This notice is exempt from review by the Office of Management and Budget under Executive Order 12866.

This action is not a rule as defined by the Regulatory Flexibility Act (5 U.S.C. 601-612) and thus is exempt from the provisions of this Act.

This notice does not contain reporting or recordkeeping requirements subject to approval by the Office of Management and Budget in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507).

This program is listed in the Catalog of Federal Domestic Assistance Programs under No. 10.557, and is subject to the provisions of Executive Order 12372, which requires intergovernmental consultation with State and local officials (7 CFR Part 3015, Subpart V, 48 FR 29114, June 24, 1983, and 49 FR 22676, May 31, 1984).

Section 17(d)(2)(A) of the Child Nutrition Act of 1966 (42 U.S.C. 1786 (d)(2)(A)) requires the Secretary of Agriculture to establish income criteria to be used with nutritional risk criteria in determining a person's eligibility for participation in the WIC Program. The law provides that persons will be income eligible for the WIC Program only if they are members of families that satisfy the income standard prescribed for reduced-price school meals under section 9(b) of the Richard B. Russell National School Lunch Act (42 U.S.C. 1758(b)). Under section 9(b), the income limit for reduced-price school meals is 185 percent of the Federal poverty guidelines, as adjusted.

Section 9(b) also requires that these guidelines be revised annually to reflect changes in the Consumer Price Index. The annual revision for 2006 was published by the Department of Health and Human Services (HHS) at 71 FR 3848, January 24, 2006. The guidelines published by HHS are referred to as the poverty guidelines.

Section 246.7(d)(1) of the WIC regulations (Title 7, Code of Federal Regulations) specifies that State agencies may prescribe income guidelines either equaling the income guidelines established under section 9 of the Richard B. Russell National School Lunch Act for reduced-price school meals or identical to State or local guidelines for free or reduced-price health care. However, in conforming WIC income guidelines to State or local health care guidelines, the State cannot establish WIC guidelines which exceed the guidelines for reduced-price school meals, or which are less than 100 percent of the Federal poverty guidelines. Consistent with the method used to compute income eligibility guidelines for reduced-price meals under the National School Lunch Program, the poverty guidelines were multiplied by 1.85 and the results rounded upward to the next whole dollar.

At this time the Department is publishing the maximum and minimum WIC income eligibility guidelines by household size for the period July 1, 2006, through June 30, 2007. Consistent with section 17(f)(17) of the Child Nutrition Act of 1966 (42 U.S.C. 1786(f)(17)), a State agency may implement the revised WIC income eligibility guidelines concurrently with the implementation of income eligibility guidelines under the Medicaid program established under Title XIX of the Social Security Act (42 U.S.C. 1396, et seq. ). State agencies may coordinate implementation with the revised Medicaid guidelines, but in no case may implementation take place later than July 1, 2006.

State agencies that do not coordinate implementation with the revised Medicaid guidelines must implement the WIC income eligibility guidelines on July 1, 2006. The first table of this notice contains the income limits by household size for the 48 contiguous States, the District of Columbia and all Territories, including Guam. Because the poverty guidelines for Alaska and Hawaii are higher than for the 48 contiguous States, separate tables for Alaska and Hawaii have been included for the convenience of the State agencies.

The information collection requirements contained in this Notice have received temporary emergency clearance by the Office of Management and Budget (OMB) under Control Number 0575-0190. However, in accordance with the Paperwork Reduction Act of 1995, RD will seek standard OMB approval of the reporting requirements contained in this Notice. Publication of this Notice hereby opens a 60-day public comment period.

Title: Section 515 Multi-Family Housing Preservation and Revitalization Restructuring Demonstration Program.

Type of Request: New collection.

Abstract: The Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2006 (Pub. L. 109-97) provides funding for, and authorizes RD to conduct a demonstration program for the preservation and revitalization of the section 515 multi-family housing portfolio. The section 515 multi-family housing program is authorized by section 515 of the Housing Act of 1949 (42 U.S.C. 1485) and provides RD the authority to make loans for low-income multi-family housing and related facilities.

RD refers to this program as Multi-Family Housing Preservation and Revitalization Restructuring Program (MPR). This NOFA sets forth the eligibility and application requirements. Information will be collected from applicants and grant recipients by Rural Development staff in its Local, Area, State, and National offices. This information will be used to determine applicant eligibility for this demonstration program. If an applicant proposal is selected, that applicant will be notified of the selection and given the opportunity to submit a formal application.

Estimate of Burden: Public reporting burden for this collection of information is estimated to average 1.26 hours per response.

Respondents: Individuals, partnerships, public and private nonprofit corporations, agencies, institutions, organizations, and Indian tribes.

Estimated Number of Respondents: 710.

Estimated Number of Responses per Respondent: 1.01.

Estimated Number of Responses: 1520.

Estimated Total Annual Burden on Respondents: 1940 hours.

Copies of this information collection can be obtained from Tracy Givelekian, Regulations and Paperwork Management Branch, at (202) 692-0039.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the RD, including whether the information will have practical utility; (b) the accuracy of the RD's estimate of the burden of the proposed collection of information including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Comments may be sent to Tracy Givelekian, Regulations and Paperwork Management Branch, U.S. Department of Agriculture, Rural Development, STOP 0742, 1400 Independence Ave. SW., Washington, DC 20250. All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

The Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2006 (Pub. L. 109-97), November 10, 2005, provides funding for, and authorizes RD to conduct a demonstration program for the preservation and revitalization of the section 515 multi-family housing portfolio. The section 515 multi-family housing program is authorized by section 515 of the Housing Act of 1949 (42 U.S.C. 1485) and provides RD the authority to make loans for low-income multi-family housing and related facilities.

This NOFA requests applications from eligible borrowers/applicants to restructure existing multi-family housing within the Agency's section 515 multi-family housing portfolio for the purpose of revitalization and preservation. The demonstration program shall be referred to in this notice as the Multi-Family Housing Preservation and Revitalization Restructuring Demonstration (MPR) program. Agency regulations for the section 515 multi-family housing program are published at 7 CFR part 3560. The MPR is intended to assure that existing rental projects will be able to continue to deliver decent, safe, and sanitary affordable rental housing for the lesser of the remaining term of the loan or 20 years from the date of the MPR transaction closing. Once an applicant and project have been selected in the process described in this notice, confirmed eligible by the Agency, and agree to participate in the MPR demonstration by written notification to the Agency, an independent third party capital needs assessment (CNA) will be conducted to provide a fair and objective review of projected capital needs. The Agency shall implement this NOFA through an MPR Conditional Commitment (MPRCC) with the eligible borrower, which will include all the terms and conditions under this NOFA, including the MPR Debt Deferral Agreement.

The primary restructuring tool to be used in this program will be up to a 20-year debt deferral of the payment on 1% section 515 loans. The cash flow from the deferred payment will be re-directed to reserve account deposits to help meet the physical needs of the property. If the resulting cash flow is not adequate to address the long-term needs of the project, other Agency restructuring tools and resources from third party sources including loans made with Agency guarantees under section 538 of the Housing Act of 1949 and 7 CFR part 3560, may be used to supplement the deferral. For the purposes of the MPR, the potential restructuring transactions will be identified in three categories:

(1) SIMPLE transactions will consist of a debt deferral only.

(2) MODERATE transactions will consist of a deferral and the use of at least one other Agency restructuring tool.

(3) COMPLEX transactions will consist of a MODERATE transaction that also includes the use of funding sources provided by a third party. Section 538 guarantees may be available to third party lenders.

Restructuring tools that may be used during the MPR demonstration based on the underwriting feasibility determination of the Agency include:

(1) A deferral of the existing Agency debt for the lesser of the remaining term of the loan or 20 years. All terms and conditions of the deferral will be described in the MPR Debt Deferral Agreement. A balloon payment of accrued principal and interest will be due at the end of the deferral period.

(2) A revitalization grant, limited to no more than $5,000 per unit will be available to fund immediate capital or reserve needs determined by the capital needs assessment process. The grant administration will be in accordance with 7 CFR part 3015.

(3) A section 515 rehabilitation loan at zero percent interest that will be amortized over 30 years.

(4) A soft mortgage will be available in limited situations to address capital needs. This will be accomplished by the use of a subordinate 1 percent section 515 rehabilitation loan that will have its interest and principal deferred, to a balloon payment, under the same terms as the longest remaining 515 debt. The total principal amount of the senior RD section 515 loan and the soft second mortgage may exceed the market value of the property. Payment of the subordinate debt will not be required from normal project operation income, but from excess cash after all other secured debts are satisfied.

(5) A subsequent section 515 rehabilitation loan at traditional rates and terms.

(6) Transfers, subordinations, and consolidations may be approved as part of a MPR transaction in accordance with existing servicing authorities of the Agency as available in 7 CFR part 3560.

Using the results of the CNA to help identify the need for resources and information regarding anticipated or available third party financing, the Agency will determine the financial feasibility of each potential transaction, using restructuring tools available either through existing regulatory authorities or specifically authorized through this demonstration program.

Project financial feasibility is determined when a property can provide affordable, safe, decent, sanitary housing for 20 years or the remaining term of the loan whichever is less, by using the authorities of this program while minimizing the cost to the Agency and without increasing rents for tenants, except when necessary to meet normal and necessary operating expenses. If the transaction is determined financially feasible by the Agency, the borrower will be offered a restructuring proposal, which will include a restrictive use covenant consistent with 7 CFR 3560.662.

If accepted by the borrower, the Agency and applicant will enter into a MPRCC. The applicant must also agree to a maximum of 20 years restricted use, pursuant to 7 CFR 3560.662 for the property when the MPR transaction is closed.

The MPR may be conducted with a stay-in owner or may involve a change in ownership. Any housing or related facilities that is constructed or repaired must meet the Agency design and construction standards and the development standards contained in 7 CFR part 1924, subparts A and C, respectively. Once constructed, section 515 multi-family housing must be managed in accordance with the, 7 CFR part 3560. Tenant eligibility will be limited to persons who qualify as a very low-, low-, or moderate-income household under Agency regulations or who are eligible under the requirements established to qualify for housing benefits provided by sources other than the Agency, such as U.S. Department of Housing and Urban Development Section 8 assistance or Low Income Housing Tax Credit Assistance, when a tenant receives such housing benefits. Additional tenant eligibility requirements are contained in 7 CFR 3560.152.

Public Law 109-97 makes funding available to the Secretary of Agriculture for RD to provide the restructuring tools of the MPR demonstration. Based on the planned use of a combination of MPR tools, the Agency anticipates that the total amount of funding available for this program is $173,951,000. The types and amount of assistance the Agency anticipates are: $165,894,000 in deferred debt, $210,000 in grants, $280,000 in zero percent loans, and $7,571,000 in soft mortgage loans. The Agency anticipates the ability to revitalize approximately 200 properties (5,400 units) with the funds available. Funding levels may differ from above when necessary to assure all funds are used.

All funding must be approved no later than September 15, 2006, and obligated by the Agency not later than September 29, 2006.

Applicants (and principals) must demonstrate:

(1) Eligibility under 7 CFR 3560.55 with the exception of the requirement described in 7 CFR 3560.55(a)(6) (have or able to obtain 2% of the total development costs for use as initial operating capital).

(2) That the project is needed in the market as evidenced by an average physical vacancy rate over the last twelve months of no more than 10% for projects of 16 units or more and 15% for projects under 16 units, except that the Agency may consider and accept documentation submitted by the applicant that demonstrates the occupancy standard will be met once a restructuring is performed.

(3) Ownership of, and the ability to operate, the facility after the transaction is completed.

(4) Compliance with any commitment to contribute funds to pay transaction costs as represented at the time of application for the MPR program.

Further, a CNA and Agency financial evaluation must demonstrate the MPR program is financially feasible and necessary for the revitalization and preservation of the property for affordable housing.

(1) In accordance with the Fair Housing Act, title VI of the Civil Rights Act of 1964, the Equal Credit Opportunity Act, the Age Discrimination Act of 1975, Executive Order 12898, the Americans with Disabilities Act, and section 504 of the Rehabilitation Act of 1973, neither the Applicant nor the Agency will discriminate against any employee, proposed intermediary or proposed ultimate recipient on the basis of sex, marital status, race, color, religion, national origin, age, physical or mental disability (provided the proposed intermediary or proposed ultimate recipient has the capacity to contract), because all or part of the proposed intermediary's or proposed ultimate recipient's income is derived from public assistance of any kind, or because the proposed intermediary or proposed ultimate recipient has in good faith exercised any right under the Consumer Credit Protection Act, with respect to any aspect of a credit transaction anytime Agency loan funds are involved.

(2) The policies and regulations contained in 7 CFR part 1901, subpart E and RD Instruction 2006-P (available in any Rural Development Office) apply to this program.

(3) The Administrator will assure that equal opportunity and nondiscrimination requirements are met in accordance with the Fair Housing Act, title VI of the Civil Rights Act of 1964, the Equal Credit Opportunity Act, the Age Discrimination Act of 1975, Executive Order 12898, the Americans with Disabilities Act, and section 504 of the Rehabilitation Act of 1973.

(4) All housing must meet the accessibility requirements found at 7 CFR 3560.60(d).

MPR tools will be used in accordance with 7 CFR part 3560 and its associated handbooks (available in any Rural Development office). The program will be administered within the resources and authorities made available to the Agency through Public Law 109-97 for the preservation and revitalization of section 515 financed properties. In the event that provisions of 7 CFR part 3560 conflicts with this demonstration program, the provisions of the MPR will take precedence.

(1) The application submission and scoring process will be completed in two phases in order to avoid unnecessary effort and expense on the part of interested borrowers/applicants and to allow additional points to be added to applicants that propose a transfer of a troubled project to an eligible owner.

The first phase is the application process, the applicant must submit a complete application no later than 30 days from the date of this publication. The applicant's submission will be classified complete when they submit a “MPR Application” for each MPR transaction they wish to be considered for in the demonstration. The MPR Application is the form attached at the end of this Notice. An electronic version of the application may be found on the Internet at http://www.rurdev.usda.gov/rd/nofas/index.html.

The second phase will be completed by the Agency and based on Agency records. Points will be assigned to each application when a proposal involving a transfer to a new eligible owner indicates that the property is currently classified by the Agency as a troubled project.

All complete and timely filed applications will then be scored and ranked based on points received during the two phase application process. Further, the Agency will categorize each MPR proposal as being potentially SIMPLE, MODERATE, or COMPLEX based on the information submitted on the application and in accordance with the category description provided in Section I of this Notice.

(2) Applications can be submitted either electronically or in hard copy. The time electronic filings will be considered received by the Agency is the actual time the transmission is received in the website mail box. The Agency will give preference to applications received electronically by using the close of business as the time a hardcopy application is received. Assistance for filing electronic and hard copy applications can be obtained from any Rural Development State Office.

The application is stored in the form of a .pdf format and may be completed as a fillable form. The form contains a button labeled “Submit by Email.” Clicking on the button will result in an e-mail containing a completed application being sent to the Multi-Family National Office for consideration.

Application forms may be downloaded from the site above or obtained by contacting the State Office in the state the project is located. Hard copy applications should be submitted to USDA Rural Housing Service; Attention: Carlton Jarratt, Senior Loan Specialist, Multi-Family Housing Office of Rental Housing Preservation—STOP 0782 (Room 1263-S), or Byron Ross, Director, Multi-Family Housing Office of Rental Housing Preservation—STOP 0781 (Room 1263-S), U.S. Department of Agriculture, Rural Housing Service, 1400 Independence Ave. SW., Washington, DC 20250-0781.

Application ranking points will be based on information, provided during the submission process. Applicants will need to provide reasonable evidence that the items have a high probability of being accomplished at the time the formal application is submitted. Points will be awarded as follows:

(1) Ownership of the property. The maximum points awarded for this criterion is 25 points. These points will be awarded in the following manner:

(i) Owner will continue ownership—25 points.

(ii) Transfer to a new eligible owner with site control as evidenced by a binding purchase agreement—20 points.

(iii) Transfer to a new owner without site control—10 points.

(2) Contribution of non-agency third party funds. Points awarded are to be based on documented written evidence that the funds are available. The maximum points awarded for this criterion is 25 points. These points will be awarded in the following manner:

(i) Owner contribution sufficient to pay transaction costs (those soft costs required to complete the transaction and include but are not limited to CNA, legal costs, appraisals and filing fees) expected to be a minimum of $5,000 that will be deposited in the property reserve account prior to closing—5 points, and

(ii) At least $3,000 to $5,000 per unit from other sources—15 points, or

(iii) Greater than $5,000 per unit from other sources—20 points.

(3) Age of Project. Since the age of the project and date that the loan was made are directly related to physical needs, a maximum of 25 points will be awarded on the following criteria:

(i) Initial loans made prior to December 21, 1979—25 points.

(ii) Initial loans made on or after December 21, 1979, but before December 15, 1989—20 points.

(iii) Initial loans made on or after December 15, 1989, but before October 1, 1991—15 points.

(iv) Initial loans made on or after October 1, 1991—10 points.

(4) Troubled Project Points. The Agency may award up to 25 additional points to facilitate the transfer and revitalization of troubled projects with an Agency classification of “C” or “D” according to HB 2-3560, Paragraph 9.7 (available at http://www.rurdevusda.gov/regs/hblist.html ). These projects may be troubled due to an act of nature or physical or financial deterioration or to correct management issues. Points will be awarded in the following manner:

(i) If the Agency servicing classification is C or D for less than 24 months—15 points.

(ii) If the Agency servicing classification is C or D for more than 24 months—25 points.

The Agency will total the selection criteria points for all applications received within the timeframes of this Notice and rank each application according to their total score. In the event that point totals are equal, the time and date the application was received by the Agency will determine the priority for selection (first come, first served).

Once priority ranking has been established, the Agency will conduct a five step process to select applicants. The five step process is needed to assure that the Agency can process the proposed transactions within available staffing resources, develop a representative sampling of revitalization transaction types, and assure an adequate pipeline of transactions to use all available funding.

Step One: The Agency will identify the highest scoring applications whose section 515 loan's unpaid principal balance total approximately $160 million.

Step Two: The Agency will identify the six states that have the most applicants identified in Step One.

Step Three: The Agency will select all the applicants identified in Step One for the six states identified in Step Two and place the applicants in funding queues by the three basic revitalization transaction types (SIMPLE, MODERATE, or COMPLEX).

Step Four: The Agency will then place the remaining applicants identified in Step One in the three funding queues. They will be placed in order of their scoring in Step One, but after the applicants placed in queue in Step Three.

Step Five: The Agency will then select the top ranked projects in each queue to result in a ratio as close as possible to 30 percent simple, 35 percent moderate and 35 percent complex. Selections will be made until the unpaid balance of selected transactions equal at least 150 percent of available deferral authority.

It is important to note that the identification of each application as being in one of the three transaction types is at the discretion of the Agency and is to be used only to attempt to develop a representative sampling of MPR transaction types. The actual transaction type that may be proposed to the applicant will be determined through the Agency underwriting process and may vary from the original transaction classification.

Those proposals that are ranked and then selected for further processing will be invited to sign an agreement to proceed. In the event that a proposal is selected for further processing and the applicant declines, the next highest ranked application will be selected. Applications can be submitted either electronically or in hard copy.

If an application is accepted for further processing, the applicant will be expected to submit additional relevant information requested that is needed to demonstrate eligibility and feasibility, consistent with this NOFA and the appropriate sections of 7 CFR part 3560, prior to the issuance of a restructuring offer.

RD will work with applicants selected for further processing in accordance with the following steps:

(1) Based on the feasibility of the type of transaction that will best suit the project and the availability of funds, further eligibility confirmation determinations will be conducted by the Office of Rental Housing Preservation with the assistance of designated Multi-Family Housing Revitalization coordinators assigned by each Rural Development State Director.

(2) A CNA will be conducted in accordance with the requirements of 7 CFR 3560.103(c) and HB 3-3560, Chapter 7, Section 5 and Unnumbered Letter, dated October 22, 2005, “Guidance on the Capital Needs Assessment Process” (available in any Rural Development State Office). The cost of the CNA will be considered a part of the project expense and may be paid from the “project reserve” with prior approval of the Agency. The Agency approval for participation in this program will be contingent upon the Agency's final approval of the CNA and concurrence of the scope of work with the owner.

(3) Underwriting will be conducted by the Office of Rental Housing Preservation with the assistance of the designated Multi-Family Housing Revitalization Coordinator assigned by each Rural Development State Director. The feasibility and structure of each revitalization proposal will be determined using this underwriting process and will include a determination of the restructuring tools that will minimize the cost to the Government consistent with the purposes of this NOFA. The Agency expects that some of the transactions proposed by selected applicants will prove to be infeasible. The applicant entity may be determined to be ineligible under Section III of this Notice. If a proposed transaction is determined infeasible or the applicant determined ineligible, the Agency will then select the next highest ranked project for processing.

Each MPR offer will be approved by the Revitalization Review committee chaired by the Deputy Administrator for Multi-Family Housing. Approved MPR offers will be presented to applicants who will then have up to 15 calendar days to accept or reject the offer in writing. Offers will expire after 15 days. The Agency will replace expired applications by selecting the next highest ranked project. Closing of MPR offers will occur within 60 days of acceptance by the applicant unless extended by the Agency.

Applicants will be selected in accordance with selection criteria and the five step process identified in Section VII of this Notice. Once selected to proceed, the Agency will provide additional guidance to the applicant and request information and documents necessary to complete the underwriting and review process. Since the character of each application may vary substantially depending on the type of transactions proposed, information requirements will be provided as appropriate. Complete project information must be submitted no later than 45 days from the date of Agency notification of the applicant's selection for further processing. Failure to submit the required information in a timely manner may result in the Agency discontinuing the processing of the request. Funding under this NOFA will be obligated under a first come, first served basis within each of the 3 funding queues described in Section VI of this Notice.

All complete applications will be evaluated, ranked and selected for further processing by a review committee. The committee will make recommendations for final decision to the Agency Administrator based on the selection criteria contained in this NOFA. The Administrator will inform applicants of the status of their request within 30 days of the application closing date of the NOFA.

All adverse determinations regarding applicant eligibility and the awarding of points as a part of the selection process are appealable. Instructions on the appeal process will be provided at the time an applicant is notified of the adverse.

Federal Agency: Rural Utilities Service (RUS).

Funding Opportunity Title: Public Television Station Digital Transition Grant Program.

Announcement Type: Initial announcement.

Catalog of Federal Domestic Assistance (CFDA) Number: 10.861.

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

• Paper copies must carry proof of shipping no later than May 15, 2006, to be eligible for FY 2006 grant funding. Late applications are not eligible for FY 2006 grant funding.

• Electronic copies must be received by May 15, 2006, to be eligible for FY 2006 grant funding. Late applications are not eligible for FY 2006 grant funding.

As part of the nation's transition to digital television, the Federal Communications Commission (FCC) required all television broadcasters to begin broadcasting using digital signals, and to cease broadcasting in analog by December 31, 2006. As of August 2005, forty of the nation's 355 public television transmitters have not launched DTV service. In addition, the vast majority of DTV stations serving rural areas have not yet been able to build out their full digital facilities that would allow them to replicate their analog services in the digital environment. It is important for these stations to be able to cover their former analog service areas, and to tailor their programs and services (e.g., education services, public health, homeland security, and local culture) to their rural constituents, and this may require transmitter/translator upgrades and other broadcast and video. If stations cannot continue to meet their analog standards of robust service, some Public Television programming will be lost, and many school systems may be left without the educational programming they count on for curriculum compliance. With the FCC deadline of December 31, 2006, for the end of the digital transition approaching, it is vital that rural stations continue their services to rural America.

On January 20, 2006, the Rural Utilities Service issued an Interim Final Rule which defines rules for the program (71 FR 3205). This regulation incorporates new statutory requirements and updates this competitive grant program.

This notice has been formatted to conform to a policy directive issued by the Office of Federal Financial Management (OFFM) of the Office of Management and Budget (OMB), published in the Federal Register on June 23, 2003, (68 FR 37370). This Notice does not change the Public Television Station Digital Transition Grant Program regulation (7 CFR part 1740).

1. General. The Administrator has determined that the following amounts are available for grants in FY 2006 under 7 CFR 1740.1.

2. Grants

a. $4.97 million is available for grants from FY 2006. Under 7 CFR 1740.2, the maximum amount for grants under this program is $1 million per applicant per year.

b. Assistance instrument: USDA Rural Development will execute grant documents appropriate to the project prior to any advance of funds with successful applicants.

Award documents specify the term of each award, and due to uncertainties in regulatory approvals of digital television broadcast facilities, the period during which grant funding is available will be extended upon request.

1. Public television stations which serve rural areas are eligible for Public Television Station Digital Transition Grants. A public television station is a noncommercial educational television broadcast station that is qualified for Community Service Grants by the Corporation for Public Broadcasting under section 396(k) of the Communications Act of 1934.

2. Individuals are not eligible for Public Television Station Digital Transition Grant Program financial assistance directly.

1. Grants shall be made to perform digital transitions of television broadcasting serving rural areas. Grant funds may be used to acquire, lease, and/or install facilities and software necessary to the digital transition. Specific purposes include:

a. Digital transmitters, translators, and repeaters, including all facilities required to initiate DTV broadcasting. All broadcast facilities acquired with grant funds shall be capable of delivering DTV programming and HDTV programming, at both the interim and final channel and power authorizations. There is no limit to the number of transmitters or translators that may be included in an application;

b. Power upgrades of existing DTV transmitter equipment;

c. Studio-to-transmitter links;

d. Equipment to allow local control over digital content and programming, including master control equipment;

e. Digital program production equipment, including cameras, editing, mixing and storage equipment;

f. Multicasting and datacasting equipment;

g. Cost of the lease of facilities, if any, for up to three years; and,

h. Associated engineering and environmental studies necessary to implementation.

2. Matching contributions: There is no requirement for matching funds in this program (see 7 CFR 1740.5) * * *

3. To be eligible for a grant, the Project must not (see 7 CFR 1740.7):

a. Include funding for ongoing operations or for facilities that will not be owned by the applicant, except for leased facilities as provided above;

b. Include costs of salaries, wages, and employee benefits of public television station personnel unless they are for construction or installation of eligible facilities;

c. Have been funded by any other source;

d. Include items bought or built prior to the application deadline specified in this Notice of Funds Availability.

C. See paragraph IV.B of this notice for a discussion of the items that make up a completed application. You may also refer to 7 CFR 1740.9 for completed grant application items.

The application guide, copies of necessary forms and samples, and the Public Television Station Digital Transition Grant Program regulation are available from these sources:

1. The Internet: http://www.usda.gov/rus/telecom/, or http://www.grants.gov.

2. Advanced Services Division, USDA Rural Development, for paper copies of these materials: (202) 690-4493.

1. Detailed information on each item required can be found in the Public Television Station Digital Transition Grant Program regulation and the Public Television Station Digital Transition Grant Program application guide. Applicants are strongly encouraged to read and apply both the regulation and the application guide. This Notice does not change the requirements for a completed application for any form of Public Television Station Digital Transition Grant Program financial assistance specified in the program regulation. The program regulation and application guide provide specific guidance on each of the items listed and the application guide provides all necessary forms and sample worksheets.

2. A completed application must include the following documentation, studies, reports and information in form satisfactory to USDA Rural Development. Applications should be prepared in conformance with the provisions in 7 CFR 1740, subpart A, and applicable USDA regulations including 7 CFR parts 3015, 3016, and 3019. Applicants must use the application guide for this program containing instructions and all necessary forms, as well as other important information, in preparing their application. Completed applications must include the following:

a. An application for federal assistance, Standard Form 424.

b. An executive summary, not to exceed two pages, describing the public television station, its service area and offerings, its current digital transition status, and the proposed project.

c. Evidence of the applicant's eligibility to apply under this Notice, proving that the applicant is a Public Television Station as defined in this Part, and that it is required by the FCC to perform the digital transition.

d. A spreadsheet showing the total project cost, with a breakdown of items sufficient to enable USDA Rural Development to determine individual item eligibility.

e. A coverage contour map showing the digital television coverage area of the application project. This map must show the counties (or county) comprising the Core Coverage Area by shading and by name. Partial counties included in the applicant's Core Coverage Area must be identified as partial and must contain an attachment with the applicant's estimate of the percentage that its coverage contour comprises the total area of the county (total area is available from American Factfinder, referenced above). If the application is for a translator, the coverage area may be estimated by the applicant through computer modeling or some other reasonable method, and this estimate is subject to acceptance by USDA Rural Development.

f. The applicant's own calculation of its Rurality score, supported by a worksheet showing the population of its Core Coverage Area, and the urban and rural populations within the Core Coverage Area. The data source for the urban and rural components of that population must be identified. If the application includes computations made by a consultant or other organization outside the public television station, the application shall state the details of that collaboration.

g. The applicant's own calculation of its Economic Need score, supported by a worksheet showing the National School Lunch Program eligibility levels for all school districts within the Core Coverage Area and averaging these eligibility percentages. The application must include a statement from the state or local organization that administers the NSLP program certifying the school district scores used in the computations.

h. If applicable, a presentation not to exceed five pages demonstrating the Critical Need for the project.

i. Evidence that the FCC has authorized the initiation of digital broadcasting at the project sites. In the event that an FCC construction permit has not been issued for one or more sites, those sites may be included in the grant, however, advance of funds for that site conditional upon the submission of a construction permit.

j. Compliance with other Federal statutes. The applicant must provide evidence or certification that it is in compliance with all applicable Federal statutes and regulations, including, but not limited to the following:

(1) Executive Order (E.O.) 11246, Equal Employment Opportunity, as amended by E.O. 11375 and as supplemented by regulations contained in 41 CFR part 60;

(2) Architectural barriers;

(3) Flood hazard area precautions;

(4) Assistance and Real Property Acquisition Policies Act of 1970;

(5) Drug-Free Workplace Act of 1998 (41 U.S.C. 701);

(6) E.O.s 12549 and 12689, Debarment and Suspension; and

(7) Byrd Anti-Lobbying Amendment (31 U.S.C. 1352).

k. Environmental impact and historic preservation. The applicant must provide details of the digital transition's impact on the environment and historic preservation, and comply with 7 CFR part 1794, which contains policies and procedures for implementing a variety of federal statutes, regulations, and executive orders generally pertaining to the protection of the quality of the human environment. This must be contained in a separate section entitled “Environmental Impact of the Digital Transition,” and must include the Environmental Questionnaire/Certification, available from USDA Rural Development, describing the impact of its digital transition. Submission of the Environmental Questionnaire/Certification alone does not constitute compliance with 7 CFR part 1794.

3. DUNS Number. As required by the OMB, all applicants for grants must now supply a Dun and Bradstreet Data Universal Numbering System (DUNS) number when applying. The Standard Form 424 (SF-424) contains a field for you to use when supplying your DUNS number. Obtaining a DUNS number costs nothing and requires a short telephone call to Dun and Bradstreet. Please see the Public Television Station Digital Transmitter Grant Program Web site or Grants.gov for more information on how to obtain a DUNS number or how to verify your organization's number.

1. Applications submitted on paper: Submit the original application and two (2) copies to USDA Rural Development.

2. Electronically submitted applications: Additional paper copies for USDA Rural Development are not necessary if you submit the application electronically through Grants.gov.

Grant applications may be submitted on paper or electronically.

1. Submitting applications on paper.

a. Address paper applications for grants to the USDA Rural Development, U.S. Department of Agriculture, 1400 Independence Ave., SW., Room 2845, STOP 1550, Washington, DC 20250-1550. Applications should be marked “Attention: Director, Advanced Services Division, Telecommunications Program.”

b. Paper applications must show proof of mailing or shipping consisting of one of the following:

(i) A legibly dated postmark applied by the U.S. Postal Service;

(ii) A legible mail receipt with the date of mailing stamped by the USPS; or

(iii) A dated shipping label, invoice, or receipt from a commercial carrier.

c. Non-USPS-applied postage dating, i.e., dated postage meter stamps, do not constitute proof of the date of mailing.

d. Due to screening procedures at the Department of Agriculture, packages arriving via the USPS are irradiated, which can damage the contents. USDA Rural Development encourages applicants to consider the impact of this procedure in selecting their application delivery method.

2. Electronically submitted applications.

a. Applications will not be accepted via facsimile machine transmission or electronic mail.

b. Electronic applications for grants will be accepted if submitted through the Federal Government's Grants.gov initiative at http://www.grants.gov.

c. How to use Grants.gov:

(i) Navigate your Web browser to http://www.grants.gov.

(ii) Follow the instructions on that Web site to find grant information.

(iii) Download a copy of the application package.

(iv) Complete the package off-line.

(v) Upload and submit the application via the Grants.gov Web site.

d. Grants.gov contains full instructions on all required passwords, credentialing and software.

e. USDA Rural Development encourages applicants who wish to apply through Grants.gov to submit their applications in advance of the deadline. Difficulties encountered by applicants filing through Grants.gov will not justify filing deadline extensions.

f. If a system problem occurs or you have technical difficulties with an electronic application, please use the customer support resources available at the Grants.gov Web site.

g. New information for FY 2006.

(I) The scoring of Rurality and Economic Need has been simplified by changing the basis for a station's coverage area from the computer-generated Longley-Rice coverage plot to an area comprised of whole counties of which the applicant's proposed cover transmitters/transmitters at least 75% geographically. A mechanism is incorporated so that urban areas on the fringe of a station's coverage area do not diminish an applicant's score.

(iii) Economic Needs scoring is based on a project area's eligibility level in the National School Lunch Program, rather than its Per Capita Income. This change is made to capture the cost of living of the project area as well as its income level.

(ii) New purposes will be funded due to appropriations language.

1. Paper applications must be postmarked and mailed, shipped, or sent overnight no later than May 15, 2006 to be eligible for FY 2006 grant funding. Late applications are not eligible for FY 2006 grant funding.

2. Electronic grant applications must be received by May 15, 2006 to be eligible for FY 2006 funding. Late applications are not eligible for FY 2006 grant funding.

1. Grant applications are scored competitively and subject to the criteria listed below.

2. Grant application scoring criteria are detailed in 7 CFR 1740.8. There are 100 points available, broken down as follows:

a. The Rurality of the Project (up to 40 points);

b. The Economic Need of the Project's Service Area (up to 30 points); and

c. The Critical Need for the project, and of the applicant, including the benefits derived from the proposed service (up to 30 points).

1. All applications for grants must be delivered to USDA Rural Development at the address and by the date specified in this notice to be eligible for funding. Each application will be reviewed for conformance with the provisions of this part. Applicants may be contacted for additional information or clarification.

2. Incomplete applications as of the deadline for submission will not be considered. If an application is determined to be incomplete, the applicant will be notified in writing and the application will be returned with no further action.

3. Applications conforming with this part will be evaluated competitively by a panel of USDA Rural Development employees selected by the Administrator of RUS, and will be awarded points as described in the scoring criteria in 7 CFR 1740.8. Applications will be ranked and grants awarded in rank order until all grant funds are expended.

4. Regardless of the score an application receives, if it is determined that the Project is technically or financially infeasible, the applicant will be notified, in writing, and the application will be returned with no further action.

1. The applicant's self scores in Rurality and Economic Need will be checked and, if necessary, corrected by USDA Rural Development.

2. The Critical Need score will be determined by USDA Rural Development based on information presented in the application. This score is intended to capture from the rural public's standpoint the necessity and usefulness of the proposed project. This scoring category will also recognize that some transition purchases are more essential than others, so that applications for first digital transmitter capability and transmitter power upgrades that extend coverage into rural-only areas will receive scoring advantages. Master control facilities which tailor programming to local needs will also be recognized in this category.

Each funded project is unique, and, therefore, various conditions may attach to different projects' which will appear in the award documents. Generally applicants whose projects are selected for awards are final by faxing an award letter. The award letter is followed with a grant agreement that contains all the terms and conditions for the grant. An applicant must execute and return the grant agreement, accompanied by any additional items required by the grant agreement.

The items listed in the program regulation at 7 CFR 1740.9(j) implement the appropriate administrative and national policy requirements.

All recipients of Public Television Station Digital Transition Grant Program financial assistance must provide annual performance activity reports to USDA Rural Development until the project is complete and the funds are expended. A final performance report is also required; the final report may serve as the last annual report. The final report must include an evaluation of the success of the project.

A. Web site: http://www.usda.gov/rus/. USDA Rural Development Web site maintains up-to-date resources and contact information for the Public Television Station Digital Transition Grant Program.

B. Phone: 202-690-4493.

C. Fax: 202-720-1051.

D. Main point of contact: Orren E. Cameron III, Director, Advanced Services Division, Telecommunications Program, USDA Rural Development, U.S. Department of Agriculture.

Gulf Coast Business Investment Mission, May 4-5, 2006. Participants for this mission will be selected by the Department of Commerce on the basis of applicability towards the goal of fostering business investment in the Gulf Coast region and U.S. exports in accordance with the criteria set forth in this announcement.

The participation fee for this mission is approximately $1,000 per company/consortium. Only one representative from the company/consortium can apply for participation in the business mission. Expenses for travel to and from the Gulf Coast region, lodging, and incidentals will be the responsibility of each mission participant.

Any partisan political activities (including political contributions) of an applicant are entirely irrelevant to the selection process.

Secretary of Commerce Carlos M. Gutierrez in coordination with Federal Coordinator Donald E. Powell, Gulf Coast Rebuilding, Department of Homeland Security, will lead a senior-level business delegation to the Gulf Coast, including Baton Rouge and New Orleans, Louisiana and Biloxi, Mississippi on May 4-5, 2006, to highlight opportunities for business investment in the Gulf Coast—specifically in Louisiana and Mississippi.

The Gulf Coast Business Investment Mission will target, but not be limited to, the following industry sectors: Agricultural Processing, Biotechnology, Chemicals, Energy, Commercial Construction, Fisheries, Information Communication Technology, Petrochemicals, Shipbuilding, Real Estate Investment and Financing, Capital Financing, Transportation, Manufacturing, Retail, and Travel & Tourism.

In order to qualify for this mission, applicants should be a senior company manager with the ability to make or recommend corporate capital allocation decisions. Applicants must also have over $5 million invested in the region already or be seriously considering and having the financial capacity to invest $5 million in the region. Selection for this mission will emphasize in particular those companies with new capital to invest in the region, whose investments will ultimately lead to economic growth, job creation in the region, and export development.

Over the past six months, Congress and the President have worked together to provide approximately $87 billion in total federal assistance for the Gulf Region. A crucial component of these efforts has been to provide tax relief to the private sector in order to encourage business development and job creation. In December of 2005, the President signed the Gulf Opportunity Zone Act, which provides $8 billion in tax relief to individuals, states, and businesses. The GO Zone Act will boost the private sector and revive the spirit of entrepreneurship across Louisiana and Mississippi. This mission will focus on the GO Zone Act's goals of Gulf private sector investment and economic development.

The Gulf Coast represents approximately 28% of U.S. domestic crude oil production and approximately 15% of U.S. national refining capacity. Additionally, trade flows between the U.S. and over 190 countries through Gulf Coast ports. The Port of New Orleans is the country's top port for imported natural rubber and coffee. Across the board, the Gulf Coast ports are national leaders in shipping agricultural products such as corn, soybeans, wheat and rice. Other leading exports from the region include chemicals, petroleum and coal products, processed foods, and transportation equipment. Additionally, the local history, arts, and cuisine of the Gulf Coast make the area a world-class travel destination. The Gulf Coast region traditionally has boasted a strong tourism industry that generates income and creates jobs.

• Bonus Depreciation: The GO Zone Act provides significant acceleration of bonus depreciation, where businesses can claim a depreciation deduction in the first year if the property used is equal to 50% of its cost.

• Small businesses: For small businesses in the affected area, the GO Zone Act will double expensing for investments and new equipment from $100,000 to $200,000.

• Education tax relief: The GO Zone Act doubles the Hope Scholarship and Lifetime Learning Credits for students attending colleges and graduate schools in the Go Zone, bolstering workforce skills of the private sector for years to come.

• Work Opportunity Tax Credit: A work-opportunity tax credit is available for employers hiring individuals located in the Go Zone.

• Employer-Provided Housing Incentives: For a six-month period, the GO Zone Act provides employers with a monthly capped 30% tax credit for the cost of employer-provided housing. In addition, up to $600 per month of such costs would be excluded from the employee's income.

The Gulf Coast Business Investment Mission will highlight nationally the investment opportunities available in the Gulf Coast following the passage of the GO Zone Act of 2005. The mission will specifically offer a program where delegation members will be briefed by leading Federal, state, and local decision-makers on the economic and business landscape in the Gulf States following Hurricanes Katrina and Rita and the opportunities available to businesses who invest in the area now. Mission members interested in exporting or developing export infrastructure will receive briefings targeted specifically at these interests. This mission is designed to highlight the opportunities for companies to invest in the Gulf Coast to foster economic growth, job creation, and export development.

The Gulf Coast Business Investment Mission will include stops in three cities: Baton Rouge and New Orleans, LA and Biloxi, MS. In each city, business delegation participants will be briefed by key federal, state, and local government officials capable of speaking to the general economic and business landscape in the Gulf Coast today, including export potential and export infrastructure, as well as the various government programs (including GO Zone and other incentives) geared towards promoting investment in the region. In addition, mission participants will hear from representatives from leading Gulf Coast businesses and business organizations.

• Briefing on the Business and Economic Landscape in Louisiana conducted by key federal, state, and local government officials.

• Tour, by motor coach, from Baton Rouse to New Orleans with stops in industrial centers, residential areas and the New Orleans Commercial District.

• Travel to Biloxi via motor coach.

• Briefing on the Business and Economic Landscape in Mississippi conducted by key federal, state, and local government officials.

• Relevance of a company's business line to mission goals.

• Company's primary business objectives for participating on this mission.

• Capacity and intent to invest $5 million or more in the region and /or current investment of $5 million or more in the Gulf Coast region.

• Rank of company official proposed for mission; participating company official should have capacity to make or recommend investment decisions.

• Timeliness of the company's signed application and supporting materials.

• Minimum of 10 and maximum of 30 participating companies on the mission.

Mission recruitment will be conducted in an open and public manner, including publication in the Federal Register , posting on the Commerce Department's Web site ( http://www.doc.gov ) and other Internet Web sites, press releases to general and trade media, direct mail, broadcast fax, notices by industry trade association and other multiplier groups, and publicity at industry meetings, symposia, conferences, and trade shows. The Department of Commerce will explore and welcome outreach assistance from other interested organizations, including other U.S. Government agencies.

Applications for the Mission will be made available March 7, 2006 through April 11, 2006. Applications can be obtained from the U.S. Department of Commerce Office of Business Liaison (202) 482-1360 or from the mission Web site at http://www.gulfcoastopportunity.gov. The application deadline is COB, Tuesday, April 11, 2006. Completed applications should be submitted to the Office of Business Liaison. Applications received after that date will be considered only if space and scheduling constraints permit.

This document contains collection-of-information requirements subject to the Paperwork Reduction Act (PRA). The use of the Business Mission Application form has been approved by OMB under control number 6900-0023. Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to penalty for failure to comply with a collection of information subject to the Paperwork Reduction Act unless that collection displays a currently valid OMB control number.

On September 9, 2005, the Department published the Preliminary Results . The Department verified questionnaire responses from respondents. For Dofasco, the Department conducted verification of Sorevco and Dofasco only, as Do Sol Galva did not ship subject merchandise during the POR. See Preliminary Results . From October 20 through October 21, 2005, the Department conducted verification of the sales questionnaire responses provided by Sorevco for this antidumping administrative review. From October 26 through October 28, 2005, the Department conducted a verification of the sales questionnaire responses submitted by Dofasco Inc. In addition, from October 24 through October 25, 2005, the Department conducted verification of the sales questionnaire responses submitted by Stelco. Our verification results are outlined in the public and proprietary versions of the Memorandum to the File: Administrative Review of Certain Corrosion-Resistant Carbon Steel Flat Products from Canada: Verification of Sorevco Inc. ( Sorevco Verification Report ), Memorandum to the File: Report on the Sales Verification of Dofasco Inc. in the Eleventh Antidumping Duty Administrative Review for Certain Corrosion-Resistant Carbon Steel Flat Products from Canada ( Dofasco Verification Report ), and Memorandum to the File: Administrative Review of Certain Corrosion-Resistant Carbon Steel Flat Products from Canada: Verification of Stelco Inc. ( Stelco Verification Report ), which are on file in the Central Records Unit (CRU), room B-099 of the Main Commerce Building.

The product covered by this antidumping duty order is certain corrosion-resistant steel, and includes flat-rolled carbon steel products, of rectangular shape, either clade, plated, or coated with corrosion-resistant metals such as zinc, aluminum, or zinc-, aluminum-, nickel- or iron-based alloys, whether or not corrugated or painted, varnished or coated with plastics or other nonmetallic substances in addition to the metallic coating, in coils (whether or not in successively superimposed layers) and of a width of 0.5 inch or greater, or in straight lengths which, if of a thickness less than 4.75 millimeters, are of a width of 0.5 inch or greater and which measures at least 10 times the thickness or if a thickness of 4.75 millimeters or more are of a width which exceeds 150 millimeters and measures at least twice the thickness, as currently classifiable in the Harmonized Tariff Schedule (HTS) under item numbers 7210.30.0030, 7210.30.0060, 7210.41.0000, 7210.49.0030, 7210.49.0090, 7210.61.0000, 7210.69.0000, 7210.70.6030, 7210.70.6060, 7210.70.6090, 7210.90.1000, 7210.90.6000, 7210.90.9000, 7212.20.0000, 7212.30.1030, 7212.30.1090, 7212.30.3000, 7212.30.5000, 7212.40.1000, 7212.40.5000, 7212.50.0000, 7212.60.0000, 7215.90.3000, 7215.90.3000, 7215.90.5000, 7217.20.1500, 7217.30.1530, 7217.30.1560, 7217.90.1000, 7217.90.5030, 7217.90.5060, and 7217.90.5090. Although the HTS subheadings are provided for convenience and customs purposes, the written description of the merchandise is dispositive.

Include in this order are corrosion-resistant flat-rolled products of non-rectangular cross-section where such cross-section is achieved subsequent to the rolling process ( i.e. , products which have been “worked after rolling”)—for example, products which have been beveled or rounded at the edges. Excluded from this order are flat-rolled steel products either plated or coated with tin, lead, chromium, chromium oxides, both tin and lead (“terne plate”), or both chromium and chromium oxides (“tin-free steel”), whether or not painted, varnished or coated with plastics or other nonmetallic substances in addition to the metallic coating. Also excluded from this order are clad products in straight lengths of 0.1875 inch or more in composite thickness and of a width which exceeds 150 millimeters and measures at least twice the thickness. Also excluded from this order are certain clad stainless flat-rolled products, which are three-layered corrosion-resistant carbon steel flat-rolled products less than 4.75 millimeters in composite thickness that consist of a carbon steel flat-rolled product clad on both sides with stainless steel in a 20%-60%-20% ratio.

We gave interested parties an opportunity to comment on our Preliminary Results following the release of our verification results for Dofasco, Sorevoco, and Stelco. The issues raised in all case and rebuttal briefs by parties to this administrative review are addressed in the Issues and Decision Memorandum for the Final Results of the Administrative Review of the Antidumping Duty Order on Certain Corrosion-Resistant Carbon Steel Flat Products from Canada , from Stephen J. Claeys to David M. Spooner, dated March 8, 2006 ( Decision Memorandum ), which is hereby adopted by this notice. A list of the issues discussed in the Decision Memorandum is appendid to this notice. The Decision Memorandum is on file in the CRU, and can be accessed directly on the Web at http://ia.ita.doc.gov .

Based on our analysis of comments received, we have corrected certain ministerial errors and made minor adjustments in the methodology that was used in the Preliminary Results concerning SAS programming errors for both Dofasco and Stelco, and disregarded Stelco's sales of off-spec, excess prime material sold through public offerings since we found them outside the ordinary course of trade. the adjustments are discussed in detail in the Decision Memorandum .

As a result of this review, we determine that the following weighted-average dumping margins exist for the period August 1, 2003, through July 31, 2004:

The Department will determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries, pursuant to 19 CFR 351.212(b). The Department calculated importer-specific duty assessment rates on the basis of the ratio of the total amount of antidumping duties calculated for the examined sales to the total entered value of the examined sales for that importer. Where the assessment rate is above de minimis , we will instruct CBP to assess duties on all entries of subject merchandise by that importer.

The Department clarified its “automatic assessment” regulation on May 6, 2003 (68 FR 23954). This clarification will apply to entries of subject merchandise during the period of review produced by companies included in these final results of reviews for which the reviewed companies did not know their merchandise was destined for the United States. In such instances, we will instruct CBP to liquidate unreviewed entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction. For a full discussion of this clarification, see Antidumping and Countervailing Duty Proceedings: Assessment of Antidumping Duties , 68 FR 23954 (May 6, 2003). In accordance with 19 CFR 356.8(a), the Department will issue appropriate assessment instructions directly to CBP on or after 41 days following the date of publication of these final results of review.

Furthermore, the following deposit requirements will be effective upon publication of the final results of this adminisrative review for all shipments of corrosion-resistant carbon steel flat products from Canada entered, or withdrawn from warehouse, for consumption on or after the publication date of these final results, as provided by section 751(a) of the Act: (1) For companies covered by this review, the cash deposit rate will be the rate listed above; (2) for previously reviewed or investigated companies not listed above, the cash deposit rate will continue to be the company-specific rate published for the most recent period; (3) if the exporter is not a firm covered in this review, a prior review, or the investigation, but the producer is, the cash deposit rate will be that established for the producer of the merchandise in these final results of review, a prior review, or in the final determination; and (4) if neither the exporter nor the producer is a firm covered in this review, a prior review, or the investigation, the cash deposit rate will be 18.71 percent, the “All Others” rate established in the less-than-fair-value investigation. These deposit requirements shall remain in effect until publication of the final results of the next administrative review.

This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) 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 presumption that reimbursement of antidumping duties occurred, and in the subsequent assessment of double antidumping duties.

This notice is the only reminder to parties subject to the administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under the APO in accordance with 19 CFR 351.305. Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.

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

On August 29, 2005, the U.S. Department of Commerce (“the Department”) published a notice of initiation of the administrative review of the antidumping duty order on certain pasta from Italy, covering the period from July 1, 2004, to June 30, 2005. See Initiation of Antidumping and Countervailing Duty Administrative Reviews and Requests for Revocation in Part , 70 FR 51009 (August 29, 2005). The preliminary results of this review are currently due no later than April 3, 2006.

Section 751(a)(3)(A) of the Tariff Act of 1930, as amended (“the Act”), requires the Department to make a preliminary determination within 245 days after the last day of the anniversary month of an order or finding for which a review is requested. Consistent with section 751(a)(3)(A) of the Act, the Department may extend the 245-day period to 365 days if it is not practicable to complete the review within a 245-day period.

We determine that completion of the preliminary results of this review within the 245-day period is not practicable because additional time is needed by the Department to gather supplemental responses from the companies participating in the review. In order to obtain and analyze necessary additional information, and in accordance with section 751(a)(3)(A) of the Act, we are extending the time period for issuing the preliminary results of review by 45 days to May 18, 2006. Therefore, the preliminary results are now due no later than May 18, 2006. The final results continue to be due 120 days after publication of the preliminary results.

This notice is published in accordance with sections 751(a)(3)(A) and 777(I) of the Act.

Fishermen and processors wishing to participate in regulated fisheries in the Exclusive Economic Zone off the coast of Alaska must obtain a Federal Fisheries Permit, a Federal Processor Permit, or an Exempted Fisheries Permit. The application information is used to identify participants in the fishery, aid enforcement of fishery regulations, and analyze activity within the fisheries.

Paper applications are required from participants, and methods of submittal include e-mail and facsimile transmission of paper forms.

OMB Number: 0648-0206.

Form Number: None.

Type of Review: Regular submission.

Affected Public: Business or other for-profit organizations, individuals or households, and not-for-profit institutions.

Estimated Number of Respondents: 889.

Estimated Time Per Response: 21 minutes for Federal Fisheries Permit application; 21 minutes for Federal Processor Permit application; and 35 hours for Exempted Fisheries Permit application.

Estimated Total Annual Burden Hours: 483.

Estimated Total Annual Cost to Public: $1,330.

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

Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.

Reporting injury to and/or mortalities of marine mammals is mandated under section 118 of the Marine Mammal Protection Act. This information is required to determine the impacts of commercial fishing on marine mammal populations. This information is also used to categorize commercial fisheries into Categories I, II, or III. The participants in the first two categories have to be authorized to take marine mammals, while those in Category III are exempt from that requirement. All categories must report injuries or mortalities on a National Marine Fisheries Service form.

Reports are required from participants, and methods of submittal include Internet, mail and facsimile transmission of paper forms.

OMB Number: 0648-0292.

Form Number: None.

Type of Review: Regular submission.

Affected Public: Not-for-profit institutions; and business or other for-profit organizations.

Estimated Number of Respondents: 200.

Estimated Time per Response: 15 minutes.

Estimated Total Annual Burden Hours: 50.

Estimated Total Annual Cost to Public: $0.

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

Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.

The Committee will receive a report from the Fishery Management Action Team (FMAT) on the status of the Omnibus SBRM Amendment to the Council's FMPs. The Committee will review the background, purpose and need for the amendment. The Committee will also review the proposed structure for the amendment and discuss and review (as available) the information necessary to complete the amendment. The Committee will identify any additional issues to be addressed in the amendment and its recommendations will be reported to the Council at its April 4-5, 2006 meeting.Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.

This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Paul J. Howard, Executive Director, at 978-465-0492, at least 5 days prior to the meeting date.

The CBTPA and ATPDEA provide for quota- and duty-free treatment for qualifying textile and apparel products. Such treatment is generally limited to products manufactured from yarns and fabrics formed in the United States or a beneficiary country. The CBTPA and ATPDEA also provide for duty-free treatment for apparel articles that are both cut (or knit-to-shape) and sewn or otherwise assembled in one or more CBTPA and ATPDEA beneficiary countries from fabric or yarn that is not formed in the United States or a beneficiary country, if it has been determined that such fabric or yarn cannot be supplied by the domestic industry in commercial quantities in a timely manner. In Executive Order No. 13191, the President delegated to CITA the authority to determine whether yarns or fabrics cannot be supplied by the domestic industry in commercial quantities in a timely manner under the CBTPA and ATPDEA and directed CITA to establish procedures to ensure appropriate public participation in any such determination. On March 6, 2001, CITA published procedures that it will follow in considering requests (66 FR 13502).

On October 5, 2005, following a determination that certain compacted, plied, ring spun cotton yarns could not be supplied by the domestic industry in commercial quantities in a timely manner under the CBTPA and ATPDEA, CITA designated certain apparel made from U.S. formed fabric containing such yarns as eligible for duty-free treatment under the CBTPA and ATPDEA. On January 10, 2006, the Chairman of CITA received a petition from The National Council of Textiles Organizations (NCTO) alleging that yarns substitutable for these yarns can be supplied by the domestic industry in commercial quantities in a timely manner, and requesting that CITA revoke its previous designation regarding these yarns. On January 17, 2006, CITA published a Federal Register notice requesting public comments on NCTO's request (71 FR 3057).

The Industry Trade Advisory Committees (ITACs) charters and members' appointments expired on February 5, 2006, and have not yet been renewed. Therefore, CITA was not able to seek ITAC advice on this request. USTR requested the advice of the U.S. International Trade Commission (ITC) on the probable economic effects on the domestic industry of granting the request.

On February 6, 2006, CITA and USTR offered to hold consultations with the Senate Finance Committee and the House Ways and Means Committee. The Senate Finance Committee responded with general procedural questions, but provided no substantive comments. CITA met with the House Ways and Means Committee on March 9, 2006, and discussed CITA's authority to revoke a prior designation and discussed the substance of the case.

CITA carefully reviewed the request, the comments, advice received, and met with interested parties on February 22, 2006. Based on our review of the information provided, the ITC report, the public comments received, and our knowledge in the industry, CITA finds that the subject yarns cannot be supplied by the domestic industry in commercial quantities in a timely manner. CITA also finds that the petitioner has not substantiated its claim that ring spun yarns currently produced by the domestic industry are substitutable for the subject compact, plied yarns.

On the basis of currently available information and our review of this request, CITA has determined that the domestic industry cannot supply the subject fabrics in commercial quantities in a timely manner. Therefore, CITA is denying the request to revoke its previous designation.

The OMB is particularly interested in comments which:

• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Corporation, including whether the information will have practical utility;

• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

• Propose ways to enhance the quality, utility, and clarity of the information to be collected; and

• Propose ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.

A 60-day public comment Notice was published in the Federal Register on November 25, 2005. This comment period ended January 24, 2006. No public comments were received from this notice.

Currently, the Corporation is soliciting comments concerning its proposed collection of State Service Plans from State Commissions. These plans are submitted by State Commissions as required by statute. The plans are elicited in order to assure that national service and volunteer service entities within a state are aware of each other and are coordinating activities to maximize their ability to leverage both human and financial resources in order to address significant unmet community needs.

This new proposed information collection consists of the following instruction:

In 2006, the Corporation requests that you address the following questions in order to comply with the statutory requirement to provide a State Service Plan:

1. Please describe your projected program focus for the next three years of planned state service activities.

2. Please describe ongoing efforts or special initiatives that involve collaborating with the Corporation State Office, State Education Agencies, state networks of volunteer centers, Campus Compacts, National Direct grantees and/or other service organizations within the state.

3. What non-monetary support do you believe you need from the Corporation (Headquarter Offices and/or your State Office) in order for your State Plan to be successful (such as training and technical assistance, for example)?

Your State Service Plan may also include other elements that you and your service partners find useful.

Type of Review: New.

Agency: Corporation for National and Community Service.

Title: State Service Plans.

OMB Number: None.

Agency Number: None.

Affected Public: State Service Commissions.

Total Respondents: 54.

Frequency: Once every three years.

Average Time Per Response: 24 hours.

Estimated Total Burden Hours: 1296 hours.

Total Burden Cost (capital/startup): None.

Total Burden Cost (operating/maintenance): None.

The OMB is particularly interested in comments which:

• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Corporation, including whether the information will have practical utility;

• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

• Propose ways to enhance the quality, utility, and clarity of the information to be collected; and

• Propose ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.

A 60-day public comment Notice was published in the Federal Register on January 4, 2006. This comment period ended March 6, 2006. No public comments were received from this notice.

Description: The Corporation is seeking approval of the National Evaluation of Youth Corps which will be used to learn about the effects of national service on youth corps participants. The study uses an experimental design to assess the outcomes associated with participation in national service. The information collection will be completed by individuals applying to Youth Corps programs.

Type of Review: New.

Agency: Corporation for National and Community Service.

Title: National Evaluation of Youth Corps.

OMB Number: None.

Agency Number: None.

Affected Public: Applicants to Youth Corps programs.

Total Respondents: 7,500.

Frequency: On occasion.

Average Time Per Response: 35 minutes.

Estimated Total Burden Hours: 4,375 hours.

Total Burden Cost (capital/startup): None.

Total Burden Cost (operating/maintenance): None.

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

Tentative Agenda: Oak Ridge Reservation Planning—Integrating Multiple Land Uses

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

Minutes: Minutes of this meeting will be available for public review and copying at the Department of Energy's Information Center at 475 Oak Ridge Turnpike, Oak Ridge, TN between 8 a.m. and 5 p.m., Monday through Friday, or by writing to Pat Halsey, Department of Energy Oak Ridge Operations Office, P.O. Box 2001, EM-90, Oak Ridge, TN 37831, or by calling her at (865) 576-4025.

EPA ICR No. 1613.02; Data Reporting Requirements for State and Local Vehicle Emission Inspection and Maintenance (I/M) Programs (Reinstatement); in 40 CFR part 51, subpart S; was approved February 22, 2006; OMB Number 2060-0252; expires February 28, 2009.

EPA ICR No. 1852.03; Exclusion Determinations for New Non-road Spark-ignited Engines at or Below 19 Kilowatts, New Non-road Compression-ignited Engines, New Marine Engines, and New On-road Heavy Duty Engines (Renewal); in 40 CFR part 85, subpart R; 40 CFR part 89, subpart A; 40 CFR part 90, subpart J; 40 CFR part 91, subpart K; was approved February 22, 2006; OMB Number 2060-0395; expires February 28, 2009.

EPA ICR No. 2186.01; National Emissions Standards for Hazardous Air Pollutants from Plating and Polishing Operations; was approved February 22, 2006; OMB Number 2060-0577; expires February 28, 2009.

EPA ICR No. 1801.04; NESHAP for Portland Cement (Renewal); in 40 CFR part 63, subpart LLL; was approved February 22, 2006; OMB Number 2060-0416; expires February 28, 2009.

EPA ICR No. 1867.03; Voluntary Aluminum Industrial Partnership (VAIP) (Renewal); was approved February 17, 2006; OMB Number 2060-0411; expires February 28, 2009.

EPA ICR No. 1856.05; NESHAP for Primary Lead Smelters (Renewal); in 40 CFR part 63, subpart TTT); was approved February 10, 2006; OMB Number 2060-0414; expires February 28, 2009.

EPA ICR No. 0983.08; NSPS for Equipment Leaks of VOC in Petroleum Refineries (Renewal); in 40 CFR part 60, subpart GGG; was approved February 14, 2006; OMB Number 2060-0067; expires February 28, 2009.

EPA ICR No. 1060.13; NSPS for Steel Plants; Electric Arc Furnaces and Argon-Oxygen Decarburization Vessels (Final Rule Amendments); in 40 CFR part 60, subparts AA and AAa); was approved February 10, 2006; OMB Number 2060-0038; expires November 30, 2006.

EPA ICR No. 1821.05; NESHAP for Steel Pickling (Renewal); in 40 CFR part 63, subpart CCC); was approved February 10, 2006; OMB Number 2060-0419; expires February 28, 2009.

EPA ICR No. 1363.14; Toxic Chemical Release Reporting (Form R) (Renewal); in 40 CFR part 372; was approved March 3, 2006; OMB Number 2070-0093; expires January 31, 2008.

EPA ICR No. 1704.08; Toxic Chemical Release Reporting, Alternate Threshold for Low Annual Reportable Amounts (Form A) (Renewal); in 40 CFR part 372; was approved March 3, 2006; OMB Number 2070-0143; expires January 31, 2008.

EPA ICR No. 1871.04; NESHAP for Source Categories (Renewal); Generic Maximum Achievable Control Technology Standards; in 40 CFR part 63, subpart YY; was approved March 3, 2006; OMB Number 2060-0420; expires March 31, 2009.

EPA ICR No. 0660.09; NSPS for Metal Coil Surface Coating (Renewal); in 40 CFR part 60, subpart TT; was approved February 17, 2006; OMB Number 2060-0107; expires February 28, 2009.

EPA ICR No. 1788.06; NESHAP for Oil and Natural Gas Production (Renewal); in 40 CFR part 63, subpart HH; was approved March 3, 2006; OMB Number 2060-0417; expires March 31, 2009.

EPA ICR No. 2163.02; NSPS: Other Solid Waste Incineration (OSWI) Units (Final Rule); in 40 CFR part 60, subpart EEEE; was approved March 6, 2006; OMB Number 2060-0563; expires March 31, 2009.

EPA ICR No. 2164.02; Emission Guidelines for Existing Other Solid Waste Incineration (OSWI) Units (Final Rule); in 40 CFR part 60, subpart FFFF; was approved March 6, 2006; OMB Number 2060-0562; expires March 31, 2009.

EPA ICR No. 1591.16; Regulation of Fuels and Fuel Additives (Direct Final and Proposed Rules for Butane and Attest Engagements); was approved March 6, 2006; OMB Number 2060-0277; expires October 31, 2007.

EPA ICR No. 1964.03; NESHAP for Wet-formed Fiberglass Mat Production (Renewal); in 40 CFR part 63, subpart HHHH; was approved March 6, 2006; OMB Number 2060-0496; expires March 31, 2009.

EPA ICR No. 2180.02; Recordkeeping and Reporting for the Performance-Based Qualification of Test Methods for Diesel Fuel (Renewal); in 40 CFR 80.29; 40 CFR 80.240; 40 CFR 80.530-80.532; 40 CFR 80.535-80.536; 40 CFR 80.550-80.555; 40 CFR 80.560-80.561; 40 CFR 80.590-80.594; 40 CFR 80.597; 40 CFR 80.600-80.604; 40 CFR 80.607; 40 CFR 80.620; was approved March 6, 2006; OMB Number 2060-0566; expires March 31, 2009.

EPA ICR No. 0575.09; Health and Safety Data Reporting; Submission of Lists and Copies of Health and Safety Studies; OMB Number 2070-0004; on February 22, 2006 OMB extended the expiration date to May 31, 2006.

EPA ICR No. 0783.48; Fuel Economy Labeling of Motor Vehicles (Proposed Rule); OMB Number 2060-0104; OMB filed comments on March 6, 2006.

The Act affords EPA a 45-day period to review, and to object to as appropriate, a title V operating permit proposed by a state permitting authority. Section 505(b)(2) of the Act, 42 U.S.C. 7661d(b)(2), authorizes any person to petition the EPA Administrator within 60 days after the expiration of the EPA review period to object to a title V operating permit if EPA has not done so. Petitions must be based only on objections to the permit that were raised with reasonable specificity during the public comment period, unless the petitioner demonstrates that it was impracticable to raise the issues during the comment period, or the grounds for the issues arose after the public comment period.

On February 18, 2004, the EPA received from the Sierra Club and American Bottom Conservancy a petition requesting that EPA object to the proposed title V operating permit for Onyx Environmental Services. The Sierra Club and American Bottom Conservancy alleged that the proposed permit (1) violates EPA's commitments and obligations to address environmental justice issues; (2) lacks a compliance schedule and certification of compliance; (3) does not address modifications Onyx allegedly took that triggered new source review requirements; (4) is based on an eight-year old application; (5) lacks practically enforceable conditions; (6) contains a permit shield that broadly insulates it from ongoing and recent violations; (7) fails to include conditions that meet the legal requirements for monitoring; (8) does not contain a statement of basis; (9) does not require prompt reporting of violations; and (10) fails to establish annual mercury and lead limits.

On February 1, 2006, the Administrator signed an order partially granting and partially denying the petition. The order explains the reasons behind EPA's conclusion that the IEPA must: (1) Address the significant comments concerning the possible need for a compliance schedule in the proposed permit; (2) require Onyx Environmental Services to submit a current compliance certification; (3) address comments concerning modifications made at the Onyx facility and the potential applicability of new source review requirements; (4) require Onyx Environmental Services to submit an updated application that reflects all applicable requirements for the source; (5) make clear either in the permit or statement of basis what constitutes “normal” operating conditions; (6) amend the permit to limit Onyx Environmental Service's election to regulatory requirements applicable to hazardous waste incinerators; (7) define the terms “container” and “containerized solids,” or explain in the statement of basis where the terms are defined; (8) provide information on where the applicable specifications pertaining to “manufacturer's specifications” can be located; (9) provide a statement of basis that complies with the requirements of EPA regulations and post its statement of basis on a Web site, or make available to the public on the Web site a notice telling the public where it can obtain the statement of basis; and (10) explain how a thirty day reporting requirement for all deviations is prompt or require a shorter reporting period for deviations as is provided for in 40 CFR part 71. The order also explains the reasons for denying Sierra Club and American Bottom Conservancy's remaining claims.

Pursuant to sections 505(b)(2) and 307 of the Act, Petitioners have 60 days from the date that this notice appears in the Federal Register to petition the United States Court of Appeals for the Seventh Circuit for review of the portions of the petition which EPA denied.

1. Submitting CBI. Do not submit this information to EPA through http://www.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:

• Identify the rulemaking by docket number and other identifying information (subject heading, Federal Register date and page number).

• 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.

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

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

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

• Provide specific examples to illustrate your concerns, and suggest alternatives.

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

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

DOE is developing the WIPP near Carlsbad in southeastern New Mexico as a deep geologic repository for disposal of TRU radioactive waste. As defined by the WIPP Land Withdrawal Act (LWA) of 1992 (Pub. L. 102-579), as amended (Pub. L. 104-201), TRU waste consists of materials containing processes having atomic numbers greater than 92 (with half-lives greater than twenty years), in concentrations greater than 100 nanocuries of alpha-emitting TRU isotopes per gram of waste. Much of the existing TRU waste consists of items contaminated during the production of nuclear weapons, such as rags, equipment, tools, and sludges.

On May 13, 1998, EPA announced its final compliance certification decision to the Secretary of Energy (published May 18, 1998, 63 FR 27354). This decision stated that the WIPP will comply with EPA's radioactive waste disposal regulations at 40 CFR part 191, subparts B and C.

The final WIPP certification decision includes conditions that (1) prohibit shipment of TRU waste for disposal at WIPP from any site other than the Los Alamos National Laboratories (LANL) until the EPA determines that the site has established and executed a quality assurance program, in accordance with §§ 194.22(a)(2)(i), 194.24(c)(3), and 194.24(c)(5) for waste characterization activities and assumptions (Condition 2 of Appendix A to 40 CFR part 194); and (2) (with the exception of specific, limited waste streams and equipment at LANL) prohibit shipment of TRU waste for disposal at WIPP (from LANL or any other site) until EPA has approved the procedures developed to comply with the waste characterization requirements of § 194.22(c)(4) (Condition 3 of Appendix A to 40 CFR part 194). The EPA's approval process for waste generator sites is described in § 194.8.

In July 2004, EPA promulgated changes to the “Criteria for the Certification and Recertification of the Waste Isolation Pilot Plant's Compliance with Disposal Regulations” (69 FR 42571-42583, July 16, 2004). These changes went into effect October 14, 2004, which modified the EPA approval of waste characterization (“WC”) programs at DOE's TRU waste sites. These revisions provide equivalent or improved oversight and better prioritization of technical issues in EPA inspections to evaluate WC activities at DOE WIPP waste generator sites, and also offer more direct public input into the Agency's decisions about what waste can be disposed of at WIPP. They do not modify the technical approach that EPA has employed since the 1998 WIPP Certification Decision.

Condition 3 of the WIPP Certification Decision requires that EPA conduct independent inspections at DOE's waste generator/storage sites of their TRU waste characterization capabilities before approving their program and the waste for disposal at the WIPP. The revised inspection and approval process gives EPA greater (a) discretion in establishing technical priorities, (b) ability to accommodate variation in the site's waste characterization capabilities, and (c) flexibility in scheduling site WC inspections. The § 194.8 changes require that EPA conduct a baseline inspection at every previously approved TRU site (such as SRS CCP). EPA expects that within two years after the effective date of October 2004 most of the previously approved TRU sites (such as Hanford, Los Alamos CCP, and Savannah River Site CCP) will undergo EPA baseline inspections. Following these inspections, the Agency will issue a new baseline compliance decision for these sites.

As part of the baseline inspection, EPA must evaluate each WC process component (equipment, procedures, and personnel training/experience) for its adequacy and appropriateness in characterizing TRU waste destined for the disposal at WIPP. During the inspection, the site demonstrates its capabilities to characterize TRU waste(s) and its ability to comply with the regulatory limits and tracking requirements under § 194.24. The baseline inspection can result in approval with limitations/conditions or may require follow-up inspection(s) before approval. The approval must specify what subsequent WC program changes or expansion should be reported to EPA. The Agency is required to assign Tier 1 (“TI”) and Tier 2 (“T2”) to the reportable changes depending on their potential impact on data quality. A T1 designation requires that the site must notify EPA of proposed changes to the approved components of an individual WC process (such as radioassay equipment or personnel), and EPA must also approve the change before it can be implemented. A WC element with a T2 designation allows the site to implement changes to the approved components of individual WC processes (such as visual examination procedures) but requires EPA notification. The Agency may choose to inspect the site to evaluate technical adequacy before approval. EPA inspections conducted to evaluate T1 or T2 changes are follow-up inspections under the authority of § 194.24(h). In addition to the follow-up inspections, if warranted, EPA may opt to conduct continued compliance inspections at TRU waste sites with a baseline approval under the authority of § 194.24(h).

The revisions to the site inspection and approval process outlined in § 194.8 require EPA to issue a Federal Register notice proposing the baseline compliance decision, docket the inspection report for public review, and seek public comment on the proposed decision for a period of 45 days. The report must describe the WC processes EPA inspected at the site, as well as their compliance with § 194.24 requirements.

From October 31-November 3, 2005, EPA performed a baseline inspection of TRU waste characterization activities of the DOE's CCP staff at SRS (EPA Inspection No. EPA-SRS-CCP-10.05-8). This inspection is the second baseline inspection that EPA has performed under the § 194.8 regulatory changes promulgated in July 2004.

The CCP is a mobile characterization program that assists TRU waste generator sites with complex waste characterization activities. At some sites (such as Los Alamos National Laboratory and Savannah River Site) and small TRU waste generator sites (such as Argonne National Laboratory and Lawrence Livermore National Laboratory) the CCP has the sole responsibility to characterize contact-handled (“CH”), retrievably-stored TRU waste destined for the disposal at the WIPP.

The purpose of EPA's inspection was to verify that CCP is characterizing CH TRU retrievably-stored debris waste (S5000) and soils/gravel (S4000) from SRS properly and in compliance with the regulatory requirements at 40 CFR 194.24. EPA did not evaluate the characterization of solid waste (S3000) at this time and will inspect this at a later date. During the inspection, EPA also evaluated CCP's use of the WIPP Waste Information System (“WWIS”) for tracking the contents of CH TRU waste containers destined for disposal at WIPP. This tracking ensures that the volume emplaced in the WIPP repository and characteristics of the emplaced wastes conform to the requirements of the WIPP LWA and the specific conditions of the WIPP Certification Decision.

During the inspection, EPA evaluated the adequacy, implementation, and effectiveness of SRS-CCP's waste characterization activities. The Agency's evaluation focused on the individual components—equipment, procedures, and personnel training/experience of the following waste characterization processes: Acceptable knowledge (“AK”), nondestructive assay (“NDA”), visual examination techniques (“VET”), visual examination/real-time radiography (“VE/RTR”), load management, and the WWIS. The overall program adequacy and effectiveness of SRS-CCP was based on the following DOE-provided upper-tier documents: (1) CCP-PO-001—Revision 11, 3/10/05—CCP Transuranic Waste Characterization Quality Assurance Project Plan and (2) CCP-PO-002—Revision 12, 3/10/05—CCP Transuranic Waste Certification Plan.

EPA evaluated the CCP-implemented waste characterization processes at SRS for specific CH TRU waste categories, as follows:

• Acceptable knowledge (AK) and load management for contact-handled (“CH”) retrievably-stored and newly-generated TRU debris waste (S5000) and soil/gravel waste (S4000).

• Visual examination techniques (“VET”) for CH newly-generated debris waste (S5000) and soil/gravel waste (S4000).

• Visual examination (“VE”) as a quality control check of real-time radiography (“RTR”) for CH retrievably-stored TRU debris waste (S5000) and soil/gravel waste (S4000).

• RTR for CH retrievably-stored TRU debris waste (S5000) and soil/gravel waste (S4000).

• Nondestructive assay (“NDA”) and the WIPP Waste Information System (“WWIS”) for CH retrievably-stored and newly-generated TRU debris waste (S5000) and soil/gravel waste (S4000).

Two NDA systems (Imaging Passive-Active Neutron/Gamma Energy Analysis [“IPAN/GEA”] system and the MCS IQ3 gamma system) were evaluated for characterizing debris (S5000) and soil/gravel (S4000) wastes.

In addition to reviewing individual components (namely, procedures, and equipment) of each of the WC processes (AK, NDA, VET, VE/RTR, load management, and the WWIS), the Agency interviewed and reviewed training records of personnel responsible for compiling data, analyzing waste contents, operating equipment, and preparing data for WWIS tracking. EPA also required radioassay replicate analysis on selected containers from the population of previously analyzed waste containers on the same system or instrument for the two different waste categories. The purpose of this replicate testing is to provide EPA with an independent means to verify that the radioassay equipment being assessed for approval can provide consistent, reproducible results for the determination of the quantity of 10 WIPP-tracked radionuclides (241Am, 137Cs, 238Pu, 239Pu, 240Pu, 242Pu, 90Sr, 233U, 234U, and 238U) as well as TRU alpha concentration. The results of the replicate analysis help EPA to determine whether:

• The instrument produces results consistent with the reported total measurement uncertainty (“TMU”) by comparing the sample standard deviation for a number of replicate measurements taken over several hours or days to the reported TMU.

• The instrument provides reproducible results over longer periods of time, such as weeks or months, by comparing the results of the replicate measurement(s) to the original reported values.

EPA's inspection team identified one finding and five concerns. The one finding and two of the concerns required a response from DOE. All concerns and findings are documented on EPA Inspection Issue Tracking Forms (see Attachments C.1 through C.6 of the baseline Inspection Report available in the EPA Docket). The Agency received responses to the one finding and two concerns which required responses and, upon further evaluation, concluded that the responses were adequate. As a result, there are no open issues resulting from this inspection.

EPA's inspection team determined that SRS-CCP's WC program activities were technically adequate. EPA is proposing to approve the SRS-CCP WC program in the configuration observed during this inspection and described in this report and in the checklists in Attachment A. This proposed approval includes the following waste characterization activities:

(1) The AK and load management process for CH retrievably-stored TRU debris and soil/gravel,

(2) The IPAN and IQ3 NDA systems for assaying soil/gravel and debris waste,

(3) VE as a QC check of the RTR process for retrievably-stored soil/gravel and debris waste,

(4) The VET process for newly-generated debris and soil/gravel wastes,

(5) The nondestructive examination process of RTR for retrievably-stored soil/gravel and debris wastes, and

(6) The WWIS process for tracking of waste contents of debris and soil/gravel wastes. As required by the new (194.8 revisions, EPA has assigned specific “tiers” to the different waste characterization processes. As seen from the table below, both T1 and T2 changes are reportable changes. A T1 change requires EPA approval prior to implementation of the change and may require EPA inspection to determine technical adequacy. A T2 change may be implemented prior to EPA approval; however, this type of change must be reported to EPA quarterly. Any changes to WC activities from the date of the baseline inspection must be reported to and, if applicable, approved by EPA, according to the following table:

EPA will notify the public of the results of its evaluations of proposed T1 and T2 changes through the WIPP Website and by sending messages via the WIPP-NEWS e-mail listserv. All T1 changes must be submitted for approval before their implementation and will be evaluated by EPA. Upon approval, EPA will post the results of the evaluations via the WIPP Website and the WIPP-NEWS listserv, as described above. The Agency will post T2 changes approximately every three months beginning with the date of EPA's approval of the TRU WC program implemented at SRS-CCP. EPA expects the first report of SRS-CCP's T2 changes approximately three months from the date of EPA's approval of the TRU WC program implemented at SRS-CCP.

The scope of the proposed site baseline compliance decision is based on EPA's inspection completed on November 3, 2005. The Agency will not approve any changes to the SRS-CCP program until this proposed baseline approval is finalized. Based on prior approvals, SRS-CCP is currently approved to dispose of debris waste (S5000) at the WIPP. SRS-CCP is permitted to continue WC and disposal of debris waste while EPA evaluates public comment to this proposed approval and establishes a final approval.

EPA has placed the report discussing the results of EPA's inspection of the CCP at SRS in the public docket as described in ADDRESSES . In accordance with 40 CFR 194.8, EPA is providing the public 45 days to comment on these documents. The Agency requests comments on the tiering designations and the proposed approval decision. EPA will accept public comment on this notice and supplemental information as described in Section 1.B. above. The EPA will not make a determination of compliance before the 45-day comment period ends. At the end of the public comment period, EPA will evaluate all relevant public comment and revise the inspection report as necessary. The Agency will then issue an approval letter and the final inspection report, both of which will be posted on the WIPP Web site. The letter of approval will allow CCP to use the approved TRU waste characterization processes to characterize TRU waste at SRS.

Information on the certification decision is filed in the official EPA Air Docket, Docket No. A-93-02 and is available for review in Washington, DC, and at the three EPA WIPP informational docket locations in New Mexico (as listed in ADDRESSES ). The dockets in New Mexico contain only major items from the official Air Docket in Washington, DC, plus those documents added to the official Air Docket since the October 1992 enactment of the WIPP LWA.

In April 2000, the Environmental Protection Agency (EPA) asked ICCVAM to evaluate the validation status of in vitro ER and AR binding and TA assays that were proposed as possible components of the EPA Endocrine Disruptor Screening Program Tier 1 screening battery. ICCVAM agreed to evaluate these test methods based on their potential interagency applicability and public health significance. NICEATM, which administers and provides scientific support for ICCVAM, subsequently compiled available data and information on in vitro ER and AR binding and TA assays in four draft Background Review Documents (BRDs) (available at http://iccvam.niehs.nih.gov/methods/endocrine.htm ).

In collaboration with the ICCVAM Endocrine Disruptor Working Group, NICEATM organized an independent scientific evaluation of the validation status of the four types of in vitro endocrine disruptor screening test methods on May 20-21, 2002, in Research Triangle Park, NC ( Federal Register , Vol. 66, No. 57, pp. 16278-16279, March 23, 2001 and Federal Register , Vol. 66, No. 67, pp. 16415-16416, April 5, 2002) (available at http://iccvam.niehs.nih.gov/methods/endocrine.htm ).

The final BRDs and the ICCVAM Test Method Evaluation Report, which includes the expert panel report, public comments, and other relevant documents, were published in May 2003 and announced in a Federal Register notice (Vol. 68, No. 106, pp. 33171-33172, June 3, 2003) (available at http://iccvam.niehs.nih.gov/methods/endocrine.htm ).

NICEATM recently reviewed the commercial availability and cost for the 78 substances recommended by ICCVAM for use in in vitro ER and AR binding and TA validation studies. A minimum of 44 substances are recommended for AR binding and TA assays, while a minimum of 53 substances are recommended for ER binding and TA assays. This review indicated that three substances [anastrazole, CGS 18320B, fadrozole] are not commercially available, one substance has restricted commercial availability [ICI 182,780] and six others [actinomycin D, hydroxyflutamide, 4-hydroxytamoxifen, methyltrienolone, 12-O-tetradecanoylphorbol-13-acetate, zearalenone] have costs that are considered excessive. ICCVAM proposes replacing the four substances that are not commercially available or have restricted availability with ones having similar ER and AR activity profiles [4-hydroxyandrostenedione, chrysin, dicofol, raloxifene HCl]. Suitable replacements (19-nortestosterone and resveratrol) were identified for metyltrienolone and zearalenone, respectively, for two of the expensive substances. NICEATM would also prefer to replace four of the highly priced substances [actinomycin D, hydroxyflutamide, 4-hydroxytamoxifen, 12-O-tetradecanoy.lphorbol-13-acetate], but has been unable to identify suitable replacements because of their unique activity profiles and/or chemical/physical properties. The revised list of 78 substances and a discussion about the proposed revisions are included and discussed in the “Addendum to the ICCVAM Evaluation of In Vitro Test Methods for Detecting Potential Endocrine Disruptors: Estrogen Receptor and Androgen Receptor Binding and Transcriptional Activation Assays,” (available at http://iccvam.niehs.nih.gov see “Test Method Evaluations”) or by contacting NICEATM (see ADDRESSES above.) ICCVAM will finalize this list after considering any public comments received and forward it to U.S. Federal agencies for their information and consideration.

NICEATM requests public comments on the four substances (listed above) proposed as replacements for substances on the list that are not readily commercially available. NICEATM also requests public comments on the proposed replacements for the two expensive substances for which replacements have been identified, and suggestions for replacements for the four expensive substances that remain on the recommended list.

In order to update the reference substance database, NICEATM request data from completed in vitro studies using or evaluating ER and AR binding and/or TA assays, and information about ongoing or planned studies using or evaluating these test methods. NICEATM also requests the submission of data from animal studies that have evaluated the endocrine activity of chemicals using, for example, the uterotropic, Hershberger, intact male, or male/female pubertal assays. NICEATM is especially interested in receiving additional data or information on any of the 78 substances included in the reference list. NICEATM previously requested data from completed studies using or evaluating ER and AR binding and/or TA assays, and information about ongoing or planned in vitro or in vivo studies using or evaluating these test methods ( Federal Register , Vol. 66, No. 57, pp. 16278-16279, March 23, 2001). Submitted data will be used to update and supplement the existing NICEATM database; the current database can be accessed in the ICCVAM Test Method Evaluation Report [NIH Publication No. 03-4503] and the four final BRDs on ER and AR binding and TA assays [NIH Publication No. 03-4504, 03-4505, 03-4506, and 03-4507] (available at http://iccvam.niehs.nih.gov/methods/endocrine.htm ).

When submitting chemical and protocol information/test data, please reference this Federal Register notice and provide appropriate contact information (name, affiliation, mailing address, phone, fax, e-mail, and sponsoring organization, as applicable).

NICEATM prefers data to be submitted as copies of pages from study notebooks and/or study reports, if available. Raw data and analyses available in electronic format may also be submitted. If data are published in the peer-reviewed literature, citations should be provided. Each submission for a chemical should preferably include the following information, as appropriate:

• Common and trade name

• Chemical Abstracts Service Registry Number (CASRN)

• Chemical class

• Product class

• Commercial source

• In vitro test protocol used

• In vitro test results

• In vivo test protocol used

• In vivo test results

• The extent to which the study complied with national or international Good Laboratory Practice (GLP) guidelines

• Date and testing organization

ICCVAM is an interagency committee composed of representatives from 15 Federal regulatory and research agencies that use or generate toxicological information. ICCVAM conducts technical evaluations of new, revised, and alternative methods with regulatory applicability and promotes the scientific validation and regulatory acceptance of toxicological test methods that more accurately assess the safety and hazards of chemicals and products and that refine, reduce, or replace animal use. The ICCVAM Authorization Act of 2000 (Pub. L. 106-545) establishes ICCVAM as a permanent interagency committee of the NIEHS under the NICEATM. NICEATM administers the ICCVAM and provides scientific and operational support for ICCVAM-related activities. NICEATM and ICCVAM work collaboratively to evaluate new and improved test methods applicable to the needs of Federal agencies. Additional information about ICCVAM and NICEATM can be found at the following Web site: http://www.iccvam.niehs.nih.gov.

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

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

FDA is requesting OMB approval under the PRA for the reporting and recordkeeping requirements contained in the regulations implementing the Prescription Drug Marketing Act of 1987 (PDMA) (Public Law 100-293). PDMA was intended to ensure that drug products purchased by consumers are safe and effective and to avoid an unacceptable risk that counterfeit, adulterated, misbranded, subpotent, or expired drugs are sold.

PDMA was enacted by Congress because there were insufficient safeguards in the drug distribution system to prevent the introduction and retail sale of substandard, ineffective, or counterfeit drugs, and that a wholesale drug diversion submarket had developed that prevented effective control over the true sources of drugs.

Congress found that large amounts of drugs had been reimported into the United States as U.S. goods returned causing a health and safety risk to U.S. consumers because the drugs may become subpotent or adulterated during foreign handling and shipping. Congress also found that a ready market for prescription drug reimports had been the catalyst for a continuing series of frauds against U.S. manufacturers and had provided the cover for the importation of foreign counterfeit drugs.

Congress also determined that the system of providing drug samples to physicians through manufacturers' representatives had resulted in the sale to consumers of misbranded, expired, and adulterated pharmaceuticals.

The bulk resale of below wholesale priced prescription drugs by health care entities for ultimate sale at retail also helped to fuel the diversion market and was an unfair form of competition to wholesalers and retailers who had to pay otherwise prevailing market prices.

FDA is requesting OMB approval for the following reporting and recordkeeping requirements:

The reporting and recordkeeping requirements are intended to help achieve the following goals:

1. To ban the reimportation of prescription drugs produced in the United States, except when reimported by the manufacturer or under FDA authorization for emergency medical care;

2. To ban the sale, purchase, or trade, or the offer to sell, purchase, or trade, of any prescription drug sample;

3. To limit the distribution of drug samples to practitioners licensed or authorized to prescribe such drugs or to pharmacies of hospitals or other health care entities at the request of a licensed or authorized practitioner;

4 To require licensed or authorized practitioners to request prescription drug samples in writing;

5. To mandate storage, handling, and recordkeeping requirements for prescription drug samples;

6. To prohibit, with certain exceptions, the sale, purchase, or trade of, or the offer to sell, purchase, or trade, prescription drugs that were purchased by hospitals or other health care entities, or which were donated or supplied at a reduced price to a charitable organization;

7. To require unauthorized wholesale distributors to provide, prior to the wholesale distribution of a prescription drug to another wholesale distributor or retail pharmacy, a statement identifying each prior sale, purchase, or trade of the drug.

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

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

Section 12.45 (21 CFR 12.45), issued under section 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371), sets forth the format and procedures for any interested person to file a petition to participate in a formal evidentiary hearing, either personally or through a representative. Section 12.45 requires that any person filing a notice of participation state their specific interest in the proceedings, including the specific issues of fact about which the person desires to be heard. This section also requires that the notice include a statement that the person will present testimony at the hearing and will comply with specific requirements in § 12.85, or, in the case of a hearing before a Public Board of Inquiry (21 CFR 13.25). In accordance with § 12.45(e) the presiding officer may omit a participant's appearance.

The presiding officer and other participants will use the collected information in a hearing to identify specific interests to be presented. This preliminary information serves to expedite the pre-hearing conference and commits participation.

The respondents are individuals or households, State or local governments, not for profit institutions, and businesses, or other for profit groups and institutions.

In the Federal Register of November 1, 2005 (70 FR 65904), FDA published a 60-day notice requesting public comment on the information collection provisions to which one comment was received. However, it was not related to the information collection.

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

Under section 903(d)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 393(d)(2)), the Commissioner of Food and Drugs is authorized to implement general powers (including conducting research) to carry out effectively the mission of FDA. Section 510 of the act (21 U.S.C. 360) requires that domestic establishments engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices intended for human use and commercial distribution register their establishments and list the devices they manufacture with FDA. Section 522 of the act (21 U.S.C. 360(l)) authorizes FDA to require manufacturers to conduct postmarket surveillance of medical devices. Section 705(b) of the act (21 U.S.C. 375(b)) authorizes FDA to collect and disseminate information regarding medical products or cosmetics in situations involving imminent danger to health, or gross deception of the consumer. These sections of the act enable FDA to enhance consumer protection from risks associated with medical device usage that are not foreseen or apparent during the premarket notification and review process.

Subsequent to the events of September 11, 2001, FDA's Center for Devices and Radiological Health (CDRH) began planning for handling medical device shortage issues associated with counter-terrorism. One of the activities related to the planning was that CDRH would establish a data collection system as a supplemental source for available product. Because of events on September 11, 2001, local and State governments have obtained stockpiles of backup supplies within their jurisdiction to cover an emergency for the first 12 hours following a terrorist attack. The second 12 hours will have additional medical devices supplied by the Centers for Disease Control's Strategic National Stockpile and the National Acquisition Center. However, if additional supplies are needed in the first 12 hours, the Department of Health and Human Services (HHS) will request that FDA provide the number of medical devices readily available to meet demands. HHS has an established transportation and delivery mechanism in place to provide these emergent needs to the local and State authorities.

The Emergency Medical Device Shortage Survey was established in 1992 to collect data to assist FDA in implementing an emergency medical device shortage program that would find resources to supplement the needed supplies. In 2004, CDRH changed the process for the data collection and the name was changed to the Emergency Shortages Data Collection System. Because of the confidentiality aspect of the information, the information is only available to those on FDA's Emergency Shortage Team (EST) and senior management with a need-to-know. The need-to-know personnel include five EST members, the EST leader, the EST data entry technician, and five senior managers.

The Emergency Shortages Data Collection System will be updated every 4 months to keep information current. CDRH learned that medical device manufacturers have a high rate of turnover in personnel and in corporate structures due to mergers with larger companies. In addition, with the constant advances in technology, some of these manufacturers are forced to discontinue product lines or add product lines to their inventory. This new data collection system process will update information on a regular basis ensuring more accurate information in an emergency/disaster.

The process consists of one scripted telephone call to the designated shortage person at the four or five largest manufacturers of specific medical devices that may be needed by first responders in a national emergency. At the current time, the list contains 67 products from 65 manufacturers. If other products or new technology are deemed necessary to add at a later date, then the EST will conduct the appropriate search to find the four or five largest manufacturers of that product line and request the manufacturer's voluntary inclusion into the program.

The Emergency Shortages Data Collection System will only include those medical devices that are expected to be in demand but in short supply in an emergency/disaster. The data collection system includes life-saving and life-sustaining products (i.e., mechanically powered ventilators) as well as products that would require frequent changes resulting in rapidly depleted supplies (i.e., face masks and gloves).

In the Federal Register of November 4, 2005 (70 FR 67177), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received.

FDA based these estimates on past experience with direct contact with the medical device manufacturers. FDA estimates that approximately 65 manufacturers would be contacted by electronic mail three times per year to get updated information at their facilities. Further, it is estimated that the manufacturers may require up to 30 minutes to check if information received previously is still current and send electronic mail back to FDA.

The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

FDA recently approved for marketing the human biological product TYSABRI (natalizumab). TYSABRI is indicated for the treatment of patients, with relapsing forms of multiple sclerosis, to reduce the frequency of clinical exacerbations. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for TYSABRI (U.S. Patent No. 5,840,299) from Athena Neurosciences, Inc., and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated July 8, 2005, FDA advised the Patent and Trademark Office that this human biological product had undergone a regulatory review period and that the approval of TYSABRI represented the first permitted commercial marketing or use of the product. Shortly thereafter, the Patent and Trademark Office requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for TYSABRI is 2,924 days. Of this time, 2,740 days occurred during the testing phase of the regulatory review period, while 184 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective : November 23, 1996. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on November 23, 1996.

2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262) : May 24, 2004. FDA has verified the applicant's claim that the product license application (BLA) for TYSABRI (BLA 125104) was initially submitted on May 24, 2004.

3. The date the application was approved : November 23, 2004. FDA has verified the applicant's claim that BLA 125104 was approved on November 23, 2004.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,189 days of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments and ask for a redetermination by May 15, 2006. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by September 12, 2006. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

In the Federal Register of March 28, 2005 (70 FR 15635), FDA published a notice announcing the availability of a draft guidance entitled “Using a Centralized IRB Process in Multicenter Clinical Trials.” The notice gave interested persons an opportunity to submit comments by May 27, 2005. The agency received only a small number of comments, and we carefully considered the received comments as we finalized the draft guidance. Other than minor editorial changes and some clarifications, no substantive changes were made to the draft guidance.

This guidance is intended to assist sponsors, institutions, IRBs, and clinical investigators involved in multicenter clinical research in meeting the requirements of 21 CFR part 56 by facilitating the use of a centralized IRB review process. The guidance does the following: (1) Describes the roles of the participants in a centralized IRB review process, (2) offers guidance on how a centralized IRB review process might consider the concerns and attitudes of the various communities participating in a multicenter clinical trial, (3) makes recommendations about documenting agreements between a central IRB and the IRBs at institutions involved in the centralized IRB review process concerning the responsibilities of a central IRB and each institution's IRB, and (4) discusses IRB procedures for implementing a centralized review process. Finally, the guidance recommends how to ensure effective IRB review for clinical trial sites not already affiliated with an IRB. This guidance applies to clinical investigations conducted under 21 CFR part 312 (investigational new drug application or IND regulations).

This level 1 guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments on the guidance. Submit a single copy of electronic comments or two paper copies, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

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

In accordance with 21 CFR 20.108(c), which states that all written agreements and understandings between FDA and others shall be published in the Federal Register , the agency is publishing notice of this confidentiality arrangement.

The Program provides a system of no-fault compensation for certain individuals who have been injured by specified childhood vaccines. Subtitle 2 of Title XXI of the PHS Act, 42 U.S.C. 300aa-10 et seq. , provides that those seeking compensation are to file a petition with the U.S. Court of Federal Claims and to serve a copy of the petition on the Secretary of Health and Human Services, who is named as the respondent in each proceeding. The Secretary has delegated his responsibility under the Program to HRSA. The Court is directed by statute to appoint special masters who take evidence, conduct hearings as appropriate, and make initial decisions as to eligibility for, and amount of, compensation.

A petition may be filed with respect to injuries, disabilities, illnesses, conditions, and deaths resulting from vaccines described in the Vaccine Injury Table (the Table) set forth at Section 2114 of the PHS Act or as set forth at 42 CFR 100.3, as applicable. This Table lists for each covered childhood vaccine the conditions which may lead to compensation and, for each condition, the time period for occurrence of the first symptom or manifestation of onset or of significant aggravation after vaccine administration. Compensation may also be awarded for conditions not listed in the Table and for conditions that are manifested outside the time periods specified in the Table, but only if the petitioner shows that the condition was caused by one of the listed vaccines.

Section 2112(b)(2) of the PHS Act, 42 U.S.C. 300aa-12(b)(2), requires that the Secretary publish in the Federal Register a notice of each petition filed. Set forth below is a list of petitions received by HRSA on October 1, 2005, through December 31, 2005.

Section 2112(b)(2) also provides that the special master “shall afford all interested persons an opportunity to submit relevant, written information” relating to the following:

1. The existence of evidence “that there is not a preponderance of the evidence that the illness, disability, injury, condition, or death described in the petition is due to factors unrelated to the administration of the vaccine described in the petition,” and

2. Any allegation in a petition that the petitioner either:

(a) “Sustained, or had significantly aggravated, any illness, disability, injury, or condition not set forth in the Table but which was caused by” one of the vaccines referred to in the Table, or

(b) “Sustained, or had significantly aggravated, any illness, disability, injury, or condition set forth in the Vaccine Injury Table the first symptom or manifestation of the onset or significant aggravation of which did not occur within the time period set forth in the Table but which was caused by a vaccine” referred to in the Table.

This notice will also serve as the special master's invitation to all interested persons to submit written information relevant to the issues described above in the case of the petitions listed below. Any person choosing to do so should file an original and three (3) copies of the information with the Clerk of the U.S. Court of Federal Claims at the address listed above (under the heading FOR FURTHER INFORMATION CONTACT ), with a copy to HRSA addressed to Acting Director, Division of Vaccine Injury Compensation Program, Healthcare Systems Bureau, 5600 Fishers Lane, Room 11C-26, Rockville, MD 20857. The Court's caption (Petitioner's Name v. Secretary of Health and Human Services) and the docket number assigned to the petition should be used as the caption for the written submission. Chapter 35 of title 44, United States Code, related to paperwork reduction, does not apply to information required for purposes of carrying out the Program.

1. Anna and Robert Perkins on behalf of Jason Perkins, Chicago, Illinois, Court of Federal Claims No: 05-1057V.

2. Ingrid Bianco on behalf of Frank John Bianco, Somers Point, New Jersey, Court of Federal Claims No: 05-1059V.

3. Patricia and Chris Riggle on behalf of Joseph William Riggle, Greenland, New Hampshire, Court of Federal Claims No: 05-1062V.

4. Barbara and John Murphy on behalf of Michael Murphy, West Friendship, Maryland, Court of Federal Claims No: 05-1063V.

5. Alisha Shepperson on behalf of Jordan Taylor Shepperson, Fort Walton Beach, Florida, Court of Federal Claims No: 05-1064V.

6. Darren McDonough on behalf of Garrett Patrick McDonough, Greensboro, North Carolina, Court of Federal Claims No: 05-1077V.

7. Mary and Michael Schoeppner on behalf of Mary Schoeppner, Tampa, Florida, Court of Federal Claims No: 05-1080V.

8. Suzanne and John Davis on behalf of Spencer Davis, Lewiston, Maine, Court of Federal Claims No: 05-1084V.

9. Leslie Wilson and Akira Ueno on behalf of Nathan Ueno, Portland, Oregon Court of Federal Claims No: 05-1102V.

10. Melissa and John Wallace on behalf of Madilyn Wallace, Boston, Massachusetts, Court of Federal Claims No: 05-1104V.

11. Jestine Lachapelle on behalf of Joshua Lachapelle, Deceased, Dover, Delaware, Court of Federal Claims No: 05-1106V.

12. Stephen Lieurance, Andover, Kansas, Court of Federal Claims No: 05-1107V.

13. Pamela and Ronald Smith on behalf of Takashi Jesse Smith, San Jose, California, Court of Federal Claims No: 05-1108V.

14. Asa and Leondra McMahon on behalf of Asa McMahon, Ithaca, New York, Court of Federal Claims No: 05-1110V.

15. James Grassman, Deceased Rancho Mirage, California, Court of Federal Claims No: 05-1114V.

16. Jorge Alberto Carcamo, Simi Valley, California, Court of Federal Claims No: 05-1116V.

17. Kristi and Scott Getson on behalf of Edward Matthew Getson, Philadelphia, Pennsylvania, Court of Federal Claims No: 05-1117V.

18. Nicole Schwartz on behalf of Alexander Schwartz, Somers Point, New Jersey, Court of Federal Claims No: 05-1118V.

19. Scott Berger, Commack, New York, Court of Federal Claims No: 05-1120V.

20. Sonali and Darryl Tang on behalf of Arman Sebastian Tang, La Mesa, California, Court of Federal Claims No: 05-1122V.

21. Roger Siekbert on behalf of Chloe Siekbert, Blue Creek, Ohio, Court of Federal Claims No: 05-1124V.

22. Julie Clinton on behalf of John Clinton, Memphis, Tennessee, Court of Federal Claims No: 05-1126V.

23. Yanitza and Joel Jimenez on behalf of Jeilynne Jimenez, Somers Point, New Jersey, Court of Federal Claims No: 05-1127V.

24. Andrea and Mitchell Mitchell on behalf of Jack Mitchell, Carmel, Indiana, Court of Federal Claims No: 05-1128V.

25. William Taylor on behalf of Joseph Taylor, Boston, Massachusetts, Court of Federal Claims No: 05-1133V.

26. Sheri and Steven Zettle on behalf of Quaid Zettle, Boston, Massachusetts, Court of Federal Claims No: 05-1134V.

27. Marcia and Joseph Ferraro on behalf of Anthony Ferraro, Boston, Massachusetts, Court of Federal Claims No: 05-1135V.

28. Kerrie and Paul Ferrara on behalf of Paul Ferrara, Boston, Massachusetts, Court of Federal Claims No: 05-1136V.

29. Ishrat and Ahmad Ahsan on behalf of Ariana Ahsan, Boston, Massachusetts, Court of Federal Claims No: 05-1137V.

30. Nicole and Bret Cochran on behalf of Jake Cochran, Boston, Massachusetts, Court of Federal Claims No: 05-1138V.

31. Lisa and James Glover on behalf of Chloe Glover, Boston, Massachusetts, Court of Federal Claims No: 05-1139V.

32. Paula Kelley, Clairton, Pennsylvania, Court of Federal Claims No: 05-1140V.

33. Renda Sue Mace and Billy Oliphant on behalf of Renda Sue Mace, Clinton, Oklahoma, Court of Federal Claims No: 05-1146V.

34. Heidi and Roderick Conner on behalf of Maryah M. Conner, Twin Falls, Idaho, Court of Federal Claims No: 05-1149V.

35. Louise Habakus on behalf of Nicholas Habakus, Red Bank, New Jersey, Court of Federal Claims No: 05-1150V.

36. Marlo Thomas, Goldsboro, North Carolina, Court of Federal Claims No: 05-1151V.

37. Marcy Miles on behalf of Sean Miles, Norwich, New York, Court of Federal Claims No: 05-1152V.

38. Jerry Fridley, Fontana, California, Court of Federal Claims No: 05-1153V.

39. Janelle and M. Thomas Jones on behalf of Benjamin Jones, Ft. Wayne, Indiana, Court of Federal Claims No: 05-1154V.

40. Linda Burton on behalf of Evan Burton, Philadelphia, Pennsylvania, Court of Federal Claims No: 05-1155V.

41. Luke James Lewis, Lackland, Texas, Court of Federal Claims No: 05-1160V.

42. Michelle and Trever Anderson on behalf of Aidan Bae Schulte Anderson, Augusta, Georgia, Court of Federal Claims No: 05-1162V.

43. Pamela Haynes on behalf of John Haynes, Boston, Massachusetts, Court of Federal Claims No: 05-1164V.

44. Theresa Lux on behalf of Katharine Lux, Boston, Massachusetts, Court of Federal Claims No: 05-1165V.

45. Christine and Cody Bielawa on behalf of Matthew Bielawa, New York, New York, Court of Federal Claims No: 05-1168V.

46. Joyce and Carl Schwenk on behalf of Justin Schwenk, Lansdale, Pennsylvania, Court of Federal Claims No: 05-1169V.

47. Don Kostenbader, Pottsville, Pennsylvania, Court of Federal Claims No: 05-1171V.

48. Theresa Cangialosi on behalf of Alexandra Coen, Philadelphia, Pennsylvania, Court of Federal Claims No: 05-1174V.

49. Kimberly and Kieran Bastible on behalf of Luke Xavier Bastible, Lake Success, New York, Court of Federal Claims No: 05-1176V.

50. Lesley Ann Jones on behalf of Jade Christine Dollar, Morton, Illinois, Court of Federal Claims No: 05-1178V.

51. Ann and Keith Dronen on behalf of Anastasia C. Dronen, Wimette, Illinois, Court of Federal Claims No: 05-1181V.

52. Joseph Demko, Sherman, Texas, Court of Federal Claims No: 05-1190V.

53. Shirley and Clarence McKinnon on behalf of Deontay Perry, Baltimore, Maryland, Court of Federal Claims No: 05-1194V.

54. Stacey and David Lavely on behalf of Jagger Lavely, Philadelphia, Pennsylvania, Court of Federal Claims No: 05-1195V.

55. Kevin Wayne Stead, Fort Bragg, North Carolina, Court of Federal Claims No: 05-1196V.

56. Lorraine and Gregory Sissons on behalf of Lauren Sissons, Philadelphia, Pennsylvania, Court of Federal Claims No: 05-1197V.

57. Tammi Halvorson on behalf of Patrick Halvorson, Boston, Massachusetts, Court of Federal Claims No: 05-1198V.

58. Roseann Havers on behalf of Mikayla Havers, Boston, Massachusetts, Court of Federal Claims No: 05-1199V.

59. Michelle Mouille on behalf of Maurice Lamkin, San Antonio, Texas, Court of Federal Claims No: 05-1204V.

60. Philip Carter, Costa Mesa, California, Court of Federal Claims No: 05-1206V.

61. Lori Bedrio on behalf of Samantha Bedrio, La Mesa, California, Court of Federal Claims No: 05-1207V.

62. Jeffrey House on behalf of Logan House, Boston, Massachusetts, Court of Federal Claims No: 05-1210V.

63. Nanette and Jeff Cunningham on behalf of Zoe Rose Cunningham, Sulphur Springs, Texas, Court of Federal Claims No: 05-1212V.

64. Charlene French, Tacoma, Washington, Court of Federal Claims No: 05-1213V.

65. Linda Reno on behalf of Connor Reno, Boston, Massachusetts, Court of Federal Claims No: 05-1214V.

66. Jenny and Glenn Hess on behalf of Jackson Connor Hess, Flint, Michigan, Court of Federal Claims No: 05-1216V.

67. Lauren and Louis Matto on behalf of Louis Matto, IV, Somers Point, New Jersey, Court of Federal Claims No: 05-1221V.

68. Carrie Ruth Brake on behalf of Stephen Joseph Brake, Winchester, Kentucky, Court of Federal Claims No: 05-1228V.

69. Brenda Deiuliis on behalf of Anthony N. Deiuliis, Pittsburgh, Pennsylvania, Court of Federal Claims No: 05-1230V.

70. Robert Smith, Dickinson, Texas, Court of Federal Claims No: 05-1231V.

71. Carrie Ruth Brake on behalf of Phillip Brake, Winchester, Kentucky, Court of Federal Claims No: 05-1233V.

72. Pamela and Greg Giacchi on behalf of Anthony Giacchi, Pompton, New Jersey, Court of Federal Claims No: 05-1235V.

73. Laurie and John M. Lupo on behalf of Jonathan David Lupo, Basking Ridge, New Jersey, Court of Federal Claims No: 05-1238V.

74. Jonathan Corneil, Wahpeton, North Dakota, Court of Federal Claims No: 05-1239V.

75. Tina L. Goodlock, Adrian, Michigan, Court of Federal Claims No: 05-1240V.

76. Lydia Cisneros and Alejandro Rodriguez on behalf of Britney Rodriguez Cisneros, Deceased, Los Angeles, California, Court of Federal Claims No: 05-1241V.

77. Joanne Arnoult on behalf of Jordan Arnoult, Marrero, Louisiana, Court of Federal Claims No: 05-1247V.

78. Janice Crabtree and Jeffery Ambroziak on behalf of William Ambroziak, Boston, Massachusetts, Court of Federal Claims No: 05-1256V.

79. Pamela and David Goggins on behalf of Allston Goggins, Boston, Massachusetts, Court of Federal Claims No: 05-1257V.

80. Michael Peace on behalf of Anaya Shanelle Peace, Dallas, Texas, Court of Federal Claims No: 05-1258V.

81. Lujene and Alan Clarke on behalf of Devon Chandler Clarke, Lake Success, New York, Court of Federal Claims No: 05-1260V.

82. Francis Perez on behalf of Mario Perez, Deceased, Willingboro, New Jersey, Court of Federal Claims No: 05-1261V.

83. Theodore W. Porada, Middleburg Heights, Ohio, Court of Federal Claims No: 05-1262V.

84. Shawnte Ayalew on behalf of Sydney Jones, Redwood City, California, Court of Federal Claims No: 05-1266V.

85. Frederick and Betty Brady on behalf of Frederick Brady Ashville, North Carolina, Court of Federal Claims No: 05-1267V.

86. Khudeza Begum on behalf of Mehabub Bhuiyan, New York, New York, Court of Federal Claims No: 05-1269V.

87. Natasha Malone on behalf of Jazmon Malone, Dallas, Texas, Court of Federal Claims No: 05-1270V.

88. Liz Warren on behalf of Milo Zada, San Francisco, California, Court of Federal Claims No: 05-1271V.

89. Alexandra and Donald Mazziotti on behalf of Gabriella Mazziotti, Portland, Oregon, Court of Federal Claims No: 05-1274V.

90. Leilani and Gary Gross on behalf of Talia Gross, Huntington Beach, California, Court of Federal Claims No: 05-1275V.

91. Mary and Joseph Hostetler on behalf of Matthew Hostetler, Apple Creek, Ohio, Court of Federal Claims No: 05-1276V.

92. John Crouch on behalf of Cody Crouch Boston, Massachusetts, Court of Federal Claims No: 05-1279V.

93. David Dearinger on behalf of George Dearinger, Everett, Washington, Court of Federal Claims No: 05-1280V.

94. Karrie and Len Jennings on behalf of Tristin Robert Jennings, Minneapolis, Minnesota, Court of Federal Claims No: 05-1283V.

95. Latricia Hewings on behalf of Miles Lee Williams, Deceased, Milwaukee, Wisconsin, Court of Federal Claims No: 05-1292V.

96. David Dearinger on behalf of Jack Dearinger, Everett, Washington, Court of Federal Claims No: 05-1293V.

97. Maloree McDonough, Little Rock, Arkansas, Court of Federal Claims No: 05-1294V.

98. Frederick James Vondrak, III on behalf of Frederick James Vondrak, IV, Novi, Michigan, Court of Federal Claims No: 05-1310V.

99. Andrew Collier on behalf of Michael Collier, Brookfield, Missouri, Court of Federal Claims No: 05-1314V.

100. Donna and Ed Iarrapino on behalf of Joseph Andrew Iarrapino, Lake Success, New York, Court of Federal Claims No: 05-1350V.

101. Denise and Michael Smith on behalf of Alexander Hunter Smith, Lake Success, New York, Court of Federal Claims No: 05-1351V.

102. Alan Peltes St. Louis, Missouri, Court of Federal Claims No: 05-1352V.

103. Jeannine and Dominic Pernice on behalf of Nicholas Pernice, Philadelphia, Pennsylvania, Court of Federal Claims No: 05-1358V.

104. Amy Sauter on behalf of Jack Sauter, Philadelphia, Pennsylvania, Court of Federal Claims No: 05-1359V.

105. Michael W. Collier, Sr. on behalf of Benjamin D. Collier, Lake Success, New York, Court of Federal Claims No: 05-1370V.

106. Melissa Steinberg, Frenchtown, New Jersey, Court of Federal Claims No: 05-1377V.

107. Karen Dola-Fein and Gregory Fein on behalf of Daniel Fein, West Hills, California, Court of Federal Claims No: 05-1379V.

108. Renee and Brendon Deyo on behalf of Bryan Deyo, Washington, DC, Court of Federal Claims No: 05-1385V.

109. Melissa Guffey on behalf of Kimberly Warfle, Paris, Tennessee, Court of Federal Claims No: 05-1399V.

110. Kimberly and Stephen Benson on behalf of Mackenzie Benson, Doyleston, Pennsylvania, Court of Federal Claims No: 05-1400V.

111. Tresa and Steven Kinzer on behalf of Samuel Kinzer, Cleveland, Tennessee, Court of Federal Claims No: 05-1401V.