set (June 30, 2009) (negative 1.43 percent), the increase in pay for FY 2009 for Federal employees stationed in Washington, DC (4.78 percent), or the average annual change in cost, per FTE FDA position, of all personnel compensation and benefits paid for the first 5 of the previous 6 fiscal years (5.54 percent).

PDUFA IV provides for this inflation adjustment to be cumulative and compounded annually after FY 2008 (see section 736(c)(1) of the act). This factor for FY 2011 (4.53 percent) is compounded by adding one to it and then multiplying it by one plus the inflation adjustment factor for FY 2010 (5.54 percent) and by one plus the inflation adjustment factor for FY 2009 (5.64 percent). The result of this multiplication of the inflation factors for the 3 years since FY 2008 (1.04.53 times 1.0554 times 1.0564 percent) becomes the inflation adjustment for FY 2011. This inflation adjustment for FY 2010 is 16.54 percent.

Increasing the FY 2011 fee revenue base of $489,412,000, by 16.54 percent yields an inflation-adjusted fee revenue amount for FY 2011 of $570,371,000, rounded to the nearest thousand dollars, before the application of the FY 2011 workload adjustment.

PDUFA IV does not allow FDA to adjust the total revenue amount for workload beginning in FY 2010 unless the independent accounting firm study is complete (see section 736(c)(2)(C) of the act). That study, conducted by Deloitte Touche, LLP, was completed on March 31, 2009, and is available online at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm164339.htm . The study found that the adjustment methodology used by FDA reasonably captures changes in workload for reviewing human drug applications under PDUFA IV. Accordingly, FDA continues to use the workload adjustment methodology prescribed in PDUFA IV.

For each fiscal year beginning in FY 2009, PDUFA IV provides that fee revenue amounts, after they have been adjusted for inflation, shall be further adjusted to reflect changes in workload for the process for the review of human drug applications (see section 736(c)(2) of the act). PDUFA IV continues the PDUFA III workload adjustment with modifications, and provides for a new additional adjustment for changes in review activity.

FDA calculated the average number of each of the four types of applications specified in the workload adjustment provision: (1) Human drug applications, (2) active commercial INDs (applications that have at least one submission during the previous 12 months), (3) efficacy supplements, and (4) manufacturing supplements received over the 5-year period that ended on June 30, 2007 (base years), and the average number of each of these types of applications over the most recent 5-year period that ended June 30, 2010.

The calculations are summarized in table 2 of this document. The 5-year averages for each application category are provided in Column 1 (“5-Year Average Base Years 2002-2007”) and Column 2a (“5 Year Average 2006-2010”).

PDUFA IV specifies that FDA make additional adjustments for changes in review activities to the first two categories (human drug applications and active commercial INDs). These adjustments, specified under PDUFA IV, are summarized in columns 2b and 2c in table 2 of this document. The number in the NDAs/BLAs line of column 2b of table 2 of this document is the percent by which the average workload for meetings, annual reports, and labeling supplements for NDAs and BLAs has changed from the 5-year period 2002 through 2007 to the 5-year period 2006 through 2010. Likewise, the number in the “Active commercial INDs” line of column 2b of table 2 of this document is the percent by which the workload for meetings and special protocol assessments for active commercial INDs has changed from the 5-year period 2002 through 2007 to the 5-year period 2006 through 2010. There is no entry in the last two lines of column 2b because the adjustment for changes in review workload does not apply to the workload for efficacy supplements and manufacturing supplements.

Column 3 of table 2 of this document reflects the percent change in workload from column 1 to column 2c. Column 4 shows the weighting factor for each type of application, estimating how much of the total FDA drug review workload was accounted for by each type of application in the table during the most recent 5 years. Column 5 of table 2 of this document is the weighted percent change in each category of workload. This was derived by multiplying the weighting factor in each line in column 4 by the percent change from the base years in column 3. At the bottom right of table 2 of this document is the sum of the values in column 5 that are added, reflecting an increase in workload of 8.54 percent for FY 2011 when compared to the base years.