Grants and cooperative agreements; availability, etc.: Human immunodeficiency virus (HIV)— Uganda; Full-Access Home-Based Confidential Counseling and Testing Program,

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Federal Register: July 29, 2005 (Volume 70, Number 145)NoticesPage 43872-43879From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr29jy05-106

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

Full-Access Home-Based Confidential Counseling and Testing Using Outreach Teams in One District in the Republic of Uganda

Announcement Type: New.

Funding Opportunity Number: AA009.

Catalog of Federal Domestic Assistance Number: 93.067.

Key Dates: Application Deadline: August 22, 2005.

I. Funding Opportunity Description

Authority: This program is authorized under Sections 307 and 317(k)(2) of the Public Health Service Act, [42 U.S.C. 242l(a) and 247b(k)(2)], as amended, and under Public Law 108-25 (United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003)

[22 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: http://www.state.gov/s/gac/rl/or/c11652.htm.

Purpose

The Centers for Disease Control and Prevention (CDC) within the U.S. Department of Health and Human Services (HHS) announces the availability of fiscal year (FY) 2005 funds for a cooperative agreement program for Full-Access Home-Based Confidential Counseling and Testing (HB--CT) by using outreach teams in one district in the Republic of Uganda.

The purpose of this funding announcement is to progressively build an indigenous, sustainable response to the national HIV epidemic in Uganda through the rapid expansion of innovative, culturally appropriate, high-quality HIV/AIDS prevention and care interventions.

Specifically, the winner of this announcement will develop a replicable model of rapid HB-CT to provide access for the entire population of a district to confidential HIV counseling and testing (CT) services within their residences. These services would include referral of those testing positive to sources of ongoing psycho-social support and basic preventative and palliative care. The provision of anti-retroviral therapy(ART) is not part of this program, although patients who qualify for ART under medical criteria may receive referrals to treatment sites as they become available.

The United States Government seeks to reduce the impact of HIV/AIDS in specific countries in sub-Saharan Africa, Asia and the Americas by working with governments and other key partners to assess the needs of each country and design a customized program of assistance that fits within the host nation's strategic plan. The President's Emergency Plan for AIDS Relief encompasses HIV/AIDS activities in more than 100 countries, and focuses on 15 countries, including Uganda, to develop comprehensive and integrated prevention, care and treatment programs.

Under the leadership of the U.S. Global AIDS Coordinator, as part of the

[Page 43873]Emergency Plan, the HHS Global AIDS Program (GAP) strengthens capacity and expands local activities in the areas of: (1) Culturally appropriate HIV primary prevention: (2) HIV care, support and treatment; and (3) capacity and infrastructure development, including surveillance. Goals and priorities include the following:

Achieving primary prevention of HIV infection through activities such as expanding confidential counseling and testing programs, building programs to reduce mother-to-child transmission, and strengthening programs to reduce transmission via blood transfusion and medical injections.

Improving the care and treatment of HIV/AIDS, sexually transmitted diseases (STDs) and related opportunistic infections by improving STD management; enhancing care and treatment of opportunistic infections, including tuberculosis (TB); and initiating programs to provide anti-retroviral therapy (ART).

Strengthening the capacity of countries to collect and use surveillance data and manage national HIV/AIDS programs by expanding HIV/STD/TB surveillance programs and strengthening laboratory support for surveillance, diagnosis, treatment, disease-monitoring and HIV screening for blood safety.

Targeted countries represent those with the most severe epidemics and the highest number of new infections. They also represent countries where the potential impact is greatest and where United States Government agencies are already active; Uganda is one of those countries.

The mission of the Emergency Plan in Uganda is to work with Ugandan and international partners to develop, evaluate, and support effective implementation of interventions to prevent HIV and related illnesses and improve care and support of persons with HIV/AIDS. In Uganda, Emergency Plan goals include treating at least 60,000 HIV-infected individuals; and providing care for 300,000 HIV-affected individuals, including orphans over the five years of Emergency Plan implementation. According to the 2002 Uganda Health Facilities Survey, confidential counseling and testing services are only available at five percent of public and private health facilities. In addition, the most recent Demographic and Health Survey in Uganda indicates that 70 percent of people would like to receive HIV testing, but only ten percent report they have been tested. Also, evidence from studies in several districts suggests that when offered confidential CT in their homes, between 50 and 90 percent accept the service. Cost-effective procedures of offering full-access HB-CT to the whole population over a relatively short period would provide an important strategy for averting infections and providing timely care to persons-living-with-HIV/AIDS (PLWHAs), especially in rural areas.

This announcement seeks to provide confidential HIV-CT services, and appropriate referrals to care and treatment, to all adults (and potentially all children) who reside in one district over a period of 24 months, to evaluate the experience, and to develop guidelines for cost-effective indigenous replication. This first phase of the program, including preparation and evaluation, will last 18 months. The grantee may complete follow-up activities and documentation of lessons learned in the form of guidelines during the last six months of this program. This program will include referrals to local care providers that offer basic preventative care, opportunistic disease management, palliative care, and, if available, ART, to persons with HIV/AIDS in the district, without taking on the long term responsibility or financial support for care provision.

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 CDC National Center for HIV, STD and TB Prevention(NCHSTP) within HHS: By 2010, work with other countries, international organizations, the U.S. Department of State, U.S. 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 and to reduce HIV transmission and improve care of persons living with HIV. Specific measurable outcomes of this program include, but are not be limited to, the number, age and sex of clients (individual and couples) provided with confidential HIV HB-CT, the percentage coverage of the population by confidential HIV HB-CT, unrecognized HIV infections discovered, the cost per client service and per unrecognized infection, and the number of persons with HIV successfully referred to an effective care or treatment provider.

This announcement is only for non-research activities supported by HHS, including the Centers for Disease Control and Prevention (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: http://www.cdc.gov/od/ads/opspoll1.htm .

Activities

Based on its competitive advantage and proven field experience, the winning applicant will undertake a broad range of activities to meet the numerical Emergency Plan targets outlined above. For each of these activities, the grantee will give priority to evidence-based, yet culturally adapted, innovative approaches.

The recipient of these funds is responsible for activities in multiple program areas designed to target underserved populations in Uganda. Either the awardee will implement activities directly or will implement them through its subgrantees and/or subcontractors; the awardee will retain overall financial and programmatic management under the oversight of HHS/CDC and the strategic direction of the Office of the U.S. Global AIDS Coordinator. The awardee must show a measurable progressive reinforcement of the capacity of indigenous organizations and local communities to respond to the national HIV epidemic, as well as progress towards the sustainability of activities.

Applicants should describe activities in detail as part of a two- 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 two-year plan, which the U.S. Government Emergency Plan team on the ground in Uganda 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. The grantee may work on some of the activities listed below in the first year and in subsequent years, and then progressively add others from the list to achieve all of the Emergency Plan performance goals, as cited in the previous section. 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. Identify project staffing needs; hire and train staff.

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2. Identify the procurement needs of the project and implementing partners for vehicles, furnishings, fittings, equipment, computers and other fixed assets procurement, and acquire from normal sources through competitive processes.

3. Establish suitable administrative and financial management structures, including a project office, if required.

4. Work within the chosen district to implement confidential HIV HB-CT in such a manner that the coverage of the district's population is progressive, predictable and comprehensive by reaching communities systematically to ensure maximum and efficient coverage for the district.

5. Work with district public and private sector stakeholders to develop an effective referral system to care and treatment providers for those testing positive.

6. Ensure that all persons testing positive receive information about a basic preventive care package and referral to an effective care provider, or treatment provider, if available.

7. Support the development of a simple data-collection system, integrated within the general Ugandan government Health Management Information System (HMIS) that reflects useful information specifically related to confidential CT activities and Emergency Plan reporting requirements, consistent with the strategic information guidance provided by the Office of the U.S. Global AIDS Coordinator.

8. Ensure the installation and operation of a commodities supply and management system for test kits and other necessary items.

9. Implement a simple quality-assurance system for confidential HIV CT in a home-based setting.

10. Evaluate the activity and disseminate conclusions.

11. Participate in working groups to produce guidelines and training manuals in collaboration with the Ugandan Ministry of Health (MOH) and other public and private stakeholders relating to full-access confidential HB-CT.

12. Undertake the above activities in a manner consistent with the Ugandan national HIV/AIDS strategy and the five-year strategy and performance goals of the President's Emergency Plan for AIDS Relief.

13. Provide information on HIV prevention methods (or strategies) including abstinence, faithfulness and, for populations engaged in high-risk behaviors, correct and consistent condom use.

Awardee activities for covering all program areas are as follows:

1. Work to link activities described here with related HIV care and other social services in the area, and promote coordination at all levels, including through bodies such as village, district, regional and national HIV coordination committees and networks of faith-based organizations.

2. Participate in relevant national technical coordination committees and in national process(es) to define, implement and monitor simplified small grants program(s) for faith- and community-based organizations, to ensure local stakeholders receive adequate information and assistance to engage and access effectively funding opportunities supported by the President's Emergency Plan and other donors.

3. Progressively reinforce the capacity of faith- and community- based organizations and village and district AIDS committees to promote quality, local ownership, accountability and sustainability of activities.

4. Develop and implement a project-specific participatory monitoring and evaluation plan by drawing on national and U.S. Government requirements and tools, including the strategic information guidance provided by the Office of the U.S. Global AIDS Coordinator.

Administration

Comply with all HHS management requirements for meeting participation and progress and financial reporting for this cooperative agreement. (See HHS Activities and Reporting sections below for details.) Comply with all policy directives established by the Office of the U.S. Global AIDS Coordinator.

In a cooperative agreement, HHS staff is substantially involved in the program activities, above and beyond routine grant monitoring.

HHS Activities for this program are as follows:

1. Organize an orientation meeting with the grantee to brief them on applicable U.S. Government, HHS, and Emergency Plan expectations, regulations and key management requirements, as well as report formats and contents. The orientation could include meetings with staff from HHS agencies and the Office of the U.S. Global AIDS Coordinator.

2. Review and approve the process used by the grantee to select key personnel and/or post-award subcontractors and/or subgrantees to be involved in the activities performed under this agreement, as part of the Emergency Plan for AIDS Relief Country Operational Plan review and approval process, managed by the Office of the U.S. Global AIDS Coordinator.

3. Review and approve grantee's annual work plan and detailed budget, as part of the Emergency Plan for AIDS Relief Country Operational Plan review and approval process, managed by the Office of the U.S. Global AIDS Coordinator.

4. Meet on a monthly basis with grantee to assess monthly expenditures in relation to approved work plan and modify plans as necessary.

5. Meet on a quarterly basis with grantee to assess quarterly technical and financial progress reports and modify plans as necessary.

6. Meet on an annual basis with grantee to review annual progress report for each U.S. Government Fiscal Year, and to review annual work plans and budgets for subsequent year, as part of 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.

7. Provide technical assistance in the development of training curricula, materials, and diagnostic therapeutic guidelines.

8. Collaborate with the recipient in the development of an appropriate information technology system for medical record-keeping and an effective monitoring and evaluation and data-collection system for semi-annual and annual Emergency Plan reporting requirements, consistent with the strategic information guidance established by the Office of the U.S. Global AIDS Coordinator.

9. Review and approve awardee's monitoring and evaluation plan and the development of further appropriate initiatives, including for compliance with the strategic information guidance established by the Office of the U.S. Global AIDS Coordinator.

10. Assist in appropriate analysis and interpretation of data collected during training sessions.

11. Provide input into the overall program strategy.

12. Collaborate with the recipient in the selection of key personnel to be involved in the activities to be performed under this agreement including approval of the overall manager of the program.

13. Provide in-country administrative support to help grantee meet U.S. Government financial and reporting requirements.

Please note: 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.

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Measurable outcomes of the program will be in alignment with the following performance goals for the Emergency Plan:

A. Prevention

Number of individuals trained to provide HIV prevention interventions, including abstinence, faithfulness and, for populations engaged in high-risk behaviors,\1\ correct and consistent condom use.

\1\ Behaviors that increase risk for HIV transmission including engaging in casual sexual encounters, engaging in sex in exchange for money or favors, having sex with an HIV-positive partner or one who status is unknown, using drugs or abusing alcohol in the context of sexual interactions, and using intravenous drugs. Women, even if faithful themselves, can still be at risk of becoming infected by their spouse, regular male partner, or someone using force against them. Other high-risk persons or groups include men who have sex with men and workers who are employed away from home.

1. Abstinence (A) and Be Faithful (B)

Number of community outreach and/or mass media (radio) programs that are A/B focused

Number of individuals reached through community outreach and/or mass media (radio) programs that are A/B focused.

B. Care and Support

1. Confidential counseling and testing

Number of patients who accept confidential counseling and testing in a health-care setting.

Number of clients served, direct.

Number of people trained in confidential counseling and testing, direct, including health-care workers.

2. Orphans and Vulnerable Children (OVC)

Number of service outlets/programs, direct and/or indirect.

Number of clients (OVC) served, direct and/or indirect.

Number of persons trained to serve OVC, direct.

3. Palliative Care: Basic Health Care and Support

Number of service outlets/programs that provide palliative care, direct and/or indirect.

Number of service outlets/programs that link HIV care with malaria and tuberculosis care and/or referral, direct and/or indirect.

Number of clients served with palliative care, direct and/ or indirect.

Number of persons trained in providing palliative care, direct.

C. HIV Treatment With ART

Number of clients enrolled in ART, direct and indirect.

Number of persons trained in providing ART, direct.

D. Strategic Information

Number of persons trained in strategic information, direct.

E. Expanded Indigenous Sustainable Response

Project-specific quantifiable milestones to measure:

a. Indigenous capacity-building.

b. Progress toward sustainability.

II. Award Information

Type of Award: Cooperative Agreement.

HHS involvement in this program is listed in the Activities Section above.

Fiscal Year Funds: 2005.

Approximate Total Funding: $1,290,000 (This amount is an estimate, and is subject to availability of funds.).

Approximate Number of Awards: One.

Approximate Average Award: $645,000 (This amount is for the first 12-month budget period, and includes direct costs.).

Floor of Award Range: None.

Ceiling of Award Range: $645,000.

Anticipated Award Date: August 31, 2005.

Budget Period Length: 12 months.

Project Period Length: Two 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.

III. Eligibility Information

III.1. Eligible Applicants

The applicants for this program are limited to the following:

1. Ugandan MOH District Directorates of Health Services (DDHS) that are able to demonstrate existing partnerships with faith-based and community-based organizations.

2. Ugandan MOH District hospitals or Regional hospitals that partner with DDHS and have existing community-level networks/programs.

3. Private, not-for-profit hospitals in Uganda (including those managed or operated by faith-based institutions) with delegated responsibility of district hospital that partner with DDHS and CBOS.

Justification for limited competition:

DDHS in Uganda are responsible for planning, management, and coordination of all health activities in each district. They also have a role in supporting supervision in health sub-districts and, through them, to lower-level health units. In this role, they are fully capable of planning the implementation of a full-access confidential HIV HB-CT program by working through the district health system and faith-based and community-based groups.

All public health units are engaged in the delivery of the Uganda National Minimum Health Care Package \2\ and collaborate with the community through integrated outreach services and community volunteers for health known as ``Community-Owned Resource Persons (CORPS).'' This is an excellent structure under which to pilot a full- access confidential HB-CT Program.

\2\ This refers to Essential Health Care Package of interventions and services which is recommended for different levels of health units in Uganda including control of communicable diseases like STD/HIV/AIDS, Malaria, TB, IMCI, Reproductive health, Immunization, Environmental Health, Health education, School Health, Epidemics & Disaster preparedness, Nutrition, Mental Health and essential Clinical care.

Linking confidential HIV HB-CT to hospitals and other health facilities will provide clients who test positive for HIV with direct referrals to basic care and palliative care services, as well as to ART, where available.

The involvement of DDHS will strengthen collaboration, advocacy and networking for all district HIV/AIDS programs.

The Ugandan MOH is responsible for the development of policies and provision of technical assistance in the implementation of confidential HIV-HB-CT. The involvement of the MOH will facilitate the development of appropriate policies and guidelines for the replication of such programs in other districts, with advice and technical assistance from U.S. Government agencies that implement the President's Emergency Plan.

Currently, VCT sites and services in Uganda are located in higher-level facilities only, the majority of which are located more than five kilometers away from where over 60 percent of the Ugandan population lives. Therefore, allowing districts to take a lead in the implementation of a confidential HIV CT program will bring confidential HIV CT nearer to the people in rural settings. Additionally, community- based and faith-based organizations are already providing most of the health care and basic social services at the community level, which makes them ideal partners to the DDHS and hospitals for successful implementation of this program.

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Using this approach in a district will complement the first full-access confidential HB-CT project currently implemented through a local non-governmental organization (PA 04228, cooperative agreement U62/CCU024535). The project undertaken under this announcement will not duplicate or replace the project just mentioned.

III.2. Cost Sharing or Matching

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 be entered into the review process. We will notify you that your application did not meet submission requirements.

HHS/CDC will consider late applications to be considered non-responsive. See section ``IV.3. Submission Dates and Times'' for more information on deadlines.

IV. Application and Submission Information

IV.1. Address to Request Application Package

To apply for this funding opportunity use application form PHS 5161-1.

HHS strongly encourages the applicant to submit your application electronically by using the forms and instructions posted for this announcement at http://www.grants.gov.

Application forms and instructions are available on the HHS/CDC Web site, at the following Internet address: http://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, you may 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: 25. 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

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.

Pages should be numbered and a complete index to the application and any appendices must be included.

Your application MUST be submitted 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:

Project Context and Background (Understanding and Need)

Project Strategy--Description and Methodologies

Project Goals

Project Outputs

Project Contribution to the Goals and Objectives of the Emergency Plan for AIDS Relief

Work Plan and Description of Project Components and Activities

Performance Measures

Timeline (e.g., GANNT Chart)

Management of Project Funds and Reporting.

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:

Project Budget and Justification

Curriculum vitae of current staff who will work on the activity

Job descriptions of proposed key positions to be created for the activity

Quality-Assurance, Monitoring-and-Evaluation, and Strategic-Information Forms

Applicant's Corporate Capability Statement

Letters of Support

Evidence of Legal Organizational Structure

The budget justification will not count in the narrative page limit.

Although the narrative addresses activities for the entire project, the applicant should provide a detailed budget only for the first year of activities, while addressing budgetary plans for subsequent years.

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 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. For more information, see the HHS/CDC Web site at: http://www.cdc.gov/od/pgo/funding/pubcommt.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 ``Administrative and National Policy Requirements.''

IV.3. Submission Dates and Times

Application Deadline Date: August 22, 2005.

Explanation of Deadlines: Applications must be received in the CDC Procurement and Grants Office by 4 p.m. eastern time on the deadline date.

You may submit your application electronically at http://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 http://www.grants.gov. We will consider electronic applications as having met

the deadline if the application 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 (http://www.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 the carrier will be able to guarantee delivery by the closing date and time. If HHS/CDC receives your submission after closing 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 carriers guarantee. If the documentation verifies

[Page 43877]a carrier problem, HHS/CDC will consider the submission as received by the deadline.

If you submit a hard copy application, HHS/CDC will not notify you upon receipt of your 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 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

Awardee may use funds for the following:

Confidential HIV CT within the program District, including required training, purchase of test kits, simple laboratory refurbishment, vehicles and logistical support to testing teams, staffing and other related commodities and expenses. Awardee must perform all procurement in a competitive and transparent manner.

Evaluation and management of the project activities.

Restrictions, which you must take into account while writing your budget, are as follows:

Funds may not be used for research.

Awards will not allow reimbursement of pre-award costs.

You may not use funds for any new construction.

Anti-retroviral drugs (ARVs)--purchase of ARVs, reagents, and laboratory equipment for antiretroviral treatment projects require pre-approval 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, you must request prior approval by HHS/CDC officials in writing, and you must perform all procurement in a competitive and transparent manner.

All requests for funds contained in the budget 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 requested).

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 standard(s) approved in writing by HHS/CDC.

A fiscal Recipient Capability Assessment may be required, prior to or post award, 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.

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.

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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: http://www.cdc.gov/od/pgo/funding/budgetguide.htm .

IV.6. Other Submission Requirements

Application Submission Address:

HHS/CDC strongly encourages you to submit electronically at: http://www.grants.gov. You will be able to download a copy of the application

package from http://www.grants.gov, complete it offline, and then

upload and submit the application via the Grants.gov site. We will not accept e-mail submissions. If you are having technical difficulties in Grants.gov, you may reach them by e-mail at http:http://www.support@grants.gov"> //www.support@grants.gov, or by phone at 1-800-518-4726 (1-800-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 to all requirements for non- electronic submissions. If we receive both electronic and back-up paper submissions by the deadline, we will consider the electronic version the official submission.

We strongly recommended that you submit your grant application by using Microsoft Office products (e.g., Microsoft Word, Microsoft Excel, etc.). If you do not have access to Microsoft Office products, you may submit a PDF file. You may find directions for creating PDF files on the Grants.gov Web site. Use of files other than Microsoft Office or PDF could make your file unreadable for our staff.

OR

Submit the original and two hard copies of your application by mail or express delivery service to the following address: Technical Information Management-AA009, 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. Understanding the issues, principles and systems requirements involved in delivering community and home-based confidential CT which provides access to the whole population of a district in the context of Uganda (25 points)

Does the applicant display knowledge of the five-year strategy and goals of the President's Emergency Plan, such that it can build on these to develop a comprehensive, collaborative project to reach underserved populations? Does the applicant demonstrate an understanding of the ethical, clinical, social, managerial and other practical issues involved in delivering comprehensive, confidential CT in a cost-effective and sensitive manner in the setting of a Ugandan district?

2. Ability to carry out the proposal (25 points)

Does the applicant demonstrate the capability to achieve the purpose of this proposal?

3. Work Plan (25 points)

Is the plan appropriate to the social, political and cultural context in Uganda? Does the applicant describe activities which are realistic, achievable, time-framed and culturally appropriate to complete this program in Uganda? Does the applicant describe strategies that are pertinent and match those identified in the five-year strategy of the President's Emergency Plan and the national HIV/AIDS strategy of the Government of the Republic of Uganda?

4. Personnel (15 points)

Are the personnel, including qualifications, training, availability, and experience adequate to carry out the proposed activities?

5. Management and Accounting Plan (10 points)

Is there a plan to manage the resources of the program, prepare reports, monitor and evaluate activities and audit expenditures? Is the plan to account for, prepare reports, monitoring and audit expenditures under this agreement adequate to manage the resources of the program and to produce, collect and analyze performance data?

6. Budget (not scored)

Is the budget for conducting the activity itemized, well-justified and consistent with the five-year strategy and goals of the President's Emergency Plan activities in Uganda, and the national HIV/AIDS strategy of the Government of the Republic of Uganda?

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:

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.

V.3. Anticipated Announcement and Award Dates

The anticipated award date is August 31. 2005.

[Page 43879]VI. Award Administration Information

VI.1. Award Notices

Successful applicants will receive a Notice of Award (NoA) from the CDC Procurement and Grants Office. The NoA shall be the only binding, authorizing document between the recipient and CDC. The NoA will be signed by an authorized Grants Management Officer, and mailed 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: http://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-10 Smoke-Free Workplace Requirements

AR-11 Healthy People 2010

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: http://www.cdc.gov/od/pgo/funding/ARs.htm .

You need to include an additional Certifications form from the PHS5161-1 application needs to be included in the Grants.gov electronic submission only. Please refer to http://www.cdc.gov/od/pgo/funding/PHS5161-1-Certificates.pdf. Once you have filled out the form, it

should be attached 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. Semi-annual progress reports not more than 30 days after the end of the reporting period.

2. 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 Uganda.

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.

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: Jonathan Mermin, MD, MPH, Global AIDS Program [GAP], Uganda Country Team, National Center for HIV, STD and TB Prevention, Centers for Disease Control and Prevention [CDC], HHS, PO Box 49, Entebbe, Uganda, Telephone: +256- 41320776, E-mail: jhm@cdc.gov.

For financial, grants management, or budget assistance, contact: Shirley Wynn, Contract Specialist, CDC Procurement and Grants Office, U.S. Department of Health and Human Services, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone: 770-488-1515, E-mail: zbx6@cdc.gov.

VIII. Other Information

Applicants can find this and other HHS funding opportunity announcements on the HHS/CDC Web site, Internet address: http://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: http://www.globalhealth.gov.

Dated: July 25, 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. 05-15003 Filed 7-28-05; 8:45 amBILLING CODE 4163-18-P

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