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Code · REGISTER · 2008-05-12 · Federal Trade Commission · Notices

Notices. Proposed Consent Agreement

19,103 words·~87 min read·/register/2008/05/12/08-1249

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 6760-01-P FEDERAL TRADE COMMISSION [File No. 081 0073] Agrium Inc. and UAP Holding Corporation; Analysis of the Complaint and Proposed Consent Order to Aid Public Comment AGENCY: Federal Trade Commission. ACTION: Proposed Consent Agreement. SUMMARY: The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices or unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the draft complaint and the terms of the consent order — embodied in the consent agreement — that would settle these allegations.
DATES: Comments must be received on or before June 4, 2008 ADDRESSES: Interested parties are invited to submit written comments. Comments should refer to “Agrium and UAP Holding Corp., File No. 081 0073,” to facilitate the organization of comments. A comment filed in paper form should include this reference both in the text and on the envelope, and should be mailed or delivered to the following address: Federal Trade Commission/Office of the Secretary, Room 135-H, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580.
Comments containing confidential material must be filed in paper form, must be clearly labeled “Confidential,” and must comply with Commission Rule 4.9(c). 16 CFR 4.9(c) (2005). 1 The FTC is requesting that any comment filed in paper form be sent by courier or overnight service, if possible, because U.S. postal mail in the Washington area and at the Commission is subject to delay due to heightened security precautions. Comments that do not contain any nonpublic information may instead be filed in electronic form by following the instructions on the web-based form at *http://secure.commentworks.com/ftc-Agrium* .
To ensure that the Commission considers an electronic comment, you must file it on that web-based form. 1 The comment must be accompanied by an explicit request for confidential treatment, including the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record. The request will be granted or denied by the Commission’s General Counsel, consistent with applicable law and the public interest. *See* Commission Rule 4.9(c), 16 CFR 4.9(c).
The FTC Act and other laws the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. All timely and responsive public comments, whether filed in paper or electronic form, will be considered by the Commission, and will be available to the public on the FTC website, to the extent practicable, at *www.ftc.gov.* As a matter of discretion, the FTC makes every effort to remove home contact information for individuals from the public comments it receives before placing those comments on the FTC website.
More information, including routine uses permitted by the Privacy Act, may be found in the FTC's privacy policy, at ( *http://www.ftc.gov/ftc/privacy.shtm* ). FOR FURTHER INFORMATION CONTACT: Donald R. Gordon, FTC Bureau of Competition, 600 Pennsylvania Avenue, NW, Washington, D.C. 20580,
(202)326-2357. SUPPLEMENTARY INFORMATION: Pursuant to section 6(f) of the Federal Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46(f), and § 2.34 of the Commission Rules of Practice, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty
(30)days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for February 27, 2008), on the World Wide Web, at *http://www.ftc.gov/os/2008/05/index.htm* . A paper copy can be obtained from the FTC Public Reference Room, Room 130-H, 600 Pennsylvania Avenue, NW, Washington, D.C. 20580, either in person or by calling
(202)326-2222. Public comments are invited, and may be filed with the Commission in either paper or electronic form. All comments should be filed as prescribed in the ADDRESSES section above, and must be received on or before the date specified in the DATES section. Analysis of Agreement Containing Consent Order to Aid Public Comment I. Introduction The Federal Trade Commission (“Commission”) has accepted for public comment from Agrium Inc. (“Agrium”), and UAP Holding Corporation, (“UAP”) (collectively “the Parties”) an Agreement Containing Consent Orders (“the proposed consent order”). The Parties have also reviewed a draft complaint contemplated by the Commission. The proposed consent order is designed to remedy likely anticompetitive effects arising from Agrium’s proposed acquisition of all of the outstanding voting stock of UAP. II. Description of the Parties and the Proposed Acquisition Agrium is a Calgary, Alberta-based agricultural products company, a major producer of fertilizer in the Americas, and is the largest operator of retail farm stores in the United States. Agrium has approximately 433 retail locations in 31 states, in all areas of the country except for a north-south band from the Northern plains to Texas. Agrium’s stores operate under the “Crop Production Services” brand in the East and Midwest, and under “Western Farm Service” in the West. Agrium had nearly $4.2 billion in sales in 2006, of which more than $1 billion came from its U.S. farm stores, the majority from fertilizer sales. Agrium is a multinational fertilizer and farm products company that develops, manufactures, and markets chemical and agricultural products and services that it distributes to customers in the Americas and elsewhere. UAP is a publicly-traded U.S. company based in Colorado that develops, manufactures, and markets a line of products and value-added services including chemicals, fertilizer, and seed to farmers, commercial growers, and regional dealers throughout the world. UAP is the second-largest operator of farm stores in the U.S., measured by sales, and its 370 retail stores operate in all 50 states—making it, with Helena Chemical, one of only two farm store operators with a national footprint. UAP’s U.S. farm store sales in 2006 constituted more than one-third of its $2.85 billion in total sales. UAP’s retail sales are weighted more toward pesticides, though fertilizer sales account for about 30% of its revenue. Agrium and UAP announced on December 3, 2007, that their respective boards of directors had approved the sale and purchase of all outstanding shares of UAP stock to Agrium for approximately $2.65 billion pursuant to the stock purchase agreements by and between Agrium and UAP. As a result of the merger, Agrium will hold 100% of the voting securities of UAP. Upon completion of the merger, UAP will become a wholly owned subsidiary of Agrium. III. The Draft Complaint The draft complaint alleges that the transaction may substantially lessen competition in the market for the retail sale of bulk fertilizer, and in certain cases related services, by farm stores. Retail farm stores sell mainly three classes of products: pesticides, seed, and fertilizer. Additionally, farm stores can deliver a range of services to meet the specific needs of particular growers. Retail farm stores, for example, often deliver fertilizer directly to the grower, and in many cases apply fertilizer to growers’ fields, usually with the store’s equipment. The stores often provide a variety of agronomic services to the grower in order to help maximize the efficiency of the fields. Farmers typically want one-stop shopping from their farm stores, favoring a single provider who can provide all the inputs and services they require. Although farmers sometimes visit the store, sales representatives from the stores also call upon the farmers, and bulk fertilizer is usually delivered to the farms in trucks or spreaders. Bulk fertilizer is a critical product without which most agricultural growers cannot profitably operate. Growers must have it, must have the proper amount, and must have it exactly on time, to produce their harvest. Fertilizer is usually applied before planting, and then again at the same time as planting. Along with occasional applications during the growing season, there is usually a fall application of fertilizer. Agricultural growers have no close substitutes for bulk fertilizer purchased through farm stores. The relevant geographic markets within which to analyze the likely effects of the proposed transaction are a series of small areas within the United States, typically extending 20-30 miles from a farm store. Transportation costs can make fertilizer prices less competitively attractive at distances over about 25-30 miles because of high fuel costs and the low price-to-weight ratio of bulk fertilizer. Furthermore, application services require application equipment that often travels slowly, and can tie up several employees and pieces of equipment if traveling more than 20-30 miles. The proposed merger of Agrium and UAP would impact six geographic markets, including three in the central “thumb” of Michigan, two in east/central Michigan, and one on the eastern shore of Maryland. The draft complaint alleges that the relevant sections of the country ( *i.e.* , the geographic markets) in which to analyze the acquisition are the areas in or near the towns of Croswell, MI; Richmond, MI; Imlay City, MI; Vestaburg, MI; Standish, MI; and Pocomoke/Girdletree, MD. In each of these identified areas, Agrium and UAP own farm stores that are well-situated among a small number of competitors in the market for the group of growers located proximate to their stores. The draft complaint further alleges that new entry would not prevent or counteract the anticompetitive effects of this acquisition in the relevant geographic markets. New farm store entry has become highly infrequent, due to the risks involved in expending significant sunk costs to obtain enough customers to make a new store viable in a mature industry. Furthermore, because reliable supply and service is so important, loyalty to existing suppliers is typically high among growers, making it particularly difficult for a new entrant to develop a sufficient customer base. The draft complaint also alleges that Agrium’s acquisition of all of the outstanding voting securities of UAP, if consummated, may substantially lessen competition in the relevant line of commerce in the relevant markets in violation of Section 7 of the Clayton Act, as amended, 15 U.S.C. § 18, and Section 5 of the Federal Trade Commission Act, as amended, 15 U.S.C. § 45, by eliminating direct competition between farm retail stores owned or controlled by Agrium and farm retail stores owned and controlled by UAP; by increasing the likelihood that Agrium will unilaterally exercise market power; and by increasing the likelihood of, or facilitating, collusion or coordinated interaction among the remaining farm retail store firms. Each of these effects increases the likelihood that the prices of bulk fertilizer or related services will increase, in the geographic markets alleged in the complaint. Other competitors are not effective competitive constraints to Agrium or UAP throughout each relevant trade area, due to factors such as location, and size and scale of their operations. IV. The Terms of the Agreement Containing Consent Orders The Agreement Containing Consent Orders (“proposed consent order”) will remedy the Commission's competitive concerns about the proposed acquisition. Under the terms of the proposed consent order, Agrium must divest five UAP farm stores and two Agrium farm stores. UAP’s farm stores that will be divested are located in Croswell, MI; Richmond, MI; Imlay City, MI; Vestaburg, MI; and Standish, MI. Agrium’s farm stores that will be divested are located in Snow Hill, MD and Keller, VA. An Order to Hold Separate and Maintain Assets requires that the stores to be divested be operated independently, and appoints an Interim Monitor to ensure that the Commission’s interests are protected. A. Key Provisions of the Decision and Order The proposed Orders will allow for effective divestiture of the key assets that today allow UAP to provide an independent competitive presence to Agrium in the relevant markets, and therefore will preserve the market structure. Paragraph II of the Decision and Order provides that Agrium divest itself of five UAP stores in Michigan, and two Agrium stores in Maryland and Virginia within 180 days of its acquisition of UAP, and that Agrium further comply with all provisions of a divestiture agreement to be approved by the Commission. The agreement also provides that the two Agrium stores located in Snow Hill, Maryland and Keller, Virginia, be sold to a single buyer. Because Agrium’s Keller location provides the Snow Hill location with dry bulk blended fertilizer, the Keller store must be sold to maintain the existing market dynamic. If the Snow Hill store were sold alone, it would be unable to sell bulk dry blended fertilizer to local farmers. The Decision and Order defines the scope of the assets to include the attributes of an ongoing business, such as necessary real property, tangible personal property, inventories, contracts, records of the business, accounts receivable permits, and intellectual property (other than the UAP and Agrium trade names). Pursuant to Paragraph II.E. of the proposed Decision and Order, Agrium also is required, for a period of up to a year, provide necessary transition services to the buyer at cost. The purpose of this provision is to allow for a relatively smooth transition of the store operation to the acquirer. Paragraph II.F. of the Decision and Order provides mechanisms for retention of each UAP store’s employees by the acquiring party. Paragraph III of the proposed Decision and Order requires that the Parties keep private, except where necessary under the agreement, confidential business information related to the divested UAP stores. Paragraph IV of the proposed Decision and Order requires that the Parties provide the Commission with “advance written notification” of intent to acquire any assets engaged in the sale of agricultural products in any area affected by the proposed divestitures. Paragraph V of the proposed Decision and Order provides for appointment of a divestiture trustee. Paragraphs VI-VIII define reporting obligations. B. Key Provisions of the Order to Hold Separate The Order to Hold Separate and Maintain Assets requires the Parties to maintain the assets to be divested as independent businesses pending divestiture, and to maintain the viability of these businesses. The proposed Order also provides for the appointment of an interim monitor to oversee the UAP assets in the relevant markets. The proposed Order incorporates the traditional provisions that allow the Interim Monitor broad oversight of the assets, and requiring the Monitor to report to the Commission on a regular basis. Furthermore, the proposed Order has provisions requiring the Parties to appoint a Manager who would run the assets on an independent basis, and requiring the Parties to give that Manager financial incentives in the success of the assets. The Parties will also be required to provide the held separate businesses with necessary support, but provides that employees of the Parties will not have access to confidential information, except to the extent necessary to accomplish the divestitures, comply with laws or regulations, or comply with the Orders. The Order requires that the Parties establish a system to prevent unauthorized disclosure of such confidential information, and, more generally, written procedures covering the management, maintenance and independence of the held separate assets. The Order also requires that the Parties provide the held separate assets with the financial resources and support that the Monitor believes are necessary to run the assets on an independent basis, including maintenance and replacement of existing assets, and business expansion. V. Opportunity for Public Comment The proposed consent order has been placed on the public record for 30 days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After 30 days, the Commission will again review the proposed consent order and the comments received and will decide whether it should withdraw from the agreement or make the proposed consent order final. By accepting the proposed consent order subject to final approval, the Commission anticipates that the competitive problems alleged in the complaint will be resolved. The purpose of this analysis is to invite public comment on the proposed consent order, in order to aid the Commission in its determination of whether to make the proposed consent order final. This analysis is not intended to constitute an official interpretation of the proposed consent order nor is it intended to modify the terms of the proposed consent order in any way. By direction of the Commission. Donald S. Clark, Secretary. [FR Doc. E8-10461 Filed 5-9-08; 8:45 am] BILLING CODE 6750-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Toxic Substances and Disease Registry [ATSDR-242] Development of Set 22 Toxicological Profiles AGENCY: Agency for Toxic Substances and Disease Registry (ATSDR), Department of Health and Human Services (HHS). ACTION: Notice of Development of Set 22 Toxicological Profiles. SUMMARY: This notice announces the development of Set 22 Toxicological Profiles. Set 22 Toxicological Profiles consists of one new draft and five updated drafts. These profiles will be available to the public for comment on or about October 17, 2008. FOR FURTHER INFORMATION CONTACT: Commander Jessilynn B. Taylor, Division of Toxicology and Environmental Medicine, Agency for Toxic Substances and Disease Registry, Mailstop F-32, 1600 Clifton Road, NE., Atlanta, Georgia 30333, telephone
(770)488-3313. Electronic access to these documents will also be available at the ATSDR Web site: *http://www.atsdr.cdc.gov/toxpro2.html.* SUPPLEMENTARY INFORMATION: The Superfund Amendments and Reauthorization Act of 1986
(SARA)(42 U.S.C. 9601 *et seq.* ) amended the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA or Superfund) (42 U.S.C. 9601 *et seq.* ) by establishing certain requirements for ATSDR and the U.S. Environmental Protection Agency
(EPA)with regard to hazardous substances that are most commonly found at facilities on the CERCLA National Priorities List (NPL). Among these statutory requirements is a mandate for the Administrator of ATSDR to prepare toxicological profiles for each substance included on the Priority List of Hazardous Substances, *http://www.atsdr.cdc.gov/cercla/07list.html.* The list identifies 275 hazardous substances that ATSDR and EPA have determined pose the most significant potential threat to human health. The availability of the revised list of the 275 priority substances was announced in the **Federal Register** on March 6, 2008 (73 FR 12178). For prior versions of the list of substances, see **Federal Register** notices dated April 17, 1987 (52 FR 12866); October 20, 1988 (53 FR 41280); October 26, 1989 (54 FR 43619); October 17, 1990 (55 FR 42067); October 17, 1991 (56 FR 52166); October 28, 1992 (57 FR 48801); February 28, 1994 (59 FR 9486); April 29, 1996 (61 FR 18744; November 17, 1997 (62 FR 61332); October 21, 1999 (64 FR 56792); October 25, 2001 (66 FR 54014); and November 7, 2003 (68 FR 63098). Notice of the availability of drafts of these five updated and one new toxicological profiles for public review and comment will be published in the **Federal Register** on or about October 17, 2008, with notice of a 90-day public comment period for each profile, starting from the actual release date. Following the close of the comment period, chemical-specific comments will be addressed, and, where appropriate, changes will be incorporated into each profile. Development of Toxicological Profiles This notice announces the development of one new and five updated toxicological profiles of priority hazardous substances comprising the twenty-second set prepared by ATSDR. The following toxicological profiles are now being developed. Toxicological profile CAS No. 1. Chromium 007440-47-3 2. Radon 010043-92-2 3. Cadmium 007440-43-9 4. Formaldehyde 000050-00-0 5. Manganese 007439-96-5 6. Perfluoroalkyls * 000375-22-4 000335-67-1 001763-23-1 * Denotes new profile. Dated: May 6, 2008. Ken Rose, Director, Office of Policy, Planning, and Evaluation, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry. [FR Doc. E8-10472 Filed 5-9-08; 8:45 am] BILLING CODE 4163-70-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-08-0493] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention
(CDC)publishes a list of information collection requests under review by the Office of Management and Budget
(OMB)in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at
(404)639-5960 or send an e-mail to *omb@cdc.gov.* Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to
(202)395-6974. Written comments should be received within 30 days of this notice. Proposed Project 2009 and 2011 National Youth Risk Behavior Surveys
(YRBS)(OMB No. 0920-0493)—Reinstatement—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description The purpose of this request is to obtain OMB approval to continue data collection for the National Youth Risk Behavior Survey (YRBS), a school-based survey that has been conducted biennially since 1991. OMB approval for the 2005 YRBS and 2007 YRBS expired November 30, 2007 (OMB No. 0920-0493). CDC seeks a three-year approval to conduct the YRBS in Spring 2009 and Spring 2011. Minor changes incorporated into this reinstatement request include: An updated title for the information collection, to accurately reflect the years in which the survey will be conducted; minor changes to the burden estimate; and minor changes to the data collection instrument. The YRBS assesses priority health risk behaviors related to the major preventable causes of mortality, morbidity, and social problems among both youth and young adults in the United States. Data on health risk behaviors of adolescents are the focus of approximately 40 national health objectives in Healthy People 2010, an initiative of the U.S. Department of Health and Human Services (HHS). The YRBS provides data to measure at least 10 of the health objectives and 3 of the 10 Leading Health Indicators established by Healthy People 2010. In addition, the YRBS can identify racial and ethnic disparities in health risk behaviors. No other national source of data measures as many of the Healthy People 2010 objectives addressing adolescent behaviors as the YRBS. The data also will have significant implications for policy and program development for school health programs nationwide. In Spring 2009 and Spring 2011, the YRBS will be conducted among nationally representative samples of students attending public and private schools in grades 9-12. Information supporting the YRBS also will be collected from school administrators and teachers. The table below reports the total number of respondents for the two cycles of data collection (2009 and 2011) annualized over the 3-year project period. There are no costs to respondents except their time. The total estimated annualized burden hours are 6,215. Estimated Annualized Burden Hours Type of respondent Form name Number of respondents Number of responses per respondent Average burden per response (in hours) State Administrators State-level Recruitment Script for the Youth Risk Behavior Survey 17 1 30/60 District Administrators District-level Recruitment Script for the Youth Risk Behavior Survey 80 1 30/60 School Administrators School-level Recruitment Script for the Youth Risk Behavior Survey 133 1 30/60 Teachers Data Collection Checklist for the Youth Risk Behavior Survey 400 1 15/60 Students Youth Risk Behavior Survey 8,000 1 45/60 Dated: April 29, 2008. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E8-10470 Filed 5-9-08; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-08-08BB] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention
(CDC)will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-0164 or send comments to Maryam Daneshvar, CDC Acting Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to *omb@cdc.gov.* Comments are invited on:
(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;
(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;
(c)ways to enhance the quality, utility, and clarity of the information to be collected; and
(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice. Proposed Project Health Hazard Evaluation Program Customer Research—New—The National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC). Background and Brief Description The Health Hazard Evaluation
(HHE)Program was mandated by specific provision of the Occupational Safety and Health Act of 1970 and the Federal Mine Safety Act of 1977. Through the HHE Program, NIOSH responds to requests to identify chemical, biological or physical hazards in workplaces throughout the United States. An HHE Program evaluation can be requested by employers, employees, employee representatives, other federal agencies, and state and local agencies. NIOSH proposes conducting a program of quantitative and qualitative research to help ensure that the HHE Program is responsive to the needs of its customers and enhances the diversity of workplaces and hazards assessed. The information from this research will be used to develop a targeted marketing campaign to increase awareness of and access to HHE Program services. To begin, NIOSH will conduct a Web based survey of potential customers in the Food and Beverage Manufacturing or Services to Buildings and Dwellings industry who are responsible for workplace health and safety. The goals of the survey are to determine:
(1)What percentage of customers are familiar with the HHE Program;
(2)how customers surveyed prefer to receive occupational safety and health-related information,
(3)what occupational safety and health communication products are most useful to customers surveyed;
(4)what barriers prevent customers surveyed from using HHE Program resources;
(5)what would motivate customers surveyed to use HHE Program resources; and
(6)what are the top occupational safety and health concerns of those surveyed. This will be followed by qualitative research (focus groups) to determine
(1)what concepts are most effective at raising awareness of the HHE Program with consumers, and
(2)what messages should be used to inform customers about the HHE Program. The results from both phases of this research will be used to design and refine a targeted marketing campaign before materials are promoted and distributed nationally. Each phase will be conducted over a two to three month period. There will be no cost to respondents other than their time. Estimated Annualized Burden Hours Type of respondent Number of respondents Number of responses per respondent Average burden (in hours) Total response burden hours Customer Survey Respondent 5,400 1 15/60 1,350 Customer Focus Group Screener 216 1 15/60 54 Customer Focus Group Concept Testing Guide 216 1 2 432 Customer Focus Group Material Testing Guide 216 1 1.5 324 Total 6048 2160 Dated: April 30, 2008. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E8-10474 Filed 5-9-08; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0271] Agency Information Collection Activities; Proposed Collection; Comment Request; Consumer Survey on the Impact of Perceptions of the 2006 Spinach Recall on Current Spinach Consumption AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed survey of how consumer perceptions of the 2006 spinach recall affect their current spinach consumption behaviors. DATES: Submit written or electronic comments on the collection of information by July 11, 2008. ADDRESSES: Submit electronic comments on the collection of information to *http://www.regulations.gov* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget
(OMB)for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the **Federal Register** concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics:
(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;
(2)the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3)ways to enhance the quality, utility, and clarity of the information to be collected; and
(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Consumer Survey on the Impact of Perceptions of the 2006 Spinach Recall on Current Spinach Consumption Under section 903(b)(2) of the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 393(b)(2)), FDA is authorized to conduct research relating to foods and to conduct educational and public information programs relating to the safety of the Nation's food supply. Under this authority, FDA is planning to conduct a consumer survey to assess how current perceptions of the 2006 spinach recall affect attitudes toward, and decisionmaking regarding, current spinach consumption. FDA will use the study to evaluate how its communications about the 2006 spinach recall affected consumers. In particular, FDA plans to evaluate the effects of emotions and cognition associated with consumer recollection of the 2006 spinach outbreak on current spinach consumption behavior. In September 2006, the United States experienced an outbreak of E. coli 0157:H7 infections in several States. Outbreak investigation by the Centers for Disease Control and Prevention, FDA, and Federal, State, and local partners linked the E. coli 0157:H7 to bagged fresh spinach that was sold nationwide ( *http://www.fda.gov/bbs/topics/NEWS/2007/NEW01593.html* ). On September 14, 2006, FDA held a press teleconference and issued a press release alerting consumers about the outbreak ( *http://www.fda.gov/bbs/topics/NEWS/2006/NEW01450.html* ). In addition to warning of the seriousness of the outbreak, the press release advised that consumers “not eat bagged fresh spinach at this time.” On September 16, 2006, FDA expanded its advice to consumers, advising them “to not eat fresh spinach or fresh spinach-containing products until further notice” ( *http://www.fda.gov/bbs/topics/NEWS/2006/NEW01452.html* ). Finally, FDA reported in its September 22, 2006, press statement that spinach grown outside the limited geographical area to which the outbreak had been traced was not implicated in the outbreak and could be consumed ( *http://www.fda.gov/bbs/topics/NEWS/2006/NEW01462.html* ). This report stated, “The public can be confident that spinach grown in the non-implicated areas can be consumed. Other produce grown in these counties is not implicated in this outbreak. Processed spinach (e.g., frozen and canned spinach) is also not implicated in this outbreak.” Market research has shown that the 2006 fresh spinach recall had a tremendous economic impact on the spinach industry, as retail sales values continued to lag for months after the recall was over ( *http://www.ers.usda.gov/AmberWaves/June07/Features/Spinach.htm* ). Consumer confidence in the product has been blamed for the slow recovery. The survey will be used to gauge whether and how FDA and media communication about the recall affected consumers' enduring emotional and cognitive perceptions about the product, and whether or not these perceptions have an impact on their current spinach consumption. Findings from this study will be used to help FDA more effectively communicate with consumers. The data will be collected using a Web-based questionnaire. A pool of 35,000 people will be screened (through self-report) on current and past fresh spinach consumption. A random sample of 1,000 consumers will be selected. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 Questionnaire No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours Screener 35,000 1 35,000 0.0055 192.5 Survey 1,000 1 1,000 0.167 167 Total 359.5 1 There are no capital costs or operating and maintenance costs associated with this collection of information. FDA's burden estimate is based on prior experience with consumer surveys that are similar to this proposed survey. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at *http://www.regulations.gov* . Dated: May 5, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8-10467 Filed 5-9-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-E-0398] (formerly Docket No. 2007E-0131) Determination of Regulatory Review Period for Purposes of Patent Extension; OMNARIS AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)has determined the regulatory review period for OMNARIS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product. ADDRESSES: Submit written comments and petitions to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.regulations.gov* . FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6222, Silver Spring, MD 20993-0002, 301-796-3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the human drug product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA approved for marketing the human drug product OMNARIS (ciclesonide). OMNARIS is indicated for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis in adults and adolescents 12 years of age and older. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for OMNARIS (U.S. Patent No. 5,482,934) from Altana Pharma AG, and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated May 16, 2007, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of OMNARIS represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that FDA determine the product's regulatory review period. FDA has determined that the applicable regulatory review period for OMNARIS is 3,196 days. Of this time, 2,893 days occurred during the testing phase of the regulatory review period, while 303 days occurred during the approval phase. These periods of time were derived from the following dates: 1. *The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective* : January 21, 1998. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on January 21, 1998. 2. *The date the application was initially submitted with respect to the human drug product under section 505(b) of the act* : December 22, 2005. FDA has verified the applicant's claim that the new drug application
(NDA)for OMNARIS (NDA 22-004) was initially submitted on December 22, 2005. 3. *The date the application was approved* : October 20, 2006. FDA has verified the applicant's claim that NDA 22-004 was approved on October 20, 2006. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,748 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments and ask for a redetermination by July 11, 2008. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by November 10, 2008. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA through FDMS only. Dated: April 28, 2008. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E8-10466 Filed 5-9-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-E-0047] (formerly Docket No. 2007E-0139) Determination of Regulatory Review Period for Purposes of Patent Extension; VECTIBIX AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)has determined the regulatory review period for VECTIBIX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product. ADDRESSES: Submit written or electronic comments and petitions to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.regulations.gov* . FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6222, Silver Spring, MD 20993-0002, 301-796-3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for marketing the human biologic product VECTIBIX (panitumumab). VECTIBIX is indicated for the treatment of EGFR-expressing, metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for VECTIBIX (U.S. Patent No. 6,235,883) from Amgen Fremont Inc., and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated May 16, 2007, FDA advised the Patent and Trademark Office that this human biological product had undergone a regulatory review period and that the approval of VECTIBIX represented the first permitted commercial marketing or use of the product. Shortly thereafter, the Patent and Trademark Office requested that FDA determine the product's regulatory review period. FDA has determined that the applicable regulatory review period for VECTIBIX is 2,662 days. Of this time, 2,479 days occurred during the testing phase of the regulatory review period, while 183 days occurred during the approval phase. These periods of time were derived from the following dates: 1. *The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective* : June 16, 1999. The applicant claims June 19, 1999, as the date the investigational new drug application
(IND)became effective. However, FDA records indicate that the IND effective date was June 16, 1999, which was 30 days after FDA receipt of the IND. 2. *The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262)* : March 29, 2006. The applicant claims December 15, 2005, as the date the original biologics license application
(BLA)for VECTIBIX (BLA 125147/0) was initially submitted. However, FDA records indicate that BLA 125147/0 was submitted in several modules under the continuous marketing application pilot program. It is FDA's position that the approval phase begins when the marketing application is complete for review. The final module of the BLA making it complete for review was submitted on March 29, 2006. 3. *The date the application was approved* : September 27, 2006. FDA has verified the applicant's claim that BLA 125147/0 was approved on September 27, 2006. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,122 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments and ask for a redetermination by July 11, 2008. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by November 10, 2008. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that on January 15, 2008, the FDA Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic submissions will be accepted by FDA through FDMS only. Dated: April 28, 2008. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E8-10512 Filed 5-9-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0281] Pilot Program to Evaluate Proposed Name Submissions; Concept Paper; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. SUMMARY: The Center for Drug Evaluation and Research
(CDER)and the Center for Biologics Evaluation and Research
(CBER)of the Food and Drug Administration
(FDA)are announcing a public technical meeting in preparation for a pilot program to enable pharmaceutical firms to evaluate proposed propriety names and submit the data generated from those evaluations to FDA for review. The purpose of the public technical meeting is to discuss a concept paper that describes the logistics of the pilot program, proposed recommendations for carrying out a proprietary name review, and the way FDA intends to review submissions made under the pilot program. FDA plans to formally issue the concept paper by the end of fiscal year
(FY)2008 and expects to begin enrollment in the pilot program in FY 2009. DATES: The public meeting will be held on June 5 and 6, 2008, from 8:30 a.m. to 5 p.m. each day. Register to make a presentation at the meeting by May 23, 2008. See section III of this document for information on how to attend or present at the meeting. Submit any written or electronic comments regarding the concept paper and pilot program by July 7, 2008. ADDRESSES: The public meeting will be held at the Crowne Plaza Hotel, 877 Georgia Ave., Silver Spring, MD 20910 (Metro: Silver Spring Station on the Red Line). Submit written or electronic requests to make a presentation at the meeting to Lana Pauls (see FOR FURTHER INFORMATION CONTACT ). A draft concept paper will be available soon. *Comment Submissions* : Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.regulations.gov* . FOR FURTHER INFORMATION CONTACT: Lana Pauls, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6196, Silver Spring, MD 20993, 301-796-0518, FAX: 301-847-8753, e-mail: *lana.pauls@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Background The Institute of Medicine
(IOM)in its 2006 report “Preventing Medication Errors” noted that “[i]n particular, drug names that look or sound alike increase the risk of medication errors.” FDA also has determined that many of the medication errors reported to the agency result from proprietary names that look or sound like the names of other medical products. Reducing the potential for medication errors due to proprietary name confusion is part of FDA's ongoing medical product risk management effort. In 2003, FDA held two public meetings that explored many of the issues involved in proprietary name review: • The June 26, 2003, public meeting on “Minimizing Medication Errors—Methods for Evaluating Proprietary Names for Their Confusion Potential,” Docket No. 2002N-0201 (68 FR 32529, May 30, 2003). Information about the meeting is available at *http://www.fda.gov/cder/meeting/drugNaming.htm* . • The December 4, 2003, meeting of the Drug Safety and Risk Management Advisory Committee (68 FR 65075, November 18, 2003). Transcripts, presentations, and materials from the meeting are available at *http://www.fda.gov/ohrms/dockets/ac/cder03.html#DrugSafetyRiskManagement* . FDA reviews proprietary names from both promotional and safety perspectives. The promotional review of proposed names considers whether the name functions to overstate the efficacy, minimize the risk, broaden the indication, make unsubstantiated superiority claims for the product, or is overly fanciful. The safety review of a proposed name is based on the findings of a Failure Modes and Effects Analysis of the proprietary name, and is focused on the avoidance of medical errors. FDA not only considers the potential for a name to be spelled similarly and/or sound similar to a currently marketed product or one that is in the approval pipeline, but also considers the potential for the proposed name to inadvertently function as a source of error for reasons other than look and sound-alike name confusion, for instance whether the abbreviation for the drug would be similar to the abbreviation of another drug product. Consideration also is given to the proposed product's characteristics including its intended use, dosage form and strength, and route of administration, because the product characteristics provide a context for communication of the product name and ultimately determine the use of the product in the usual clinical practice setting. In addition, because product-name confusion can occur at any point in the medication use process, FDA considers the potential for confusion throughout the process, including product procurement, prescribing and ordering, dispensing, administration, and monitoring the impact of the medication. Currently, the data generated to access this information is internal to FDA. However, there have been a number of calls for industry to become involved in the name testing process including IOM's 2006 report, IOM's 1999 report “To Err is Human,” Recommendation #238 from the HHS Advisory Committee on Regulatory Reform's November 21, 2002 report, and, most recently, in the Prescription Drug User Fee Act (PDUFA IV) performance goals. In Title I of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Public Law 110-85), Congress reauthorized and expanded the Prescription Drug User Fee program for FY 2008 through FY 2012 (PDUFA IV). As part of the performance goals and procedures set forth in an enclosure to the letter from the Secretary of the Health and Human Services referred to in section 101(c) of FDAAA, FDA agreed to publish a concept paper on and implement a pilot program to enable pharmaceutical firms participating in the pilot to evaluate proposed proprietary names and submit the data generated from those evaluations to FDA for review. This process is consistent with other areas of drug review in which FDA evaluates data generated by firms rather than producing such data independently. FDA intends the concept paper to provide transparency to the FDA review processes, as well as to provide a consistent, scientific approach to the review of proprietary names data. FDA agreed to conduct a public meeting to discuss the content of the concept paper, which will describe the logistics of the pilot program, proposed recommendations for carrying out a proprietary name review, and the way FDA intends to review submissions made under the pilot program. FDA is developing the concept paper, which contains its current thinking on the logistics of the pilot and name testing and evaluation under the pilot. The concept paper will be available at the Division of Dockets Management and on the Internet prior to the meeting (see ADDRESSES ). FDA welcomes written and electronic comments on the draft concept paper before and after the public meeting (see section IV of this document). II. Scope of Public Meeting At the public meeting, FDA will present its current thinking on proprietary name review testing and the proposed pilot program, and will solicit feedback from industry, patient safety groups, academics, health care professionals, other governmental agencies, and the public. The meeting will include panel discussions and individual and/or joint presentations. Some of the key questions that will be considered at the meeting include, but are not limited to, the following: 1. What are best practices in safety and promotional testing of proprietary names? What are the limitations of current methods and how may they be overcome? 2. What combination of tests should be undertaken and what data should be submitted by sponsors participating in the pilot? Discussion of testing procedures should focus on advances in the field of name testing since the 2003 public meetings (e.g., improvements in test design, accuracy, and validation, as well as use of practitioner input in the range of clinical settings in which drugs are procured, prescribed, prepared/dispensed, administered, and monitored). 3. How should testing be standardized to achieve valid, reliable results across studies? 4. What criteria should FDA consider in evaluating the testing done and the data submitted? 5. How should the pilot program be structured and evaluated? 6. Are there any public health concerns raised by the pilot program and how should they be addressed? Speakers who wish to present material in the public meeting must register before the meeting (see section III of this document). Time will be allowed for questions and answers after each panel discussion. Information gathered from the meeting and from comments submitted to the docket will be used to develop the final concept paper. FDA intends to publish the final concept paper by the end of FY 2008 and expects to begin enrollment in the pilot in FY 2009. III. Attendance and Registration There is no fee to attend the meeting, and attendees who do not wish to make an oral presentation do not need to register. Seating will be on a first-come, first-served basis. If you would like to make an oral presentation during the meeting, you must register and provide an abstract of your presentation by close of business on May 23, 2008. You must provide your name, title, business affiliation (if applicable), address, telephone and fax numbers, and e-mail address to Lana Pauls (see FOR FURTHER INFORMATION CONTACT ). You should identify the topic or section of the draft concept paper you wish to address in your presentation, whether you wish to address comments on day one or day two, and the approximate time requested for your presentation. FDA has identified topics of special interest in section II of this document and is posting a draft concept paper and agenda on the Internet (see ADDRESSES ). The Centers may change the time allotted depending on the number of people requesting to present. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations and to request time for a joint presentation. Persons registered to make an oral presentation should check in before the meeting. If you need special accommodations because of disability, please contact Lana Pauls (see FOR FURTHER INFORMATION CONTACT ) at least 7 days before the meeting. IV. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding issues and questions presented in the concept paper or at the meeting. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at *http://www.regulations.gov* . V. Transcripts Please be advised that as soon as a transcript is available, it will be accessible at *http://www.fda.gov/ohrms/dockets/ac/acmenu.htm* . It may be viewed at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to Division of Freedom of Information (HFI-35), Office of Management Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857. Dated: May 6, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8-10513 Filed 5-9-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Child Health and Human Development; Notice of Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the National Advisory Child Health and Human Development Council. The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. *Name of Committee:* National Advisory Child Health and Human Development Council; NACHHD Subcommittee on Planning and Policy. *Date:* May 15, 2008. *Time:* 2 p.m. to 3:30 p.m. *Agenda:* Topics to be discussed include:
(1)Report of the Director;
(2)Budget Updates;
(3)Legislative Updates. *Place:* National Institutes of Health, Building 31, 31 Center Drive, Room 2A03, Bethesda, MD 20892, (Telephone Conference Call). *Contact Person:* Mona Rowe, Executive Secretary, NICHD/NIH/OSPAC, 31 Center Drive, Suite 2A-18, Bethesda, MD 20892,
(301)496-1877. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the Executive Secretary's need for confirmation from subcommittee members on their availability to participate in this meeting. Information is also available on the Institute's/Center's home page: *http://www.nichd.nih.gov/about/nachhd.htm,* where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS) Dated: May 2, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8-10325 Filed 5-9-08; 8:45 am] BILLING CODE 4140-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* Arthritis and Musculoskeletal and Skin Diseases Special Grants Review Committee. *Date:* June 12-13, 2008. *Time:* 7 a.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814. *Contact Person:* Helen Lin, PhD, Scientific Review Administrator, NIH/NIAMS/RB, 6701 Democracy Blvd., Suite 800, Plaza One, Bethesda, MD 20817, 301-594-4952, *linh1@mail.nih.gov.* (Catalogue of Federal Domestic Assistance Program Nos. 93.846, Arthritis, Musculoskeletal and Skin Diseases Research, National Institutes of Health, HHS) Dated: April 30, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8-10330 Filed 5-9-08; 8:45 am] BILLING CODE 4140-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; R13 Conference. *Date:* May 12, 2008. *Time:* 2 p.m. to 4 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). *Contact Person:* D. G. Patel, Phd, Scientific Review Officer, Review Branch, DEA, Niddk, National Institutes of Health, Room 756, 6707 Democracy Boulevard, Bethesda, MD 20892-5452,
(301)594-7682, *pateldg@niddk.nih.gov.* This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) Dated: May 2, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8-10460 Filed 5-9-08; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-R1-R-2008-N0101; 1265000010137-S3] Sheldon National Wildlife Refuge, Lakeview, OR AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of intent to prepare a comprehensive conservation plan and environmental impact statement; announcement of four public open house meetings; and request for comments. SUMMARY: We, the U.S. Fish and Wildlife Service (Service), intend to prepare a comprehensive conservation plan
(CCP)for the Sheldon National Wildlife Refuge (Refuge). An environmental impact statement
(EIS)evaluating effects of various CCP alternatives, will also be prepared. The Refuge is located in Washoe and Humboldt County, Nevada, and Lake County, Oregon. We provide this notice in compliance with our CCP policy to: advise other Federal and State agencies, Tribes, and the public of our intentions, and obtain suggestions and information on the scope of issues to consider in the planning process. We are also announcing public open house meetings and requesting public comments. DATES: Please provide your written comments by June 30th, 2008. We will hold four open house public meetings to begin the CCP planning process; see *Public Meetings* under SUPPLEMENTARY INFORMATION for dates, times, and locations. ADDRESSES: Additional information concerning CCP development is available on the following Internet site: *http://www.fws.gov/pacific/planning.* See SUPPLEMENTARY INFORMATION for the addresses of the four public open house meeting locations. Send your comments or requests for more information by any of the following methods. *E-mail: SheldonCCP@fws.gov.* *U.S. Mail:* Paul Steblein, Project Leader, Sheldon-Hart Mountain National Wildlife Refuge Complex, P.O. Box 111, Lakeview, OR 97630. FOR FURTHER INFORMATION CONTACT: Paul Steblein, Project Leader, via E-mail: *SheldonCCP@fws.gov* or at phone number:
(541)947-3315. SUPPLEMENTARY INFORMATION: Introduction With this notice, we initiate our process for developing a CCP for Sheldon National Wildlife Refuge in Washoe and Humboldt Counties, Nevada, and Lake County, Oregon. This notice complies with our CCP policy and the National Environmental Policy Act of 1969, as amended
(NEPA)to
(1)Advise other Federal and State agencies, Tribes, and the public of our intention to conduct detailed planning on this refuge, and
(2)obtain suggestions and information on the scope of issues to consider in the environmental document and during development of the CCP. Background The CCP Process The National Wildlife Refuge System Improvement Act of 1997 (16 U.S.C. 668dd-668ee) (Improvement Act), which amended the National Wildlife Refuge System Administration Act of 1966, requires us to develop a CCP for each national wildlife refuge. The purpose for developing a CCP is to provide refuge managers with a 15-year plan for achieving refuge purposes and contributing toward the mission of the National Wildlife Refuge System, consistent with sound principles of fish and wildlife management, conservation, legal mandates, and our policies. We will review and update the CCP at least every 15 years in accordance with the Improvement Act. Each unit of the National Wildlife Refuge System was established for specific purposes. We use these purposes as the foundation for developing and prioritizing the management goals and objectives for each refuge within the National Wildlife Refuge System mission, and to determine how the public can use each refuge. The planning process is a way for us and the public to identify and evaluate management goals and objectives for wildlife habitat conservation and wildlife-dependent recreation opportunities compatible with each refuge's establishing purposes and the mission of the National Wildlife Refuge System. Our CCP process provides participation opportunities for Tribal, state, and local governments; agencies; organizations; and the public. At this time we encourage input in the form of issues, concerns, ideas, and suggestions for the future management of Sheldon National Wildlife Refuge. We will conduct the environmental review of the Sheldon CCP/EIS in accordance with the requirements of NEPA, NEPA regulations (40 CFR parts 1500-1508); other appropriate Federal laws and regulations; and our policies and procedures for compliance with those laws and regulations. Sheldon National Wildlife Refuge The Refuge's approved boundary encompasses approximately 572,876 acres of high desert sagebrush-steppe ecosystem in Washoe and Humboldt Counties, Nevada and Lake County, Oregon. The Refuge was originally established in 1931, and the Refuge purposes are: • “* * * as a refuge and breeding ground for wild animals and birds * * *” (Executive Order 5540 dated January 26, 1931 signed by Herbert Hoover); • “* * * set apart for the conservation and development of natural wildlife resources and for the protection and improvement of public grazing lands and natural forage resources * * * ” and “* * * the natural resources therein shall be first utilized for the purpose of sustaining in a healthy condition a maximum of three thousand five hundred (3,500) antelope, the primary species, and such non-predatory secondary species in such numbers as may be necessary to maintain a balanced wildlife population * * *.” (Executive Order 7522 dated December 21, 1936); • “* * * to conserve
(1)fish or wildlife which are listed as endangered species or threatened species * * * or
(B)plants * * *” 16 U.S.C. 1534 (Endangered Species Act of 1973); and • “* * * for use as an inviolate sanctuary, or for any other management purpose, for migratory birds.” 16 U.S.C. 715d (Migratory Bird Conservation Act of 1929). The high desert is characterized by wide-open spaces and a variety of landforms. The two most common landforms include narrow canyons that empty into rolling valleys with no drainage outlets to the ocean, and broad flat tables that end abruptly in vertical cliffs. The elevations of these landforms range from a high of 7,294 feet on Catnip Mountain, to a low of approximately 4,200 feet on the northeastern boundary. The area generally decreases in altitude from west to east. The extent of the sagebrush-steppe ecosystem has substantially declined across the landscape primarily as a result of habitat conversion, catastrophic wildfire, and introduced exotic species. The Refuge currently represents one of the last reasonably intact examples of a sagebrush-steppe ecosystem in the Great Basin. It provides a variety of critical habitats for a host of species endemic to sagebrush-steppe, including pronghorn antelope, mule deer, greater sage-grouse, pygmy rabbit, migratory birds, desert fishes, and a range of rare plants and invertebrates. Preliminary Issues, Concerns, and Opportunities We have identified preliminary issues, concerns, and opportunities that we may address in the CCP. Additional issues may be identified during public scoping. *Habitat Management and Restoration:* What actions shall the Service take to sustain and restore priority species and habitats over the next 15 years? *Public Use and Access:* What type and level of recreational opportunities should be provided? How will public use and associated facilities be managed, taking into consideration wildlife disturbance, restrictions, liability, compatibility, and future needs? *Cultural Resources:* How will the Refuge protect and manage its significant archaeological and historic sites? What level and type of cultural resources education should be provided to the public? *Feral Horses and Burros:* How can feral horses and burros best be managed for the long term consistent with refuge purposes? Should interim management guidelines adopted under the recent Feral Horse and Burro Management EA continue in the future? Public Open House Meetings Four public open house meetings will be held to provide opportunities for the public to learn more about the Refuge and its programs from the CCP planning team and to obtain public comments. Meeting details follow. Date Time Location May 14, 2008 6 p.m. to 9 p.m. Daly Middle School Gym, 220 South H Street, Lakeview, Oregon. May 22, 2008 6 p.m. to 9 p.m. West Hall, Convention and Visitors Authority, 50 W. Winnemucca Blvd., Winnemucca, NV. June 4, 2008 6 p.m. to 9 p.m. Christian Life Assembly, 225 West B Street, Alturas, CA. June 11, 2008 6 p.m. to 9 p.m. Pantera/Tartuca Rooms, Siena Hotel and Casino, One South Lake Street, Reno, NV. Public Availability of Comments Before including your address, phone number, e-mail address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. Dated: April 14, 2008. David J. Wesley, Acting Regional Director, Region 1, Portland, Oregon. [FR Doc. E8-10480 Filed 5-9-08; 8:45 am] BILLING CODE 4310-55-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-R9-IA-2008-N0105; 96300-1671-0000-P5] Receipt of Applications for Permit AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of receipt of applications for permit. SUMMARY: The public is invited to comment on the following applications to conduct certain activities with endangered species and marine mammals. DATES: Written data, comments or requests must be received by June 11, 2008. ADDRESSES: Documents and other information submitted with these applications are available for review, subject to the requirements of the Privacy Act and Freedom of Information Act, by any party who submits a written request for a copy of such documents within 30 days of the date of publication of this notice to: U.S. Fish and Wildlife Service, Division of Management Authority, 4401 North Fairfax Drive, Room 212, Arlington, Virginia 22203; fax 703/358-2281. FOR FURTHER INFORMATION CONTACT: Division of Management Authority, telephone 703/358-2104. SUPPLEMENTARY INFORMATION: Endangered Species The public is invited to comment on the following application for a permit to conduct certain activities with endangered species. This notice is provided pursuant to Section 10(c) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 *et seq.* ). Written data, comments, or requests for copies of these complete applications should be submitted to the Director (address above). Applicant: David P. Butts, Ogden, UT, PRT-180382 The applicant requests a permit to import the sport-hunted trophy of one male bontebok ( *Damaliscus pygargus pygargus* ) culled from a captive herd maintained under the management program of the Republic of South Africa, for the purpose of enhancement of the survival of the species. Marine Mammals The public is invited to comment on the following applications for a permit to conduct certain activities with marine mammals. The applications were submitted to satisfy requirements of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361 *et seq.* ), and the regulations governing marine mammals (50 CFR Part 18). Written data, comments, or requests for copies of the complete applications or requests for a public hearing on these applications should be submitted to the Director (address above). Anyone requesting a hearing should give specific reasons why a hearing would be appropriate. The holding of such a hearing is at the discretion of the Director. Applicant: Christopher M. Hanks, Lawrenceburg, KY, PRT-180764 The applicant requests a permit to import a polar bear ( *Ursus maritimus* ) sport hunted from the Lancaster Sound polar bear population in Canada for personal, noncommercial use. Applicant: Jeffrey J. Sevor, Winter Park, FL, PRT-180595 The applicant requests a permit to import a polar bear ( *Ursus maritimus* ) sport hunted from the Lancaster Sound polar bear population in Canada for personal, noncommercial use. Applicant: Ronald E. Kreider, Manheim, PA, PRT-180798 The applicant requests a permit to import a polar bear ( *Ursus maritimus* ) sport hunted from the Northern Beaufort Sea polar bear population in Canada for personal, noncommercial use. Applicant: Donald C. Hershey, Lancaster, PA, PRT-180799 The applicant requests a permit to import a polar bear ( *Ursus maritimus* ) sport hunted from the Northern Beaufort Sea polar bear population in Canada for personal, noncommercial use. Applicant: Timothy R. Decker, Apple Valley, CA, PRT-180800 The applicant requests a permit to import a polar bear (Ursus maritimus) sport hunted from the Lancaster Sound polar bear population in Canada for personal, noncommercial use. Applicant: Everett C. Madson, Omaha, NE, PRT-180801 The applicant requests a permit to import a polar bear ( *Ursus maritimus* ) sport hunted from the Lancaster Sound polar bear population in Canada for personal, noncommercial use. Applicant: Lee L. Moore, Baker, MT, PRT-181015 The applicant requests a permit to import a polar bear ( *Ursus maritimus* ) sport hunted from the Lancaster Sound polar bear population in Canada for personal, noncommercial use. Applicant: Thomas A. Kooistra, Wyoming, MI, PRT-181018 The applicant requests a permit to import a polar bear ( *Ursus maritimus* ) sport hunted from the Lancaster Sound polar bear population in Canada for personal, noncommercial use. Dated: April 18, 2008. Lisa J. Lierheimer, Senior Permit Biologist, Branch of Permits, Division of Management Authority. [FR Doc. E8-10500 Filed 5-9-08; 8:45 am] BILLING CODE 4310-55-P DEPARTMENT OF THE INTERIOR National Park Service National Register of Historic Places; Notification of Pending Nominations and Related Actions Nominations for the following properties being considered for listing or related actions in the National Register were received by the National Park Service before April 25, 2008. Pursuant to section 60.13 of 36 CFR Part 60 written comments concerning the significance of these properties under the National Register criteria for evaluation may be forwarded by United States Postal Service, to the National Register of Historic Places, National Park Service, 1849 C St., NW, 2280, Washington, DC 20240; by all other carriers, National Register of Historic Places, National Park Service, 1201 Eye St., NW, 8th floor, Washington, DC 20005; or by fax, 202-371-6447. Written or faxed comments should be submitted by May 27, 2008. J. Paul Loether, Chief, National Register of Historic Places/National Historic Landmarks Program. ARKANSAS Baxter County Cold Water School, 2422 Co. Rd. 73, Big Flat, 08000485 Cleburne County Rector House, 603 W. Quitman St., Heber Springs, 08000486 Jackson County Weldon Gin Company Historic District (Cotton and Rice Farm History and Architecture in the Arkansas Delta MPS) NE corner of jct. of Washington St. & AR 17, Weldon, 08000487 Johnson County Stokes, Fremont, House, 319 Grandview Ave., Clarksville, 08000488 White County Collison House, 206 N. Main St., Bald Knob, 08000489 Woodruff County Cotton Plant Water Tower (New Deal Recovery Efforts in Arkansas MPS) Jct. of N. Main & N. Vine Sts., Cotton Plant, 08000490 Yell County Ward's Crossing Bridge (Historic Bridges of Arkansas MPS) Co. Rd. 8, Plainview, 08000491 GEORGIA Pulaski County Hawkinsville Public School, 215 Warren St., Hawkinsville, 08000492 Richmond County Cauley-Wheeler Memorial Building, 1339 Laney-Walker Blvd., Augusta, 08000493 MINNESOTA Todd County Northern Pacific Railway Depot and Freighthouse, 1st. Ave. N., Staples, 08000494 NORTH CAROLINA Rutherford County Carson—Andrews Mill and Ben F.W. Andrews House, Both sides of NC 1007, E., S., and W. of jct. with NC 1796, Washburn, 08000495 WEST VIRGINIA Logan County Blair Mountain Battlefield, Address Restricted, Logan, 08000496 [FR Doc. E8-10487 Filed 5-9-08; 8:45 am] BILLING CODE 4312-51-P DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation and Liability Act Notice is hereby given that on May 5, 2008, a proposed consent decree in *United States* v. *Daniel Rapier et al.* , Civil Action No. 06cv1686, was lodged with the United States District Court for the Southern District of Indiana. In this cost recovery action brought pursuant to the Comprehensive Environmental Response, Compensation and Liability Act, 42 U.S.C. 9607, the United States sought recovery of unreimbursed past response costs and prejudgment interest incurred by the United States Environmental Protection Agency at the Laurel Stone Church Road Superfund Site located near Laurel in Franklin County, Indiana. Under the proposed consent decree, Franklin County, Indiana, Gale Hornsby, and Juanita Hornsby will pay a total of $350,000 to the Hazardous Substance Superfund. This amount was determined based on the Hornsbys' ability to pay a judgment as calculated by a Department of Justice financial analyst, and the County's ability to pay a judgment as calculated by an independent financial analyst hired by the Department of Justice. In addition, under the proposed consent decree Daniel Rapier and Naomi Rapier will pay a total of $45,000 to the Hazardous Substance Superfund. The Department of Justice will accept comments relating to the proposed consent decree for a period of thirty
(30)days from the date of publication of this notice. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and mailed either electronically to *pubcomment-ees.enrd@usdoj.gov* or in hard copy to P.O. Box 7611, U.S. Department of Justice, Washington, DC 20044-7611. Comments should refer to *United States* v. *Daniel Rapier et al.* , Civil No. 06cv1686 (S.D. Ind.) and D.J. Reference No. 90-11-3-08896. The proposed consent decree may be examined at:
(1)The Office of the United States Attorney for the Southern District of Indiana, 10 W Market St., Suite 2100, Indianapolis, IN 46204,
(317)226-6333; and
(2)the United States Environmental Protection Agency (Region 5), 77 West Jackson Boulevard, Chicago, Illinois 60604-3590 (contact Jeffrey A. Cahn (312-886-6670)). During the comment period, the proposed consent decree may also be examined on the following Department of Justice Web site: *http://www.usdoj.gov/enrd/Consent_Decree.html.* A copy of the proposed consent decree may also be obtained by mail from the Department of Justice Consent Decree Library, P.O. Box 7611, Washington, DC 20044-7611 or by faxing or e-mailing a request to Tonia Fleetwood ( *tonia.fleetwood@usdoj.gov* ), fax no.
(202)514-0097, phone confirmation number
(202)514-1547. In requesting a copy from the Consent Decree Library, please refer to the referenced case and D.J. Reference No. 90-11-3-08896, and enclose a check in the amount of $7 for the consent decree (28 pages at 25 cents per page reproduction costs), made payable to the U.S. Treasury. William D. Brighton, Assistant Chief, Environmental Enforcement Section, Environment and Natural Resources Division. [FR Doc. E8-10389 Filed 5-9-08; 8:45 am] BILLING CODE 4410-15-P DEPARTMENT OF LABOR Employment and Training Administration Request for Certification of Compliance—Rural Industrialization Loan and Grant Program AGENCY: Employment and Training Administration, Labor. ACTION: Notice. SUMMARY: The Employment and Training Administration is issuing this notice to announce the receipt of a “Certification of Non-Relocation and Market and Capacity Information Report” (Form 4279-2) for the following: *Applicant/Location:* Puerto Rico Network of Integrative Medicine, Inc./Arecibo, Puerto Rico. *Principal Product/Purpose:* The loan, guarantee, or grant application is for the acquisition and remodeling of an existing hospital. The NAICS industry code for this enterprise is: 622110 General Medical and Surgical Hospitals. DATES: All interested parties may submit comments in writing no later than May 27, 2008. Copies of adverse comments received will be forwarded to the applicant noted above. ADDRESSES: Address all comments concerning this notice to Anthony D. Dais, U.S. Department of Labor, Employment and Training Administration, 200 Constitution Avenue, NW., Room S-4231, Washington, DC 20210; or e-mail *Dais.Anthony@dol.gov* ; or transmit via fax
(202)693-3015 (this is not a toll-free number). FOR FURTHER INFORMATION CONTACT: Anthony D. Dais, at telephone number
(202)693-2784 (this is not a toll-free number). SUPPLEMENTARY INFORMATION: Section 188 of the Consolidated Farm and Rural Development Act of 1972, as established under 29 CFR Part 75, authorizes the United States Department of Agriculture to make or guarantee loans or grants to finance industrial and business activities in rural areas. The Secretary of Labor must review the application for financial assistance for the purpose of certifying to the Secretary of Agriculture that the assistance is not calculated, or likely, to result in:
(a)A transfer of any employment or business activity from one area to another by the loan applicant's business operation; or
(b)An increase in the production of goods, materials, services, or facilities in an area where there is not sufficient demand to employ the efficient capacity of existing competitive enterprises unless the financial assistance will not have an adverse impact on existing competitive enterprises in the area. The Employment and Training Administration within the Department of Labor is responsible for the review and certification process. Comments should address the two bases for certification and, if possible, provide data to assist in the analysis of these issues. Signed: at Washington, DC this 5th of May, 2008. Gay M. Gilbert, Administrator, Office of Workforce Investment, Employment and Training Administration. [FR Doc. E8-10498 Filed 5-9-08; 8:45 am] BILLING CODE 4510-FN-P DEPARTMENT OF LABOR Employment and Training Administration [SGA/DFA-PY-07-08] Solicitation for Grant Applications (SGA); Office of Apprenticeship and the Women's Bureau SGA AGENCY: Employment and Training Administration (ETA), Labor. ACTION: Notice: Amendment to SGA/DFA-PY-07-08. SUMMARY: The Employment and Training Administration published a document in the **Federal Register** on April 22, 2008, announcing the availability of funds and solicitation for grant applications
(SGA)for the Women in Apprenticeship and Nontraditional Occupations. This notice is a second amendment to the SGA and it amends a Web site link in “Section IV., Application and Submission Information,” under the specific heading, “Electronic Submissions.” FOR FURTHER INFORMATION CONTACT: James Stockton, Grant Officer, Division of Federal Assistance, at
(202)693-3335. *Supplementary Information Correction:* In the **Federal Register** of April 22, in FR Doc. E8-8651. On page 21652 under the second
(2nd)paragraph titled, “Electronic Submissions,” the Web site link is changed from “Get Started,” with registration steps at *http:www.grants.gov/GetStarted* to “ *Get Registered* ” *http://www.grants.gov/applicants/get_registered.jsp* . EFFECTIVE DATE: This notice is effective May 12, 2008. Signed at Washington, DC, this 6th day of May, 2008. James W. Stockton, Grant Officer. [FR Doc. E8-10497 Filed 5-9-08; 8:45 am] BILLING CODE 4510-FN-P NUCLEAR REGULATORY COMMISSION [Docket No. 40-6563] Environmental Assessment and Finding of No Significant Impact Related to Issuance of License Amendment for the Removal of Unreacted Ore From Plant 6W, Mallinckrodt Inc., St. Louis, Missouri; License No. STB-401 AGENCY: Nuclear Regulatory Commission. ACTION: Environmental Assessment and Finding of No Significant Impact. FOR FURTHER INFORMATION CONTACT: John Buckley, Division of Waste Management and Environmental Protection, Office of Federal and State Materials and Environmental Management Programs, U.S. Nuclear Regulatory Commission, Mail Stop: T8F5, Washington, DC 20555-0001. Telephone:
(301)415-6607; e-mail: *john.buckley@nrc.gov.* SUPPLEMENTARY INFORMATION: 1. Introduction The U.S. Nuclear Regulatory Commission
(NRC)is considering approval of Mallinckrodt Inc.'s (Mallinckrodt's) license amendment request (ADAMS No. ML073390035) for removal of unreacted ore
(URO)from Plant 6W, a portion of Mallinckrodt's site located in St. Louis, Missouri. As part of its review, the NRC staff has prepared this environmental assessment (EA). The EA evaluates Mallinckrodt's request, as supplemented by its responses dated January 28, 2008 (ML080350013), and March 17, 2008 (ML080800076), to the NRC's request for additional information (ML073550832). 2. Background Mallinckrodt has been operating at the St. Louis Plant since 1867 producing various products including metallic oxides and salts, ammonia, and organic chemicals. From 1942 to 1957, Mallinckrodt was under contract with the Manhattan Engineering District and the Atomic Energy Commission (MED-AEC) to process uranium ore to produce uranium for development of atomic weapons. Remediation of MED-AEC contamination at the St. Louis Plant site is being performed by the U.S. Army Corp of Engineers (USACE) under the Formerly Utilized Sites Remedial Action Program (FUSRAP). The Plant 6W area (described below) contains widespread contamination from MED-AEC operations. In addition to its MED-AEC operations, Mallinckrodt extracted Columbium and Tantalum (C-T) from natural ores and tin slags from 1961 to 1985. These ores contained uranium and thorium isotopes, and were thus source material which required a 10 CFR Part 40 possession and use license. Mallinckrodt was issued License No. STB-401 in 1961. The C-T operations produced the URO at issue here. The URO is comprised of columbite ore and tin slag that did not dissolve by acid leaching, and portions that precipitated as insoluble fluoride compounds UF <sup>4</sup> and ThF <sup>4</sup> . The URO is buried in a set of 10 trenches within the Plant 6W area, and is surrounded by MED-AEC contamination. C-T processing was shut down from 1985 through early 1987, when Mallinckrodt began a two month pilot production run. During the pilot production run, approximately 20,000 pounds of tin slag were processed. In July 1993, NRC amended Mallinckrodt's license to a possession only license for purposes of decommissioning the NRC-licensed site and eventually terminating the NRC license. Approximately 6 Ci of natural uranium and 19 Ci of natural thorium isotopes were contained in the ores and tin slags processed under License STB-401. Mallinckrodt needs to remove the URO so that USACE can proceed with its FUSRAP action. Mallinckrodt and USACE worked cooperatively to reach an agreement in 2007 that defines a geographical boundary between buried URO in trenches numbered 1-9, and surrounding land within Plant 6W. Under the agreement Mallinckrodt is responsible for removal of all material within the geographical boundary, including the URO in the nine burial trenches, and USACE is responsible for remediation of the remainder of Plant 6W. Prior to removal of URO from Trench 10, Mallinckrodt and USACE will need to conclude a similar delineation agreement—to be examined by NRC—defining the geographical boundary of Trench 10. With the exception of the buried URO, the remediation of the Plant 6W area will be conducted by USACE pursuant to FUSRAP. Mallinckrodt's St. Louis facility as a whole contains more than 50 buildings in an area covering approximately 43 acres. The facility has been traditionally subdivided into areas called “Plants” based on similar operations being performed within each plant. C-T processing and support occurred in 21 buildings, mainly within Plant 5, but also within Plants 1, 3, 6, 7 and 8. Select buildings and areas in Plants 6 and 7 were used to receive and store feed materials and drummed URO waste. In 1972-73 approximately 300 cubic yards (yd 3 ) of URO was buried in the set of 10 trenches located on the western portion of Plant 6—now designated as Plant 6W. Plant 6W is an uncovered area of approximately 60,000 ft 2 (200 ft x 300 ft) of which the burials occupy an area of approximately 4500 ft 2 . A portion of Trench 10 is located beneath a corner of Building 101, so that the URO within Trench 10 is not fully accessible. The initial amendment request for removal of URO from Plant 6W did not include removal of URO from Trench 10. Mallinckrodt requested that NRC approve the removal of URO from Trench 10 in its March 17, 2008, supplement. This request is discussed below under the “Connected Action” heading. Mallinckrodt is conducting its decommissioning activities of the C-T processing areas in two phases. The NRC approved the Phase 1 decommissioning plan
(DP)in May 2002. In Phase 1, Mallinckrodt decommissioned the buildings and equipment to the extent necessary to meet NRC's guidelines for unrestricted release. Mallinckrodt completed Phase 1 decommissioning activities in February 2007. Phase 2 will include the remediation of the building slabs and foundations, paved surfaces, and all remaining subsurface materials. Mallinckrodt submitted its Phase 2 DP for NRC review and approval in 2003. The staff is still reviewing the Phase 2 DP. Mallinckrodt originally planned to remove the URO from Plant 6W as part of its Phase 2 decommissioning activities. However, in order to coordinate schedules for remediation of Plant 6W with USACE, Mallinckrodt is proposing to remove the URO buried in Plant 6W under this separate licensing action prior to approval and implementation of the Phase 2 DP. 3. Need for the Proposed Action The ultimate goal of the C-T project decommissioning being overseen by the NRC is to remediate those areas of the St. Louis site associated with past C-T production, to the extent necessary to permit the termination of License STB-401. As noted above, Plant 6W contains MED-AEC contamination and URO from C-T operations in ten burial pits, and Mallinckrodt is responsible for removing this URO. Removal of the URO prior to Phase 2 decommissioning activities will remove a significant source of radioactive material from the St. Louis Plant site, thereby reducing the risk of exposure to Mallinckrodt workers during these subsequent decommissioning activities. 4. Proposed Action Mallinckrodt plans to remove URO and adjacent soil from the set of ten trenches in Plant 6W, and ship the material by rail to a regulated disposal facility. The specific disposal facility will depend on whether the URO and soil contains more or less than the exempted quantity of source material—0.05% by weight—as set forth in 10 CFR Part 40.13(a). Non-URO and soil materials with surface contamination meeting the standards in NRC Policy and Guidance Directive FC 83-23 can be released from the site in accordance with license condition 16. 4.1 Site Description The facility is located adjacent to the west bank of the Mississippi River. The area surrounding the site is completely developed, and includes a mixture of commercial, industrial and residential uses. The St. Louis plant is located within Census Tract 1267. The residential population within this tract was 2,867 in 1990, and the total residential population within one mile of the plant was approximately 10,000. Section 1 of the DP provides maps showing the site location, plant site, and C-T production and process areas. The Mississippi, Missouri, and Meramec rivers are the main surface water bodies near the facility. Storm runoff from the St. Louis plant flows via the sewer system to the Metropolitan Sewer District. The City of St. Louis municipal water intakes are located up-stream from the St. Louis, Plant. The Mississippi River is subject to flooding. A levee constructed in 1964 on City of St. Louis property protects the plant from flood waters. The St. Louis plant is underlain by two unconsolidated soil units and one bedrock unit. The upper soil unit consists of fill material and is between 12 and 30 feet thick. This unit contains a perched groundwater unit at depths of three to nine feet below the surface. The lower soil unit is composed of silt and clay above sandy alluvium, and ranges between 0 and 60 feet thick. Groundwater in the sandy alluvium is saline and very hard, and flows to the east towards the Mississippi River. The bedrock unit is limestone. Groundwater in the bedrock is saline and non-potable. Groundwater beneath the St. Louis Plant and surrounding area is not used for drinking water, and there are no drinking water wells located near the plant. The climate in the St. Louis area is warm and moist in the summer and cold and dry in the winter. The annual average high and low temperatures are 88 degrees Fahrenheit and 23 degree Fahrenheit, respectively. The average annual precipitation is 36 inches. 4.2 Source Removal Criteria As indicated above, the disposal criterion for the removed URO and soil depends on whether or not the 10 CFR part 40.13(a) exemption limit is exceeded. Equipment with surface contamination meeting the requirements of NRC Policy and Guidance Directive FC 83-23 can be released in accordance with license condition 16, as indicated in the following chart. Equipment Surface Release Limits Equipment location Average (dpma/100 cm 2 ) Maximum (dpma/100 cm 2 ) Removable (dpma/100 cm 2 ) Any 2400 7200 500 At the Plant 6W site, Mallinckrodt will remove all material within a geographical boundary agreed to between Mallinckrodt and USACE. Completion of the removal action will be verified by measurement of the excavation width and depth. Because this URO source removal action is based upon agreed geographical boundaries, a residual radioactivity concentration criterion—applicable in decommissioning actions—will not be applicable here. Similarly, a final status survey will not be required. Mallinckrodt will demonstrate completion of the URO removal action by documenting the removal of the volume of material specified in the Mallinckrodt/USACE delineation agreements. 4.3 Site Characterization URO was buried in Plant 6W in a set of ten excavated trenches. Mallinckrodt estimates that the URO contains about 1.8 wt% thorium and about 0.15 wt% uranium. Approximately 290 yd 3 of URO was packaged in 305 thirty-gallon steel drums. The drums were placed in the trenches in a two-foot layer with approximately 3-4 feet of clean cover consisting of compact soil. 4.4 Areas To Be Remediated As stated above, Mallinckrodt and USACE have agreed upon a defined geographic boundary for nine of the trenches in Plant 6W. Mallinckrodt initially planned to remove URO buried in Trench 10 later, during Phase 2 decommissioning. However, if removal of URO from Trench 10 benefits Mallinckrodt/USACE remediation activities in Plant 6W, Mallinckrodt may elect to establish a delineation agreement with USACE for Trench 10 as well, and remove URO from Trench 10 under this proposed license amendment. URO burials in Trenches 1-9 occupy an area of about 418 square yards (yd 2 ). Allowing for sloping excavation side walls results in a total volume of excavated material of about 2605 yd 3 . The URO from Trench 10 adds approximately 900 yd 3 which brings the total excavated volume to 3495 yd 3 . 4.5 Approach to URO Removal Mallinckrodt is proposing to treat removal of the URO as a volume of material within specified geographical bounds. Land outside the boundary is the responsibility of USACE under FUSRAP. Mallinckrodt is proposing to remove the URO using the following steps: • Utility lines, including water, electricity, gas, etc., will be located and marked prior to initiation of remediation activities and will be relocated as necessary to perform this work; • Macadam pavement atop URO burials one through nine will be removed; • Soil covering the buried URO will be removed by excavation; • Water misting or similarly effective dust control methods will be used as necessary to prevent the release of airborne dust during excavation and materials handling activities; • Extent of the removal is to be verified by visual inspection and, where necessary confirmed by appropriate radiation measurements; • URO contents will be transported to the rail loading facility on site for loading and delivery to a carrier for transport; • Excavated soil and URO may be mixed in order to satisfy disposal site criteria; and • Backfill will be specified to ensure no subsidence or, by agreement with the USACE, excavation cavities may be left to facilitate FUSRAP remediation nearby. 4.6 Environmental Safety Program Mallinckrodt has committed to perform URO removal activities in accordance with a Health and Safety Program, which includes:
(1)An Industrial Safety Program;
(2)a Radiation Protection Program; and
(3)an Environmental Safety Program. Only the Environmental Safety Program is discussed here. Implementation of the overall Health and Safety Program will be evaluated during NRC site inspections. Mallinckrodt has committed to implement an Environmental Protection Program to monitor air and water effluents discharged during the URO removal project. During soil handling activities, Mallinckrodt has committed to routinely collect samples or take measurements at on-site and site boundary or off-site locations to determine the extent of environmental discharges during remediation. The amendment request states that Mallinckrodt will be responsible for overall project direction and ensuring that NRC requirements are met. The remediation contractors will be responsible for implementation of the radiological, occupational, environmental safety and quality assurance programs. The contractor will also be responsible for providing trained personnel to conduct decommissioning activities. The amendment request describes an acceptable organizational structure and presents minimum qualifications for safety related personnel. 4.7 ALARA Plan Mallinckrodt has committed to keeping radiation exposures to workers and the environment ALARA, by implementing health safety practices specified in the Radiation Protection Program. The remediation contractor is responsible for implementing the Radiation Protection Program. Under the Radiation Protection Program, the contractor is required to consider how exposures will be kept ALARA in the preparation of safety work permits. In addition, all individuals will be trained in the concepts of ALARA before being allowed to work in controlled areas. The Radiation Protection Program requires that workers be adequately trained. All unescorted individuals involved in C-T Project decommissioning activities will be required to receive Industrial Safety Training and Radiation Safety Training. All individuals will receive Radiation Safety Training before entering a controlled area to perform work. Mallinckrodt will also implement an Environmental Safety Program to monitor air and water effluents discharged during URO source removal. Mallinckrodt will routinely collect samples or take measurements at locations on-site, site boundaries, and off-site, to determine the extent of environmental discharges. Environmental sampling stations will collect continuous samples during URO source removal activities to verify that there are no significant adverse impacts to workers or the environment. Mallinckrodt has also committed to monitor direct radiation using thermoluminescent dosimeters (TLDs). TLDs will be placed at various locations around the perimeter of the controlled area to ensure that direct radiation in unrestricted areas does not exceed the public dose limits specified in 10 CFR 20.1301. The Radiation Control and Environmental Safety Programs described in the license amendment request are acceptable programs which should keep radiation exposures to workers, and the environment ALARA. 5. Alternatives to the Proposed Action Removal of the URO from Plant 6W contributes to the systematic remediation of the C-T process areas at the St. Louis Plant. Removal of the URO from Plant 6W was initially supposed to occur as part of Phase 2 decommissioning activities. Removal of the URO as a separate licensing action, before the Phase 2 DP has been approved, provides Mallinckrodt the opportunity to coordinate remediation activities of Plant 6 with USACE and remove a significant source of radioactive material from the St. Louis Plant site. There are two possible alternatives to the proposed action:
(1)No action alternative; and
(2)removal of URO during Phase 2 decommissioning activities. The “no action” alternative is not an acceptable alternative because the URO burial pits contain residual contamination exceeding NRC's release criteria. Although the second alternative would be an acceptable decommissioning approach, this alternative delays USACE remediation activities in Plant 6W. Delaying USACE remediation activities in Plant 6 increases the potential dose to Mallinckrodt workers since a significant source of radioactive material remains on site. 6. Affected Environment As stated in the Background section above, MED-AEC contamination at Mallinckrodt facility is being removed by USACE under FUSRAP. USACE developed a preferred cleanup approach for the MED-AEC contamination, based on the data and findings presented in four documents:
(1)Remedial Investigation Report;
(2)Baseline Risk Assessment;
(3)Initial Screening of Alternatives; and
(4)Feasibility Study. Section 2.2 of the Feasibility Study provides an evaluation of the affected environment surrounding the Mallinckrodt facility. The findings in Section 2.2 of the Feasibility Study also apply to remediation of the C-T process areas. The NRC staff incorporates by reference the Feasibility Study's Section 2.2 discussion of the following topics:
(1)Land use and recreational and esthetic resources;
(2)Climatology, meteorology, and air quality;
(3)Geology and soils;
(4)Water resources;
(5)Biological resources;
(6)Threatened and endangered species;
(7)Wetlands and floodplains;
(8)Population and socioeconomics; and
(9)Historical, archeological, and cultural resources. 7. Environmental Impacts 7.1 Radiological Impacts Removal of the URO from Plant 6W creates a potential for radiological environmental impacts. Radiological environmental impacts that could result from remediation activities include exposure, inhalation, and ingestion hazards to workers and the public. These hazards could occur during the excavation and handling of the URO and surrounding soil. Mallinckrodt has committed to perform work activities in accordance with a Health and Safety Program as described in the amendment request. The Health and Safety Program will consist of:
(1)An Industrial Safety Program;
(2)a Radiation Protection Program; and
(3)an Environmental Safety Program. The Radiation Protection Program will contain controls to monitor exposures to workers. Action levels have been established based on 10 CFR 20, Appendix B. If action levels are exceeded, Mallinckrodt will take corrective action, as necessary. The Radiation Protection Program will keep exposures due to ingestion and inhalation ALARA by controlling and monitoring airborne releases in work areas, and by utilizing respiratory protection, as necessary. Mallinckrodt will implement the NRC-approved Environmental Safety Program developed for Phase 1 decommissioning activities to monitor air and water effluents discharged during the URO source removal action. If necessary, Mallinckrodt will revise elements of the Phase 1 Environmental Safety Program to effectively control URO removal activities. Mallinckrodt will collect air and water samples on-site and off-site routinely to determine the extent of environmental discharges. Mallinckrodt does not anticipate the need for effluent air monitoring since there will likely be no point sources of effluent air. However, if such a need arises, Mallinckrodt will use aN exhaust ventilation system, and the effluent air will be sampled and analyzed. Mallinckrodt will provide environmental monitoring stations to verify that there are no significant adverse impacts to the workers or the environment. Mallinckrodt has committed to minimize the production of contaminated liquids. There are four potential sources of contaminated liquids: Water collection in an excavation pit; sink and shower water; fluids produced by decontamination of equipment; and water used for dust suppression. Sink and shower water is expected to contain insignificant amounts of radioactivity and will be discharged into the sewer in accordance with 10 CFR Part 20.2003. If rain water or surface water is collected, it will ordinarily be used for dust suppression of URO and adjacent soils destined for NRC-approved disposal. Aqueous waste from decontamination fluids and dust suppression containing potentially significant concentrations of radionuclides will be filtered to remove the solids, sampled and analyzed to estimate the concentration in the sewerage. The concentration will be compared with 10 CFR Part 20 concentration limits and the total inventory discharged will be calculated. Mallinckrodt has also committed to monitor direct radiation using TLDs. TLDs will be placed at various locations around the perimeter of the controlled area for the source removal action, to ensure that direct radiation from the URO does not exceed the limits specified in 10 CFR 20.1301 for unrestricted areas. Mallinckrodt has established action levels to aid in compliance with environmental safety regulations in 10 CFR Part 20. The action levels for environmental air, effluent water and sewage are 0.75, 0.6, and 0.6 of the limits, respectively. If action levels are exceeded, Mallinckrodt will take corrective actions. Mallinckrodt has performed dose assessments to determine an occupational exposure estimate, and the dose associated with credible accident scenarios. The occupational exposure estimate for a representative worker during URO removal is 83 mrem/yr. 7.2 Non-Radiological Impacts The St. Louis Plant is located in an area, which is completely developed with no pre-settlement vegetation existing. Land use within a one mile radius from the site is a mixture of commercial, industrial, and residential. Commercial or industrial properties in the area include McKinley Iron Company, Thomas and Proetz Lumber Company, and several railroad properties. The USACE Feasibility Study states that there was no sign of federal or state designated endangered or threatened species present at the Mallinckrodt facility. The Feasibility Study also states that the Mallinckrodt facility does not contain any historic buildings. Further, available data indicate that there are no archeological sites in the area. The residential population within one mile of the site is approximately 10,000 persons, with most of the residences located on the opposite side of Interstate 70. The URO removal action is a small scale activity requiring relatively few workers. Due to the small number of workers and the short duration of the project, this effort should have minimal socioeconomic impact on the local community. NRC staff performed an environmental justice review of the Mallinckrodt site for approval of the Phase 1 DP. The review concluded that since Phase 1 decommissioning activities result in an insignificant risk to the public health and safety, and the human environment, that there are no environmental justice issues with this site. As was the case during Phase 1 decommissioning activities, URO burial removal activities result in an insignificant risk to the public health and safety, and the human environment. Therefore, the conclusion that there is no environmental justice issue associated with this site remains valid. Air quality and noise impacts may result from excavation and handling of URO and surrounding soil, and transport of waste. Mallinckrodt will use appropriate dust control measures during URO and soil handling. These activities will be short in duration; and, therefore, will have minimal impact on the surrounding community and environment. The St. Louis Plant can be serviced by road, rail, and river barge. Interstate 70 (east and west) can be accessed within one mile from the St. Louis Plant. Rail lines from the Chicago, Burlington, and Quincy Railroad, the Norfolk and Western Railroad, and the St. Louis Terminal Railroad Association, transect the St. Louis Plant from north to south. URO and adjacent soils will be shipped from the site by rail. The total volume of such materials to be shipped from the site is estimated to be approximately 3495 yd 3 . Approximately 50 gondola-type rail cars will be required to transport the URO and adjacent soil to a disposal facility. This small number of rail cars will have an insignificant impact on the local rail traffic. The staff incorporates by reference, the USACE Feasibility Study, Appendix C, ALARA Analysis, which calculates the risk to a worker or member of the public during waste transport. 7.3 Connected Action Mallinckrodt has determined that it may be beneficial to demolish Building 101. As stated above, such action would make Trench 10 fully accessible, and allow all URO from Plant 6W to be moved offsite. Building 101 was not used for C-T processing activities. Mallinckrodt performed a final status survey on the exterior of Building 101 as part of Phase 1 decommissioning activities. A final status survey report was submitted to NRC in March 2004 (ML042600286). NRC released Building 101 for unrestricted use in February 2007 (ML070530675) and it is currently used by Mallinckrodt for business operations not regulated by the NRC. Ordinarily, since Mallinckrodt could demolish Building 101 at any time without NRC approval, such action would not be a federal action requiring the NRC staff's environmental review. However, it appears that but for the need to make the URO in Trench 10 accessible, in furtherance of the removal action being evaluated in this EA, Building 101 would not be slated for demolition at this time. This nexus between the potential demolition and the licensed action brings Building 101 within the scope of this EA. Building 101 is a 243 ft by 23 ft cinder block building constructed in 1973. As noted above, although Building 101 was not used for C-T processing activities, Mallinckrodt surveyed the exterior of the building for radioactivity. The NRC performed a confirmatory survey of the building exterior during a February 2007 inspection (ML070530262) and released the building for unrestricted use the same month. Since radioactivity is not a concern, demolition of building 101 will involve the use of standard demolition equipment. The volume of building rubble to be disposed should be less than 2,500 yd 3 . Since radioactive material is not a concern and the building has no historic significance, the environmental impacts associated with the demolition of this building will be equal to the demolition of any cinder block building in an industrial area. The volume of rubble to be transported from the site as the result of Building 101's demolition would have an insignificant impact on the local transportation system. The URO in Trench 10 has the same radiological characteristics as the URO in the other nine trenches, and the same removal techniques would be used for it. Mallinckrodt must conclude a delineation agreement with USACE prior to removal of URO from Trench 10. Accordingly, the NRC staff has determined that Mallinckrodt may remove URO from Trench 10 under this proposed license amendment. This conditional approval is reflected in License Condition 19. 7.4 Cumulative Impacts The URO removal action will have a small, insignificant cumulative impact on conditions at the Mallinckrodt site. The Plant 6W area is a small part of Mallinckrodt's larger operating industrial facility at the St. Louis site. The volume of material to be removed from the trenches is relatively small compared to volume of material to be removed by USACE from Plant 6 under FUSRAP. The URO removal activities are expected to be completed within 12 months. The Mallinckrodt facility is an operating industrial facility located in a highly industrial area. Further, USACE is conducting remedial activities at the site. As such, the increased noise from URO removal activities will be insignificant. As described earlier, the URO removal action will generate a relatively small volume of material that will be transported from the site to a disposal facility. While local rail traffic will thus be increased, the small number of rail cars required will have an insignificant cumulative impact on the transportation system in the St. Louis metropolitan area. The small short term negative impacts associated with the URO removal action are outweighed by the significant positive impact resulting from the removal of URO from the Mallinckrodt facility. Removing the URO from Plant 6W now will reduce the potential radiological dose to Mallinckrodt workers later, when such workers will be conducting Phase 2 decommissioning activities. 8. Agencies and Persons Consulted and Sources Used Much of the information contained in this EA was taken directly from the Mallinckrodt license amendment request and the USACE Feasibility Study. In preparation of the Feasibility Study, USACE consulted with the U.S. Fish and Wildlife Service and the State Historic Preservation Office. Since Plant 6W URO removal activities will be occurring at the same site as USACE decommissioning activities, with a much more limited scope, NRC has utilized the input of the U.S. Fish and Wildlife Service and the State Historic Preservation Office by reference of the Feasibility Study. NRC staff provided a draft of this EA to the State of Missouri for review, and the State's concerns were addressed in the final EA. 9. Conclusion Radiological exposures to workers and the public will be in accordance with 10 CFR Part 20 limits. NRC believes the amendment request contains sufficient controls to keep potential doses to workers and the public from direct exposure, airborne material, and released effluents, ALARA. The staff also believes that the remediation alternative proposed by Mallinckrodt minimizes the potential dose to workers and members of the public, and other environmental impacts. 10. List of Preparers This EA was prepared by John Buckley, Senior Project Manager, Division of Waste Management and Environmental Protection, Office of Federal and State Materials and Environmental Management Programs. No other sources were used beyond those referenced. 11. Finding of No Significant Impact Pursuant to 10 CFR Part 51, NRC has prepared this EA related to the approval of Mallinckrodt's license amendment request for removal of URO from Plant 6W. On the basis of this EA, NRC has concluded that this Federal action would not have any significant effect on the quality of the human environment and does not warrant the preparation of an Environmental Impact Statement. Accordingly, it has been determined that a Finding of No Significant Impact is appropriate. Since the conclusion of this EA is that the remediation of the Plant 6W URO burial trenches of Mallinckrodt's St. Louis Plant represents no significant risk to the public health and safety and the human environment, NRC concludes that there are no environmental justice issues related to the URO removal action. The aforementioned documents related to this proposed action are available for public inspection and copying at NRC's Public Document Room at One White Flint North, 11555 Rockville Pike, Rockville, MD 20852-2738. 12. List of References 12.1 Mallinckrodt Chemical, Inc., Request for NRC License Amendment To Remove URO From Plant 6W, November 20, 2007. 12.2 Mallinckrodt Chemical, Inc., Mallinckrodt C-T Project Decommissioning Plan (DP), Part 1, January 18, 2001. 12.3 U.S. Army Corps of Engineers, Proposed Plan for the St. Louis Downtown Site, April 1998. 12.4 U.S. Army Corps of Engineers, Feasibility Study for the St. Louis Downtown Site, April 1998. 12.5 NRC, Policy and Guidance Directive FC 83-23, “Termination of Byproduct, Source, and Special Nuclear Material Licenses,” November 1983. 12.6 NRC, 10 CFR part 20, “Radiological Criteria for License Termination: Final Rule,” July 1997. FOR FURTHER INFORMATION CONTACT: John Buckley, Decommissioning and Uranium Recovery Licensing Directorate, Division of Waste Management and Environmental Protection, Office of Federal and State Materials and Environmental Protection Programs. Telephone: 301-415-6607, e-mail: *john.buckley@nrc.gov* . Dated at Rockville, Maryland, this 30th day of April 2008. For the Nuclear Regulatory Commission. Rebecca Tadesse, Acting Deputy Director, Decommissioning and Uranium Recovery Licensing Directorate, Division of Waste Management, and Environmental Protection, Office of Federal and State Materials and Environmental Protection Programs. [FR Doc. E8-10482 Filed 5-9-08; 8:45 am] BILLING CODE 7590-01-P SECURITIES AND EXCHANGE COMMISSION [File No. 500-1] In the Matter of: American Motorcycle Corp. (f/k/a Scope Industries, Inc.); Order of Suspension of Trading May 8, 2008. It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of American Motorcycle Corp. (f/k/a Scope Industries, Inc.) because it has not filed any periodic reports since the period ended September 30, 2000. The Commission is of the opinion that the public interest and the protection of investors require a suspension of trading in the securities of the above-listed company. Therefore, it is ordered, pursuant to Section 12(k) of the Securities Exchange Act of 1934, that trading in American Motorcycle Corp. (f/k/a Scope Industries, Inc.) is suspended for the period from 9:30 a.m. EDT on May 8, 2008, through 11:59 p.m. EDT on May 21, 2008. By the Commission. Nancy M. Morris, Secretary. [FR Doc. 08-1249 Filed 5-8-08; 10:18 am]
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  • 38 Stat. 721
  • 44 USC 3501-3520
  • 5 CFR 1320.3(c)
  • Pub. L. 98-417
  • Pub. L. 100-670
  • Pub. L. 110-85
  • 16 USC 668dd-668ee
  • EO 5540
  • EO 7522
  • 50 CFR 18
  • 36 CFR 60
  • 29 CFR 75
  • 10 CFR 40
  • 10 CFR 20
  • 10 CFR 51
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U.S.C.§ 18
U.S.C.§ 45
U.S.C.§ 9601
U.S.C.§ 3502
U.S.C.§ 3506
U.S.C.§ 393
Stat.38 Stat. 721
Cite44 USC 3501-3520
Cite5 CFR 1320.3(c)
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