Title: Regulations Governing the Inspection and Grading of Manufactured or Processed Dairy Products—Record Keeping (Subpart B).

OMB Number: 0581-0110.

Expiration Date of Approval: July 30, 2005.

Type of Request: Extension and revision of a currently approved information collection.

Abstract: The Agricultural Marketing Act (AMA) of 1946 (7 U.S.C. 1621 et seq. ) directs the Department to develop programs which will provide for and facilitate the marketing of agricultural products. One of these programs is the USDA voluntary inspection and grading program for dairy products (7 CFR part 58) where these dairy products are graded according to U.S. grade standards by a USDA grader. The dairy products under the dairy program may be identified with the USDA grade mark. Dairy processors, buyers, retailers, institutional users, and consumers have requested that such a program be developed to assure the uniform quality of dairy products purchased. In order for any service program to perform satisfactorily, there are regulations for the provider and user. For these reasons, the dairy inspection and grading program regulations were developed and issued under the authority of the Act. These regulations are essential to administer the program to meet the needs of the user and to carry out the purposes of the Act.

The information collection requirements in this request are essential to carry out the intent of the AMA to ensure that dairy products are produced under sanitary conditions and that buyers are purchasing a quality product. In order for the Regulations governing the Inspection and Grading of Manufactured or Processed Dairy Products to serve the government, industry, and the consumer, laboratory test results must be recorded.

Respondents are not required to submit information to the agency. The records are to be evaluated by a USDA inspector at the time of an inspection. These records include quality tests of each producer, plant records of a required tests and analysis, and starter and cheese make records. These records required by USDA are also records that are routinely used by the inspected facility for their own supervisory and quality control purposes.

Estimate of Burden: Public reporting burden for this collection of information is estimated to average 2.85 hours per response.

Respondents: Dairy products manufacturing facilities.

Estimated Number of Respondents: 487.

Estimated Number of Responses: 1388.

Estimated Number of Responses per Respondent: 2.85.

Estimated Total Annual Burden on Respondents: 3956.

Comments are invited on: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the 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 those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Comments may be sent to Reginald Pasteur, 1400 Independence Avenue, SW., Room 2746—South, Washington, DC 20250-0230. All comments received will be available for public inspection during regular business hours at the same address.

All responses to this notice will be summarized and included in the request for OMB approval. All comments will become a matter of public record.

On May 27, 2005, the Committee for Purchase From People Who are Blind or Severely Disabled published notice (70 FR 30692) of proposed additions to the Procurement List.

After consideration of the material presented to it concerning capability of qualified nonprofit agencies to provide the products and services and impact of the additions on the current or most recent contractors, the Committee has determined that the product and service listed below are suitable for procurement by the Federal government under 41 U.S.C. 46-48c and 41 CFR 51-2.4.

I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:

1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will furnish the product and service to the government.

2. The action will result in authorizing small entities to furnish the product and service to the government.

3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 46-48c) in connection with the product and service proposed for addition to the Procurement List.

Accordingly, the following product and service are added to the Procurement List:

On May 27, 2005, the Committee for Purchase From People Who are Blind or Severely Disabled published notice (70 FR 30692) of proposed deletions to the Procurement List.

After consideration of the relevant matter presented, the Committee has determined that the service listed below is no longer suitable for procurement by the Federal government under 41 U.S.C. 46-48c and 41 CFR 51-2.4.

I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:

1. The action may result in additional reporting, recordkeeping or other compliance requirements for small entities.

2. The action may result in authorizing small entities to furnish the service to the government.

3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 46-48c) in connection with the service deleted from the Procurement List.

Accordingly, the following service is deleted from the Procurement List:

This notice is published pursuant to 41 U.S.C. 47(a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.

If the Committee approves the proposed addition, the entities of the Federal Government identified in the notice for each product or service will be required to procure the product listed below from nonprofit agencies employing persons who are blind or have other severe disabilities.

I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:

1. If approved, the action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will furnish the product to the Government.

2. If approved, the action will result in authorizing small entities to furnish the product to the Government.

3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 46-48c) in connection with the product proposed for addition to the Procurement List.

Comments on this certification are invited. Commenters should identify the statement(s) underlying the certification on which they are providing additional information.

The following product is proposed for addition to Procurement List for production by the nonprofit agencies listed:

On January 12, 2005, the Department published the preliminary results of this review. See Certain Cased Pencils from the People's Republic of China; Preliminary Results of Antidumping Duty Administrative Review and Intent to Rescind in Part , 70 FR 2115 ( Preliminary Results ). The POR is December 1, 2002, through November 30, 2003. On February 11, 2005, we received case briefs from China First Pencil Co., Ltd. (CFP)/Three Star Stationery Industry Corp. (Three Star)(CFP/Three Star) 1 , Orient International Holding Shanghai Foreign Trade Co., Ltd. (SFTC), and Shandong Rongxin Import & Export Co. Ltd. (Rongxin), the respondents, and Sanford LLP, Musgrave Pencil Company, Rose Moon, Inc., and General Pencil Company, domestic interested parties. We received rebuttal briefs from CFP/Three Star, SFTC, and Rongxin on February 24, 2005, and from the domestic interested parties on February 25, 2005 2 . On May 19, 2005, we rejected Rongxin's rebuttal brief because it contained new argument. Rongxin resubmitted its rebuttal brief on May 23, 2005, in accordance with the deadline set by the Department. On May 26, 2005, we issued a supplemental questionnaire and requested comments from CFP/Three Star on documents we placed on the record from a prior review. CFP/Three Star submitted its response and comments on June 7, 2005. The domestic interested parties submitted comments on CFP/Three Star's submission on June 15, 2005. As described in more detail below in comment 1, on June 15, 2005, the Department placed an additional document on the record of this segment of the proceeding and requested that CFP/Three Star and the domestic interested parties submit comments by June 20, 2005. CFP/Three Star and the domestic interested parties submitted comments on this document on June 20, 2005.

Imports covered by this order are shipments of certain cased pencils of any shape or dimension (except as noted below) which are writing and/or drawing instruments that feature cores of graphite or other materials, encased in wood and/or man-made materials, whether or not decorated and whether or not tipped ( e.g. , with erasers, etc.) in any fashion, and either sharpened or unsharpened. The pencils subject to the order are classified under subheading 9609.10.00 of the Harmonized Tariff Schedule of the United States (HTSUS). Specifically excluded from the scope of the order are mechanical pencils, cosmetic pencils, pens, non-cased crayons (wax), pastels, charcoals, chalks, and pencils produced under U.S. patent number 6,217,242, from paper infused with scents by the means covered in the above-referenced patent, thereby having odors distinct from those that may emanate from pencils lacking the scent infusion. Also excluded from the scope of the order are pencils with all of the following physical characteristics: 1) length: 13.5 or more inches; 2) sheath diameter: not less than one-and-one quarter inches at any point (before sharpening); and 3) core length: not more than 15 percent of the length of the pencil.

Although the HTSUS subheading is provided for convenience and customs purposes, our written description of the scope of the order is dispositive.

The Department is rescinding this review with respect to Tianjin Custom Wood Processing Co., Ltd. (TCW) because TCW reported it did not export subject merchandise to the United States during the POR. See the Preliminary Results ; see also; TCW's February 19, 2004, response to the Department's questionnaire. TCW's claim that it did not export subject merchandise during the POR is supported by U.S. Customs and Border Protection (CBP) data and entry documents. Moreover, there is no evidence on the record of this segment of the proceeding indicating that TCW exported subject merchandise during the POR. Therefore, we are rescinding this review with respect to TCW.

All issues raised in the case and rebuttal briefs by parties to this administrative review are addressed in the “Issues and Decision Memorandum” ( Decision Memorandum ) from Barbara E. Tillman, Acting Deputy Assistant Secretary for Import Administration, to Joseph A. Spetrini, Acting Assistant Secretary for Import Administration, dated July 11, 2005, which is hereby adopted by this notice. A list of the issues which parties have raised and to which we have responded, all of which are in the Decision Memorandum , is attached to this notice as an Appendix. Parties can find a complete discussion of all issues raised in this review and the corresponding recommendations in this public memorandum, which is on file in the Central Records Unit, room B-099 of the main Department of Commerce building. In addition, a complete version of the Decision Memorandum can be accessed directly on Import Administration's Web site at www.ia.ita.doc.gov.frn The paper copy and the electronic version of the Decision Memorandum are identical in content.

Based on our analysis of the comments received, we have made changes in the margin calculations for CFP/Three Star, SFTC and Rongxin. The specific calculation changes made can be found in our calculation memoranda dated July 11, 2005. These changes are listed below.

We collapsed CFP with its subsidiaries Shanghai First Writing Instrument Co., Ltd., (First), Shanghai Great Wall Pencil Co., Ltd. (Great Wall), and China First Pencil Fang Zheng Co., Ltd. (Fang Zheng). We converted transportation expenses from Indian rupees to U.S. dollars in the calculation of normal value. We also corrected the calculation of cost of manufacturing in the computer program to exclude packing. In addition, we corrected the computer program to correctly calculate slat consumption for ordinary size pencils.

We determine that the following weighted-average, ad valorem , percentage margins exist for the period December 1, 2002, through November 30, 2003:

The following cash deposit requirements will be effective upon publication of this notice of final results of administrative review for all shipments of pencils from the PRC entered, or withdrawn from warehouse, for consumption on or after the date of publication, as provided by section 751(a)(1) of the Act: (1) the cash deposit rates for the reviewed companies will be the rates shown above; (2) for previously reviewed or investigated companies not listed above, that have separate rates, the cash deposit rate will continue to be the company-specific rate published for the most recent period; (3) the cash deposit rate for all other PRC exporters will be 114.90 percent; and 4) the cash deposit rate for non-PRC exporters will be the rate applicable to the PRC exporter that supplied that exporter.

These deposit requirements shall remain in effect until publication of the final results of the next administrative review.

On December 28, 1994 the Department of Commerce (the Department) published and antidumping duty order on certain cased pencils from the Peoples' Republic of China. See Antidumping Duty Order: Certain Cased Pencils from the People's Republic of China , 59 FR 66909 (December 28, 1994) (the order). On January 31, 2005, the Department published a notice of initiation of administrative review of the order covering the period December 1, 2003, through November 30, 2004. See Initiation of Antidumping and Countervailing Duty Administrative Reviews and Request for Revocation in Part , 70 FR 4818 (January 31, 2005). The preliminary results are currently due no later than September 2, 2005.

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 and a final determination within 120 days after the date on which the preliminary determination is published. However, if it is not practicable to complete the review within these time periods, section 751(a)(3)(A) of the Act allows the Department to extend the 245-day time limit for the preliminary determination to a maximum of 365 days and the time limit for the final determination to 180 days (or 300 days if the Department does not extend the time limit for the preliminary determination) from the date of publication of the preliminary determination.

We determine that it is not practicable to complete the preliminary results of this review within the original time limit due to complex issues relating to the calculation of certain surrogate values. Therefore, the Department is extending the time limit for completion of the preliminary results by 105 days until no later than December 16, 2005. We intend to issue the final results no later than 120 days after the publication of the preliminary results notice.

This extension is in accordance with section 751(a)(3)(A) of the Act.

On July 24, 1996, the Department published in the Federal Register the antidumping duty order on pasta from Italy; see Notice of Antidumping Duty Order and Amended Final Determination of Sales at Less Than Fair Value: Certain Pasta From Italy , 61 FR 38547. On July 1, 2004, we published in the Federal Register the notice of Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation: Opportunity To Request Administrative Review , 69 FR 39903.

We received requests for review from petitioners 4 and from seven individual Italian exporters/producers of pasta, in accordance with 19 CFR 351.213(b)(2). In addition, on July 30, 2004, Pallante and Pagani requested that the Department revoke the antidumping duty order with respect to their companies. See “Revocation” section of this notice.

On August 30, 2004, we published the notice of initiation of this antidumping duty administrative review covering the period July 1, 2003, through June 30, 2004, listing these seven companies as respondents: Barilla, Indalco, Riscossa, Russo, Corticella, Pagani, and Pallante. 5 See Initiation of Antidumping and Countervailing Duty Administrative Reviews and Requests for Revocation in Part , 69 FR 52857 (August 30, 2004) (“Initiation Notice”).

On December 7, 2004, the Department extended the due date for the preliminary results of review from April 4, 2005, to July 18, 2005. See Certain Pasta from Italy: Extension of Time Limits for the Preliminary Results of Antidumping Duty Administrative Review , 69 FR 74493 (December 14, 2004).

During the months from January to June 2005, the Department issued supplemental questionnaires to each respondent, as applicable.

We conducted verification of the cost and sales information as follows: 1) Pagani sales verification from April 25 through April 29, 2005, and cost verification from May 16 through May 20, 2005; and 2) Pallante cost verification from May 23 through May 27, 2005, and sales verification from June 6 through June 10, 2005. We also verified the CEP information submitted by Pallante from June 20 through June 22, 2005.

On October 19, 2004, Russo withdrew its request for administrative review of the antidumping duty order. Because the request was timely filed, i.e., with 30 days of publication of the Initiation Notice , and because there were no other requests for review of the above-mentioned company, we rescinded the review with respect to Russo in accordance with 19 CFR 351.213(d)(1). See Certain Pasta from Italy: Notice of Partial Rescission of Antidumping Duty Administrative Review , 69 FR 74494 (December 14, 2004).

Imports covered by this order are shipments of certain non-egg dry pasta in packages of five pounds four ounces or less, whether or not enriched or fortified or containing milk or other optional ingredients such as chopped vegetables, vegetable purees, milk, gluten, diastasis, vitamins, coloring and flavorings, and up to two percent egg white. The pasta covered by this scope is typically sold in the retail market, in fiberboard or cardboard cartons, or polyethylene or polypropylene bags of varying dimensions.

Excluded from the scope of this order are refrigerated, frozen, or canned pastas, as well as all forms of egg pasta, with the exception of non-egg dry pasta containing up to two percent egg white. Also excluded are imports of organic pasta from Italy that are accompanied by the appropriate certificate issued by the Instituto Mediterraneo Di Certificazione, by Bioagricoop Scrl, by QC&I International Services, by Ecocert Italia, by Consorzio per il Controllo dei Prodotti Biologici, or by Associazione Italiana per l'Agricoltura Biologica.

The merchandise subject to this order is currently classifiable under item 1902.19.20 of the Harmonized Tariff Schedule of the United States (“ HTSUS ”). Although the HTSUS subheading is provided for convenience and customs purposes, the written description of the merchandise subject to the order is dispositive.

As provided in section 782(i) of Tariff Act of 1930, as amended (“the Act”), we conducted verification of the sales and cost information provided by Pagani and Pallante, and the CEP information provided by Pallante. We used standard verification procedures, including on-site inspection of the manufacturers' facilities and examination of relevant sales and financial records. Our verification results are detailed in the company-specific verification reports placed in the case file in the Central Records Unit (“CRU”) located in room B-099 of the main Department building. We made minor revisions to certain sales and cost data based on verification findings. See the company-specific verification reports and calculation memoranda, in the CRU.

In accordance with section 771(16) of the Act, we first attempted to match contemporaneous sales of products sold in the United States and comparison markets that were identical with respect to the following characteristics: (1) pasta shape; (2) type of wheat;

(3) additives; and (4) enrichment. When there were no sales of identical merchandise in the home market to compare with U.S. sales, we compared U.S. sales with the most similar product based on the characteristics listed above, in descending order of priority. When there were no appropriate comparison market sales of comparable merchandise, we compared the merchandise sold in the United States to constructed value (“CV”), in accordance with section 773(a)(4) of the Act.

For purposes of the preliminary results, where appropriate, we have calculated the adjustment for differences in merchandise based on the difference in the variable cost of manufacturing (“VCOM”) between each U.S. model and the most similar home market model selected for comparison.

To determine whether sales of certain pasta from Italy were made in the United States at less than NV, we compared the EP or CEP to the NV, as described in the “Export Price and Constructed Export Price” and “Normal Value” sections of this notice. In accordance with section 777A(d)(2) of the Act, we calculated monthly weighted-average prices for NV and compared these to individual U.S. transactions. See the company-specific verification reports and calculation memoranda, available in the CRU.

For the price to the United States, we used, as appropriate, EP or CEP, in accordance with sections 772(a) and (b) of the Act. We calculated EP when the merchandise was sold by the producer or exporter outside of the United States directly to the first unaffiliated purchaser in the United States prior to importation and when CEP was not otherwise warranted based on the facts on the record. We calculated CEP for those sales for which a person in the United States, affiliated with the foreign exporter or acting for the account of the exporter, made the sale to the first unaffiliated purchaser in the United States of the subject merchandise. We based EP and CEP on the packed cost-insurance-freight (“CIF”), ex-factory, free-on-board (“FOB”), or delivered prices to the first unaffiliated customer in, or for exportation to, the United States. When appropriate, we made adjustments to these prices to reflect billing adjustments, discounts, and rebates.

In accordance with section 772(c)(2) of the Act, we made deductions, where appropriate, for movement expenses including inland freight from plant or warehouse to port of exportation, insurance to port of exportation, domestic brokerage, handling and loading charges, export duties, international freight, marine insurance, U.S. inland freight expenses, warehousing, and U.S. duties. In addition, when appropriate, we increased EP or CEP as applicable, by an amount equal to the countervailing duty rate attributed to export subsidies in the most recently completed administrative review, in accordance with section 772(c)(1)(C) of the Act.

In a “voluntary” submission to the Department, Pagani claimed an adjustment for “interest revenue” for certain U.S. sales during the POR. Petitioners objected to this adjustment on the grounds that the revenue had been received after the POR, and claimed that it was not a bona fide adjustment. We collected detailed information about this claimed adjustment and also examined it at verification. Based on our analysis of Pagani's submissions, we determine that Pagani has not adequately demonstrated that the underlying payments were related either to interest revenue or to the sales during the POR to which they were allocated. Therefore, we have disallowed this adjustment for purposes of the preliminary results. 6

For CEP, in accordance with section 772(d)(1) of the Act, when appropriate, we deducted from the starting price those selling expenses that were incurred in selling the subject merchandise in the United States, including direct selling expenses (advertising, cost of credit, warranties, banking, slotting fees, and commissions paid to unaffiliated sales agents). In addition, we deducted indirect selling expenses that related to economic activity in the United States. These expenses include certain indirect selling expenses incurred by affiliated U.S. distributors. We also deducted from CEP an amount for profit in accordance with sections 772(d)(3) and (f)(2)(D) of the Act.

Barilla, Corticella, Indalco, Pagani, and Riscossa reported resales to the United States of subject merchandise purchased in Italy from unaffiliated producers. In those situations in which an unaffiliated producer of the subject pasta knew at the time of the sale that the merchandise was destined for the United States, the relevant basis for the EP would be the price between that producer and the respondent. See Dynamic Random Access Memory Semiconductors of One Megabit or Above From the Republic of Korea: Final Results of Antidumping Duty Administrative Review, Partial Rescission of Administrative Review and Notice of Determination Not to Revoke Order , 63 FR 50867, 50876 (September 23, 1998). In the instant review, we determine that it is reasonable to assume that the unaffiliated producers knew or had reason to know at the time of sale that the ultimate destination of the merchandise was the United States because virtually all enriched pasta is sold to the United States. See, e.g., Notice of Preliminary Results and Partial Rescission of Antidumping Duty Administrative Review and Intent Not to Revoke in Part: For the Sixth Administrative Review of the Antidumping Duty Order on Certain Pasta from Italy , 68 FR 47020, 47028 (August 7, 2003); Notice of Preliminary Results and Partial Rescission of Antidumping Duty Administrative Review: Certain Pasta from Italy , 63 FR 42368, 42370 (August 7, 1998). Accordingly, consistent with our methodology in prior reviews ( see id .), when a respondent purchased pasta from other producers and we were able to identify resales of this merchandise to the United States, we excluded these sales of the purchased pasta from the margin calculation for that respondent.

Where the purchased pasta was commingled with the respondent's production and the respondent could not identify the portion of subject merchandise purchased from unaffiliated producers, we included the sale in our margin calculation. Inasmuch as the percentage of pasta purchased by any single respondent was an insignificant part of its U.S. sales database and the respondent was unable to identify the volume of purchased pasta in sales of commingled merchandise, we determined to include such sales in our margin calculations.

To determine whether there was a sufficient volume of sales in the home market to serve as a viable basis for calculating NV, we compared each respondent's volume of home market sales of the foreign like product to the volume of its U.S. sales of the subject merchandise. Pursuant to sections 773(a)(1)(B) and (C) of the Act, because each respondent had an aggregate volume of home market sales of the foreign like product that was greater than five percent of its aggregate volume of U.S. sales of the subject merchandise, we determined that the home market was viable for all producers.

Barilla, Corticella, Pagani, and Pallante reported sales of the foreign like product to affiliated end-users and an affiliated resellers. 7 The Department calculates NV based on a sale to an affiliated party only if it is satisfied that the price to the affiliated party is comparable to the price at which sales are made to parties not affiliated with the producer or exporter, i.e. , sales at arm's length. See 19 CFR 351.403(c). To test whether these sales were made at arm's length, we compared the starting prices of sales to affiliated and unaffiliated customers net of all movement charges, direct selling expenses, discounts and packing. In accordance with the Department's current practice, if the prices charged to an affiliated party were, on average, between 98 and 102 percent of the prices charged to unaffiliated parties for merchandise identical or most similar to that sold to the affiliated party, we consider the sales to be at arm's-length prices and included such sales in the calculation of NV. See 19 CFR 351.403(c). Conversely, where sales to the affiliated party did not pass the arm's-length test, all sales to that affiliated party were excluded from the NV calculation. See Antidumping Proceedings: Affiliated Party Sales in the Ordinary Course of Trade , 67 FR 69186 (Nov. 15, 2002).

We conducted a COP analysis of Barilla, Corticella, Indalco, Pagani, Pallante, and Riscossa, pursuant to section 773(b) of the Act, to determine whether the respondents' comparison market sales were made below the COP. We calculated the COP based on the sum of the cost of materials and fabrication for the foreign like product, plus amounts for selling, general, and administrative expenses (“SG&A”) and packing, in accordance with section 773(b)(3) of the Act. We relied on the COP data submitted by each respondent in its cost questionnaire responses, except in specific instances where based on our review of the submissions and, in some instances, our verification findings, we find that an adjustment is required, as discussed below:

1. We increased Pagani's total cost of manufacture (“COM”) to correct an error in Pagani's yield calculation.

2. We increased Pagani's general and administrative (“G&A”) expenses to include certain unreported expenses.

3. We increased Pagani's reported G&A expenses by adding its parent's general expenses to Pagani's.

See Memorandum from Nancy M. Decker to Neal M. Halper regarding Pagani's Cost of Production and Constructed Value Calculation Adjustments for the Preliminary Results (July 15, 2005).

1. We increased Pallante's total COM to correct an error in Pallante's yield calculation and to include certain unreported expenses.

2. We increased Pallante's reported G&A expenses to include certain unreported expenses.

3. We increased Pallante's reported total packing costs to include certain unreported expenses.

See Memorandum from James Balog to Neal M. Halper regarding Pallante's Cost of Production and Constructed Value Calculation Adjustments for the Preliminary Results (July 15, 2005).

As required under section 773(b)(2) of the Act, we compared the weighted-average COP to the per-unit price of the comparison market sales of the foreign like product to determine whether these sales had been made at prices below the COP within an extended period of time in substantial quantities, and whether such prices were sufficient to permit the recovery of all costs within a reasonable period of time. We determined the net comparison market prices for the sales-below-cost test by subtracting from the gross unit price any applicable movement charges, discounts, rebates, direct and indirect selling expenses (also excluded from the COP), and packing expenses.

Pursuant to section 773(b)(2)(C)(i) of the Act, where less than 20 percent of sales of a given product were at prices less than the COP, we did not disregard any below-cost sales of that product because we determined that the below-cost sales were not made in “substantial quantities.” Where 20 percent or more of a respondent's sales of a given product during the POR were at prices less than the COP, we determined such sales to have been made in “substantial quantities.” See section 773(b)(2)(C) of the Act. The sales were made within an extended period of time in accordance with section 773(b)(2)(B) of the Act, because they were made over the course of the POR. In such cases, because we compared prices to POR-average costs, we also determined that such sales were not made at prices which would permit recovery of all costs within a reasonable period of time, in accordance with section 773(b)(2)(D) of the Act. Based on this methodology, for Barilla, Corticella, Indalco, Pagani, Pallante, and Riscossa, for purposes of this administrative review, we disregarded certain below-cost sales and used the remaining sales as the basis for determining NV, in accordance with section 773(b)(1) of the Act. See the company-specific calculation memoranda on file in the CRU, for our calculation methodology and results.

We calculated NV based on ex-works, FOB or delivered prices to comparison market customers. We made deductions from the starting price, when appropriate, for handling, loading, inland freight, warehousing, inland insurance, billing adjustments, discounts, and rebates. In accordance with sections 773(a)(6)(A) and (B) of the Act, we added U.S. packing costs and deducted comparison market packing, respectively. In addition, we made circumstance-of-sale (“COS”) adjustments for direct expenses, including imputed credit expenses, advertising, warranty expenses, commissions, and bank charges, in accordance with section 773(a)(6)(C)(iii) of the Act.

We also made adjustments, in accordance with 19 CFR 351.410(e), for indirect selling expenses incurred in the home market or U.S. where commissions were granted on sales in one market but not in the other, the “commission offset.” Specifically, where commissions are incurred in one market, but not in the other, we will limit the amount of such adjustment to the amount of either the selling expenses incurred in the one market or the commissions allowed in the other market, whichever is less.

When comparing U.S. sales with comparison market sales of similar, but not identical, merchandise, we also made adjustments for physical differences in the merchandise, in accordance with section 773(a)(6)(C)(ii) of the Act and 19 CFR 351.411. We based this adjustment on the difference in the VCOM for the foreign like product and subject merchandise, using POR-average costs.

Sales of pasta purchased by the respondents from unaffiliated producers and resold in the comparison market were treated in the same manner described above in the “Export Price and Constructed Export Price” section of this notice.

When we could not determine the NV based on comparison market sales because there were no contemporaneous sales of a comparable product, we compared the EP to CV. In accordance with section 773(e) of the Act, we calculated CV based on the sum of the COM of the product sold in the United States, plus amounts for SG&A expenses, profit, and U.S. packing costs. In accordance with section 773(e)(2)(A) of the Act, we based SG&A expenses and profit on the amounts incurred in connection with the production and sale of the foreign like product in the comparison market.

For price-to-CV comparisons, we made adjustments to CV for COS differences, in accordance with section 773(a)(8) of the Act and 19 CFR 351.410. We made COS adjustments by deducting direct selling expenses incurred on comparison market sales and adding U.S. direct selling expenses.

In accordance with section 773(a)(1)(B) of the Act, we determined NV based on sales in the comparison market at the same level of trade (“LOT”) as the EP and CEP sales, to the extent practicable. When there were no sales at the same LOT, we compared U.S. sales to comparison market sales at a different LOT. When NV is based on CV, the NV LOT is that of the sales from which we derive SG&A expenses and profit.

Pursuant to 19 CFR 351.412, to determine whether comparison market sales are at a different LOT, we examine stages in the marketing process and selling functions along the chain of distribution between the producer and the unaffiliated (or arm's-length) customers. If the comparison market sales are at a different LOT and the differences affect price comparability, as manifested in a pattern of consistent price differences between the sales on which NV is based and comparison market sales at the LOT of the export transaction, we will make an LOT adjustment under section 773(a)(7)(A) of the Act.

Finally, if the NV LOT is more remote from the factory than the CEP LOT and there is no basis for determining whether the differences in LOT between NV and CEP affected price comparability, we will grant a CEP offset, pursuant to section 773(a)(7)(B) of the Act. See Notice of Final Determination of Sales at Less Than Fair Value: Certain Cut-to-Length Carbon Steel Plate from South Africa , 62 FR 61731, 61732-33 (November 19, 1997). Specifically in this review, we did not make an LOT adjustment for any respondent. However, we are preliminarily granting a CEP offset for Barilla and Pallante.

For a detailed description of our LOT methodology and a summary of company-specific LOT findings for these preliminary results, see the company-specific calculation memoranda, all on file in the CRU.

For purposes of these preliminary results, we made currency conversions in accordance with section 773A(a) of the Act, based on the official exchange rates published by the Federal Reserve Bank.

On July 30, 2004, Pallante and Pagani submitted requests for revocation of the antidumping duty order with respect to their sales of the subject merchandise pursuant to 19 CFR 351.222(b). The Department “may revoke, in whole or in part” an antidumping duty order upon completion of a review under section 751 of the Act. While Congress has not specified the procedures that the Department must follow in revoking an order, the Department has developed a procedure for revocation that is described in 19 CFR 351.222. This regulation requires that one or more exporters and producers covered by the order and desiring revocation submit the following: (1) a certification that the company has sold the subject merchandise at not less than NV in the current review period and that the company will not sell at less than NV in the future; (2) a certification that the company sold the subject merchandise in each of the three years forming the basis of the request in commercial quantities; and (3) an agreement to immediate reinstatement of the order if the Department concludes that the company, subsequent to the revocation, has sold subject merchandise at less than NV. See 19 CFR 351.222(e)(1). Both Pallante and Pagani provided the certifications and agreements required by 19 CFR 351.222(e)(1).

Upon receipt of such a request, the Department, pursuant to 19 CFR 351.222(b)(2), will consider the following in determining whether to revoke the order in part: (1) whether the producer or exporter requesting revocation has sold subject merchandise at not less than NV for a period of at least three consecutive years; (2) whether the continued application of the antidumping duty order is otherwise necessary to offset dumping; and (3) whether the producer or exporter requesting revocation in part has agreed in writing to the immediate reinstatement of the order, as long as any exporter or producer is subject to the order, if the Department concludes that the exporter or producer, subsequent to revocation, sold the subject merchandise at less than NV.

Both Pallante and Pagani had de minimis or zero dumping margins in the two preceding years. See Notice of Final Results of the Sixth Administrative Review of the Antidumping Duty Order on Certain Pasta from Italy and Determination Not to Revoke in Part , 69 FR 6255, 6257 (February 10, 2004) and Notice of Final Results of Antidumping Duty Administrative Review and Determination Not to Revoke in Part: Certain Pasta from Italy , 68 FR 6882, 6883 (February 11, 2003), respectively. However, in the current review we preliminarily find that Pagani sold subject merchandise at less than NV. See July 15, 2005, Memorandum to the File, RE: Preliminary Calculation Memorandum for Pagani. Because we preliminarily find that Pagani made sales of subject merchandise at less than NV, we preliminarily intend not to revoke the antidumping duty order with respect to Pagani. Regarding Pallante, the Department preliminarily finds a de minimis rate for the current review. See July 15, 2005, Memorandum to the File, RE: Preliminary Calculation Memorandum for Pallante. Therefore, we preliminarily find that Pallante sold subject merchandise at not less than NV for three consecutive years as required under 19 CFR 351.222(b).

In determining whether three years of no dumping establishes a sufficient basis to make a revocation determination, the Department must be able to determine that the company continued to participate meaningfully in the U.S. market during each of the three years at issue, i.e. , that the company made sales in commercial quantities during each of those years. See Certain Corrosion-Resistant Carbon Steel Flat Products and Certain Cut-to-Length Carbon Steel Plate From Canada; Final Results of Antidumping Duty Administrative Reviews and Determination To Revoke in Part , 64 FR 2173, 2175 (January 13, 1999); see also Pure Magnesium From Canada; Final Results of Antidumping Duty Administrative Review and Determination Not to Revoke Order in Part , 64 FR 12977, 12979 (March 16, 1999); and Notice of Final Results of Antidumping Duty Administrative Review and Determination Not to Revoke the Antidumping Order: Brass Sheet and Strip from the Netherlands , 65 FR 742 (January 6, 2000). The Department preliminarily finds that Pallante sold subject merchandise to the United States in commercial quantities during each of the consecutive three years within the meaning of 19 CFR 351.222(e)(1)(ii). See the July 7, 2005, Pallante Sales Verification Report at Exhibits S-27 and VF-19; see also Pallante's March 22, 2005, Questionnaire Response at Exhibit 1. Therefore, we reasonably conclude that the de minimis margins calculated for Pallante in the last three years are reflective of the company's normal commercial experience. Because Pagani sold at less than NV during the 2003 to 2004 POR, the Department did not determine whether Pagani sold in commercial quantities during each of the last three years.

With respect to 19 CFR 351.222(b)(2)(i)(C), in considering whether continued application of the order is necessary to offset dumping, “the Department may consider trends in prices and costs, investment, currency movements, production capacity, as well as all other market and economic factors relevant to a particular case.” Proposed Regulation Concerning the Revocation of Antidumping Duty Orders , 64 FR 29818, 29820 (June 3, 1999). Based upon sales over three consecutive years resulting in de minimis margins, the Department presumes that the company requesting revocation is not likely to resume selling subject merchandise at less than NV in the near future unless the Department has been presented with evidence to demonstrate that dumping would likely resume if the order were revoked. In this proceeding, we have not received any evidence that demonstrates that Pallante would likely resume dumping in the future if the order were revoked. Therefore, we preliminarily determine that the order is no longer necessary to offset dumping for Pallante.

Because all requirements under the regulation have been satisfied, if these preliminary findings are affirmed in our final results, we intend to revoke the antidumping duty order with respect to subject merchandise produced and exported by Pallante. Also, in accordance with 19 CFR 351.222(f)(3), if these findings are affirmed in our final results, we will terminate the suspension of liquidation for any such merchandise entered, or withdrawn from warehouse, for consumption on or after the first day after the period under review, and will instruct CBP to refund any cash deposit.

As a result of our review, we preliminarily determine that the following percentage weighted-average margins exist for the period July 1, 2003, through June 30, 2004:

The Department will disclose calculations performed within five days of the date of publication of this notice to the parties of this proceeding, in accordance with 19 CFR 351.224(b). An interested party may request a hearing within 30 days of publication of these preliminary results. See 19 CFR 351.310(c). Any hearing, if requested, ordinarily will be held 44 days after the date of publication, or the first working day thereafter. Interested parties may submit case briefs no later than 30 days after the date of publication of these preliminary results of review. Rebuttal briefs, limited to issues raised in such briefs, may be filed no later than 35 days after the date of publication. Parties who submit arguments are requested to submit with the argument (1) a statement of the issue, and (2) a brief summary of the argument. Further, parties submitting written comments are requested to provide the Department with an additional copy of the public version of any such comments on diskette. The Department will issue the final results of this administrative review, which will include the results of its analysis of issues raised in any such comments, or at a hearing, if requested, within 120 days of publication of these preliminary results.

Pursuant to 19 CFR 351.212(b), the Department calculated an assessment rate for each importer of the subject merchandise. Upon issuance of the final results of this administrative review, if any importer-specific assessment rates calculated in the final results are above de minimis ( i.e. , at or above 0.5 percent), the Department will issue appraisement instructions directly to CBP to assess antidumping duties on appropriate entries by applying the assessment rate to the entered value of the merchandise. For assessment purposes, we calculated importer-specific assessment rates for the subject merchandise by aggregating the dumping margins for all U.S. sales to each importer and dividing the amount by the total entered value of the sales to that importer. Where appropriate, to calculate the entered value, we subtracted international movement expenses ( e.g. , international freight) from the gross sales value.

To calculate the cash deposit rate for each producer and/or exporter included in this administrative review, we divided the total dumping margins for each company by the total net value for that company's sales during the review period.

The following deposit rates will be effective upon publication of the final results of this administrative review for all shipments of pasta from Italy entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided by section 751(a)(2)(C) of the Act: (1) The cash deposit rates for the companies listed above will be the rates established in the final results of this review, except if the rate is less than 0.5 percent and, therefore, de minimis , the cash deposit will be zero; (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 final results in which that manufacturer or exporter participated; (3) if the exporter is not a firm covered in this review, a prior review, or the original less-than-fair-value (“LTFV”) investigation, but the manufacturer is, the cash deposit rate will be the rate established for the most recent final results for the manufacturer of the merchandise; and (4) if neither the exporter nor the manufacturer is a firm covered in this or any previous review conducted by the Department, the cash deposit rate will be 11.26 percent, the “All Others” rate established in the LTFV investigation. See Notice of Antidumping Duty Order and Amended Final Determination of Sales at Less Than Fair Value: Certain Pasta from Italy , 61 FR 38547 (July 24, 1996).

These cash deposit requirements, when imposed, shall remain in effect until publication of the final results of the next administrative review.

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

These preliminary results of this administrative review are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act.

The Department of Commerce (“the Department”) published an antidumping duty order on polyvinyl alcohol (“PVA”) from the People's Republic of China (“PRC”) on October 1, 2003 ( see Antidumping Duty Order: Polyvinyl Alcohol from the People's Republic of China , 68 FR 56620). On October 29, 2004, Petitioners 1 requested that the Department conduct an antidumping duty administrative review of Sinopec Sichuan Vinylon Works.

On November 19, 2004, the Department published in the Federal Register a notice of the initiation of the antidumping duty administrative review of PVA from the PRC for the period March 20, 2003, through September 30, 2004. See Initiation of Antidumping and Countervailing Duty Administrative Reviews , 69 FR 67701 (November 19, 2004). 2 On June 23, 2005, the Department published in the Federal Register a notice extending the time limit for the preliminary results of the administrative review from July 3, 2005, to August 2, 2005. See Extension of Time Limit for the Preliminary Results of the Antidumping Duty Administrative Review: Polyvinyl Alcohol from the People's Republic of China , 70 FR 36375 (June 23, 2005). The preliminary results of review are currently due no later than August 2, 2005.

Pursuant to section 751(a)(3)(A) of the Tariff Act of 1930, as amended (“the Act”), the Department shall issue preliminary results in an antidumping administrative review of an antidumping duty order within 245 days after the last day of the anniversary month of the date of publication of the order.

The Act further provides, however, that the Department may extend the deadline for completion of the preliminary results of review from 245 days to 365 days if it determines that it is not practicable to complete the preliminary results within the 245-day period. Completion of the preliminary results of this review within the 245-day period is not practicable because the Department needs additional time to research and analyze a significant amount of information pertaining to the respondent company's large number of factors of production, review and issue supplemental questionnaires, and evaluate certain issues raised by Petitioners.

Because it is not practicable to complete this review within the time specified under the Act, we are extending the time period for issuing the preliminary results of review by an additional 45 days until September 16, 2005, in accordance with section 751(a)(3)(A) of the Act. The final results continue to be due 120 days after the publication of the preliminary results.

NIST may enter into a Cooperative Research and Development Agreement (“CRADA”) with the licensee to perform further research on the invention for purposes of commercialization. The inventions available for licensing are:

Title: Surface Charge Modification Within Preformed Polymer Microchannels with Multiple Applications Including Modulating Electroosmotic Flow And Creating Microarrays.

Abstract: A laser was used to modify the charge on the surface(s) of a preformed polymeric microchannel ( e.g. imprinted, embossed, injection molded, ablated, etc.). It is shown that the fluid flow induced by an electric field applied along the length of the channel increases in velocity in the regions that have been exposed to the laser, therefore indicating a change in the surface charge. Furthermore, the laser can be used to create well-defined spots within the channel that have a higher surface charge than the surrounding material. These spots have been shown to selectively bind proteins in a linear or 2-dimensional microarray pattern.

Title: Mixing Reactions by Temperature Gradient Focusing.

Abstract: The invention provides a variant of temperature gradient focusing that involves analyte-ligand interactions occurring as a result of focusing one (either analyte or the ligand) and allowing interactions with the other to occur within the “focus space.” The interaction can be between biological molecules or other chemical species. Moving the focused “product” through the temperature gradient after mixing allows additional information to be inferred if the assay displays a physical property change such as melting or precipitation.

Title: Chiral Temperature Gradient Focusing.

Abstract: The invention provides a variant of temperature gradient focusing that uses chirally selective additives to modify the electrophoretic mobility of analytes thereby providing a method for focusing and separation of analytes based on their chirality.

Title: Microfluidic Flow Manipulation Device.

Abstract: The invention relates to a new method of mixing or splitting streams in a microchannel. A pre-formed imprinted T-channel is modified by a pulsed UV-excimer laser to create a series of slanted wells at the junction. The presence of the wells leads to a high degree of lateral transport within the channel. The later transport provides rapid mixing of two confluent streams undergoing electroosmotic flow.

Title: Micellar Gradient Focusing.

Abstract: The invention provides a method for focusing (concentrations and/or separation) based upon affinity of an analyte for a pseudostationary phase such as a micellar phase. The method works by creating a gradient in the capacity factor of the solute of interest to the micellar phase in the channel. The solute has an inherent electrophoretic mobility when free in solution. When interacting with the micelles, the solute assumes the electrophoretic mobility of the micelle. On one side of the gradient, the solutes strongly interact with the micelles and have a net mobility dominated by that of the micelles. On the other side of the gradient, the capacity factor is low and the solute assumes its native electrophoretic mobility. If the micelles are charged, a combination of electrokinetic and pressure-driven flow can be applied so that the micelles and the mobile phase move in opposite directions. Conversely, the focusing can be performed with a neutral surfactant if the analyte is changed and made to migrate in the opposite direction of the mobile phase. Under these conditions, the analyte can be made to focus at a point along the micellar gradient. Different analytes with different affinities for the micellar phase (or different electrophoretic mobilities) will focus at different points. The method provides a focusing equivalent of micellar electrokinetic chromatography.

Title: A Direct Procedure For Classifying Image Smoothness Based on Singular Integral Operators And Fast Fourier Transform Algorithm.s

Abstract: This invention provides a class of new image deblurring procedures. These procedures are based on a reformulation of the image deblurring problem in which Lipschitz (Besov) spaces are used to calibrate the lack of smoothness in the unknown desire sharp image.

Title: Microfluidic Platform of Arrayed Switchable Spin-Valve Elements for High-Throughput Sorting and Manipulation of Magnetic Particles and Biomelecules.

Abstract: The invention presents a microfluidic platform that incorporates an array of spin-valve elements to selectively trap, manipulate and release magnetic particles with high throughput and specificity. The array of spin-valve elements can exist in a ferromagnetic “on” state, thereby acting like mini bar magnets with local magnetic fields. The magnetic field gradients provide the trapping field to confine the magnetic particles. The spin-valve element can be turned to the antiferromagnetic “off” state where they no longer produce a local magnetic field. In the absence of the local magnetic field, the magnetic particles are released from the trap. The platform consists of a membrane that can separate the traps from the magnetic particle fluid, or it is possible to have the magnetic particle fluid on the same side of the traps. The “on/off” magnetic characteristic of these elements make it possible to apply an external global magnetic field to rotate the magnetic particles while they are confined by the spin-valve elements.

In an open meeting held in Washington, DC on May 19, 2005, the Commission decided the following:

The Flood Control Act of 1954 authorized the closure of a 1,500-foot gap and construction of a gated outlet in the Mississippi River levee at the lower end of the New Madrid Floodway. The Water Resources Development Act of 1986 authorized channel modifications and pumping stations for the St. Johns Bayou Basin and the New Madrid Floodway.

The First Phase of the St. Johns Bayou and New Madrid Floodway Project (Alternative 2, Authorized Project) consists of channel enlargement and improvement in the St. Johns Bayou Basin along the lower 4.5 miles of St. Johns Bayou, beginning at New Madrid, Missouri, then continuing 8.1 miles along the Birds Point New Madrid Setback Levee Ditch and ending with 10.8 miles along the St. James Ditch. The first item of work, consisting of selective clearing and snagging, has already been completed along a 4.3-mile reach of the Setback Levee Ditch beginning at the confluence with St. James Ditch.

The Authorized Project also includes a 1,000 cubic feet per second (cfs) pumping station that would be located a few hundred feet east of the existing gravity outlet at the lower end of St. Johns Bayou. The 1,500-ft gap in the Mississippi River levee at the lower end of the New Madrid Floodway would be closed. A 1,500 cfs pumping station and gravity outlet structure would be built in the levee closure at the lower end of the New Madrid Floodway. The channel enlargement work and both pumping stations are features of the St. Johns Bayou and New Madrid Floodway Project, and the levee closure is a feature of the Mississippi River Levees Project.

A final EIS, entitled Mississippi Rivers and Tributaries, Mississippi River Levees (MRL) and Channel Improvement, was prepared by the U.S. Army Corps of Engineers, Vicksburg District, in February 1976. This document was filed with the Council of Environmental Quality in April 1976. A final EIS, entitled St. Johns Bayou/New Madrid Floodway Project Final Supplemental Environmental Impact Statement, was filed in 1982. A Draft Supplemental Environmental Impact Statement (DSEIS) was prepared to supplement both of these previous documents. The DSEIS was submitted for public review and comment in April 1999. The Final Supplemental Environmental Impact Statement (FSEIS) was filed in September 2000.

The RSEIS documented the formulation and evaluation of additional alternatives to address concerns expressed by various resource agencies and environmental advocacy groups that environmental losses were not acceptable. The RSEIS included alternative levee closure locations for the New Madrid Floodway; an array of pump and gate operation alternatives that increase connectivity of the floodway with the Mississippi River to minimize impacts on fish habitat; significant avoid and minimize measures to benefit fish and wildlife resources; and mitigation measures that compensate for losses to wildlife habitat (bottomland hardwoods and agricultural areas), shorebird habitat, waterfowl habitat during February “ March, and mid-season (1 April to 15 May) fish rearing habitat. The final RSEIS was filed with EPA in July 2002.

The RSEIS expressed the Corps' analysis of unavoidable losses to mid-season fish rearing habitat as Habitat Units (HU). The RSEIS used those HU lost to calculate the required acres of compensatory mitigation. The method set out in the RSEIS was reforestation of agricultural areas. Therefore, the RSEIS stated that reforestation of 8,375 acres of agricultural areas (1,317 acres in the St. Johns Bayou Basin and 7,058 in the New Madrid Floodway) would mitigate for the unavoidable impacts to 4,213 mid-season fish rearing HU (1,884 HU in the St. Johns Basin and 2,329 HU in the New Madrid Floodway).

An inconsistency over required mitigation existed in the previous Record of Decision, State of Missouri 401-Water Quality Certification, and the Administrative Record. Therefore, the purpose of this DRSEIS II is to clarify the mitigation required in terms of HU and Average Daily Flooded Acres (ADFA). Additional mitigation features would also be investigated to ensure that the ADFA compensatory mitigation requirement, or its equivalent, is met and all habitat impacts for each respective resource ( e.g. , wildlife, shorebird, waterfowl, and mid-season fish rearing) are adequately compensated.

Other matters for the DRSEIS II may include, but are not limited to, a review of: hypoxia, the cost-benefit analysis, Swampbuster provisions, the 2.5% discount rate, cost-share issues for levee closure, and other relevant subjects or information.

The recommended flood damage reduction features as outlined in the RSEIS would not be addressed in this DRSEIS. Therefore, no additional flood damage reduction alternatives would be analyzed in the St. Johns Bayou Basin or the New Madrid Floodway. In addition to clarifying the inconsistency concerning the required amount of mitigation, the DRSEIS II would also address additional mitigation features to compensate for the unavoidable impacts to fish and wildlife resources.

Reforestation of frequently flooded agricultural land remains one means of providing the required 8375 ADFA of compensatory mitigation. If reforestation of agricultural lands were the only compensatory mitigation method employed, then the actual acres required would be no less than 8375 acres (assuming each acre is an ADFA), and could conceivably be more in order to assure that the ADFA equivalent habitat requirement is also met.

In addition to reforestation of agricultural areas, other compensatory mitigation measures would also be formulated. These measures include but are not limited to calculating expected benefits to mid-season fish rearing habitat from the creation of shorebird areas (moist soil units) and the Big Oak Tree State Park water supply feature, creation and/or enhancement of permanent waterbody features, and creation and/or enhancement of backwater flooding events. Measures that provide the highest duration of flooding during the mid-season fish rearing period (1 April to 15 May) offer the highest potential benefits.

Other matters such as hypoxia, the cost-benefit analysis, Swampbuster provisions, the 2.5% discount rate, cost-share issues for levee closure, and other relevant subjects or information, may also be explored in the DRSEIS II.

Coordination with appropriate resource and regulatory agencies would be maintained throughout the formulation of this DRSEIS II. Comments and concerns that have been expressed since the signing of the ROD will be used to identify significant issues. This Notice of Intent also serves as a scoping document. The purpose of this notice is to advise all interested parties of the intent to supplement the RSEIS and to solicit comments and information concerning compensatory mitigation, hypoxia, the cost-benefit analysis, Swampbuster provisions, the 2.5% discount rate, cost-share issues for levee closure, and other relevant subjects or information. Comments would be used to determine opportunities to develop additional compensatory mitigation strategies and other strategies that relate to, but are not limited to, hypoxia, the cost-benefit analysis, Swampbuster provisions, the 2.5% discount rate, cost-share issues for levee closure, and any other relevant subject or information, and to evaluate the probable impact (including cumulative impacts) of compensatory mitigation, as well as the probable impacts of such issues that may include, but are not limited to, hypoxia, the cost-benefit analysis, Swampbuster provisions, the 2.5% discount rate, cost-share issues for levee closure, and any other relevant subjects or information. This notice is being circulated to Federal, State, and local environmental resource and regulatory agencies; Indian Tribes; non-governmental organizations, and the general public.

Comments to this Notice of Intent are requested by 5 August 2005 at the above address. It is anticipated that the DRSEIS II will be available for public review in August 2005.

Working Group Charge: The charge for the Working Group on the Public Education Requirements of the Lead and Copper Rule (WGPE) is to (1) review the current public education requirements to find and define the need for improvements and make recommendations to the full NDWAC accordingly; (2) develop language for communicating the risk and a suggested response to the public; and (3) define the delivery means to the public. The NDWAC established a target date of May 2006 to complete these tasks.

Selection Criteria: The criteria for selecting WGPE members are as follows: the members are recognized experts in their fields; the members are as impartial and objective as possible; the members collectively represent an array of backgrounds and perspectives within the water sector and related disciplines ( e.g., public health); and the members are available to fully participate in the WGPE. The schedule remains flexible, however, it is estimated that the first WGPE meeting will be convened in the Fall of 2005, and subsequent meetings will be conducted over a relatively short time frame of approximately one (1) year. Over the course of this period, WGPE members will be asked to attend a maximum of four (4) in-person meetings, participate in conference calls and video conferencing as necessary, participate in the discussion of key issues at all meetings, and review and finalize the products and outputs of the WGPE. The EPA is looking to create a diverse working group. Potential nominations could include individuals from the drinking water industries, stakeholder organizations, state and local officials, public health officials, environmental organizations, and risk communication experts. The Agency is looking for a range of industry representation in terms of the size of the population served, as well as investor and publicly owned and operated facilities. This is not an exhaustive list; it is only intended to provide a framework to consider potential nominees.

Nomination of a Member: Any interested person or organization may nominate qualified individuals for membership to the WGPE. Name, occupation, position, address, and telephone number should identify all nominees. To be considered, all nominations must include a current resume providing the nominee's background, experience, and qualifications, in addition to a statement (not to exceed two (2) paragraphs) about their particular expertise and interest in the public education requirements of the Lead and Copper Rule. Please note that the Agency will not formally acknowledge or respond to nominations.

I. Background

On December 14, 1998, we published a notice in the Federal Register (63 FR 68780) announcing establishment of the Medicare Coverage Advisory Committee (MCAC). The Secretary signed the initial Medicare Coverage Advisory Committee Charter on November 24, 1998. The charter was renewed by the Secretary and will terminate on November 24, 2006, unless renewed again by the Secretary.

The Medicare Coverage Advisory Committee is governed by provisions of the Federal Advisory Committee Act (Pub. L. 92-463), as amended (5 U.S.C. App. 2), which sets forth standards for the formulation and use of advisory committees, and is authorized by section 222 of the Public Health Service Act, as amended (42 U.S.C. 217A).

The MCAC consists of a pool of 100 appointed members. Members are selected from among authorities in clinical medicine of all specialties, administrative medicine, public health, biologic and physical sciences, health care data and information management and analysis, patient advocacy, the economics of health care, medical ethics, and other related professions (for example, epidemiology and biostatistics), and methodology of trial design. A maximum of 88 members are standard voting members, and 12 are nonvoting members (6 of whom are representatives of consumer interests, and 6 of whom are representatives of industry interests).

The MCAC functions on a committee basis. The committee reviews and evaluates medical literature, reviews technology assessments, and examines data and information on the effectiveness and appropriateness of medical items and services that are covered or are eligible for coverage under Medicare. The Committee works from an agenda provided by the Designated Federal Official that lists specific issues and develops technical advice to assist us in determining reasonable and necessary applications of medical services and technology when making national coverage decisions for Medicare.

As of November 2005, there will be 15 terms of membership expiring, one of which is a non-voting industry representative. Accordingly, we are requesting nominations for both voting and nonvoting members to serve on the MCAC. Nominees are selected based upon their individual qualifications, and not as representatives of professional associations or societies. We have a special interest in ensuring that women, minority groups, and physically challenged individuals are adequately represented on the MCAC. Therefore, we encourage nominations of qualified candidates from these groups.

All nominations must be accompanied by curricula vitae. Nomination packages must be sent to Kimberly Long at the address listed in the Addresses section.

Nominees for voting membership must have expertise and experience in one or more of the following fields: Clinical medicine of all specialties, administrative medicine, public health, patient advocacy, biologic and physical sciences, health care data and information management and analysis, the economics of health care, medical ethics, and other related professions (for example, epidemiology and biostatistics), and methodology of trial design.

We are also seeking nominations for one nonvoting industry representative. Nominees for this position must possess appropriate qualifications to understand and contribute to the MCAC's work.

The nomination letter must include a statement that the nominee is willing to serve as a member of the MCAC and appears to have no conflict of interest that would preclude membership. We are requesting that all curricula vitae include the following: Date of birth, place of birth, social security number, title and current position, professional affiliation, home and business address, telephone and fax numbers, e-mail address, and a list of areas of expertise. In the nominations letter, we are requesting that the nominee specify whether applying for a voting membership position or the industry representative nonvoting position. Potential candidates will be asked to provide detailed information concerning financial holdings, consultancies, and research grants or contracts in order to permit evaluation of possible sources of conflict of interest.

Members are invited to serve for overlapping 2-year terms. A member can serve after the expiration of the member's term until a successor takes office. Any interested person may nominate one or more qualified persons. Self-nominations are also accepted.

Section 222 of the Public Health Service Act, as amended, grants to the Secretary of the Department of Health and Human Services (HHS) (the Secretary) the authority to establish an advisory panel if the Secretary finds the panel necessary and in the public interest. The Secretary signed the charter establishing the Advisory Panel on Medicare Education (the Panel) on January 21, 1999, and renewed the charter on January 14, 2005. The Panel advises HHS and the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education materials serving the Medicare program.

The goals of the Panel are to provide advice on the following:

• Developing and implementing a national Medicare education program that describes the options for selecting health plans and prescription drug benefits under Medicare.

• Enhancing the Federal government's effectiveness in informing the Medicare consumer, including the appropriate use of public-private partnerships.

• Expanding outreach to vulnerable and underserved communities, including racial and ethnic minorities, in the context of a national Medicare education program.

• Assembling an information base of best practices for helping consumers evaluate health plan options and building a community infrastructure for information, counseling, and assistance.

The Panel shall consist of a maximum of 20 members. The charter requires that meetings be held approximately four times per year. Members are expected to attend all meetings.

This notice is an invitation to interested organizations or individuals to submit their nominations for membership on the Panel. The Secretary, or his designee, will appoint the new members to the Panel from among those candidates determined to have the expertise required to meet specific agency needs, and in a manner to ensure an appropriate balance of membership.

Each nomination must state that the nominee has expressed a willingness to serve as a Panel member and must be accompanied by a resume and a brief summary of the nominee's experience. In order to permit an evaluation of possible sources of conflict of interest, potential candidates will be asked to provide detailed information concerning such matters as financial holdings, consultancies, and research grants or contracts. Self-nominations will also be accepted.

I. Background

On December 14, 1998, we published a notice in the Federal Register (63 FR 68780) to describe the Medicare Coverage Advisory Committee (MCAC), which provides advice and recommendations to us about clinical issues. This notice announces a public meeting of the Committee.

Meeting Topic: The Committee will discuss evidence, hear presentations and public comments, and make recommendations regarding the treatments for bone fractures that fail to progress to union. The MCAC will discuss scientific evidence on the effectiveness of certain procedures used in the Medicare population to treat bone fractures where progress to union has stopped. Committee members will be given a presentation reviewing the current literature of treatments and will also receive public comments to assist in the discussions and recommendations regarding net health outcomes of treatments for bone fractures that fail to progress to union.

Background information about this topic, including panel materials, is available on the Internet at http://www.cms.hhs.gov/coverage/ .

This meeting is open to the public. The Committee will hear oral presentations from the public for approximately 45 minutes. The Committee may limit the number and duration of oral presentations to the time available. If you wish to make formal presentations, you must notify the Executive Secretary named in the FOR FURTHER INFORMATION CONTACT section and submit the following by the Deadline for Presentations and Comments date listed in the DATES section of this notice: A brief statement of the general nature of the evidence or arguments you wish to present, the names and addresses of proposed participants, and a written copy of your presentation. Your presentation should consider the questions we have posed to the Committee and focus on the issues specific to the topic. The questions will be available on our Web site at http://www.cms.hhs.gov/mcac/default.asp meetings. We require that you declare at the meeting whether or not you have any financial involvement with manufacturers of any items or services being discussed (or with their competitors).

After the public and CMS presentations, the Committee will deliberate openly on the topic. Interested persons may observe the deliberations, but the Committee will not hear further comments during this time except at the request of the chairperson. The Committee will also allow a 15 minute unscheduled open public session for any attendee to address issues specific to the topic. At the conclusion of the day, the members will vote and the Committee will make its recommendation.

The Coverage and Analysis Group is coordinating meeting registration. While there is no registration fee, individuals must register to attend. You may register by contacting Maria Ellis at 410-786-0309, mailing address: Coverage and Analysis Group, OCSQ; Centers for Medicare & Medicaid Services; 7500 Security Blvd., Mailstop: C1-09-06; Baltimore, MD 21244, or by e-mail at Maria.Ellis@cms.hhs.gov . Please provide your name, address, organization, telephone and fax number, and e-mail address.

You will receive a registration confirmation with instructions for your arrival at the CMS complex. You will be notified if the seating capacity has been reached.

This meeting is located on Federal property; therefore, for security reasons, any individuals wishing to attend this meeting must register by close of business on September 28, 2005.

This meeting will be held in a Federal government building; therefore, Federal security measures are applicable. In planning your arrival time, we recommend allowing additional time to clear security.

In order to gain access to the building and grounds, individuals must present photographic identification to the Federal Protective Service or Guard Service personnel before being allowed entrance.

Security measures also include inspection of vehicles, inside and out, at the entrance to the grounds. In addition, all individuals entering the building must pass through a metal detector. All items brought to CMS, whether personal or for the purpose of demonstration or to support a demonstration, are subject to inspection. We cannot assume responsibility for coordinating the receipt, transfer, transport, storage, set-up, safety, or timely arrival of any personal belongings or items used for demonstration or to support a demonstration.

Parking permits and instructions will be issued upon arrival.

All visitors must be escorted in areas other than the lower and first floor levels in the Central Building.

In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces the quarterly meeting of the Practicing Physicians Advisory Council (the Council). The Secretary is mandated by section 1868(a)(1) of the Social Security Act (the Act) to appoint a Practicing Physicians Advisory Council (the Council) based on nominations submitted by medical organizations representing physicians. The Council meets quarterly to discuss certain proposed changes in regulations and carrier manual instructions related to physicians' services, as identified by the Secretary. To the extent feasible and consistent with statutory deadlines, the Council's consultation must occur before Federal Register publication of the proposed changes. The Council submits an annual report on its recommendations to the Secretary and the Administrator of the Centers for Medicare & Medicaid Services not later than December 31 of each year.

The Council consists of 15 physicians, including the Chair. Members of the Council include both participating and nonparticipating physicians, and physicians practicing in rural and underserved urban areas. At least 11 members of the Council must be physicians as described in section 1861(r)(1) of the Act; that is, State-licensed doctors of medicine or osteopathy. The remaining 4 members may include dentists, podiatrists, optometrists and chiropractors. Members serve for overlapping 4-year terms; terms of more than 2 years are contingent upon the renewal of the Council by appropriate action prior to its termination.

Section 1868(a)(2) of the Act provides that the Council meet quarterly to discuss certain proposed changes in regulations and manual issuances that relate to physicians' services, identified by the Secretary. Council members are expected to participate in all meetings. Section 1868(a)(3) of the Act provides for payment of expenses and a per diem allowance for Council members at a rate equal to payment provided members of other advisory committees. In addition to making these payments, the Department of Health and Human Services and CMS provide management and support services to the Council. The Secretary will appoint new members to the Council from among those candidates determined to have the expertise required to meet specific agency needs in a manner to ensure appropriate balance of the Council's membership.

The Council held its first meeting on May 11, 1992. The current members are: Ronald Castellanos, M.D. Chairperson; Jose Azocar, M.D.; M. Leroy Sprang, M.D.; Rebecca Gaughan, M.D.; Peter Grimm, D.O.; Carlos R. Hamilton, M.D.; Dennis K. Iglar, M.D.; Joe Johnson, D.C.; Christopher Leggett, M.D.; Barbara McAneny, M.D.; Geraldine O'Shea, D.O.; Laura B. Powers, M.D.; Gregory J. Przybylski, M.D.; Anthony Senagore, M.D.; and Robert L. Urata, M.D.

The meeting will commence with the swearing-in of one Council member. The Council's Executive Director will give a status report and the CMS responses to the recommendations made by the Council at the May 23, 2005 meeting and prior meeting recommendations. Additionally, an update will be provided on the Physician Regulatory Issues Team. In accordance with the Council charter, we are requesting assistance with the following agenda topics:

• Competitive Acquisition for Drugs.

• Physician Fee Schedule Proposed Rule.

• Part D Prescription Drug Program.

• Outpatient Proposed Rule.

• Surgical Care Improvement Partnership Program.

• Alliance for Cardiac Care Excellence Program.

• NPI-Outreach and Implementation.

For additional information and clarification on these topics, contact the DFO as provided in the For Further Information Contact section of this notice. Individual physicians or medical organizations that represent physicians wishing to make a 5-minute oral presentation on agenda issues must contact the DFO by 12 noon, e.d.t., August 5, 2005, to be scheduled. Testimony is limited to agenda topics only. The number of oral presentations may be limited by the time available. A written copy of the presenter's oral remarks must be submitted to Kelly Buchanan, DFO, no later than 12 noon, e.d.t., August 5, 2005, for distribution to Council members for review prior to the meeting. Physicians and medical organizations not scheduled to speak may also submit written comments to the DFO for distribution no later than noon, e.d.t., August 5, 2005. The meeting is open to the public, but attendance is limited to the space available.

Special Accommodations: Individuals requiring sign language interpretation or other special accommodation must contact the DFO by e-mail at PPAC@cms.hhs.gov or by telephone at (410) 786-6132 at least 10 days before the meeting.

The Peer Review Improvement Act of 1982 (Title I, Subtitle C of Public Law 97-248) amended Part B of Title XI of the Social Security Act (the Act) to establish the Peer Review Organization (PRO) program. The PRO program (now called the Quality Improvement Organization (QIO) program) was established to redirect, simplify, and enhance the cost-effectiveness and efficiency of the medical peer review process. Sections 1152 and 1153 of the Act define the types of organizations eligible to become QIOs, and establish certain limitations and priorities regarding QIO contracting.

The Secretary enters into contracts with QIOs to perform three broad functions:

• Improve quality of care for beneficiaries by ensuring that beneficiary care meets professionally recognized standards of health care;

• Protect the integrity of the Medicare Trust Fund by ensuring that Medicare only pays for services and items that are reasonable and medically necessary and that are provided in the most economical setting;

• Protect beneficiaries by expeditiously addressing individual cases such as beneficiary quality of care complaints, contested hospital issued notices of noncoverage (HINNs), alleged Emergency Medical Treatment and Labor Act (EMTALA) violations (patient dumping), and other statutory responsibilities.

Section 1154 of the Act requires that QIOs review those services furnished by physicians; other health care practitioners; and institutional and non-institutional providers of health care services, including health maintenance organizations and competitive medical plans. Section 109 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), Pub. L. 108-173, amended section 1154(a)(1) of the Act to expand the scope of review of QIOs to include Medicare Advantage Organizations and prescription drug sponsors. Section 109 of the MMA also created a new section 1154(a)(17) of the Act, which requires QIOs to offer to providers, practitioners, Medicare Advantage Plans, and prescription drug sponsors quality improvement assistance pertaining to prescription drug therapy. We will not evaluate QIOs on these provisions in the current Scope of Work (SOW) because these provisions of sections 1154(a)(1) and (a)(17) of the Act were not included in the contract.

Section 1153(h)(2) of the Act requires the Secretary to publish in the Federal Register the general criteria and standards that would be used to evaluate the efficient and effective performance of contract obligations by QIOs and to provide the opportunity for public comment. The QIO contracts for the 7th SOW were awarded for 3 years with starting dates staggered into three approximately equal groups (rounds) starting August 2002, November 2002, and February 2003, respectively.

On July 23, 2004, we published a notice with comment in the Federal Register titled “Medicare Program; Evaluation Criteria and Standards for Quality Improvement Organizations.” The comment period for this notice closed on August 23, 2004. The evaluation criteria published in the notice are currently being used to evaluate QIO performance on the 7th SOW. The evaluation criteria is listed here for the reader's convenience. No modifications were made to the evaluation criteria based on comments provided in response to the notice.

Under the 7th Round contracts, QIOs are responsible for completing tasks in the following four areas, with additional subtasks contained in the first three areas:

Task 4 —Improving Beneficiary Safety and Health Through Developmental Activities (Special Studies defined as work that we direct a QIO to perform or work that a QIO elects to perform with our approval that is not currently defined in the Tasks, but falls within the scope of the contract and section 1154 of the Act).

Under this contract, to merit having its contract renewed non-competitively, the QIO must meet the performance criteria (including a score of 1.0 or greater for Tasks 1a through 1e and 2b) on 10 of 12 subtasks (9 of 11 for States with no MA plans) of Tasks 1 through 3 of the 7th SOW. To renew the QIO's contract non-competitively for both of the subtasks that do not meet the criteria, the QIO must have: (1) Achieved a score of 0.6 or better on all quantitative subtasks, and (2) for the remaining subtasks only, in the judgment of the Project Officer, the QIO expended a reasonable effort to address these subtasks, and developed and implemented an appropriate initial work plan. The work plan must have been assessed by the Project Officer during the contract period to determine if it was achieving results likely to lead to success in meeting contractual performance expectations and had made appropriate adjustments to its work plan based on these results.

To be considered successful (that is, meeting the criteria outlined in the J-7 found at http://www.cms.hhs.gov/qio/2.asp ), though not meriting a non-competitive renewal, the QIO must meet the performance criteria (including a score of 1.0 or greater for Tasks 1a through 1e and 2b) on 9 of 12 subtasks (8 of 11 for States with no MA plans) of Tasks 1 through 3 of the 7th Round Contract. For the subtasks that do not meet the criteria, the QIO must—

• Achieve a score of 0.6 or better on all quantitative subtasks;

• For the remaining subtasks only, in the judgment of the Project Officer, the QIO has expended a reasonable effort to address these subtasks, developed and implemented an appropriate initial work plan that was assessed by the Project Officer during the contract period to determine if it was achieving results likely to lead to success in meeting contractual performance expectations, and had made appropriate adjustments to its work plan based on these results; and

• Failed to meet the criteria in no more than two subtasks of any one task.

For Task 4, except as provided in Task 3b that is evaluated by the Task Leader, all special studies approved under this task will be evaluated individually, based on study-specific evaluation criteria. The QIO's success or failure on a special study will not be factored into the evaluation of the QIO's work under Tasks 1 through 3.

However, meeting the minimum performance standards does not guarantee a noncompetitive renewal of the QIO's contract. For example, an organization within a particular State meeting the definition of a QIO may express interest in competing for a contract currently held by a QIO from outside that State, according to section 1153(i) of the Act. In this case, we will compete the contract despite acceptable performance by the current QIO. We will make a final decision on renewal/non-renewal by the end of the 30th month of the 7th Round contract. We will issue a “Notice of Intent to Non-renew the QIO Contract” letter to all QIOs that do not meet the minimum performance standards no later than the end of the 33rd month of the contract. The QIO will be considered to have met minimum performance standards if the QIO had demonstrated acceptable performance in each Task area as specified in section III of this notice, Standards for Minimum Performance.

If the QIO has not met the criteria to merit a noncompetitive renewal, it will be notified of our intention not to renew its contract and will be informed of its right to request an opportunity to provide information about its performance under the contract to a CMS-wide panel. The panel includes representatives from each of the four QIO Regional Offices and the Central Office. The QIO's Project Officer will not be eligible to represent the Regional Office on the panel when it reviews the work of his or her QIO. However, the Project Officer will be available to answer any questions. Also, the QIO will be given the opportunity to provide additional information. The panel will have the right to create its own procedures, but must apply them consistently to all QIOs. At a minimum, the panel will use the criteria listed below for all Tasks:

• The degree of collaboration the QIO exhibited with the Quality Improvement Organization Support Centers (QIOSCs) and other QIOs, both by sharing the lessons and tools it developed and by adopting practices and tools developed by other QIOs.

• Whether the QIO was a new contractor in the 7th SOW.

• Whether specific identifiable circumstances uniquely interfered with the QIO's efforts.

• Evidence suggesting that the QIO has done exceptional work in one or more of the other Task areas.

• Any other issues that the panel may deem relevant.

Upon completion of its review, the panel will recommend a final disposition of the QIO's contract renewal to the Director of CMS' Office of Clinical Standards and Quality (OCSQ).

We will evaluate the QIO's performance on each sub-task by some combination of the following elements:

• Statewide improvement on the quality measure(s).

• Improvement on the quality of care measure(s) among a group of identified participants as defined within each subtask.

• Satisfaction among providers and practitioners regarding their interaction with the QIO.

Satisfaction will be assessed using a survey, the purpose of which will be to:

• Measure satisfaction as one component of the QIO's evaluation.

• Identify opportunities where the QIO can improve satisfaction.

Task 1 (including subtasks a through e) and subtask 2b will be evaluated quantitatively. The QIO's success will be measured by assessing its relative improvement on each evaluation criterion. The term “improvement” as used in the 7th Round Contract will be defined mathematically to mean the relative reduction in the failure rate. The expected minimum improvement level, as determined by our management and defined in the J-7 at http:www.cms.hhs.gov/qio/2.asp , will serve as the reference point for each calculated relative improvement.

In a number of the Task 1 subtasks, statewide improvement will be averaged with the improvement among a set of identified participant providers. In these cases, we have set a target percentage of identified participant providers. The relative weights of the statewide improvement and of identified participants' improvement will combine to equal 80 percent of the subtask's weight, and will be a function of the percentage of the target percentage (up to 150 percent) that the QIO identifies as participants. Tasks 1f, 2a, 2c and all of Task 3 will be evaluated by the Project Officer using qualitative measures based on information provided in reports developed from data provided by the QIOs on the QIO's status to date.

The QIO will be held accountable for improvement in the quality of care measure rates for all nursing homes in the State and for identified participant nursing homes. QIOs will be evaluated based on the following components: Statewide improvement on the set of three to five publicly reported quality of care measures that the QIO has selected in consultation with stakeholders, improvement in the selected nursing home publicly reported quality of care measures for identified participants, and nursing home satisfaction based on a survey of identified participating nursing homes. To view the weighting criteria for each component, go to http://www.cms.hhs.gov/qio/2.asp for a copy of the J-7.

The QIO will be held accountable for improvement in the Outcome Based Quality Improvement (OBQI) quality of care measure rates for a set of home health agencies that are identified participants. The QIOs will be evaluated based on the following components: The extent to which the number of participating home health agencies, with significant improvement in a targeted outcome, equals or exceeds 30 percent of the total number of home health agencies in the State, and the identified participant satisfaction that will be measured by a survey of identified participant home health agencies using a composite measure of satisfaction that reflects the type of activities that QIOs are expected to have undertaken with these providers.

QIOs will be evaluated on the following criteria: Statewide improvement on the quality of care measures listed in the 7th Round Contract, and hospital satisfaction based on feedback from the hospitals in the State. To view the specific criteria, go to http://www.cms.hhs.gov/qio/2.asp for a copy of the J-7.

QIOs will be evaluated based on the following general criteria: statewide improvement on quality of care measures, improvement on diabetes and cancer screening quality of care measures for identified participant physicians, and physician satisfaction based on feedback from physician designees in the State who participated with the QIO. To view the specific criteria for this task, go to http://www.cms.hhs.gov/qio/2.asp for a copy of the J-7.

The QIO's work on this task will be primarily evaluated on the success of the QIO's efforts to reduce disparity between the targeted underserved group and their geographically relevant non-underserved reference group from baseline to re-measurement. To be judged to have performed minimally successful on this task, the QIO must demonstrate disparity reduction. QIOs will also be evaluated on three factors that collectively demonstrate knowledge generated by the QIO about the underserved target group, the interventions planned upon the basis of that knowledge, the use of literature on effective interventions, and by demonstrating the effectiveness of their interventions through analyses comparing the intervention group and a contrast group. To view the specific criteria for this task, go to http://www.cms.hhs.gov/qio/2.asp for a copy of the J-7.

QIOs will be expected to have demonstrated appropriate activity to include MAs in Tasks 1a to 1e as determined by the Project Officer. We will survey MAs that have worked with the QIO using a composite measure of satisfaction that reflects the types of activities that QIOs are expected to have undertaken with these organizations. We will further use the results of the Medicare+Choice Quality Review Organizations (M+CQRO) or accreditation organization evaluation of the Quality Assessment and Performance Improvement (QAPI) projects to determine if expected improvement was demonstrated.

QIO success will be assessed on the timely completion and submission of a project work plan, timely completion and submission of all required reports and deliverables, and the extent to which the QIO uses information we have provided as well as any other feedback the QIO receives to refine its project activities to achieve the desired outcome.

The evaluation for this task will be based on the following elements:

• We will determine the completeness of the assessment survey information for each hospital.

• We will review hospital data submitted to the national repository via QualityNet Exchange to determine the proportion of hospitals within the State that have implemented a data abstraction system to abstract quality of care measures.

• We will review hospital satisfaction with the QIO data abstraction support. To view specific criteria for this task, go to http://www.cms.hhs.gov/qio/2.asp for a copy of the J-7.

QIO success on this task will be assessed on the following elements: The establishment and use of a Consumer Advisory Council to advise and provide guidance regarding consumer related activities, the QIO's success at broadening consumer representation on the QIO Board of Directors, the successful operation of a beneficiary helpline, and the publication and distribution of an annual report.

QIO success will be assessed by the timeliness of completed reviews, quality improvement activities as the result of beneficiary complaints, reliability of the review of cases as determined by QIO assessment of the review determinations, and beneficiary satisfaction with the complaint process.

The QIO must complete reviews within the prescribed timeframes. The QIO must also meet one of the following criteria: with respect to the absolute payment error rate, the follow-up payment error rate must be no greater than 1.5 standard errors above the baseline error rate, or the QIO must have made acceptable progress in improving provider performance in relation to all projects approved or directed by us.

The QIO will be assessed on the timeliness of reviews for HINN/NODMAR, EMTALA review, other case review activities and post review activities.

We received several public comments on the 2004 Federal Register notice with comment period.

Comment: One commenter expressed concern over the hospital satisfaction survey in Task 1c. The commenter noted that some hospitals have changed to acute care hospitals late in the SOW. The commenter believes this does not provide the QIO ample opportunity to work with the hospital before the hospital completes the satisfaction survey. The commenter recommended that we establish a cut-off date for new entries as acute care hospitals participating in the satisfaction survey.

Response: While we understand the concern that hospitals with only recent experience in acute care could have an impact on the hospital satisfaction survey, we do not believe that it would be a significant impact for the 7th SOW. The Task 1c satisfaction scores from the first two rounds appear to support our position. All QIOs in the first two rounds received scores that met or exceeded the 80 percent passing threshold. The suggestion to include a cut-off date is a reasonable one that we can consider for subsequent Scopes of Work. We intend to evaluate all rounds for the current SOW identically.

Comment: One commenter expressed concern about the project plan requirements in Task 2a. Specifically, the commenter stated that the task only required a project plan for the Nursing Home Quality Initiative. The commenter requested more specific language in the evaluation criteria to address this issue.

Response: For the 7th SOW, we are requiring only one formal project plan for the Nursing Home Quality Initiative. A deliverable has not been added for subsequent plans. QIOs will not be held accountable for failing to deliver project plans that are not required deliverables for the task.

Comment: One commenter stated that there are no historical data to demonstrate that nursing homes' thresholds and home health thresholds are achievable or realistic.

Response: We believe that the thresholds are achievable for most QIOs. The results of the 1st Round 28-month evaluations show that the majority of the QIOs (87 percent) achieved or exceeded the target performance. Therefore, there is no indication that these thresholds should be changed.

Comment: One commenter stated that the tasks to be evaluated subjectively would be less ambiguous if the components of the evaluation were known before the start of the SOW.

Response: We agree with this comment. However, QIOs were provided a copy of the J-7 before the start of the SOW. The tool used to do the actual evaluation was based on the materials provided in the J-7, and did not include any criteria or standards not in the SOW. We will produce the tool for the 8th SOW early in the contract period. It will be distributed to QIOs as soon as it is available.

Comment: Three commenters questioned how statistical significance could be calculated for home health agencies with a small number of episodes of care.

Response: We use the Fisher's exact test to calculate statistical significance for agency outcomes with 10 to 30 episodes of care. This test does not require a large sample to estimate statistical significance. More information on this test can be found in Categorical Data Analysis by Alan Agresti. Additionally, we tested the impact of small HHAs by recalculating evaluation results. Excluding all HHAs with fewer than 30 episodes of care did not substantively improve the overall evaluation results. Based on this information, we decided not to modify the 1b evaluation criteria.

Comment: One commenter questioned how we determined the home health task denominator for the 30 percent.

Response: The home health denominator is made up of two components. It includes identified participants and non-identified participants. Identified participants are defined as all home health agencies that submitted an OBQI plan of action (POA) and have at least a one 3-bar OBQI report for any reporting period ending at least 12 months after the POA submission date. A 3-bar report allows the HHA to compare current outcome rates to prior year outcome rates and national outcome rates. Non-identified participants are defined as having no OBQI plan of action submitted, but with a 3-bar OBQI report for the reporting period ending in the 24th month of the contract. This definition recognizes the dynamic nature of the home health industry, and counts only agencies with sufficient caseload during the 24 months included in the 3-bar report. We believe that this definition provides QIOs with the best opportunity to successfully pass the evaluation, while including all agencies operating with a sufficient caseload during a large part of the SOW.

Comment: One commenter stated that many of the Task 1c hospital indicators will have a small number in the denominator. The commenter stated that by collecting the same number of cases for all States, the precision and confidence interval is much smaller for a large State, thereby making the evaluation of the QIO less accurate.

Response: The assumption on the part of the commenter is not completely accurate. The evaluation score equally weights the four conditions for hospital public reporting (see http://www.cms.hhs.gov/quality/hospital for list of conditions) to provide a more robust estimate of quality improvement. Three of the four conditions have large enough samples so that sample size (not population size) is the primary determinant driving the precision of the estimates. Acute Myocardial Infarction measures, one of the four conditions, with systematically small samples are weighted accordingly to minimize the impact of any unreliable estimates on the overall evaluation. AMI is the only one of the four conditions with systematically small samples. It is weighted accordingly to minimize the impact of any unreliable estimates on the overall evaluation.

Comment: One commenter stated that the Task 2b evaluation should not be considered under the quantitative evaluation criteria. The commenter stated that the largest weighted criterion for this task is related to the Reporting Hospital Quality Data for Annual Payment Update (RHQDAPU), which does not have a quantitative measurement.

Response: The RHQDAPU criterion for this subtask is dichotomous in nature and requires that QIOs contact all hospitals in their State and assist them in their data submission into the Standard Data Processing System Clinical Warehouse. QIOs must also document their communication and assistance with all hospitals, participating and non-participating. Although this task does involve some activities that may be evaluated in a qualitative manner, the majority of the activities are quantitative in nature. Therefore, we have chosen to evaluate this task quantitatively.

Comment: One commenter expressed concern over the lateness of data for Task 1d. The commenter believes that this has made it nearly impossible to assess the effectiveness of the QIO interventions, or to identify other areas for intervention.

Response: We recognize that time lags can hinder the QIO's technical assistance to providers in the outpatient setting. We have set the baseline period to allow QIOs to work with providers during the transition period between SOWs. Much of this work is reflected in the next SOW's evaluation results. The relative stability of QIOs in their States lessens the impact of the time lag.

Comment: One commenter suggested that we change the evaluation criteria in the J-7 for Task 1e to make them the same as the evaluation criteria that were originally developed for their QIO's improvement project.

Response: We assume the commenter is referring to the use of sub-county targeting in the evaluation of this Task. We have already modified the evaluation on this Task to allow sub-county targeting. This modification to the evaluation was approved by the Project Officers in the beginning of the SOW. We do not anticipate any further changes at this point.

Comment: One commenter suggested that Task 3 activities be elevated to a higher position in the SOW. This commenter believes the current Task 3 should be Task 1 or Task 2 to increase its importance in the contract.

Response: We agree that all of the Tasks performed by the QIOs are important to foster quality improvement in the health care delivered to Medicare beneficiaries. The evaluation criteria reflect this belief. Task 3 comprises 3 out of 12 subtasks evaluated by us. QIOs must successfully perform Task 3 work in order to be granted non-competitive contract renewal. We believe that the stringent evaluation criteria in place for this task reflect the importance of the work.

Comment: One commenter asked about the provider satisfaction survey and how we plan to use the survey if the QIO does not have a sufficient sample size.

Response: Identifying opportunities for improvement is part of a quality improvement feedback cycle. We believe that the results of the satisfaction survey are useful to QIOs in identifying quality improvement opportunities. CMS and its statistical contractor have provided all QIOs with detailed information about their satisfaction survey results. The statistical contractor will also write a national analysis of the survey results to identify opportunities for QIO program improvement as a whole. In the few instances with insufficient sample size, we use the actual satisfaction rate to evaluate QIO performance. However, we grant QIOs a passing evaluation score when the overall evaluation status (that is, pass vs. fail) is sensitive to this potentially unreliable rate. Usually this rate does not affect a QIO's overall evaluation status on a particular subtask, since its relative weight is small in a subtask's evaluation.

Comment: One commenter stated that, with the development of the Excel spreadsheet to evaluate the qualitative tasks, these tasks are no longer qualitative. They are now being evaluated in a quantitative way.

Response: The Excel tool allows Project Officers to subjectively evaluate QIO performance in the qualitative tasks. It was developed in response to concerns from QIOs about inter-region variation in the 6th SOW. It uses the same evaluation criterion provided in the J-7, and is not intended to make the evaluation quantitative in nature. Rather, it gives some consistency to the subjective review by the Project Officers. We agree that this tool should be provided to QIOs as early as possible in the contract cycle. We will strive to provide this tool to the QIOs as early as possible for the 8th SOW.

Comment: One commenter stated that a great deal of effort was put into the National Voluntary Hospital Reporting Initiative (NVHRI), but this effort was not included in the evaluation criteria.

Response: We appreciate the fact that the NVHRI did require some additional effort on the part of the hospitals. However, participation could not be included in the evaluation criteria because this was a voluntary program on the part of hospitals. The voluntary nature of the program requires a different approach by the QIO than is required by the other subtasks and deliverables of the contract.

Comment: One commenter stated that for those States with 100 percent participation in hospital public reporting, the Hospital Generated Data (HGD) Survey is redundant. The commenter stated that the same information may be obtained through both sources.

Response: We have been careful to avoid redundant activities for both providers and QIOs. The HGD Survey does not determine if a hospital is a reporting hospital. Instead, it assesses the hospital's ability to collect data. Therefore both the survey and the actual hospital reporting are necessary and provide different information to us.

Comment: One commenter questioned the evaluation criteria for Task 3b. In the J-7, the term “reliability” is used. The guidance document states that the QIO will be evaluated based on both “reliability” and “validity of review.” This commenter also requested clarification as to why Tasks 3a and 3b require reliability while Task 3c does not require validity for evaluation.

Response: The reliability of the review is the primary criterion for evaluating this component of the task. We will ensure consistency in documents released for the 8th SOW. The evaluation criteria were chosen for each subtask in Task 3 based on the appropriateness for the task.

Comment: One commenter expressed concern over using Medicare physician billing as the method to measure the rate of statewide and identified participants' improvement in quality care measures for Task 1d.

Response: We are investigating this method of measuring improvement for the Round 1 evaluations, and have so far found nothing large-scale or systematic that would alter evaluation results for Task 1d. We believe that the evaluation measures are relatively stable and reliable estimates, and that billing issues as a whole do not contribute significant bias to these estimates. We understand the limitations of using billing information to estimate quality improvement, and are working to minimize its impact by identifying these problems and reporting questionable billing issues to the appropriate parties.

We are adopting the provisions of the notice with comment as final.

In accordance with the provisions of Executive Order 12866, this notice with comment period was not reviewed by the Office of Management and Budget.

FDA is announcing the availability of a guidance for industry entitled “Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers.” This guidance provides a description and basis for a process by which to select an MRSD for a first-in-human clinical trial of a new molecular entity in adult healthy volunteers. In the Federal Register of January 16, 2003 (68 FR 2340), FDA published a notice making available a draft guidance entitled “Estimating the Safe Starting Dose in Clinical Trials for Therapeutics in Adult Healthy Volunteers.” The notice gave interested persons an opportunity to submit comments. As a result of the comments, certain sections of this guidance were reworded to improve clarity. The guidance outlines a recommended standardized approach (including common conversion factors for calculating human equivalent doses) and vocabulary for selecting an MRSD based on animal data, and discusses factors to be considered in determining reasonable safety margins. This approach is applicable to a first-in-human trial of a new drug or biological therapeutic, regardless of intended clinical use. The guidance also discusses alternative approaches and provides some examples of circumstances under which alternative approaches for selection of an MRSD should be considered. Dose escalation is not addressed.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers. 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 at any time. Submit a single copy of electronic comments or two paper copies of any mailed comments, 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 document at either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm .

Scientists at the National Cancer Institute (NCI), NIH, have developed a novel anti-cancer agent, the aminoflavone prodrug (AFP-464, NSC 710464) which is a lysyl prodrug of aminoflavone (AF, NSC 686288). AFP-464 displays improved solubility in aqueous solutions over the parent compound AF and can be converted rapidly to AF in plasma. In the NCI 60-cell-line screen, both AFP-464 and AF have demonstrated anti-proliferative activity against several renal, breast and ovarian cancer cell lines. AFP-464 and AF have also demonstrated anti-tumor activity in human renal and breast carcinoma xenografts. Pharmacokinetic studies and toxicology studies of AFP-464 have been completed.

The results of the pre-clinical studies conducted by NCI have led to a decision by the NCI to initiate NCI-sponsored clinical trials of AFP-464. The Cancer Therapy Evaluation Program (CTEP), NCI expects to file an Investigational New Drug Application with the FDA for AFP-464 before the end of 2005.

Patent Portfolio: The patent portfolio for the aminoflavone compounds and the aminoflavone prodrug, claiming the compositions of matter and methods in the treatment of cancer includes issued patents and patent applications claiming rights worldwide, as provided below (websites for patent application publications are included).

Patents and patent applications for the aminoflavone compounds, entitled “5-Aminoflavone Derivative,” consist of:

1. U.S. Patent No. 5,539,112 (issued 07/23/1996), ( http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=/netahtml/srchnum.htm&r=1&f=G&l=50&s1=5539112.WKU.&OS=PN/5539112&RS=PN/5539112 );

2. European Patent No. 0638566 (issued 01/07/1999 and validated in GB, DE, FR, ES and IT), ( http://v3.espacenet.com/textdoc?DB=EPODOC&IDX=EP0638566&F=0 );

3. Canadian Patent Application No. 2129813 (filed 08/09/1994), ( http://patents1.ic.gc.ca/details?patent_number=2129813&language=EN ).

Patents and patent applications for the aminoflavone prodrug, entitled “Aminoflavone Compounds, Compositions, and Methods of Use Thereof,” consist of:

1. U.S. Patent No. 6,812,246 (issued 11/02/2004), ( http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=/netahtml/srchnum.htm&r=1&f=G&l=50&s1=6812246.WKU.&OS=PN/6812246&RS=PN/6812246 );

2. European Patent Application No. 01923228.9 (filed April 6, 2001, now allowed and validated in GB, DE, FR, IT, ES, LU, BE, CH, and IE), ( http://v3.espacenet.com/textdoc?DB=EPODOC&IDX=US2004019227&F=0) ;

3. Canada Patent Application No. 2405747 (filed April 6, 2001), http://patents1.ic.gc.ca/details?patent_number=2405747&language=EN );

4. Australia Patent Application No. 2001249940 (filed April 6, 2001), ( http://apa.hpa.com.au:8080/ipapa/view?hit=1&page=1 ).

Licensing and Cooperative Research and Development Agreement Opportunity: The National Cancer Institute (NCI) seeks a collaborator to co-develop the aminoflavone pro-drug (AFP-464) for clinical use. A Cooperative Research and Development Agreement (CRADA) is the anticipated collaborative agreement to be entered into with NCI pursuant to the Federal Technology Transfer Act of 1986 and Executive Order 12591 of April 10, 1987, as amended. A CRADA is an agreement designed to enable certain collaborations between Government laboratories and non-Government laboratories. A CRADA is not a grant, and it is not a contract for the procurement of goods/services. The NCI is prohibited from transferring funds to a CRADA collaborator. Under a CRADA, NCI can contribute facilities, staff, materials, and expertise. The CRADA collaborator can contribute facilities, staff, materials, expertise, and funds. The CRADA collaborator will also have an option to negotiate the terms of an exclusive or non-exclusive commercialization license to subject inventions arising under the CRADA. The goals of the CRADA include the rapid publication of research results and timely commercialization of products, diagnostics, and treatments that result from the research. Licensing the above patent rights will be necessary to commercialize AFP-464 if clinical trials results are favorable. It is expected that a licensee to the above patent rights will become the NCI CRADA collaborator in the clinical development of AFP-464.

Those interested in this CRADA opportunity should prepare a confidential proposal and submit it to the NCI Technology Transfer Branch. Preference will be given to proposals received by the NCI within thirty days of publication of this announcement. Selection criteria for choosing the CRADA Collaborator shall include, but not be limited to: 1. Demonstrated expertise and success in clinical development of anti-cancer agents; 2. possession of the resources needed to support and perform the research and development activities to develop AFP-464 ( e.g. facilities, personnel and expertise); 3. the ability to provide financial support for the CRADA-related Government activities; 4. the demonstration of the necessary resources to produce and supply formulated AFP-464 for all clinical trials in a timely manner; 5. the willingness to cooperate with the NCI in the timely publication of research results; 6. the willingness to accept the legal provisions and language of the CRADA with only minor modifications, if any; and 7. the agreement to be bound by the appropriate HHS regulations relating to human subjects.

E-276-2003/0-PCT-02 provides nucleic acid molecules comprising expressible sequences, which could be reporter or therapeutic genes, whose expression depends on the presence of HIV Tat and Rev proteins. This invention could be used for detection of HIV infection, in screening assays to identify compounds that inhibit HIV infection, and potentially as a therapeutic to kill HIV-infected cells and treat HIV-infected subjects.

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

The field of use may be limited to the development of FDA-approvable HIV clinical diagnostic kit.

It has to be noted that the non-exclusive license opportunities in the field(s) of use of the development of HIV detection kit/reagent for research use and/or cellular screening method for research use, as well as the exclusive license opportunity in the field of use of the development of a novel therapeutic against HIV infections are still available for subject invention.

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

FEMA is seeking to extend the use of the Standard Flood Hazard Determination Form, required by Title V, Section 528 of the National Flood Insurance Reform Act of 1994 (NFIRA). The form records the determination of whether a structure is located within an identified Special Flood Hazard Area and whether flood insurance is available. Federally-regulated lender institutions, are mandated to complete this form for any loan made, increased, extended, renewed, or purchased.

Title: Standard Flood Hazard Determination Form.

Type of Information Collection: Extension of a currently approved collection.

OMB Number: 1660-0040.

Form Numbers: FEMA 81-93 Standard Flood Hazard Determination Form.

Abstract: On September 23, 1994, the President signed the Riegle Community Development and Regulatory Improvement Act of 1994. Title V of this Act is the National Flood Insurance Reform Act (NFIRA). Section 528 of the NFIRA requires that FEMA develop a standard hazard determination form for recording the determination of whether a structure is located within an identified Special Flood Hazard Area and whether flood insurance is available. Section 528 of the NFIRA also requires the use of this form by regulated lending institutions, Federal agency lenders, the Federal National Mortgage Association, the Federal Home Loan Mortgage Corporation, and the Government National Mortgage Association for any loan made, increased, extended, renewed or purchased by these entities. The form developed to comply with the above requirements is the Standard Flood Hazard Determination form (FEMA Form 83-93, dated October 2002). This form will be completed by federally regulated lending institutions when making, increasing, extending, renewing or purchasing each loan for the purpose of documenting the factors considered as to whether flood insurance is required and available. An estimated 33,000,000 such uses are made each year. This number is entirely driven by the volume of mortgage transactions, of which fluctuations in interest rates is a principal factor.

Affected Public: Business or other for-profit, Federal Government.

Estimated Total Annual Burden Hours: 10,890,000 hours.

Estimated Cost: The total cost to federally-regulated lenders for completing FEMA Form 81-93 totals $295,119,000, representing an average cost of $8.00 per loan transaction (respondent).

Comments: Written comments are solicited to (a) evaluate whether the proposed data collection is necessary for the proper performance of the agency, including whether the information shall have practical utility; (b) 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; (c) enhance the quality, utility, and clarity of the information to be collected; and (d) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g. , permitting electronic submission of responses. Comments should be received within 60 days of the date of this notice.

The notice of a major disaster declaration for the State of Florida is hereby amended to include the following areas among those areas determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of July 10, 2005:

The notice of a major disaster declaration for the State of Mississippi is hereby amended to include the following areas among those areas determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of July 10, 2005:

The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Under Secretary for Emergency Preparedness and Response, Department of Homeland Security, under Executive Order 12148, as amended, Jesse Munoz, of FEMA is appointed to act as the Federal Coordinating Officer for this declared disaster.

This action terminates my appointment of Justo Hernandez as Federal Coordinating Officer for this disaster.

In accordance with the December 12, 1988 court order in National Coalition for the Homeless v. Veterans Administration, No. 88-2503-OG (D.D.C.), HUD publishes a notice, on a weekly basis, identifying unutilized, underutilized, excess and surplus Federal buildings and real property that HUD has reviewed for suitability for use to assist the homeless. Today's notice is for the purpose of announcing that no additional properties have been determined suitable or unsuitable this week.

The National Wildlife Refuge System Administration Act of 1966, as amended by the National Wildlife Refuge System Improvement Act of 1997 (16 U.S.C. 668dd-668ee et seq ) requires the Service to develop a Comprehensive Conservation Plan (CCP) for each National Wildlife Refuge. The purpose for developing a CCP is to provide refuge managers with a 15-year strategy for achieving refuge purposes and contributing toward the mission of the National Wildlife Refuge System (Refuge System), consistent with sound principles of fish and wildlife science, conservation, legal mandates, and Service policies. In addition to outlining broad management direction for conserving wildlife and their habitats, the CCPs identify wildlife-dependent recreational opportunities available to the public, including opportunities for hunting, fishing, wildlife observation and photography, and environmental education and interpretation. The National Wildlife Refuge System Administration Act of 1966, as amended by the National Wildlife Refuge System Improvement Act of 1997, requires the Service to review and update these CCPs at least every 15 years. Revisions to the CCP will be prepared in accordance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370d).

The CCP for the Refuge Units in San Diego Bay was initiated in June 2000. At that time and throughout the process, public comments were requested, considered, and incorporated in numerous ways. Public outreach has included scoping meetings, public workshops, planning updates, a CCP webpage, and two Federal Register notices. When the CCP was initiated, these refuge lands were referred to as the Sweetwater Marsh National Wildlife Refuge and the South San Diego Bay Unit of the San Diego National Wildlife Refuge. However, in June 2004, these lands were reorganized into the San Diego Bay National Wildlife Refuge. This action was taken to streamline management and facilitate public understanding and recognition of the two refuge areas within San Diego Bay. This change had no affect on the approved refuge boundaries or the current management practices. All that changed were the names. We now refer to these areas as the Sweetwater Marsh and South San Diego Bay Units of the San Diego Bay National Wildlife Refuge.

The San Diego Bay National Wildlife Refuge is located approximately 10 miles north of the United States-Mexico border in southwestern San Diego County, California. Collectively, the two Refuge Units encompass approximately 2,620 acres of land and water in and around the south end of San Diego Bay. The native coastal salt marsh and intertidal mudflats preserved within this Refuge annually provide essential foraging and resting habitat for tens of thousands of migratory shorebirds and wintering waterfowl traveling along the Pacific Flyway.

The Sweetwater Marsh Unit was established as a National Wildlife Refuge in 1988. Encompassing approximately 316 acres, this Refuge was established to protect federally listed endangered and threatened species. The coastal salt marsh and upland areas within the Sweetwater Marsh Unit support 6 federally listed species, including 3 listed birds that nest within the Unit, one State-listed endangered species, and 26 species of birds identified by the Service as Birds of Conservation Concern.

The South San Diego Bay Unit was established in 1999 as a unit of the San Diego National Wildlife Refuge for the purpose of protecting, managing, and restoring habitats for federally listed endangered and threatened species and migratory birds. The Service currently manages approximately 2,300 acres of the 3,940 acres included within the Unit's approved acquisition boundary. The majority of this management area is leased to the Service by the California State Lands Commission. Included within this Unit is the largest remaining expanse of intertidal mudflats in San Diego Bay. This and other habitats within the Unit support 5 federally listed endangered and threatened species, 1 State-listed endangered species, and 19 species of birds identified by the Service as Birds of Conservation Concern. Open water is the dominant habitat, followed by intertidal mudflats, disturbed uplands, salt marsh, and freshwater wetlands. The Unit includes an active commercial solar salt operation that is managed under a Special Use Permit. The salt pond levees provide important nesting habitat for a variety of colonial nesting seabirds.

The CCP is intended to provide a coherent, integrated set of management actions consistent with the purposes for which the two Refuge Units were established; the mandates of the Refuge System; and the vision, goals, and objectives defined in the CCP. The CCP identifies the Refuge Units' roles in support of the mission of the Refuge System, describes the Service's management actions, and provides a basis for budget needs. This CCP is also intended to satisfy a condition of the Public Agency Lease between the California State Lands Commission and the Service, requiring management and public access plans for the South San Diego Bay Unit and to fulfill the Service's obligation described in a Cooperative Agreement between the Service and the Unified Port of San Diego to prepare “a holistic habitat restoration plan” for a 1,035-acre portion of the existing salt ponds within the South San Diego Bay Unit.

The Draft CCP/EIS identifies and evaluates three alternatives for managing the Sweetwater Marsh Unit and four alternatives for managing the South San Diego Bay Unit for the next 15 years. One alternative for each Refuge Unit that appears to best meet the Refuge purposes is identified as the preferred alternative. The preferred alternatives were identified based on the analysis presented in the Draft CCP/EIS, which may be modified following the completion of the public comment period based on comments received from other agencies, Tribal governments, non-governmental organizations, or individuals.

Under Alternative A—No Action, the Sweetwater Marsh Unit would continue to be managed as it has in the past. No major changes in habitat management would occur. The existing wildlife observation, photography, environmental education, and interpretation programs would remain unchanged.

Under Alternative B, current management activities would be expanded to emphasize enhancement of existing salt marsh habitat. Tidal and freshwater circulation within the salt marsh would be improved to enhance habitat quality for the endangered light-footed clapper rail and other trust species. Existing public uses would continue with added opportunities for environmental interpretation provided adjacent to Paradise Marsh and the F&G Street Marsh.

Under Alternative C (the preferred alternative), management activities would be expanded to include restoration of intertidal and upland habitat. The existing trail system on Gunpowder Point would be redesigned and new interpretive elements would be provided to better complement the existing environmental education programs supported by the Refuge.

Under Alternative A—No Action, the South San Diego Bay Unit would continue to be managed as it has in the past. No major changes in habitat management would occur. The existing opportunities for fishing, wildlife observation, photography, environmental education, and boating would remain unchanged and commercial solar salt production would continue. The Service would continue to pursue land management opportunities within the approved acquisition boundary for the Unit. This activity would occur under any of the alternatives evaluated for this Unit.

Under Alternative B, current management activities would be expanded to emphasize enhancement of nesting opportunities in and around the salt ponds for the California least tern, western snowy plover, and various other colonial seabirds. New nesting habitat would be created and levee tops would be capped with clean, light sand to improve the quality of available nesting substrate. The current public use programs would remain unchanged.

Under Alternative C, portions of the salt ponds and all of the Otay River floodplain would be restored to native coastal habitats, and the nesting enhancements described in Alternative B would be implemented. Two restoration options are presented for both the salt ponds and the Otay River floodplain that could result in the restoration of up to 410 acres of intertidal habitat in the salt works and 140 acres of habitat, including intertidal salt marsh, freshwater wetlands, and native uplands, within the Otay River floodplain. Opportunities for fishing and wildlife observation would be expanded, the Otay Valley Regional Trail would be facilitated, and the construction of a boardwalk along the south side of the salt ponds is proposed. The commercial solar salt operation would continue within a reduced footprint.

Under Alternative D (the preferred alternative), the habitat potential within the salt ponds would be maximized. Approximately 600 acres of salt ponds would be restored to tidal influence to support intertidal mudflat and coastal salt marsh habitats. Additionally, some 30 acres of new nesting habitat would be created, 230 acres of pond area would be managed to benefit waterfowl and shorebird foraging and nesting, and 44 acres of salt ponds and associated levees would be managed to sustain a viable population of brine invertebrates to support the foraging needs of specific species of migratory birds. The Otay River floodplain would be restored as described in Alternative C and the nesting enhancements described under Alternative B would be implemented. Opportunities for wildlife observation, photography, and environmental interpretation would be expanded, the regional trail and boardwalk described in Alternative C would be provided, and the other public uses that are currently provided, including fishing, environmental education, and boating, would be maintained. Restoration under this alternative would be phased and would ultimately result in the closure of the existing commercial solar salt operation.

A draft predator management plan has also been prepared to accompany the CCP. Implementation of this plan is proposed pursuant to the Service's endangered species management responsibilities and would occur on the Refuge in conjunction with other wildlife and habitat management activities. Species to benefit from the implementation of predator management include the federally listed endangered California least tern and light-footed clapper rail and the threatened western snowy plover. The predator management plan has been developed as a comprehensive wildlife damage control program that addresses a range of management actions from vegetation control and nesting habitat enhancement to non-lethal and lethal control of both mammalian and avian predators. Under this plan, the most effective, selective, and humane techniques available to deter or remove individual predators or species that threaten nesting, breeding, or foraging California least terns, western snowy plovers, or light-footed clapper rails would be implemented.

After the review and comment period ends for this Draft CCP/EIS, comments will be analyzed by the Service and addressed in the Final CCP/EIS. All comments received from individuals, including names and addresses, become part of the official public record and may be released. Requests for such comments will be handled in accordance with the Freedom of Information Act, the Council on Environmental Quality's NEPA regulations, and Service and Departmental policies and procedures.

The Final EIS analyzes four action alternatives and the no action alternative to manage pests at Horning. The alternatives can be summarized as follows:

Alternative A—Maximum Production Integrated Pest Management. Pests would be managed using all identified biological, chemical, prescribed fire, cultural, and other pest control methods, including aerial application by helicopter.

Alternative B—Integrated Pest Management with Environmental Protection Emphasis. Pests would be managed using all of the methods in Alternative A, with special exceptions designed to further protect workers' health and safety and the environment. The limitations were based on results of the human health and ecological risk assessment, scoping comments, and consultation with the National Oceanic and Atmospheric Administration's Fisheries office under the Endangered Species Act.

Alternative C—Ground-Based Integrated Pest Management. This alternative is identical to Alternative B except for the exclusion of helicopter application.

Alternative D—Pest Management with No Pesticides. Pests would be managed using only the non-pesticide biological, prescribed fire, cultural, and other methods listed under Alternative A.

Alternative E—No Action: Continuation of Current Management Approach. The current management system allows for use of all non-pesticide pest control practices at the seed orchard, as well as the use of pesticides on a specific case-by-case basis. All non-pesticide biological, prescribed fire, cultural, and other methods would be used in accordance with current procedures. When a specific need is identified for a biological or chemical pesticide, the action would be reviewed to determine whether it is encompassed by an existing environmental assessment (EA) or EIS.

Agency Preferred Alternative: BLM's preferred alternative is Alternative B. Public participation has occurred throughout the NEPA process. Two Notices of Intent were filed in the Federal Register (FR) on March 26, 1999 (64 FR 14747) and March 29, 2001 (66 FR 17192). BLM held an open house, conducted direct mailings and a site visit during scoping to solicit comments and ideas. BLM provided a 60-day written comment period for review of the Draft EIS, during which two public meetings were conducted at the Horning Seed Orchard on July 17, 2003 from 1 to 3 p.m. and 5 to 7 p.m. A new appendix in the Final EIS provides a complete set of public comments received on the Draft EIS, with BLM's response to each comment.

Following the 30-day availability period that begins with publication of EPA's Federal Register Notice of Availability, BLM will issue a Record of Decision announcing selection of the alternative to be implemented. This forest management decision may be protested under 43 CFR 5003—Administrative Remedies. In accordance with 43 CFR 5003.2, the decision for this project will not be subject to protest until the publication of a notice of decision in a newspaper of general circulation, a minimum of 30 days after the Notice of Availability of this Final EIS. Protests of the decision must be filed with this office within 15 days of the publication of a notice of decision in the newspaper. If no protest is received by the close of business (4 p.m. Pacific standard time) on the 15th day, the decision will become final. If a timely protest is received, the decision will be reconsidered in light of the protest and other pertinent information available in accordance with 43 CFR 5003.3.

The Final EIS analyzes three action alternatives and the no action alternative to manage pests at Provolt and Sprague. The alternatives can be summarized as follows:

Alternative A—Maximum Production Integrated Pest Management. Pests would be managed using all identified biological, chemical, prescribed fire, cultural, and other pest control methods, including aerial application by helicopter.

Alternative B—Integrated Pest Management with Environmental Protection Emphasis. Pests would be managed using all of the methods in Alternative A, with special exceptions designed to further protect workers' health and safety and the environment.

The limitations were based on results of the human health and ecological risk assessment, scoping comments, and consultation with the National Oceanic and Atmospheric Administration's Fisheries office under the Endangered Species Act.

Alternative C—Pest Management with No Pesticides. Pests would be managed using only the non-pesticide biological, prescribed fire, cultural, and other methods listed under Alternative A.

Alternative D—No Action: Continuation of Current Management Approach. The current management system allows for use of all non-pesticide pest control practices at the seed orchard, as well as the use of pesticides on a specific case-by-case basis. All non-pesticide biological, prescribed fire, cultural, and other methods would be used in accordance with current procedures. When a specific need is identified for a biological or chemical pesticide, the action would be reviewed to determine whether it is encompassed by an existing environmental assessment (EA) or EIS.

Agency Preferred Alternative: BLM's preferred alternative is Alternative B.

Public participation has occurred throughout the NEPA process. Two Notices of Intent were filed in the Federal Register (FR) on March 26, 1999 (64 FR 14747) and March 29, 2001 (66 FR 17192). An open house, mailouts, and a site visit were conducted during scoping to solicit comments and ideas. A written comment period of 60 days was provided for review of the Draft EIS, during which two public meetings were conducted at the Sprague Seed Orchard on July 14, 2003 from 1 to 3 p.m. and 5 to 7 p.m., and at the Provolt Seed Orchard on July 15, 2003 from 1 to 3 p.m. and 5 to 7 p.m. A new appendix in the Final EIS provides a complete set of public comments received on the Draft EIS, along with BLM's response to each comment.

Following the 30-day availability period that begins with publication of EPA's Federal Register Notice of Availability, BLM will issue a Record of Decision announcing selection of the alternative to be implemented. This forest management decision may be protested under 43 CFR 5003—Administrative Remedies. In accordance with 43 CFR 5003.2, the decision for this project will not be subject to protest until the publication of a notice of decision in a newspaper of general circulation, a minimum of 30 days after the Notice of Availability of this Final EIS. Protests of the decision must be filed with this office within 15 days of the publication of a notice of decision in the newspaper. If no protest is received by the close of business (4:30 p.m. Pacific Standard Time) on the 15th day, the decision will become final. If a timely protest is received, the decision will be reconsidered in light of the protest and other pertinent information available in accordance with 43 CFR 5003.3.

The Final EIS analyzes four action alternatives and the no action alternative to manage pests at Tyrrell. The alternatives can be summarized as follows:

Alternative A—Maximum Production Integrated Pest Management. Pests would be managed using all identified biological, chemical, prescribed fire, cultural, and other pest control methods, including aerial application by helicopter.

Alternative B—Integrated Pest Management with Environmental Protection Emphasis. Pests would be managed using all of the methods in Alternative A, with special exceptions designed to further protect workers' health and safety and the environment. The limitations were based on results of the human health and ecological risk assessment, scoping comments, and consultation with the National Oceanic and Atmospheric Administration's Fisheries office under the Endangered Species Act.

Alternative C—Ground-Based Integrated Pest Management. This alternative is identical to Alternative B except for the exclusion of helicopter application.

Alternative D—Pest Management with No Pesticides. Pests would be managed using only the non-pesticide biological, prescribed fire, cultural, and other methods listed under Alternative A.

Alternative E—No action: Continuation of Current Management Approach. The current management system allows for use of all non-pesticide pest control practices at the seed orchard, as well as the use of pesticides on a specific case-by-case basis. All non-pesticide biological, prescribed fire, cultural, and other methods would be used in accordance with current procedures. When a specific need is identified for a biological or chemical pesticide, the action would be reviewed to determine whether it is encompassed by an existing environmental assessment or EIS.

Agency Preferred Alternative: BLM's preferred alternative is Alternative B.

Public participation has occurred throughout the NEPA process. Two Notices of Intent were filed in the Federal Register on March 26, 1999 (64 FR 14747) and March 29, 2001 (66 FR 17192). An open house, direct mailings, and a site visit were conducted during scoping to solicit comments and ideas. A written comment period of 60 days was provided for review of the Draft EIS, during which two public meetings were conducted at the Tyrrell Seed Orchard on July 16, 2003 from 1 to 3 p.m. and 5 to 7 p.m. A new appendix in the Final EIS provides a complete set of public comments received on the Draft EIS, along with BLM's response to each comment.

Following the 30-day availability period that begins with publication of EPA's Federal Register Notice of Availability, BLM will issue a Record of Decision announcing selection of the alternative to be implemented. This forest management decision may be protested under 43 CFR part 5003— Administrative Remedies. In accordance with 43 CFR 5003.2, the decision for this project will not be subject to protest until the publication of a notice of decision in a newspaper of general circulation, a minimum of 30 days after the Notice of Availability of this Final EIS. Protests of the decision must be filed with this office within 15 days of the publication of a notice of decision in the newspaper. If no protest is received by the close of business (4:15 p.m. Pacific standard time) on the 15th day, the decision will become final. If a timely protest is received, the decision will be reconsidered in light of the protest and other pertinent information available in accordance with 43 CFR 5003.3.

The amended protraction diagrams were prepared at the request of the U.S. Forest Service and are necessary to accommodate Revision of Primary Base Quadrangle Maps for the Geometronics Service Center.

The lands for the prepared amended protraction diagrams are:

We will place copies of the plats of the amended protraction diagrams we described in the open files. They will be available to the public as a matter of information.

If BLM receives a protest against these amended protraction diagrams, as shown on these plats, prior to the date of the official filings, we will stay the filings pending our consideration of the protest.

We will not officially file these plats of the amended protraction diagrams until the day after we have accepted or dismissed all protests and they have become final, including decisions or appeals.

Title: 30 CFR PART 206—PRODUCT VALUATION, subpart C—Federal Oil and subpart D—Federal Gas (Form MMS-4393, Request to Exceed Regulatory Allowance Limitation).

OMB Control Number: 1010-0136.

Bureau Form Number: Form MMS-4393.

Abstract: The Department of the Interior is responsible for matters relevant to mineral resource development on Federal and Indian lands and the Outer Continental Shelf (OCS). The Secretary of the Interior is responsible for managing the production of minerals from Federal and Indian lands and the OCS, collecting royalties from lessees who produce minerals, and distributing the funds collected in accordance with applicable laws. The MMS assists the Secretary in performing the royalty management functions.

When a company or an individual enters into a lease to explore, develop, produce, and dispose of minerals from Federal or Indian lands, that company or individual agrees to pay the lessor a share (royalty) of the value received from production from the leased lands. The lease creates a business relationship between the lessor and the lessee. The lessee is required to report various kinds of information to the lessor relative to the disposition of the leased minerals. Such information is similar to data reported to private and public mineral interest owners and is generally available within the records of the lessee or others involved in developing, transporting, processing, purchasing, or selling of such minerals. The information collected includes data necessary to ensure that the royalties are paid appropriately.

Section 101(a) of the Federal Oil and Gas Royalty Management Act of 1982 (FOGRMA), as amended, requires that the Secretary “establish a comprehensive inspection, collection, and fiscal and production accounting and auditing system to provide the capability to accurately determine oil and gas royalties, interest, fines, penalties, fees, deposits, and other payments owed, and collect and account for such amounts in a timely manner.” In order to accomplish these tasks, MMS developed valuation regulations for Federal leases at 30 CFR part 206—Product Valuation. Market value is a basic principle underlying royalty valuation. Consequently, these regulations include methods to capture the true market value of crude oil and gas produced from Federal leases, both onshore and offshore. The valuation regulations at 30 CFR part 206 require companies to collect and/or submit information used to value their Federal oil and gas.

The MMS uses the information collected to ensure that proper royalty is paid on oil and gas produced from Federal onshore and offshore leases. Please refer to the chart for all reporting requirements and associated burden hours. Regulations developed ensure the information requested is the minimum necessary to carry out our mission and places the least possible burden on respondents. The requested information provides a critical link to establishing the proper value of oil and gas from Federal lands. If the information is not collected, it may result in a loss of royalties for both Federal and state governments.

Under certain circumstances, lessees are authorized to claim a transportation allowance for the reasonable actual costs of transporting the royalty portion of produced oil and gas from the lease to a processing or sales point not in the immediate lease area.

When gas is processed for the recovery of gas plant products, lessees may claim a processing allowance. Transportation and processing allowances are a part of the product valuation process that MMS uses to determine if the lessee is reporting and paying the proper royalty amount.

The regulations establish a limit on transportation allowance deductions for oil and gas at 50 percent of the value of the oil and gas at the point of sale. The MMS may approve a transportation allowance in excess of 50 percent upon proper application from the lessee. Similarly, the regulations establish a limit of 66 2/3 percent of the value of each gas plant product as an allowable gas processing deduction. The MMS may also approve a processing allowance in excess of 66 2/3 percent upon proper application from the lessee.

The MMS may approve an allowance exceeding the regulatory allowance limit upon proper application from the lessee. To request permission to exceed a regulatory allowance limit, lessees must write a letter to MMS explaining why a higher allowance limit is necessary and provide supporting documentation. The MMS developed Form MMS-4393, Request to Exceed Regulatory Allowance Limitation, to accompany the lessee's letter requesting approval to exceed the regulatory allowance limit. This form provides MMS with the data necessary to make a decision and track deductions on royalty reports. Data reported on the form is also subject to subsequent audit and adjustment.

Proprietary information submitted to MMS under this collection is protected, and no items of a sensitive nature are collected. A response is mandatory for valuation requirements and required to obtain the benefit of allowances.

Applicable citations of the laws pertaining to mineral leases include Public Law 97-451—Jan. 12, 1983 (Federal Oil and Gas Royalty Management Act of 1982 [FOGRMA]); Public Law 104-185—Aug. 13, 1996 (Federal Oil and Gas Royalty Simplification and Fairness Act of 1996 [RSFA]), as corrected by Public Law 104-200—Sept. 22, 1996); the Mineral Leasing Act of 1920, Section 36, as amended (30 U.S.C. 192); Outer Continental Shelf Lands Act of 1953, Section 27, as amended (43 U.S.C. 1353); 30 U.S.C. 189 pertaining to Public Lands; 30 U.S.C. 359 pertaining to Acquired Lands; and 43 U.S.C. 1334 pertaining to OCS Lands. Public laws pertaining to mineral royalties are located on our Web site at http://www.mrm.mms.gov/Laws_R_D/PublicLawsAMR.htm.

The applicable regulations include 30 CFR part 206—Product Valuation. In addition, we also are including applicable citations from the 2004 Federal Oil Valuation Rule (69 FR 24959, published May 5, 2004) and the 2005 Federal Gas Valuation Rule (70 FR 11869, published March 10, 2005).

Frequency of Response: Monthly, and when necessary, annually.

Estimated Number and Description of Respondents: 100 Federal lessees.

Estimated Annual Reporting and Recordkeeping “Hour” Burden: 21,815 hours.

We are revising this ICR to include non-standard reporting requirements that were overlooked in the previous renewal, and we have adjusted the burden hours accordingly. The hours also reflect our recent analysis related to the implementation of the 2004 Federal Oil Valuation rule and the 2005 Federal Gas Valuation rule. We have not included in our estimates certain requirements performed in the normal course of business and considered usual and customary. The following chart shows the breakdown of the estimated burden hours by CFR section and paragraph: