Tribal Self-Governance Program Planning Cooperative Agreement; New Funding Cycle for Fiscal Year 2006, 74020-74024 [E5-7280]

Download as PDF 74020 Federal Register / Vol. 70, No. 239 / Wednesday, December 14, 2005 / Notices I. Background DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D–0483] Guidance for Industry and Food and Drug Administration; Requesting an Extension to Use Existing Label Stock After the Trans Fat Labeling Effective Date of January 1, 2006; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled, ‘‘Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006.’’ The trans fat final rule published in the Federal Register on July 11, 2003. This guidance document provides guidance to FDA and the food industry about when and how businesses may request the agency to consider enforcement discretion for the use, on products introduced into interstate commerce on or after the January 1, 2006, effective date, of some or all existing label stock that does not declare trans fat labeling in compliance with the final rule. DATES: This guidance is final upon the date of publication. Submit written or electronic comments on the guidance at any time. ADDRESSES: Submit written requests for single copies of this guidance to the Office of Nutritional Products, Labeling and Dietary Supplements (HFS–800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the guidance 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. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Julie Moss, Center for Food Safety and Applied Nutrition (HFS–830), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740–3835, 301–436–2373, FAX: 301–436–2636. SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: VerDate Aug<31>2005 15:29 Dec 13, 2005 Jkt 208001 FDA is announcing the availability of a guidance document entitled ‘‘Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006.’’ FDA issued a final rule on July 11, 2003 (68 FR 41434), to require food labels to bear the gram amount of trans fat without a percent Daily Value in the Nutrition Facts panel (http:// www.cfsan.fda.gov/~acrobat/ fr03711a.pdf). The trans fat final rule becomes effective on January 1, 2006. This guidance document provides guidance to FDA staff and the food industry about when and how businesses may request the agency to consider enforcement discretion for the use, on products introduced into interstate commerce on or after the January 1, 2006 effective date, of some or all existing label stock that does not declare trans fat labeling in compliance with the final rule. In compliance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104–121), we are making available this guidance that states in plain language the factors the agency intends to consider concerning requests for enforcement discretion by small and other businesses regarding compliance with this regulation. FDA is issuing this guidance as a level 1 guidance consistent with FDA’s good guidance practices regulation § 10.115 (21 CFR 10.115). Consistent with FDA’s good guidance practices regulation, the agency will accept comment, but is implementing the guidance document immediately in accordance with § 10.115(g)(2), because the agency has determined that prior public participation is not feasible or appropriate. This document affects the trans fat labeling effective date of January 1, 2006, so it is urgent that FDA explains its new enforcement policy before that date. This guidance represents the agency’s current thinking on the subject. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You may use an alternative approach if such approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance (see FOR FURTHER INFORMATION CONTACT). II. Paperwork Reduction Act of 1995 This final guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collection of information in this guidance was approved under OMB control number 0910–0571. III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document at any time. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The guidance and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. IV. Electronic Access Persons with access to the Internet may obtain the guidance document at http://www.cfsan.fda.gov/ guidance.html. Dated: December 5, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–23987 Filed 12–13–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service [Funding Opportunity Number: HHS–2006– IHS–TSGP–0001; CFDA Number: 93.210] Tribal Self-Governance Program Planning Cooperative Agreement; New Funding Cycle for Fiscal Year 2006 Key Dates: Applications Due—January 20, 2006; Objective Review Committee to Evaluate Applications—March 8–9, 2006; Anticipated Project Start Date— April 1 , 2006. I. Funding Opportunity Description The purpose of the program is to award cooperative agreements that provide planning resources to Tribes interested in participating in the Tribal Self-Governance Program (TSGP) as authorized by Title V, Tribal SelfGovernance Amendments of 2000 of the Indian Self-Determination and Education Assistance Act of Public Law (Pub. L.) 93–638, as amended. The TSGP is designed to promote selfdetermination by allowing Tribes to assume more control of Indian Health Service (IHS) programs and services through compacts negotiated with the IHS. The Planning Cooperative E:\FR\FM\14DEN1.SGM 14DEN1 Federal Register / Vol. 70, No. 239 / Wednesday, December 14, 2005 / Notices Alaska Native Village Corporations, who are located within the area served by an Alaska Native regional health entity already participating in compact status, are not eligible (Pub. L. 106–260, Title V, section 12(a)(2)). Agreement allows a Tribe to gather information to determine the current types and amounts of Programs, Services, Functions, and Activities (PSFAs), and funding available at the Service Unit, Area, and Headquarters levels and identify programmatic alternatives that will better meet the needs of Tribal members. II. Award Information Type of Award: Cooperative Agreement. Estimated Funds Available: The total amount identified for Fiscal Year (FY) 2006 is $600,000 for approximately twelve (12) Tribes to enter the TSGP planning process for compacts beginning in Fiscal Year (FY) 2007 or Calendar Year (CY) 2007. Awards under this announcement are subject to the availability of funds. Anticipated Number of Awards: The estimated number of awards to be funded is approximately 12. Project Period: 12 months. Award Amount: $50,000 per year. Programmatic Involvement: IHS TSGP funds will be awarded as cooperative agreements and will have substantial programmatic involvement to establish a basic understanding of IHS Programs, Services, Functions and Activities (PSFAs) as operations at the Service Unit, Area, and Headquarters levels. The IHS roles and responsibilities will include: • Identification of IHS staff that will consult with applicants on methods used by the IHS to manage and deliver health care. • Provide applicants with a list of laws and regulations that provide authority for the various IHS programs. The Grantee roles and responsibilities will include: • Research and analysis of the complex IHS budget, at the Service Unit, Area, and Headquarters levels. • Establishment of a process through which Tribes can effectively approach the IHS to identify programs and associated funding which could be incorporated into programs. III. Eligibility Information 1. Eligible Applicants To be eligible for a Planning Cooperative Agreement under this announcement, an applicant must meet all of the following criteria: A. Be a Federally-recognized Tribe as defined in Title V, Public Law 106–260, Tribal Self-Governance Amendments of 2000, of the Indian Self-Determination and Education Assistance Act (the Act), Public Law 93–638, as amended. However, Alaska Native Villages or VerDate Aug<31>2005 15:29 Dec 13, 2005 Jkt 208001 2. Cost Sharing or Matching Funds The Self-Governance Planning Cooperative Agreement Announcement does not require matching funds or cost sharing to participate in the competitive grant process. 3. Other Requirements The following documentation is required (if applicable): A. This program is described at 93.210 in the Catalog of Federal Domestic Assistance. There is limited competition under this announcement because the authorizing legislation restricts eligibility to Tribes that meet specific criteria. (Refer to Section III, ELIGIBLE APPLICANTS in this announcement.) B. Request participation in selfgovernance by resolution by the governing body of the Indian Tribe. An Indian Tribe that is proposing a cooperative agreement affecting another Indian Tribe must include resolutions from all affected Tribes to be served. C. Demonstrate, for three fiscal years, financial stability and financial management capability, which is defined as no uncorrected significant and material audit exceptions in the required annual audit of the Indian Tribe’s self-determination contracts or self-governance funding agreements with any Federal agency. D. Grantees are required to submit a current version of the organization’s audit report. Audit reports can be lengthy, therefore, the applicants may submit them separately via regular mail by the due date (January 20, 2006). If the grantee determines that audit reports are not lengthy, the applicants may scan the documents and attach them to the electronic application. Applicants must submit two copies of the audits that reflect three previous fiscal years under separate cover directly to the Division of Grants Operations, 801 Thompson Avenue, TMP 360, Rockville, MD 20852, referencing the Funding Opportunity Number, HHS–2006–IHS– TSGP–0001, as prescribed by Public Law 98–502, the Single Audit Act, as amended (see OMB Circular A–133, revised June 24, 1997, Audits of States, Local Governments, and Non-Profit Organizations), for the three previous fiscal years. If this documentation is not submitted by the due date, the application will be considered as unresponsive and will not be PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 74021 considered. Applicants must include the grant tracking number assigned to their electronic submission by Grants.gov and the date submitted via Grants.gov in their cover letter transmitting the required audits for the previous three fiscal years. E. Tribal Resolution—A resolution of the Indian Tribe served by the project should accompany the application submission. An Indian Tribe that is proposing a project affecting another Indian Tribe must include resolutions from all affected Tribes to be served. Tribal Consortia applying for a Planning Cooperative Agreement, a minimum of two individual Tribal Council Resolutions must be submitted. Draft resolutions are acceptable in lieu of an official resolution. However, an official signed Tribal resolution must be received by the Division of Grants Operations (DGO) by the end of the Objective Review (March 9, 2006). If an official signed resolution is not submitted by March 9, 2006, the application will be considered incomplete and will be returned without consideration. *It is highly recommended that the Tribal resolution be sent by Federal Express for proof of receipt. IV. Application and Submission Information 1. Application package may be found on http://Grants.gov Information regarding the electronic application process may be obtained from either of the following persons: Ms. Mary E. Trujillo, Office of Tribal Self-Governance, Indian Health Service, 801 Thompson Avenue, Suite 240, Rockville, Maryland 20852. (301) 443–7821. Ms. Patricia Spotted Horse, Division of Grants Operations, Indian Health Service, 801 Thompson Avenue, TMP 360, Rockville, Maryland 20852. (301) 443–5204. • Web address to obtain application kit: http://www.ihs.gov/ NonMedicalPrograms/gogp/ gogp_submission.asp 2. Content and Form of Application Submission A. All applications should: • Be single spaced. • Be typewritten. • Have consecutively numbered pages. • Use black type not smaller than 12 characters per one inch. • Be printed on one side only of standard size 81⁄2″ × 11″ paper. • Contain a narrative that does not exceed 7 typed pages that includes the E:\FR\FM\14DEN1.SGM 14DEN1 74022 Federal Register / Vol. 70, No. 239 / Wednesday, December 14, 2005 / Notices sections listed below. (The 7 page narrative does not include the work plan, standard forms, Tribal resolution(s), table of contents, budget, budget justifications, narratives, and/or other appendix items.) Public Policy Requirements: All Federal-wide public policies apply to HHS grants with exception of Lobbying and Discrimination. 3. Submission Dates and Times Applications must be submitted online by January 20, 2006. Late applications not accepted for processing will be returned to the applicant and will not be considered for funding. 4. Intergovernmental Review This funding opportunity is not subject to Executive Order 12372, ‘‘Intergovernmental Review of Federal Programs.’’ State approval is not required. 5. Funding Restrictions A. Only one planning cooperative agreement will be awarded per applicant. A. Each planning cooperative agreement shall not exceed $50,000. The available funds are inclusive of direct and indirect costs. B. Planning awards shall not exceed a maximum period of one year. C. Pre-award costs are not allowable. 6. Other Submission Requirements The application must comply with the following: A. Abstract (one page)—Summarizes the project. B. Application for Federal Assistance (SF–424, Rev. 09/03). C. Narrative (no more than 7 pages) with time frame chart (one page); pages numbered consecutively, including appendices, and Table of Contents, and should include the following: (1) Background information on the Tribe. (1) Objectives and activities that provide a description of what will be accomplished. (2) A line-item budget and narrative justification. (3) Appendix to include: a. Resumes or position descriptions of key staff. b. Contractors/Consultants resumes or qualifications. c. Proposed Scope of Work. Electronic Transmission—The preferred method for receipt of applications is electronic submission through http://Grants.gov. However, should any technical problems arise regarding the submission, please contact our Grants Policy Staff at (301) 443– VerDate Aug<31>2005 15:29 Dec 13, 2005 Jkt 208001 6528 at least ten days prior to the application deadline. To submit an application electronically, please use the http://www.Grants.gov apply 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 us. Please note the following: • Under the new IHS requirements, paper applications are not the preferred method. However, if you have technical problems submitting your application on-line, and you have contacted the Grants Policy Staff and advised them of the difficulties you are having in submitting your application on-line, and if it is determined by the Grants Policy Staff that the technical difficulties cannot be resolved, you may submit a paper application after you have downloaded the application package from Grants.gov. The paper application may be sent directly to the Division of Grants Operations, 801 Thompson Avenue, TMP 360, Rockville, MD 20852 by the due date, January 20, 2006. • When you enter the Grants.gov site, you will find information about submitting an application electronically through the site, as well as the hours of operation. We strongly recommend that you do not wait until the deadline date to begin the application process through Grants.gov. • To use Grants.gov, you, as the applicant, must have a DUNS Number and register in the Central Contractor Registry (CCR). You should allow a minimum of 10–15 days to complete CCR registration. See below on how to apply. • You must submit all documents electronically, including all information typically included on the SF–424 and all necessary assurances and certifications. • Your application 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 Indian Health Service will retrieve your application from Grants.gov. • You may access the electronic application for this program on http:// www.Grants.gov. • You must search for the downloadable application package by CFDA number. • To receive an application package, the applicant must provide the Funding PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 Opportunity Number: HHS–2006–IHS– TSGP–0001. E-mail applications will not be accepted under this announcement. DUNS Number: Beginning October 1, 2003, applicants were required to have a Dun and Brandstreet (DUNS) Number. 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 Central Contractor Registry (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 in the appendix of the TSGP Planning Cooperative Agreement application kit or on http:// www.Grants.gov/CCRRegister. More detailed information regarding these registration processes can be found at http://www.Grants.gov. V. Application Review Information 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. 1. Criteria Goals And Objectives of the Project (30 points). Are the goals and objectives measurable; are they consistent with the purpose of the program and terms of this announcement; and, are they achievable as demonstrated by an implementation schedule? Organizational Capabilities And Qualifications (25 points). Describe the organizational structure of the Tribe/ Tribal organization and the ability of the organization to manage the proposed project. Include resumes or position descriptions of key staff showing requisite experience and expertise and, where applicable, include resumes of consultants that demonstrate experience and expertise relevant to the project. Methodology (20 points). Describe fully and clearly the methodology used to reflect the needs of Tribal members E:\FR\FM\14DEN1.SGM 14DEN1 Federal Register / Vol. 70, No. 239 / Wednesday, December 14, 2005 / Notices and if the project can be accomplished with expected available resources. Budget Justification (15 points). Submit a line-item budget with a brief narrative justification for all expenditures. Are costs identified reasonable and allowable in accordance with OMB Circulars A–87, ‘‘Cost Principles for State and Local Governments’’ and A–122, ‘‘Cost Principles for Non-Profit Organizations?’’ Management Of Health Program(s) (10 points). Does the applicant propose an improved approach to managing the health program(s) and state/demonstrate how the delivery of quality health services will be maintained under selfgovernance? Appendix Items: • Work plan for proposed objectives. • Position descriptions for key staff. • Resumes of key staff that reflect current duties. • Consultant proposed scope of work (if applicable). • Indirect Cost Agreement. • Organizational chart (optional). 2. Review and Selection Process In addition to the above criteria/ requirements, applications are considered according to the following: A. Application Submission (Application Deadline: January 20, 2006). Applications submitted in advance of or by the deadline and verified by the tracking number will undergo a preliminary review to determine that: (1) The applicant and proposed project type is eligible in accordance with this grant announcement. (2) The application is not a duplication of a previously funded project. (3) 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. Competitive Review of Eligible Applications (Objective Review: March 8–9, 2006). Applications meeting eligibility 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 these applications. The review will be conducted in accordance with the IHS Objective Review Guidelines. The technical review process ensures selection of quality projects in a national competition for limited funding. Applications will be evaluated VerDate Aug<31>2005 15:29 Dec 13, 2005 Jkt 208001 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, determine the likelihood of success, and assign a numerical score to each application. The scoring of approved applications will assist the IHS in determining which proposals will be funded if the amount of TSGP funding is not sufficient to support all approved applications. Applications recommended for approval, having a score of 60 or above by the ORC and scored high enough to be considered for funding, are forwarded by the Division of Grants Operations (DGO) for cost analysis and further recommendation. The program official forwards the final approval list to the IHS Director for final review and approval. Applications scoring below 60 points will be disapproved and returned to the applicant. 74023 • 45 CFR part 92, ‘‘Department of Health and Human Services, Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments Including Indian Tribes.’’ • Public Health Service Grants Policy Statement. • Grants Policy Directives. • Appropriate Cost Principles: OMB Circular A–87, ‘‘State and Local Governments.’’ • OMB Circular A–133, ‘‘Audits of States, Local Governments, and NonProfit Organizations.’’ • Other Applicable OMB Circulars. 3. Reporting A. Progress Report. NOTE: In making the final selections, the IHS Director will consider the ranking factor and the status of the applicant’s single audit reports. The comments from the ORC will be advisory only. The IHS Director will make the final decision on awards. 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. 3. Anticipated Award Date B. Financial Status Report Earliest Anticipated Award Date: April 1, 2006. 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/project period. Standard Form 269 (long form) will be used for financial reporting. Grantees are responsible and accountable for accurate reporting of the Progress Reports and Financial Status Reports which are generally due semiannually. Financial Status Reports (SF– 269) are due 90 days after each budget period and the final SF–269 must be verified from the grantee records on how the value was derived. Grantees are allowed a reasonable period of time in which to submit financial and performance reports. Failure to submit required reports within the time allowed may result in suspension or termination of an active grant, 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 nonfunding or non-award of other eligible projects or activities. This applies whether the delinquency is attributable to the failure of the grantee organization or the individual responsible for preparation of the reports. VI. Award Administration Information 1. Award Notices Division of Grants Operations (DGO) will not award a grant without an approved application in conformance with regulatory and policy requirements which describes the purpose and scope of the project to be funded. When the application is approved for funding, the DGO will prepare a Notice of Award (NoA) with special terms and conditions binding upon the award and refer to all general terms applicable to the award. The NoA will serve as the official notification of a grant award and will state the amount of Federal funds awarded, the purpose of the grant, the terms and conditions of the grant award, the effective date of the award, the project period, and the budget period. Any other correspondence announcing to the Project Director that an application was selected is not an authorization to begin performance. 2. Administrative and National Policy Requirements Grants are administered in accordance with the following documents: • This grant announcement. • Health and Human Services regulations governing Public Law 93– 638 grants at 42 CFR 36.101 et seq. PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\14DEN1.SGM 14DEN1 74024 Federal Register / Vol. 70, No. 239 / Wednesday, December 14, 2005 / Notices VII. Agency Contact(s) 1. Questions on the programmatic and technical issues may be directed to: Mary E. Trujillo, Program Specialist, Telephone No.: 301–443–7821. Fax No.: 301–443–1050. E-mail: metrujil@hqe.ihs.gov. 2. Questions on grants management and fiscal matters may be directed to: Patricia Spotted Horse, Grants Management Specialist, Telephone No.: 301–443–5204. Fax No.: 301–443–9602. E-mail: pspotted@hqe.ihs.gov. VIII. Other Information The Public Health Service (PHS) strongly encourages all grant and contract recipients to provide a smokefree workplace and promote the non-use of all tobacco products. In addition, Public Law 103–227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of the facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. Dated: December 7, 2005. Robert G. McSwain, Deputy Director, Indian Health Service. [FR Doc. E5–7280 Filed 12–13–05; 8:45 am] Name of Committee: NIH Advisory Board for Clinical Research. Date: January 30, 2006. Open: 10 a.m. to 1:30 p.m. To review the Clinical Center operating plan, ABCR workgroups and Budgetary issues. National Institutes of Health, Building 10, 10 Center Drive, 4–2551, CRC Medical Board Room, Bethesda, MD 20892. Closed: 1:30 p.m. to 2 p.m. Agenda: To review and evaluate for discussion of personal qualifications and performance the disclosure of which constitute a clearly unwarranted invasion of privacy. Place: National Institutes of Health, Building 10, 10 Center Drive, 4–2551, CRC Medical Board Room, Bethesda, MD 20892. Contact Person: Maureen E. Gormley, Executive Secretary, Mark O. Hatfield Clinical Research Center, National Institutes of Health, Building 10, Room 6–15610, Bethesda MD 20892, 301/496–2897. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. Dated: December 7, 2005. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 05–24015 Filed 12–13–05; 8:45am] BILLING CODE 4140–01–M BILLING CODE 4160–16–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting Clinical Center; Notice of 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 a meeting of the NIH Advisory Board for Clinical Research. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The meeting will be closed to the public in accordance with the provisions set froth in section 552b(c)(6), Title 5 U.S.C., as amended for discussion of personal qualifications and performance, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. VerDate Aug<31>2005 15:29 Dec 13, 2005 Jkt 208001 Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel, Genomics of Transplantation Cooperative Research Program. Date: December 19–21, 2005. PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 Time: 6 p.m. to 4 p.m. Agenda: To review and evaluate cooperative agreement applications. Place: Double Tree Rockville, 1750 Rockville Pike, Rockville, MD 20852. Contact Person: Quirijn Vos, PhD, Scientific Review Administrator, Scientific Review Program, Division of Extramural Activities, NIAID/NIH/DHHS, 6700B Rockledge Drive, MSC 7616, Bethesda, MD 20892–7616, (301) 496–2550, qvos@niaid.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. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: December 6, 2005. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 05–24009 Filed 12–13–05; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental Health; 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 contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Mental Health Special Emphasis Panel, SBIR Phase 1 Contracts Topics 053 and 056. Date: January 5, 2006. Time: 12 p.m. to 4 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call). Contact Person: Tracy Waldeck, PhD, Scientific Review Administrator, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience Center, 6001 Executive Blvd., Room 6132, MSC 9608, Bethesda, MD 20852–9609, 301/435–0322, waldeckt@mail.nih.gov. E:\FR\FM\14DEN1.SGM 14DEN1

Agencies

[Federal Register Volume 70, Number 239 (Wednesday, December 14, 2005)]
[Notices]
[Pages 74020-74024]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E5-7280]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Indian Health Service

[Funding Opportunity Number: HHS-2006-IHS-TSGP-0001; CFDA Number: 
93.210]


Tribal Self-Governance Program Planning Cooperative Agreement; 
New Funding Cycle for Fiscal Year 2006

    Key Dates: Applications Due--January 20, 2006; Objective Review 
Committee to Evaluate Applications--March 8-9, 2006; Anticipated 
Project Start Date--April 1 , 2006.

I. Funding Opportunity Description

    The purpose of the program is to award cooperative agreements that 
provide planning resources to Tribes interested in participating in the 
Tribal Self-Governance Program (TSGP) as authorized by Title V, Tribal 
Self-Governance Amendments of 2000 of the Indian Self-Determination and 
Education Assistance Act of Public Law (Pub. L.) 93-638, as amended. 
The TSGP is designed to promote self-determination by allowing Tribes 
to assume more control of Indian Health Service (IHS) programs and 
services through compacts negotiated with the IHS. The Planning 
Cooperative

[[Page 74021]]

Agreement allows a Tribe to gather information to determine the current 
types and amounts of Programs, Services, Functions, and Activities 
(PSFAs), and funding available at the Service Unit, Area, and 
Headquarters levels and identify programmatic alternatives that will 
better meet the needs of Tribal members.

II. Award Information

    Type of Award: Cooperative Agreement.
    Estimated Funds Available: The total amount identified for Fiscal 
Year (FY) 2006 is $600,000 for approximately twelve (12) Tribes to 
enter the TSGP planning process for compacts beginning in Fiscal Year 
(FY) 2007 or Calendar Year (CY) 2007. Awards under this announcement 
are subject to the availability of funds.
    Anticipated Number of Awards: The estimated number of awards to be 
funded is approximately 12.
    Project Period: 12 months.
    Award Amount: $50,000 per year.
    Programmatic Involvement: IHS TSGP funds will be awarded as 
cooperative agreements and will have substantial programmatic 
involvement to establish a basic understanding of IHS Programs, 
Services, Functions and Activities (PSFAs) as operations at the Service 
Unit, Area, and Headquarters levels.
    The IHS roles and responsibilities will include:
     Identification of IHS staff that will consult with 
applicants on methods used by the IHS to manage and deliver health 
care.
     Provide applicants with a list of laws and regulations 
that provide authority for the various IHS programs.
    The Grantee roles and responsibilities will include:
     Research and analysis of the complex IHS budget, at the 
Service Unit, Area, and Headquarters levels.
     Establishment of a process through which Tribes can 
effectively approach the IHS to identify programs and associated 
funding which could be incorporated into programs.

III. Eligibility Information

1. Eligible Applicants

    To be eligible for a Planning Cooperative Agreement under this 
announcement, an applicant must meet all of the following criteria:
    A. Be a Federally-recognized Tribe as defined in Title V, Public 
Law 106-260, Tribal Self-Governance Amendments of 2000, of the Indian 
Self-Determination and Education Assistance Act (the Act), Public Law 
93-638, as amended. However, Alaska Native Villages or Alaska Native 
Village Corporations, who are located within the area served by an 
Alaska Native regional health entity already participating in compact 
status, are not eligible (Pub. L. 106-260, Title V, section 12(a)(2)).

2. Cost Sharing or Matching Funds

    The Self-Governance Planning Cooperative Agreement Announcement 
does not require matching funds or cost sharing to participate in the 
competitive grant process.

3. Other Requirements

    The following documentation is required (if applicable):
    A. This program is described at 93.210 in the Catalog of Federal 
Domestic Assistance. There is limited competition under this 
announcement because the authorizing legislation restricts eligibility 
to Tribes that meet specific criteria. (Refer to Section III, ELIGIBLE 
APPLICANTS in this announcement.)
    B. Request participation in self-governance by resolution by the 
governing body of the Indian Tribe. An Indian Tribe that is proposing a 
cooperative agreement affecting another Indian Tribe must include 
resolutions from all affected Tribes to be served.
    C. Demonstrate, for three fiscal years, financial stability and 
financial management capability, which is defined as no uncorrected 
significant and material audit exceptions in the required annual audit 
of the Indian Tribe's self-determination contracts or self-governance 
funding agreements with any Federal agency.
    D. Grantees are required to submit a current version of the 
organization's audit report. Audit reports can be lengthy, therefore, 
the applicants may submit them separately via regular mail by the due 
date (January 20, 2006). If the grantee determines that audit reports 
are not lengthy, the applicants may scan the documents and attach them 
to the electronic application. Applicants must submit two copies of the 
audits that reflect three previous fiscal years under separate cover 
directly to the Division of Grants Operations, 801 Thompson Avenue, TMP 
360, Rockville, MD 20852, referencing the Funding Opportunity Number, 
HHS-2006-IHS-TSGP-0001, as prescribed by Public Law 98-502, the Single 
Audit Act, as amended (see OMB Circular A-133, revised June 24, 1997, 
Audits of States, Local Governments, and Non-Profit Organizations), for 
the three previous fiscal years. If this documentation is not submitted 
by the due date, the application will be considered as unresponsive and 
will not be considered. Applicants must include the grant tracking 
number assigned to their electronic submission by Grants.gov and the 
date submitted via Grants.gov in their cover letter transmitting the 
required audits for the previous three fiscal years.
    E. Tribal Resolution--A resolution of the Indian Tribe served by 
the project should accompany the application submission. An Indian 
Tribe that is proposing a project affecting another Indian Tribe must 
include resolutions from all affected Tribes to be served. Tribal 
Consortia applying for a Planning Cooperative Agreement, a minimum of 
two individual Tribal Council Resolutions must be submitted. Draft 
resolutions are acceptable in lieu of an official resolution. However, 
an official signed Tribal resolution must be received by the Division 
of Grants Operations (DGO) by the end of the Objective Review (March 9, 
2006). If an official signed resolution is not submitted by March 9, 
2006, the application will be considered incomplete and will be 
returned without consideration.
    *It is highly recommended that the Tribal resolution be sent by 
Federal Express for proof of receipt.

IV. Application and Submission Information

1. Application package may be found on http://Grants.gov

    Information regarding the electronic application process may be 
obtained from either of the following persons:

Ms. Mary E. Trujillo, Office of Tribal Self-Governance, Indian Health 
Service, 801 Thompson Avenue, Suite 240, Rockville, Maryland 20852. 
(301) 443-7821.

Ms. Patricia Spotted Horse, Division of Grants Operations, Indian 
Health Service, 801 Thompson Avenue, TMP 360, Rockville, Maryland 
20852. (301) 443-5204.

     Web address to obtain application kit: http://www.ihs.gov/
NonMedicalPrograms/gogp/gogp_submission.asp

2. Content and Form of Application Submission

    A. All applications should:
     Be single spaced.
     Be typewritten.
     Have consecutively numbered pages.
     Use black type not smaller than 12 characters per one 
inch.
     Be printed on one side only of standard size 8\1/2\'' x 
11'' paper.
     Contain a narrative that does not exceed 7 typed pages 
that includes the

[[Page 74022]]

sections listed below. (The 7 page narrative does not include the work 
plan, standard forms, Tribal resolution(s), table of contents, budget, 
budget justifications, narratives, and/or other appendix items.)
    Public Policy Requirements: All Federal-wide public policies apply 
to HHS grants with exception of Lobbying and Discrimination.

3. Submission Dates and Times

    Applications must be submitted on-line by January 20, 2006. Late 
applications not accepted for processing will be returned to the 
applicant and will not be considered for funding.

4. Intergovernmental Review

    This funding opportunity is not subject to Executive Order 12372, 
``Intergovernmental Review of Federal Programs.'' State approval is not 
required.

5. Funding Restrictions

    A. Only one planning cooperative agreement will be awarded per 
applicant.
    A. Each planning cooperative agreement shall not exceed $50,000. 
The available funds are inclusive of direct and indirect costs.
    B. Planning awards shall not exceed a maximum period of one year.
    C. Pre-award costs are not allowable.

6. Other Submission Requirements

    The application must comply with the following:
    A. Abstract (one page)--Summarizes the project.
    B. Application for Federal Assistance (SF-424, Rev. 09/03).
    C. Narrative (no more than 7 pages) with time frame chart (one 
page); pages numbered consecutively, including appendices, and Table of 
Contents, and should include the following:
    (1) Background information on the Tribe.
    (1) Objectives and activities that provide a description of what 
will be accomplished.
    (2) A line-item budget and narrative justification.
    (3) Appendix to include:
    a. Resumes or position descriptions of key staff.
    b. Contractors/Consultants resumes or qualifications.
    c. Proposed Scope of Work.
    Electronic Transmission--The preferred method for receipt of 
applications is electronic submission through http://Grants.gov. 
However, should any technical problems arise regarding the submission, 
please contact our Grants Policy Staff at (301) 443-6528 at least ten 
days prior to the application deadline. To submit an application 
electronically, please use the http://www.Grants.gov apply 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 us.
    Please note the following:
     Under the new IHS requirements, paper applications are not 
the preferred method. However, if you have technical problems 
submitting your application on-line, and you have contacted the Grants 
Policy Staff and advised them of the difficulties you are having in 
submitting your application on-line, and if it is determined by the 
Grants Policy Staff that the technical difficulties cannot be resolved, 
you may submit a paper application after you have downloaded the 
application package from Grants.gov. The paper application may be sent 
directly to the Division of Grants Operations, 801 Thompson Avenue, TMP 
360, Rockville, MD 20852 by the due date, January 20, 2006.
     When you enter the Grants.gov site, you will find 
information about submitting an application electronically through the 
site, as well as the hours of operation. We strongly recommend that you 
do not wait until the deadline date to begin the application process 
through Grants.gov.
     To use Grants.gov, you, as the applicant, must have a DUNS 
Number and register in the Central Contractor Registry (CCR). You 
should allow a minimum of 10-15 days to complete CCR registration. See 
below on how to apply.
     You must submit all documents electronically, including 
all information typically included on the SF-424 and all necessary 
assurances and certifications.
     Your application 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 Indian Health Service will retrieve 
your application from Grants.gov.
     You may access the electronic application for this program 
on http://www.Grants.gov.
     You must search for the downloadable application package 
by CFDA number.
     To receive an application package, the applicant must 
provide the Funding Opportunity Number: HHS-2006-IHS-TSGP-0001.
    E-mail applications will not be accepted under this announcement.
    DUNS Number: Beginning October 1, 2003, applicants were required to 
have a Dun and Brandstreet (DUNS) Number. 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 Central Contractor Registry (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 in the appendix 
of the TSGP Planning Cooperative Agreement application kit or on http:/
/www.Grants.gov/CCRRegister.
    More detailed information regarding these registration processes 
can be found at http://www.Grants.gov.

V. Application Review Information

    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.

1. Criteria

    Goals And Objectives of the Project (30 points). Are the goals and 
objectives measurable; are they consistent with the purpose of the 
program and terms of this announcement; and, are they achievable as 
demonstrated by an implementation schedule?
    Organizational Capabilities And Qualifications (25 points). 
Describe the organizational structure of the Tribe/Tribal organization 
and the ability of the organization to manage the proposed project. 
Include resumes or position descriptions of key staff showing requisite 
experience and expertise and, where applicable, include resumes of 
consultants that demonstrate experience and expertise relevant to the 
project.
    Methodology (20 points). Describe fully and clearly the methodology 
used to reflect the needs of Tribal members

[[Page 74023]]

and if the project can be accomplished with expected available 
resources.
    Budget Justification (15 points). Submit a line-item budget with a 
brief narrative justification for all expenditures. Are costs 
identified reasonable and allowable in accordance with OMB Circulars A-
87, ``Cost Principles for State and Local Governments'' and A-122, 
``Cost Principles for Non-Profit Organizations?''
    Management Of Health Program(s) (10 points). Does the applicant 
propose an improved approach to managing the health program(s) and 
state/demonstrate how the delivery of quality health services will be 
maintained under self-governance?
    Appendix Items:
     Work plan for proposed objectives.
     Position descriptions for key staff.
     Resumes of key staff that reflect current duties.
     Consultant proposed scope of work (if applicable).
     Indirect Cost Agreement.
     Organizational chart (optional).

2. Review and Selection Process

    In addition to the above criteria/requirements, applications are 
considered according to the following:
    A. Application Submission (Application Deadline: January 20, 2006). 
Applications submitted in advance of or by the deadline and verified by 
the tracking number will undergo a preliminary review to determine 
that:
    (1) The applicant and proposed project type is eligible in 
accordance with this grant announcement.
    (2) The application is not a duplication of a previously funded 
project.
    (3) 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. Competitive Review of Eligible Applications (Objective Review: 
March 8-9, 2006). Applications meeting eligibility 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 these 
applications. The review will be conducted in accordance with the IHS 
Objective Review Guidelines. The technical review process ensures 
selection of quality projects in a national competition for limited 
funding. Applications 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, determine the likelihood of 
success, and assign a numerical score to each application. The scoring 
of approved applications will assist the IHS in determining which 
proposals will be funded if the amount of TSGP funding is not 
sufficient to support all approved applications. Applications 
recommended for approval, having a score of 60 or above by the ORC and 
scored high enough to be considered for funding, are forwarded by the 
Division of Grants Operations (DGO) for cost analysis and further 
recommendation. The program official forwards the final approval list 
to the IHS Director for final review and approval. Applications scoring 
below 60 points will be disapproved and returned to the applicant.


    NOTE: In making the final selections, the IHS Director will 
consider the ranking factor and the status of the applicant's single 
audit reports. The comments from the ORC will be advisory only. The 
IHS Director will make the final decision on awards.

3. Anticipated Award Date

    Earliest Anticipated Award Date: April 1, 2006.

VI. Award Administration Information

1. Award Notices

    Division of Grants Operations (DGO) will not award a grant without 
an approved application in conformance with regulatory and policy 
requirements which describes the purpose and scope of the project to be 
funded. When the application is approved for funding, the DGO will 
prepare a Notice of Award (NoA) with special terms and conditions 
binding upon the award and refer to all general terms applicable to the 
award. The NoA will serve as the official notification of a grant award 
and will state the amount of Federal funds awarded, the purpose of the 
grant, the terms and conditions of the grant award, the effective date 
of the award, the project period, and the budget period. Any other 
correspondence announcing to the Project Director that an application 
was selected is not an authorization to begin performance.

2. Administrative and National Policy Requirements

    Grants are administered in accordance with the following documents:
     This grant announcement.
     Health and Human Services regulations governing Public Law 
93-638 grants at 42 CFR 36.101 et seq.
     45 CFR part 92, ``Department of Health and Human Services, 
Uniform Administrative Requirements for Grants and Cooperative 
Agreements to State and Local Governments Including Indian Tribes.''
     Public Health Service Grants Policy Statement.
     Grants Policy Directives.
     Appropriate Cost Principles: OMB Circular A-87, ``State 
and Local Governments.''
     OMB Circular A-133, ``Audits of States, Local Governments, 
and Non-Profit Organizations.''
     Other Applicable OMB Circulars.

3. 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/project period. Standard 
Form 269 (long form) will be used for financial reporting.
    Grantees are responsible and accountable for accurate reporting of 
the Progress Reports and Financial Status Reports which are generally 
due semi-annually. Financial Status Reports (SF-269) are due 90 days 
after each budget period and the final SF-269 must be verified from the 
grantee records on how the value was derived. Grantees are allowed a 
reasonable period of time in which to submit financial and performance 
reports.
    Failure to submit required reports within the time allowed may 
result in suspension or termination of an active grant, 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 grantee organization or the 
individual responsible for preparation of the reports.

[[Page 74024]]

VII. Agency Contact(s)

    1. Questions on the programmatic and technical issues may be 
directed to: Mary E. Trujillo, Program Specialist, Telephone No.: 301-
443-7821. Fax No.: 301-443-1050. E-mail: metrujil@hqe.ihs.gov.
    2. Questions on grants management and fiscal matters may be 
directed to: Patricia Spotted Horse, Grants Management Specialist, 
Telephone No.: 301-443-5204. Fax No.: 301-443-9602. E-mail: 
pspotted@hqe.ihs.gov.

VIII. Other Information

    The Public Health Service (PHS) strongly encourages all grant and 
contract recipients to provide a smoke-free workplace and promote the 
non-use of all tobacco products. In addition, Public Law 103-227, the 
Pro-Children Act of 1994, prohibits smoking in certain facilities (or 
in some cases, any portion of the facility) in which regular or routine 
education, library, day care, health care or early childhood 
development services are provided to children. This is consistent with 
the PHS mission to protect and advance the physical and mental health 
of the American people.

    Dated: December 7, 2005.
Robert G. McSwain,
Deputy Director, Indian Health Service.
 [FR Doc. E5-7280 Filed 12-13-05; 8:45 am]
BILLING CODE 4160-16-P