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Code · REGISTER · 2007-05-17 · Environmental Protection Agency (EPA) · Notices

Notices. Notice of meeting

9,428 words·~43 min read·/register/2007/05/17/07-2427

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

BILLING CODE 6560-50-M ENVIRONMENTAL PROTECTION AGENCY [FRL-8316-2] Gulf of Mexico Program Citizens Advisory Committee Meeting AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of meeting. SUMMARY: Under the Federal Advisory Committee Act (Pub. L. 92-463), EPA gives notice of a meeting of the Gulf of Mexico Program
(GMP)Citizens Advisory Committee (CAC). For information on access or services for individuals with disabilities, please contact Gloria Car, U.S.EPA, at
(228)688-2421 or *car.gloria@epa.gov.* To request accommodation of a disability, please contact Gloria Car, preferably at least 10 days prior to the meeting, to give EPA as much time as possible to process your request. DATES: The meeting will be held on Tuesday, June 19, 2007, from 1 p.m. to 4:30 p.m. and Wednesday, June 20, 2007, from 8:30 a.m. to 12 p.m. ADDRESSES: The meeting will be held at the River House, Stennis Space Center, Mississippi 39529,
(228)688-3726. FOR FURTHER INFORMATION CONTACT: Gloria D. Car, Designated Federal Officer, Gulf of Mexico Program Office, Mail Code EPA/GMPO, Stennis Space Center, MS 39529-6000 at
(228)688-2421. SUPPLEMENTARY INFORMATION: The proposed agenda includes the following topics: Gulf of Mexico Program Updates; Presentation on Liquified Natural Gas Facilities; Nature Conservancy Presentation; Priority Interests of the Citizens Advisory Committee; Citizens Advisory Committee membership status. The meeting is open to the public. Dated: May 10, 2007. Gloria D. Car, Designated Federal Officer. [FR Doc. E7-9505 Filed 5-16-07; 8:45 am] BILLING CODE 6560-50-P FEDERAL COMMUNICATIONS COMMISSION [MM Docket No. 93-8; DA 07-2005] Commission Seeks To Update the Record for a Petition for Reconsideration Regarding Home Shopping Stations AGENCY: Federal Communications Commission. ACTION: Notice. SUMMARY: In this document, the Commission seeks to update the record for a Petition for Reconsideration filed by the Center for the Study of Commercialism (CSC), concerning stations that air home shopping programming and their status. The Commission seeks comment on CSC's argument that the Commission failed to consider in its public interest analysis the significant amount of commercial programming broadcast by home shopping stations; on the specific issues concerning how home shopping stations serve the people in their communities, including the elderly and homebound; on CSC's assertion that the Commission failed to consider information relevant to one of three statutory factors, *i.e.* , competing demands for the spectrum; and on CSC's assertion that the Cable Act requires the Commission to consider non-broadcast uses in its analysis of competing demands for spectrum. The Commission would like to update the record for this proceeding before ruling on the petition. DATES: Comments for this proceeding are due on or before June 18, 2007; reply comments are due on or before July 2, 2007. ADDRESSES: You may submit comments, identified by MM Docket No. 93-8, by any of the following methods: • Federal eRulemaking Portal: *http://www.regulations.gov* . Follow the instructions for submitting comments. • Federal Communications Commission's Web site: *http://www.fcc.gov/cgb/ecfs/* . Follow the instructions for submitting comments. • People with Disabilities: Contact the FCC to request reasonable accommodations (accessible format documents, sign language interpreters, CART, etc.) by e-mail: *FCC504@fcc.gov* or phone: 202-418-0530 or TTY: 202-418-0432. For detailed instructions for submitting comments and additional information on the rulemaking process, see the SUPPLEMENTARY INFORMATION section of this document. FOR FURTHER INFORMATION CONTACT: For additional information on this proceeding, contact Belinda Nixon, *Belinda.Nixon@fcc.gov* of the Media Bureau, Policy Division,
(202)418-1382. Press inquiries should be directed to Mary Diamond of the Media Bureau,
(202)418-2388. TTY:
(202)418-7172 or
(888)835-5322. SUPPLEMENTARY INFORMATION: This is a summary of the Commission's Public Notice, DA 07-2005 released on May 4, 2007. The full text of this document is available for public inspection and copying during regular business hours in the FCC Reference Center, Federal Communications Commission, 445 12th Street, SW., CY-A257, Washington, DC 20554. These documents will also be available via ECFS ( *http://www.fcc.gov/cgb/ecfs/* ). (Documents will be available electronically in ASCII, Word 97, and/or Adobe Acrobat.) The complete text may be purchased from the Commission's copy contractor, 445 12th Street, SW., Room CY-B402, Washington, DC 20554. To request this document in accessible formats (computer diskettes, large print, audio recording, and Braille), send an e-mail to *fcc504@fcc.gov* or call the Commission's Consumer and Governmental Affairs Bureau at
(202)418-0530 (voice),
(202)418-0432 (TTY). Summary of the Notice 1. In this Public Notice, the Commission seeks to update the record for a Petition for Reconsideration of its *Report and Order* in MM Docket No. 93-8 (58 FR 39156-01), concerning stations that air home shopping programming and their status under section 4(g) of the Cable Television Consumer Protection and Competition Act of 1992. In the *Report and Order* , the Commission concluded that television broadcast stations that are used predominantly for the transmission of sales presentations or program length commercials (such as home shopping stations) serve the public interest and are therefore qualified for mandatory cable carriage. The Center for the Study of Commercialism
(CSC)filed a petition for reconsideration of that order. We issue this Public Notice because the Commission would like to update the record for this proceeding before ruling on the petition. 2. On January 14, 1993, the Commission opened a proceeding to implement section 4(g) of the Cable Act of 1992. The Cable Act requires the Commission to determine, regardless of prior proceedings, whether home shopping broadcast stations are serving the public interest, convenience, and necessity. Pursuant to this provision, if the Commission finds that these stations serve the public interest, it must qualify them as local commercial television stations for the purposes of mandatory cable carriage, or must-carry. If the Commission found that one or more such stations did not serve the public interest, then the Act required the Commission to provide them with reasonable time to provide different programming. The Cable Act further provides that the Commission consider three factors in making its public interest determination: “The viewing of home shopping stations, the level of competing demands for the spectrum allocated to such stations, and the role of such stations in providing competition to nonbroadcast services offering similar programming.” 3. In the *Report and Order* , the Commission noted that the overwhelming majority of commenters in the proceeding contended that home shopping stations do serve the public interest, that their programming format should not adversely affect their renewal expectancy, and that they should be eligible for must-carry status. Addressing the first of the three factors enumerated in Section 4(g), the Commission found that home shopping stations have significant viewership. With respect to the second factor, the Commission found that it must consider the demands only of other television broadcasters and not the demands of services other than broadcast television. The Commission further found that the licensing process adequately took into account the competing demands of television broadcasters for the television broadcast spectrum. Finally, turning to the third factor, the Commission found that the existence and carriage of home shopping broadcast stations play a role in providing competition for nonbroadcast services supplying similar programming. Thus, the Commission found that each of the three statutory factors supported a conclusion that home shopping stations are serving the public interest. 4. In addition, the Commission found that other factors, including the following, supported its conclusion:
(1)Home shopping stations provide a needed and valuable service to people without the time or ability to obtain goods outside the home, including the disabled, elderly, and homebound;
(2)home shopping stations fulfill public interest programming obligations;
(3)the role played by the Home Shopping Network in assisting minority-controlled and other small and marginal stations to attain financial viability; and
(4)lack of evidence that the marketplace had failed to serve television viewers based on the then-present number and variety of home shopping services. Accordingly, the Commission concluded that home shopping stations serve the public interest, and it therefore qualified them as local commercial television stations for the purposes of mandatory cable carriage. 5. CSC argues that
(1)the Commission did not consider the amount of the commercial programming home shopping stations broadcast when it concluded that such stations discharge their obligation to broadcast programming that is in the public interest; and
(2)the Commission did not consider information relevant to the second of the three factors in section 4(g) relating to competing uses for the television broadcast spectrum. 6. In order to update our records for this proceeding, we seek comment on the issues presented in the petition for reconsideration filed by CSC. CSC argues that the Commission failed to consider in its public interest analysis the significant amount of commercial programming broadcast by home shopping stations. We seek comments on this assertion. Additionally, in order to update the record, we're now seeking comment on the specific issues concerning how home shopping stations serve the people in their communities, including the elderly and homebound. 7. We also seek comment on CSC's assertion that the Commission failed to consider information relevant to the second statutory factor, *i.e.* , competing demands for the spectrum. Specifically, CSC claims that the Commission failed to consider evidence regarding Congressional intent that the Commission consider non-broadcast uses for the television broadcast spectrum, such as those of police and fire departments. We seek comment on CSC's assertion that the Cable Act requires the Commission to consider non-broadcast uses in its analysis of competing demands for spectrum. 8. Finally, given the passage of time since the *Report and Order* was adopted, we seek comment on the current number of broadcast stations that provide home shopping programs for the majority of their broadcast day. How do home shopping stations meet their public interest obligations? In particular, how do they comply with the requirements of the Children's Television Act of 1990 and licensees' obligation to provide coverage of issues facing their communities? 9. *Ex Parte Rules.* This proceeding will be treated as a “permit-but-disclose” proceeding subject to the “permit-but-disclose” requirements under section 1.1206(b) of the Commission's rules. *Ex parte* presentations are permissible if disclosed in accordance with Commission rules, except during the Sunshine Agenda period when presentations, *ex parte* or otherwise, are generally prohibited. Persons making oral *ex parte* presentations are reminded that a memorandum summarizing a presentation must contain a summary of the substance of the presentation and not merely a listing of the subjects discussed. More than a one- or two-sentence description of the views and arguments presented is generally required. Additional rules pertaining to oral and written presentations are set forth in section 1.1206(b). 10. Pursuant to Sections 1.415 and 1.419 of the Commission's rules, interested parties may file comments and reply comments on or before the dates indicated on the first page of this document. All filings must be submitted in MM Docket No. 93-8. Pleadings sent via e-mail to the Commission will be considered informal and will not be part of the official record. Comments may be filed using:
(1)The Commission's Electronic Comment Filing System (ECFS),
(2)the Federal Government's eRulemaking Portal, or
(3)by filing paper copies. • Electronic Filers: Comments may be filed electronically using the Internet by accessing the ECFS: *http://www.fcc.gov/cgb/ecfs/* or the Federal eRulemaking Portal: *http://www.regulations.gov.* Filers should follow the instructions provided on the website for submitting comments. • For ECFS filers, in completing the transmittal screen, filers should include their full name, U.S. Postal service mailing address, and the applicable docket number: MM Docket No. 93-8. Parties may also submit an electronic comment by Internet e-mail. To get filing instructions, filers should send an e-mail to *ecfs@fcc.gov* , and include the following words in the body of the message: “get form”. A sample form and instructions will be sent in response. • Paper Filers: Parties who choose to file by paper must file an original and four copies of each filing. Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail (although we continue to experience delays in receiving U.S. Postal Service mail). All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission. • The Commission's contractor will receive hand-delivered or messenger-delivered paper filings for the Commission's Secretary at 236 Massachusetts Avenue, NE., Suite 110, Washington, DC 20002. The filing hours at this location are 8 a.m. to 7 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes must be disposed of *before* entering the building. • Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9300 East Hampton Drive, Capitol Heights, MD 20743. • U.S. Postal Service first-class mail, Express Mail, and Priority Mail should be addressed to 445 12th Street, SW., Washington, D.C. 20554. • People with Disabilities: To request materials in accessible formats for persons with disabilities (Braille, large print, electronic files, audio format), send an e-mail to *fcc504@fcc.gov* or contact the Consumer and Governmental Affairs Bureau at
(202)418-0530 or
(202)418-7365 (TTY). • Copies of any filed documents in this matter are also available for inspection in the Commission's Reference Information Center: 445 12th Street, SW., Washington, DC 20554,
(202)418-7092. Federal Communications Commission. Elizabeth Andrion, Deputy Chief, Media Bureau. [FR Doc. E7-9552 Filed 5-16-07; 8:45 am] BILLING CODE 6712-01-P FEDERAL RESERVE SYSTEM Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMB AGENCY: Board of Governors of the Federal Reserve System SUMMARY: Background. Notice is hereby given of the final approval of proposed information collections by the Board of Governors of the Federal Reserve System (Board) under OMB delegated authority, as per 5 CFR 1320.16 (OMB Regulations on Controlling Paperwork Burdens on the Public). Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the Paperwork Reduction Act Submission, supporting statements and approved collection of information instruments are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. FOR FURTHER INFORMATION CONTACT: Federal Reserve Board Clearance Officer --Michelle Shore--Division of Research and Statistics, Board of Governors of the Federal Reserve System, Washington, DC 20551 (202-452-3829). OMB Desk Officer--Alexander T. Hunt--Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503. Final approval under OMB delegated authority of the extension for three years, without revision, of the following reports: *1. Report title:* Notification of Nonfinancial Data Processing Activities *Agency form number:* FR 4021 *OMB control number:* 7100-0306 *Frequency:* On occasion *Reporters:* Bank holding companies *Annual reporting hours:* 4 hours *Estimated average hours per response:* 2 hours *Number of respondents:* 2 *General description of report:* This information collection is required to obtain a benefit. (12 U.S.C. 1843(c)(8),
(j)and (k)) and may be given confidential treatment upon request (5 U.S.C. 552(b)(4)). *Abstract:* Bank holding companies submit this notification to request permission to administer the 49-percent revenue limit on nonfinancial data processing activities on a business-line or multiple-entity basis. A request may be filed in a letter form; there is no reporting form for this information collection. *2. Report title:* Survey of Financial Management Behaviors of Military Personnel *Agency form number:* FR 1375 *OMB control number:* 7100-0307 *Frequency:* Semi-annually *Reporters:* Military personnel *Annual reporting hours:* 2,640 hours *Estimated average hours per response:* 20 minutes *Number of respondents:* 4,000 *General description of report:* This information collection is voluntary. The statutory basis for collecting this information is section 2A of the Federal Reserve Act [12 U.S.C. § 225a]; the Bank Merger Act [12 U.S.C. § 1828(c)]; and sections 3 and 4 of the Bank Holding Company Act [12 U.S.C. §§ 1842 and 1843 and 12 U.S.C. §§ 353 and 461]. No issue of confidentiality normally arises because names and any other characteristics that would permit personal identification of respondents will not be reported to the Board. *Abstract:* This survey gathers data from two groups of military personnel:
(1)those completing a financial education course as part of their advanced training and
(2)those not completing a financial education course. These two groups are surveyed on their financial management behaviors and changes in their financial situations over time. Data from the survey help to determine the effectiveness of financial education for young adults in the military and the durability of the effects as measured by financial status of those receiving financial education early in their military careers. *3. Report title:* Survey to Obtain Information on the Relevant Market in Individual Merger Cases *Agency form number:* FR 2060 *OMB control number:* 7100-0232 *Frequency:* On occasion *Reporters:* Small businesses and consumers *Annual reporting hours:* 18 hours *Estimated average hours per response:* Small businesses, 10 minutes; Consumers, 6 minutes. *Number of respondents:* 25 small businesses and 50 consumers per survey *General description of report:* This information collection is voluntary (12 U.S.C. 1817(j), 1828(c), and 1842)) and is given confidential treatment (5 U.S.C. 552 (b)(4) and (b)(6)). *Abstract:* The Federal Reserve uses this information to define relevant banking markets for specific merger and acquisition applications and to evaluate changes in competition that would result from proposed transactions. *4. Report title:* Notice of Branch Closure *Agency form number:* FR 4031 *OMB control number:* 7100-0264 *Frequency:* On occasion *Reporters:* State member banks *Annual burden hours:* 423 hours *Estimated average hours per response:* Reporting requirements, 2 hours; Disclosure requirements, 1 hour; Recordkeeping requirements, 8 hours. *Number of respondents:* 124 *General description of report:* This information collection is mandatory (12 U.S.C. 1831r-l(a)(1)) and may be given confidential treatment upon request (5 U.S.C. 552(b)(4)). *Abstract:* The mandatory reporting, recordkeeping, and disclosure requirements regarding the closing of any branch of an insured depository institution are imposed by section 228 of the Federal Deposit Insurance Corporation Improvement Act of 1991. There is no reporting form associated with the reporting portion of this information collection; state member banks notify the Federal Reserve by letter prior to closing a branch. The Federal Reserve uses the information to fulfill its statutory obligation to supervise state member banks. *5. Report title:* Reports Related to Securities of State Member Banks as Required by Regulation H *Agency form number:* Reg H-1 *OMB Control number:* 7100-0091 *Frequency:* Quarterly and on occasion *Reporters:* State member banks *Annual reporting hours:* 1,477 hours *Estimated average hours per response:* 5.11 hours *Number of respondents:* 17 *General description of report:* This information collection is mandatory (15 U.S.C. 781(i)) and is not given confidential treatment. *Abstract:* The Federal Reserve's Regulation H requires certain state member banks to submit information relating to their securities to the Federal Reserve on the same forms that bank holding companies and nonbank entities use to submit similar information to the Securities and Exchange Commission. The information is primarily used for public disclosure and is available to the public upon request. *Current Actions:* On March 9, 2007, the Federal Reserve published a notice in the Federal Register (72 FR 10762) requesting public comment for 60 days on the extension, without revision, of the: FR 4021, FR 1375, FR 2060, FR 4031, and Reg H-1. The comment period for this notice expired on May 8, 2007. No substantive comments were received. Board of Governors of the Federal Reserve System, May 11, 2007. Jennifer J. Johnson Secretary of the Board. [FR Doc. E7-9444 Filed 5-16-07; 8:45 am] BILLING CODE 6210-01-S FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 *et seq.* ) (BHC Act), Regulation Y (12 CFR Part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below. The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The application also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Additional information on all bank holding companies may be obtained from the National Information Center website at *www.ffiec.gov/nic/* . Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than June 11, 2007. **A. Federal Reserve Bank of Dallas** (W. Arthur Tribble, Vice President) 2200 North Pearl Street, Dallas, Texas 75201-2272: *1. Umphrey II Family Limited Partnership and Hillister Enterprises II, Inc.* , Beaumont, Texas; to become bank holding companies by acquiring 19.61 percent of the voting shares of CBFH, Inc., Beaumont, Texas, and thereby indirectly acquire voting shares of County Bancshares, Inc., Newton, Texas; Newton Delaware Financial Corporation, Dover, Delaware; and CountyBank, National Association, Newton, Texas. In connection with this application, CBFH, Inc., Beaumont, Texas, also has applied to become a bank holding company by acquiring 100 percent of the voting shares of County Bancshares, Inc., Newton, Texas, and thereby indirectly acquire voting shares of Newton Delaware Financial Corporation, Dover, Delaware, and CountyBank, National Association, Newton, Texas. Board of Governors of the Federal Reserve System, May 11, 2007. Jennifer J. Johnson, Secretary of the Board. [FR Doc. E7-9441 Filed 5-17-07; 8:45 am] BILLING CODE 6210-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary [Document Identifier: OS-0990-0000] 30-Day Notice AGENCY: Office of the Secretary, HHS. ACTION: Agency information collection activities: proposed collection; comment request. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects:
(1)The necessity and utility of the proposed information collection for the proper performance of the agency's functions;
(2)the accuracy of the estimated burden;
(3)ways to enhance the quality, utility, and clarity of the information to be collected; and
(4)the use of automated collection techniques or other forms of information technology to minimize the information collection burden. *Type of Information Collection Request:* New collection. *Title of Information Collection:* Understanding Barriers and Successful Strategies for Faith-Based Organizations in Accessing Grants. *Form/OMB No.:* OS-0990-0000. *Use:* The Understanding Barriers and Successful Strategies for Faith-Based Organizations
(FBOs)in Accessing Grants study will identify perceived or underlying barriers faith-based organizations may face in applying for federal discretionary grants, as well as identify the strategies and approaches used by successful applicants. The data gathered will help Health and Human Services understand the effectiveness of its past internal efforts to ensure that FBOs had equal access to grants, and whether additional steps should be considered. Additionally, this study should provide future FBO grant applicants, as well as other nonprofit organizations, information that could be used to improve the quality of their grant applications and their capacity to seek federal funding. *Frequency:* Single time. *Affected Public:* Not-for-profit institutions. *Annual Number of Respondents:* 290. *Total Annual Responses:* 290. *Average Burden Per Response:* 35.2 minutes. *Total Annual Hours:* 170. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, e-mail your request, including your address, phone number, OMB number, and OS document identifier, to *Sherette.funncoleman@hhs.gov* , or call the Reports Clearance Office on
(202)690-6162. Written comments and recommendations for the proposed information collections must be received within 30 days of this notice directly to the Desk Officer at the address below: OMB Desk Officer: John Kraemer, OMB Human Resources and Housing Branch, Attention: (OMB #0990-0000), New Executive Office Building, Room 10235, Washington DC 20503. Dated: May 10, 2007. Alice Bettencourt, Office of the Secretary, Paperwork Reduction Act Reports Clearance Officer. [FR Doc. E7-9529 Filed 5-16-07; 8:45 am] BILLING CODE 4154-07-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Toxicology Program
(NTP)Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); the Murine Local Lymph Node Assay: Request for Comments, Nominations of Scientific Experts, and Submission of Data AGENCY: National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). ACTION: Request for comments, submission of relevant data, and nominations of scientific experts. SUMMARY: The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) received a nomination from the U.S. Consumer Product Safety Commission
(CPSC)to evaluate the validation status of:
(1)The murine local lymph node assay
(LLNA)as a stand-alone assay for determining potency (including severity) for the purpose of hazard classification;
(2)the “cut-down” or “limit dose” LLNA approach;
(3)non-radiolabeled LLNA methods;
(4)the use of the LLNA for testing mixtures, aqueous solutions, and metals; and
(5)the current applicability domain (i.e., the types of chemicals and substances for which the LLNA has been validated). ICCVAM reviewed the nomination, assigned it a high priority, and proposed that NICEATM and ICCVAM carry out the following activities in its evaluation:
(1)Initiate a review of the current literature and available data, including the preparation of a comprehensive background review document, and
(2)convene a peer review panel to review the various proposed LLNA uses and procedures for which sufficient data and information are available to adequately assess their validation status. ICCVAM also recommends development of performance standards for the LLNA. At this time, NICEATM requests:
(1)Public comments on the appropriateness and relative priority of these activities,
(2)nominations of expert scientists to consider as members of a possible peer review panel, and
(3)submission of data for the LLNA and/or modified versions of the LLNA. DATES: Submit comments, data, and nominations by June 15, 2007. Relevant data will also be accepted after this date and considered when feasible. ADDRESSES: Dr. William S. Stokes, NICEATM Director, NIEHS, P.O. Box 12233, MD EC-17, Research Triangle Park, NC 27709,
(fax)919-541-0947, (e-mail) *niceatm@niehs.nih.gov.* Courier address: NICEATM, 79 T.W. Alexander Drive, Building 4401, Room 3128, Research Triangle Park, NC 27709. Responses can be submitted electronically at the ICCVAM-NICEATM Web site: *http://iccvam.niehs.nih.gov/contact/FR_pubcomment.htm* or by e-mail, mail, or fax. FOR FURTHER INFORMATION CONTACT: Other correspondence should be directed to Dr. William S. Stokes (919-541-2384 or *niceatm@niehs.nih.gov* ). SUPPLEMENTARY INFORMATION: Background ICCVAM previously evaluated the validation status of the LLNA as a stand-alone alternative method to the Guinea Pig Maximization Test
(GPMT)and the Buehler Assay (NIH publication No. 99-4494; available at *http://iccvam.niehs.nih.gov/methods/immunotox/llna.htm* ). Based on this evaluation, ICCVAM recommended the LLNA as a valid substitute for the guinea pig methods for most testing situations. The Environmental Protection Agency, Food and Drug Administration, and the CPSC subsequently accepted the method as a valid substitute. The OECD also adopted the LLNA as OECD Test Guideline 429. In January 2007, the CPSC submitted a nomination to NICEATM ( *http://iccvam.niehs.nih.gov/SuppDocs/submission.htm* ) requesting that ICCVAM assess the validation status of: • The LLNA as a stand-alone test for potency determinations (including severity) for the purpose of hazard classification. • LLNA protocols that do not require the use of radioactive materials. • The LLNA “cut-down” or “limit dose” procedure. • The ability of the LLNA to test mixtures, aqueous solutions, and metals. • The current applicability domain (i.e., the types of chemicals and substances for which the LLNA has been determined to be useful). Since 2003, ICCVAM has routinely developed performance standards for test methods; however, they were not developed for the LLNA, which was reviewed in 1999. Accordingly, ICCVAM proposes to now develop performance standards for the LLNA. Performance standards communicate the basis by which new proprietary and nonproprietary test methods have been determined to have sufficient relevance and reliability for specific testing purposes. Performance standards based on test methods accepted by regulatory agencies can be used to evaluate the reliability and relevance of other test methods that are based on similar scientific principles and measure or predict the same biological or toxic effect. On January 24, 2007, ICCVAM unanimously endorsed with a high priority:
(1)Developing performance standards for the LLNA and
(2)initiating a review of the available data and information associated with the CPSC nominated activities. A determination of which (if any) of the nominated activities will move forward will be made subsequent to this review and after consideration of comments by the public and the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM). If a decision is made to proceed with evaluation of these test methods, ICCVAM and NICEATM propose convening a peer review panel to review the usefulness and limitations of each of the LLNA methods listed above. The panel would also formulate conclusions on the adequacy of draft ICCVAM performance standards, any proposed future validation studies, and draft ICCVAM-proposed standardized test method protocols. Request for Public Comments and Nominations of Scientific Experts NICEATM requests public comments on the appropriateness and relative priority of the nominated activities. NICEATM also requests the nominations of scientists with relevant knowledge and experience to serve on the panel if a panel meeting occurs. Areas of relevant expertise include, but are not limited to: physiology, pharmacology, immunology, skin sensitization testing in animals, development and use of in vitro methodologies, biostatistics, knowledge about the use of chemical datasets for validation of toxicity studies, and hazard classification of chemicals and products. Each nomination should include the person's name, affiliation, contact information (i.e., mailing address, e-mail address, telephone and fax numbers), curriculum vitae, and a brief summary of relevant experience and qualifications. Request for Data NICEATM invites the submission of data from standard LLNA testing (i.e., OECD TG 429) with mixtures, aqueous solutions, and/or metals, as well as corresponding data from human and other animal studies. In addition, NICEATM invites the submission of data supporting the use of
(1)the LLNA as a stand-alone test for determining potency (including severity) for the purpose of hazard classification,
(2)the LLNA “cut-down” or “limit dose” procedure, and
(3)LLNA protocols that do not require the use of radioactivity. Although data can be accepted at any time, data submitted by June 15, 2007, will be considered during the ICCVAM evaluation process. Submitted data will be used to further evaluate the usefulness and limitations of the LLNA and may be incorporated into future NICEATM and ICCVAM reports and publications as appropriate. The data will also be included in a database to support the investigation of other test methods for assessing skin sensitization. When submitting chemical and protocol information/test data, please reference this **Federal Register** notice and provide appropriate contact information (name, affiliation, mailing address, phone, fax, e-mail, and sponsoring organization, as applicable). NICEATM prefers data to be submitted as copies of pages from study notebooks and/or study reports, if available. Raw data and analyses available in electronic format may also be submitted. Each submission for a chemical should preferably include the following information, as appropriate: • Common and trade name. • Chemical Abstracts Service Registry Number (CASRN). • Chemical class. • Product class. • Commercial source. • LLNA protocol used. • Individual animal responses. • The extent to which the study complied with national or international Good Laboratory Practice
(GLP)guidelines. • Date and testing organization. • Sensitization data from other test methods. Consideration by SACATM On June 12, 2007, SACATM will meet at the Marriott Bethesda North Hotel and Conference Center in Bethesda, Maryland. The agenda includes consideration of the nominated LLNA activities, priorities, and proposed activities *http://ntp.niehs.nih.gov/go/7441* ) and an opportunity for oral public comments. The SACATM meeting was announced in a separate **Federal Register** notice ( **Federal Register** Vol. 72, No. 83, pp. 23831-32, May 1, 2007). Background Information on ICCVAM and NICEATM ICCVAM is an interagency committee composed of representatives from 15 federal regulatory and research agencies that use or generate toxicological information. ICCVAM conducts technical evaluations of new, revised, and alternative methods with regulatory applicability and promotes the scientific validation and regulatory acceptance of toxicological test methods that more accurately assess the safety and hazards of chemicals and products and that refine, reduce, or replace animal use. The ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-3, available at *http://iccvam.niehs.nih.gov/about/PL106545.htm* ) establishes ICCVAM as a permanent interagency committee of the NIEHS under NICEATM. NICEATM administers ICCVAM and provides scientific and operational support for ICCVAM-related activities. NICEATM and ICCVAM work collaboratively to evaluate new and improved test methods applicable to the needs of federal agencies. Additional information about ICCVAM and NICEATM is available on the following Web site: *http://iccvam.niehs.nih.gov* . Dated: May 8, 2007. David A. Schwartz, Director, National Institute of Environmental Health Sciences and National Toxicology Program. [FR Doc. E7-9544 Filed 5-16-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel: Evaluation of Vaccination Reminder/Recall Systems for Adolescent Patients, Funding Opportunity Announcement
(FOA)IP07-007, Strategies to Reach the “Unreachable” Through Immunization Registries, FOA IP07-010, and Using Provider Reminder/Recall to Enhance Up-to-Date Coverage of 18-Month Olds, FOA IP07-012 In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention
(CDC)announces a meeting of the aforementioned Special Emphasis Panel. *Time and Date:* 12 p.m.-4 p.m., June 18, 2007 (Closed). *Place:* Teleconference. *Status:* The meeting will be closed to the public in accordance with provisions set forth in section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Matters to be Discussed:* The meeting will include the review, discussion, and evaluation of research grant applications in response to FOA IP07-007, “Evaluation of Vaccination Reminder/Recall Systems for Adolescent Patients,” FOA IP07-010, “Strategies to Reach the “Unreachable” Through Immunization Registries,” and FOA IP07-012, “Using Provider Reminder/Recall to Enhance Up-to-Date Coverage of 18-Month Olds.” *For Further Information Contact:* Trudy Messmer, Ph.D., Designated Federal Official, 1600 Clifton Road, Mailstop C-19, Atlanta, GA 30333, telephone
(404)639-3770. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: May 10, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7-9498 Filed 5-16-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Healthcare Infection Control Practices Advisory Committee (HICPAC): Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention
(CDC)announces the aforementioned meeting. *Times and Dates:* 8:30 a.m.-5 p.m., June 11, 2007. 8:30 a.m.-3 p.m., June 12, 2007. *Place:* CDC Roybal Campus, Bldg 19, Auditorium B3, 1600 Clifton Road, NE., Atlanta, GA 30333. *Status:* Open to the public, limited only by the space available. *Purpose:* The Committee is charged with providing advice and guidance to the Secretary, the Assistant Secretary for Health, the Director, CDC, and the Director, National Center for Infectious Diseases (NCID), regarding
(1)the practice of hospital infection control;
(2)strategies for surveillance, prevention, and control of infections (e.g., nosocomial infections), antimicrobial resistance, and related events in settings where healthcare is provided; and
(3)periodic updating of guidelines and other policy statements regarding prevention of healthcare-associated infections and healthcare-related conditions. *Matters to be Discussed:* Agenda items will include: Guideline Planning, Discussion of Norovirus Guideline, Discussion of Urinary Track Infection Guideline, Healthcare Infection Control Information Technology follow up and Surveillance Definitions discussion. Agenda items are subject to change as priorities dictate. *Contact Person for More Information:* Angela B. Scott, Committee Management Specialist, HICPAC, Division of Healthcare Quality Promotion, NCID, CDC, l600 Clifton Road, NE., M/S A-07, Atlanta, GA 30333, telephone 404/639-1526. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Dated: May 10, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7-9479 Filed 5-16-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; Comment Request; Physicians' Experience of Ethical Dilemmas and Resource Allocation SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Dental and Craniofacial Research (NIDCR), the National Institutes of Health
(NIH)will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget
(OMB)for review and approval. Proposed Collection *Title:* Physicians' Experience of Ethical Dilemmas and Resource Allocation. *Type of Information Collection Request:* New. *Need and Use of Information Collection:* Health care costs are rising ceaselessly and there are currently no generally accepted way of controlling them. This study will access the experience of physicians regarding resource allocation in clinical practice, and how allocation decisions made at other levels shapes this experience. The primary objectives of the study are to determine if physicians make decisions to withhold interventions on the basis of cost, how often they report doing so, what types of care are withheld, and what criteria are used in making such decisions. The findings will provide valuable information concerning:
(1)The practice of resource allocation in clinical practice,
(2)the possible effects of perceived constraints on this practice, and
(3)international comparisons on these two aspects. *Frequency of Response:* Once. *Affected Public:* Individuals or households; Businesses or other for-profit; Not-for-profit institutions. *Type of Respondents:* Physicians. The annual reporting burden is as follows: *Estimated Number of Respondents:* 250; *Estimated Number of Responses per Respondent:* 1; *Average Burden Hours Per Response:* .0.3674; and E *stimated Total Annual Burden Hours Requested:* 91.85. The annualized cost to respondents is estimated at: $5,218. There are no Capital Costs, Operating Costs and/or Maintenance Costs to report. A.12-1.—Estimates of Hour Burden Type of respondents Number of respondents Frequency of response Average time per response Annual hour burden Physicians (internists) 250 1 0.3674 91.85 Total 250 91.85 *Request for Comments:* Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points:
(1)Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility;
(2)The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3)Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4)Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Dr. Marion Danis, Department of Clinical Bioethics, Building 10, room 1C118, National Institutes of Health, Bethesda, MD 20892, or call non-toll-free number 301-435-8727 or e-mail your request, including your address to: *mdanis@cc.nih.gov.* *Comments Due Date:* Comments regarding this information collection are best assured of having their full effect if received within 60-days of the date of this publication. David K. Henderson, Deputy Director, Warren G. Magnuson Clinical Center, National Institutes of Health. Ezekiel J. Emanuel, Director, Department of Clinical Bioethics, Warren G. Magnuson Clinical Center, National Institutes of Health. [FR Doc. E7-9543 Filed 5-16-07; 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. Humanized Anti-Carcinoma CC49 Monoclonal Antibodies *Description of Technology:* The technology describes the humanization of a murine anti-carcinoma antibody CC49 which has been shown to react with Tumor Associated Glycoprotein 72 (TAG-72), an antigen which is expressed on human breast, ovarian, colorectal, and other carcinomas. The invention includes a new method of humanization of a rodent antibody which is based on grafting all the Complementarity Determining Residues
(CDRs)of a rodent antibody onto a human antibody framework. Additionally, the method identifies Specificity Determining Residues (SDRs), the amino acid residues in the hypervariable regions of an antibody that are most critical for antigen binding activity and of rendering any antibody minimally immunogenic in humans by transferring the SDRs of the antibody to a human antibody framework. The resulting humanized antibodies, including CDR variants thereof (including a CH2 deleted version), are also embodied in the invention, as are methods of using the antibodies for therapeutic and diagnostic purposes. Furthermore, these antibodies are suitable for radiolabeling for the application in radioimmunotherapy
(RIT)based treatment of several cancers. Phase I results of radioimmunotherapy for ovarian cancer using 90 Yttrium-CC49 murine monoclonal antibodies have shown promising results and confirms feasibility of the use of these antibodies for RIT. Promising pharmacokinetic data for the radiolabeled humanized antibodies in colon carcinoma xenograft models were recently published. Applications and Modality 1. A humanized anti-cancer CC49 monoclonal antibody has been developed. 2. New methods of humanization of rodent antibodies have been identified. 3. The antibody(s) has been shown to react with Tumor Associated Glycoprotein 72 (TAG-72), an antigen which is expressed on human breast, ovarian, colorectal, and other carcinomas. 4. These antibodies are suitable for radiolabeling for the application in radioimmunotherapy
(RIT)based treatment of several cancers. 5. These antibodies can be useful in diagnosis and treatment of several cancers. *Development Status:* The technology is currently in the pre-clinical stage of development. Phase I results of radioimmunotherapy for ovarian cancer using 90 Yttrium-CC49 murine monoclonal antibodies have shown promising results and confirms feasibility of the use of these antibodies for radioimmunotherapy (RIT). *Inventors:* Syed V. Kashmiri (NCI), Eduardo A. Padlan (NIDDK), Jeffrey Schlom (NCI). Publications 1. RD Alvarez *et al.* A Phase I study of combined modality 90 Yttrium-CC49 intraperitoneal radioimmunotherapy for ovarian cancer. Clin Cancer Res. 2002 Sep; 8(9):2806-2811. 2. A Forero *et al.* A novel monoclonal antibody design for radioimmunotherapy. Cancer Biother Radiopharm. 2003 Oct;18(5):751-759. 3. PC Chinn *et al.* Pharmacokinetics and tumor localization of
(111)in-labeled HuCC49DeltaC(H)2 in BALB/c mice and athymic murine colon carcinoma xenograft. Cancer Biother Radiopharm. 2006 Apr;21(2):106-116. Patent Status 1. U.S. Patent No. 6,818,749 issued November 16, 2004 and U.S. Patent Application 10/927,433 filed August 25, 2004 as well as issued and pending foreign counterparts [HHS Ref. No. E-259-1998]; 2. European Patent No. 00365997 issued September 14, 1994 and its counterpart in Japan [HHS Ref. Nos. D-003-1992/0-EP-07 and D-003-1992/0-JP-05]; 3. U.S. Patent No. 5,472,693 issued December 5, 1995 [HHS Ref. No. D-003-1992/2-US-01]; 4. U.S. Patent No. 6,051,225 issued April 18, 2000 [HHS Ref. No. D-003-1992/3-US-01]; 5. U.S. Patent No. 5,993,813 issued November 30, 1999 [HHS Ref. No. D-003-1992/2-US-02]; 6. U.S. Patent No. 6,641,999 issued November 4, 2003 [HHS Ref. No. D-003-1992/2-US-04]; 7. European Patent No. 628078 issued December 8, 1999 and its counterparts in Japan, Canada and Australia [HHS Ref. Nos. D-004-1992/0-EP-06, D-004-1992/0-JP-03, D-004-1992/0-CA-04 and D-004-1992/0-AU-05]; 8. U.S. Patent No. 5,877,291 issued March 2, 1999 [HHS Ref. No. D-004-1992/1-US-01]; 9. U.S. Patent No. 5,892,020 issued April 6, 1999 [HHS Ref. No. D-004-1992/1-US-01] and its foreign counterparts; 10. Taiwanese Patent No. 173667 issued July 10, 2003 [HHS Ref. No. D-001-1996/0-TW-03]; 11. U.S. Patent No. 6,737,060 issued May 18, 2004 [HHS Ref. No. D-001-1996/1-US-03]; 12. U.S. Patent No. 6,737,061 issued May 18, 2004 [HHS Ref. No. D-001-1996/1-US-04]; 13. U.S. Patent No. 6,753,152 issued June 22, 2004 [HHS Ref. No. D-001-1996/1-US-05]; 14. U.S. Patent No. 6,752,990 issued June 22, 2004 [HHS Ref. No. D-001-1996/1-US-06]; 15. U.S. Patent No. 6,329,507 issued December 11, 2001 [HHS Ref. No. D-001-2006/0-US-01] and 16. U.S. Patent No. 6,071,515 issued June 6, 2000 [HHS Ref. No. D-001-2006/0-US-03]. *Licensing Availability:* Available for exclusive and non-exclusive licensing. *Licensing Contact:* Michelle Booden, PhD.; 301/451-7337; *boodenm@mail.nih.gov* *Collaborative Research Opportunity:* The National Cancer Institute's Laboratory of Tumor Immunology and Biology is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize anti-carcinoma antibodies. Please contact John D. Hewes, Ph.D. at 301-435-3121 or *hewesj@mail.nih.gov* for more information. Enhanced T-cell Activation by Costimulation: an Effective Immunotherapy for Cancer and Infectious Diseases *Description of Technology:* Cancer immunotherapy is a recent approach where tumor associated antigens (TAAs), which are primarily expressed in human tumor cells and not expressed or minimally expressed in normal tissues, are employed to generate a tumor specific immune response. Specifically, these antigens serve as targets for the host immune system and elicit responses that result in tumor destruction. The initiation of an effective T-cell immune response to antigens requires two signals. The first one is antigen specific via the peptide/major histocompatibility complex and the second or “costimulatory” signal is required for cytokine production, proliferation, and other aspects of T-cell activation. The present technology describes recombinant poxvirus vectors encoding at least three or more costimulatory molecules and TAAs. The use of three costimulatory molecules such as B7.1, ICAM-1 and LFA-3 (TRICOM®) has been shown to act in synergy with several tumor antigens and antigen epitopes to activate T cells. The effects with TRICOM® were significantly greater than with one or two costimulatory molecules. Laboratory results support the greater effect of TRICOM® to activate both CD4+ and CD8+ T cells. The invention also describes the use of at least one target antigen or immunological epitope as an immunogen or vaccine in conjunction with TRICOM®. The antigens include but are not limited to carcinoembryonic antigen (CEA), prostate-specific antigen (PSA), and MUC-1. The combination of CEA, MUC-1, and TRICOM® is referred to as PANVAC® and the combination of PSA and TRICOM® is referred to as PROSTVAC®. *Licensing Availability:* The technology is available for exclusive and non-exclusive licensing in combinations and for different fields of use. Some potential licensing opportunities are as follows: 1. TRICOM® (alone or with a transgene for a tumor antigen and/or an immunostimulatory molecule); 2. The antigens only, including but not limited to CEA, PSA, and MUC-1; 3. PANVAC® and/or PROSTVAC®; and 4. Recombinant fowlpox-GM-CSF. *Application(s) and Modality:* Vector-based TRICOM® (alone or with a transgene for a tumor antigen and/or an immunostimulatory molecule), PANVAC® and PROSTVAC® and combinations thereof can be a potential novel immunotherapeutic approach for the treatment of cancer and infectious diseases. Advantages 1. The technology is beyond proof-of-concept, supported by laboratory results and publications. 2. Phase I and Phase II clinical data available. 3. Fewer validation studies are required compared to other immunotherapy related technologies. *Development Status:* Phase I and Phase II results available for poxvirus recombinants containing transgenes for TRICOM®, CEA-TRICOM®, PANVAC®, and PROSTVAC®. Further clinical studies are ongoing for other combinations. *Inventors:* Jeffrey Schlom
(NCI)*et al.* Publications 1. Kaufman HL, Cohen S, Cheung K, DeRaffele, Mitcham J, Moroziewicz D, Schlom J, and Hesdorffer C. Local delivery of vaccinia virus expressing multiple costimulatory molecules for the treatment of established tumors. *Human Gene Ther.* 17:239-244, 2006. 2. Kantoff PW GL, Tannenbaum SI, Bilhartz DL, Pittman WG, Schuetz TJ. Randomized, double-blind, vector-controlled study of targeted immunotherapy in patients
(pts)with hormone-refractory prostate cancer (HRPC). 2006 ASCO Annual Meeting Proceedings, Part I, abstract 2501. * J Clin Oncol.* ; 24. 3. Marshall J, Gulley JL, Arlen PM, Beetham PK, Tsang KY, Slack R, Hodge JW, Doren S, Grosenbach DW, Hwang J, Fox E, Odogwa L, Park S, Panicali D, Schlom J. A phase I study of sequential vaccinations with fowlpox-CEA(6D)-TRICOM (B7-1/ICAM-1/LFA-3) alone and sequentially with vaccinia-CEA(6D)-TRICOM, with and without GM-CSF, in patients with CEA-expressing carcinomas. *J Clin Oncol.* 23:720-731, 2005. 4. Palena C, Foon KA, Panicali D, Yafal AG, Chinsangaram J, Hodge JW, Schlom J, and Tsang KY. A potential approach to immunotherapy of chronic lymphocytic leukemia (CLL): enhanced immunogenicity of CLL cells via infection with vectors encoding for multiple costimulatory molecules. *Blood* 106:3515-3523, 2005. 5. Gulley J, Todd N, Dahut W, Schlom J, Arlen P. A phase II study of PROSTVAC-VF vaccine, and the role of GM-CSF, in patients
(pts)with metastatic androgen insensitive prostate cancer
(AIPC)[abstract]. *J Clin Oncol.* 2005; 23 (16S Pt 1): 2504. 6. Yang S, Hodge JW, Grosenbach DW, and Schlom J. Vaccines with enhanced costimulation maintain high avidity memory CTL. *J. Immunol.* 175:3715-3723, 2005. 7. Yang S, Tsang KY, and Schlom J. Induction of higher avidity human CTL by vector-mediated enhanced costimulation of antigen-presenting cells. *Clin Cancer Res.* 11:5603-5615, 2005. 8. Hodge JW, Chakraborty M, Kudo-Saito C, Garnett CT, Schlom J. Multiple costimulatory modalities enhance CTL avidity. *J Immunol.* 174:5994-6004, 2005. 9. Tsang K-Y, Palena C, Yokokawa J, Arlen PM, Gulley JL, Mazzara GP, Gritz L, Gómez Yafal A, Ogueta S, Greenhalgh P, Manson K, Panicali D, and Schlom J. Analyses of recombinant vaccinia and fowlpox vaccine vectors expressing transgenes for two human tumor antigens and three human costimulatory molecules. *Clin Cancer Res.* 11:1597-1607, 2005. 10. Chakraborty M, Abrams SI, Coleman CN, Camphausen K, Schlom J, Hodge JW. External beam radiation of tumors alters phenotype of tumor cells to render them susceptible to vaccine-mediated T-cell killing. *Cancer Res.* 64:4328-4337, 2004. 11. Zeytin HE, Patel AC, Rogers CJ, et al. Combination of a poxvirus-based vaccine with a cyclooxygenase-2 inhibitor (celecoxib) elicits antitumor immunity and long-term survival in CEA.Tg/MIN mice. *Cancer Res.* 64:3668-3678, 2004. 12. Palena C, Zhu M-Z, Schlom J, and Tsang K-Y. Human B cells that hyperexpress a triad of costimulatory molecules via avipoxvector infection: an alternative source of efficient antigen-presenting cells. *Blood* 104:192-199, 2004. 13. Kudo-Saito C, Schlom J, and Hodge JW. Intratumoral vaccination and diversified subcutaneous/intratumoral vaccination with recombinant poxviruses encoding a tumor antigen and multiple costimulatory molecules. *Clin Cancer Res.* 10:1090-1099, 2004. 14. Hodge JW, Poole DJ, Aarts WM, Gomez Yafal A, Gritz L, and Schlom J. Modified vaccinia virus ankara recombinants are as potent as vaccinia recombinants in diversified prime and boost vaccine regimens to elicit therapeutic antitumor responses. *Cancer Res.* 63:7942-7949, 2003. 15. Hodge JW, Grosenbach DW, Aarts Wm, Poole DJ, and Schlom J. Vaccine therapy of established tumors in the absence of autoimmunity. *Clin Cancer Res.* 9:1837-1849, 2003. 16. Aarts WM, Schlom J, and Hodge JW. Vector-based vaccine/cytokine combination therapy to enhance induction of immune responses to a self-antigen and anti-tumor activity. *Cancer Res.* 62:5770-5777, 2002. 17. Hodge JW, Sabzevari H, Yafal AG, Gritz L, Lorenz MG, Schlom J. A triad of costimulatory molecules synergize to amplify T-cell activation. *Cancer Res.* 59: 5800-5807, 1999. Patent Status 1. U.S. Patent No. 6,969,609 issued November 29, 2005 as well as issued and pending foreign counterparts [HHS Ref. No. E-256-1998/0]; 2. U.S. Patent Application No. 11/321,868 filed December 30, 2005 [HHS Ref. No. E-256-1998/1]; and 3. U.S. Patent No. 6,756,038 issued June 29, 2004 as well as issued and pending foreign counterparts [HHS Ref. No. E-099-1996/0]; 4. U.S. Patent No. 6,001,349 issued December 14, 1999 as well as issued and pending foreign counterparts [HHS Ref. No E-200-1990/3-US-01]; 5. U.S. Patent No. 6,165,460 issued December 26, 2000; as well as issued and pending foreign counterparts [HHS Ref. No E-200-1990/4-US-01]; 6. U.S. Patent No. 7,118,738 issued October 10, 2006 as well as issued and pending foreign counterparts [HHS Ref. No E-154-1998/0-US-07]; 7. PCT Application No. PCT/US97/12203 filed July 15, 1997 [HHS Ref. No E-259-1994/3-PCT-02]; 8. U.S. Patent Application Nos. 10/197,127 and 08/686,280 filed July 17, 2002 and July 25, 1996 [HHS Ref. No E-259-1994/3-US-08 and /4-US-01]; 9. U.S. Patent No. 6,946,133 issued September 20, 2005 as well as issued and pending foreign counterparts [HHS Ref. No E-062-1996/0-US-01]; 10. U.S. Patent Application No. 11/606,929 filed December 1, 2006 [E-062-1996/0-US-11]; 11. U.S. Patent Nos. 6,893,869, 6,548,068 and 6,045,802 issued May 17, 2005, April 15, 2003 and April 4, 2000 respectively, as well as issued and pending foreign counterparts [HHS Ref. Nos. E-260-1994/1-US-03, US-02, US-01]; and 12. U.S. Patent. Application No. 11/090,686 filed March 8, 2005 [HHS Ref. No E-260-1994/1-US-04]. *Licensing Contact:* Michelle Booden, PhD, 301/451-7337; *boodenm@mail.nih.gov.* *Cooperative Research and Development Agreement (CRADA) Opportunity:* A CRADA partner for the further co-development of this technology is currently being sought by the Laboratory of Tumor Immunology and Biology, Center for Cancer Research, NCI. The CRADA partner will: 1. Generate and characterize recombinant poxviruses expressing specific tumor-associated antigens, cytokines, and/or T-cell costimulatory factors, 2. Analyze the recombinant poxviruses containing these genes with respect to appropriate expression of the encoded gene product(s), 3. Supply adequate amounts of recombinant virus stocks for preclinical testing, 4. Manufacture and test selected recombinant viruses for use in human clinical trials, 5. Submit Drug Master Files detailing the development, manufacture, and testing of live recombinant vaccines to support the NCI-sponsored INDs, 6. Supply adequate amounts of clinical grade recombinant poxvirus vaccines for clinical trials conducted at the NCI Center for Cancer Research (CCR), and 7. Provide adequate amounts of vaccines for extramural clinical trials through a clinical agreement with the Division of Cancer Treatment and Diagnosis, NCI. NCI will: 1. Provide genes of tumor-associated antigens, cytokines and other immunostimulatory molecules for incorporation into poxvirus vectors, 2. Evaluate recombinant vectors in preclinical models alone and in combination therapies, 3. Conduct clinical trials of recombinant vaccines alone and in combination therapies, and 4. Provide Drug Master Files currently supporting the clinical use of the recombinant poxvirus vaccines. If interested in the above described CRADA, please submit a statement of interest and capability to Kevin Chang, PhD, in the NCI Technology Transfer Center at *changke@mail.nih.gov* or 301-496-0477. Dated: May 11, 2007. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E7-9541 Filed 5-16-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Complementary and Alternative Medicine; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following 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:* National Center for Complementary and Alternative Medicine Special Emphasis Panel; Basic Science. *Date:* June 11-12, 2007. *Time:* 8 a.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* Courtyard Marriott, Washingtonian Center, 240 Boardwalk Place (Rio), Gaithersburg, MD 20878. *Contact Person:* Dale L. Birkle, Ph.D, Scientific Review Administrator, Office of Scientific Review, National Center for Complementary, and Alternative Medicine, NIH, 6707 Democracy Blvd., Suite 401, Bethesda, MD 20892,
(301)451-6570. *birkled@mail.nih.gov.* *Name of Committee:* National Center for Complementary and Alternative Medicine Special Emphasis Panel; Centers of Excellence for Research on Complementary and Alternative Medicine. *Date:* June 20-22, 2007. *Time:* 8 a.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* Bethesda Marriott, 5151 Pooks Hill Road, Bethesda, MD 20814. *Contact Person:* Martina Schmidt, Ph.D, Scientific Review Administrator, Office of Scientific Review, National Center for Complementary, and Alternative Medicine, NIH, 6707 Democracy Blvd., Suite 401, Bethesda, MD 20892,
(301)594-3456. *schmidma@mail.nih.gov.* Dated: May 8, 2007. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 07-2427 Filed 5-16-07; 8:45 am]
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