Title: WIC Federal and State Agreement.

OMB Number: 0584-0332.

Expiration Date: 9/30/06.

Type of Request: Revision of a currently approved collection.

Abstract: The proposed information collection relates to the reporting and recordkeeping burden associated with completing and submitting form FNS-339, the WIC Federal and State Agreement. The Agreement is the contract between USDA and Special Supplemental Nutrition Program for Women, Infants and Children (WIC) State agencies which empowers the Department to release funds to the States for the administration of the WIC Program in the jurisdiction of the State in accordance with the provisions of 7 CFR part 246.

The Agreement requires the signature of the agency official and includes a certification/assurance regarding drug-free workplace, a certification regarding lobbying and a disclosure of lobbying activities.

Estimate of Burden: Public reporting burden for this collection of information is estimated to average .25 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

Respondents: The Chief Health Officer of the State agency.

Estimated Number of Respondents: 107 respondents.

Estimated Number of Responses Per Respondent: One.

Estimated Time Per Response: .25 of hour.

Estimated Total Annual Burden on Respondents: 26.75 hours.

On March 8, 2006, the Department of Commerce (“Department”) received a petition on imports of certain activated carbon from the People's Republic of China (“PRC”) filed in proper form by Calgon Carbon Corporation and Norit Americas Inc. (“Petitioners”). The period of investigation (“POI”) is July 1, 2005, through December 31, 2005.

In accordance with section 732(b) of the Tariff Act of 1930, as amended (“the Act”), Petitioners alleged that imports of certain activated carbon from the PRC are being, or are likely to be, sold in the United States at less than fair value within the meaning of section 731 of the Act, and that such imports are materially injuring and threaten to injure an industry in the United States. The Department issued supplemental questions to Petitioners on March 10, 2006, and Petitioners filed their response on March 15, 2006.

The merchandise subject to this investigation is certain activated carbon. Certain activated carbon is a powdered, granular or pelletized carbon product obtained by “activating” with heat and steam various materials containing carbon, including but not limited to coal (including bituminous, lignite and anthracite), wood, coconut shells, olive stones, and peat. The thermal and steam treatments remove organic materials and create an internal pore structure in the carbon material. The producer can also use carbon dioxide gas (CO2) in place of steam in this process. The vast majority of the internal porosity developed during the high temperature steam (or CO2 gas) activated process is a direct result of oxidation of a portion of the solid carbon atoms in the raw material, converting them into a gaseous form of carbon.

The scope of this investigation covers all forms of activated carbon that are activated by steam or CO2, regardless of the raw material, grade, mixture, additives, further washing or post-activation chemical treatment (chemical or water washing, chemical impregnation or other treatment), or product form. Unless specifically excluded, the scope of this investigation covers all physical forms of certain activated carbon, including powdered activated carbon (“PAC”), granular activated carbon (“GAC”), and pelletized activated carbon.

Excluded from the scope of the investigation are chemically-activated carbons. The carbon-based raw material used in the chemical activation process is treated with a strong chemical agent, including but not limited to phosphoric acid, zinc chloride sulfuric acid or potassium hydroxide, that dehydrates molecules in the raw material, and results in the formation of water that is removed from the raw material by moderate heat treatment. The activated carbon created by chemical activation has internal porosity developed primarily due to the action of the chemical dehydration agent. Chemically activated carbons are typically used to activate raw materials with a lignocellulosic component such as cellulose, including wood, sawdust, paper mill waste and peat.

To the extent that an imported activated carbon product is a blend of steam and chemically activated carbons, products containing 50 percent or more steam (or CO2 gas) activated carbons are within this scope, and those containing more than 50 percent chemically activated carbons are outside this scope.

Also excluded from the scope are reactivated carbons. Reactivated carbons are previously used activated carbons that have had adsorbed materials removed from their pore structure after use through the application of heat, steam and/or chemicals.

Also excluded from the scope is activated carbon cloth. Activated carbon cloth is a woven textile fabric made of or containing activated carbon fibers. It is used in masks and filters and clothing of various types where a woven format is required.

Any activated carbon meeting the physical description of subject merchandise provided above that is not expressly excluded from the scope is included within this scope. The products under investigation are currently classifiable under the Harmonized Tariff Schedule of the United States (“HTSUS”) subheading 3802.10.00. Although HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of this investigation is dispositive.

During our review of the petition, we discussed the scope with Petitioners to ensure that it accurately reflects the product for which the domestic industry is seeking relief. Petitioners had previously filed a petition on activated carbon from the People's Republic of China on January 26, 2006. On March 8, 2006, Petitioners filed a petition on certain activated carbon from the People's Republic of China. This petition changed the scope and domestic like product definition from the January 26, 2006 petition, which was subsequently withdrawn, to exclude chemically activated carbons. In the March 8, 2006, petition on certain activated carbon, Petitioners addressed their determination to limit the scope to only steam activated carbons and submitted information to support their assertion that chemical and steam activated carbons should not be considered within the scope or the domestic like product.

Moreover, as discussed in the preamble to the Department's regulations, we are setting aside a period for interested parties to raise issues regarding product coverage. See Antidumping Duties; Countervailing Duties; Final Rule, 62 FR 27296, 27323 (May 19, 1997). The Department encourages all interested parties to submit such comments within 20 calendar days of publication of this initiation notice. Comments should be addressed to Import Administration's Central Records Unit in Room 1870, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW, Washington, DC 20230 - Attention: Catherine Bertrand and Carrie Blozy, Room 4003. The period of scope consultations is intended to provide the Department with ample opportunity to consider all comments and consult with interested parties prior to the issuance of the preliminary determination.

Determination of Industry Support for the Petition

Section 732(b)(1) of the Act requires that a petition be filed by or on behalf of the domestic industry. In order to determine whether a petition has been filed by or on behalf of the industry, the Department, pursuant to section 732(c)(4)(A) of the Act, determines whether

a minimum percentage of the relevant industry supports the petition. A petition meets this requirement if the domestic producers or workers who support the petition account for: (i) At least 25 percent of the total production of the domestic like product; and (ii) more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the petition. Moreover, section 732(c)(4)(D) of the Act provides that, if the petition does not establish support of domestic producers or workers accounting for more than 50 percent of the total production of the domestic like product, the Department shall: (i) poll the industry or rely on other information in order to determine if there is support for the petition, as required by subparagraph (A), or (ii) determine industry support using a statistically valid sampling method.

Section 771(4)(A) of the Act defines the “industry” as the producers of a domestic like product. Thus, to determine whether a petition has the requisite industry support, the statute directs the Department to look to producers and workers who produce the domestic like product. The International Trade Commission (“ITC”), which is responsible for determining whether “the domestic industry” has been injured, must also determine what constitutes a domestic like product in order to define the industry. While both the Department and the ITC must apply the same statutory definition regarding the domestic like product (section 771(10) of the Act), they do so for different purposes and pursuant to a separate and distinct authority. In addition, the Department's determination is subject to limitations of time and information. Although this may result in different definitions of the like product, such differences do not render the decision of either agency contrary to law. See USEC, Inc. v. United States, 132 F. Supp. 2d 1, 8 (CIT 2001), citing Algoma Steel Corp. Ltd. v. United States, 688 F. Supp. 639, 644 (1988), aff'd 865 F.2d 240 (Fed. Cir. 1989), cert. denied 492 U.S. 919 (1989).

Section 771(10) of the Act defines the domestic like product as “a product which is like, or in the absence of like, most similar in characteristics and uses with, the article subject to an investigation under this title.” Thus, the reference point from which the domestic like product analysis begins is “the article subject to an investigation,” (i.e., the class or kind of merchandise to be investigated, which normally will be the scope as defined in the petition).

With regard to the domestic like product, Petitioner does not offer a definition of domestic like product distinct from the scope of the investigation. Based on our analysis of the information submitted on the record, we have determined that certain activated carbon constitutes a single domestic like product and we have analyzed industry support in terms of that domestic like product. For a discussion of the domestic like product analysis in this case, see the Initiation Checklist, at Attachment I (Industry Support).

On March 15, 2006, we received an industry support challenge from importers of activated carbon.1 We also received a letter of opposition to the petition from California Carbon, a U.S. producer of activated carbon, on March 24, 2006. See Initiation Checklist at Attachment I (Industry Support). Our review of the data provided in the petition, supplemental submissions, and other information readily available to the Department indicates that Petitioners have established industry support representing at least 25 percent of the total production of the domestic like product; and more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for or opposition to the petition, requiring no further action by the Department pursuant to section 732(c)(4)(D) of the Act. Therefore, the domestic producers (or workers) who support the petition account for at least 25 percent of the total production of the domestic like product, and the requirements of section 732(c)(4)(A)(i) of the Act are met. Furthermore, the domestic producers who support the petition account for more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the petition. Thus, the requirements of section 732(c)(4)(A)(ii) of the Act also are met. Accordingly, the Department determines that the petition was filed on behalf of the domestic industry within the meaning of section 732(b)(1) of the Act. See Initiation Checklist at Attachment I (Industry Support).

The Department finds that Petitioners filed the petition on behalf of the domestic industry because they are an interested party as defined in sections 771(9)(E) and (F) of the Act and they have demonstrated sufficient industry support with respect to the antidumping investigation that they are requesting the Department initiate. See Initiation Checklist at Attachment I (Industry Support).

Petitioners relied on three U.S. prices for certain activated carbon manufactured in the PRC and offered for sale in the United States. Two prices were for POI sales of PAC and the other was for a sale of GAC. In each case, the U.S. price was the winning bid listed on a publically available bid sheet from a U.S. municipal water authority buying activated carbon. Each bid sheet identifies the price, terms of sale, and supplier of the winning bid. Because each of the bid prices were for delivery to the applicable municipal water authority, Petitioners deducted from the price, the costs associated with exporting and delivering the product, including U.S. inland freight, the U.S. importer/distributor profit margin, ocean freight and insurance charges, U.S. duty, port and wharfage fees, foreign inland freight costs, and foreign brokerage and handling. The Department recalculated one export price to adjust the U.S. inland freight figure used by Petitioners. See Initiation Checklist.

Petitioners stated that the PRC is a non-market economy (“NME”) and no determination to the contrary has yet been made by the Department. In previous investigations, the Department has determined that the PRC is a NME. See Notice of Final Determination of Sales at Less Than Fair Value: Magnesium Metal from the People's Republic of China, 70 FR 9037 (February 24, 2005), Notice of Final Determination of Sales at Less Than Fair Value: Certain Tissue Paper Products from the People's Republic of China, 70 FR 7475 (February 14, 2005), and Notice of Final Determination of Sales at Less Than Fair Value: Certain Frozen and Canned Warmwater Shrimp from the People's Republic of China, 69 FR 70997 (December 8, 2004). In accordance with section 771(18)(C)(i) of the Act, the presumption of NME status remains in effect until revoked by the Department. The presumption of NME status for the PRC has not been revoked by the Department and remains in effect for purposes of the initiation of this investigation. Accordingly, the normal value (“NV”) of the product is appropriately based on factors of production valued in a surrogate market economy country in accordance with section 773(c) of the Act. In the course of this investigation, all parties will have the opportunity to provide relevant information related to the issues of the PRC's NME status and the granting of separate rates to individual exporters.

Petitioners selected India as the surrogate country. Petitioners argued that, pursuant to section 773(c)(4) of the Act, India is an appropriate surrogate because it is a market-economy country that is at a comparable level of economic development to the PRC and is a significant producer and exporter of activated carbon. Based on the information provided by Petitioners, we believe that its use of India as a surrogate country is appropriate for purposes of initiating this investigation. After the initiation of the investigation, we will solicit comments regarding surrogate country selection. Also, pursuant to 19 CFR 351.301(c)(3)(i), interested parties will be provided an opportunity to submit publicly available information to value factors of production within 40 days after the date of publication of the preliminary determination.

Petitioners provided three dumping margin calculations using the Department's NME methodology as required by 19 CFR 351.202(b)(7)(i)(C). Petitioners calculated normal values based on consumption rates for producing activated carbon experienced by U.S. producers. In accordance with section 773(c)(4) of the Act, Petitioners valued factors of production, where possible, on reasonably available, public surrogate country data. To value certain factors of production, Petitioners used official Indian government import statistics, excluding those values from countries previously determined by the Department to be NME countries and excluding imports into India from Indonesia, Republic of Korea and Thailand, because the Department has previously excluded prices from these countries because they maintain broadly-available, non-industry specific export subsidies. See Automotive Replacement Glass Windshields From the People's Republic of China: Final Results of Administrative Review, 69 FR 61790 (October 21, 2004), and accompanying Issues and Decision Memorandum at Comment 5.

For the surrogate value for coal, Petitioners only used coking coal imports into India from New Zealand. We have recalculated the normal values to use a surrogate value for coking coal that is based on Indian imports of coking coal from all sources, except those specifically excluded above due to NME status or availability of export subsidies. See Initiation Checklist for details of the recalculation.

For inputs valued in Indian rupees and not contemporaneous with the POI, Petitioners used information from the wholesale price indices (“WPI”) in India as published by the International Monetary Fund in the International Financial Statistics to determine the appropriate adjustments for inflation. In addition, Petitioners made currency conversions, where necessary, based on the average rupee/U.S. dollar exchange rate for the POI, as reported on the Department's Web site.

For the normal value calculations, Petitioners derived the figures for factory overhead, selling, general and administrative expenses (“SG&A”), and profit from the financial ratios of an Indian activated carbon producer, Indo German Carbons Ltd. See Petition at page 63 and Initiation Checklist.

Based on the data provided by Petitioners, there is reason to believe that imports of certain activated carbon from the PRC are being, or are likely to be, sold in the United States at less than fair value. Based upon comparisons of export price to the NV, calculated in accordance with section 773(c) of the Act, the estimated recalculated dumping margins for certain activated carbon from the PRC range from 114.33 percent to 333.66 percent.

Allegations and Evidence of Material Injury and Causation

Petitioners allege that the U.S. industry producing the domestic like product is being materially injured, or is threatened with material injury, by reason of the individual and cumulated imports of the subject merchandise sold at less than NV. Petitioners contend that the industry's injured condition is illustrated by the decline in customer base, market share, domestic shipments, prices and financial performance. We have assessed the allegations and supporting evidence regarding material injury and causation, and we have determined that these allegations are properly supported by adequate evidence and meet the statutory requirements for initiation. See Initiation Checklist at Attachment II (Injury).

The Department recently modified the process by which exporters and producers may obtain separate-rate status in NME investigations. See Policy Bulletin 05.1: Separate-Rates Practice and Application of Combination Rates in Antidumping Investigations involving Non-Market Economy Countries (Separate Rates and Combination Rates Bulletin), (April 5, 2005), available on the Department's Web site at http://ia.ita.doc.gov. The process now requires the submission of a separate-rate status application. Based on our experience in processing the separate rates applications in the antidumping duty investigations of Certain Artist Canvas from the People's Republic of China, Diamond Sawblades and Parts Thereof from the People's Republic of China and the Republic of Korea and Ceratin Lined Paper Products from India, Indonesia, and the People's Republic of China, we have modified the application for this investigation to make it more administrable and easier for applicants to complete. See Initiation of Antidumping Duty Investigation: Certain Artist Canvas From the People's Republic of China, 70 FR 21996, 21999 (April 28, 2005), Initiation of Antidumping Duty Investigations: Diamond Sawblades and Parts Thereof from the People's Republic of China and the Republic of Korea, 70 FR 35625, 35629 (June 21, 2005), and Initiation of Antidumping Duty Investigations: Certain Lined Paper Products from India, Indonesia, and the People's Republic of China, 70 FR 58374, 58379 (October 6, 2005). The specific requirements for submitting the separate-rates application in this investigation are outlined in detail in the application itself, which will be available on the Department's Website at http://ia.ita.doc.gov on the date of publication of this initiation notice in the Federal Register. Please refer to this application for all instructions.

For NME investigations, it is the Department's practice to request quantity and value information from all known exporters identified in the petition. In addition, the Department typically requests the assistance of the NME government in transmitting the Department's quantity and value questionnaire to all companies who manufacture and export subject merchandise to the United States, as well as to manufacturers who produce the subject merchandise for companies who were engaged in exporting subject merchandise to the United States during the period of investigation. The quantity and value data received from NME exporters is used as the basis to select the mandatory respondents. Although many NME exporters respond to the quantity and value information request, at times some exporters may not have received the quantity and value questionnaire or may not have received it in time to respond by the specified deadline.

The Department is now publicizing its requirement that quantity and value responses must be submitted for both the quantity and value questionnaire and the separate-rates application by the respective deadlines in order to receive consideration for separate-rate status. This new procedure will be applied to all future investigations. Appendix I of this notice contains the quantity and value questionnaire that must be submitted by all NME exporters. In addition, the Department will post the quantity and value questionnaire along with the filing instructions on the IA Website (http://ia.ita.doc.gov). This quantity and value questionnaire is due no later than 15 calendar days from the date of publication of this notice. Consistent with Department practice, if a deadline falls on a weekend, federal holiday, or any other day when the Department is closed, the Department will accept the response on the next business day. See Notice of Clarification: Application of “Next Business Day” rule for Administrative Determination Deadlines Pursuant to the Tariff Act of 1930, as amended, 70 FR 24533 (May 10, 2005). The Department will continue to send the quantity and value questionnaire to those exporters identified in the petition and the NME government.

The Department will calculate combination rates for certain respondents that are eligible for a separate rate in this investigation. The Separate Rates and Combination Rates Bulletin, states:

{w}hile continuing the practice of assigning separate rates only to exporters, all separate rates that the Department will now assign in its NME investigations will be specific to those producers that supplied the exporter during the period of investigation. Note, however, that one rate is calculated for the exporter and all of the producers which supplied subject merchandise to it during the period of investigation. This practice applies both to mandatory respondents receiving an individually calculated separate rate as well as the pool of non-investigated firms receiving the weighted-average of the individually calculated rates. This practice is referred to as the application of “combination rates” because such rates apply to specific combinations of exporters and one or more producers. The cash-deposit rate assigned to an exporter will apply only to merchandise both exported by the firm in question and produced by a firm that supplied the exporter during the period of investigation.

Separate Rates and Combination Rates Bulletin, at page 6.

Based upon our examination of the petition on certain activated carbon from the PRC, we find that this petition meets the requirements of section 732 of the Act. Therefore, we are initiating an antidumping duty investigation to determine whether imports of certain activated carbon from the PRC are being, or are likely to be, sold in the United States at less than fair value. Unless postponed, we will make our preliminary determinations no later than 140 days after the date of these initiations.

In accordance with section 732(b)(3)(A) of the Act, a copy of the public version of the petition has been provided to the government of the PRC.

We have notified the ITC of our initiation, as required by section 732(d) of the Act.

The ITC will preliminarily determine, within 25 days after the date on which it receives notice of this initiation, whether there is a reasonable indication that imports of certain activated carbon from the PRC are causing material injury, or threatening to cause material injury, to a U.S. industry. See section 733(a)(2) of the Act. A negative ITC determination will result in the investigation being terminated; otherwise, this investigation will proceed according to statutory and regulatory time limits.

This notice is issued and published pursuant to section 777(i) of the Act.

• Please report quantity on a kilogram basis. If any conversions were used, please provide the conversion formula and source.

• Please report all sales on the same terms (e.g., free on board).

• All sales values should be reported in U.S. dollars. Please indicate any exchange rates used and their respective dates and sources.

• Generally, a U.S. sale is classified as an export price sale when the first sale to an unaffiliated person occurs before importation into the United States.

• Please include any sales exported by your company directly to the United States.

• Please include any sales exported by your company to a third-country market economy reseller where you had knowledge that the merchandise was destined to be resold to the United States.

• If you are a producer of subject merchandise, please include any sales manufactured by your company that were subsequently exported by an affiliated exporter to the United States.

• Please do not include any sales of merchandise manufactured in Hong Kong in your figures.

• Generally, a U.S. sale is classified as a constructed export price sale when the first sale to an unaffiliated person occurs after importation. However, if the first sale to the unaffiliated person is made by a person in the United States affiliated with the foreign exporter, constructed export price applies even if the sale occurs prior to importation.

• Please include any sales exported by your company directly to the United States.

• Please include any sales exported by your company to a third-country market economy reseller where you had knowledge that the merchandise was destined to be resold to the United States.

• If you are a producer of subject merchandise, please include any sales manufactured by your company that were subsequently exported by an affiliated exporter to the United States.

• Please do not include any sales of merchandise manufactured in Hong Kong in your figures.

• Further manufacture or assembly costs include amounts incurred for direct materials, labor and overhead, plus amounts for general and administrative expense, interest expense, and additional packing expense incurred in the country of further manufacture, as well as all costs involved in moving the product from the U.S. port of entry to the further manufacturer.

On August 31, 2005, the Department of Commerce (the Department) received timely requests for an administrative review of the antidumping duty order on corrosion-resistant carbon steel flat products from Canada, with respect to Stelco Inc. (Stelco) and Dofasco Inc., Sorevco Inc., and Do Sol Galva Ltd. (collectively Dofasco). On September 28, 2005, the Department published a notice of initiation of this administrative review for the period of August 1, 2004 through July 31, 2005. See Initiation of Antidumping and Countervailing Duty Administrative Reviews and Requests for Revocation in Part, 70 FR 56631 (September 28, 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 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 that 245-day period to 365 days if it determines it is not practicable to complete the review within the foregoing time period.

In light of the complexity in analyzing issues pertaining to level of trade, it is not practicable for the Department to complete this review by the current deadline of May 3, 2006. Therefore, in accordance with section 751(a)(3)(A) of the Act, the Department is extending the time limit for the preliminary results until no later than August 31, 2006, which is 365 days after the last day of the anniversary month of the date of publication of the order. The final results continue to be due 120 days after the publication of the preliminary results, in accordance with section 351.213 (h) of the Department's regulations.

This notice is issued and published in accordance to sections 751(a)(1) and 777(i)(1) of the Act.

Electronic Access: The full funding opportunity announcement for the worsted wool fabrics program is available through FedGrants at http://www.grants.gov. The Catalog of Federal Domestic Assistance (CFDA) Number is 11.113, Special Projects.

Statutory Authority: Section 4002(c)(6) of the Miscellaneous Trade and Technical Corrections Act of 2004 (Pub. L. 108-429, 118 Stat. 2603) (the “Act”).

Program Description: Section 4002(c)(6)(A) of the Act authorizes the Secretary of Commerce to provide grants to persons (including firms, corporations, or other legal entities) who were, during calendar years 1999, 2000, and 2001, manufacturers of two categories of worsted wool fabrics. The first category are manufacturers of worsted wool fabrics, containing 85 percent or more by weight of wool, with average fiber diameters greater than 18.5 micron (Harmonized Tariff Schedule of the United States (HTS) heading 9902.51.11); the total amount of available funds is $2,666,000, to be allocated among such manufacturers on the basis of the percentage of each manufacturers' production of worsted wool fabric included in HTS 9902.51.11. The second category are manufacturers of worsted wool fabrics, containing 85 percent or more by weight of wool, with average fiber diameters of 18.5 micron or less (HTS heading 9902.51.12); the total amount of available funds is $2,666,000, to be allocated among such manufacturers on the basis of the percentage of each manufacturers' production of worsted wool fabric included in HTS 9902.51.12.

Funding Availability: The Secretary of Commerce is authorized under section 4002(c)(6)(A) of the Act to provide grants to manufacturers of certain worsted wool fabrics. Funding for the worsted wool fabrics grant program will be provided by the Department of the Treasury from amounts in the Wool Apparel Manufacturers Trust Fund (the “Trust Fund”). The total amount of grants to manufacturers of worsted wool fabrics described in HTS 9902.51.11 shall be $2,666,000 in calendar year 2006. The total amount of grants to manufacturers of worsted wool fabrics described in HTS 9902.51.12 shall also be $2,666,000 in calendar year 2006.

Eligibility Criteria: Eligible applicants for the worsted wool fabric program include persons (including firms, corporations, or other legal entities) who were, during calendar years 1999, 2000 and 2001, manufacturers of worsted wool fabric of the kind described in HTS 9902.51.11 or 9902.51.12. Any manufacturer who becomes a successor-of-interest to a manufacturer of the worsted wool fabrics described in HTS 9902.51.11 or HTS 9902.51.12 during 1999, 2000 or 2001 because of a reorganization or otherwise, shall be eligible to apply for such grants.

Applications to Receive Allocations: An applicant must have produced worsted wool fabric of a kind described in HTS 9902.51.11 or 9902.51.12 in the United States in each of calendar years 1999, 2000 and 2001. Applicants must provide: (1) Company name, address, contact and phone number; (2) Federal tax identification number; (3) the name and address of each plant or location in the United States where worsted wool fabrics of the kind described in HTS 9902.51.11 or HTS 9902.51.12 was woven by the applicant; (4) the quantity, in linear yards, of worsted wool fabric production described in HTS 9902.51.11 or 9902.51.12, as appropriate, woven in the United States in each of calendar years 1999, 2000 and 2001; and (5) the value of worsted wool fabric production described in HTS 9902.51.11 or 9902.51.12, as appropriate, woven in the United States in each of calendar years 1999, 2000 and 2001. This data must indicate actual production (not estimates) of worsted wool fabric of the kind described in HTS 9902.51.11 or 9902.51.12.

At the conclusion of the application, the applicant must attest that “all information contained in the application is complete and correct and no false claims, statements, or representations have been made.” Applicants should be aware that, generally, pursuant to 31 U.S.C. 3729, persons providing a false or fraudulent claims, and, pursuant to 18 U.S.C. 1001, persons making materially false statements or representations, are subject to civil or criminal penalties, respectively.

Information that is marked “business confidential” will be protected from disclosure to the full extent permitted by law.

Other Application Requirements: Complete applications must include the following forms and documents: CD-346, Applicant for Funding Assistance; CD-511, Certifications Regarding Debarment, Suspension and Other Responsibility Matters; Drug-Free Workplace Requirements and Lobbying; SF-424, Application for Federal Assistance; and SF-424B, Assurances—Non-Construction Programs. The CD forms are available via Web site: http://www.osec.doc.gov/forms/direct.htm. The SF forms are available via Web site: http://www.whitehouse.gov/omb/grants/grants_forms.html.

This document contains collection-of-information requirements subject to the Paperwork Reduction Act (PRA). The use of Standard Forms 269, 424, 424A, 424B, SF-LLL, and CD-346 has been approved by the Office of Management and Budget (OMB) under the respective control numbers 0348-0039, 0348-0043, 0348-0044, 0348-0040, 0348-0046, and 0605-0001. Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA unless that collection of information displays a currently valid OMB control number.

Allocation Procedures: Section 4002(c)(6)(A) of the Act requires that each grant be allocated among eligible applicants on the basis of the percentage of each manufacturers' production of the fabric described in HTS 9902.51.11 or HTS 9902.51.12 for calendar years 1999, 2000, and 2001, compared to the production of such fabric by all manufacturers who qualify for such grants. Following the closing date of the receipt of applications, the Department shall calculate the appropriate allocation of the allotted funds among eligible applicants in accordance with the statutory procedures. Award decisions shall be final and not subject to appeal or protest.

Intergovernmental Review: Applications under this program are not subject to Executive Order 12372, “Intergovernmental Review of Federal Programs.”

Administrative and National Policy Requirements: Department of Commerce Pre-Award Notifications for Grants and Cooperative Agreements, which are contained in the Federal Register Notice of December 30, 2004 (69 FR 78389), are applicable to this solicitation.

It has been determined that this notice is not significant for purposes of E.O. 12866.

Administrative Procedure/Regulatory Flexibility: Prior notice and an opportunity for public comment are not required by the Administrative Procedure Act for rules concerning public property, loans, grants, benefits, and contracts (5 U.S.C. 553(a)(2)). Because notice and opportunity for comment are not required pursuant to 5 USC 553 or any other law, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) are inapplicable. Therefore, a regulatory flexibility analysis is not required and has not been prepared

The following listed species are covered in this notice:

Chinook salmon (Oncorhynchus tshawytscha): threatened lower Columbia River (LCR); threatened upper Willamette River (UWR).

Chum salmon (O. keta): threatened Columbia River (CR).

Steelhead (O. mykiss): threatened LCR; threatened UWR.

Coho salmon (O. kisutch): threatened LCR.

Scientific research permits are issued in accordance with section 10(a)(1)(A) of the ESA (16 U.S.C. 1531 et. seq) and regulations governing listed fish and wildlife permits (50 CFR 222-226). NMFS issues permits based on findings that such permits: (1) Are applied for in good faith; (2) if granted and exercised, would not operate to the disadvantage of the listed species that are the subject of the permit; and (3) are consistent with the purposes and policy of section 2 of the ESA. The authority to take listed species is subject to conditions set forth in the permits.

Anyone requesting a hearing on an application listed in this notice should set out the specific reasons why a hearing on that application would be appropriate (see ADDRESSES). Such hearings are held at the discretion of the Assistant Administrator for Fisheries, NMFS.

The EES Consulting, Inc. (EESC) is asking for a 3-year research permit to take juvenile LCR Chinook salmon, LCR coho salmon, and LCR steelhead in selected tributaries of the Cowlitz River in Washington. The research is designed to provide information on fish presence, abundance, distribution, and movement within the upper Cowlitz River. The research would benefit listed salmonids by providing baseline information about fish populations in areas affected by the Packwood Lake Hydroelectric Project, and that information, in turn, would be used during the Federal Energy Regulatory Commission's relicensing negotiations. The EESC proposes to observe fish and use backpack electrofishing equipment to capture them. The captured fish would be anesthetized, sampled for tissues and biological information, and released. The EESC does not intend to kill any fish being captured but some may die as an unintentional result of the research activities.

The Oregon Department of Environmental Quality (ODEQ) is asking for a 5-year research permit to take juvenile LCR Chinook salmon, UWR Chinook salmon, LCR coho salmon, CR chum salmon, LCR steelhead, and UWR steelhead in the Willamette Basin, Oregon. The purpose of the research is to evaluate the overall ecological health of the region's streams by evaluating vertebrate and macroinvertebrate assemblages and comparing them to such assemblages in relatively unimpaired reference streams. The research would benefit listed species by allowing the ODEQ to more effectively assess the condition of habitat streams in the Willamette Basin. The information from the study would be used to guide listed species recovery planning and limiting factor analyses. The ODEQ proposes to capture fish using backpack, boat-, or raft-mounted electrofishing equipment or seines (beach or boat) measure them, check them for external pathology, and release them. The ODEQ does not intend to kill any fish being captured but some may die as an unintentional result of the research activities.

This notice is provided pursuant to section 10(c) of the ESA. NMFS will evaluate the application, associated documents, and comments submitted to determine whether the application meets the requirements of section 10(a) of the ESA and Federal regulations. The final permit decisions will not be made until after the end of the 30-day comment period. NMFS will publish notice of its final action in the Federal Register.

NMFS provided public notice through an earlier Federal Register notice of availability (67 FR 16367, April 5, 2002) of a State of Hawaii application for an individual ITP for listed sea turtles in inshore marine fisheries in the Hawaiian Islands managed by the State of Hawaii. NMFS is responsible for analyzing these permit applications and authorizing those which meet legal requirements under the Endangered Species Act (ESA). On May 9, 2002, NMFS published a notice of intent to prepare an EIS in accordance with the National Environmental Policy Act (NEPA) in connection with agency action on the ITP application. On September 22, 2003 (68 FR 55023), NMFS published a notice of intent to hold public scoping meetings on the EIS. However, September 19, 2005, the State of Hawaii informed NMFS that they wished to withdraw and revise their application for an ITP. At that time the state expressed concerns that management measures identified in the ITP for monk seals needed further community input and agency consultation prior to issuance of a final ITP . NMFS will continue to work with the state as they revise their application. The timeline for completion of the revised application is uncertain and elements of the conservation plan may change. NMFS will publish an updated notice on the appropriate NEPA analysis once a revised application is received.

As federal action (i.e., issuance of an ITP) is no longer proposed for the application received March 21, 2002, and amended in May 2005, an EIS is not needed and the notice of intent to prepare an EIS is cancelled.

The Charter Halibut Stakeholder Committee will convene for its third meeting to continue development of two alternatives to allocate halibut between the charter and commercial sectors. One alternative would be a percentage allocation to the charter sector. Elements to be considered include, but are not limited to: (1) A percentage based allocation that would float up and down with halibut abundance; (2) Subdivision of Area 2C and 3A into smaller geographic sub-districts; (3) Management measures that will be used to enforce the allocation, including: (a) the current suite of measures to reduce harvests under the Guideline Harvest Level (GHL) (i.e., one trip per vessel per day, no harvest by skipper and crew, and annual limit of 5 or 6 fish per person (for Area 2C only); (b) Limits on the number of lines fished to the number of clients; (c) Other annual bag limits; (d) Limits on days fished (either total number of days or by excluding specific days of the week); (e) Reduced daily limits including size limitations for the second fish caught; (f) Subtraction of any allocation overage from the following year's allocation; (g) Federal limited entry program with delayed transferability; (h) Mechanisms which, if the charter harvest continues to grow, would allow for an orderly and compensated allocation shift from the longline sector to the charter sector, including the use of a charter stamp or other funding mechanisms to generate funds to buy commercial quota shares to convert commercial allocation to the charter sector and to pay for management of the charter fishery.

A second alternative would be an Individual Fishing Quota (IFQ) program, including, but not be limited to: (1) Elements of the previously proposed (2001) charter IFQ program; (2) A modified IFQ program, including, but not be limited to, including recent participants who were not included in the 2001 plan. Such approaches might include a “leveling” plan, other effort based mechanisms to update 1998 and 1999 history, new history approaches, an effort based transferable seat program, or other options; (3) Subdivision of Area 2C and 3A into smaller geographic sub-districts; and (4) Other elements to be identified by the committee.

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

These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Gail Bendixen at (907) 271-2809 at least 7 working days prior to the meeting date.

Section 156 of Title 35, United States Code, generally provides that the term of a patent may be extended for a period of up to five years if the patent claims a product, or a method of making or using a product, that has been subject to certain defined regulatory review, and that the patent may be extended for interim periods of up to a year if the regulatory review is anticipated to extend beyond the expiration date of the patent.

On March 26, 2003, patent owner, Hoechst Roussel Vet S.A., timely filed an application under 35 U.S.C. 156(d)(5) for an interim extension of the term of U.S. Patent No. 4,585,770. On March 31, 2004, patent owner, Hoechst Roussel Vet S.A., timely filed a second application under 35 U.S.C. 156(d)(5) for a second interim extension of the term of U.S. Patent No. 4,585,770. On March 29, 2005, patent owner, Hoechst Roussel Vet S.A., timely filed a third application under 35 U.S.C. 156(d)(5) for a third interim extension of the term of U.S. Patent No. 4,585,770. The patent claims the active ingredient, zilpaterol hydrochloride, in the animal drug product Zilmax®. The application indicates that an Investigational New Animal Drug Application for the animal drug product, Zilmax® (zilpaterol hydrochloride), has been filed and is currently undergoing regulatory review before the Food and Drug Administration for permission to market or use the product commercially.

Review of the application indicates that, except for permission to market or use the product commercially, the subject patent would be eligible for an extension of the patent term under 35 U.S.C. 156, and that the patent should be extended for one year as required by 35 U.S.C. 156(d)(5)(B). Since it is apparent that the regulatory review period has continued beyond the original expiration date of the patent (October 12, 2003), interim extension of the patent term under 35 U.S.C. 156(d)(5) is appropriate.

An interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. Patent No. 4,585,770, is granted for a period of one year from the original expiration date of the patent, i.e., until October 12, 2004; a second interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. Patent No. 4,585,770, is granted for an additional period of one year from the extended expiration date of the patent, i.e., until October 12, 2005; and a third interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. Patent No. 4,585,770, is granted for an additional period of one year from the extended expiration date of the patent, i.e., until October 12, 2006.

Section 156 of Title 35, United States Code, generally provides that the term of a patent may be extended for a period of up to five years if the patent claims a product, or a method of making or using a product, that has been subject to certain defined regulatory review, and that the patent may be extended for interim periods of up to a year if the regulatory review is anticipated to extend beyond the expiration date of the patent.

On May 17, 2005, patent owner L'Oreal S.A., timely filed an application under 35 U.S.C. 156(d)(5) for a third subsequent interim extension of the term of U.S. Patent No. 4,585,597. The patent claims the active ingredient Mexoryl® SX (ecamsule), in the human drug product ANTHELIOS® SP Topical Cream (HELIOBLOCK® SX Cream), a method of use of the active ingredient, and a method of manufacturing the active ingredient. The application indicates, and the Food and Drug Administration has confirmed, that a New Drug Application for the human drug product Mexoryl® SX (ecamsule) has been filed and is currently undergoing regulatory review before the Food and Drug Administration for permission to market or use the product commercially.

Review of the application indicates that, except for permission to market or use the product commercially, the subject patent would be eligible for an extension of the patent term under 35 U.S.C. 156, and that the patent should be extended for an additional year as required by 35 U.S.C. 156(d)(5)(B). Since it is apparent that the regulatory review period has continued beyond the extended expiration date of the patent (June 16, 2005), interim extension of the patent term under 35 U.S.C. 156(d)(5) is appropriate.

An interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. Patent No. 4,585,597 is granted for a period of one year from the expiration date of the patent, i.e., until June 16, 2006.

In 1973, the Commission issued safety requirements for electrically operated toys and children's articles to protect children from unreasonable risks of injury from electric shock, electrical burns, and thermal burns. These regulations are codified at 16 CFR part 1505 and were issued under the authority of sections 2 and 3 of the Federal Hazardous Substances Act (15 U.S.C. 1261, 1262).

These regulations are applicable to toys, games, and other articles intended for use by children that are powered by electrical current from a 120 volt circuit. Video games and articles designed primarily for use by adults that may be incidentally used by children are not subject to these regulations.

The regulations prescribe design, construction, performance, and labeling requirements for electrically operated toys and children's articles. The regulations also require manufacturers and importers of those products to develop and maintain a quality assurance program. Additionally, section 1505.4(a)(3) of the regulations requires those firms to maintain records for three years containing information about: (1) Material and production specifications; (2) the quality assurance program used; (3) results of all tests and inspections conducted; and (4) sales and distribution of electrically operated toys and children's articles.

The Office of Management and Budget (OMB) approved the collection of information requirements in the regulations under control number 3041-0035. OMB's most recent extension of approval expires on June 30, 2006. The Commission now proposes to request an extension of approval without change for the information collection requirements in the regulations.

The safety need for this collection of information remains. Specifically, if a manufacturer or importer distributes products that violate the requirements of the regulations, the records required by section 1505.4(a)(3) can be used by the firm and the Commission (i) to identify specific lots or production lines of products which fail to comply with applicable requirements, and (ii) to notify distributors and retailers in the event the products are subject to recall.

The Commission staff estimates that about 40 firms are subject to the testing and recordkeeping requirements of the regulations. Each one may have an average of ten products each year for which testing and recordkeeping would be required. The Commission staff estimates that the tests required by the regulations can be performed on one product in 16 hours and that recordkeeping and maintenance can be performed for one product in four hours. Thus, the total annual burden imposed by the regulations on all manufacturers and importers is about 8,000 hours. Using the rate of $42.84 per hour as the average total compensation (Bureau of Labor Statistics, September 2005), the estimated annualized cost is $343,000.

The Commission solicits written comments from all interested persons about the proposed collection of information. The Commission specifically solicits information relevant to the following topics:

The National Reconnaissance Office systems of records notices subject to the Privacy Act of 1974, (5 U.S.C. 552a), as amended, have been published in the Federal Register and are available from the address above.

The proposed system report, as required by 5 U.S.C. 552a(r) of the Privacy Act of 1974, as amended, was submitted on March 23, 2006, to the House Committee on Government Reform, the Senate Committee on Governmental Affairs, and the Office of Management and Budget (OMB) pursuant to paragraph 4c of Appendix I to OMB Circular No. A-130, “Federal Agency Responsibilities for Maintaining Records About Individuals,” dated February 8, 1996 (February 20, 1996, 61 FR 6427).

The National Reconnaissance Office systems of records notices subject to the Privacy Act of 1974, (5 U.S.C. 552a), as amended, have been published in the Federal Register and are available from the address above.

The proposed system report, as required by 5 U.S.C. 552a(r) of the Privacy Act of 1974, as amended, was submitted on March 23, 2006, to the House Committee on Government Reform, the Senate Committee on Homeland Security and Governmental Affairs, and the Office of Management and Budget (OMB) pursuant to paragraph 4c of Appendix I to OMB Circular No. A-130, “Federal Agency Responsibilities for Maintaining Records About Individuals,” dated February 8, 1996 (February 20, 1996, 61 FR 6427).

The Commission is established by the Secretary of Education to begin a national dialogue about the future of higher education in this country. The purpose of this Commission is to consider how best to improve our system of higher education to ensure that our graduates are well prepared to meet our future workforce needs and are able to participate fully in the changing economy. The Commission shall consider federal, state, local and institutional roles in higher education and analyze whether the current goals of higher education are appropriate and achievable. The Commission will also focus on the increasing tuition costs and the perception of many families, particularly low-income families, that higher education is inaccessible.

The agenda for this meeting will include a discussion between commission members regarding preliminary findings, possible recommendations and a proposed format for the final report. A written report to the Secretary is due by August 2006.

Individuals who will need accommodations for a disability in order to attend the meeting (e.g., interpreting services, assistive listening devices, or materials in alternative format) should notify Kristen Vetri at (202) 401-0429 no later than May 8, 2006. We will attempt to meet requests for accommodations after this date but cannot guarantee their availability. The meeting site is accessible to individuals with disabilities.

Individuals interested in attending the meeting must register in advance because of limited space issues. Please contact Kristen Vetri at (202) 401-0429 or by e-mail at Kristen.Vetri@ed.gov.

Opportunities for public comment are available through the Commission's Web site at http://www.ed.gov/about/bdscomm/list/hiedfuture/index.html. Records are kept of all Commission proceedings and are available for public inspection at the staff office for the Commission from the hours of 9 a.m. to 5 p.m.

How Can I Access the Docket and/or Submit Comments?

EPA has established a public docket for this ICR under Docket ID No. EPA-HQ-ORD-2005-0530, which is available for online viewing at http://www.regulations.gov, or in person viewing at the Office of Environmental Information Docket in the EPA Docket Center (EPA/DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room is open from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is 202-566-1744, and the telephone number for the Office of Environmental Information Docket is 202-566-1742.

Use http://www.regulations.gov to obtain a copy of the draft collection of information, submit or view public comments, access the index listing of the contents of the docket, and to access those documents in the public docket that are available electronically. Once in the system, select “search,” then key in the docket ID number identified in this document.

Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically solicits comments and information to enable it to:

(i) Evaluate 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;

(ii) 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;

(iii) Enhance the quality, utility, and clarity of the information to be collected; and

(iv) 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. In particular, EPA is requesting comments from very small businesses (those that employ less than 25) on examples of specific additional efforts that EPA could make to reduce the paperwork burden for very small businesses affected by this collection.

You may find the following suggestions helpful for preparing your comments:

1. Explain your views as clearly as possible and provide specific examples.

2. Describe any assumptions that you used.

3. Provide copies of any technical information and/or data you used that support your views.

4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.

5. Offer alternative ways to improve the collection activity.

6. Make sure to submit your comments by the deadline identified under DATES.

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

Affected entities: Entities potentially affected by this action are primarily manufacturers and vendors of ambient air quality monitoring instruments that are used by state and local air quality monitoring agencies in their federally required air surveillance monitoring networks, and agents acting for such instrument manufacturers or vendors. Other entities potentially affected may include state or local air monitoring agencies, other users of ambient air quality monitoring instruments, or any other applicant for a reference or equivalent method determination.

Title: Application for Reference and Equivalent Method Determination (OMB Control No. 2080-0005; EPA ICR 0559.09.

ICR numbers: EPA ICR No. 0559.08; OMB Control No. 2080-0005.

ICR status: This ICR is currently scheduled to expire on January 2008. Revisions to the ICR are being made in response to proposed revisions to the NAAQS for particulate matter. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information, unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register when approved, are listed in 40 CFR part 9, are displayed either by publication in the Federal Register or by other appropriate means, such as on the related collection instrument or form, if applicable. The display of OMB control numbers in certain EPA regulations is consolidated in 40 CFR part 9.

Abstract: To determine compliance with the NAAQS, State air monitoring agencies are required to use, in their air quality monitoring networks, air monitoring methods that have been formally designated by the EPA as either reference or equivalent methods under EPA regulations at 40 CFR part 53. A manufacturer or seller of an air monitoring method (e.g. an air monitoring sampler or analyzer) that seeks to obtain such EPA designation of one of its products must carry out prescribed tests of the method. The test results and other information must then be submitted to the EPA in the form of an application for a reference or equivalent method determination in accordance with 40 CFR part 53. The EPA uses this information, under the provisions of part 53, to determine whether the particular method should be designated as either a reference or equivalent method. After a method is designated, the applicant must also maintain records of the names and mailing addresses of all ultimate purchasers of all analyzers or samplers sold as designated methods under the method designation. If the method designated is a method for fine particulate matter (PM2.5) and coarse particulate matter (PM10-2.5), the applicant must also submit a checklist signed by an ISO-certified auditor to indicate that the samplers or analyzers sold as part of the designated method are manufactured in an ISO 9001-registered facility. Also, an applicant must submit a minor application to seek approval for any proposed modifications to previously designated methods.

A response to this collection of information is voluntary, but it is required to obtain the benefit of EPA designation under 40 CFR part 53. Submission of some information that is claimed by the applicant to be confidential business information may be necessary to make a reference or equivalent method determination. The confidentiality of any submitted information identified as confidential business information by the applicant will be protected in full accordance with 40 CFR 53.15 and all applicable provisions of 40 CFR part 2.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for EPA's regulations are listed in 40 CFR part 9 and 48 CFR Chapter 15.

The EPA would like to solicit comment to:

(i) Evaluate 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;

(ii) evaluate the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(iii) enhance the quality, utility, and clarity of the information to be collected; and

(iv) minimize the burden of the collection information on those who are to respond, including through the use of appropriate automated technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average approximately 7,492 hours during the next three years. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements which have subsequently changed; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

The ICR provides a detailed explanation of the Agency's estimate, which is only briefly summarized here:

Estimated total number of potential respondents: 22.

Frequency of response: Annual.

Estimated total average number of responses for each respondent: 1.

Estimated total annual burden hours: 7,492.

Estimated total annual costs: $650,494. This includes an estimated burden cost of $517,831 and an estimated cost of $132,668 for capital investment or maintenance and operational costs

There is an increase of 2,774 hours in the total estimated respondent burden compared with that identified in the ICR currently approved by OMB. This increase reflects EPA's estimate that an average of 1.33 additional applications for reference or equivalent method determinations, and an average of 1.67 additional minor applications for approval of modifications, will be received annually following promulgation of the proposed regulation changes. It is estimated that there will be a corresponding increase in total respondent costs of $219,112 for these additional applications and an increase in $4,415 for these additional minor modifications.

EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.12. At that time, EPA will issue another Federal Register notice pursuant to 5 CFR 1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB.

The purpose of this notice is to announce that on March 21, 2006, USEPA granted NNEPA's request to supplement its existing full delegation of authority to administer the part 71 Federal operating permits program to include the Power Plants.

The Act and its implementing regulations under 40 CFR part 71 authorize USEPA to delegate authority to administer the part 71 program to any eligible Tribe that submits a demonstration of adequate regulatory procedures and authority for administration of the part 71 operating permits program.

In order to be considered an “eligible tribe,” the NNEPA submitted, in August 2005, an application for a determination, under the provisions of the Tribal Authority Rule (TAR), 40 CFR part 49, that it is eligible to be treated in the same manner as a state for the purpose of receiving delegation of authority to administer the Federal part 71 operating permit program for the Power Plants. Region IX reviewed NNEPA's application and determined that it met the four criteria for eligibility, identified in 40 CFR 49.6, for the Power Plants, and was thus eligible for entering into a supplemental delegation agreement with USEPA Region IX to administer the part 71 program for the Power Plants. USEPA Region IX's eligibility determination was signed on March 21, 2006.

On October 15, 2004, USEPA Region IX and the NNEPA entered into a delegation of authority agreement (October 2004 Delegation Agreement) to allow NNEPA to administer the Federal part 71 operating permits program on behalf of USEPA for all part 71 sources except for the Power Plants within a Delegated Program Area specified in that agreement. The October 2004 Delegation Agreement excluded the Power Plants because the Navajo Nation and the participants of the Power Plants disagree as to the Nation's jurisdiction to regulate the Power Plants under a delegated Part 71 Program based on the existence of certain provisions contained in leases and grants of rights-of-way (the “Covenants” and “Grants”) as between the Navajo Nation and the two facilities.

In light of this disagreement, on May 18, 2005, NNEPA entered into a voluntary compliance agreement (VCA) with the participants of the Power Plants, which provides that the parties will not assert or challenge any effect of the Covenants and Grants on the authority of NNEPA to administer a delegated part 71 program on behalf of USEPA with respect to the Plants or on the applicability to the Plants of the requirements of the Navajo Nation laws that have been expressly incorporated into a part 71 permit administered by the Navajo Nation EPA, without prejudice to their rights to assert or challenge the Covenants or Grants after expiration or termination of the VCA. Therefore, for so long as the VCA remains in effect, the VCA resolves the dispute between the Navajo Nation and the Power Plants as to impact of the Covenants or Grants on NNEPA's ability to regulate the Power Plants pursuant to the delegation of the administration of the part 71 Program.

In August 2005, NNEPA submitted a request to the USEPA Region IX, pursuant to 40 CFR 71.10, to supplement the October 2004 Delegation Agreement by delegating authority to NNEPA to administer the Part 71 Program with respect to the Power Plants. As part of its request, NNEPA submitted a legal opinion from its attorney general stating that the Navajo Nation Air Pollution Prevention and Control Act, the Navajo Nation Air Quality Control Program Operating Permit Regulations and the VCA provide it adequate authority to carry out all aspects of the delegated program for the Power Plants. NNEPA also provided all necessary documentation to demonstrate that it has adequate authority and adequate resources to administer the part 71 Federal permitting program for the Power Plants.

Pursuant to 40 CFR 71.10(b), USEPA hereby notifies the public that effective March 21, 2006, it has granted NNEPA's request and is fully delegating the authority to administer the federal operating permits program for the Power Plants as set forth under 40 CFR part 71 and in the Agreement. The terms and conditions for the supplemental delegation are specified in the Agreement between USEPA Region IX and NNEPA signed and dated on March 21, 2006.

If, at any time, USEPA determines that NNEPA is not adequately administering or cannot adequately administer the requirements of part 71 or fulfill the terms of the Agreement, this supplemental delegation may be revoked, in whole or in part, pursuant to 40 CFR 71.10(c), after appropriate consultation with NNEPA. The Agreement also provides that the supplemental delegation will automatically terminate with respect to either Power Plant for which the VCA has terminated or expired. USEPA will notify the public through a Federal Register notice of a partial or full termination of this Agreement.

Under the supplemental delegation, USEPA retains its authority to (1) object to the issuance of any part 71 permit for the Power Plants, (2) act upon petitions submitted by the public regarding the Power Plants, and (3) collect fees from the owners or operators of the Power Plants if it is demonstrated that NNEPA is not adequately administering the part 71 program with respect to the Power Plants, in accordance with the Agreement, 40 CFR part 71, and/or the Act. Because USEPA is retaining its authority to act upon petitions submitted pursuant to 40 CFR 71.10(h) and 71.11(n), any such petitions must be submitted to USEPA Region IX following the procedures set forth in those regulations.

USEPA also notifies the public, pursuant to 40 CFR 71.9(c)(2)(ii), that effective March 21, 2006, it has suspended collection of its part 71 permit fees for the Power Plants. In delegating the administration of the part 71 program, USEPA has determined that NNEPA can collect fees under tribal law sufficient to fund the delegated part 71 program for the Power Plants and carry out the duties specified in the Agreement.

The originally proposed general permits and the modifications being proposed today cover storm water discharges from municipal separate storm sewer systems (MS4s) meeting the definition of a “small municipal separate storm sewer system” at 40 CFR 122.26(b)(16) and designated under 40 CFR 122.32(a)(1) or 40 CFR 122.32(a)(2). An MS4 consists of a system of conveyances (including roads with drainage systems, municipal streets, catch basins, curbs, gutters, ditches, manmade channels, or storm drains) that collects storm water; is owned or operated by the United States, a State, city, town, borough, county, parish, district, association, or other public body (created by or pursuant to State law) having jurisdiction over disposal of sewage, industrial wastes, storm water, or other wastes, including special districts under State law such as a sewer district, flood control district or drainage district, or similar entity, or an Indian tribe or an authorized Indian tribal organization, or a designated and approved management agency under section 208 of the CWA; and discharges to waters of the United States. A small MS4 typically serves a population of less than 100,000. Only those small MS4s located in a Census-defined Urbanized Area or having been designated by the Director are required to apply for permits (see 40 CFR 122.32). Maps of Urbanized Areas and lists of cities and counties within them are available online at http://cfpub.epa.gov/npdes/stormwater/urbanmaps.cfm.

Subsequent to EPA Region 6's proposal of the general permits for small MS4s on September 9, 2003, the U.S. Court of Appeals for the Ninth Circuit denied EPA's petition for rehearing in litigation over EPA's storm water Phase II regulations. Environmental Defense Center, et al. v. EPA, No. 70014 & consolidated cases (9th Cir., Sept. 15, 2003). Plaintiffs in that litigation challenged the Phase II NPDES storm water regulations issued by EPA pursuant to Clean Water Act (CWA) section 402(p)(6). Among other things, the Phase II regulations require NPDES permits for storm water discharges from certain MS4s for which NPDES permits were not required under CWA section 402(p)(2) and the Phase I NPDES storm water regulations. The regulations also require the newly regulated MS4s to develop, implement, and enforce a storm water management program containing, amongst other things, best management practices (BMPs) identified by the discharger. The regulations authorize the use of general permits and require that these BMPs (as well as measurable goals associated with these BMPs) be identified in the Notice of Intent (NOI) filed by the MS4 in seeking authorization under a general permit. Relying on the “traditional'' general permit model, the Agency did not require NOIs to be reviewed by the Agency, made available to the public for review and comment, or to be subject to public hearings. The Ninth Circuit held that EPA's failure to address these issues in establishing NOI requirements violated various provisions of CWA section 402, and remanded the Phase II regulations on three grounds related to the use of NPDES permits to authorize discharges from small MS4s: (1) Public availability of Notices of Intent (NOIs), (2) opportunity for public hearing, and (3) Permitting Authority review of NOIs.

On April 16, 2004, EPA's Office of Wastewater Management issued guidance to NPDES Permitting Authorities entitled “Implementing the Partial Remand of the Stormwater Phase II Regulations Regarding Notices of Intent & NPDES General Permitting for Phase II MS4s” (available at http://www.epa.gov/npdes/pubs/hanlonphase2apr14signed.pdf). This document provides guidance to permitting authorities on addressing the Court's partial remand when issuing general permits for small MS4s. Today's revisions to the originally proposed general permits are in response to the partial remand to the Phase II regulations and issues raised in the Court's decision and are consistent with EPA's Office of Wastewater Management Guidance.

The public comment period on the proposed general permits is being reopened, in accordance with procedures at 40 CFR 124.14, for the limited purpose of accepting public comments on today's proposed changes to the draft permits. EPA's public comment and public hearing procedures may be found at 40 CFR 124.10 and 124.12 (48 FR 142664, April 1, 1983, as amended at 49 FR 38051, September 26, 1984). Following the end of the supplemental comment period, the Director will make a final permit decision and notice will be published in the Federal Register.

The text of the report follows:

The Office of the Comptroller of the Currency (OCC), the Board of Governors of the Federal Reserve System (FRB), the Federal Deposit Insurance Corporation (FDIC), and the Office of Thrift Supervision (OTS) (“the Federal banking agencies” or “the agencies”) must jointly submit an annual report to the Committee on Financial Services of the U.S. House of Representatives and the Committee on Banking, Housing, and Urban Affairs of the U.S. Senate describing differences between the accounting and capital standards used by the agencies. The report must be published in the Federal Register.

This report, which covers differences existing as of December 31, 2005, is the fourth joint annual report on differences in accounting and capital standards to be submitted pursuant to section 37(c) of the Federal Deposit Insurance Act (12 U.S.C. 1831n(c)), as amended. Prior to the agencies' first joint annual report, section 37(c) required a separate report from each agency.

Since the agencies filed their first reports on accounting and capital differences in 1990, the agencies have acted in concert to harmonize their accounting and capital standards and eliminate as many differences as possible. Section 303 of the Riegle Community Development and Regulatory Improvement Act of 1994 (12 U.S.C. 4803) also directs the agencies to work jointly to make uniform all regulations and guidelines implementing common statutory or supervisory policies. The results of these efforts must be “consistent with the principles of safety and soundness, statutory law and policy, and the public interest.” In recent years, the agencies have revised their capital standards to address changes in credit and certain other risk exposures within the banking system and to align the amount of capital institutions are required to hold more closely with the credit risks and certain other risks to which they are exposed. These revisions have been made in a uniform manner whenever possible and practicable to minimize interagency differences.

While the differences in capital standards have diminished over time, a few differences remain. Some of the remaining capital differences are statutorily mandated. Others were significant historically but now no longer affect in a measurable way, either individually or in the aggregate, institutions supervised by the Federal banking agencies. In this regard, the OTS plans to eliminate two such de minimis differences during 2006 that have been fully discussed in previous joint annual reports ((i) covered assets and (ii) pledged deposits, nonwithdrawable accounts, and certain certificates), and these differences have been excluded from this annual report.

In addition to the specific differences in capital standards noted below, the agencies may have differences in how they apply certain aspects of their rules. These differences usually arise as a result of case-specific inquiries that have only been presented to one agency. Agency staffs seek to minimize these occurrences by coordinating responses to the fullest extent reasonably practicable.

The Federal banking agencies have substantially similar capital adequacy standards. These standards employ a common regulatory framework that establishes minimum leverage and risk-based capital ratios for all banking organizations (banks, bank holding companies, and savings associations). The agencies view the leverage and risk-based capital requirements as minimum standards, and most institutions are expected to operate with capital levels well above the minimums, particularly those institutions that are expanding or experiencing unusual or high levels of risk.

The OCC, the FRB, and the FDIC, under the auspices of the Federal Financial Institutions Examination Council, have developed uniform Reports of Condition and Income (Call Reports) for all insured commercial banks and state-chartered savings banks. The OTS requires each OTS-supervised savings association to file the Thrift Financial Report (TFR). The reporting standards for recognition and measurement in the Call Reports and the TFR are consistent with generally accepted accounting principles (GAAP). Thus, there are no significant differences in regulatory accounting standards for regulatory reports filed with the Federal banking agencies. Only one minor difference remains between the accounting standards of the OTS and those of the other federal banking agencies, and that difference relates to push-down accounting, as more fully explained below.

The Gramm-Leach-Bliley Act (GLBA) establishes the framework for financial subsidiaries of banks.1 GLBA amends the National Bank Act to permit national banks to conduct certain expanded financial activities through financial subsidiaries. Section 121(a) of the GLBA (12 U.S.C. 24a) imposes a number of conditions and requirements upon national banks that have financial subsidiaries, including specifying the treatment that applies for regulatory capital purposes. The statute requires that a national bank deduct from assets and tangible equity the aggregate amount of its equity investments in financial subsidiaries. The statute further requires that the financial subsidiary's assets and liabilities not be consolidated with those of the parent national bank for applicable capital purposes.

State member banks may have financial subsidiaries subject to all of the same restrictions that apply to national banks.2 State nonmember banks may also have financial subsidiaries, but they are subject only to a subset of the statutory requirements that apply to national banks and state member banks.3 Finally, national banks, state member banks, and state nonmember banks may not establish or acquire a financial subsidiary or commence a new activity in a financial subsidiary if the bank, or any of its insured depository institution affiliates, has received a less than satisfactory rating as of its most recent examination under the Community Reinvestment Act.4

The OCC, the FDIC, and the FRB adopted final rules implementing their respective provisions of Section 121 of GLBA for national banks in March 2000, for state nonmember banks in January 2001, and for state member banks in August 2001. GLBA did not provide new authority to OTS-supervised savings associations to own, hold, or operate financial subsidiaries, as defined.

Banks supervised by the OCC, the FRB, and the FDIC generally consolidate all significant majority-owned subsidiaries other than financial subsidiaries for regulatory capital purposes. This practice assures that capital requirements are related to the aggregate credit (and, where applicable, market) risks to which the banking organization is exposed. For subsidiaries other than financial subsidiaries that are not consolidated on a line-for-line basis for financial reporting purposes, joint ventures, and associated companies, the parent banking organization's investment in each such subordinate organization is, for risk-based capital purposes, deducted from capital or assigned to the 100 percent risk-weight category, depending upon the circumstances. The FRB's and the FDIC's rules also permit the banking organization to consolidate the investment on a pro rata basis in appropriate circumstances. These options for handling unconsolidated subsidiaries, joint ventures, and associated companies for purposes of determining the capital adequacy of the parent banking organization provide the agencies with the flexibility necessary to ensure that institutions maintain capital levels that are commensurate with the actual risks involved.

Under the OTS's capital regulations, a statutorily mandated distinction is drawn between subsidiaries, which generally are majority-owned, that are engaged in activities that are permissible for national banks and those that are engaged in activities “impermissible” for national banks. Where subsidiaries engage in activities that are impermissible for national banks, the OTS requires the deduction of the parent's investment in these subsidiaries from the parent's assets and capital. If a subsidiary's activities are permissible for a national bank, that subsidiary's assets are generally consolidated with those of the parent on a line-for-line basis. If a subordinate organization, other than a subsidiary, engages in impermissible activities, the OTS will generally deduct investments in and loans to that organization.5 If such a subordinate organization engages solely in permissible activities, the OTS may, depending upon the nature and risk of the activity, either assign investments in and loans to that organization to the 100 percent risk-weight category or require full deduction of the investments and loans.

The FRB and the OCC assign a zero percent risk weight to claims collateralized by cash on deposit in the institution or by securities issued or guaranteed by the U.S. Government, U.S. Government agencies, or the central governments of other countries that are members of the Organization for Economic Cooperation and Development (OECD). The OCC and the FRB rules require the collateral to be marked to market daily and a positive margin of collateral protection to be maintained daily. The FRB requires qualifying claims to be fully collateralized, while the OCC rule permits partial collateralization.

The FDIC and the OTS assign a zero percent risk weight to claims on qualifying securities firms that are collateralized by cash on deposit in the institution or by securities issued or guaranteed by the U.S. Government, U.S. Government agencies, or other OECD central governments. The FDIC and the OTS accord a 20 percent risk weight to such claims on other parties.

Under the Federal banking agencies' capital standards, noncumulative perpetual preferred stock is a component of Tier 1 capital. The capital standards of the OCC, the FRB, and the FDIC require noncumulative perpetual preferred stock to give the issuer the option to waive the payment of dividends and to provide that waived dividends neither accumulate to future periods nor represent a contingent claim on the issuer.

As a result of these requirements, if a bank supervised by the OCC, the FRB, or the FDIC issues perpetual preferred stock and is required to pay dividends in a form other than cash, e.g., stock, when cash dividends are not or cannot be paid, the bank does not have the option to waive or eliminate dividends, and the stock would not qualify as noncumulative. If an OTS-supervised savings association issues perpetual preferred stock that requires the payment of dividends in the form of stock when cash dividends are not paid, the stock may, subject to supervisory approval, qualify as noncumulative.

The FRB, the FDIC, and the OTS apply a 100 percent risk weight to equity securities of government-sponsored enterprises (GSEs), other than the 20 percent risk weighting of Federal Home Loan Bank stock held by banking organizations as a condition of membership. The OCC applies a 20 percent risk weight to all GSE equity securities.

The OCC, the FRB, and the FDIC limit the amount of subordinated debt and intermediate-term preferred stock that may be treated as part of Tier 2 capital to 50 percent of Tier 1 capital. The OTS does not prescribe such a restriction. The OTS does, however, limit the amount of Tier 2 capital to 100 percent of Tier 1 capital, as do the other agencies.

In addition, for banking organizations supervised by the OCC, the FRB, and the FDIC, at the beginning of each of the last five years of the life of a subordinated debt or limited-life preferred stock instrument, the amount that is eligible for inclusion in Tier 2 capital is reduced by 20 percent of the original amount of that instrument (net of redemptions). The OTS provides thrifts the option of using either the discounting approach used by the other federal banking agencies, or an approach which, during the last seven years of the instrument's life, allows for the full inclusion of all such instruments, provided that the aggregate amount of such instruments maturing in any one year does not exceed 20 percent of the thrift's total capital.

Savings associations supervised by the OTS, by statute, must satisfy a 1.5 percent minimum tangible capital requirement. Other subsequent statutory and regulatory changes, however, imposed higher capital standards rendering it unlikely, if not impossible, for the 1.5 percent tangible capital requirement to function as a meaningful regulatory trigger. This statutory tangible capital requirement does not apply to institutions supervised by the OCC, the FRB, or the FDIC.

In 1996, the OCC, the FRB, and the FDIC adopted rules requiring banks and bank holding companies with significant exposure to market risk to measure and maintain capital to support that risk. The OTS did not adopt a market risk rule because no OTS-supervised savings association engaged in the threshold level of trading activity addressed by the other agencies' rules. As the nature of many savings associations' activities has changed since 1996, market risk has become an increasingly more significant risk factor to consider in the capital management process. Accordingly, the OTS plans to shortly propose a market risk rule substantially similar to those of the other banking agencies.

Push-down accounting is the establishment of a new accounting basis for a depository institution in its separate financial statements as a result of the institution becoming substantially wholly owned. Under push-down accounting, when a depository institution is acquired in a purchase, yet retains its separate corporate existence, the assets and liabilities of the acquired institution are restated to their fair values as of the acquisition date. These values, including any goodwill, are reflected in the separate financial statements of the acquired institution, as well as in any consolidated financial statements of the institution's parent.

The OCC, the FRB, and the FDIC require the use of push-down accounting for regulatory reporting purposes when an institution's voting stock becomes at least 95 percent owned by an investor or a group of investors acting collaboratively. This approach is generally consistent with accounting interpretations issued by the staff of the Securities and Exchange Commission. The OTS requires the use of push-down accounting when an institution's voting stock becomes at least 90 percent owned by an investor or investor group.

In the United States, the Food and Drug Administration (“FDA”) must approve the marketing of any pharmaceutical drug, whether brand-name or generic. The Hatch-Waxman Act establishes the regulatory framework under which the FDA may approve a generic drug to be marketed. Typically, a brand-name drug obtains FDA approval through a New Drug Application (“NDA”), and a generic drug manufacturer obtains FDA approval through an Abbreviated New Drug Application (“ANDA”) in which it may be allowed to rely on the clinical data first submitted by the brand-name drug manufacturer.

To encourage generic entry as soon as is warranted, the Hatch-Waxman Act allows generic drug manufacturers, in certain circumstances, to market a generic drug prior to the expiration of claimed patent protection for the corresponding brand-name drug. To be permitted to do so, a generic drug manufacturer must first submit a “paragraph IV” ANDA in which it certifies that (a) its generic drug will not infringe patents listed in the FDA's “Orange Book” (“Orange Book patents”) as claiming the relevant brand-name drug product, and/or (b) the relevant Orange Book patents are invalid. If the paragraph IV ANDA leads to litigation, then 30 months after the litigation was filed (or after final decision in the litigation, if earlier), the FDA may authorize the marketing of the generic drug under the ANDA application.

At that point, the first-filed paragraph IV ANDA applicant becomes entitled to a 180-day marketing exclusivity period, during which the FDA cannot approve any other, later-filed paragraph IV ANDA for a generic drug corresponding to the same brand-name drug product.2 This protects the first FDA-approved paragraph IV ANDA applicant from competition with other generic ANDA applicants during this time.

The 180-day marketing exclusivity period does not preclude competition from NDA-approved “authorized generics,” however.3 An authorized generic is chemically identical to a particular brand-name drug, which the brand-name manufacturer authorizes to be marketed in a generic version under the NDA-approval that the FDA granted for the brand-name drug. The brand-name manufacturer either sells the authorized generic itself through a subsidiary or licenses a generic firm to sell the authorized generic. The trade dress typically differs for the brand-name drug and its authorized generic equivalent, but the drug product is exactly the same.

In recent years and with increasing frequency, brand-name drug manufacturers have begun to market authorized generic drugs at precisely the same time that a paragraph IV generic is beginning its period of 180-day marketing exclusivity. The likely effects of this practice on generic competition have been subject to some debate. In the short run, the entry of an authorized generic drug may benefit consumers by creating additional competition that lowers generic prices further than if only the paragraph IV generic were marketed. Many generic manufacturers assert, however, that in the long run, consumers will be harmed because an expectation of competition from authorized generics will significantly decrease the incentives of generic manufacturers to pursue entry prior to patent expiration. For a generic manufacturer, the additional competition from an authorized generic may result in significantly less profit during the period of 180-day exclusivity than if the generic manufacturer had no authorized-generic competition during that time.

Currently, there is no publicly available, comprehensive economic study that assesses the likely short- and long-run effects of entry by authorized generics on generic competition.4 Given the importance of generic drugs in lowering health care costs, Senators Grassley, Leahy, and Rockefeller have requested that the Commission conduct a study of “the short term and long term effects on competition of the practice of “authorized” generics.” 5 In addition, Representative Waxman, one of the co-authors of the Hatch-Waxman Act, has requested that the FTC study “the impact of so-called “authorized generics” on competition in the prescription drug marketplace.” 6

The Commission proposes to undertake such a study, as described in this notice, to examine both the likely short-term competitive effects of authorized generic drug entry and, to the extent possible, the likely long-term impact of entry by authorized generic drugs on competition by generic manufacturers.7 Among other things, the proposed study will examine actual wholesale prices (including rebates, discounts, etc.) for brand-name and generic drugs, both with and without competition from authorized generics; business reasons (including profitability assessments) that support authorized generic entry; factors (including product development and litigation costs) relevant to the decisions of generic firms about whether and under what circumstances to seek entry prior to patent expiration; and licensing agreements with authorized generics. These data will enable the proposed study to make new contributions to the economic literature on the effects of generic drug entry on prescription drug prices and, in particular, the role of the 180-day period of exclusivity in generic competition prior to patent expiration.

To obtain the relevant data, the Commission proposes to send special orders pursuant to Section 6(b) of the FTC Act, 15 U.S.C. 46(b), to brand-drug companies with products that have first faced generic competition since January 1, 1999; 8 generic drug companies that have marketed authorized generic drugs since January 1, 1999 (“authorized generic companies”); and generic drug companies that have filed an ANDA containing paragraph III and IV certifications since January 1, 1999 (“independent generic companies”). The Commission has entered into an agreement with the FDA to obtain information to identify the brand-drug companies and independent generic companies that meet these criteria. Information received from the brand-name companies in response to the special orders will permit the Commission to issue subsequent special orders to authorized generic companies. Based on a preliminary analysis, approximately 80 brand-name drug manufacturers, 10 authorized generic drug companies, and 100 independent generic companies meet these criteria.

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

The FTC invites comment on the following: (1) Whether the proposed collections of information are necessary for the proper performance of the functions of the FTC, including whether the information will have practical utility; (2) the accuracy of the FTC's estimate of the burden of the proposed collections of information; (3) ways to limit the number of companies included in the study without undermining the validity and reliability of the study results (e.g., reduce the number of drug products studied by only including those products in an oral solid form, eliminate those generic companies that have filed only one ANDA during the study period, reduce the study time period, etc.); (4) ways to enhance the quality, utility, and clarity of the information to be collected; and (5) ways to minimize the burden of collecting the information on those who are to respond, including through the use of collection techniques or other form of information technology, e.g., permitting electronic submissions of responses. All comments should be filed as prescribed in the ADDRESSES section above, and must be received on or before June 5, 2006.

The FTC proposes to send information requests to approximately 80 brand-name drug manufacturers, 10 authorized generic drug companies, and 100 independent generic companies. As described above, the brand-name companies to which the information requests would be sent include those companies with products that have first faced generic drug competition since January 1, 1999 or that have received notice of the filing of an ANDA, as defined by 21 U.S.C. 355(j)(IV), as to one or more of their products since January 1, 1999. The FTC also proposes to send special orders to generic drug companies that have marketed authorized generic drugs since January 1, 1999. In addition, the FTC proposes to send special orders to generic drug companies that filed an ANDA since January 1, 1999.

In addition to routine questions about the name, address, organization chart(s), and incorporation date of the responding company and its subsidiaries, and the name, business address, and official capacity of the official supervising the company's response, the FTC will ask the three different company types to provide answers to the following questions for a list of specific drug products that the FTC will provide:

1. For each identified drug product, submit any documents, including studies, surveys, analyses, and reports (both internal and external), that are dated after January 1, 1998 and were prepared or received by or for any senior vice president (or equivalent position) with product line responsibility for the specified drug product or any officer(s) or director(s) of the company (or, in the case of unincorporated entities, individuals exercising similar functions) that evaluated, considered, analyzed, or discussed how to respond (including through pricing changes) to (a) future or current generic competition, (b) the expiration of the patent(s) claiming the identified drug product or its use, (c) whether to license or otherwise market the identified drug product as an authorized generic drug product, and/or (d) whether to refrain from marketing an authorized generic, including but not limited to, agreements to do so. This request includes documents that discuss future generic entry for either specified products or responses to generic entry in general. For each such document, indicate (if not contained in the document itself) the date of preparation and the name and title of each individual who prepared the document, and group the documents by identified drug product. If the company licensed or otherwise authorized the marketing of the identified drug product as an authorized generic, provide the license agreement with the authorized generic company and the supplemental application the company filed with the FDA pursuant to 21 U.S.C. 356a(b) that had the effect of allowing the company to license or otherwise market the identified drug product as an authorized generic.

2. For each identified drug product, provide the following information:

a. A detailed description of the product, including its brand name or identification number, its common name, and its biological or chemical class; its application status at the FDA for each of its indication(s) or end use(s), and intended indication(s) or end use(s), including the date the New Drug Application was filed and approved, and the date the product was first marketed in the United States, as both a brand-name drug and, if applicable, an authorized generic;

b. A detailed description of every SKU of the product as both a brand-name drug and, if applicable, an authorized generic, including product form, dosage strength, bottle or box size, route of administration, and the date first marketed in the United States;

c. The identification number of each SKU of each product;

d. A list of all patents listed in the Orange Book for each drug product whether owned, licensed, or controlled by the company, including patent or patent application number, title, priority date, inventor, date filed, date issued, date of patent expiration, status, and a copy of all relevant claims.

3. For each SKU listed in response to Specification 2c above, state for every month from a full calendar year preceding generic entry to the present, for sales in the United States (e.g., if generic entry occurred in July 2002, the company is to provide the following information for every month beginning January 1, 2001):

a. The company's total sales, net of discounts, rebates, promotions, returns and chargebacks, to all customers in units, total prescriptions, and dollars;

b. The company's total sales, net of discounts, rebates, promotions, returns and chargebacks, to hospitals, clinics and long-term care facilities, including but not limited to independent cancer care centers and pain centers, in units, total prescriptions, and dollars; 9

c. The company's standard or actual cost of goods sold in dollars, reported by material cost, labor cost, manufacturing cost, distribution cost, API cost, overhead cost, other cost, and variances;

d. The company's prices, including: (1) List price; (2) average wholesale price; (3) wholesale acquisition cost; (4) price to Medicare; (5) price to Medicaid; (6) the maximum allowable cost; and (7) average manufacturer price (“AMP”) as defined by, and reported to, the Centers for Medicare and Medicaid Services.

Authorized Generic Company Questions [If a Brand Drug Company uses a subsidiary, division, or affiliated company to distribute the authorized generic drug, the “company” referred to in these questions is that subsidiary, division, or affiliated company.]:

1. For each identified drug product that is licensed to, or otherwise marketed by, the company:

a. Provide any documents, including studies, surveys, analyses, and reports (both internal and external), that are dated after January 1, 1998 and were prepared or received by or for any senior vice president (or equivalent position) with product line responsibility for the specified drug product or any officer(s) or director(s) of the company (or, in the case of unincorporated entities, individuals exercising similar functions) that evaluated, considered, analyzed, or discussed whether or how to proceed with generic entry, including discussion related to whether to file an ANDA containing a paragraph III or IV certification (regardless of whether the company filed such ANDA), whether or when to launch commercial marketing, and the impact that entry by an authorized generic drug would have on generic entry by an ANDA drug product. This request includes documents that discuss future generic entry for either specified products or responses to generic entry in general. For each such document, indicate (if not contained in the document itself) the date of preparation and the name and title of each individual who prepared each such document;

b. Provide a copy of the license agreement, or other marketing authorization, with the brand-name company.

2. For each identified drug product that is licensed to, or otherwise marketed by, the company, provide the following information:

a. A detailed description of every SKU of the product, including product form, dosage strength, bottle or box size, route of administration, and the date first sold in the United States;

b. The identification number of each SKU of each product.

3. For each SKU of each relevant product listed in response to Specification 2b above, state for every month from the date of first commercial marketing to the present, for sales in the United States:

a. The company's total sales, net of discounts, rebates, promotions, returns and chargebacks, to all customers in units, total prescriptions, and dollars;

b. The company's total sales, net of discounts, rebates, promotions, returns and chargebacks, to hospitals, clinics and long-term care facilities, including but not limited to independent cancer care centers and pain centers, in units, total prescriptions, and dollars;

c. The company's standard or actual cost of goods sold in dollars, reported by material cost, labor cost, manufacturing cost, distribution cost, API cost, overhead cost, other cost, and variances;

d. The company's prices, in each relevant area, including: (1) List price; (2) average wholesale price; (3) wholesale acquisition cost; (4) price to Medicare; (5) price to Medicaid; (6) the maximum allowable cost; and (7) average manufacturer price (“AMP”) as defined by, and reported to, the Centers for Medicare and Medicaid Services.

1. For each identified product, and for any other brand drug product for which the company has evaluated, considered, analyzed, or discussed whether or how to proceed with generic entry, submit the following:

a. Any documents, including studies, surveys, analyses, and reports (both internal and external), that are dated after January 1, 1998 and were prepared or received by or for any senior vice president (or equivalent position) with product line responsibility for the specified drug product or any officer(s) or director(s) of the company (or, in the case of unincorporated entities, individuals exercising similar functions) that evaluated, considered, analyzed, or discussed whether or how to proceed with generic entry, including discussion related to (a) whether to file an ANDA containing a paragraph III or IV certification (regardless of whether the company filed such ANDA), (b) whether or when to launch commercial marketing, and/or (c) the impact that entry by an authorized generic drug would have on generic entry by the company's ANDA drug product. This request includes documents that discuss future generic entry for either specified products or responses to generic entry in general. For each such document, indicate (if not contained in the document itself) the date of preparation and the name and title of each individual who prepared each such document. Submit a copy of the ANDA application for each identified drug product;

b. Any documents sufficient to show the identified product's development costs, costs to file ANDA, and patent-related litigation costs.

2. For each identified product, state the following:

a. A detailed description of the product, including its brand name or identification number, its common name, and its therapeutic class; its application status at the FDA for each of its indication(s) or end use(s), and intended indication(s) or end use(s), including the date the application was filed and approved, and the date the product was first sold in the United States;

b. A detailed description of every SKU of the product, including product form, dosage strength, bottle or box size, route of administration, and the date first sold in the relevant area;

c. The identification number of each SKU of each product.

3. For each SKU listed in response to Specification 2c, state for every month from the date of first commercial marketing to the present, for sales in the United States:

a. The company's total sales, net of discounts, rebates, promotions, returns and chargebacks, to all customers in units, total prescriptions, and dollars;

b. The company's total sales, net of discounts, rebates, promotions, returns and chargebacks, to hospitals, clinics and long-term care facilities, including but not limited to independent cancer care centers and pain centers, in units, total prescriptions, and dollars;

c. The company's standard or actual cost of goods sold in dollars, reported by material cost, labor cost, manufacturing cost, distribution cost, API cost, overhead cost, other cost, and variances;

d. The company's prices, in each relevant area, including: (1) List price; (2) average wholesale price; (3) wholesale acquisition cost; (4) price to Medicare; (5) price to Medicaid; (6) the maximum allowable cost; and (7) average manufacturer price (“AMP”) as defined by, and reported to, the Centers for Medicare and Medicaid Services.

The FTC will request IMS Health (IMS) data if the company obtains such information in the regular course of business, as follows:

If the company obtains IMS Health (IMS) data in the regular course of business, provide for each identified drug product, for every month from January 1999 (or date of first commercial marketing, where applicable) to the present for sales in the United States:

a. IMS Retail Perspective data, or the equivalent thereof, by product form, by strength, and by diagnosis, for total sales in dollars and units, by customer channel, including, but not limited to independent pharmacies, chain pharmacies, mass merchandisers, proprietary stores, and food stores with pharmacies;

b. IMS Provider Perspective data, or the equivalent thereof, by product form, by strength, and by diagnosis, for total sales in dollars and units, by customer channel, including, but not limited to, non-federal hospitals, federal facilities, mail order, and long-term care facilities, clinics, and closed wall HMOs;

c. IMS National Prescription Audit data, or the equivalent thereof, by product form, by strength, and by diagnosis, for newly dispensed prescriptions, refill dispensed prescriptions, total dispensed prescriptions, total units, and total dollar sales;

d. IMS Retail Method of Payment Report, or the equivalent thereof, by product form, by strength, and by diagnosis, for total sales in dollars and units, by customer channel, including, but not limited to, private managed care, and public managed care;

e. IMS Integrated Promotional Services Total Promotion Report, by product form, for total dollars spent for: (1) Detailing; (2) physician and pharmacist marketing; (3) medical and other journal advertising; and (4) any other promotional spending, including, but not limited to, direct consumer advertising;

f. Any other IMS data, or the equivalent thereof, used in the ordinary course of business;

g. All supporting definitions and materials for any IMS data provided.

The FTC will obtain the information sought by interrogatories and document requests under Section 6(b) of the FTC Act, 15 U.S.C. 46(b). The FTC will use available information technology (e.g., electronic submission of financial information) to ease the collection of the requested information.

It should be noted that subsequent to this notice, any destruction, removal, mutilation, alteration, or falsification of documentary evidence that may be responsive to this information collection within the possession or control of a person, partnership or corporation subject to the FTC Act may be subject to criminal prosecution. 15 U.S.C. 50; see also 18 U.S.C. 1505.

The information presented in the study will not identify company-specific data. See 15 U.S.C. 57b-2(d)(1)(B). Rather, the Commission anticipates using primarily aggregated totals, on a level sufficient to protect individual companies' confidential information, to provide a factual summary of the effect of authorized generic entry since 1999. Section 6(f) of the FTC Act, 15 U.S.C. 46(f), bars the Commission from publicly disclosing trade secrets or confidential commercial or financial information it receives from persons pursuant to, among other methods, special orders authorized by Section 6(b) of the FTC Act. Such information also would be exempt from disclosure under the Freedom of Information Act. 5 U.S.C. 552(b)(4). Moreover, under Section 21(c) of the FTC Act, 15 U.S.C. 57b-2(c), a submitter who designates a submission as confidential is entitled to 10 days' advance notice of any anticipated public disclosure by the Commission, assuming that the Commission has determined that the information does not, in fact, constitute 6(f) material. Although materials covered under one or more of these various sections are protected by stringent confidentiality constraints, the FTC Act and the Commission's rules authorize disclosure in limited circumstances (e.g., official requests by Congress, requests from other agencies for law enforcement purposes, administrative or judicial proceedings). Even in those limited contexts, however, the Commission's rules may afford the submitter advance notice to seek a protective order. See 15 U.S.C. 57b-2(c); 16 CFR 4.9-4.11.

The FTC proposes to use three different sets of questions for the three drug company types: Brand-name companies, authorized generic companies, and independent generic companies. The drug products that the FTC will study will be identified for each company. Although the questions vary, the FTC does not anticipate this will have a significant effect on the effort required to respond to them.

The FTC has estimated three average response times depending upon the number of drug products for which the company is required to provide a response: Companies with one to five drug products, companies with six to 10 drug products, and companies with more than 10 drug products. The FTC anticipates that the majority of burden hours will be primarily to search, retrieve, and copy relevant documents necessary to answer question number 1 for each of the company types, and that the hours necessary to obtain the financial information will not vary depending upon the number of drug products. The total estimated burden to answer the questions and to produce documents based on the number of drug products identified for each company is based on the following:

Based on preliminary information, the FTC anticipates that it will seek information about 1 to 5 drug products from approximately 130 companies, for 6 to 10 drug products from 20 companies, and for greater than 10 drug products from 40 companies. Thus, the cumulative hours burden to produce documents and prepare the response sought will be approximately 39,040 hours (140 hours x 130 companies + 226 x 20 companies + 408 hours x 40 companies).

It is not possible to calculate with precision the labor costs associated with answering the questions and producing the documents requested, as responses will entail participation by management and/or support staff at various compensation levels among many different companies. Individuals among some or all of those labor categories may be involved in the information collection process. Nonetheless, the FTC has assumed that mid-management personnel and outside legal counsel will handle most of the tasks involved in gathering and producing the responsive information, and has applied an average hourly wage of $250/hour for their labor. Thus, the labor costs per company should range between $35,000 (140 hours × $250/hour) and $102,000 (408 hours × $250/hour).

The FTC estimates that the capital or other non-labor costs associated with the information requests will be minimal. Although the information requests may require that respondent retain copies of the information provided to the Commission, industry members should already have in place the means to store information of the volume requested.

The AHRQ Quality Indicators (AHRQ QIs) are a unique set of measures of health care quality that make use of readily available hospital inpatient administrative data. The QIs have been used for various purposes. Some of these include tracking, hospital self-assessment, reporting of hospital-specific quality or pay for performance. The AHRQ QIs are provider- and area-level quality indicators and currently consist of four modules: The Prevention Quality Indicators (PQI), the Inpatient Quality Indicators, the Patient Safety Indicators (PSI) and the Pediatric Quality Indicators (PedsQIs). In response to feedback from the AHRQ QI user community, AHRQ is committed to developing composite measures in an effort to provide an overall view of quality that is complete, useful and easily understandable to consumers and others within the health care field.

The Computer Matching and Privacy Protection Act of 1988 (Public Law (Pub. L.) 100-503), amended the Privacy Act (5 U.S.C. 552a) by describing the manner in which computer matching involving Federal agencies could be performed and adding certain protections for individuals applying for and receiving Federal benefits. Section 7201 of the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508) further amended the Privacy Act regarding protections for such individuals. The Privacy Act, as amended, regulates the use of computer matching by Federal agencies when records in a system of records are matched with other Federal, state, or local government records. It requires Federal agencies involved in computer matching programs to:

1. Negotiate written agreements with the other agencies participating in the matching programs;

2. Obtain the Data Integrity Board approval of the match agreements;

3. Furnish detailed reports about matching programs to Congress and OMB;

4. Notify applicants and beneficiaries that the records are subject to matching; and,

5. Verify match findings before reducing, suspending, terminating, or denying an individual's benefits or payments.

CMS has taken action to ensure that all CMPs that this Agency participates in comply with the requirements of the Privacy Act of 1974, as amended.

DHS has the mission to lead the unified national effort to secure the United States of America. It has the responsibility to prevent and deter terrorist attacks and protect against and respond to threats and hazards to the Nation. As a part of this mission, the Department ensures safe and secure borders, facilitates lawful immigrants and visitors, and promotes the free flow of commerce among nations.

This Directive establishes policy and procedures to ensure the integration of environmental considerations into the unique mission of the Department. It outlines roles and responsibilities for compliance with the National Environmental Policy Act (NEPA), 42 U.S.C. 4321 et seq., and other laws and requirements for stewardship of the environment. This Directive also establishes a framework for the detailed, balanced, and systematic consideration of environmental stewardship in the planning and execution of DHS activities.

NEPA is the basic charter and foundation for stewardship of environmental resources by the agencies of the Federal government within the United States. It establishes policy, sets goals, and provides a tool for carrying out national environmental policy. NEPA requires agencies to use all practical means within their authority to create and maintain conditions under which people and nature can exist in productive harmony and fulfill the social, economic, and other needs of present and future generations of Americans. 42 U.S.C. 4331.

This Directive includes processes for preparing Environmental Assessments (EA), Findings of No Significant Impact (FONSI), and Environmental Impact Statements (EIS). It also includes procedures for DHS to establish new or revised Categorical Exclusions (CATEX). DHS will use this Directive in conjunction with NEPA, the Council on Environmental Quality (CEQ) regulations at 40 CFR parts 1500-1508, and other pertinent environmental laws, regulations, and Executive Orders (E.O.).