Enhancement of Laboratory Quality System Approach in Building the Capacity of Health Laboratories To Support HIV/AIDS Prevention, Care and Treatment Services in the United Republic of Tanzania, 53224-53229 [05-17679]

Download as PDF 53224 Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Notices V.3. Anticipated Announcement and Award Dates October 30, 2005. VI. Award Administration Information VI.1. Award Notices Successful applicants will receive a Notice of Award (NoA) from the HHS/ CDC Procurement and Grants Office. The NoA shall be the only binding, authorizing document between the recipient and HHS/CDC. An authorized Grants Management Officer will sign the NoA, and mail it to the recipient fiscal officer identified in the application. Unsuccessful applicants will receive notification of the results of the application review by mail. VI.2. Administrative and National Policy Requirements 45 CFR Part 74 as Appropriate For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address: https:// www.access.gpo.gov/nara/cfr/cfr-tablesearch.html. The following additional requirements apply to this project: • AR–4 HIV/AIDS Confidentiality Provisions • AR–6 Patient Care • AR–8 Public Health System Reporting Requirements • AR–12 Lobbying Restrictions • AR–14 Accounting System Requirements • AR–15 Proof of Non-Profit Status • AR–23 States and Faith Based Organization Applicants can find additional information on these requirements on the HHS/CDC Web site at the following Internet address: https://www.cdc.gov/ od/pgo/funding/ARs.htm. You need to include an additional Certifications form from the PHS 5161– 1 application in your Grants.gov electronic submission only. Please refer to https://www.cdc.gov/od/pgo/funding/ PHS5161–11Certificates.pdf. Once you have filled out the form, please attach it to the Grants.gov submission as Other Attachments Form. VI.3. Reporting Requirements You must provide HHS/CDC with an original, plus two hard copies of the following reports: 1. In year one, quarterly progress reports, due 30 days after the end of each quarter. In subsequent years, a semi-annual progress report is required no later than 30 days after the reporting period. 2. Interim progress report, no less than 90 days before the end of the VerDate Aug<18>2005 15:05 Sep 06, 2005 Jkt 205001 budget period. The progress report will serve as the non-competing continuation application, and must contain the following elements: a. Current Budget Period Activities Objectives. b. Current Budget Period Financial Progress. c. New Budget Period Program Proposed Activity Objectives. d. Budget. e. Measures of Effectiveness, including progress against the numerical goals of the President’s Emergency Plan for AIDS Relief for Southern Sudan. f. Additional Requested Information. 3. Financial status report, no more than 90 days after the end of the budget period. 4. Final financial and performance reports, no more than 90 days after the end of the project period. 5. Annual progress report, due no more than 60 days after the end of the budget period. Reports should include progress against the numerical goals of the President’s Emergency Plan for AIDS Relief for Southern Sudan. Recipients must mail these reports to the Grants Management or Contract Specialist listed in the ‘‘Agency Contacts’’ section of this announcement. Web site of the HHS Office of Global Health Affairs, Internet address: www.globalhealth.gov. VII. Agency Contacts I. Funding Opportunity Description We encourage inquiries concerning this announcement. For general questions, contact: Technical Information Management Section, CDC Procurement and Grants Office, U.S. Department of Health and Human Services, 2920 Brandywine Road, Atlanta, GA 30341. Telephone: 770–488–2700. For program technical assistance, contact: Thomas Boo, Medical Officer, GAP, CDC-Kenya, Centers for Disease Control and Prevention, HHS/CDC Global AIDS Program, P.O. Box 606 Village Market, 00621 Nairobi, Kenya. Telephone: 254–20–271–3008, ext. 149 or Mobile: +254–722–200–189. E-mail: tboo@ke.cdc.gov. For financial, grants management, or budget assistance, contact: Diane Flournoy, Grants Management Specialist, CDC Procurement and Grants Office, U.S. Department of Health and Human Services, 2920 Brandywine Road, Atlanta, GA 30341. Telephone: 770–488–2072. E-mail: dmf6@cdc.gov. Authority: This program is authorized under Sections 301(a) and 307 of the Public Health Service Act [42 U.S.C. 241 and 242l], as amended, and under Public Law 108–25 (United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003) [U.S.C. 7601]. VIII. Other Information Applicants can find this and other HHS funding opportunity announcements on the HHS/CDC Web site, Internet address: www.cdc.gov (Click on ‘‘Funding’’ then ‘‘Grants and Cooperative Agreements’’), and on the PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 Dated: August 31, 2005. William P. Nichols, Director, Procurement and Grants Office, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services. [FR Doc. 05–17678 Filed 9–6–05; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Enhancement of Laboratory Quality System Approach in Building the Capacity of Health Laboratories To Support HIV/AIDS Prevention, Care and Treatment Services in the United Republic of Tanzania Announcement Type: New. Funding Opportunity Number: CDC– RFA–AA086. Catalog of Federal Domestic Assistance Number: 93.067. Key Date: Application Deadline: October 3, 2005. Background: President Bush’s Emergency Plan for AIDS Relief has called for immediate, comprehensive and evidence-based action to turn the tide of global HIV/AIDS. The initiative aims to treat more than two million HIV-infected people with effective combination anti-retroviral therapy by 2008; care for ten million HIV-infected and affected persons, including those orphaned by HIV/AIDS, by 2008; and prevent seven million infections by 2010, with a focus on 15 priority countries, including 12 in subSaharan Africa. The five-year strategy for the Emergency Plan is available at the following Internet address: https:// www.state.gov/s/gac/rl/or/c11652.htm. Over the same time period, as part of a collective national response, the Emergency Plan goals specific to Tanzania are to treat at least 150,000 HIV-infected individuals, and care for 750,000 HIV-affected individuals, including orphans. Purpose: The purpose of this cooperative agreement is to collaborate E:\FR\FM\07SEN1.SGM 07SEN1 Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Notices with the National Institute for Medical Research (NIMR), and the Tanzanian Ministry of Health (MOH) to establish the National Laboratory Quality Assurance and Training Center that will: (1) Provide leadership in HIV/ AIDS related laboratory training; and (2) provide technical assistance and leadership in assuring highly functional and operational testing systems, and assuring quality systems integration, in building the capacity of health laboratories to support HIV/AIDS prevention, care and treatment in the United Republic of Tanzania. Measurable outcomes of the program will be in alignment with the performance goals of the President’s Emergency Plan and with one (or more) of the following performance goal(s) for the National Center for HIV, Sexually Transmitted Diseases, and Tuberculosis Prevention of the Centers for Disease Control and Prevention (CDC) within the U.S. Department of Health and Human Services (HHS): By 2010, work with other countries, international organizations, the Department of State, United States Agency for International Development (USAID), and other partners to achieve the United Nations General Assembly Special Session on HIV/AIDS goal of reducing prevalence among young persons 15 to 24 years of age, reducing HIV transmission, and improving care of persons living with HIV/AIDS (PLWHA). Activities: Applicants should describe activities in detail as part of a four-year action plan (U.S. Government Fiscal Years 2005–2008 inclusive) that reflects the policies and goals outlined in the five-year strategy for the President’s Emergency Plan. The grantee will produce an annual operational plan in the context of this four-year plan, which the U.S. Government Emergency Plan team on the ground in Tanzania will review as part of the annual Emergency Plan for AIDS Relief Country Operational Plan review and approval process managed by the Office of the U.S. Global AIDS Coordinator. HHS/CDC, under the guidance of the U.S. Global AIDS Coordinator, will approve funds for activities on an annual basis, based on documented performance toward achieving Emergency Plan goals, as part of the annual Emergency Plan for AIDS Relief Country Operational Plan review and approval process. Awardee activities for this program are as follows: 1. Provide leadership in HIV/AIDSrelated laboratory training: a. Develop training materials (including doing educational design) for VerDate Aug<18>2005 15:05 Sep 06, 2005 Jkt 205001 local training and at the peripheral levels. b. Deliver training in HIV/AIDSrelated testing and testing-specific quality assurance. c. Train trainers in a laboratoryquality systems approach. d. Serve as a central area for receiving and delivering distance-based training (e.g., satellite- and Internet-based training). e. Serve as liaison with international training efforts with the goal of producing standardized, harmonized curricula. 2. Provide technical assistance and leadership in assuring highly functional and operational testing systems, and assuring quality systems integration, in building the capacity of health laboratories to support HIV/AIDS prevention, care and treatment: a. Provide assistance and leadership in the development of standard operating procedures for quality system components (for example: Sample management; process control; and information management). b. Serve as the primary resource for receipt of, and knowledge transfer of, international standards and guidelines for quality systems, such as those from the International Organization for Standardization (IOS) and the U.S. National Committee for Clinical Laboratory Standards (NCCLS). c. Provide technical assistance and coordination support for external quality-assessment (proficiency testing) programs. 3. Serve as a supra-reference laboratory for HIV-related Testing in Tanzania: a. Evaluate, provide and assist, when needed, with technology transfer for new diagnostic tests, diagnostic testing algorithms, tests to stage disease and monitor immune function, and tests for anti-retroviral resistance. b. Serve as the ultimate referral laboratory in Tanzania for samples that present unusual or unique testing. In a cooperative agreement, HHS staff is substantially involved in the program activities, above and beyond routine grant monitoring. CDC Activities for this program are as follows: 1. Collaborate with the applicant, the Tanzania MOH and other in-country and international partners, in the development of plans for program assistance based on the country needs, the HHS technical assistance portfolio, and HIV laboratory activities conducted by other partners. 2. Provide consultation and scientific and technical assistance based on the ‘‘CDC Global AIDS Program (GAP) PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 53225 Technical Strategies’’ document to promote the use of best practices known at the time. 3. Facilitate in-country planning and review meetings for the purpose of ensuring coordination of country-based program technical assistance activities. HHS will act as liaison and assist in coordinating activities, as required, between the applicant and other nongovernmental organizations (NGOs), the Government of the United Republic of Tanzania, and other Emergency Plan partners. Either HHS staff or staff from organizations that have successfully competed for funding under a separate HHS contract, cooperative agreement or grant will provide technical assistance and training. This announcement is only for nonresearch activities supported by HHS/ CDC. If an applicant proposes research activities, HHS will not review the application. For the definition of ‘‘research’’, please see the HHS/CDC Web site at the following Internet address: https://www.cdc.gov/od/ads/ opspoll1.htm. II. Award Information Type of Award: Cooperative Agreement. HHS involvement in this program is listed in the Activities Section above. Fiscal Year Funds: 2006. Approximate Total Funding: $3,600,000. (This amount is an estimate for the entire project period, and is subject to availability of funds.) Approximate Number of Awards: Two. Approximate Average Award: $450,000. (This amount is for the first 12-month budget period, and includes indirect costs.) Floor of Award Range: None. Ceiling of Award Range: $600,000. (This ceiling is for the first 12-month budget period.) Anticipated Award Date: October 30, 2005. Budget Period Length: 12 months. Project Period Length: Four years. Throughout the project period, HHS’ commitment to continuation of awards will be conditioned on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the Federal Government, through the Emergency Plan for AIDS Relief review and approval process for Country Operational Plans, managed by the Office of the U.S. Global AIDS Coordinator. E:\FR\FM\07SEN1.SGM 07SEN1 53226 Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Notices III. Eligibility Information III.1. Eligible Applicants Applications may be submitted by: • Public nonprofit organizations. • Private nonprofit organizations. • Universities. • Colleges. • For profit organizations. • Small, minority, women-owned businesses. • Community-based organizations. • Research institutions. • Hospitals. • Faith-based organizations. • Federally recognized Indian tribal governments. • Indian tribes. • Indian tribal organizations. • State and local governments or their Bona Fide Agents (this includes the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Mariana Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau). • Political subdivisions of States (in consultation with States). In addition, applicants must meet the criteria listed below: • Be local indigenous to Tanzania. • Have at least three years of documented HIV/AIDS related program implementation experience in Tanzania particularly related laboratory training and lab quality assurance. • Provide letters of support from the Tanzania Ministry of Health and the National Institute for Medical Research as evidence of having established working relationships that can build upon an existing framework. III.2. Cost Sharing or Matching Funds Matching funds are not required for this program. Although matching funds are not required, preference will go to organizations that can leverage additional funds to contribute to program goals. III.3. Other If applicants request a funding amount greater than the ceiling of the award range, HHS/CDC will consider the application non-responsive, and it will not enter into the review process. We will notify you that your application did not meet the submission requirements. Special Requirements: If your application is incomplete or nonresponsive to the special requirements listed in this section, it will not enter into the review process. We will notify you that your application did not meet submission requirements. VerDate Aug<18>2005 15:05 Sep 06, 2005 Jkt 205001 • HHS/CDC will consider late applications non-responsive. See section ‘‘IV.3. Submission Dates and Times’’ for more information on deadlines. • Note: Title 2 of the United States Code Section 1611 states that an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting a grant, loan, or an award. IV. Application and Submission Information IV.1. Address To Request Application Package To apply for this funding opportunity use application form PHS 5161–1. Electronic Submission: HHS strongly encourages you to submit your application electronically by using the forms and instructions posted for this announcement on www.Grants.gov, the official Federal agency wide E-grant Web site. Only applicants who apply on-line are permitted to forego paper copy submission of all application forms. Paper Submission: Application forms and instructions are available on the HHS/CDC Web site, at the following Internet address: www.cdc.gov/od/pgo/ forminfo.htm. If you do not have access to the Internet, or if you have difficulty accessing the forms on-line, contact the HHS/CDC Procurement and Grants Office Technical Information Management Section (PGO–TIM) staff at 770–488–2700. We can mail application forms to you. IV.2. Content and Form of Submission Application: You must submit a project narrative with your application forms. You must submit the narrative in the following format: • Maximum number of pages: 35. If your narrative exceeds the page limit, we will only review the first pages within the page limit. • Font size: 12 point unreduced. • Double-spaced. • Paper size: 8.5 by 11 inches. • Page margin size: One inch. • Printed only on one side of page. • Held together only by rubber bands or metal clips; not bound in any other way. • You MUST submit your application in English. Your narrative should address activities to be conducted over the entire project period, and must include the following items in the order listed: • Executive Summary. Provide a clear and concise summary of the proposed goals, major objectives and activities required for achievement PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 of program goals, the amount of funding requested for budget year one of this cooperative agreement, and the project’s contribution to the Goals and Objectives of the Emergency Plan for AIDS Relief. • Needs Assessment and Capacity Describe the documented need for the proposed activities; current activities that provide relevant experience and expertise to perform the proposed activities; and collaborative relationships with other agencies and organizations that will be involved in the proposed activities. • Year One Operational and Evaluation Plan Provide specific, measurable, and time-phased year one objectives for each proposed project; the specific activities proposed to achieve the year one objectives; and a projected timetable for completion that displays dates for the accomplishment of tasks and identifies responsible parties. For each year one objective, specify how achievement will be measured and documented. • Four-Year Plan Describe realistic four-year goals and measurable, time-phased objectives for each proposed project; the major activities to achieve each objective; plans for collaboration with partners, including the CDC; and the evaluation process that will be used to determine effectiveness and initiate modifications, as needed. • Management and Staffing Plan Describe how the program will be effectively managed. Include the following: a. Management structure, including the lines of authority and plans for fiscal control. b. The staff positions responsible for implementation of the program. c. Qualifications and experience of the designated staff. • Budget and Justification Provide a detailed 12-month budget request and line item justification that is consistent with the purpose of the program and the proposed objectives and activities. The budget must be included within the 35 pages. You may include additional information in the application appendices. The appendices will not count toward the narrative page limit. This additional information includes the following: • Curriculum Vitas. • Resumes. • Organizational Charts. • Letters of Support. You must have a Dun and Bradstreet Data Universal Numbering System (DUNS) number to apply for a grant or cooperative agreement from the Federal government. The DUNS number is a E:\FR\FM\07SEN1.SGM 07SEN1 Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Notices 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 www.dunandbradstreet.com or call 1– 866–705–5711. For more information, see the HHS/ CDC Web site at: https://www.cdc.gov/ od/pgo/funding/grantmain.htm. If your application form does not have a DUNS number field, please write your DUNS number at the top of the first page of your application, and/or include your DUNS number in your application cover letter. Additional requirements that could require you to submit additional documentation with your application are listed in section ‘‘VI.2. Administrative and National Policy Requirements.’’ IV.3. Submission Dates and Times Application Deadline Date: October 7, 2005. Explanation of Deadlines: Applications must be received in the HHS/CDC Procurement and Grants Office by 4 p.m. Eastern Time on the deadline date. You may submit your applications electronically at www.grants.gov. We consider applications completed on-line through Grants.gov as formally submitted when the applicant organization’s Authorizing Official electronically submits the application to www.grants.gov. Electronic applications will be considered as having met the deadline if the applicant organization’s Authorizing Official has submitted the application electronically to Grants.gov on or before the deadline date and time. If you submit your application electronically through Grants.gov, your application will be electronically time/ date stamped, which will serve as receipt of submission. You will receive an e-mail notice of receipt when HHS/ CDC receives the application. If you submit your application by the United States Postal Service or commercial delivery service, you must ensure that the carrier will be able to guarantee delivery by the closing date and time. If HHS/CDC receives your submission after the closing date because: (1) Carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time; or (2) significant weather delays or natural disasters, you will have the opportunity to submit documentation of the carrier’s guarantee. If the documentation verifies a carrier problem, HHS/CDC will consider the submission as having been received by the deadline. VerDate Aug<18>2005 15:05 Sep 06, 2005 Jkt 205001 If you submit a hard copy application, HHS/CDC will not notify you upon receipt of the submission. If you have a question about the receipt of your application, first contact your courier. If you still have a question, contact the PGO–TIM staff at 770–488–2700. Before calling, please wait two to three days after the submission deadline. This will allow time for us to process and log submissions. This announcement is the definitive guide on the application content, submission address, and deadline. It supersedes information provided in the application instructions. If your submission does not meet the deadline above, it will not be eligible for review, and we will discard it. We will notify you that you did not meet the submission requirements. IV.4. Intergovernmental Review of Applications Executive Order 12372 does not apply to this program. IV.5. Funding Restrictions Restrictions, which you must take into account while writing your budget, are as follows: • Funds may not be used for research. • Reimbursement of pre-award costs is not allowed. • Funds may not be used for any new construction. • Antiretroviral drugs—the purchase of ARVs, reagents, and laboratory equipment for antiretroviral treatment projects requires pre-approval in writing from HHS/CDC officials. • Needle exchange—No funds appropriated under this solicitation shall be used to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug. • Funds may be spent for reasonable program purposes, including personnel, travel, supplies, and services. Equipment may be purchased if deemed necessary to accomplish program objectives; however, prior approval by HHS/CDC officials must be requested in writing. • All requests for funds contained in the budget shall be stated in U.S. dollars. Once an award is made, HHS/ CDC will not compensate foreign grantees for currency exchange fluctuations through the issuance of supplemental awards. • The costs that are generally allowable in grants to domestic organizations are allowable to foreign institutions and international organizations, with the following exception: With the exception of the American University, Beirut and the PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 53227 World Health Organization, Indirect Costs will not be paid (either directly or through sub-award) to organizations located outside the territorial limits of the United States or to international organizations, regardless of their location. • The applicant may contract with other organizations under this program; however, the applicant must perform a substantial portion of the activities (including program management and operations, and delivery of prevention services for which funds are required). • You must obtain an annual audit of these HHS/CDC funds (program-specific audit) by a U.S.-based audit firm with international branches and current licensure/authority in-country, and in accordance with International Accounting Standard(s) or equivalent standards approved in writing by HHS/ CDC. • A Fiscal Recipient Capability Assessment may be required, prior to or post award, in order to review the applicant’s business management and fiscal capabilities regarding the handling of U.S. Federal funds. Prostitution and Related Activities The U.S. Government is opposed to prostitution and related activities, which are inherently harmful and dehumanizing, and contribute to the phenomenon of trafficking in persons. Any entity that receives, directly or indirectly, U.S. Government funds in connection with this document (‘‘recipient’’) cannot use such U.S. Government funds to promote or advocate the legalization or practice of prostitution or sex trafficking. Nothing in the preceding sentence shall be construed to preclude the provision to individuals of palliative care, treatment, or post-exposure pharmaceutical prophylaxis, and necessary pharmaceuticals and commodities, including test kits, condoms, and, when proven effective, microbicides. A recipient that is otherwise eligible to receive funds in connection with this document to prevent, treat, or monitor HIV/AIDS shall not be required to endorse or utilize a multisectoral approach to combating HIV/AIDS, or to endorse, utilize, or participate in a prevention method or treatment program to which the recipient has a religious or moral objection. Any information provided by recipients about the use of condoms as part of projects or activities that are funded in connection with this document shall be medically accurate and shall include the public health benefits and failure rates of such use. E:\FR\FM\07SEN1.SGM 07SEN1 53228 Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Notices In addition, any recipient must have a policy explicitly opposing prostitution and sex trafficking. The preceding sentence shall not apply to any ‘‘exempt organizations’’ (defined as the Global Fund to Fight AIDS, Tuberculosis and Malaria, the World Health Organization and its six Regional Offices, the International AIDS Vaccine Initiative or to any United Nations agency). The following definition applies for purposes of this clause: • Sex trafficking means the recruitment, harboring, transportation, provision, or obtaining of a person for the purpose of a commercial sex act. 22 U.S.C. 7102(9). All recipients must insert provisions implementing the applicable parts of this section, ‘‘Prostitution and Related Activities,’’ in all subagreements under this award. These provisions must be express terms and conditions of the subagreement, must acknowledge that compliance with this section, ‘‘Prostitution and Related Activities,’’ is a prerequisite to receipt and expenditure of U.S. government funds in connection with this document, and must acknowledge that any violation of the provisions shall be grounds for unilateral termination of the agreement prior to the end of its term. Recipients must agree that HHS may, at any reasonable time, inspect the documents and materials maintained or prepared by the recipient in the usual course of its operations that relate to the organization’s compliance with this section, ‘‘Prostitution and Related Activities.’’ All prime recipients that receive U.S. Government funds (‘‘prime recipients’’) in connection with this document must certify compliance prior to actual receipt of such funds in a written statement that makes reference to this document (e.g., ‘‘[Prime recipient’s name] certifies compliance with the section, ‘Prostitution and Related Activities.’ ’’) addressed to the agency’s grants officer. Such certifications by prime recipients are prerequisites to the payment of any U.S. Government funds in connection with this document. Recipients’ compliance with this section, ‘‘Prostitution and Related Activities,’’ is an express term and condition of receiving U.S. Government funds in connection with this document, and any violation of it shall be grounds for unilateral termination by HHS of the agreement with HHS in connection with this document prior to the end of its term. The recipient shall refund to HHS the entire amount furnished in connection with this document in the event HHS determines the recipient has not complied with this VerDate Aug<18>2005 15:05 Sep 06, 2005 Jkt 205001 section, ‘‘Prostitution and Related Activities.’’ You may find guidance for completing your budget on the HHS/ CDC Web site, at the following Internet address: https://www.cdc.gov/od/pgo/ funding/budgetguide.htm. IV.6. Other Submission Requirements Application Submission Address Electronic Submission: HHS/CDC strongly encourages you to submit electronically at www.Grants.gov. The application package can be downloaded from www.Grants.gov. You will be able to complete it off-line, and then upload and submit the application via the Grants.gov Web site. We will not accept e-mail submissions. If you are having technical difficulties in Grants.gov, customer service can be reached by email at support@grants.gov or by phone at 1–800–518–4726 (1–800–518– GRANTS). The Customer Support Center is open from 7 a.m. to 9 p.m. Eastern Time, Monday through Friday. HHS/CDC recommends that you submit your application to Grants.gov early enough to resolve any unanticipated difficulties prior to the deadline. You may also submit a backup paper submission of your application. We must receive any such paper submission in accordance with the requirements for timely submission detailed in Section IV.3. of the grant announcement. You must clearly mark the paper submission: ‘‘BACK-UP FOR ELECTRONIC SUBMISSION.’’ The paper submission must conform with all requirements for non-electronic submissions. If we receive both electronic and back-up paper submissions by the deadline, the electronic version will be considered the official submission. We strongly recommend that you submit the grant application by using Microsoft Office products (e.g., Microsoft Word, Microsoft Excel, etc.). If you do not have access to Microsoft Office products, a PDF file may be submitted. You may find directions for creating PDF files on the Grants.gov Web site. Use of file formats other than Microsoft Office or PDF could make your file unreadable for our staff. or Paper Submission: Submit the original and two hard copies of your application by mail or express delivery service to the following address: Technical Information ManagementAA086, CDC Procurement and Grants Office, U.S. Department of Health and Human Services, 2920 Brandywine Road, Atlanta, GA 30341. PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 V. Application Review Information V.1. Criteria Applicants must provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the cooperative agreement. Measures of effectiveness must relate to the performance goals stated in the ‘‘Purpose’’ section of this announcement. Measures must be objective and quantitative, and must measure the intended outcome. Applicants must submit these measures of effectiveness with the application, and they will be an element of evaluation. We will evaluate your application against the following criteria: 1. Technical Approach (25 Points) Does the applicant describe strategies that are pertinent and match those identified in the five-year strategy of the President’s Emergency Plan and activities that are evidence-based, realistic, achievable, measurable and appropriate to achieve the goals of the Emergency Plan? Does the applicant’s proposal include an overall design strategy, including measurable time lines? Does the proposal address regular monitoring and evaluation, and the potential effectiveness of the proposed activities in meeting objectives? 2. Understanding of the Problem (20 Points) Does the applicant demonstrate a clear and concise understanding of the nature of the problem described in the Purpose section of this announcement? Does the proposal specifically include a description of the public health importance of the planned activities to be undertaken, and a realistic presentation of proposed objectives and projects? 3. Ability To Carry Out the Project (20 Points) Does the applicant document demonstrated capability to achieve the purpose of the project? 4. Personnel (20 Points) Are the professional personnel involved in this project qualified, with evidence of experience in working with HIV/AIDS, opportunistic infections, and HIV/STD surveillance? 5. Plans for Administration and Management of Projects (15 Points) Is there a plan to manage the resources of the program, prepare reports, monitor and evaluate activities and audit expenditures? E:\FR\FM\07SEN1.SGM 07SEN1 Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Notices 6. Budget (Not Scored) Is the itemized budget for conducting the project, along with justification, reasonable and consistent with stated objectives, the five-year strategy and goals of the President’s Emergency Plan and Emergency Plan, and planned program activities? V.2. Review and Selection Process The HHS/CDC Procurement and Grants Office (PGO) staff will review applications for completeness, and HHS Global AIDS program will review them for responsiveness. Incomplete applications and applications that are non-responsive to the eligibility criteria will not advance through the review process. Applicants will receive notification that their application did not meet submission requirements. An objective review panel will evaluate complete and responsive applications according to the criteria listed in the ‘‘V.1. Criteria’’ section above. All persons who serve on the panel will be external to the U.S. Government Country Program Office. The panel may include both Federal and non-Federal participants. In addition, the following factors could affect the funding decision: While U.S.-based organizations are eligible to apply, we will give preference to existing national/ Tanzanian organizations. It is possible for one organization to apply as lead grantee with a plan that includes partnering with other organizations, preferably local. Although matching funds are not required, preference will be go to organizations that can leverage additional funds to contribute to program goals. Applications will be funded in order by score and rank determined by the review panel. HHS/CDC will provide justification for any decision to fund out of rank order. In addition, the following factors may affect the funding decision: • Maintaining geographic diversity V.3. Anticipated Announcement and Award Dates October 30, 2005. VI. Award Administration Information VI.1. Award Notices Successful applicants will receive a Notice of Award (NoA) from the HHS/ CDC Procurement and Grants Office. The NoA shall be the only binding, authorizing document between the recipient and HHS/CDC. An authorized Grants Management Officer will sign the NoA and mail it to the recipient fiscal officer identified in the application. VerDate Aug<18>2005 15:05 Sep 06, 2005 Jkt 205001 Unsuccessful applicants will receive notification of the results of the application review by mail. VI.2. Administrative and National Policy Requirements 45 CFR Part 74 and Part 92 For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address: https:// www.access.gpo.gov/nara/cfr/cfr-tablesearch.html. The following additional requirements apply to this project: • AR–4 HIV/AIDS Confidentiality Provisions. • AR–6 Patient Care. • AR–8 Public Health System Reporting Requirements. • AR–12 Lobbying Restrictions. • AR–14 Accounting System Requirements. Applicants can find additional information on these requirements on the HHS/CDC Web site at the following Internet address: https://www.cdc.gov/ od/pgo/funding/ARs.htm. You need to include an additional Certifications form from the PHS5161– 1 application in the Grants.gov electronic submission only. Please refer to https://www.cdc.gov/od/pgo/funding/ PHS5161–1-Certificates.PDF. Once you have filled out the form, please attach it to the Grants.gov submission as Other Attachment Forms. VI.3. Reporting Requirements You must provide HHS/CDC with an original, plus two hard copies, of the following reports: 1. Interim progress report, due no less than 90 days before the end of the budget period. The progress report will serve as your non-competing continuation application, and must contain the following elements: a. Current Budget Period Activities Objectives. b. Current Budget Period Financial Progress. c. New Budget Period Program Proposed Activity Objectives. d. Budget. e. Measures of Effectiveness, including progress against the numerical goals of the President’s Emergency Plan for AIDS Relief for Tanzania. f. Additional Requested Information. 2. Annual progress report, due no later than 90 days after the end of the budget period. 3. Financial status report, due no later than 90 days after the end of the budget period. 4. Final financial and performance reports, due no later than 90 days after the end of the project period. PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 53229 Recipients must mail these reports to the Grants Management or Contract Specialist listed in the ‘‘Agency Contacts’’ section of this announcement. VII. Agency Contacts We encourage inquiries concerning this announcement. For general questions, contact: Technical Information Management Section, CDC Procurement and Grants Office, U.S. Department of Health and Human Services, 2920 Brandywine Road, Atlanta, GA 30341. Telephone: 770–488–2700. For program technical assistance, contact: Cecil Threat, Project Officer, Global AIDS Program, c/o American Embassy, 2140 Dar es Salaam Place, Washington, DC 20521–2140. Telephone: 255 22 212 1407. Cell: 255 744 222986. Fax: 255 22 212 1462. Email: Cthreat@cdc.gov. For financial, grants management, or budget assistance, contact: Diane Flournoy, Grants Management Specialist, CDC Procurement and Grants Office, U.S. Department of Health and Human Services, 2920 Brandywine Road, Atlanta, GA 30341. Telephone: 770–488–2072. E-mail: dmf6@cdc.gov. VIII. Other Information Applicants can find this and other HHS funding opportunity announcements on the HHS/CDC Web site, Internet address: www.cdc.gov (click on ‘‘Funding’’ then ‘‘Grants and Cooperative Agreements’’), and on the Web site of the HHS Office of Global Health Affairs, Internet address: www.globalhealth.gov. Dated: August 31, 2005. William P. Nichols, Director, Procurement and Grants Office, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services. [FR Doc. 05–17679 Filed 9–6–05; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [ATSDR 213] Fees for Sanitation Inspections of Cruise Ships Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: SUMMARY: This notice announces fees for vessel sanitation inspections for E:\FR\FM\07SEN1.SGM 07SEN1

Agencies

[Federal Register Volume 70, Number 172 (Wednesday, September 7, 2005)]
[Notices]
[Pages 53224-53229]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-17679]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Enhancement of Laboratory Quality System Approach in Building the 
Capacity of Health Laboratories To Support HIV/AIDS Prevention, Care 
and Treatment Services in the United Republic of Tanzania

    Announcement Type: New.
    Funding Opportunity Number: CDC-RFA-AA086.
    Catalog of Federal Domestic Assistance Number: 93.067.
    Key Date: Application Deadline: October 3, 2005.

I. Funding Opportunity Description

    Authority: This program is authorized under Sections 301(a) and 
307 of the Public Health Service Act [42 U.S.C. 241 and 242l], as 
amended, and under Public Law 108-25 (United States Leadership 
Against HIV/AIDS, Tuberculosis and Malaria Act of 2003) [U.S.C. 
7601].

    Background: President Bush's Emergency Plan for AIDS Relief has 
called for immediate, comprehensive and evidence-based action to turn 
the tide of global HIV/AIDS.
    The initiative aims to treat more than two million HIV-infected 
people with effective combination anti-retroviral therapy by 2008; care 
for ten million HIV-infected and affected persons, including those 
orphaned by HIV/AIDS, by 2008; and prevent seven million infections by 
2010, with a focus on 15 priority countries, including 12 in sub-
Saharan Africa. The five-year strategy for the Emergency Plan is 
available at the following Internet address: https://www.state.gov/s/
gac/rl/or/c11652.htm.
    Over the same time period, as part of a collective national 
response, the Emergency Plan goals specific to Tanzania are to treat at 
least 150,000 HIV-infected individuals, and care for 750,000 HIV-
affected individuals, including orphans.
    Purpose: The purpose of this cooperative agreement is to 
collaborate

[[Page 53225]]

with the National Institute for Medical Research (NIMR), and the 
Tanzanian Ministry of Health (MOH) to establish the National Laboratory 
Quality Assurance and Training Center that will: (1) Provide leadership 
in HIV/AIDS related laboratory training; and (2) provide technical 
assistance and leadership in assuring highly functional and operational 
testing systems, and assuring quality systems integration, in building 
the capacity of health laboratories to support HIV/AIDS prevention, 
care and treatment in the United Republic of Tanzania.
    Measurable outcomes of the program will be in alignment with the 
performance goals of the President's Emergency Plan and with one (or 
more) of the following performance goal(s) for the National Center for 
HIV, Sexually Transmitted Diseases, and Tuberculosis Prevention of the 
Centers for Disease Control and Prevention (CDC) within the U.S. 
Department of Health and Human Services (HHS): By 2010, work with other 
countries, international organizations, the Department of State, United 
States Agency for International Development (USAID), and other partners 
to achieve the United Nations General Assembly Special Session on HIV/
AIDS goal of reducing prevalence among young persons 15 to 24 years of 
age, reducing HIV transmission, and improving care of persons living 
with HIV/AIDS (PLWHA).
    Activities: Applicants should describe activities in detail as part 
of a four-year action plan (U.S. Government Fiscal Years 2005-2008 
inclusive) that reflects the policies and goals outlined in the five-
year strategy for the President's Emergency Plan.
    The grantee will produce an annual operational plan in the context 
of this four-year plan, which the U.S. Government Emergency Plan team 
on the ground in Tanzania will review as part of the annual Emergency 
Plan for AIDS Relief Country Operational Plan review and approval 
process managed by the Office of the U.S. Global AIDS Coordinator. HHS/
CDC, under the guidance of the U.S. Global AIDS Coordinator, will 
approve funds for activities on an annual basis, based on documented 
performance toward achieving Emergency Plan goals, as part of the 
annual Emergency Plan for AIDS Relief Country Operational Plan review 
and approval process.
    Awardee activities for this program are as follows:
    1. Provide leadership in HIV/AIDS-related laboratory training:
    a. Develop training materials (including doing educational design) 
for local training and at the peripheral levels.
    b. Deliver training in HIV/AIDS-related testing and testing-
specific quality assurance.
    c. Train trainers in a laboratory-quality systems approach.
    d. Serve as a central area for receiving and delivering distance-
based training (e.g., satellite- and Internet-based training).
    e. Serve as liaison with international training efforts with the 
goal of producing standardized, harmonized curricula.
    2. Provide technical assistance and leadership in assuring highly 
functional and operational testing systems, and assuring quality 
systems integration, in building the capacity of health laboratories to 
support HIV/AIDS prevention, care and treatment:
    a. Provide assistance and leadership in the development of standard 
operating procedures for quality system components (for example: Sample 
management; process control; and information management).
    b. Serve as the primary resource for receipt of, and knowledge 
transfer of, international standards and guidelines for quality 
systems, such as those from the International Organization for 
Standardization (IOS) and the U.S. National Committee for Clinical 
Laboratory Standards (NCCLS).
    c. Provide technical assistance and coordination support for 
external quality-assessment (proficiency testing) programs.
    3. Serve as a supra-reference laboratory for HIV-related Testing in 
Tanzania:
    a. Evaluate, provide and assist, when needed, with technology 
transfer for new diagnostic tests, diagnostic testing algorithms, tests 
to stage disease and monitor immune function, and tests for anti-
retroviral resistance.
    b. Serve as the ultimate referral laboratory in Tanzania for 
samples that present unusual or unique testing.
    In a cooperative agreement, HHS staff is substantially involved in 
the program activities, above and beyond routine grant monitoring.
    CDC Activities for this program are as follows:
    1. Collaborate with the applicant, the Tanzania MOH and other in-
country and international partners, in the development of plans for 
program assistance based on the country needs, the HHS technical 
assistance portfolio, and HIV laboratory activities conducted by other 
partners.
    2. Provide consultation and scientific and technical assistance 
based on the ``CDC Global AIDS Program (GAP) Technical Strategies'' 
document to promote the use of best practices known at the time.
    3. Facilitate in-country planning and review meetings for the 
purpose of ensuring coordination of country-based program technical 
assistance activities. HHS will act as liaison and assist in 
coordinating activities, as required, between the applicant and other 
non-governmental organizations (NGOs), the Government of the United 
Republic of Tanzania, and other Emergency Plan partners.
    Either HHS staff or staff from organizations that have successfully 
competed for funding under a separate HHS contract, cooperative 
agreement or grant will provide technical assistance and training.
    This announcement is only for non-research activities supported by 
HHS/CDC. If an applicant proposes research activities, HHS will not 
review the application. For the definition of ``research'', please see 
the HHS/CDC Web site at the following Internet address: https://
www.cdc.gov/od/ads/opspoll1.htm.

II. Award Information

    Type of Award: Cooperative Agreement.
    HHS involvement in this program is listed in the Activities Section 
above.
    Fiscal Year Funds: 2006.
    Approximate Total Funding: $3,600,000. (This amount is an estimate 
for the entire project period, and is subject to availability of 
funds.)
    Approximate Number of Awards: Two.
    Approximate Average Award: $450,000. (This amount is for the first 
12-month budget period, and includes indirect costs.)
    Floor of Award Range: None.
    Ceiling of Award Range: $600,000. (This ceiling is for the first 
12-month budget period.)
    Anticipated Award Date: October 30, 2005.
    Budget Period Length: 12 months.
    Project Period Length: Four years.
    Throughout the project period, HHS' commitment to continuation of 
awards will be conditioned on the availability of funds, evidence of 
satisfactory progress by the recipient (as documented in required 
reports), and the determination that continued funding is in the best 
interest of the Federal Government, through the Emergency Plan for AIDS 
Relief review and approval process for Country Operational Plans, 
managed by the Office of the U.S. Global AIDS Coordinator.

[[Page 53226]]

III. Eligibility Information

III.1. Eligible Applicants

    Applications may be submitted by:
     Public nonprofit organizations.
     Private nonprofit organizations.
     Universities.
     Colleges.
     For profit organizations.
     Small, minority, women-owned businesses.
     Community-based organizations.
     Research institutions.
     Hospitals.
     Faith-based organizations.
     Federally recognized Indian tribal governments.
     Indian tribes.
     Indian tribal organizations.
     State and local governments or their Bona Fide Agents 
(this includes the District of Columbia, the Commonwealth of Puerto 
Rico, the Virgin Islands, the Commonwealth of the Northern Mariana 
Islands, American Samoa, Guam, the Federated States of Micronesia, the 
Republic of the Marshall Islands, and the Republic of Palau).
     Political subdivisions of States (in consultation with 
States).
    In addition, applicants must meet the criteria listed below:
     Be local indigenous to Tanzania.
     Have at least three years of documented HIV/AIDS related 
program implementation experience in Tanzania particularly related 
laboratory training and lab quality assurance.
     Provide letters of support from the Tanzania Ministry of 
Health and the National Institute for Medical Research as evidence of 
having established working relationships that can build upon an 
existing framework.

III.2. Cost Sharing or Matching Funds

    Matching funds are not required for this program. Although matching 
funds are not required, preference will go to organizations that can 
leverage additional funds to contribute to program goals.

III.3. Other

    If applicants request a funding amount greater than the ceiling of 
the award range, HHS/CDC will consider the application non-responsive, 
and it will not enter into the review process. We will notify you that 
your application did not meet the submission requirements.
    Special Requirements: If your application is incomplete or non-
responsive to the special requirements listed in this section, it will 
not enter into the review process. We will notify you that your 
application did not meet submission requirements.
     HHS/CDC will consider late applications non-responsive. 
See section ``IV.3. Submission Dates and Times'' for more information 
on deadlines.

     Note: Title 2 of the United States Code Section 1611 
states that an organization described in Section 501(c)(4) of the 
Internal Revenue Code that engages in lobbying activities is not 
eligible to receive Federal funds constituting a grant, loan, or an 
award.

IV. Application and Submission Information

IV.1. Address To Request Application Package

    To apply for this funding opportunity use application form PHS 
5161-1.
    Electronic Submission: HHS strongly encourages you to submit your 
application electronically by using the forms and instructions posted 
for this announcement on www.Grants.gov, the official Federal agency 
wide E-grant Web site. Only applicants who apply on-line are permitted 
to forego paper copy submission of all application forms.
    Paper Submission: Application forms and instructions are available 
on the HHS/CDC Web site, at the following Internet address: 
www.cdc.gov/od/pgo/forminfo.htm.
    If you do not have access to the Internet, or if you have 
difficulty accessing the forms on-line, contact the HHS/CDC Procurement 
and Grants Office Technical Information Management Section (PGO-TIM) 
staff at 770-488-2700. We can mail application forms to you.

IV.2. Content and Form of Submission

    Application: You must submit a project narrative with your 
application forms. You must submit the narrative in the following 
format:
     Maximum number of pages: 35. If your narrative exceeds the 
page limit, we will only review the first pages within the page limit.
     Font size: 12 point unreduced.
     Double-spaced.
     Paper size: 8.5 by 11 inches.
     Page margin size: One inch.
     Printed only on one side of page.
     Held together only by rubber bands or metal clips; not 
bound in any other way.
     You MUST submit your application in English.
    Your narrative should address activities to be conducted over the 
entire project period, and must include the following items in the 
order listed:
     Executive Summary.
    Provide a clear and concise summary of the proposed goals, major 
objectives and activities required for achievement of program goals, 
the amount of funding requested for budget year one of this cooperative 
agreement, and the project's contribution to the Goals and Objectives 
of the Emergency Plan for AIDS Relief.
     Needs Assessment and Capacity
    Describe the documented need for the proposed activities; current 
activities that provide relevant experience and expertise to perform 
the proposed activities; and collaborative relationships with other 
agencies and organizations that will be involved in the proposed 
activities.
     Year One Operational and Evaluation Plan
    Provide specific, measurable, and time-phased year one objectives 
for each proposed project; the specific activities proposed to achieve 
the year one objectives; and a projected timetable for completion that 
displays dates for the accomplishment of tasks and identifies 
responsible parties. For each year one objective, specify how 
achievement will be measured and documented.
     Four-Year Plan
    Describe realistic four-year goals and measurable, time-phased 
objectives for each proposed project; the major activities to achieve 
each objective; plans for collaboration with partners, including the 
CDC; and the evaluation process that will be used to determine 
effectiveness and initiate modifications, as needed.
     Management and Staffing Plan
    Describe how the program will be effectively managed. Include the 
following:
    a. Management structure, including the lines of authority and plans 
for fiscal control.
    b. The staff positions responsible for implementation of the 
program.
    c. Qualifications and experience of the designated staff.
     Budget and Justification
    Provide a detailed 12-month budget request and line item 
justification that is consistent with the purpose of the program and 
the proposed objectives and activities. The budget must be included 
within the 35 pages.
    You may include additional information in the application 
appendices. The appendices will not count toward the narrative page 
limit. This additional information includes the following:
     Curriculum Vitas.
     Resumes.
     Organizational Charts.
     Letters of Support.
    You must have a Dun and Bradstreet Data Universal Numbering System 
(DUNS) number to apply for a grant or cooperative agreement from the 
Federal government. The DUNS number is a

[[Page 53227]]

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 www.dunandbradstreet.com or call 1-866-
705-5711.
    For more information, see the HHS/CDC Web site at: https://
www.cdc.gov/od/pgo/funding/grantmain.htm. If your application form does 
not have a DUNS number field, please write your DUNS number at the top 
of the first page of your application, and/or include your DUNS number 
in your application cover letter.
    Additional requirements that could require you to submit additional 
documentation with your application are listed in section ``VI.2. 
Administrative and National Policy Requirements.''

IV.3. Submission Dates and Times

    Application Deadline Date: October 7, 2005.
    Explanation of Deadlines: Applications must be received in the HHS/
CDC Procurement and Grants Office by 4 p.m. Eastern Time on the 
deadline date.
    You may submit your applications electronically at www.grants.gov. 
We consider applications completed on-line through Grants.gov as 
formally submitted when the applicant organization's Authorizing 
Official electronically submits the application to www.grants.gov. 
Electronic applications will be considered as having met the deadline 
if the applicant organization's Authorizing Official has submitted the 
application electronically to Grants.gov on or before the deadline date 
and time.
    If you submit your application electronically through Grants.gov, 
your application will be electronically time/date stamped, which will 
serve as receipt of submission. You will receive an e-mail notice of 
receipt when HHS/CDC receives the application.
    If you submit your application by the United States Postal Service 
or commercial delivery service, you must ensure that the carrier will 
be able to guarantee delivery by the closing date and time. If HHS/CDC 
receives your submission after the closing date because: (1) Carrier 
error, when the carrier accepted the package with a guarantee for 
delivery by the closing date and time; or (2) significant weather 
delays or natural disasters, you will have the opportunity to submit 
documentation of the carrier's guarantee. If the documentation verifies 
a carrier problem, HHS/CDC will consider the submission as having been 
received by the deadline.
    If you submit a hard copy application, HHS/CDC will not notify you 
upon receipt of the submission. If you have a question about the 
receipt of your application, first contact your courier. If you still 
have a question, contact the PGO-TIM staff at 770-488-2700. Before 
calling, please wait two to three days after the submission deadline. 
This will allow time for us to process and log submissions.
    This announcement is the definitive guide on the application 
content, submission address, and deadline. It supersedes information 
provided in the application instructions. If your submission does not 
meet the deadline above, it will not be eligible for review, and we 
will discard it. We will notify you that you did not meet the 
submission requirements.

IV.4. Intergovernmental Review of Applications

    Executive Order 12372 does not apply to this program.

IV.5. Funding Restrictions

    Restrictions, which you must take into account while writing your 
budget, are as follows:
     Funds may not be used for research.
     Reimbursement of pre-award costs is not allowed.
     Funds may not be used for any new construction.
     Antiretroviral drugs--the purchase of ARVs, reagents, and 
laboratory equipment for antiretroviral treatment projects requires 
pre-approval in writing from HHS/CDC officials.
     Needle exchange--No funds appropriated under this 
solicitation shall be used to carry out any program of distributing 
sterile needles or syringes for the hypodermic injection of any illegal 
drug.
     Funds may be spent for reasonable program purposes, 
including personnel, travel, supplies, and services. Equipment may be 
purchased if deemed necessary to accomplish program objectives; 
however, prior approval by HHS/CDC officials must be requested in 
writing.
     All requests for funds contained in the budget shall be 
stated in U.S. dollars. Once an award is made, HHS/CDC will not 
compensate foreign grantees for currency exchange fluctuations through 
the issuance of supplemental awards.
     The costs that are generally allowable in grants to 
domestic organizations are allowable to foreign institutions and 
international organizations, with the following exception: With the 
exception of the American University, Beirut and the World Health 
Organization, Indirect Costs will not be paid (either directly or 
through sub-award) to organizations located outside the territorial 
limits of the United States or to international organizations, 
regardless of their location.
     The applicant may contract with other organizations under 
this program; however, the applicant must perform a substantial portion 
of the activities (including program management and operations, and 
delivery of prevention services for which funds are required).
     You must obtain an annual audit of these HHS/CDC funds 
(program-specific audit) by a U.S.-based audit firm with international 
branches and current licensure/authority in-country, and in accordance 
with International Accounting Standard(s) or equivalent standards 
approved in writing by HHS/CDC.
     A Fiscal Recipient Capability Assessment may be required, 
prior to or post award, in order to review the applicant's business 
management and fiscal capabilities regarding the handling of U.S. 
Federal funds.
Prostitution and Related Activities
    The U.S. Government is opposed to prostitution and related 
activities, which are inherently harmful and dehumanizing, and 
contribute to the phenomenon of trafficking in persons.
    Any entity that receives, directly or indirectly, U.S. Government 
funds in connection with this document (``recipient'') cannot use such 
U.S. Government funds to promote or advocate the legalization or 
practice of prostitution or sex trafficking. Nothing in the preceding 
sentence shall be construed to preclude the provision to individuals of 
palliative care, treatment, or post-exposure pharmaceutical 
prophylaxis, and necessary pharmaceuticals and commodities, including 
test kits, condoms, and, when proven effective, microbicides.
    A recipient that is otherwise eligible to receive funds in 
connection with this document to prevent, treat, or monitor HIV/AIDS 
shall not be required to endorse or utilize a multisectoral approach to 
combating HIV/AIDS, or to endorse, utilize, or participate in a 
prevention method or treatment program to which the recipient has a 
religious or moral objection. Any information provided by recipients 
about the use of condoms as part of projects or activities that are 
funded in connection with this document shall be medically accurate and 
shall include the public health benefits and failure rates of such use.

[[Page 53228]]

    In addition, any recipient must have a policy explicitly opposing 
prostitution and sex trafficking. The preceding sentence shall not 
apply to any ``exempt organizations'' (defined as the Global Fund to 
Fight AIDS, Tuberculosis and Malaria, the World Health Organization and 
its six Regional Offices, the International AIDS Vaccine Initiative or 
to any United Nations agency).
    The following definition applies for purposes of this clause:
     Sex trafficking means the recruitment, harboring, 
transportation, provision, or obtaining of a person for the purpose of 
a commercial sex act. 22 U.S.C. 7102(9).
    All recipients must insert provisions implementing the applicable 
parts of this section, ``Prostitution and Related Activities,'' in all 
subagreements under this award. These provisions must be express terms 
and conditions of the subagreement, must acknowledge that compliance 
with this section, ``Prostitution and Related Activities,'' is a 
prerequisite to receipt and expenditure of U.S. government funds in 
connection with this document, and must acknowledge that any violation 
of the provisions shall be grounds for unilateral termination of the 
agreement prior to the end of its term. Recipients must agree that HHS 
may, at any reasonable time, inspect the documents and materials 
maintained or prepared by the recipient in the usual course of its 
operations that relate to the organization's compliance with this 
section, ``Prostitution and Related Activities.''
    All prime recipients that receive U.S. Government funds (``prime 
recipients'') in connection with this document must certify compliance 
prior to actual receipt of such funds in a written statement that makes 
reference to this document (e.g., ``[Prime recipient's name] certifies 
compliance with the section, `Prostitution and Related Activities.' '') 
addressed to the agency's grants officer. Such certifications by prime 
recipients are prerequisites to the payment of any U.S. Government 
funds in connection with this document.
    Recipients' compliance with this section, ``Prostitution and 
Related Activities,'' is an express term and condition of receiving 
U.S. Government funds in connection with this document, and any 
violation of it shall be grounds for unilateral termination by HHS of 
the agreement with HHS in connection with this document prior to the 
end of its term. The recipient shall refund to HHS the entire amount 
furnished in connection with this document in the event HHS determines 
the recipient has not complied with this section, ``Prostitution and 
Related Activities.''
    You may find guidance for completing your budget on the HHS/CDC Web 
site, at the following Internet address: https://www.cdc.gov/od/pgo/
funding/budgetguide.htm.

IV.6. Other Submission Requirements

Application Submission Address
    Electronic Submission: HHS/CDC strongly encourages you to submit 
electronically at www.Grants.gov. The application package can be 
downloaded from www.Grants.gov. You will be able to complete it off-
line, and then upload and submit the application via the Grants.gov Web 
site. We will not accept e-mail submissions. If you are having 
technical difficulties in Grants.gov, customer service can be reached 
by e-mail at support@grants.gov or by phone at 1-800-518-4726 (1-800-
518-GRANTS). The Customer Support Center is open from 7 a.m. to 9 p.m. 
Eastern Time, Monday through Friday.
    HHS/CDC recommends that you submit your application to Grants.gov 
early enough to resolve any unanticipated difficulties prior to the 
deadline. You may also submit a back-up paper submission of your 
application. We must receive any such paper submission in accordance 
with the requirements for timely submission detailed in Section IV.3. 
of the grant announcement. You must clearly mark the paper submission: 
``BACK-UP FOR ELECTRONIC SUBMISSION.''
    The paper submission must conform with all requirements for non-
electronic submissions. If we receive both electronic and back-up paper 
submissions by the deadline, the electronic version will be considered 
the official submission.
    We strongly recommend that you submit the grant application by 
using Microsoft Office products (e.g., Microsoft Word, Microsoft Excel, 
etc.). If you do not have access to Microsoft Office products, a PDF 
file may be submitted. You may find directions for creating PDF files 
on the Grants.gov Web site. Use of file formats other than Microsoft 
Office or PDF could make your file unreadable for our staff.

     or

    Paper Submission: Submit the original and two hard copies of your 
application by mail or express delivery service to the following 
address: Technical Information Management-AA086, CDC Procurement and 
Grants Office, U.S. Department of Health and Human Services, 2920 
Brandywine Road, Atlanta, GA 30341.

V. Application Review Information

V.1. Criteria

    Applicants must provide measures of effectiveness that will 
demonstrate the accomplishment of the various identified objectives of 
the cooperative agreement. Measures of effectiveness must relate to the 
performance goals stated in the ``Purpose'' section of this 
announcement. Measures must be objective and quantitative, and must 
measure the intended outcome. Applicants must submit these measures of 
effectiveness with the application, and they will be an element of 
evaluation.
    We will evaluate your application against the following criteria:
1. Technical Approach (25 Points)
    Does the applicant describe strategies that are pertinent and match 
those identified in the five-year strategy of the President's Emergency 
Plan and activities that are evidence-based, realistic, achievable, 
measurable and appropriate to achieve the goals of the Emergency Plan? 
Does the applicant's proposal include an overall design strategy, 
including measurable time lines? Does the proposal address regular 
monitoring and evaluation, and the potential effectiveness of the 
proposed activities in meeting objectives?
2. Understanding of the Problem (20 Points)
    Does the applicant demonstrate a clear and concise understanding of 
the nature of the problem described in the Purpose section of this 
announcement? Does the proposal specifically include a description of 
the public health importance of the planned activities to be 
undertaken, and a realistic presentation of proposed objectives and 
projects?
3. Ability To Carry Out the Project (20 Points)
    Does the applicant document demonstrated capability to achieve the 
purpose of the project?
4. Personnel (20 Points)
    Are the professional personnel involved in this project qualified, 
with evidence of experience in working with HIV/AIDS, opportunistic 
infections, and HIV/STD surveillance?
5. Plans for Administration and Management of Projects (15 Points)
    Is there a plan to manage the resources of the program, prepare 
reports, monitor and evaluate activities and audit expenditures?

[[Page 53229]]

6. Budget (Not Scored)
    Is the itemized budget for conducting the project, along with 
justification, reasonable and consistent with stated objectives, the 
five-year strategy and goals of the President's Emergency Plan and 
Emergency Plan, and planned program activities?

V.2. Review and Selection Process

    The HHS/CDC Procurement and Grants Office (PGO) staff will review 
applications for completeness, and HHS Global AIDS program will review 
them for responsiveness. Incomplete applications and applications that 
are non-responsive to the eligibility criteria will not advance through 
the review process. Applicants will receive notification that their 
application did not meet submission requirements.
    An objective review panel will evaluate complete and responsive 
applications according to the criteria listed in the ``V.1. Criteria'' 
section above. All persons who serve on the panel will be external to 
the U.S. Government Country Program Office. The panel may include both 
Federal and non-Federal participants.
    In addition, the following factors could affect the funding 
decision:
    While U.S.-based organizations are eligible to apply, we will give 
preference to existing national/Tanzanian organizations. It is possible 
for one organization to apply as lead grantee with a plan that includes 
partnering with other organizations, preferably local. Although 
matching funds are not required, preference will be go to organizations 
that can leverage additional funds to contribute to program goals.
    Applications will be funded in order by score and rank determined 
by the review panel. HHS/CDC will provide justification for any 
decision to fund out of rank order.
    In addition, the following factors may affect the funding decision:
     Maintaining geographic diversity

V.3. Anticipated Announcement and Award Dates

    October 30, 2005.

VI. Award Administration Information

VI.1. Award Notices

    Successful applicants will receive a Notice of Award (NoA) from the 
HHS/CDC Procurement and Grants Office. The NoA shall be the only 
binding, authorizing document between the recipient and HHS/CDC. An 
authorized Grants Management Officer will sign the NoA and mail it to 
the recipient fiscal officer identified in the application.
    Unsuccessful applicants will receive notification of the results of 
the application review by mail.

VI.2. Administrative and National Policy Requirements

45 CFR Part 74 and Part 92
    For more information on the Code of Federal Regulations, see the 
National Archives and Records Administration at the following Internet 
address: https://www.access.gpo.gov/nara/cfr/cfr-table-search.html.
    The following additional requirements apply to this project:
     AR-4 HIV/AIDS Confidentiality Provisions.
     AR-6 Patient Care.
     AR-8 Public Health System Reporting Requirements.
     AR-12 Lobbying Restrictions.
     AR-14 Accounting System Requirements.
    Applicants can find additional information on these requirements on 
the HHS/CDC Web site at the following Internet address: https://
www.cdc.gov/od/pgo/funding/ARs.htm.
    You need to include an additional Certifications form from the 
PHS5161-1 application in the Grants.gov electronic submission only. 
Please refer to https://www.cdc.gov/od/pgo/funding/PHS5161-1-
Certificates.PDF. Once you have filled out the form, please attach it 
to the Grants.gov submission as Other Attachment Forms.

VI.3. Reporting Requirements

    You must provide HHS/CDC with an original, plus two hard copies, of 
the following reports:
    1. Interim progress report, due no less than 90 days before the end 
of the budget period. The progress report will serve as your non-
competing continuation application, and must contain the following 
elements:
    a. Current Budget Period Activities Objectives.
    b. Current Budget Period Financial Progress.
    c. New Budget Period Program Proposed Activity Objectives.
    d. Budget.
    e. Measures of Effectiveness, including progress against the 
numerical goals of the President's Emergency Plan for AIDS Relief for 
Tanzania.
    f. Additional Requested Information.
    2. Annual progress report, due no later than 90 days after the end 
of the budget period.
    3. Financial status report, due no later than 90 days after the end 
of the budget period.
    4. Final financial and performance reports, due no later than 90 
days after the end of the project period.
    Recipients must mail these reports to the Grants Management or 
Contract Specialist listed in the ``Agency Contacts'' section of this 
announcement.

VII. Agency Contacts

    We encourage inquiries concerning this announcement.
    For general questions, contact: Technical Information Management 
Section, CDC Procurement and Grants Office, U.S. Department of Health 
and Human Services, 2920 Brandywine Road, Atlanta, GA 30341. Telephone: 
770-488-2700.
    For program technical assistance, contact: Cecil Threat, Project 
Officer, Global AIDS Program, c/o American Embassy, 2140 Dar es Salaam 
Place, Washington, DC 20521-2140. Telephone: 255 22 212 1407. Cell: 255 
744 222986. Fax: 255 22 212 1462. E-mail: Cthreat@cdc.gov.
    For financial, grants management, or budget assistance, contact: 
Diane Flournoy, Grants Management Specialist, CDC Procurement and 
Grants Office, U.S. Department of Health and Human Services, 2920 
Brandywine Road, Atlanta, GA 30341. Telephone: 770-488-2072. E-mail: 
dmf6@cdc.gov.

VIII. Other Information

    Applicants can find this and other HHS funding opportunity 
announcements on the HHS/CDC Web site, Internet address: www.cdc.gov 
(click on ``Funding'' then ``Grants and Cooperative Agreements''), and 
on the Web site of the HHS Office of Global Health Affairs, Internet 
address: www.globalhealth.gov.

    Dated: August 31, 2005.
William P. Nichols,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention, U.S. Department of Health and Human Services.
[FR Doc. 05-17679 Filed 9-6-05; 8:45 am]
BILLING CODE 4163-18-P
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