Rules and Regulations. Notice of filing dates for special election
14,265 words·~65 min read·
/register/2008/03/05/08-936A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 1610-01-M FEDERAL ELECTION COMMISSION [Notice 2008-6] Filing Dates for the Mississippi Special Election In the 1st Congressional District AGENCY: Federal Election Commission. ACTION: Notice of filing dates for special election. SUMMARY: Mississippi has scheduled a Special General Election on April 22, 2008, to fill the U.S. House of Representatives seat in the First Congressional District formerly held by Senator Roger Wicker. Under Mississippi law, a majority winner in a nonpartisan special election is declared elected.
Should no candidate achieve a majority vote, a Special Runoff Election will be held on May 13, 2008, between the top two vote-getters in the Special General Election. Committees participating in the Mississippi special elections are required to file pre- and post-election reports. Filing dates for these reports are affected by whether one or two elections are held. FOR FURTHER INFORMATION CONTACT: Mr. Kevin R. Salley, Information Division, 999 E Street, NW., Washington, DC 20463;
Telephone:
(202)694-1100; Toll Free
(800)424-9530. SUPPLEMENTARY INFORMATION: Principal Campaign Committees All principal campaign committees of candidates who participate in the Mississippi Special General and Special Runoff Elections shall file a 12-day Pre-General Report on April 10, 2008; a Pre-Runoff Report on May 1, 2008; and a Post-Runoff Report on June 12, 2008. (See chart below for the closing date for each report.) If only one election is held, all principal campaign committees of candidates in the Special General Election shall file a 12-day Pre-General Report on April 10, 2008; and a Post-General Report on May 22, 2008. (See chart below for the closing date for each report.) Unauthorized Committees (PACs and Party Committees) Political committees filing on a quarterly basis in 2008 are subject to special election reporting if they make previously undisclosed contributions or expenditures in connection with the Mississippi Special General or Special Runoff Election by the close of books for the applicable report(s). (See chart below for the closing date for each report.) Committees filing monthly that support candidates in the Mississippi Special General or Special Runoff Election should continue to file according to the monthly reporting schedule. Additional disclosure information in connection with the Mississippi Special Election may be found on the FEC Web site at *http://www.fec.gov/info/report_dates.shtml* . Calendar of Reporting Dates for Mississippi Special Election Report Close of books 1 Reg./Cert. & overnight mailing deadline Filing deadline If only the special general is held (04/22/08), committees involved must file: April Quarterly —Waived— Pre-General 04/02/08 04/07/08 04/10/08 Post-General 05/12/08 05/22/08 05/22/08 July Quarterly 06/30/08 07/15/08 07/15/08 If two elections are held, committees involved only in the special general (04/22/08) must file: April Quarterly —Waived— Pre-General 04/02/08 04/07/08 04/10/08 July Quarterly 06/30/08 07/15/08 07/15/08 Committees involved in the special general (04/22/08) and special runoff (05/13/08) must file: April Quarterly —Waived— Pre-General 04/02/08 04/07/08 04/10/08 Pre-Runoff 04/23/08 04/28/08 05/01/08 Post-Runoff 06/02/08 06/12/08 06/12/08 July Quarterly 06/30/08 07/15/08 07/15/08 Committees involved only in the special runoff (05/13/08) must file: Pre-Runoff 04/23/08 04/28/08 05/01/08 Post-Runoff 06/02/08 06/12/08 06/12/08 July Quarterly 06/30/08 07/15/08 07/15/08 1 The reporting period always begins the day after the closing date of the last report filed. If the committee is new and has not previously filed a report, the first report must cover all activity that occurred before the committee registered up through the close of books for the first report due. Dated: February 28, 2008. David M. Mason, Chairman, Federal Election Commission. [FR Doc. E8-4184 Filed 3-4-08; 8:45 am] BILLING CODE 6715-01-P FEDERAL MARITIME COMMISSION Notice of Agreements Filed The Commission hereby gives notice of the filing of the following agreements under the Shipping Act of 1984. Interested parties may submit comments on agreements to the Secretary, Federal Maritime Commission, Washington, DC 20573, within ten days of the date this notice appears in the **Federal Register** . Copies of agreements are available through the Commission's Office of Agreements (202-523-5793 or *tradeanalysis@fmc.gov* ). *Agreement No.:* 010099-047. *Title:* International Council of Containership Operators. *Parties:* A.P. Moller-Maersk A/S; ANL Container Line Pty Ltd.; American President Lines, Ltd.; APL Co. Pte. Ltd.; APL Ltd.; Atlantic Container Line AB; China Shipping Container Lines Co., Ltd.; CMA CGM, S.A.; Companhia Libra de Navegacao; Compania Libra de Navegacion Uruguay S.A.; COSCO Container Lines Co. Ltd; Crowley Maritime Corporation; Delmas SAS; Evergreen Marine Corporation (Taiwan), Ltd.; Hamburg-Süd KG; Hanjin Shipping Co., Ltd.; Hapag-Lloyd AG; Hapag-Lloyd USA LLC; Hyundai Merchant Marine Co., Ltd.; Kawasaki Kisen Kaisha, Ltd.; MISC Berhad; Mediterranean Shipping Co. S.A.; Mitsui O.S.K. Lines, Ltd.; Neptune Orient Lines, Ltd.; Nippon Yusen Kaisha; Norasia Container Line Ltd.; Orient Overseas Container Line, Ltd.; Pacific International Lines
(Pte)Ltd.; Safmarine Container Line N.V.; United Arab Shipping Company (S.A.G.); Wan Hai Lines Ltd.; Yang Ming Transport Marine Corp.; and Zim Integrated Shipping Services Ltd. *Filing Party:* John Longstreth, Esq.; Kirkpatrick & Lockhart Preston Gates Ellis LLP; 1601 K Street, NW., Washington, DC 20006-1600. *Synopsis:* The amendment changes Malaysia International Shipping Corporation's corporate name to MISC Berhad. *Agreement No.:* 012029. *Title:* MSC/Crowley Bahamas Space Charter Agreement. *Parties:* Crowley Liner Service, Inc. and Mediterranean Shipping Co. S.A. *Filing Party:* Wayne R. Rohde, Esq.; Sher & Blackwell LLP; 1850 M Street, NW., Suite 900, Washington, DC 20036. *Synopsis:* The agreement authorizes the parties to charter space to and from one another between ports in Florida and ports in the Bahamas. *Agreement No.:* 012030. *Title:* GWF/Maruba Space Charter Agreement. *Parties:* Empresa de Navegacion Maruba S.A. and Great White Fleet Ltd. (“GWF”). *Filing Party:* Wade S. Hooker, Esq.; 211 Central Park W; New York, NY 20573. *Synopsis:* The agreement authorizes Maruba to charter space in the trade on GWF vessels between ports in Florida and ports in Guatemala and Honduras. By Order of the Federal Maritime Commission. Dated: February 29, 2008. Karen V. Gregory, Assistant Secretary. [FR Doc. E8-4252 Filed 3-4-08; 8:45 am] BILLING CODE 6730-01-P FEDERAL RESERVE SYSTEM Federal Open Market Committee; Domestic Policy Directive of January 29-30, 2008 In accordance with § 271.25 of its rules regarding availability of information (12 CFR part 271), there is set forth below the domestic policy directive issued by the Federal Open Market Committee at its meeting held on January 29-30, 2008. 1 1 Copies of the Minutes of the Federal Open Market Committee meeting on January 29-30, 2008, which includes the domestic policy directive issued at the meeting, are available upon request to the Board of Governors of the Federal Reserve System, Washington, D.C. 20551. The minutes are published in the Federal Reserve Bulletin and in the Board's annual report. The Federal Open Market Committee seeks monetary and financial conditions that will foster price stability and promote sustainable growth in output. To further its long-run objectives, the Committee in the immediate future seeks conditions in reserve markets consistent with reducing the federal funds rate at an average of around 3 1/2 percent. By order of the Federal Open Market Committee, February 26, 2008. Brian F. Madigan, Secretary, Federal Open Market Committee. [FR Doc. E8-4230 Filed 3-4-08; 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 applications 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 31, 2008. **A. Federal Reserve Bank of Kansas City** (Todd Offenbacker, Assistant Vice President) 925 Grand Avenue, Kansas City, Missouri 64198-0001: *1. First Liberty Capital Corporation Employee Stock Ownership Plan and First Liberty Capital Corporation* , both of Hugo, Colorado; to acquire up to 100 percent of the voting shares of First Mountain Bank, Leadville. Board of Governors of the Federal Reserve System, February 29, 2008. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E8-4211 Filed 3-4-08; 8:45 am] BILLING CODE 6210-01-S FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies; Correction This notice corrects a notice (FR Doc. E8-3313) published on page 9806 of the issue for Friday, February 22, 2008. Under the Federal Reserve Bank of New York heading, the entry for Tompkins Financial Corporation, Ithaca, New York, is revised to read as follows: **A. Federal Reserve Bank of New York** (Anne MacEwen, Bank Applications Officer) 33 Liberty Street, New York, New York 10045-0001: *1. Tompkins Financial Corporation* , Ithaca, New York; to acquire and thereby merge with Sleepy Hollow Bancorp Inc., and thereby indirectly acquire voting shares of Sleepy Hollow Bank, both of Sleepy Hollow, New York. Comments on this application must be received by March 20, 2008. Board of Governors of the Federal Reserve System, February 29, 2008. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E8-4212 Filed 3-4-08 8:45 am] BILLING CODE 6210-01-S FEDERAL TRADE COMMISSION [File No. 072 3210] American Cash Market, Inc.; 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 31, 2008. ADDRESSES: Interested parties are invited to submit written comments. Comments should refer to “American Cash Market, File No. 072 3210,” 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-AmericanCashMarket* . 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 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: Cara Peterson or Quisaira Whitney, FTC Bureau of Consumer Protection, 600 Pennsylvania Avenue, NW, Washington, D.C. 20580,
(202)326-3224. 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/2008/02/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 The Federal Trade Commission has accepted, subject to final approval, an agreement containing a consent order from American Cash Market, Inc. (“respondent”). The proposed consent order has been placed on the public record for thirty
(30)days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty
(30)days, the Commission will again review the agreement and the comments received, and will decide whether it should withdraw from the agreement or make final the agreement’s proposed order. Respondent engaged in practices that violate Section 144 of the Truth in Lending Act (“TILA”), 15 U.S.C. § 1664, and Section 226.24(c) of its implementing Regulation Z, 12 C.F.R. § 226.24(c). Respondent disseminated payday loan advertisements on the Internet stating the number of payments or period of repayment, or the amount of a finance charge, as terms for obtaining a payday loan. These advertisements failed, however, to disclose the “annual percentage rate” or “APR” for these loans as required by TILA and its implementing Regulation Z. TILA and Regulation Z require that advertisers, including payday loan advertisers, disclose APRs on their loans to assist consumers in comparison shopping. The respondent’s failure to disclose the APR for its advertised payday loans undermined consumers’ ability to compare these loans to those offered by other payday lenders. The respondent’s failure to disclose the APR for its advertised payday loans also frustrated consumers’ ability to compare these loans to alternative forms of credit. Through its law enforcement actions the Commission intends to promote compliance with the APR disclosure requirements of TILA and Regulation Z, thereby promoting comparison shopping relating to payday loans. The proposed consent order contains provisions designed to prevent respondent from failing to make disclosures required by TILA and Regulation Z in the future. Part I.A. of the proposed order prohibits respondent, in connection with any advertisement of consumer credit, from stating the amount or percentage of any down payment, the number of payments or period of repayment, the amount of any payment, or the amount of any finance charge, without disclosing clearly and conspicuously all of the terms required by TILA and Regulation Z, including the amount or percentage of the down payment, the terms of repayment, and the annual percentage rate, using that term or the abbreviation “APR.” Part I.B. of the proposed order prohibits respondent from stating a rate of finance charge without stating the rate as an “annual percentage rate” or the abbreviation “APR.” Part I.C. of the proposed order prohibits respondent from failing to comply in any other respect with TILA or Regulation Z. Part II of the proposed order contains a document retention requirement, the purpose of which is to ensure compliance with the proposed order. It requires that respondent maintain all records that will demonstrate compliance with the proposed order. Part III of the proposed order requires respondent to distribute copies of the order to various principals, officers, directors, and managers, and all current and future employees, agents and representatives having responsibilities with respect to the subject matter of the order. Part IV of the proposed order requires respondent to notify the Commission of any changes in its corporate structure that might affect compliance with the order. Part V of the proposed order requires respondent to file with the Commission one or more reports detailing compliance with the order. Part VI of the proposed order is a “sunset” provision, dictating the conditions under which the order will terminate twenty years from the date it is issued or twenty years after a complaint is filed in federal court, by either the United States or the FTC, alleging any violation of the order. The purpose of this analysis is to facilitate public comment on the proposed order, and it is not intended to constitute an official interpretation of the agreement and proposed order or to modify in any way their terms. By direction of the Commission. Donald S. Clark, Secretary. [FR Doc. E8-4304 Filed 3-4-08: 8:45 am] BILLING CODE 6750-01-S FEDERAL TRADE COMMISSION [File No. 072 3212] Anderson Payday Loans; 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 31, 2008. ADDRESSES: Interested parties are invited to submit written comments. Comments should refer to “Anderson Payday Loans, File No. 072 3212,” 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-AndersonPaydayLoans* . 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.htm* . FOR FURTHER INFORMATION CONTACT: Cara Peterson or Quisaira Whitney, FTC Bureau of Consumer Protection, 600 Pennsylvania Avenue, NW, Washington, D.C. 20580,
(202)326-3224. 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/2008/02/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 The Federal Trade Commission has accepted, subject to final approval, an agreement containing a consent order from Anderson Payday Loans (“respondent”). The proposed consent order has been placed on the public record for thirty
(30)days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty
(30)days, the Commission will again review the agreement and the comments received, and will decide whether it should withdraw from the agreement or make final the agreement’s proposed order. Respondent engaged in practices that violate Section 144 of the Truth in Lending Act (“TILA”), 15 U.S.C. § 1664, and Section 226.24(c) of its implementing Regulation Z, 12 C.F.R. § 226.24(c). Respondent disseminated payday loan advertisements on the Internet stating the number of payments or period of repayment, or the amount of a finance charge, as terms for obtaining a payday loan. These advertisements failed, however, to disclose the “annual percentage rate” or “APR” for these loans as required by TILA and its implementing Regulation Z. TILA and Regulation Z require that advertisers, including payday loan advertisers, disclose APRs on their loans to assist consumers in comparison shopping. The respondent’s failure to disclose the APR for its advertised payday loans undermined consumers’ ability to compare these loans to those offered by other payday lenders. The respondent’s failure to disclose the APR for its advertised payday loans also frustrated consumers’ ability to compare these loans to alternative forms of credit. Through its law enforcement actions the Commission intends to promote compliance with the APR disclosure requirements of TILA and Regulation Z, thereby promoting comparison shopping relating to payday loans. The proposed consent order contains provisions designed to prevent respondent from failing to make disclosures required by TILA and Regulation Z in the future. Part I.A. of the proposed order prohibits respondent, in connection with any advertisement of consumer credit, from stating the amount or percentage of any down payment, the number of payments or period of repayment, the amount of any payment, or the amount of any finance charge, without disclosing clearly and conspicuously all of the terms required by TILA and Regulation Z, including the amount or percentage of the down payment, the terms of repayment, and the annual percentage rate, using that term or the abbreviation “APR.” Part I.B. of the proposed order prohibits respondent from stating a rate of finance charge without stating the rate as an “annual percentage rate” or the abbreviation “APR.” Part I.C. of the proposed order prohibits respondent from failing to comply in any other respect with TILA or Regulation Z. Part II of the proposed order contains a document retention requirement, the purpose of which is to ensure compliance with the proposed order. It requires that respondent maintain all records that will demonstrate compliance with the proposed order. Part III of the proposed order requires respondent to distribute copies of the order to various principals, officers, directors, and managers, and all current and future employees, agents and representatives having responsibilities with respect to the subject matter of the order. Part IV of the proposed order requires respondent to notify the Commission of any changes in its corporate structure that might affect compliance with the order. Part V of the proposed order requires respondent to file with the Commission one or more reports detailing compliance with the order. Part VI of the proposed order is a “sunset” provision, dictating the conditions under which the order will terminate twenty years from the date it is issued or twenty years after a complaint is filed in federal court, by either the United States or the FTC, alleging any violation of the order. The purpose of this analysis is to facilitate public comment on the proposed order, and it is not intended to constitute an official interpretation of the agreement and proposed order or to modify in any way their terms. By direction of the Commission. Donald S. Clark, Secretary. [FR Doc. E8-4303 Filed 3-4-08: 8:45 am] BILLING CODE 6750-01-S FEDERAL TRADE COMMISSION [File No. 072 3203] Cash Pro d/b/a MakePaydayToday.com; 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 31, 2008 ADDRESSES: Interested parties are invited to submit written comments. Comments should refer to “Cash Pro, File No. 072 3203,” 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-CashPro* . 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.htm* . FOR FURTHER INFORMATION CONTACT: Cara Peterson or Quisaira Whitney, FTC Bureau of Consumer Protection, 600 Pennsylvania Avenue, NW, Washington, D.C. 20580,
(202)326-3224. 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/2008/02/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 The Federal Trade Commission has accepted, subject to final approval, an agreement containing a consent order from CashPro d/b/a MakePaydayToday.com (“respondent”). The proposed consent order has been placed on the public record for thirty
(30)days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty
(30)days, the Commission will again review the agreement and the comments received, and will decide whether it should withdraw from the agreement or make final the agreement’s proposed order. Respondent engaged in practices that violate Section 144 of the Truth in Lending Act (“TILA”), 15 U.S.C. § 1664, and Section 226.24(c) of its implementing Regulation Z, 12 C.F.R. § 226.24(c). Respondent disseminated payday loan advertisements on the Internet stating the number of payments or period of repayment, or the amount of a finance charge, as terms for obtaining a payday loan. These advertisements failed, however, to disclose the “annual percentage rate” or “APR” for these loans as required by TILA and its implementing Regulation Z. TILA and Regulation Z require that advertisers, including payday loan advertisers, disclose APRs on their loans to assist consumers in comparison shopping. The respondent’s failure to disclose the APR for its advertised payday loans undermined consumers’ ability to compare these loans to those offered by other payday lenders. The respondent’s failure to disclose the APR for its advertised payday loans also frustrated consumers’ ability to compare these loans to alternative forms of credit. Through its law enforcement actions the Commission intends to promote compliance with the APR disclosure requirements of TILA and Regulation Z, thereby promoting comparison shopping relating to payday loans. The proposed consent order contains provisions designed to prevent respondent from failing to make disclosures required by TILA and Regulation Z in the future. Part I.A. of the proposed order prohibits respondent, in connection with any advertisement of consumer credit, from stating the amount or percentage of any down payment, the number of payments or period of repayment, the amount of any payment, or the amount of any finance charge, without disclosing clearly and conspicuously all of the terms required by TILA and Regulation Z, including the amount or percentage of the down payment, the terms of repayment, and the annual percentage rate, using that term or the abbreviation “APR.” Part I.B. of the proposed order prohibits respondent from stating a rate of finance charge without stating the rate as an “annual percentage rate” or the abbreviation “APR.” Part I.C. of the proposed order prohibits respondent from failing to comply in any other respect with TILA or Regulation Z. Part II of the proposed order contains a document retention requirement, the purpose of which is to ensure compliance with the proposed order. It requires that respondent maintain all records that will demonstrate compliance with the proposed order. Part III of the proposed order requires respondent to distribute copies of the order to various principals, officers, directors, and managers, and all current and future employees, agents and representatives having responsibilities with respect to the subject matter of the order. Part IV of the proposed order requires respondent to notify the Commission of any changes in its corporate structure that might affect compliance with the order. Part V of the proposed order requires respondent to file with the Commission one or more reports detailing compliance with the order. Part VI of the proposed order is a “sunset” provision, dictating the conditions under which the order will terminate twenty years from the date it is issued or twenty years after a complaint is filed in federal court, by either the United States or the FTC, alleging any violation of the order. The purpose of this analysis is to facilitate public comment on the proposed order, and it is not intended to constitute an official interpretation of the agreement and proposed order or to modify in any way their terms. By direction of the Commission. Donald S. Clark, Secretary. [FR Doc. E8-4302 Filed 3-4-08: 8:45 am] BILLING CODE 6750-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families State Median Income Estimate for a Four-Person Family: Notice of the Federal Fiscal Year
(FFY)2009 State Median Income Estimates for Use Under the Low Income Home Energy Assistance Program (LIHEAP) (CFDA Number 93.568) Administered by the U.S. Department of Health and Human Services (HHS), Administration for Children and Families, Office of Community Services, Division of Energy Assistance AGENCY: Administration for Children and Families, Office of Community Services, Division of Energy Assistance, HHS. ACTION: Notice of State median income estimates for FFY 2009. SUMMARY: This notice announces the estimated median income for four-person families in each State and the District of Columbia for FFY 2009 (October 1, 2008 to September 30, 2009). LIHEAP grantees may adopt the State median income estimates beginning with the date of publication in the **Federal Register** or at a later date as discussed below. This enables LIHEAP grantees to choose to implement this notice during the period between the heating and cooling seasons. However, by October 1, 2008, or the beginning of a grantee's fiscal year, whichever is later, LIHEAP grantees using State median income estimates must adjust their income eligibility criteria to be in accord with the FFY 2009 State median income estimates. This listing of estimated State median incomes provides one of the maximum income criteria that LIHEAP grantees may use in determining a household's income eligibility for LIHEAP. DATES: *Effective Date:* The estimates become effective at any time between the date of this publication and October 1, 2008, or the beginning of a LIHEAP grantee's fiscal year, whichever is later. FOR FURTHER INFORMATION CONTACT: Peter Edelman, Office of Community Services, Division of Energy Assistance, 5th Floor West, 370 L'Enfant Promenade, SW., Washington, DC 20447, Telephone:
(202)401-5292, *E-Mail: peter.edelman@acf.hhs.gov.* SUPPLEMENTARY INFORMATION: Under the provisions of section 2603(11) of Title XXVI of the Omnibus Budget Reconciliation Act of 1981, Public Law (Pub. L.) 97-35, as amended, HHS announces the estimated median income of a four-person family for each State, the District of Columbia, and the United States for FFY 2009 (October 1, 2008, through September 30, 2009). Section 2605(b)(2)(B)(ii) of the LIHEAP statute provides that 60 percent of the median income for each State, as annually established by the Secretary of Health and Human Services, is one of the income criteria that LIHEAP grantees may use in determining a household's eligibility for LIHEAP. LIHEAP was last authorized by the Energy Policy Act of 2005, PL 109-58, enacted on August 8, 2005. This authorization expired on September 30, 2007. Reauthorization of LIHEAP is pending. Estimates of the median income for a four-person family for each State and the District of Columbia for FFY 2009 have been produced by the U.S. Census Bureau, U.S. Department of Commerce. In developing these estimates, the U.S. Census Bureau used the most recently available income data, which was data from the 2006 American Community Survey (ACS). For additional information about the ACS State median income estimates, see *http://www.census.gov/hhes/www/income/medincsizeandstate.html* or contact the U.S. Census Bureau's Housing and Household Economic Statistics Division at
(301)763-3243. For additional information about the ACS in general, see *http://www.census.gov/acs/www/.* The State median income estimates, like those that derive from any survey, are subject to two types of errors:
(1)Nonsampling Error, which consists of random errors that increase the variability of the data and non-random errors that consistently direct the data into a specific direction; and
(2)Sampling Error, which consists of the error that arises from the use of probability sampling to create the sample. For additional information about the accuracy of the ACS State median income estimates, see *http://www.census.gov/acs/www/Downloads/ACS/accuracy2006.pdf.* A State-by-State listing of median income and 60 percent of median income for a four-person family for FFY 2009 follows. The listing describes the method for adjusting median income for families of different sizes as specified in regulations applicable to LIHEAP, at 45 CFR 96.85(b), published in the **Federal Register** on March 3, 1988 at 53 FR 6824. Dated: February 11, 2008. Josephine B. Robinson, Director, Office of Community Services. Estimated State Median Income for a Four-Person Family, by State, Federal Fiscal Year [(FFY) 2009 1 ] States Estimated state median income for a four-person family 2 60 percent of estimated State median income for a four-person family 3 Alabama $60,298 $36,179 Alaska 71,781 43,069 Arizona 65,050 39,030 Arkansas 52,185 31,311 California 74,801 44,881 Colorado 75,775 45,465 Connecticut 93,821 56,293 Delaware 78,321 46,993 District of Columbia 71,571 42,943 Florida 65,024 39,014 Georgia 66,711 40,027 Hawaii 84,472 50,683 Idaho 58,066 34,840 Illinois 75,484 45,290 Indiana 67,787 40,672 Iowa 67,792 40,675 Kansas 67,897 40,738 Kentucky 60,202 36,121 Louisiana 60,161 36,097 Maine 63,501 38,101 Maryland 94,017 56,410 Massachusetts 89,347 53,608 Michigan 72,591 43,555 Minnesota 81,477 48,886 Mississippi 52,992 31,795 Missouri 63,274 37,964 Montana 60,576 36,346 Nebraska 68,917 41,350 Nevada 66,095 39,657 New Hampshire 87,396 52,438 New Jersey 94,441 56,665 New Mexico 52,034 31,220 New York 75,513 45,308 North Carolina 61,420 36,852 North Dakota 67,560 40,536 Ohio 68,579 41,147 Oklahoma 55,031 33,019 Oregon 64,832 38,899 Pennsylvania 74,072 44,443 Rhode Island 78,189 46,913 South Carolina 59,663 35,798 South Dakota 63,508 38,105 Tennessee 60,143 36,086 Texas 59,808 35,885 Utah 63,586 38,152 Vermont 67,884 40,730 Virginia 78,413 47,048 Washington 75,140 45,084 West Virginia 55,920 33,552 Wisconsin 72,495 43,497 Wyoming 71,559 42,935 Note: FFY 2009 covers the period of October 1, 2008 through September 30, 2009. The estimated median income for a four-person family living in the United States is $70,354 for FFY 2009. The estimates become effective for the Low Income Home Energy Assistance Program (LIHEAP) at any time between the date of this publication and October 1, 2008, or the beginning of a LIHEAP grantee's fiscal year, whichever is later. 1 Prepared by the U.S. Census Bureau from the 2006 American Community Survey (ACS). The State median income estimates, like those that derive from any survey, are subject to two types of errors:
(1)Nonsampling Error, which consists of random errors that increase the variability of the data and non-random errors that consistently direct the data into a specific direction; and
(2)Sampling Error, which consists of the error that arises from the use of probability sampling to create the sample. 2 In accordance with 45 CFR 96.85, each State's estimated median income for a four-person family is multiplied by the following percentages to adjust for family size for LIHEAP: 52 percent for one person, 68 percent for two persons, 84 percent for three persons, 100 percent for four persons, 116 percent for five persons, and 132 percent for six persons. For each additional family member above six persons, add 3 percentage points to the percentage for a six-person family (132 percent), and multiply the new percentage by the State's estimated median income for a four-person family. 3 These figures were calculated by the Division of Energy Assistance (DEA). DEA calculated these figures by multiplying the estimated State median income for a four-person family for each State by 60 percent. [FR Doc. E8-4190 Filed 3-4-08; 8:45 am] BILLING CODE 4184-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0144] Agency Information Collection Activities; Proposed Collection; Comment Request; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions (Form FDA 3674) 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 certification to accompany human drug, biological product, and device applications or submissions (Form FDA 3674). DATES: Submit written or electronic comments on the collection of information by May 5, 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, 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. Certification to Accompany Drug, Biological Product, and Device Applications or Submissions (Form FDA 3674)—(OMB Control Number 0910-0616)—Extension The information required under section 402(j)(5)(B) of the Public Health Service Act (PHS Act) (42 U.S.C. 282(j)(5)(B)) will be submitted in the form of a certification with applications and submissions currently submitted to FDA under part 312 (21 CFR part 312) and 21 CFR part 314 (human drugs) and approved under OMB control numbers 0910-0014 (expires May 31, 2009) and 0910-0001 (expires May 31, 2008), respectively; submitted to FDA under part 312 and 21 CFR part 601 (biological products) and approved under OMB control numbers 0910-0014 and 0910-0338 (expires June 30, 2010); and submitted to FDA under 21 CFR parts 807 and 814 (devices) and approved under OMB control numbers 0910-0120 (expires August 31, 2010) and 0910-0231 (expires November 30, 2010), respectively. Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Public Law 110-85) amended the PHS Act by adding section 402(j) (42 U.S.C. 282(j)). The new provisions require additional information to be submitted to the clinical trials data bank ( *ClinicalTrials.gov* ) 1 previously established by the National Institutes of Health/National Library of Medicine, including expanded information on clinical trials and information on the results of clinical trials. The provisions include new responsibilities for FDA as well as several amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act). 1 (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the **Federal Register** .) One new provision, section 402(j)(5)(B) of the PHS Act, requires that a certification accompany human drug, biological, and device product submissions made to FDA. Specifically, at the time of submission of an application under sections 505, 515, or 520(m) of the FD&C Act (21 U.S.C. 355, 360e, or 360j(m)), or under section 351 of the PHS Act (42 U.S.C. 262), or submission of a report under section 510(k) of the FD&C Act (21 U.S.C. 360(k)), such application or submission must be accompanied by a certification that all applicable requirements of section 402(j) of the PHS Act have been met. Where available, such certification must include the appropriate National Clinical Trial
(NCT)numbers. The proposed collection of information is necessary to satisfy the previously mentioned statutory requirement. The importance of obtaining these data relates to adherence to the legal requirements for submissions to the clinical trials registry and results data bank and ensuring that individuals and organizations submitting applications or reports to FDA under the listed provisions of the FD&C Act or the PHS Act adhere to the appropriate legal and regulatory requirements for certifying to having complied with those requirements. The failure to submit the certification required by section 402(j)(5)(B) of the PHS Act, and the knowing submission of a false certification are both prohibited acts under section 301 of the FD&C Act (21 U.S.C. 331). Violations are subject to civil money penalties. Investigational New Drug Applications FDA's Center for Drug Evaluation and Research
(CDER)received 1,837 investigational new drug applications
(INDs)and 24,581 new IND amendments in fiscal year
(FY)2004. CDER anticipates that IND and amendment submission rates will remain at or near this level in the near future. FDA's Center for Biologics Evaluation and Research
(CBER)received 227 new INDs and 6,689 new IND amendments in FY 2004. CBER anticipates that IND and amendment submission rates will remain at or near this level in the near future. The estimated total number of submissions (new INDs and new submissions) subject to mandatory certification requirements under section 402(j)(5)(B) of the PHS Act is 26,418 for CDER plus 6,916 for CBER, or 33,334 submissions per year. The minutes per response is the estimated number of minutes that a respondent would spend preparing the information to be submitted to FDA under section 402(j)(5)(B) of the PHS Act, including the time it takes to type the necessary information. Based on its experience reviewing INDs and consideration of the previously mentioned information, FDA estimated that approximately 15.0 minutes on average would be needed per response for certifications which accompany IND applications and submissions. It is assumed that most submissions to investigational applications will reference only a few protocols for which the sponsor/applicant/submitter has obtained an NCT number from *ClinicalTrials.gov* prior to making the submission to FDA. It is also assumed that the sponsor/applicant/submitter has electronic capabilities allowing them to retrieve the information necessary to complete the form in an efficient manner. Marketing Applications/Submissions CDER and CBER received 214 new drug applications (NDA)/biologics license applications (BLA)/resubmissions and 8,535 NDA/BLA amendments in FY 2004. CDER and CBER received 259 efficacy supplements/resubmissions to previously approved NDAs/BLAs; 2,500 manufacturing submissions; and 1,273 labeling submissions in FY 2004. CDER and CBER anticipate that new drug/biologic and efficacy supplement submission rates will remain at or near this level in the near future. FDA's Center for Devices and Radiological Health
(CDRH)received 51 new applications for premarket approvals (PMA); 3,635 premarket notification submissions under section 510(k) of the FD&C Act; and 9 applications for humanitarian device exemptions (HDE), for a total of 3,695 new applications/submissions in FY 2004. CDRH received 2,267 PMA/510(k)/HDE amendments in FY 2004. CDRH received 2,705 PMA/510(k)/HDE supplements in FY 2004. CDRH anticipates that application, amendment, and supplement rates will remain at or near this level in the near future. The estimated total number of new submissions (new marketing applications/submissions, amendments, and supplements) subject to the mandatory certification requirements under section 402(j)(5)(B) of the PHS Act is 12,781 for CDER and CBER plus 8,667 for CDRH, or 21,448 new submissions per year. The hours per response is the estimated number of hours that a respondent would spend preparing the information to be submitted to FDA under section 402(j)(5)(B) of the PHS Act, including the time it takes to type the necessary information and compile a list of relevant NCT numbers. Based on its experience reviewing NDAs, BLAs, PMAs, HDEs, and 510(k)s, and consideration of the previously mentioned information, FDA estimated that approximately 45.0 minutes on average would be needed per response for certifications which accompany NDA, BLA, PMA, HDE, and 510(k) applications and submissions. It is assumed that the sponsor/applicant/submitter has electronic capabilities allowing them to retrieve the information necessary to complete the form in an efficient manner. Table 1 of this document provides an estimate of the annual reporting burden for the submission of information to satisfy the requirements of section 402(j)(5)(B) of the PHS Act. **Table 1.—Estimated Annual Reporting Burden** 1 Investigational Applications Marketing Applications Hours per Response Total Hours CDER (new application) 1,837 ---- .25 459 CBER (new application) 227 ---- .25 57 CDER (amendment) 24,581 ---- .25 6,145 CBER (amendment) 6,689 ---- .25 1,672 CDER/CBER (new application/resubmission) ---- 214 .75 161 CDRH (new application) ---- 3,695 .75 2,771 CDER/CBER (amendment) ---- 8,535 .75 6,401 CDRH (amendment) ---- 2,267 .75 1,700 CDER/CBER (efficacy supplement/resubmission) ---- 259 .75 194 CDER/CBER (manufacturing supplement) ---- 2,500 .75 1,875 CDER/CBER (labeling supplement) ---- 1,273 .75 955 CDRH (supplement) ---- 2,705 .75 2,029 Total 24,419 1 There are no capital costs or operating and maintenance costs associated with this collection of information. We believe the estimate of 24,419 hours per year accurately reflects the burden. We recognize that individuals or entities less familiar with FDA forms and the clinical trials data bank ( *ClinicalTrials.gov* ) may require greater than 15 and 45 minutes (depending on the type of application/submission) per response. 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: February 28, 2008. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E8-4158 Filed 3-4-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration
(FDA)is announcing an amendment to the notice of a meeting of the Oncologic Drugs Advisory Committee. This meeting was announced in the **Federal Register** of January 25, 2008 (73 FR 4580). The amendment is being made to reflect a change in the *Date and Time* , *Agenda* , and *Procedure* portions of the document. There are no other changes. FOR FURTHER INFORMATION CONTACT: Nicole Vesely, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, Rm. 1093), Rockville, MD 20857, 301-827-6793, FAX: 301-827-6776, e-mail: *nicole.vesely@fda.hhs.gov* , or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512542. Please call the Information Line for up-to-date information on this meeting. SUPPLEMENTARY INFORMATION: In the **Federal Register** of January 25, 2008, FDA announced that a meeting of the Oncologic Drugs Advisory Committee would be held on March 12 and 13, 2008. On page 4580, in the third column, the *Date and Time* portion of the meeting is amended to read as follows: *Date and Time* : The meeting will be held on March 12 and 13, 2008, from 8 a.m. to 4 p.m. On page 4580, beginning in the third column, the *Agenda* portion of the meeting is amended to read as follows: *Agenda* : On March 12, 2008, the committee will discuss biologic license application
(BLA)125268, proposed trade name NPLATE (romiplostim), Amgen, Inc., proposed indication for the treatment of thrombocytopenia in adults with chronic immune (idiopathic) thrombocytopenia purpura
(ITP)who are nonsplenectomized and have had an inadequate response or are intolerant to corticosteroids and/or immunoglobulins; or patients who are splenectomized and have an inadequate response to splenectomy. On March 13, 2008, the committee will discuss the cumulative data, including recent study results, on the risks of erythropoeisis-stimulating agents when administered to patients with cancer. Agents to be discussed include ARANESP (darbepoetin alfa), EPOGEN (epoetin alfa), PROCRIT (epoetin alfa), Amgen, Inc.) and MIRCERA (methoxy polyethylene glycol-epoetin beta, Hoffman-La Roche, Inc.). This is a followup to the May 10, 2007, Oncologic Drugs Advisory Committee Meeting. On page 4581, beginning in the first column, the *Procedure* portion of the meeting is amended to read as follows: *Procedure* : Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before February 27, 2008. Oral presentations from the public will be scheduled between approximately 1 p.m. to 2 p.m. on March 12, 2008, and between approximately 1 p.m. to 2 p.m. on March 13, 2008. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before February 19, 2008. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by February 20, 2008. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Nicole Vesely at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at *http://www.fda.gov/oc/advisory/default.htm* for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: February 26, 2008. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E8-4157 Filed 3-4-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pediatric Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration
(FDA)is announcing an amendment to the notice of meeting of the Pediatric Advisory Committee. This meeting was originally announced in the **Federal Register** of January 25, 2008 (73 FR 4581). The amendment is being made to reflect a change in the *Agenda* portion of the document. There are no other changes. FOR FURTHER INFORMATION CONTACT: Carlos Peña, Office of the Commissioner (HF-33), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3340, e-mail: *carlos.Peña@fda.hhs.gov* , or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 8732310001. Please call the Information Line for up-to-date information on this meeting. SUPPLEMENTARY INFORMATION: In the **Federal Register** of January 25, 2008, FDA announced that a meeting of the Pediatric Advisory Committee would be held on March 25, 2008. On page 4581, in the third column, the *Agenda* portion of document is changed to read as follows: *Agenda* : On March 25, 2008, the Pediatric Advisory Committee will hear and discuss reports by the agency, as mandated in section 17 of the Best Pharmaceuticals for Children Act, on adverse event reports for TOPROL XL (metoprolol), BREVIBLOC (esmolol HCl), LOTENSIN (benazepril), COREG (carvedilol), COLAZAL (balsalazide), ELOXATIN (oxaliplatin), CELEBREX (celecoxib), and SUPRANE (desflurane). The Pediatric Advisory Committee will also hear an update on TRILEPTAL (oxcarbazepine) and the FDA Amendments Act of 2007. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at *http://www.fda.gov/ohrms/dockets/ac/acmenu.htm* , click on the year 2008 and scroll down to the appropriate advisory committee link. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees. Dated: February 26, 2008. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E8-4156 Filed 3-4-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration
(HRSA)publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on
(301)443-1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Proposed Project: The National Sample Survey of Registered Nurses 2008 (OMB No. 0915-0276)—Reinstatement With Change The National Sample Survey of Registered Nurses (NSSRN) is carried out to assist in fulfilling the Congressional mandate of Section 806(f) of the Public Health Service Act (42 U.S.C. 296e) which requires that discipline-specific workforce information and analytical activities are carried out as part of the advanced nursing education, workforce diversity, and basic nursing education and practice programs. Government agencies, legislative bodies and health professionals used data from previous national sample surveys of registered nurses to inform workforce policies. The information from this survey will continue to serve policy makers, and other consumers. The data collected in this survey will provide information on employment status of registered nurses (RNs), the setting in which they are employed and the proportion of RNs who are employed either full-time and part-time in nursing. The data will also indicate the number of RNs who are employed in jobs unrelated to nursing. The proposed survey design for the 2008 NSSRN updates that of the previous eight surveys. A probability sample is selected from a sampling frame compiled from files provided by the State Boards of Nursing in the 50 States and the District of Columbia. These files constitute a multiple sampling frame of all RNs licensed in the 50 States and the District of Columbia. Sampling rates are set for each State based on considerations of statistical precision of the estimates and the costs involved in obtaining reliable national and State-level estimates. Each sampled nurse will be asked to complete a self-administered questionnaire, which includes items on educational background, duties, employment status and setting, geographic mobility, and income. An electronic version was offered in the 2004 survey and will be again considered as a mode for response. *Estimated burden is as follows:* Form Number of respondents Responses per respondent Total responses Hours per response Total burden hours Nursing Survey 39,984 1 39,984 .33 13,195 Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to the desk officer for HRSA, either by e-mail to *OIRA_submission@omb.eop.gov* or by fax to 202-395-6974. Please direct all correspondence to the “attention of the desk officer for HRSA.” Dated: February 28, 2008. Alexandra Huttinger, Director, Division of Policy Review and Coordination. [FR Doc. E8-4269 Filed 3-4-08; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Reimbursement of Travel and Subsistence Expenses Toward Living Organ Donation Eligibility Guidelines AGENCY: Health Resources and Services Administration, HHS. ACTION: Request for Comments on Proposed Changes to the Reimbursement of Travel and Subsistence Expenses Program Eligibility Criteria. SUMMARY: The Health Resources and Services Administration
(HRSA)published the final eligibility guidelines for the Reimbursement of Travel and Subsistence Expense Program in the **Federal Register** on October 5, 2007 (72 FR 57049). The purpose of this notice was to inform the public of the eligibility requirements for participation in the Reimbursement of Travel and Subsistence Expenses toward Living Organ Donation Program. HRSA is requesting public comments concerning recommended change to a specific section of the reimbursement program eligibility guidelines. DATES: Written comments must be submitted to the office in the address section below by mail or e-mail on or before April 4, 2008. ADDRESSES: Please send all written comments to James F. Burdick, M.D., Director, Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration, Room 12C-06, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857; telephone
(301)443-7577; fax
(301)594-6095; or e-mail: *jburdick@hrsa.gov* . FOR FURTHER INFORMATION CONTACT: James F. Burdick, M.D., Director, Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration, Parklawn Building, Room 12C-06, 5600 Fishers Lane, Rockville, Maryland 20857; telephone
(301)443-7577; fax
(301)594-6095; or e-mail: *jburdick@hrsa.gov* . SUPPLEMENTARY INFORMATION: In its final program eligibility guidelines, HRSA explained that “[t]he Program will pay for a total of up to five trips; three for the donor and two for accompanying persons. The accompanying persons need not be the same each trip.” (72 FR 57052). HRSA proposes amending this paragraph to read: “[t]he Program will pay for a total of up to five trips; three for the donor and two for accompanying persons. However, in cases in which the transplant center requests the donor to return to the transplant center for additional visits as a result of donor complications or other health related issues, NLDAC may provide reimbursement for the additional visit(s) for the donor and an accompanying person. The accompanying persons need not be the same in each trip.” The purpose of this proposed change is to accommodate individuals who experience donor complications or other health related issues relating to donation. HRSA is requesting comments on this specific section. Dated: February 26, 2008. Elizabeth M. Duke, Administrator. [FR Doc. E8-4185 Filed 3-4-08; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. SUMMARY: The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. ADDRESSES: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. PSM Peptides as Vaccine Targets Against Methicillin-Resistant Staphylococcus aureus *Description of Technology:* Available for licensing and commercial development are compositions and methods for the treatment and inhibition of Methicillin-resistant *Staphylococcus aureus* (MRSA), a dangerous human pathogen. The invention concerns immunogenic peptides that can be used to induce protective immunity against MRSA, including phenol-soluble modulin
(PSM)peptides. In addition to the MRSA infections that occur in immunocompromised patients in hospitals, new MRSA strains have recently emerged that can cause severe infections (such as necrotizing fasciitis) or death in otherwise healthy adults. These strains are increasingly involved in community-associated (CA)-MRSA infections, and can be contracted outside of the health care settings. The incidence of CA-MRSA infections is increasing and the majority of infections in patients reporting to emergency departments in the U.S. is now due to CA-MRSA. The invention describes a class of secreted staphylococcal peptides with an extraordinary ability to recruit, activate, and subsequently lyse human neutrophils, thus eliminating the main cellular defense against *S. aureus* infection. The peptides are encoded by the PSM gene cluster and include PSMα1, PSMα2, PSMα3, and PSMα4, all of which activate and subsequently lyse neutrophils. These peptides are produced at especially high levels in CA-MRSA and to a large extent determine their aggressive behavior and ability to cause disease in animal models of infection. Thus, the peptides represent a set of virulence factors of *S. aureus* that account for the enhanced virulence of CA-MRSA. The identification of these peptides enables the production of vaccines and other preventative and/or therapeutic agents for use in subjects infected with MRSA. *Applications:* Development of new classes of antibiotics and vaccines against Methicillin-resistant *Staphylococcus aureus* infections. *Inventors:* Michael Otto and Rong Wang (NIAID). *Publication:* R Wang et al. Identification of novel cytolytic peptides as key virulence determinants for community-associated MRSA. Nat Med. 2007. Dec;13(12):1510-1514. *Patent Status:* U.S. Provisional Application No. 60/933,573 filed 06 Jun 2007 (HHS Reference No. E-239-2007/0-US-01); U.S. Provisional Application No. 60/983,141 filed 26 Oct 2007 (HHS Reference No. E-239-2007/1-US-01). *Development Status:* Early stage. *Licensing Status:* Available for non-exclusive or exclusive licensing. *Licensing Contact:* Cristina Thalhammer-Reyero, PhD., M.B.A.; 301-435-4507; *thalhamc@mail.nih.gov* . *Collaborative Research Opportunity:* The NIAID Laboratory of Human Bacterial Pathogenesis is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. Please contact William Ronnenberg at 301-451-3522 or *wronnenberg@mail.nih.gov* for more information. Active MRI Compatible and Visible iMRI Catheter *Description of Technology:* MRI is a promising imaging modality that provides superior soft tissue contrast and multi planar real-time imaging without harmful ionizing radiation for therapeutic procedures. Interventional magnetic resonance imaging
(iMRI)has gained important popularity in many fields such as interventional cardiology and radiology, owing to the development of minimally invasive techniques and visible catheters under MRI for conducting MRI-guided procedures and therapies. This invention relates to a novel MRI compatible and active visible catheter for conducting interventional and intraoperative procedures under the guidance of MRI. The catheter features a non conductive transmission line and the use of ultrasonic transducers that transform RF signals to ultrasonic signals for transmitting RF signal to the MRI scanner. The unique design of this catheter overcomes the concern of patient/sample heating (due to the coupling between RF transmission energy and long conductors within catheter) associated with the design of conventional active MRI catheters. *Inventor:* Ozgur Kocaturk (NHLBI). *Patent Status:* U.S. Provisional Application No. 60/716,503 filed 14 Sep 2005 (HHS Reference No. E-298-2005/0-US-01); PCT Application No. PCT/US2006/035636 filed 13 Sep 2006, which published as WO 2007/033240 on 22 Mar 2007 (HHS Reference No. E-298-2005/0-PCT-02). *Licensing Status:* Available for exclusive or non-exclusive licensing. *Licensing Contact:* Michael Shmilovich, Esq.; 301/435-5019; *shmilovm@mail.nih.gov* . *Collaborative Research Opportunity:* The National Heart, Lung, and Blood Institute, Cardiac Catheterization Lab is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize the alternative Active MRI compatible and visible catheters using ultrasonic technology. Please contact Peg Koelble at *koelblep@nhlbi.nih.gov* for more information. Immunoglobulins With Potent and Broad Antiviral
(HIV)Activity Based on scFv Joined by Flexible Linker to Fc *Description of Technology:* This invention describes methods of inhibiting viral infection (e.g., HIV-1 infection). The method comprises administering a fusion protein comprising a small size, single chain Fv
(scFv)antibody binding domain joined to an Fc region by a long flexible linker. In particular, scFv m6 or m9, the single chain variable fragments that were previously identified from a phage display library for binding to gp140 <sup>89.6</sup> , gp120 <sup>JRFL</sup> , gp140 <sup>IIIB</sup> , and their complex with two-domain soluble CD4 is joined to Fc by a long flexible linker to provide a new agent for the inhibition of HIV infection or immunotherapy of HIV-infected individuals. The Fc region provides stability, long half-life, and biological effector functions. The scFv-Fc fragment provides antigen recognition and neutralizing activity. The small size of the scFv-Fc fusion molecule provides easy access to conserved viral epitopes exposed before or during viral entry. In addition, these fusion molecules exhibit neutralization activity that is higher than that of whole IgGs. Thus, this invention may offer a novel approach to treat and prevent HIV-1 infection and/or AIDS. *Inventors:* Dimiter Dimitrov
(NCI)and Mei-Yun Zhang (NCI/SAIC). *Patent Status:* U.S. Patent Application No. 10/573,962 filed 29 Mar 2006, claiming priority to 29 Sep 2003 (HHS Reference No. E-316-2003/0-US-03). *Licensing Status:* Available for exclusive or non-exclusive licensing. *Licensing Contact:* Sally Hu; 301/435-5606; *hus@mail.nih.gov* . Modulators of Nuclear Hormone Receptor Activity: Novel Compounds, Diverse Applications for Infectious Diseases, Including Anthrax ( B. anthracis ) *Description of Technology:* Nuclear hormones such as glucocorticoids dampen inflammatory responses, and thus provide protection to mammals against inflammatory disease and septic shock. The Anthrax lethal factor represses nuclear hormone receptor activity, and thus may contribute to the infectious agent causing even more damage to the host. This observation can be exploited to find new means of studying and interfering with the normal function of nuclear hormone receptors. Scientists at NIH have shown that under the appropriate conditions, these molecules can be used to modulate the activity of various nuclear hormone receptors. Identifying useful agents that modify these important receptors can provide relief in several human disorders such as inflammation, autoimmune disorders, arthritis, malignancies, shock and hypertension. *Applications:* This invention provides novel agents that can interfere with the action of nuclear hormone receptors. It is well known that malfunction or overdrive of these receptors can lead to a number of diseases such as enhanced inflammation; worse sequelae of infection including shock; diabetes; hypertension and steroid resistance. Hence a means of controlling or fine-tuning the activity of these receptors can be of great benefit. Current means of affecting steroid receptor activity are accompanied by undesirable side-effects. Since the conditions for which these treatments are sought tend to be chronic, there is a critical need for safer drugs that will have manageable side-effects. *Advantages:* The observation that the lethal factor from Anthrax has a striking effect on the activity of nuclear hormone receptors opens up new routes to controlling their activity. The means of action of this repressor is sufficiently different from known modulators of hormone receptors (i.e., the classical antagonists). For instance, the repression of receptor activity is non-competitive, and does not affect hormone binding or DNA binding. Also, the efficacy of nuclear hormone receptor repression by Anthrax lethal factor is sufficiently high that the pharmacological effect of this molecule is seen at vanishingly small concentrations. Taken together, these attributes may satisfy some of the golden rules of drug development such as the uniqueness or novelty of the agent's structure, a low threshold for activity, high level of sophistication and knowledge in the field of enquiry, and the leeway to further refine the molecule by rational means. *Development Status:* In vitro studies have been completed, and a limited number of animal studies have been carried out. *Inventors:* Esther M. Sternberg (NIMH), Jeanette Webster (NIMH), Leonardo H. Tonelli (NIMH), Stephen H. Leppla (NIAID), Mahtab Moayeri (NIAID). *Patent Status:* U.S. Patent Application No. 10/530,254 filed 04 Apr 2005, claiming priority to 04 Oct 2002 (HHS Reference No. E-247-2002/1-US-02). *Licensing Status:* Available for exclusive or non-exclusive licensing. *Licensing Contact:* Peter Soukas; 301/435-4646; *soukasp@mail.nih.gov* . Dated: February 27, 2008. Bonny Harbinger, Deputy Director, Office of Technology Transfer, National Institutes of Health. [FR Doc. E8-4187 Filed 3-4-08; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. SUMMARY: The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. ADDRESSES: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. Novel Adjuvant Therapy Using TIMP-2 Variants *Description of Technology:* Angiogenesis inhibitors are drugs that are being used in cancer therapy to block the development of new blood vessels which could potentially cut off a tumor's supply of oxygen and nutrients. This in turn might stop the tumor from growing and spreading to other parts of the body. Human protein tissue inhibitor of metalloproteinases-2 (TIMP-2) has been shown to inhibit angiogenesis *in vivo* independent of metalloproteinase inhibition. The inventors have demonstrated that TIMP-2, as well as TIMP-2 variants lacking metalloproteinase inhibitor activity can revert aggressive tumor cell phenotype to a more differentiated state. In addition, TIMP-2 and the TIMP-2 variants also sensitize tumor cells to the induction of apoptosis by cytotoxic drugs (doxorubicin), thereby enhancing their effectiveness. Novel methods of cancer therapy are disclosed using TIMP-2 or TIMP-2 variants that combine the known anti-angiogenic activity of TIMP-2, with direct tumor-differentiating and chemo-sensitizing activity of TIMP-2. *Applications:* TIMP-2 or TIMP-2 variants can be administered for the inhibition of tumor cell growth and promotion of tumor cell differentiation. TIMP-2 or TIMP-2 variants can be administered to enhance the cytotoxic activity of a chemotherapeutic agent. Adjuvant therapy has application in the treatment of wide variety of carcinomas or melanomas. *Advantages:* A novel cancer therapy that combines the known anti-angiogenic activity of TIMP-2, with a novel direct tumor-differentiating and chemo-sensitizing activity of TIMP-2. Enhances cytotoxicity of conventional chemotherapeutic agents when combined with TIMP-2 or TIMP-2 variants. *Development Status:* *In vivo* and *in vitro* experiments have been conducted. The technology continues to be developed. *Market:* 600,000 deaths from cancer related diseases estimated in 2007. The technology platform involving novel anti-angiogenic cancer therapy technology has a potential market of more than 2 billion U.S. dollars. *Inventors:* William G. Stetler-Stevenson et al. (NCI). *Publication:* DW Seo, H Li, L Guedez, PT Wingfield, T Diaz, R Salloum, BY Wei, WG Stetler-Stevenson. TIMP-2 mediated inhibition of angiogenesis: an MMP-independent mechanism. Cell. 2003 Jul 25;114(2):171-180. [ *PubMed abs* ] *Patent Status:* U.S. Provisional Application No. 60/953,352 filed 01 Aug 2007 (HHS Reference No. E-297-2007/0-US-01). *Licensing Status:* Available for exclusive or non-exclusive licensing. *Licensing Contact:* Surekha Vathyam; 301-435-4076; *vathyams@mail.nih.gov* . *Collaborative Research Opportunity:* The NCI Laboratory of Extracellular Matrix Pathology, Cell and Cancer Biology Branch, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize novel cancer therapy methods using TIMP-2 variants. Please contact John D. Hewes, Ph.D., at 301-435-3121 or *hewesj@mail.nih.gov* for more information. Mucin Genes as a Diagnosis Marker for Pulmonary Fibrosis *Description of Technology:* Familial pulmonary fibrosis
(FPF)is a rare type of interstitial lung disease for which there is currently no cure. FPF is part of a group of interstitial lung diseases called idiopathic interstitial pneumonias
(IIP)that lead to hypoxic respiratory insufficiency. The current invention has identified genes that are associated with FPF, and a possible means of early detection and treatment. The invention discloses an association between FPF and mutations in the genes encoding the MUC2 and MUC5AC mucins that predispose a subject to IIP. The occurrence of single nucleotide polymorphisms
(SNPs)in these mutant genes further enable a significant diagnostic association between these polymorphisms and both familial and sporadic forms of pulmonary fibrosis. This invention may also have diagnostic value for other IIPs including idiopathic pulmonary fibrosis (IPF); a disease that presents late in life and is lethal within 4-5 years of diagnosis. This technology presents opportunities for early detection of subjects at high risk for the development of pulmonary fibrosis, and possibly other similar diseases such as asthma, chronic obstructive pulmonary disease
(COPD)and obliterative bronchitis, which also involve fibrosis of the airways. It is also conceivable that mucin, and synthetic molecules that mimic it, may be used as therapeutic agents for the prevention and treatment of pulmonary fibrosis. *Applications:* Diagnosis of diseases involving pulmonary fibrosis. *Inventors:* David A. Schwartz (NIEHS), Lauranell H. Burch (NIEHS), *et al.* *Publication:* MP Steele, MC Speer, JE Loyd, KK Brown, A Herron, SH Slifer, LH Burch, MM Wahidi, JA Phillips III, TA Sporn, HP McAdams, MI Schwarz, DA Schwartz. Clinical and Pathologic Features of Familial Interstitial Pneumonia. Am J Respir Crit Care Med. 2005 Nov 1;172(9): 1146-1152. *Patent Status:* U.S. Provisional Application No. 60/992,079 filed 03 Dec 2007 (HHS Reference No. E-016-2007/0-US-01). *Licensing Status:* Available for exclusive or non-exclusive licensing. *Licensing Contact:* Jasbir (Jesse) S. Kindra, J.D., M.S.; 301-435-5170; *kindraj@mail.nih.gov* . P53 and VGEF Regulate Tumor Growth of NO <sup>2</sup> Expressing Cancer Cells *Description of Technology:* The increased expression of nitric oxide synthase 2 (NOS2), an inducible enzyme that produces nitric oxide (NO), has been found in a variety of human cancers. It also has been shown that NOS2-specific inhibitors can reduce the growth of experimental tumors in mice. These findings suggest a pathophysiological role for NO in the development and progression of cancer. However, the function of NO and NOS2 in carcinogenesis is uncertain. NO had been found to either inhibit or stimulate tumor growth, and high concentrations of NO also are known to induce cell death in many cell types including tumor cells. On the other hand, low NO concentrations found in human tissue can have an opposite effect and protect against programmed cell death, or apoptosis, from various stimuli. The role of NO and NOS2 in tumor progression, particularly with respect to p53, therefore need to be further defined. This invention comprises methods of screening for modulators of NOS2 expression in p53 mutant cells, both *in vivo* and *in vitro* , as well as methods for predicting the chemotherapeutic benefit of administering NOS2-inhibitors to cancer patients. It has been demonstrated that NOS2-expressing cancer cells with wild-type p53 have reduced tumor growth in athymic nude mice whereas NOS2-expressing cancer cells with mutated p53 have accelerated tumor growth. Therefore, this invention has potential application for a number of cancers that overexpress NOS2 and have a high frequency of p53 mutations, including breast, brain, head, neck, lung and colon cancers. *Applications:* Method to treat cancer with NOS2 inhibitors. Method to screen for NOS2 modulators. Method to predict therapeutic benefits of NOS2 inhibitors in patients. *Market:* An estimated 1,444,920 new cancer diagnoses in the U.S. in 2007. 600,000 deaths caused by cancer in the U.S. in 2006. Cancer is the second leading cause of death in United States. It is estimated that market for cancer drugs would double to $50 billion a year in 2010 from $25 billion in 2006. *Development Status:* The technology is currently in the pre-clinical stage of development. *Inventors:* Stefan Ambs and Curt Harris (NCI). *Publications:* 1. JE Goodman *et al.* Nitric oxide and p53 in cancer-prone chronic inflammation and oxyradical overload diseases. Environ Mol Mutagen. 2004;44(1):3-9. 2. LJ Hofseth *et al.* Nitric oxide in cancer and chemoprevention. Free Radic Biol Med. 2003Apr 15;34(8):955-968. *Patent Status:* U.S. Patent Application No. 11/195,006 filed 01 Aug 2005 (HHS Reference No. E-223-1998/0-US-04). U.S. Patent Application No. 09/830,977 filed 02 May 2001 (HHS Reference No. E-223-1998/0-US-03). PCT Patent Application No. PCT/US1999/27410 filed 17 Nov 1998 (HHS Reference No. E-223-1998/0-PCT-02). U.S. Provisional Patent Application No. 60/109,563 filed 23 Nov 1998 (HHS Reference No. E-223-1998/0-US-01). *Licensing Status:* Available for exclusive or non-exclusive licensing. *Licensing Contact:* Jennifer Wong; 301/435-4633; *wongje@mail.nih.gov* . Dated: February 26, 2008. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E8-4200 Filed 3-4-08; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings 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 meetings. The meetings 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:* Center for Scientific Review Special Emphasis Panel, Member Conflicts: Musculoskeletal Rehabilitation Sciences. *Date:* March 18, 2008. *Time:* 4 p.m. to 6 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). *Contact Person:* John P. Holden, PhD, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4211, MSC 7814, Bethesda, MD 20892, 301-496-8551, *holdenjo@csr.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. *Name of Committee:* Center for Scientific Review Special Emphasis Panel, Infectious Diseases Microbiology Fellowships. *Date:* March 19-20, 2008. *Time:* 8 a.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). *Contact Person:* Alexander D. Politis, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3210, MSC 7808, Bethesda, MD 20892, 301-435-1150, *politisa@csr.nih.gov.* *Name of Committee:* Center for Scientific Review Special Emphasis Panel, Cancer Drug and Therapeutics Development SBIR/STTR. *Date:* March 20-21, 2008. *Time:* 9 a.m. to 8 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). *Contact Person:* Steven B. Scholnick, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6152, MSC 7804, Bethesda, MD 20892, 301-435-1719, *scholnis@csr.nih.gov.* *Name of Committee:* Center for Scientific Review Special Emphasis Panel, Member Conflicts: Skeletal Muscle and Exercise Physiology. *Date:* March 20, 2008. *Time:* 3:30 p.m. to 6 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). *Contact Person:* John P. Holden, PhD, Center for Scientic Review, National Institutes of Health, 6701 Rockledge Drive, Room 4211, MSC 7814, Bethesda, MD 20892, 301-496-8551, *holdenjo@csr.nih.gov* . *Name of Committee:* Center for Scientific Review Special Emphasis Panel, Developmental Pharmacology. *Date:* March 26, 2008. *Time:* 1 p.m. to 3 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). *Contact Person:* Janet M. Larkin, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 1102, MSC 7840, Bethesda, MD 20892, 301-435-1026, *larkinja@csr.nih.gov* . *Name of Committee:* Center for Scientific Review Special Emphasis Panel, Behavioral and Social HIV/AIDS Review of SBIR Applications. *Date:* March 28, 2008. *Time:* 1 p.m. to 3 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). *Contact Person:* Mark P. Rubert, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5218, MSC 7852, Bethesda, MD 20892, 301-435-1775, *rubertm@csr.nih.gov* . *Name of Committee:* Center for Scientific Review Special Emphasis Panel, Development of Assays for High Throughput Screening
(HTS)in the Molecular Libraries Probe Production Centers Network (MLPCN). *Date:* April 3, 2008. *Time:* 8:30 a.m. to 5:30 p.m. *Agenda:* To review and evaluate grant applications. *Place:* Georgetown Suites, 1000 29th Street, NW, Washington, DC 20007. *Contact Person:* George W. Chacko, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5170, MSC 7849, Bethesda, MD 20892, 301-435-1245, *chackoge@csr.nih.gov* . (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: February 27, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 08-936 Filed 3-04-08; 8:45 am]
Connectionstraces to 17
Traces to 17 documents
U.S. Code
- Definitions§ 1841
- Acquisition of bank shares or assets§ 1842
- Interests in nonbanking organizations§ 1843
- Additional powers of Commission§ 46
- Advertising of credit other than open end plans§ 1664
- Definitions§ 3502
- Federal agency responsibilities§ 3506
- Director of National Institutes of Health§ 282
- New drugs§ 355
- Regulation of biological products§ 262
- Registration of producers of drugs or devices§ 360
- Prohibited acts§ 331
- Generally applicable provisions§ 296e
- Domestic and foreign protection of federally owned inventions§ 207
12 references not yet in our index
- 12 CFR 271
- 12 CFR 225
- 38 Stat. 721
- 45 CFR 96.85(b)
- 45 CFR 96.85
- 44 USC 3501-3520
- 5 CFR 1320.3(c)
- 21 CFR 312
- 21 CFR 314
- 21 CFR 601
- Pub. L. 110-85
- 21 CFR 14
Citation graph
cites case law
Rules and Regulations
Notice of filing dates for special election
Cite12 CFR 271
Cite12 CFR 225
Stat.38 Stat. 721
Cites 29 · showing 12Cited by 0 across 0 sources