Rules and Regulations. Proposed consent agreement

7,685 words·~35 min read·/register/2006/02/27/06-1762·

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

BILLING CODE 6705-01-P FEDERAL RESERVE SYSTEM Change in Bank Control Notices; Acquisition of Shares of Bank or Bank Holding Companies The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board’s Regulation Y (12 CFR 225.41) to acquire a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)). The notices are available for immediate inspection at the Federal Reserve Bank indicated.

The notices also will be available for inspection at the office of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than March 14, 2006. **A. Federal Reserve Bank of Chicago** (Patrick M. Wilder, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414: *1. Matthew J. and Gayle M. Ahlers, and the Matthew J.

Ahlers Family, (consisting of Matthew, Gayle, Michael, Carolyn, Emily, Jeffery, and Matthew Jr. Ahlers)* , all of Le Mars, Iowa, to acquire additional voting shares of Primebank, Inc., Le Mars, Iowa, and thereby indirectly acquire voting shares of Primebank, Le Mars, Iowa. Board of Governors of the Federal Reserve System, February 22, 2006. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E6-2712 Filed 2-24-06; 8:45 am] BILLING CODE 6210-01-S FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 *et seq.* ) (BHC Act), Regulation Y (12 CFR Part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below.

The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The application also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843).

Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Additional information on all bank holding companies may be obtained from the National Information Center website at *www.ffiec.gov/nic/* . Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than March 24, 2006. **A. Federal Reserve Bank of St. Louis** (Glenda Wilson, Community Affairs Officer) 411 Locust Street, St.

Louis, Missouri 63166-2034: *1. First M&F Corporation* , Kosciusko, Mississippi; to merge with Crockett County Bancshares, Inc., Bells, Tennessee, and thereby indirectly acquire Bells Banking Company, Bells, Tennessee. **B. Federal Reserve Bank of Kansas City** (Donna J. Ward, Assistant Vice President) 925 Grand Avenue, Kansas City, Missouri 64198-0001: *1. Sundance State Bank Profit Sharing and Employee Stock Ownership Plan and Trust* , Sundance, Wyoming; to acquire an additional .67 percent, for a total of 26.73 percent, of the voting shares of Sundance Bankshares, Inc., and thereby indirectly acquire additional voting shares of Sundance State Bank, all located in Sundance, Wyoming.

Board of Governors of the Federal Reserve System, February 22, 2006. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E6-2713 Filed 2-24-06; 8:45 am] BILLING CODE 6210-01-S FEDERAL TRADE COMMISSION [File No. 041 0097] Health Care Alliance of Laredo, L.C.; Analysis of 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 March 15, 2006. ADDRESSES: Interested parties are invited to submit written comments. Comments should refer to “Health Care Alliance of Laredo, File No. 041 0097,” 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, NW., Washington, DC 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 as part of or as an attachment to email messages directed to the following e-mail box: *consentagreement@ftc.gov* . 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 Web site, to the extent practicable, at *http://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 Web site. 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.htm* . FOR FURTHER INFORMATION CONTACT: John DeGeeter, Bureau of Competition, 600 Pennsylvania Avenue, NW., Washington, DC 20580,

(202)326-2783. 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 13, 2006), on the World Wide Web, at *http://www.ftc.gov/os/2006/02/index.htm* . A paper copy can be obtained from the FTC Public Reference Room, Room 130-H, 600 Pennsylvania Avenue, NW., Washington, DC 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 The Federal Trade Commission has accepted, subject to final approval, an agreement containing a proposed consent order with Health Care Alliance of Laredo, L.C. (“HAL”). The agreement settles charges that HAL violated section 5 of the Federal Trade Commission Act, 15 U.S.C. 45, by orchestrating and implementing agreements among physician members of HAL to fix prices and other terms on which they would deal with health plans, and to refuse to deal with such purchasers except on collectively-determined terms. The proposed consent order has been placed on the public record for 30 days to receive comments from interested persons. Comments received during this period will become part of the public record. After 30 days, the Commission will review the agreement and the comments received, and will decide whether it should withdraw from the agreement or make the proposed order final. The purpose of this analysis is to facilitate public comment on the proposed order. The analysis is not intended to constitute an official interpretation of the agreement and proposed order, or to modify their terms in any way. Further, the proposed consent order has been entered into for settlement purposes only and does not constitute an admission by HAL that it violated the law or that the facts alleged in the complaint (other than jurisdictional facts) are true. The Complaint The allegations of the complaint are summarized below. HAL is a multi-specialty independent practice association (“IPA”) in the Laredo, Texas, area with approximately 80 member physicians, a substantial majority of whom are competitors of one another. HAL contracts with payors on behalf of its member physicians and thereby establishes uniform prices and other contract terms applicable to its members. Although purporting to employ a “messenger model,” 2 from 1998 to 2005, HAL attempted to and did negotiate higher reimbursement rates for its member physicians, sent payor offers to its members only after HAL negotiated and approved the rates, and urged its members not to deal individually with payors. HAL's Board of Managers, nine physicians who are elected by and represent HAL's physician members, authorized and directed each step of the contracting process. The Board initiated negotiations by directing HAL personnel to contact a payor. On several occasions, HAL personnel contacted payors after learning that the payors were soliciting contracts with individual physicians. HAL personnel told the payors that HAL would represent and contract on behalf of HAL's physician members. As negotiations between payors and HAL personnel proceeded, HAL personnel were required to report to the Board on the progress of negotiations, and to seek authorization from the Board before making counterproposals. Ultimately, the Board either accepted or rejected contracts which HAL personnel presented to it. If the Board accepted the contract, HAL would then, and only then, “messenger” the contract to HAL's members for their individual acceptance or rejection. HAL did not messenger any rates proposed by the payors during negotiations, and messengered only the rates that the Board approved. HAL members were fully aware of the payor negotiations HAL conducted on their behalf. HAL's staff provided updates to members on the status of contract negotiations via telephone, monthly newsletters, and monthly meetings. On several occasions, as HAL personnel were attempting to negotiate a group contract, HAL urged its members not to negotiate individually with the health plans, and significant numbers of HAL members refused to deal individually with those payors. 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). 2 Some arrangements can facilitate contracting between health care providers and payors without fostering an illegal agreement among competing physicians on fees or fee-related terms. One such approach, sometimes referred to as a “messenger model” arrangement, is described in the 1996 Statements of Antitrust Enforcement Policy in Health Care jointly issued by the Federal Trade Commission and U.S. Department of Justice, at 125. *See http://www.ftc.gov/reports/hlth3s.htm#9* . HAL members also had direct input in payor negotiations, aside from their representation on the Board. In 1999, HAL surveyed its members, asking them for “the 20 most common codes used in the office and the maximum discount that you are willing to accept.” HAL's Executive Director explained that “[t]his will help me when I negotiate contracts on behalf of the organization, since I would present these codes as those for which I will seek the advantageous rates.” In addition to the 1999 survey, HAL personnel and Board members regularly solicited input on acceptable rates from HAL's members, which were then used in negotiations with payors. HAL has orchestrated collective agreements on fees and other terms of dealing with health plans, carried out collective negotiations with health plans, and fostered refusals to deal. HAL succeeded in forcing numerous health plans to raise the fees paid to HAL physician members, and thereby raised the cost of medical care in the Laredo, Texas, area. HAL engaged in no efficiency-enhancing integration sufficient to justify joint negotiation of fees. By the acts set forth in the Complaint, HAL violated Section 5 of the FTC Act. The Proposed Consent Order The proposed order is designed to remedy the illegal conduct charged in the complaint and prevent its recurrence. It is similar to recent consent orders that the Commission has issued to settle charges that physician groups engaged in unlawful agreements to raise fees they receive from health plans. The proposed order's specific provisions are as follows: Paragraph II.A prohibits HAL from entering into or facilitating any agreement between or among any physicians:

(1)To negotiate with payors on any physician's behalf;

(2)to deal, not to deal, or threaten not to deal with payors;

(3)on what terms to deal with any payor; or

(4)not to deal individually with any payor, or to deal with any payor only through an arrangement involving HAL. Other parts of Paragraph II reinforce these general prohibitions. Paragraph II.B prohibits HAL from facilitating exchanges of information between physicians concerning whether, or on what terms, to contract with a payor. Paragraph II.C bars attempts to engage in any action prohibited by Paragraph II.A or II.B, and Paragraph II.D proscribes HAL from inducing anyone to engage in any action prohibited by Paragraphs II.A through II.C. As in other Commission orders addressing providers' collective bargaining with health care purchasers, certain kinds of agreements are excluded from the general bar on joint negotiations. HAL would not be precluded from engaging in conduct that is reasonably necessary to form or participate in legitimate joint contracting arrangements among competing physicians in a “qualified risk-sharing joint arrangement” or a “qualified clinically-integrated joint arrangement.” The arrangement, however, must not facilitate the refusal of, or restrict, physicians in contracting with payors outside of the arrangement. As defined in the proposed order, a “qualified risk-sharing joint arrangement” possesses two key characteristics. First, all physician participants must share substantial financial risk through the arrangement, such that the arrangement creates incentives for the physician participants jointly to control costs and improve quality by managing the provision of services. Second, any agreement concerning reimbursement or other terms or conditions of dealing must be reasonably necessary to obtain significant efficiencies through the joint arrangement. A “qualified clinically-integrated joint arrangement,” on the other hand, need not involve any sharing of financial risk. Instead, as defined in the proposed order, physician participants must participate in active and ongoing programs to evaluate and modify their clinical practice patterns in order to control costs and ensure the quality of services provided, and the arrangement must create a high degree of interdependence and cooperation among physicians. As with qualified risk-sharing arrangements, any agreement concerning price or other terms of dealing must be reasonably necessary to achieve the efficiency goals of the joint arrangement. Paragraph III, for three years, requires HAL to notify the Commission before entering into any arrangement to act as a messenger, or as an agent on behalf of any physicians, with payors regarding contracts. Paragraph III also sets out the information necessary to make the notification complete. Paragraph IV, for three years, requires HAL to notify the Commission before participating in contracting with health plans on behalf of a qualified risk-sharing joint arrangement, or a qualified clinically-integrated joint arrangement. The contracting discussions that trigger the notice provision may be either among physicians, or between HAL and health plans. Paragraph IV also sets out the information necessary to satisfy the notification requirement. Paragraph V requires HAL to distribute the complaint and order to all physicians who have participated in HAL, and to payors that negotiated contracts with HAL or indicated an interest in contracting with HAL. Paragraph V.D requires HAL, at any payor's request and without penalty, or, at the latest, within one year after the order is made final, to terminate its current contracts with respect to providing physician services. Paragraph V.D also allows any contract currently in effect to be extended, upon mutual consent of HAL and the contracted payor, to any date no later than one year from when the order became final. This extension allows both parties to negotiate a termination date that would equitably enable them to prepare for the impending contract termination. Paragraph V.E requires HAL to distribute payor requests for contract termination to all physicians who participate in HAL. Paragraphs VI, VII, and VIII of the proposed order impose various obligations on HAL to report or provide access to information to the Commission to facilitate monitoring HAL's compliance with the order. The proposed order will expire in 20 years. The purpose of this analysis is to facilitate public comment on the proposed order. It is not intended to constitute an official interpretation of the proposed order to modify its terms in any way. By direction of the Commission. Donald S. Clark, Secretary. [FR Doc. E6-2721 Filed 2-24-06; 8:45 am] BILLING CODE 6750-01-P GENERAL SERVICES ADMINISTRATION Notice of Intent to Prepare an Environmental Impact Statement for the Calexico West Port of Entry Expansion/Renovation, Calexico, California AGENCY: Public Buildings Service, GSA ACTION: Notice of Intent to Prepare an Environmental Impact Statement

(EIS)and Public Scoping Meeting SUMMARY: The General Services Administration

(GSA)announces its intent to prepare an Environmental Impact Statement

(EIS)for the expansion/renovation of the Calexico West Port of Entry (POE), located in Calexico, California. The purpose of the expansion/renovation is to reduce traffic congestion in Calexico and Mexicali city centers caused by vehicles crossing the border, to improve border security; and to provide safe, secure, and efficient operational areas for the public and Federal employees. This facility serves both vehicular and pedestrian traffic into and out of the Mexican city of Mexicali. The need for this expansion/renovation derives from the substantial increase in its use by international travelers. The existing POE is not equipped to process this increase within an acceptable level of service consistent with the Federal Inspection Service's minimum standards. Problems at the current facility are mostly related to inadequate space for inspection operations, equipment, and personnel. The facility also requires seismic retrofitting. The EIS will address potential environmental impacts of the alternatives for the proposed project related to geology and soils, water resources, land use, biological resources, cultural resources, visual resources, infrastructure, traffic, air quality, noise, human health and safety, socioeconomics, and environmental justice. The existing contamination of the New River and traffic congestion have been identified as potential environmental impacts. Information regarding other potential environmental impacts will be gathered during the public scoping process. DATES: The views and comments of the public are necessary in determining the scope and content of the environmental analysis in connection with the proposed project. A public scoping meeting for the proposed project will be held on Wednesday, March 8, 2006 from 3 to 6 p.m. at the Calexico City Hall, 608 Heber Avenue in Calexico, California. Interested parties may attend to present questions and concerns that they believe should be addressed in the EIS. Comments and questions can also be submitted to the Point of Contact (see the ADDRESS section below). Due to time limits mandated by Federal law, responses to scoping are requested no later than 45 days after publication of this notice. It is anticipated that the Draft EIS will be available for public review and comment in January of 2007. ADDRESSES: Submit comments and questions to Mr. Morris Angell, Regional Environmental Quality Advisor, 450 Golden Gate Avenue, 3rd Floor East, San Francisco, California, 94102, 415-522-3473, *morris.angell@gsa.gov* . FOR FURTHER INFORMATION CONTACT: If you require additional information regarding the public scoping meeting or the proposed project, or require special assistance to attend the meeting, please contact Morris Angell, GSA Regional Environmental Quality Advisor, (see the ADDRESS section above). SUPPLEMENTARY INFORMATION: GSA is proposing two alternative actions: 1) construct a new vehicle and pedestrian inspection facility on the existing site and federally owned vacant land immediately to the west of the current facility, and 2) a “no action” alternative. Under the “no action” alternative, the existing facilities and their operation will remain unchanged. Dated: February 10, 2006. Peter G. Stamison, Regional Administrator, Public Buildings Service, Pacific Rim Region. Dated: February 10, 2006. Jeffrey Neely, Assistant Regional Administrator, Public Buildings Service, Pacific Rim Region. [FR Doc. E6-2694 Filed 2-24-06; 8:45 am] BILLING CODE 6820-YF-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-06-0428] 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 404-639-5960 and send comments to Seleda Perryman, CDC Assistant 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 PHS Supplements to the Application for Federal Assistance SF-424 (0920-0428)—Revision—Office of the Director (OD), Centers for Disease Control and Prevention

(CDC)is requesting a three-year extension for continued use of the Supplements to the Request for Federal Assistance Application (SF-424). Background and Brief Description The Checklist, Program Narrative, and the Public Health System Impact Statement (third party notification) (PHSIS) are a part of the standard application for State and local governments and for private non-profit and for-profit organizations when applying for financial assistance from PHS grant programs. The Checklist assists applicants to ensure that they have included all required information necessary to process the application. The Checklist data helps to reduce the time required to process and review grant applications, expediting the issuance of grant awards. The PHSIS Third Party Notification Form is used to inform State and local health agencies of community-based proposals submitted by non-governmental applicants for Federal funding. There may be some revisions made to one or more of the forms to allow the respondents easy web-base access. This should not affect the current burden. There is no cost to the respondents other than their time. Estimate of Annualized Burden Table Respondents Number of respondents Number of responses/ respondent Average burden/ response (in hrs.) Total burden (in hrs.) State and local health departments; non-profit and for-profit organizations 7,457 1 5.7255 42,695 Total 42,695 Dated: February 21, 2006. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E6-2709 Filed 2-24-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-06-0463] 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)639-4766 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 Longitudinal Surveillance for Beryllium Disease Prevention—0920-0463—Extension—National Institute for Occupational Safety and Health (NIOSH)—Centers for Disease Control and Prevention (CDC). Background and Brief Description The mission of the National Institute for Occupational Safety and Health (NIOSH) is to promote safety and health at work for all people through research and prevention. The Occupational Safety and Health Act, Public Law 91-596 (section 20[a][1]) authorizes the National Institute for Occupational Safety and Health (NIOSH) to conduct research to advance the health and safety of workers. NIOSH is conducting a study of beryllium workers. Beryllium is a lightweight metal with many applications. Exposed workers may be found in the primary production, nuclear power and weapons, aerospace, scrap metal reclamation, specialty ceramics, and electronics industries, among others. The size of the U.S. workforce at risk of chronic beryllium disease (CBD), from either current or past work-related exposure to the metal, may be as high as one million. Demand for beryllium is growing worldwide, which means that increasing numbers of workers are likely to be exposed. CBD is a chronic granulomatous lung disease mediated through an immunologic mechanism in workers who become sensitized to the metal. Sensitization can be detected with a blood test called the beryllium lymphocyte proliferation test (BeLPT), which is used by the industry as a surveillance tool. Use of this test for surveillance was first reported in 1989. Sensitized workers, identified through workplace surveillance programs, undergo clinical diagnostic tests to determine whether they have CBD. Research has indicated certain genetic determinants in the risk of CBD; follow-up studies will be invaluable for further characterizing the genetic contribution to sensitization and disease. NIOSH is in a unique position to accomplish this research for a number of reasons:

(a)It has a successful collaboration with the leading manufacturer of beryllium in the US. This has allowed us to establish well-characterized worker cohorts within the beryllium industry.

(b)It is conducting industrial hygiene research that should significantly improve workplace-based exposure assessment methods. This research will allow characterization of jobs and tasks by physicochemical characteristics, leading to an estimation of dose rather than mass concentration-based exposure.

(c)It has pioneered the evaluation of the dermal exposure route in the beryllium sensitization process.

(d)It has developed and improved genetic research that will contribute to the understanding of risk variability in sensitization and disease, as well as discerning the underlying mechanisms.

(e)NIOSH has the institutional stability to continue longitudinal evaluations of health outcomes in relation to exposure and genetic risk factors. NIOSH has been conducting this survey of beryllium workers for three years and this extension will allow for completion of the data collection on former workers. Workers are asked to complete an interviewer administered medical and work history questionnaire and to give a blood sample. Without medical and work history data on former workers, NIOSH staff will be unable to conduct the necessary research to make recommendations for preventing beryllium sensitization and disease. Follow-up on this cohort will provide invaluable information on the natural history of disease, gene-gene, and gene-environment interactions, which can become the basis for prevention policy at both company and government levels. There are no costs to the respondents other than their time. The only change to this previously approved project is a decrease in the burden hours because the proposed data collection is almost complete. The total estimated annualized burden hours are 50. Estimated Annualized Burden Hours Respondents Number of respondents Number of responses per respondent Average burden per response (in hours) Former Workers 100 1 30/60 Dated: February 21, 2006. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. 1 [FR Doc. E6-2710 Filed 2-24-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N-0443] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Focus Groups as Used by the Food and Drug Administration AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a proposed collection of information has been submitted to the Office of Management and Budget

(OMB)for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by March 29, 2006. ADDRESSES: OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for FDA, FAX: 202-395-6974. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Focus Groups as Used by the Food and Drug Administration—(OMB Control Number 0910-0497)—Extension FDA will collect and use information gathered through the focus group vehicle. This information will be used to develop programmatic proposals, and as such, compliments other important research findings to develop these proposals. Focus groups do provide an important role in gathering information because they allow for a more in-depth understanding of consumers' attitudes, beliefs, motivations, and feelings than do quantitative studies. Also, information from these focus groups will be used to develop policy and redirect resources, when necessary, to our constituents. If this information is not collected, a vital link in information gathering by FDA to develop policy and programmatic proposals will be missed causing further delays in policy and program development. In the **Federal Register** of November 25, 2005 (FR 70 71165), FDA published a 60-day notice requesting public comment on the information collection provisions. FDA received one comment, however it was not related to the information collection. Annually, FDA projects about 28 focus group studies using 286 focus groups lasting an average of 1.78 hours each. FDA has allowed burden for unplanned focus groups to be completed so as not to restrict the agency's ability to gather information on public sentiment for its proposals in its regulatory as well as other programs. To arrive at each center's estimated burden we multiplied the number of focus groups per study by the number of participants per group. ( *e.g.,* Center for Biologics Evaluation and Research (CBER): 5x9=45). We multiplied that total by the hours of duration for each group to arrive at the total burden hours. ( *e.g.,* CBER: 45x1.58=71.1). The total annual estimated burden imposed by this collection of information is 4,252 hours annually. FDA estimates the burden of this collection of information as follows: Table 1.—Estimated Annual Reporting Burden 1 FDA Center Subject No. of Focus Groups per Study No. of Focus Groups Sessions Conducted Annually No. of Participants per Group Hours of Duration for Each Group (Includes Screening) Total Hours Center for Biologics Evaluation and Research May use focus groups when appropriate 1 5 9 1.58 71 Center for Drug Evaluation and Research Varies ( *e.g.,* direct-to-consumer Rx drug promotion, physician labeling of Rx drugs, medication guides, over-the-counter drug labeling, risk communication) 10 200 9 1.58 2,844 Center for Devices and Radiological Health Varies ( *e.g.,* FDA Seal of Approval, patient labeling, tampons, on-line sales of medical products, latex gloves) 4 16 9 2.08 300 Center for Food Safety and Applied Nutrition Varies ( *e.g.,* food safety, nutrition, dietary supplements, and consumer education) 8 40 9 1.58 569 Center for Veterinary Medicine Varies ( *e.g.,* animal nutrition, supplements, labeling of animal Rx) 5 25 9 2.08 468 Total 28 286 1.78 4,252 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: February 21, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-2726 Filed 2-24-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0080] Agency Information Collection Activities; Proposed Collection; Comment Request; Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition 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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the labeling requirements for aluminum content in large volume parenterals (LVPs), small volume parenterals (SVPs), and pharmacy bulk packages

(PBPs)used in total parenteral nutrition (TPN). DATES: Submit written or electronic comments on the collection of information by April 28, 2006. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* . 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: Karen Nelson, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482. 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, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics:

(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;

(2)the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

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

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition—21 CFR 201.323 (OMB Control Number 0910-0439)—Extension FDA is requesting OMB approval under the PRA for the labeling requirements for aluminum content in LVPs, SVPs, and PBPs used in TPN. As explained in the final rule on aluminum content labeling requirements published in the **Federal Register** of January 26, 2000 (65 FR 4103) (the January 2000, final rule), aluminum content in parenteral drug products could result in a toxic accumulation of aluminum in the tissues of individuals receiving TPN therapy. Research indicates that neonates and patient populations with impaired kidney function may be at high risk of exposure to unsafe amounts of aluminum. Studies show that aluminum may accumulate in the bone, urine, and plasma of infants receiving TPN. Many drug products used routinely in parenteral therapy may contain levels of aluminum sufficiently high to cause clinical manifestations. Generally, when medication and nutrition are administered orally, the gastrointestinal tract acts as an efficient barrier to the absorption of aluminum, and relatively little ingested aluminum actually reaches body tissues. However, parenterally administered drug products containing aluminum bypass the protective mechanism of the gastrointestinal tract, and aluminum circulates and is deposited in human tissues. Aluminum toxicity is difficult to identify in infants because few reliable techniques are available to evaluate bone metabolism in premature infants. Techniques used to evaluate the effects of aluminum on bone in adults cannot be used in premature infants. Although aluminum toxicity is not commonly detected clinically, it can be serious in selected patient populations, such as neonates, and may be more common than is recognized. FDA amended its regulations to add labeling requirements for aluminum content in LVPs, SVPs, and PBPs used in TPN. FDA specified an upper limit of aluminum permitted in LVPs and required applicants to submit to FDA validated assay methods for determining aluminum content in parenteral drug products. The agency added these requirements because of evidence linking the use of parenteral drug products containing aluminum to morbidity and mortality among patients on TPN therapy, especially among premature neonates and patients with impaired kidney function. The information collection reporting requirements are as follows: Section 201.323(b) (21 CFR 201.323(b)) requires that the package insert of all large volume parenterals used in total parenteral nutrition therapy state that the drug product contains no more than 25 micrograms (μg)/liter (L). This information must be contained in the “Precautions” section of the labeling of all LVPs used in TPN therapy. Section 201.323(c) (21 CFR 201.323(c)) requires that the maximum level of aluminum present at expiry be stated on the immediate container label of all SVP drug products and PBPs used in the preparation of TPN solutions. The aluminum content must be stated as prescribed in the regulation. The immediate container label of all SVP drug products and PBPs that are lyophilized powders used in the preparation of TPN solutions must contain the statement prescribed in the regulation. Section 201.323(d) (21 CFR 201.323(d)) requires that the package insert for all LVPs, SVPs, and PBPs used in TPN contain a warning statement, prescribed in the regulation, intended for patients with impaired kidney function and for neonates receiving TPN therapy. This information must be contained in the “Warnings” section of the labeling. Section 201.323(e) (21 CFR 201.323(e)) requires that applicants and manufacturers must use validated assay methods to determine the aluminum content in parenteral drug products. The assay methods must comply with current good manufacturing practice requirements. Applicants must submit to FDA both validation of the method used and release data for several batches. Manufacturers of parenteral drug products not subject to an approved application must make assay methodology available to FDA during inspections. Holders of pending applications must submit an amendment to the application. Compliance with the information collection burdens under § 201.323(b), (c), and

(d)consists of submitting application supplements to FDA containing the revised labeling for each product, and analytical method validation must be submitted under § 201.323(e). During the period since the publication of the January 2000, final rule, FDA has received approximately 100 supplements and analytical method validation from approximately four respondents. Because the final rule was effective on July 26, 2004, FDA expects to receive fewer submissions per year. FDA estimates that it will take approximately 14 hours to prepare and submit to FDA each submission. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 201.323(b),(c),(d) 4 1.25 5 14 70 201.323(e) 4 1.25 5 14 70 Total 140 1 There are no capital costs or operating and maintenance costs associated with this collection. Dated: February 21, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-2727 Filed 2-24-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency Open Meeting of the Federal Interagency Committee on Emergency Medical Services (FICEMS) AGENCY: Federal Emergency Management Agency (FEMA), Department of Homeland Security. ACTION: Notice of open meeting. SUMMARY: FEMA announces the following open meeting. *Name:* Federal Interagency Committee on Emergency Medical Services (FICEMS). *Date of Meeting:* March 2, 2006. *Place:* 10th Floor MacCracken Room, FAA Building, 800 Independence Ave SW., Washington, DC 20591. *Times:* 10:30 a.m.—Main FICEMS Meeting; 1 p.m.—FICEMS Ambulance Safety Subcommittee. *Proposed Agenda:* Review and submission for approval of previous FICEMS Committee Meeting Minutes; Ambulance Safety Subcommittee Meeting Minutes; Action Items review; presentation of member agency reports; and reports of other interested parties. SUPPLEMENTARY INFORMATION: This meeting will be open to the public with limited seating available on a first-come, first-served basis. See the Response and Security Procedures below. *Response Procedures:* Committee Members and members of the general public who plan to attend the meeting should contact Mr. Mike McKay, on or before Tuesday, February 28, 2006, via mail at NATEK Incorporated, 21355 Ridgetop Circle, Suite 200, Dulles, Virginia 20166-8503, or by telephone at

(703)674-0190, or via facsimile at

(703)674-0195, or via e-mail at *mmckay@natekinc.com.* This is necessary to be able to create and provide a current roster of visitors to FAA Security per directives. *Security Procedures:* All visitors must have a valid picture identification card and their vehicles will be subject to search by Security personnel. All visitors will be issued a visitor pass which must be worn at all times while in the facility. Please allow adequate time before the meeting to complete the security process. *Conference Call Capabilities:* If you are not able to attend in person, a toll free number has been set up for teleconferencing. The toll free number will be available from 10 a.m. until 4 p.m. Members should call in around 10:30 a.m. The number is 1-800-320-4330. The FICEMS conference code is “361352#,” which is different. *FICEMS Meeting Minutes:* Minutes of the meeting will be prepared and will be available upon request 30 days after they have been approved at the next FICEMS Committee Meeting. The minutes will also be posted on the United States Fire Administration Web site at *http://www.usfa.fema.gov/fire-service/ems/ficems.shtm* within 30 days after their approval at the next FICEMS Committee Meeting. Dated: February 23, 2006. R. David Paulison, Acting Director, Federal Emergency Management Agency, Department of Homeland Security. [FR Doc. E6-2718 Filed 2-24-06; 8:45 am] BILLING CODE 9110-17-P DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services Agency Information Collection Activities: Extension of a Currently Approved Information Collection; Comment Request ACTION: 30-Day Notice of Information Collection Under Review; Contacts Concerning Project Speak Out, Form G-1046; OMB Control Number 1615-0074. The Department of Homeland Security, U.S. Citizenship and Immigration Services (USCIS) has submitted the following information collection request to the Office of Management and Budget

(OMB)for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection was previously published in the **Federal Register** on December 23, 2005, at 70 FR 76322. The notice allowed for a 60-day public comment period. No comments were received on this information collection. The purpose of this notice is to allow an additional 30 days for public comments. Comments are encouraged and will be accepted until March 29, 2006. This process is conducted in accordance with 5 CFR 1320.10. Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the Department of Homeland Security (DHS), USCIS, Director, Regulatory Management Division, Clearance Office, 111 Massachusetts Avenue, 3rd floor, Washington, DC 20529. Comments may also be submitted to DHS via facsimile to 202-272-8352 or via e-mail at *rfs.regs@dhs.gov* . When submitting comments by e-mail please make sure to add OMB Control Number 1615-0074 in the subject box. Written comments and suggestions from the public and affected agencies should address one or more of the following four points:

(1)Evaluate whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(2)Evaluate the accuracy of the agencies estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;

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

(4)Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Overview of This Information Collection

(1)*Type of Information Collection:* Extension of a currently approved information collection.

(2)*Title of the Form/Collection:* Contacts Concerning Project Speak Out.

(3)*Agency form number, if any, and the applicable component of the Department of Homeland Security sponsoring the collection:* Form G-1046; U.S. Citizenship and Immigration Services.

(4)*Affected public who will be asked or required to respond, as well as a brief abstract: Primary:* Individuals or households; Not-for-profit institutions. This form provides a standardized way of recording the number of individuals contacting the Community Based Organizations concerning the practitioner fraud pilot program. The USCIS will use the information collected on the form to determine how many persons are served by the program and if its public outreach efforts are successful.

(5)*An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond:* 6,000 responses at 42 minutes per response, plus 600 submissions at 10 minutes per submission.

(6)*An estimate of the total public burden (in hours) associated with the collection:* 4,300 annual burden hours. If you have additional comments, suggestions, or need a copy of the proposed information collection instrument with instructions, or additional information, please visit the USCIS Web site at: *http://uscis.gov/graphics/formsfee/forms/pra/index.htm* . If additional information is required contact: USCIS, Regulatory Management Division, 111 Massachusetts Avenue, 3rd Floor, Washington, DC 20529,

(202)272-8377. Dated: February 21, 2006. Richard A. Sloan, Director, Regulatory Management Division, U.S. Citizenship and Immigration Services. [FR Doc. 06-1762 Filed 2-24-06; 8:45 am]

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