03-17156. Expansion of Reference Laboratory Infrastructure To Support HIV/AIDS/STD/TB Control Activities in the Republic of Zambia; Notice of Availability of Funds

Application Deadline: August 7, 2003.

A. Authority and Catalog of Federal Domestic Assistance Number

This program is authorized under section 307 of the Public Health Service Act, (42 U.S.C. 2421), as amended. The Catalog of Federal Domestic Assistance number is 93.941.

B. Purpose

The Centers for Disease Control and Prevention (CDC), announces the availability of fiscal year (FY) 2003 funds for a cooperative agreement program with the national reference laboratories that support HIV, Sexually Transmitted Infections (STIs) and Tuberculosis (TB) surveillance and control activities in Zambia.

The purpose of this program is to build Zambia's national reference laboratory capacity to effectively monitor and control HIV/AIDS and Sexually Transmitted Diseases (STDs), as well as TB, the most common opportunistic infection associated with HIV in Zambia. Funds in this agreement may be used to support surveillance of these diseases and enhancements in information technology and capacity to analyze and disseminate reference laboratory findings. Collaborative activities between CDC and reference laboratories are intended to profoundly improve the effectiveness of HIV/AIDS, STD and TB program activities in Zambia.

The United States Government (USG) seeks to reduce the impact of HIV/AIDS in specific countries in sub-Saharan Africa, Asia and the Americas through its Leadership and Investment in Fighting an Epidemic (LIFE) initiative. To carry out this initiative, the Department of Health and Human Services (HHS) has organized its Global AIDS Program (GAP) to strengthen capacity and expand activities in the areas of (1) HIV prevention; (2) HIV care, support and treatment; and (3) capacity and infrastructure development, especially for HIV/AIDS surveillance activities.

Targeted countries represent those with the most severe epidemics and the highest number of new infections. They also represent countries where the potential for impact is greatest and where U.S. Government agencies are already active. Zambia is one of these targeted countries.

Through CDC, HHS is working in a collaborative manner with national governments and other agencies to develop programs of assistance to address the HIV/AIDS epidemics in LIFE Initiative countries. In particular, CDC's mission in Zambia is to improve surveillance for HIV, TB and STIs and to strengthen and make more effective programs for preventing and treating these diseases.

Measurable outcomes of the program will be in alignment with one or more of the following performance goals for the National Center for HIV/STD/TB Prevention: Strengthen the capacity nationwide to monitor the epidemic, develop and implement effective HIV prevention interventions and evaluate prevention programs, and improve HIV/AIDS information management and decision making by developing well coordinated databases by 2005.

C. Eligible Applicants

Applications may be submitted by research institutions, hospitals, and government reference laboratories in Zambia. Applicants must be actively involved in surveillance of HIV, STIs or TB on a national or regional level. CDC has been working closely with the Government of the Republic of Zambia (GRZ) to build its national laboratory system. Because the intent of this agreement is to support national public health laboratory infrastructure, applicants must have a mandate from the GRZ to provide reference laboratory services within the system.

D. Funding

Availability of Funds

Approximately $300,000 is available in FY 2003 to fund approximately three awards. It is expected that the average award will be $100,000, ranging from $90,000 to $110,000. It is expected that the awards will begin on or about September 15, 2003, and will be made for a 12-month budget period within a project period of up to five years. Funding estimates may change.

Continuation awards within an approved project period will be made on the basis of satisfactory progress as evidenced by required reports and the availability of funds.

Use of Funds

Funds may not be used for:

1. Funds received from this announcement will not be used for the purchase of antiretroviral drugs for treatment of established HIV infection (with the exception AZT and nevirapine in Prevention of Mother to Child Transmission (PMTCT) cases and with prior written approval), occupational exposures, and non-occupational exposures and will not be used for the purchase of machines and reagents to conduct the necessary laboratory monitoring for patient care.

2. No funds appropriated under this Act 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 used for:

1. 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 CDC officials must be requested in writing.

2. 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.

3. 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.)

All requests for funds contained in the budget, shall be stated in U.S. dollars. Once an award is made, CDC will not compensate foreign grantees for currency exchange fluctuations through the issuance of supplemental awards.

You must obtain annual audit of these 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 Standards or equivalent standard(s) approved in writing by 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.

Recipient Financial Participation

Matching funds are not required for this program.

E. Program Requirements

In conducting activities to achieve the purpose of this program, the recipient will be responsible for the activities listed in 1. Recipient Activities, and CDC will be responsible for activities listed in 2. CDC Activities.

1. Recipient Activities

a. The applicant will plan and implement activities to build information technology capacity that supports reference laboratory work. This may include a local area network (LAN) and Internet access that will be used to disseminate information and communicate with public health officials within and outside of Zambia. This may also include training in the analysis and handling of laboratory data.

b. The applicant will plan and implement laboratory-based activities to monitor the impact or assist in controlling HIV, STDs or TB in Zambia. This may include disease or drug-resistance surveillance, infrastructure building and training.

2. CDC Activities

a. CDC will provide technical assistance in designing and building local area networks, setup of databases and other information technology projects.

b. CDC will provide specifications for computer equipment and assist in the procurement process in order to achieve project goals.

c. CDC will assist in developing and implementing data and information dissemination plans for HIV, AIDS, TB, and STI data and results.

d. CDC provide technical assistance including support from Atlanta-based staff for planning and implementing laboratory activities, particularly in the areas of disease surveillance and laboratory quality assurance from reference labs to peripheral labs.

e. CDC will also assist in developing specifications for laboratory equipment and supplies as needed to achieve project objectives.

F. Content

Applications

The Program Announcement title and number must appear in the application. Use the information in the Program Requirements, Other Requirements, and Evaluation Criteria sections to develop the application content. Your application will be evaluated on the criteria listed, so it is important to follow them in laying out your program plan. The narrative should be no more than 20 pages, double-spaced, printed on one side, with one-inch margins, and unreduced 12-point font.

The narrative should consist of background information about the laboratory and its place in the national laboratory structure, objectives for the agreement and a description of how they will be accomplished, background on the staff members who will work with CDC to implement the project, and a description of prior and proposed collaboration with the Zambia CDC office. A detailed budget justification is required.

G. Submission and Deadline

Application Forms

Submit the signed original and two copies of your proposal and PHS 5161-1 (OMB Number 0920-0428). Forms are available 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 CDC Procurement and Grants Office Technical Information Management Section (PGO-TIM) at 770-488-2700. Application forms can be mailed to you. Forms are also available in the application kit, available from the CDC Zambia Office, American Embassy, Lusaka, tel. [phone].

Submission Date, Time, and Address

The application must be received by 4 p.m. eastern time August 7, 2003. Submit the application to: Technical Information Management-PA 03061, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146, USA.

Applications may be e-mailed to [e-mail]. If you e-mail your application, you must also mail a hard copy of the application to the address listed above, for documentation purposes.

CDC Acknowledgement of Application Receipt

A postcard will be mailed by PGO-TIM, notifying you that CDC has received your application.

Deadline

Applications shall be considered as meeting the deadline if they are received before 4:00 p.m. eastern time on the deadline date. Any applicant who sends their application by the United States Postal Service or commercial delivery services must ensure that the carrier will be able to guarantee delivery of the application by the closing date and time. If an application is received after closing due to (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, CDC will upon receipt of proper documentation, consider the application as having been received by the deadline.

Any application that does not meet the above criteria will not be eligible for competition, and will be discarded. The applicant will be notified of their failure to meet the submission requirements.

H. Evaluation Criteria

Application

Applicants are required to 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. These measures of effectiveness must be submitted with the application and will be an element of evaluation.

An independent review group appointed by CDC will evaluate each application against the following criteria:

1. Importance of the Laboratory in Zambia's Public Health Laboratory Network (40 points)

The extent to which the applicant's proposal demonstrates the key role of the laboratory for HIV, STD or TB control programs and disease surveillance in Zambia.

2. Ability To Jointly Work with CDC on the Project (20 points)

The extent to which the applicant documents their ability to work with CDC to jointly develop laboratory capacity in the areas of HIV, STIs or TB.

3. Personnel (20 points)

The extent to which professional personnel involved in this project are qualified to develop and implement laboratory projects in the areas of HIV, STIs or TB.

4. Administration (20 points)

The adequacy of the plans to account for, prepare reports, monitor, and audit expenditures under this agreement.

5. Budget (Reviewed, but not scored)

The extent to which the itemized budget for conducting the project is itemized and justified.

Does the application adequately address the requirements of title 45 CFR part 46 for the protection of human subjects? Not scored; however, an application can be disapproved if the research risks are sufficiently serious and protection against risks is so inadequate as to make the entire application unacceptable.

Does the application adequately address the CDC policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research? This includes:

1. The proposed plan for the inclusion of both sexes and racial ethnic minority populations for appropriate representation.

2. The proposed justification when representation is limited or absent.

3. A statement as to whether the design of the study is adequate to measure differences when warranted.

4. A statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community(ies) and recognition of mutual benefits.

I. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two copies of:

1. Interim progress report, 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. Detailed Line-Item Budget and Justification.

e. Additional Requested Information.

2. Financial status report, no more than 90 days after the end of the budget period.

3. Final financial and performance reports, no more than 90 days after the end of the project period.

Send all reports to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

Additional Requirements

The following additional requirements are applicable to this program. For a complete description of each, see Attachment I of the program announcement.

AR-1 Human Subjects Requirements

AR-4 HIV/AIDS Confidentiality Provisions

AR-12 Lobbying Restrictions

AR-14 Accounting System Requirements

Executive Order 12372 does not apply to this program.

J. Where To Obtain Additional Information

This and other CDC announcements, the necessary applications, and associated forms can be found on the CDC Web site, Internet address http://www.cdc.gov.

Click on “Funding” then “Grants and Cooperative Agreements”.

For general questions about this announcement, contact: Technical Information Management, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146.

Telephone: [phone].

For business management and budget assistance, contact: Shirley Wynn, Grants Management Specialist, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Road, Atlanta, GA 30341-4146. Telephone: [phone]. E-mail: [e-mail].

For program technical assistance, contact: David B. Nelson, Chief of Party, Global AIDS Program, Zambia, American Embassy, Corner of Independence and United Nations Avenues, Lusaka, Zambia. Telephone: [phone]. E-mail: [e-mail].

Dated: July 1, 2003.

Sandra R. Manning,

Director, Procurement and Grants Office, Centers for Disease Control and Prevention.