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Code · REGISTER · 2007-07-20 · Office of Governmentwide Policy, General Services Administration (GSA) · Notices

Notices. Notice of intent and request for comments

13,945 words·~63 min read·/register/2007/07/20/07-3523

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

BILLING CODE 6715-07-M FEDERAL RESERVE SYSTEM Change in Bank Control Notices; Acquisition of Shares of Bank or Bank Holding Companies The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board’s Regulation Y (12 CFR 225.41) to acquire a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)). The notices are available for immediate inspection at the Federal Reserve Bank indicated.
The notices also will be available for inspection at the office of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than August 6, 2007. **A. Federal Reserve Bank of Chicago** (Burl Thornton, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414: *1. David A. Davis* , Muskego, Wisconsin; to acquire voting shares of Capital Commerce Bancorp, Inc., and thereby indirectly acquire voting shares of MW Bank, both of Milwaukee, Wisconsin.
Board of Governors of the Federal Reserve System, July 17, 2007. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E7-14066 Filed 7-19-07; 8:45 am] BILLING CODE 6210-01-S GENERAL SERVICES ADMINISTRATION Request for Comments on Proposed Federal Emergency Travel Guide AGENCY: Office of Governmentwide Policy, General Services Administration (GSA). ACTION: Notice of intent and request for comments. SUMMARY: The General Services Administration
(GSA)is proposing to create a Federal Emergency Travel Guide in the event of evacuation, catastrophic event or natural disaster. The guide is intended to prepare the Federal Government to continue official travel operations in an emergency situation while safeguarding Federal employees officially away from their official or temporary duty stations. The guide, non-regulatory in nature, will serve as a supplement to the Federal Travel Regulation
(FTR)(41 CFR chapters 300-304). DATES: Please submit comments by September 18, 2007. ADDRESSES: Written comments should be sent to Ms. Jane Groat, Travel Policy Management (MTT), Office of Governmentwide Policy, General Services Administration, 1800 F Street, NW., Washington, DC 20405. E-mail comments may be sent to *perdiem@gsa.gov* . Please entitle your letter or e-mail with “Federal Emergency Travel Guide comments”. FOR FURTHER INFORMATION CONTACT: Jane Groat, Travel Policy Management (MTT), telephone 202-501-4318. SUPPLEMENTARY INFORMATION: To access the draft guide, you may visit *http://www.gsa.gov/travelpolicy* (click Library). A hard copy of the draft guide is not available. GSA is interested to learn from Federal,
(1)how to improve the draft guide;
(2)whether Federal agencies and employees agree that the guide will be a useful tool;
(3)what Federal agencies already have related policies in place (and identify a web site)—employees on site in support of an incident of National significance are generally under the effect of a National Response Plan and follow those established guides;
(4)what kinds of things need to be added to the guide for governmentwide benefit; and
(5)any other related comment/suggestion. If you comment, please include your name, title, your capacity (i.e., an employee, an official, or an Emergency Response Team), telephone, agency, email and hard addresses. Are you commenting from personal experience as a traveler, a supervisor/manager, or an Emergency Response Team? Have you had a need for emergency guides? If you survived a horrific event or emergency, what help/assistance was needed the most, where did expectations and support fall short, and what would your recommendations be? If you are a private sector travel or transportation service provider to the Government, we will also welcome your comments. Dated: July 16, 2007. Patrick Mc Connell, Acting Director, Travel Policy Management. [FR Doc. E7-14052 Filed 7-19-07; 8:45 am] BILLING CODE 6820-14-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10224, CMS-10240 and CMS-10052] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Centers for Medicare & Medicaid Services, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services
(CMS)is publishing the following summary of proposed collections 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. 1. *Type of Information Collection Request:* New collection; *Title of Information Collection:* HCPCS Level II Code Modification Request Process; *Use:* For Medicare and other health insurance programs to ensure that claims are processed in an orderly and consistent manner, standardized coding systems are essential. The Healthcare Common Procedure Coding System (HCPCS) Level II Code Set is one of the standard code sets used for this purpose. Level II of the HCPCS, also referred to as alpha-numeric codes, is a standardized coding system that is used primarily to identify products, supplies, and services not included in the Current Procedural Terminology
(CPT)codes, such as ambulatory services and durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) when used in the home or outpatient setting. As technology evolves and new products are developed, there are continuous changes to the HCPCS codeset. Modifications to the HCPCS are initiated via application form submitted by any interested stakeholder. These applications have been received on an on-going basis with an annual deadline for each cycle. In October 2003, the Secretary of Health and Human Services delegated CMS authority to maintain and distribute HCPCS Level II Codes. As a result, the National Panel was delineated and CMS continued with the decision-making process under its current structure, the CMS HCPCS Workgroup. CMS' Council on Technological Innovation
(CTI)has instituted a number of improvements to the HCPCS process. Specific process refinements include public notification of CMS' preliminary decisions, and a new opportunity to respond to CMS' preliminary decisions at a public meeting before a final decision is reached by the workgroup. CMS has streamlined the form into a user-friendly application. The content of the material is the same, but the questions have been refined. CMS is also preparing a system of records
(SOR)notice. Applications are received, and distributed to all workgroup members. Workgroup members review the material and provide comments at the HCPCS workgroup meetings. Discussions are posted to CMS' HCPCS website. Final decisions are released to the applicant via letter; and all resulting modifications to the HCPCS codes are reflected on the HCPCS update. *Form Number:* CMS-10224 (OMB#: 0938-New); *Frequency:* Reporting: Occasionally; *Affected Public:* Business or other for-profit and State, Local or Tribal Government; *Number of Respondents:* 300; *Total Annual Responses:* 300; *Total Annual Hours:* 3,300. 2. *Type of Information Collection Request:* New collection; *Title of Information Collection:* Data Collection for the Nursing Home Value-Based Purchasing (NHVBP) Demonstration; *Use:* The NHVBP Demonstration is a CMS “pay-for-performance” initiative to improve the quality of care furnished to Medicare beneficiaries residing in nursing homes. Under this three-year demonstration project, CMS will assess the performance of nursing homes based on selected quality measures, and then make additional payments to those nursing homes that achieve a higher performance based on those measures. In the first year of the demonstration, quality will be assessed based on the following four domains: staffing, appropriate hospitalizations, outcome measures from the minimum data set (MDS), and survey deficiencies. Additional quality measures may be added in the second and third years of the demonstration as deemed appropriate. The main purpose of the NHVBP data collection effort is to gather information that will enable CMS to determine which nursing homes will be eligible to receive incentive payments under the NHVBP Demonstration. All measures included in the MDS outcomes, survey deficiency, and appropriate hospitalization domains can be calculated from existing secondary data sources, such as the MDS, annual nursing home certification surveys, and Medicare claims data. However, for the staffing domain, no satisfactory alternative source for these data has been identified. Therefore, CMS will collect payroll-based staffing and resident census information to help assess the quality of care in participating nursing homes. CMS will additionally collect data on two measures, staff immunization status and use of resident care experience surveys, which may be included in the payment determination during the second and third years of the demonstration. *Form Number:* CMS-10240 (OMB#: 0938-New); *Frequency:* Reporting: Once; *Affected Public:* Business or other for-profit and not-for-profit institutions; *Number of Respondents:* 1,250; *Total Annual Responses:* 2,000; *Total Annual Hours:* 49,170. 3. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Recognition of pass-through payment for additional
(new)categories of devices under the Outpatient Prospective Payment System and Supporting Regulations in 42 CFR, Part 419; *Use:* Section 201(b) of the Balanced Budget Act of 1999 amended section 1833(t) of the Social Security Act (the Act) by adding new section 1833(t)(6). This provision requires the Secretary to make additional payments to hospitals for a period of 2 to 3 years for certain drugs, radiopharmaceuticals, biological agents, medical devices and brachytherapy devices. Section 1833(t)(6)(A)(iv) establishes the criteria for determining the application of this provision to new items. Section 1833(t)(6)(C)(ii) provides that the additional payment for medical devices be the amount by which the hospital's charges for the device, adjusted to cost, exceed the portion of the otherwise applicable hospital outpatient department fee schedule amount determined by the Secretary to be associated with the device. Section 402 of the Benefits Improvement and Protection Act of 2000 made changes to the transitional pass-through provision for medical devices. The most significant change is the required use of categories as the basis for determining transitional pass-through eligibility for medical devices, through the addition of section 1833(t)(6)(B) of the Act. Interested parties such as hospitals, device manufacturers, pharmaceutical companies, and physicians apply for transitional pass-through payment for certain items used with services covered in the outpatient prospective payment system. After CMS receives all requested information, CMS will evaluate the information to determine if the creation of an additional category of medical devices for transitional pass-through payments is justified. *Form Number:* CMS-10052 (OMB#: 0938-0857); *Frequency:* Reporting: Yearly; *Affected Public:* Business or other for-profit; *Number of Respondents:* 10; *Total Annual Responses:* 10; *Total Annual Hours:* 160. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS' Web Site address at *http://www.cms.hhs.gov/PaperworkReductionActof1995* , or E-mail your request, including your address, phone number, OMB number, and CMS document identifier, to *Paperwork@cms.hhs.gov* , or call the Reports Clearance Office on
(410)786-1326. To be assured consideration, comments and recommendations for the proposed information collections must be received at the address below, no later than 5 p.m. on September 18, 2007. CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development—C, *Attention:* Bonnie L Harkless, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Dated: July 12, 2007. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E7-13904 Filed 7-19-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-R-244 and CMS-18F5] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Centers for Medicare & Medicaid Services, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services, is publishing the following summary of proposed collections 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 function;
(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. 1. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* The Medicare and Medicaid Programs: Programs of All-inclusive Care for the Elderly (PACE); *Form Number:* CMS-R-244 (OMB#: 0938-0790); *Use:* PACE organizations must demonstrate their ability to provide quality community-based care for the frail elderly who meet their State's nursing home eligibility standards using capitated payments from Medicare and the State. PACE programs must provide all Medicare and Medicaid covered services including hospital, nursing home, home health, and other specialized services. This collection is necessary to ensure that only appropriate organizations are selected to become PACE organizations and that CMS has the information necessary to monitor the care they provide; *Frequency:* Reporting—Once and on occasion; *Affected Public:* Not-for-profit institutions and State, Local, or Tribal Governments; *Number of Respondents:* 54; *Total Annual Responses:* 108; *Total Annual Hours:* 44131.50. 2. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Application for Hospital Insurance Benefits; *Form Number:* CMS-18F5 (OMB#: 0938-0251); *Use:* The CMS-18F5 form is used to establish entitlement to and enrollment in Part A of Medicare for beneficiaries who are not automatically entitled to Medicare Part A under Title XVIII of the Social Security Act and must file an application. Sections 226(a), 227 and 1818A of the Social Security Act and sections 42 CFR 406.10, 406.11 and 406.20 outline the requirements for entitlement to Medicare hospital insurance (Part A). Section 42 CFR 406.6 provides information about who needs to file an application for Part A and who does not. Section 42 CFR 406.7 lists the CMS-18F5 form as the application to be used by individuals applying for Part A of Medicare. The CMS-18F5 form was designed to capture all the information needed to make a determination of an individual's entitlement to hospital insurance (Part A); *Frequency:* Reporting—once; *Affected Public:* Individuals or households; *Number of Respondents:* 50,000; *Total Annual Responses:* 50,000; *Total Annual Hours:* 12,495. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS Web Site address at *http://www.cms.hhs.gov/PaperworkReductionActof1995* , or E-mail your request, including your address, phone number, OMB number, and CMS document identifier, to *Paperwork@cms.hhs.gov* , or call the Reports Clearance Office on
(410)786-1326. Written comments and recommendations for the proposed information collections must be mailed or faxed within 30 days of this notice directly to the OMB desk officer: OMB Human Resources and Housing Branch, *Attention:* Carolyn Lovett, New Executive Office Building, Room 10235, Washington, DC 20503, Fax Number:
(202)395-6974. Dated: July 12, 2007. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E7-13905 Filed 7-19-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Blood Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. *Name of Committee* : Blood Products Advisory Committee. *General Function of the Committee* : To provide advice and recommendations to the agency on FDA's regulatory issues. *Date and Time* : The meeting will be held on August 16, 2007, from 8 a.m. to 5 p.m. *Location* : Doubletree Hotel and Executive Meeting Center, 8120 Wisconsin Ave., Bethesda, MD 20814. *Contact Person* : Donald W. Jehn or Pearline K. Muckelvene, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike (HFM-71), Rockville, MD 20852, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014519516. Please call the Information Line for up-to-date information on this meeting. A notice in the **Federal Register** about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency's Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. *Agenda* : On August 16, 2007, the Committee will hear updates on the following topics:
(1)Summary of the May 10 through 11, 2007, and the August 6 through 7, 2007, meetings of the Department of Health and Human Services Advisory Committee on Blood Safety and Availability;
(2)summary of the April 25 through 26, 2007, FDA Workshop on Immune Globulins for Primary Immune Deficiency Diseases: Antibody Specificity, Potency and Testing; and
(3)summary of the August 15, 2007, FDA Workshop on Licensure of Apheresis Blood Products. The Committee will then hear informational presentations relating to World Health Organization
(WHO)biological standards on the following topics:
(1)Summary of the January 29 through 30, 2007, WHO meeting with WHO collaborating centers for biological standards and standardization to support the development of WHO biological reference preparations for high risk blood safety-related in vitro diagnostics;
(2)potency and safety standards for plasma derivatives; and
(3)joint FDA/WHO minimum potency standards for certain blood grouping reagents. The Committee will hear the response of the Office of Blood Research and Review to their office level site visit of July 22, 2005. In the afternoon the Committee will discuss measles antibody levels in U.S. Immune Globulin products. 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 2007 and scroll down to the appropriate advisory committee link. *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 August 8, 2007. Oral presentations from the public will be scheduled between approximately 11:15 a.m. and 11:45 p.m. and between approximately 3:30 p.m. and 4 p.m. on August 16, 2007. 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 July 31, 2007. 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 August 1, 2007. 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 Donald W. Jehn or Pearline K. Muckelvene at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: July 16, 2007. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E7-14088 Filed 7-19-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Joint Meeting of the Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. *Name of Committees* : Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. *General Function of the Committees* : To provide advice and recommendations to the agency on FDA's regulatory issues. *Date and Time* : The meeting will be held on September 11, 2007, from 8 a.m. to 5 p.m. *Location* : Hilton Washington DC North/Gaithersburg, The Ballrooms, 620 Perry Pkwy., Gaithersburg, MD, 301-977-8900. *Contact Person* : Mimi Phan, 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, 301-827-7001, FAX: 301-827-6776, e-mail: *Mimi.Phan@fda.hhs.gov* , or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512533 or 3014512535. Please call the Information Line for up-to-date information on this meeting. A notice in the **Federal Register** about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency's Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. *Agenda* : The committee will discuss updated information on the risks and benefits of erythropoeisis-stimulating agents (ARANESP, Amgen, Inc., EPOGEN, Amgen, Inc., and PROCRIT, Amgen, Inc.) when used in the treatment of anemia due to chronic renal failure. This discussion follows a March 9, 2007, FDA Public Health Advisory regarding the use of these agents ( *http://www.fda.gov/cder/drug/advisory/RHE2007.htm* ). 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 2007 and scroll down to the appropriate advisory committee link. *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 August 27, 2007. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. 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 August 17, 2007. 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 August 20, 2007. 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 Mimi Phan at 301-827-7001, at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: July 16, 2007. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E7-14086 Filed 7-19-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0277] Food Labeling: Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria; Public Hearing; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public hearing; request for comments. SUMMARY: The Food and Drug Administration
(FDA)is announcing a public hearing concerning the use of symbols to communicate nutrition information on food labels. The purpose of the hearing is for FDA to solicit information and comments from interested persons about programs currently in use regarding the use of symbols to communicate nutrition information on food labels. DATES: The public hearing will be held on September 10 and 11, 2007, from 9 a.m. to 5 p.m. See section V of this document for additional dates associated with registration and participation in the hearing. Submit written or electronic comments (i.e., submissions other than notices of participation and written material associated with an oral presentation) by November 12, 2007. The administrative record of the hearing will remain open until November 12, 2007. ADDRESSES: *Public hearing* . The public hearing will be held at The Inn & Conference Center by Marriott, University of Maryland, University College, 3501 University Blvd. E., Adelphi, Maryland 20783. *Registration and notice of participation and written material associated with an oral presentation* . Submit electronic requests to register and notices of participation for the hearing to *http://www.cfsan.fda.gov/register.html* . We encourage you to use this method to submit notices of participation, if possible. Submit written requests to register and notices of participation, and written material associated with an oral presentation to: Kathy Houston, Z-Tech Corp., 1803 Research Blvd., suite 301, Rockville, MD 20850, 301-251-4976, FAX: 301-315-2801, or e-mail: *khouston@z-techcorp.com* . *Comments* . Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . For additional information on submitting comments, see section VI in this document. FOR FURTHER INFORMATION CONTACT: *To submit an oral or written notice of participation by phone, by fax, or by e-mail, or to submit written material associated with an oral presentation by fax or by e-mail* : Kathy Houston, Z-Tech Corp., 1803 Research Blvd., suite 301, Rockville, MD 20850. *For all other questions about the hearing or if you need special accommodations due to a disability* : Juanita Yates, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 301-436-1731, e-mail: *Juanita.Yates@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Background In the United States, the Nutrition Labeling and Education Act of 1990 (the 1990 amendments) (Public Law 101-535) amended the Federal Food, Drug, and Cosmetic Act (the act) to require nutrition labeling on the labels of packaged foods to enable consumers to make more informed and healthier food choices in the context of their daily diet. In 1993, FDA established regulations that implemented the 1990 amendments, including provisions concerning the use of claims on the label or in labeling of a food. Among these regulations, the agency set forth general principles for nutrient content claims (21 CFR 101.13), which are claims that characterize the level of a nutrient in a food (e.g., “low fat,” “good source of fiber”), and for health claims (21 CFR 101.14), which are claims that characterize the relationship of a food substance to a disease or health-related condition (e.g., “calcium may reduce the risk of osteoporosis”). A. Use of Nutrition Symbols on Food Labels in the United States. In recent years, domestic manufacturers and retailers have begun to include symbols that indicate nutritional quality on the label or in labeling of a food. Symbol programs have been instituted by companies to promote their products and provide consumers with easily understandable nutrition information to aid them in their food purchases. Various food manufacturers, grocery stores, trade organizations, and health organizations have developed, or are currently developing, symbols and icons that indicate specific nutritional attributes of food products. Although each symbol intends to indicate that the food product bearing the symbol is a healthful choice, each symbol program has different nutrient requirements. The selected nutrients and the nutrient levels required for eligibility vary among the different symbol programs in use. With the increasingly widespread availability of these symbols from manufacturers, retailers, and third party organizations, it is possible that eligible food products could bear multiple nutrition symbols. B. Use of Nutrition Symbols on Food Labels in Other Countries A few countries around the world have already instituted voluntary labeling systems for government-designed front-label 1 nutrition symbols. These symbol systems vary in their format. Some systems have detailed graphic illustrations that indicate the content of a number of selected nutrients, while others simply present a single icon indicating that a food is healthful (with further information available elsewhere, such as in booklets and web sites). Also in use internationally are industry-designed nutrition symbol systems that are available for use in countries that do not have a government-designed symbol program or, in certain countries, that exist as alternatives to the government-designed symbols. 1 As used in this notice, the term “front label” means the part of the label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale. In the United States, the front label is known as the principal display panel (21 CFR 1.1). II. Purpose and Scope of the Hearing The purpose of the hearing is for FDA to solicit information and comments from interested persons about programs currently in use regarding the use of symbols to communicate nutrition information on food labels. This notice describes the scope of the hearing. We invite information and comment on the issues and questions in section III of this document. If you are interested in this hearing or this subject, you may address as many of the following questions as you wish. We do not expect you to address all questions. When possible, please provide scientific information and data in support of your comments. In addition, to the extent possible, please provide as specific information as is feasible about the estimated costs and benefits associated with your responses (e.g., the costs and benefits of current practices and/or the cost and benefits of any recommendations you may make). III. Issues and Questions for Discussion The following issues and questions will be discussed at the public hearing: *Issue 1* : There are many food label nutrition symbol programs currently in the domestic and international marketplace. Each system uses different nutrition criteria and requirements regarding eligibility for use. The agency would like information on the food products that bear nutrition symbols and the nutrient requirements for those symbols. Question 1. In what product categories are nutrition symbols used (e.g., packaged foods, fresh produce, meat/poultry, seafood)? Question 2. Which symbols are nutrient specific, and which are summary symbols based on multiple nutrients? Question 3. What are the nutritional criteria, including calories, included in a symbol system and how were those particular nutritional criteria chosen for inclusion? Question 4. What nutrient thresholds and/or algorithms are used to determine if a food product may display a nutrient specific or summary symbol? Question 5. Are nutrition symbols presented together with front label nutrition claims such as “low fat” or “good source of calcium” and, if so, to what extent and for what types of claims? Question 6. Are there programs to educate consumers to understand the nutrition symbols or is all information contained in the symbols? When education programs are available, how are they presented? *Issue 2* : The presence of nutrition symbols could affect the food purchasing decisions of consumers. Symbols could help consumers make food choices, but it is also possible that symbols could introduce confusion when making decisions. The agency would like information on consumer research that supported the development of these programs and research that illustrates how these programs are understood and utilized by consumers. Question 7. What are consumer attitudes toward nutrition symbols? Question 8. What are consumer attitudes toward products or brands that carry a nutrition symbol compared to other products or brands in the same product category (e.g., cereals) and in other categories that do not carry such a symbol? Question 9. What are consumer interpretations of symbol-carrying products or brands in terms of their overall healthfulness, specific health benefits, featured nutrition attributes, nonfeatured nutrition attributes, quality, safety, and any other non-nutrition attributes? Question 10. What is consumer perception of the presence of multiple and different nutrition symbols on front labels of different brands in a given product category, e.g., cereals? Question 11. What is consumer interpretation of the co-existence on the food label of symbols and/or other nutrition messages, when present, and quantitative nutrition information (e.g., the Nutrition Facts label that appears on foods in the United States)? Question 12. What is consumer interpretation of the co-existence of front-label nutrition symbols and nutrition symbols present on the tags of supermarket shelves, when available? Question 13. When do consumers use nutrition symbols and what do they use them for? Question 14. Do nutrition symbols on food labels direct consumers toward purchase of foods that bear them and, if so, to what extent? Question 15. Do symbols affect the nutritional quality of the total diet of consumers who use the symbols and, if so, to what extent? *Issue 3* : The availability of a nutrition symbol for use on the food label could have an impact on costs for both industry and for consumers. The agency would like information on possible economic impacts. Question 16. To what extent, if any, have products been developed or re-formulated to qualify them for a given nutrition symbol? Question 17. What are the costs associated with product development, re-formulation, or both? Question 18. What are the costs associated with putting symbols on packages? Question 19. What, if any, are the price differences between symbol-carrying products and other products within the same category? Question 20. Has inclusion of nutrition symbols on the labels of food products affected the sales of those products? IV. Notice of Hearing Under 21 CFR Part 15 By delegation from the Commissioner of Food and Drugs (the Commissioner) (Staff Manual Guide 1410.21 paragraph 1.f. (5)), the Assistant Commissioner for Policy finds that it is in the public interest to permit persons to present information and views at a public hearing regarding the use of symbols to communicate nutrition information on food labels and is announcing that the public hearing will be held in accordance with part 15 (21 CFR part 15). The presiding officer will be the Commissioner or his designee. The presiding officer will be accompanied by a panel of FDA employees with relevant expertise. Persons who wish to participate in the hearing (either by making a presentation or as a member of the audience) must file a notice of participation (see DATES, ADDRESSES, FOR FURTHER INFORMATION CONTACT , and section V of this document). By delegation from the Commissioner (Staff Manual Guide 1410.21 paragraph 1.f. (5)), the Assistant Commissioner for Policy has determined under § 15.20(c) that advance submissions of oral presentations are necessary for the panel to formulate useful questions to be posed at the hearing under § 15.30(e), and that the submission of a comprehensive outline or summary is an acceptable alternative to the submission of the full text of the oral presentation. For efficiency, we request that individuals and organizations with common interests consolidate their requests for oral presentation and request time for a joint presentation through a single representative. After reviewing the notices of participation and accompanying information, we will schedule each oral presentation and notify each participant of the time allotted to the presenter and the approximate time that the presentation is scheduled to begin. If time permits, we may allow interested persons who attend the hearing but did not submit a notice of participation in advance to make an oral presentation at the conclusion of the hearing. The hearing schedule will be available at the hearing. After the hearing, the schedule and a list of participants will be placed on file in the Division of Dockets Management (see ADDRESSES ) under the docket number listed in brackets in the heading of this notice. To ensure timely handling of any mailed notices of participation, written material associated with presentations, or comments, any outer envelope should be clearly marked with the docket number listed in brackets in the heading of this notice along with the statement “Food Labeling: Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria; Public Hearing.” Under § 15.30(f), the hearing is informal, and the rules of evidence do not apply. No participant may interrupt the presentation of another participant. Only the presiding officer and panel members may question any person during or at the conclusion of each presentation. Public hearings under part 15 are subject to FDA's policy and procedures for electronic media coverage of FDA's public administrative proceedings (part 10 (21 CFR part 10, subpart C)). Under § 10.205, representatives of the electronic media may be permitted, subject to the procedures and limitations in § 10.206, to videotape, film, or otherwise record FDA's public administrative proceedings, including presentations by participants. The hearing will be transcribed as stipulated in § 15.30(b). For additional information about transcripts, see section VII in this document. Any handicapped persons requiring special accommodations to attend the hearing should direct those needs to the appropriate contact person (see FOR FURTHER INFORMATION CONTACT ). To the extent that the conditions for the hearing, as described in this document, conflict with any provisions set out in part 15, this notice acts as a waiver of these provisions as specified in §§ 10.19 and 15.30(h). In particular, § 15.21(a) states that the notice of hearing will provide persons an opportunity to file a written notice of participation with the Division of Dockets Management within a specified period of time. If the public interest requires, e.g., if a hearing is to be conducted within a short period of time, the notice may name a specific FDA employee and telephone number to whom an oral notice of participation may be given. If the public interest requires, the notice may also provide for submitting notices of participation at the time of the hearing. In this document, the conditions for the hearing specify that notices of participation be submitted electronically to an agency Web site, to a contact person who will accept notices of participation by mail, telephone, fax, or e-mail, or in person on the day of the hearing (as space permits). In addition, the conditions for the hearing specify that written material associated with an oral presentation be provided to a contact person (who will accept it by mail, fax, or e-mail) rather than to the Division of Dockets Management. We are using these procedures to facilitate the exchange of information between participants and the agency. By delegation from the Commissioner (Staff Manual Guide 1410.21 paragraph 1.f. (5)), the Assistant Commissioner for Policy finds under § 10.19 that no participant will be prejudiced, the ends of justice will thereby be served, and the action is in accordance with law if notices of participation are submitted by the procedures listed in this notice rather than to the Division of Dockets Management. V. How to Participate in the Hearing Registration by submission of a notice of participation is necessary to ensure participation and will be accepted on a first-come, first-served basis. The notice of participation may be submitted electronically, orally, or by fax, mail, or e-mail (see ADDRESSES and FOR FURTHER INFORMATION CONTACT ). We encourage you to submit your notice of participation electronically. A single copy of any notice of participation is sufficient. The notice of participation must include your name, title, business affiliation (if applicable), address, telephone number, fax number (if available), and e-mail address (if available). If you wish to request an opportunity to make an oral presentation during the open public comment period of the hearing, your notice of participation also must include the title of your presentation, the sponsor of the oral presentation (e.g., the organization paying travel expenses or fees), if any; and the approximate amount of time requested for the presentation. Presentations will be limited to the questions and subject matter identified in section III of this document, and, depending on the number of requests received, we may be obliged to limit the time allotted for each presentation (e.g., 5 minutes each). Under § 15.20(c), if you request an opportunity to make an oral presentation, you must submit your presentation (either as the full text of the presentation, or as a comprehensive outline or summary). You may submit your presentation by e-mail, fax, or mail. A single copy of your presentation is sufficient. See ADDRESSES and FOR FURTHER INFORMATION CONTACT for information on where to send your presentation. Persons who wish to request an opportunity to make an oral presentation at the hearing must submit a notice of participation by August 24, 2007, and also must submit either the full text of the oral presentation, or a comprehensive outline or summary of the oral presentation, by August 31, 2007. All other persons wishing to attend the hearing must submit a notice of participation by August 31, 2007. Persons requiring special accommodations due to a disability must submit a notice of participation by August 31, 2007, and should inform the contact person of their request (see FOR FURTHER INFORMATION CONTACT ). Individuals who request an opportunity to make an oral presentation will be notified of the scheduled time for their presentation prior to the hearing. We also will accept notices of participation onsite on a first come, first served basis; however, the anticipated maximum seating capacity is 75 to 100, and registration will be closed when the maximum seating capacity is reached. Requests for an opportunity to make a presentation from individuals or organizations that did not make such a request in advance may be granted if time permits. Persons who submit a notice of participation in advance of the hearing should check in at the on-site registration desk between 8:30 and 9 a.m. Persons who wish to submit a notice of participation onsite may do so at the registration desk between 8:30 and 9 a.m. on either day of the hearing. We encourage all participants to attend the entire hearing. All submissions and comments received may be posted without change to *http://www.fda.gov/ohrms/dockets/default.htm* , including any personal information provided. VI. Request for Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments for consideration at or after the hearing in addition to, or in place of, a request for an opportunity to make an oral presentation (see section V of this document). Submit two paper copies of any written comments, except that individuals may submit one copy. Comments are to be identified with the agency name and docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. VII. Transcripts Transcripts of the hearing will be available for review at the Division of Dockets Management (see ADDRESSES ) and on the Internet at *http://www.fda.gov/ohrms/dockets* approximately 30 days after the hearing. You may place orders for copies of the transcript through the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers lane, rm. 6-30, Rockville, MD 20857, at a cost of 10 cents per page. Dated: July 13, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-14046 Filed 7-19-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food Safety and Defense . . . Be ALERT; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Atlanta District and Southeast Regional Office (SER), in collaboration with Georgia Food Safety and Defense Task Force, and the Metro Environmental Health Directors Food Service Advisory Committee, is announcing a public workshop entitled “Food Safety and Defense . . . Be ALERT!” This public workshop will provide information about how to control foodborne illness risk factors and how to secure food from intentional contamination (food defense awareness). The target audience will be operators of small, independent (non-chain) retail and food service establishments. *Date and Time* : This public workshop will be held on Wednesday, August 15, 2007, from 9 a.m. to 3 p.m. *Location* : The public workshop will be held at the Hilton Atlanta Northeast Hotel, 5993 Peachtree Industrial Blvd., Norcross, GA. *Contact* : JoAnn Pittman, Food and Drug Administration, Atlanta District, Southeast Region, 60 8th St., NE., Atlanta, GA 30309, 404-253-1272, FAX: 404-253-1202, or e-mail: *JoAnn.Pittman@fda.hhs.gov* . *Registration is at no charge* : The registration deadline is August 1, 2007; please see instructions in this document. Those accepted into the workshop will receive confirmation. Registration at the site is not guaranteed but, may be possible on a space available basis (100 maximum) on the day of the public workshop beginning at 9 a.m. If you need special accommodations due to a disability, please contact JoAnn Pittman (see Contact) at least 7 days in advance. *Registration Form Instructions* : To register, please complete the registration form in this document and submit to “ Food and Drug Administration, Attn: Dan Redditt, 60 8th St., NE.. Atlanta, GA 30309.” We encourage you to fax the completed registration form to: 404-253-2257 or 404-253-1202. To obtain a copy of the registration form, please contact: Dan Redditt at 404-253-1265 or via e-mail at *joseph.redditt@fda.hhs.gov* . **Food Safety and Defense . . . Be ALERT! Public Workshop Registration Form** Name: Affiliation: Mailing Address: City/State/Zip Code: Phone: Fax: E-mail: Special Accommodations Required: *Transcripts* : Transcripts of the public workshop will not be available due to the format of this workshop. Workshop handouts may be requested at cost through the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 15 working days after the public workshop at a cost of 10 cents per page. SUPPLEMENTARY INFORMATION: This public workshop is being held in response to the large volume of food safety and food defense concerns from FDA-regulated products in facilities, such as manufacturers, processors, distributors, retailers, and restaurants, originating from the area covered by the FDA, Atlanta District, Southeast Region. The Atlanta District, Southeast Region presents this workshop to help achieve objectives set forth in section 406 of the Food and Drug Administration Modernization Act of 1997 (21 U.S.C. 393), which include working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public. This is consistent with the purposes of the Retail Food Specialists and Public Affairs Specialists, which are in part to respond to industry inquiries, develop educational materials, sponsor workshops and conferences to provide firms, particularly small businesses, with firsthand working knowledge of FDA's guidance, requirements, and compliance policies. This workshop is also consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121) as outreach activities by Government agencies to small businesses. The purpose of this workshop is to increase the knowledge of operators of small, independent, retail and food service establishments relative to food safety and food defense principles and to increase the application of these principles in their respective operations. The workshop will also present information that will enable food facilities, manufacturers, processors, distributors, retailers, and restaurants, to better comply with the regulations authorized by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), and with food safety and food defense guidance, especially in light of growing concerns about food defense. Information presented will be based on the agency position as articulated through regulation, guidance, and information previously made available to the public. Topics to be discussed at the workshop include:
(1)Pre-Workshop Assessment,
(2)The Headline You Don't Want to Make,
(3)Tools for Keeping Your Food Safe—Interactive Demonstrations,
(4)Be A.L.E.R.T. to Terrorism: Keeping Your Foods Secure, and
(5)Making the Commitment (Post-Workshop Assessment), and Q and A. FDA expects that participation in this public workshop will provide industry with greater understanding of the regulatory and guidance perspectives on food safety and food defense and increase voluntary compliance and food defense awareness. Dated: July 16, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-14045 Filed 7-19 -07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service Office of Urban Indian Health Programs *Announcement Type:* Competitive Supplemental Grant Announcement. *Funding Opportunity Number:* HHS-2007-IHS-UIHP-0001. *Catalog of Federal Domestic Assistance Number:* 93.193. Note: This funding opportunity has been amended to provide additional funds to support the supplemental competitive 4-in-1 Title V grants. The estimated total award amount increased from $316,000 to $350,000. Seven grant supplements will be issued under this announcement. As a result of the notice of amendment, the application deadline date has been revised to allow applicants at least 30 days to apply for the opportunity. The new application deadline date is August 20, 2007. This amendment supersedes the **Federal Register** Notice that was issued July 11, 2007, FR Doc. 07-3359. *Key Dates: Application Deadline Date:* August 20, 2007. *Review Date:* August 23, 2007. *Earliest Anticipated Start Date:* August 31, 2007. I. Funding Opportunity Description The Indian Health Service (IHS), Office of Urban Indian Health Programs (OUIHP) announces competitive 4-in-1 Title V grant supplements responding to an Office of Minority Health, HIV/AIDS Initiative. This program is authorized under the authority of the Snyder Act and 25 U.S.C. 1652, 1653 of the Indian Health Care Improvement Act, Public Law 94-437, as amended. This program is described at 93.193 in the Catalog of Federal Domestic Assistance (CFDA). This competitive supplement seeks to expand OUIHP's existing Title V grants to increase the number of American Indian/Alaska Native (AI/AN) with the awareness of his/her HIV status. This will provide routine and/or rapid HIV screening, prevention, pre and post test counseling, case management (if available) and data collection. Enhancement of urban Indian health program HIV/AIDS activities is necessary to reduce the incidence of HIV/AIDS in the urban Indian health communities. The purpose of the announcement is to respond to the fact that communities of color have been disproportionately affected by HIV and the need exists for access to early testing, diagnosis, treatment and prevention services. Over the past decade, the AI/AN community has developed and maintained a higher rate of HIV than Caucasians. It has also been demonstrated that AI/ANs have a decreased longevity once diagnosed compared to other races/ethnicities. These supplements will be used to enhance HIV testing, including rapid testing and/or standard HIV antibody testing and to provide a more focused effort to address HIV/AIDS prevention targeting some of the largest urban Indian populations in the United States. The nature of these projects will require collaboration with the OUIHP to:
(1)Coordinate activities;
(2)participate in projects in other operating divisions of the Department such as CDC, SAMHSA, HRSA and the Office of Minority Health; and
(3)submit and share data on HIV/AIDS testing, treatment and education. II. Award Information *Type of Award:* Title V Grant Supplements. *Estimated Funds Available:* The total amount identified for Fiscal Year
(FY)2007 is seven supplement awards totaling $350,000. The award is for one year in duration and the average award, per program is approximately $50,000. Awards under this announcement are subject to the availability of funds. *Anticipated Number of Awards:* Seven grant supplements will be made under the Program. *Project Period:* April 1, 2007—March 31, 2008. *Award Amount:* $350,000. A. Requirements of Recipient Activities In FY 2007 each grantee's attempted goal shall include screening as many individuals as possible; however, increasing screening 10% or to a minimum of 200 American Indians/Alaska Natives (AI/AN) tested per program funded—adjusted due to variations in size of facility and user population may be required. This does not include counts of re-testing individuals in the same year. Each program shall also collect evidence, as part of the testing process, to potentially address utility and barriers of increased routine HIV screening within this population. III. Eligibility Information 1. *Eligible Applicants:* Urban Indian organizations, as defined by 25 U.S.C. 1603(h), limited to Urban Indian organizations which meet the following criteria: a. Received State certification to conduct HIV rapid testing; b. Health professionals and staff have been trained in the HIV/AIDS screening tools, education, prevention, counseling, and other interventions for American Indians/Alaskan Natives; c. Attuned to the risk factors driving the HIV/AIDS epidemics among urban American Indians/Alaskan Natives; d. Developed programs to address community and group support to sustain risk-reduction skills; e. Implemented HIV/AIDS quality assurance and improvement programs; and f. Must provide proof of non-profit status with the application. 2. Cost Sharing or Matching: This program does not require matching funds or cost sharing. 3. If the application budget exceeds $50,000 it will not be considered for review. IV. Application and Submission Information 1. Applicant package may be found in *Grants.gov* ( *www.grants.gov* ) or at: *http://www.ihs.gov/NonMedicalPrograms/gogp/gogp_funding.asp.* Information regarding the electronic application process may be directed to Michelle G. Bulls at
(301)443-6290. 2. Content and Form of Application Submission: • Be single spaced. • Be typewritten. • Have consecutively numbered pages. • Use black type not smaller than 12 characters per one inch. • Contain a narrative that does not exceed 25 typed pages that includes the other submission requirements below. The 25 page narrative does not include the work plan, standard forms, table of contents, budget, budget justifications, narratives, and/or other appendix items. Public Policy Requirements: All Federal-wide public policies apply to IHS grants with the exception of the Lobbying and Discrimination public policy. 3. Submission Dates and Times: The application from each Urban Indian organization must be submitted electronically through *Grants.gov* by 12 midnight Eastern Standard Time (EST). If technical challenges arise and the urban Indian organizations are unable to successfully complete the electronic application process, each organization must contact Michelle G. Bulls, Grants Policy Staff fifteen days prior to the application deadline and advise of the difficulties that they are experiencing. Each organization must obtain prior approval, in writing (e-mails are acceptable), from Ms. Bulls allowing the paper submission. If submission of a paper application is requested and approved, the original and two copies may be sent to the appropriate grants contact that is listed in Section IV.1 above. Applications not submitted through *Grants.gov* , without an approved waiver, may be returned to the organizations without review or consideration. A late application will be returned to the organization without review or consideration. 4. Intergovernmental Review: Executive Order 12372 requiring intergovernmental review is not applicable to this program. 5. Funding Restrictions: A. Pre-award costs are allowable pending prior approval from the awarding agency. However, in accordance with 45 CFR part 74, all pre-award costs are incurred at the recipient's risk. The awarding office is under no obligation to reimburse such costs if for any reason any of the Urban Indian organizations do not receive an award or if the award to the recipient is less than anticipated. B. The available funds are inclusive of direct and appropriate indirect costs. C. Only one grant supplement will be awarded to each organization. D. IHS will acknowledge receipt of the application. 6. Other Submission Requirements: Electronic Submission—Each Urban Indian organization must submit through *Grants.gov.* However, should any technical challenges arise regarding the submission, please contact *Grants.gov* Customer Support at 1-800-518-4726 or *support@grants.gov* . The Contact Center hours of operation are Monday-Friday from 7 a.m. to 9 p.m. EST. If you require additional assistance please call
(301)443-6290 and identify the need for assistance regarding your *Grants.gov* application. Your call will be transferred to the appropriate grants staff member. Each organization must seek assistance at least fifteen days prior to the application deadline. If each organization doesn't adhere to the timelines for Central Contractor Registry (CCR), *Grants.gov* registration and request timely assistance with technical issues paper application submission may not be granted. To submit an application electronically, please use the *Grants.gov* Web site. Download a copy of the application package on the *Grants.gov* Web site, complete it offline and then upload and submit the application via the *Grants.gov* site. You may not e-mail an electronic copy of a grant application to IHS. Please be reminded of the following: • Under the new IHS application submission requirements, paper applications are not the preferred method. However, if any Urban Indian organization has technical problems submitting the application on-line, please directly contact *Grants.gov* Customer Support at: *http://www.grants.gov/CustomerSupport* . • Upon contacting *Grants.gov* , obtain a *Grants.gov* tracking number as proof of contact. The tracking number is helpful if there are technical issues that cannot be resolved and a waiver request from Grants Policy must be obtained. If any of the organizations are still unable to successfully submit the application on-line, please contact Michelle G. Bulls, Grants Policy Staff at
(301)443-6290 at least fifteen days prior to the application deadline to advise her of the difficulties you have experienced. • If it is determined that a formal waiver is necessary, each organization must submit a request, in writing (e-mails are acceptable), to *Michelle.Bulls@ihs.gov* providing a justification for the need to deviate from the standard electronic submission process. Upon receipt of approval, a hard-copy application package must be downloaded from *Grants.gov* , and sent directly to the Division of Grants Operations (DGO), 801 Thompson Avenue, TMP 360, Rockville, MD 20852 by August 20, 2007. • Upon entering the *Grants.gov* Web site, there is information available that outlines the requirements to each Urban Indian organization regarding electronic submission of application and hours of operation. We strongly encourage that each organization does not wait until the deadline date to begin the application process as the registration process for CCR and *Grants.gov* could take up to fifteen working days. • To use *Grants.gov,* each Urban Indian organization must have a Dun and Bradstreet
(DUNS)Number and register in the CCR. Each organization should allow a minimum of ten working days to complete CCR registration. See below on how to apply. • Each organization must submit all documents electronically, including all information typically included on the SF-424 and all necessary assurances and certifications. • Please use the optional attachment feature in *Grants.gov* to attach additional documentation that may be requested by IHS. • Each organization must comply with any page limitation requirements described in the program announcement. • After you electronically submit your application, you will receive an automatic acknowledgment from *Grants.gov* that contains a *Grants.gov* tracking number. The DGO will retrieve your application from *Grants.gov.* The DGO will notify each organization that the application has been received. • You may access the electronic application for this program on *Grants.gov.* • You may search for the downloadable application package using either the CFDA number or the Funding Opportunity Number. Both numbers are identified in the heading of this announcement. • To receive an application package, each Urban Indian organization must provide the Funding Opportunity Number: HHS-2007-IHS-UIHP-0001. E-mail applications will not be accepted under this announcement. DUNS Number Applicants are required to have a DUNS number to apply for a grant or cooperative agreement from the Federal Government. The DUNS number is a nine-digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, access *http://www.dunandbradstreet.com* or call 1-866-705-5711. Interested parties may wish to obtain their DUNS number by phone to expedite the process. Applications submitted electronically must also be registered with the CCR. A DUNS number is required before CCR registration can be completed. Many organizations may already have a DUNS number. Please use the number listed above to investigate whether or not your organization has a DUNS number. Registration with the CCR is free of charge. Applicants may register by calling 1-888-227-2423. Please review and complete the CCR Registration Worksheet located on *http://www.grants.gov/CCR* Register. More detailed information regarding these registration processes can be found at *Grants.gov.* V. Application Review Information 1. Criteria The instructions for preparing the application narrative also constitute the evaluation criteria for reviewing and scoring the application. Weights assigned to each section are noted in parentheses. The narrative should include the first year of activities; information for multi-year projects should be included as an appendix (see E. “Categorical Budget and Budget Justification”) at the end of this section for more information. The narrative should be written in a manner that is clear to outside reviewers unfamiliar with prior related activities of the Urban Indian organization. It should be well organized, succinct, and contain all information necessary for reviewers to understand the project fully. A. Understanding of the Need and Necessary Capacity (30 Points) 1. Understanding of the Problem a. Define the project target population, identify their unique characteristics, and describe the impact of HIV on the population. b. Describe the gaps/barriers in HIV testing for the population. c. Describe the unique cultural or sociological barriers of the target population to adequate access for the described services. 2. Facility Capability a. Briefly describe your clinic programs and services and how this initiative complements and/or expands existing efforts. b. Describe your clinic's ability to conduct this initiative through: • Your clinic's own resources. • Describe collaboration with other providers. • Identify and describe partnerships established to accept referrals for counseling, testing, and referral and confirmatory blood tests and/or social services for individuals who test HIV positive. • Identify and describe partnerships established to refer out of your clinic for specialized treatment, care, confirmatory testing (if applicable) and counseling services. B. Work Plan (40 Points) 1. Project Goal and Objectives Address all of the following program goals and objectives of the project. The objectives must be specific as well as quantitatively and qualitatively measurable to ensure achievement of goal(s). • President's Initiative for HIV/AIDS Explain how the continuation program addresses the President's Initiative for HIV/AIDS objective requiring testing of those who do not know their status. For a more direct and relevant program initiative, this proposal will be enumerated in the development of the new IHS HIV/AIDS Strategic Plan. • HHS Strategic Plan Support Describe how implementing, expanding and making routine HIV/AIDS direct service opportunities in your clinic ensures an innovative approach towards achievement of two most critical HHS Strategic Plan Objectives relative to the health status of AI/AN: Objective 3.4—Eliminate racial and ethnic health disparities Objective 3.6—Increase access to health services for AI/AN • Office of the Secretary Minority AIDS Initiative Address how the Minority AIDS Initiative Goals/Objectives will be supported. If a goal/objective is not applicable to your program, explain why it is not applicable. Provide quantitative and qualitative objectives for each of the following. 1. Expand Services a. Increase the number of clients receiving services; b. Increase the number of clients that receive an HIV test and are provided results and know their status; and c. Increase the number of clients treated and/or referred into the system for medical care. 2. Build Capacity a. Identify the number of providers that have expanded their: • Knowledge of HIV screening methods; • Knowledge of streamlining procedures; and • Collaboration with outside entities such as CDC, HRSA, and/or State health departments. 3. Best Practices Models a. Identify best practice models of implementation of expanded services. 4. Enumerate lessons observed and address barriers to care. • IHS Strategic Plan Support Describe how this project integrates with the IHS Strategic Plan which includes concepts surrounding: 1. Building and sustaining healthy communities 2. Providing accessible, quality health care, and 3. Fostering collaboration and innovation across the Indian health network. • IHS HIV/AIDS Administrative Work Plan Goals Describe how the IHS HIV/AIDS Administrative work plan goals will be supported. If a goal is not applicable to your program, explain why it is not applicable. 1. Assist AI/AN in becoming aware of serostatus; 2. Reduce the transmission of HIV through behavior change, prevention education and open discussion; 3. Ensure access (and linkages) to services for those living with HIV/AIDS and those at risk; 4. Make routine HIV/AIDS services and ensure quality HIV/AIDS care is delivered within the Indian health system; 5. Reduce stigma and discrimination surrounding HIV/AIDS; and 6. Form sustainable collaborations and integrative approaches (i.e. STD and HIV integration) to build capacity and maximize resources for surveillance, prevention, treatment and mitigation. • Implementation Plan 1. Identify the proposed program activities and explain how these activities will meet the needs of the target population. 2. Describe any anticipated outcomes that may be achieved from this project plan. 3. Provide a timeline for implementation. 4. Has the program identified and agreed to follow the State regulations for HIV testing in their state? 5. How will individuals be selected for testing to identify selection criteria and which group(s)—if any—will you be able, via State regulations, to offer testing in an opt-out format? 6. How will you ensure that clients receive their test results, particularly clients who test positive? 7. How will you ensure that individuals with initial HIV-positive test results will receive confirmatory tests? If you do not provide confirmatory HIV testing, you must provide a letter of intent or MOA with an external laboratory documenting the process through which initial HIV-positive test results will be confirmed. 8. What are your strategies to linking potential seropositive patients to care? 9. What are your quality assurance strategies? 10. How will you train, support and retain staff providing counseling and testing? 11. How will you ensure client confidentiality? 12. How will you ensure that your services are culturally sensitive and relevant? • Staffing Plan Describe the existing or proposed positions to be funded and provide names and roles of the key position(s) carrying out this project, their qualifications and how they relate to the organizations, with regard to supervision and quality control. C. Project Evaluation (10 Points) 1. Evaluation Plan The grantee shall provide a plan for monitoring and evaluating the HIV rapid test and/or standard HIV antibody test. 2. Reporting Requirements The following quantitative and qualitative measures shall be addressed: • Indicators (quantitative) 1. Number of tests offered and number of test refusals 2. Number of clients who refused due to prior knowledge of status 3. Number of individuals tested with breakdown of rapid versus standard antibody test 4. Number of negative results 5. Number of false negatives and/or false positives after confirmatory testing 6. Number of reactive tests and confirmed seropositive (actual and proportion) 7. Number of individuals receiving their confirmatory test results 8. Number of clients linked to care/treatment or referrals for prevention counseling 9. Number of post-test counseling sessions 10. Number of pre-test counseling sessions (brief) 11. Number of prevention counseling sessions (more depth) due to higher risk populations 12. Number of missed follow up after rapid test is reactive 13. Transmission category (if known) 14. Measures in place to protect confidentiality • Qualitative Information 1. Identify Testing Methodology a. Will testing be rapid or standard? b. Opt-out format should be utilized. Unless otherwise determined by State regulations—please explain. c. Is your methodology based on risk-based screening? Based on what risk criteria? Are you offering more routine screening? What are the criteria for offering tests if any? 2. Identify barriers of implementation • Plan for obtaining knowledge, attitudes, and behavior data. D. Organizational Capabilities and Qualifications (10 Points) This section outlines the broader capacity of the organization to complete the project outlined in the work plan. It includes the identification of personnel responsible for completing tasks and the chain of responsibility for successful completion of the project outlined in the work plan. 1. Describe the organizational structure. 2. Describe the ability of the organization to manage the proposed project. Include information regarding similarly sized projects in scope and financial assistance as well as other grants and projects successfully completed. 3. Describe what equipment (i.e., phone, websites, etc.) and facility space (i.e., office space) will be available for use during the proposed project. Include information about any equipment not currently available that will be purchased throughout the agreement. 4. List key personnel who will work on the project. • Identify existing personnel and new program staff to be hired. • In the appendix, include position descriptions and resumes for all key personnel. Position descriptions should clearly describe each position and duties indicating desired qualifications, experience, and requirements related to the proposed project and how they will be supervised. Resumes must indicate that the proposed staff member is qualified to carry out the proposed project activities and who will determine if the work of a contractor is acceptable. • Note who will be writing the progress reports. • If a position is to be filled, indicate that information on the proposed position description. • If the project requires additional personnel beyond those covered by the supplemental grant (i.e., IT support, volunteers, interviewers, etc.), note these and address how these positions will be filled and, if funds are required, the source of these funds. • If personnel are to be only partially funded by this supplemental grant, indicate the percentage of time to be allocated to this project and identify the resources used to fund the remainder of the individual's salary. E. Categorical Budget and Budget Justification (10 Points) This section should provide a clear estimate of the project program costs and justification for expenses for the entire grant period. The budget and budget justification should be consistent with the tasks identified in the work plan. 1. Categorical budget (Form SF 424A, Budget Information Non-Construction Programs) completing each of the budget periods requested. 2. Narrative justification for all costs, explaining why each line item is necessary or relevant to the proposed project. Include sufficient details to facilitate the determination of cost allowability. 3. Budget justification should include a brief program narrative for the second and third years. 4. If indirect costs are claimed, indicate and apply the current negotiated rate to the budget. Include a copy of the rate agreement in the appendix. 2. Review and Selection Process In addition to the above criteria/requirements, the application will be considered according to the following: A. The submission deadline: August 20, 2007. The application submitted in advance of or by the deadline and verified by the postmark will undergo a preliminary review to determine that: • The applicant is eligible in accordance with this grant announcement. • The application is not a duplication of a previously funded project. • The application narrative, forms, and materials submitted meet the requirements of the announcement allowing the review panel to undertake an in-depth evaluation; otherwise, it may be returned. B. The Objective Review date is August 23, 2007. The application requirements that are complete, responsive, and conform to this program announcement will be reviewed for merit by the Ad Hoc Objective Review Committee
(ORC)appointed by the IHS to review and make recommendations on this application. Prior to ORC review, the application will be screened to determine that programs proposed are those which the IHS has the authority to provide, either directly or through funding agreement, and that those programs are designed for the benefit of IHS beneficiaries. If an Urban Indian organization does not meet these requirements, the application will not be reviewed. The ORC review will be conducted in accordance with the IHS Objective Review Guidelines. The application will be evaluated and rated on the basis of the evaluation criteria listed in section V.1. The criteria are used to evaluate the quality of a proposed project and determine the likelihood of success. 3. Anticipated Announcement and Award Dates Anticipated announcement date is August 20, 2007 with an Award Date of August 24, 2007. VI. Award Administration Information 1. Award Notices The Notice of Award
(NoA)will be initiated by the DGO and will be mailed via postal mail to the Urban Indian organization. The NoA will be signed by the Grants Management Officer and this is the authorizing document under which funds are dispersed. The NoA, is the legally binding document, will serve as the official notification of the grant award and will reflect the amount of Federal funds awarded for the purpose of the grant, the terms and conditions of the award, the effective date of the award, and the budget/project period. 2. Administrative Requirements Grants are administered in accordance with the following documents: • This Program Announcement. • 45 CFR Part 74, “Uniform Administrative Requirements for Awards to Institutions of Higher Education, Hospitals, Other Non-Profit Organizations, and Commercial Organizations.” • Grants Policy Guidance: HHS Grants Policy Statement, January 2007. • “Non-Profit Organizations” (Title 2 Part 230). • Audit Requirements: OMB Circular A-133, “Audits of States, Local Governments, and Non-Profit Organizations.” 3. Indirect Costs This section applies to indirect costs in accordance with HHS Grants Policy Statement, Part II-27, IHS requires applicants to have a current indirect cost rate agreement in place prior to award. The rate agreement must be prepared in accordance with the applicable cost principles and guidance as provided by the cognizant agency or office. A current rate means the rate covering the applicable activities and the award budget period. If the current rate is not on file with the awarding office, the award shall include funds for reimbursement of indirect costs. However, the indirect costs portion will remain restricted until the current rate is provided to DGO. If an Urban Indian organization has questions regarding the indirect costs policy, please contact the DGO at
(301)443-5204. 4. Reporting A. Progress Report. Program progress reports are required semi-annually. These reports will include a brief comparison of actual accomplishments to the goals established for the period, reasons for slippage (if applicable), and other pertinent information as required. A final report must be submitted within 90 days of expiration of the budget/project period. B. Financial Status Report. Semi-annual financial status reports must be submitted within 30 days of the end of the half year. Final financial status reports are due within 90 days of expiration of the budget period. Standard Form 269 (long form) will be used for financial reporting. Failure to submit required reports within the time allowed may result in suspension or termination of an active agreement, withholding of additional awards for the project, or other enforcement actions such as withholding of payments or converting to the reimbursement method of payment. Continued failure to submit required reports may result in one or both of the following:
(1)The imposition of special award provisions; and
(2)the non-funding or non-award of other eligible projects or activities. This applies whether the delinquency is attributable to the failure of the organization or the individual responsible for preparation of the reports. Telecommunication for the hearing impaired is available at: TTY 301-443-6394. VII. Agency Contacts For program-related information: Phyllis S. Wolfe, Director, Office of Urban Indian Health Programs, 801 Thompson Avenue, Suite 200, Rockville, Maryland 20852,
(301)443-4680 or *phyllis.wolfe@ihs.gov.* For general information regarding this announcement: Danielle Steward, Health Systems Specialist, Office of Urban Indian Health Programs, 801 Thompson Road, Room 200, Rockville, MD 20852,
(301)443-4680 or *danielle.steward@ihs.gov.* For specific grant-related and business management information: Denise Clark, Senior Grants Management Specialist, 801 Thompson Avenue, TMP 360, Rockville, MD 20852, 301-443-5204 or *denise.clark@ihs.gov.* VIII. Other Information None. Dated: July 16, 2007. Robert G. McSwain, Deputy Director, Indian Health Service. [FR Doc. E7-14033 Filed 7-19-07; 8:45 am] BILLING CODE 4165-16-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. Photosensitization by Nuclear Receptor-Ligand Complexes and Cell Ablation Uses Thereof *Description of Technology:* Androgen receptors
(AR)mediate the effects of male steroid hormones and contribute to a wide variety of physiological and pathophysiological conditions. Prostate cancer development and progression are mediated through AR, a ligand-dependent transcription factor, and it is present in all stages of prostate carcinoma. Increased levels of PSA, an AR-induced prostate tumor-specific protein, are indicative of prostate cancer. Benign, non-cancerous conditions are also AR-dependent and can be therapeutic targets as well. This technology is a method to cause AR-induced cell death (apoptosis) through photoactivation of a non-steroidal androgen receptor antagonist 1,2,3,4-tetrahydro-2,2-dimethyl-6-(trifluoromethyl)-8-pyridono[5,6-g] quinoline (TDPQ). Upon TDPQ binding to AR, a highly potent photocytoxic reaction induced once the TDPQ-AR complex is exposed to visible light irradiation of a specific wavelength. The inventors have cell-culture results demonstrating that cell death is a function of TDPQ, AR and light irradiation. This treatment method can potentially target AR-containing cancerous cells, while sparing nearby cells that lack AR. The process has been extended to other nuclear receptors by choice of other photoactivatable ligands for these receptors. Certain suitable ligands are marketed drugs. *Applications:* Therapeutic compounds to treat AR related conditions such as prostate cancer, baldness, hirsutism, and acne; Potential therapeutics for progesterone and glucorticoid receptor ligand related conditions such as breast and brain cancers, lymphoma, leukemia and arthritis; Method to treat androgen, progesterone, and glucorticoid receptor related conditions. *Market:* Prostate cancer is the second most common type of cancer among men, wherein one in six men will be diagnosed with prostate cancer; An estimated 218,890 new cases of prostate cancer and 27,050 deaths due to prostate cancer in the U.S. in 2007; Hirsutism affects approximately 5% of adult women in the United States; Hair loss and acne industries are worth several billions of dollars. *Development Status:* The technology is currently in the pre-clinical stage of development. *Inventors:* William T. Schrader *et al.* (NIEHS). *Publications:* 1. B Risek *et al.* Androgen Receptor-Mediated Apoptosis is Regulated by Photoactivatable AR Ligands. Abstract submitted to the Endocrine Society; To be presented at the Annual Meeting of the Endocrine Society in Toronto, Canada in June 2007. 2. B Risek *et al.* Photocytotoxic Properties of the Non-Steroidal Androgen Receptor Antagonist TDPQ. Presented at the Annual Meeting of the Endocrine Society in Boston, MA in June 2006. *Patent Status:* U.S. Provisional Application No. 60/926,218 filed 24 Apr 2007 (HHS Reference No. E-108-2007/0-US-01). *Licensing Status:* Available for exclusive or non-exclusive licensing. *Licensing Contact:* Jennifer Wong; 301/435-4633; *wongje@mail.nih.gov.* Method of Treating or Preventing Oxidative Stress-Related Diseases (Stroke and Neurodegenerative Diseases, Wound Healing and Cardiovascular Diseases) *Description of Technology:* Reactive oxygen species
(ROS)and reactive nitrogen species
(RNS)produce oxidative stress to DNA, lipids and proteins thus causing cellular and tissue damage. A number of diseases are associated with oxidative stress including Alzheimer's disease, ischemic stroke, heart disease, cancer, hepatitis, and autoimmune disease. Uric acid is a natural antioxidant effective in reducing ROS and research has shown that uric acid contributes approximately two-thirds of all free radical scavenging capacity in plasma. Because uric oxide is too insoluble to be used as a therapeutic agent, scientists at the NIH developed uric acid analogs with improved anti-oxidative and solubility properties for use as free radical scavengers or antioxidants. These analogs increased survival of PC12 and hippocampal neurons after challenge by Fe, MPP and Glutamate. When administered to a mouse model of focal ischemic stroke, these compounds protect neuronal cells from ROS and reduce brain damage and ameliorate neurological deficits. Other studies show a single application of these analogs on skin lacerations in mice decreased the time for wound repair. Available for licensing are methods of treating ischemic stroke and wound healing, and for the prevention or treatment of other oxidative stress-related diseases, such as epilepsy, Parkinson's disease and dementia. *Applications* : Novel uric acid analogs for use as antioxidants to help reduce the risk of stroke, neurological diseases and assisting with wound repair. *Market:* Stroke is the third-leading cause of death and the leading cause of severe neurological disability worldwide; Americans will pay approximately $62.7 billion dollars in 2007 for stroke-related medical costs and disability. *Development Status:* Pre-clinical data. *Inventors:* Nigel H. Greig (NIA), Mark P. Mattson (NIA), *et al.* *Patent Status:* U.S. Provisional Application No. 60/839,800 filed 23 Aug 2006 (HHS Reference No. E-059-2006/0-US-01). *Licensing Status:* Available for licensing. *Licensing Contact:* Norbert Pontzer, PhD, J.D.; 301/435-5502; *pontzern@mail.nih.gov.* *Collaborative Research Opportunity:* The National Institute on Aging, Laboratory of Neurosciences, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize the described uric acid analogue technology in the treatment of neurodegenerative diseases, wound healing and cardiovascular disease. Please contact John D. Hewes, PhD at 301-435-3121 or *hewesj@mail.nih.gov* for more information. Thiazepine Inhibitors of HIV-1 Integrase *Description of Technology:* The human immunodeficiency virus
(HIV)is the causative agent of acquired immunodeficiency syndrome (AIDS). Drug resistance is a critical factor contributing to the gradual loss of clinical benefit of treatments for HIV infection. Accordingly, combination therapies have further evolved to address the mutating resistance of HIV. However, there has been great concern regarding the apparent growing resistance of HIV strains to current therapies. It has been found that a certain class of compounds including thiazepines and analogs and derivatives thereof are effective and selective anti-integrase inhibitors. These compounds have been found to inhibit both viral replication and the activity of purified HIV-1 integrase. The subject invention provides for such compounds and for methods of inhibiting HIV integrase. *Inventors:* Yves Pommier *et al.* (NCI). *Patent Status:* U.S. Patent No. 7,015,212 issued 21 Mar 2006 (HHS Reference No. E-036-1999/0-US-03). *Licensing Status:* Available for exclusive or non-exclusive licensing. *Licensing Contact:* Sally Hu, PhD, MBA; 301/435-5606; *hus@mail.nih.gov.* *Collaborative Research Opportunity:* The Laboratory of Molecular Pharmacology of the National Cancer Institute is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize anti-integrase inhibitors. Please contact John D. Hewes, PhD at 301-435-3121 or *hewesj@mail.nih.gov* for more information. Dated: July 13, 2007. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E7-14031 Filed 7-19-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Eye Institute; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* National Eye Institute Special Emphasis Panel, NEI Clinical Applications II. *Date:* July 25, 2007. *Time:* 10:30 a.m. to 11:15 a.m. *Agenda:* To review and evaluate grant applications. *Place:* National Eye Institute, 5635 Fishers Lane, Bethesda, MD 20892 (Telephone Conference Call). *Contact Person:* Anne E Schaffner, PhD, Scientific Review Administrator, Division of Extramural Research, National Eye Institute, 5635 Fishers Lane, Suite 1300, MSC 9300, Bethesda, MD 20892-9300,
(301)451-2020, *aes@nei.nih.gov* . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.867, Vision Research, National Institutes of Health, HHS) Dated: July 12, 2007. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 07-3523 Filed 7-19-07; 8:45 am]
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  • 42 CFR 406.10
  • 42 CFR 406.6
  • 42 CFR 406.7
  • Pub. L. 101-535
  • 21 CFR 15
  • 21 CFR 10
  • Pub. L. 104-121
  • Pub. L. 94-437
  • 45 CFR 74
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