The application deadline date has been extended to August 15, 2008.

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention (CDC)

Strengthening the Delivery and Quality of Laboratory Services and Enhancing Healthcare Worker and Laboratory Safety in the Republic of South Africa Under the President’s Emergency Plan for AIDS Relief

 

Announcement Type: New

Funding Opportunity Number: CDC-RFA-PS08-868

Catalog of Federal Domestic Assistance Number: 93.067

Application Deadline: August 15, 2008

 

I.  Funding Opportunity Description

 

Authority:  This program is authorized under Public Law 108-25 (United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003) [22 U.S.C. 7601].

 

Background:

The U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) 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 10 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 PEPFAR can be viewed at http://www.state.gov/s/gac/rl/or/c11652.htm

 

Over the same time period, as part of a collective national response, the PEPFAR goals specific to South Africa are to treat at least 500,000 HIV-infected persons and care for 2,500,000 HIV-affected individuals, including orphans.

 

Purpose:

Under the leadership of the U.S. Global AIDS Coordinator, as part of PEPFAR, the U.S. Department of Health and Human Services’ Centers for Disease Control and Prevention (HHS/CDC) works with host countries and other key partners to assess the needs of each country and designs a customized program of assistance that fits within the host nation's strategic plan.

 

HHS/CDC focuses on two or three major program areas in each country.  Goals and priorities include the following:

·        Achieving primary prevention of HIV infection through activities such as expanding confidential counseling and testing programs, and building programs to reduce mother to child transmission;

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

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

 

Measures must be implemented in South Africa to strengthen existing and to advance new collaborations to support PEPFAR overarching laboratory program goals.  PEPFAR funds should be used to address gaps identified by the South African National Department of Health (NDOH), National Health Laboratory Services (NHLS), National Institute of Occupational Health (NIOH), and National Institute of Communicable Diseases (NICD) to address laboratory specific unmet needs and policy or administrative issues that impede full implementation of public laboratory programs in support of the National ARV rollout and the National TB Strategic Plan.  Consistent with the priorities identified by the NDOH, and implemented by the NICD and NHLS, PEPFAR will continue to provide funding to assure the accuracy and quality of testing services in support of rapid scale-up of HIV testing and TB diagnostic capacity, and to build long term sustainability of quality laboratory systems, as well as address existing gaps in laboratory testing outreach, penetration, and quality of overall services in South Africa.

 

Measurable outcomes of the program will be in alignment with the following performance goals for PEPFAR (HHS/CDC will help the partner develop specific outcomes for this program):

I.        Training

A.     Number of individuals trained in HIV and TB related laboratory activities. To include:  Quality Assurance, External Quality Assurance, epidemiology, surveillance, laboratory management, bio-safety, infection control, rapid diagnostics, and molecular diagnostics.

 

This indicator will measure the number of individuals trained in the above areas.  As the number of staff receiving training increases, it is expected that testing capacity and overall EQA performance will improve. 

 

The measurable outcomes attempt to capture the impact of training indirectly, as well as general national laboratory performance and quality measures which are dependent on well trained staff and will ultimately provide for long term sustainability of quality laboratory systems and improved implementation of national roll out strategies and programs.

 

II.     HIV

A.     Number of laboratories with the capacity to perform HIV ELISAs, CD4s, viral loads, infant PCR, Chemistry and Hematology.

 

Recognizing that access to laboratory services is an important programmatic strategy for providing adequate HIV care and treatment, this indicator will measure the number of laboratories providing the above mentioned testing services.  By collecting this data shortcomings, the number of available service delivery laboratories may be identified within specific testing areas.  This indicator can be used to identify specific testing needs and identify areas in which services may need to increase to address national coverage within the country. This indicator will be able to monitor increases in service delivery and assist in setting goals that include tangible increases in the number of laboratory services provided within a country, which will indicate further overall reach of coverage, access, and utilization.

 

B.     Number of laboratories enrolled in EQA (External Quality Assurance): HIV ELISAs, CD4s, viral loads, infant PCR, Chemistry and Hematology.

 

EQA participation is one method of monitoring performance and general quality of services provided within a laboratory in relation to a specific test.   Increasing participation in EQA programs is one important programmatic strategy for providing quality laboratory services.  This indicator will measure the number of laboratories participating in a national or international sponsored EQA program.  This indicator can be used to identify specific EQA testing needs and identify areas where EQA programs may need to increase within the country. This indicator will be able to identify EQA enrollment and assist in setting EQA coverage goals within the country, which will indicate overall reach of coverage.

 

C.     Number of laboratories achieving ≥ 80% successful EQA results:   HIV ELISAs, CD4s, viral loads, infant PCR, Chemistry and Hematology.

 

This indicator will measure the number of laboratories participating in an EQA program and attaining ≥80% successful performance.  This indicator can be used to target specific quality assurance needs and identify areas where EQA programs and training initiatives may need to focus within the country. The target, ≥ 80%, will serve as a baseline, it is expected that overtime this percent may increase incrementally in the future, based on overall laboratory performance over the program years. 

 

D.     Number of tests performed:  HIV ELISAs, CD4s, viral loads, infant PCR, Chemistry and Hematology.

 

This indicator will measure the number of tests provided by laboratories in relation to HIV treatment and care.  By collecting this data, the number of laboratory tests performed can be measured.  This indicator may be used in conjunction with EQA measures above, in broad and very general terms, to identify and elicit discussion regarding the performance and validity of testing services in general, and may guide future areas of programmatic and laboratory quality assurance focus. 

 

 

III.   Tuberculosis (TB)

A.     Number of laboratories with the capacity to perform smear, culture, and drug susceptability test (DST)

 

Recognizing that access to TB laboratory services is an important programmatic strategy for providing adequate TB care and treatment, as well as identifying and monitoring MDR and XDR cases.  This indicator will measure the number of laboratories providing TB related testing services.  By collecting this data, shortcomings in the number of available service delivery laboratories can be identified, specifically in relation to smear and culture and DST.  This indicator can be used to identify specific testing needs and identify areas in which services may need to increase to address national coverage within the country TB services.  This indicator will be able to monitor increases in TB service delivery and assist in setting goals that include tangible increases in the number of culture and DST laboratory services provided within the country, which will indicate further overall reach of coverage, access, and utilization.

 

B.     Number of laboratories enrolled in EQA: smear, culture and DST

 

This indicator will measure the number of laboratories participating in a TB EQA program.  This indicator can be used to identify specific EQA testing needs and identify areas where EQA programs may need to increase within the country.  This indicator will be able to identify EQA enrollment and assist in setting EQA coverage goals within the country, which will indicate overall reach of coverage.

 

C.     Number of laboratories achieving ≥ 80% successful EQA results:  smear, culture and DST

 

This indicator will measure the number of laboratories participating in an EQA program and attaining ≥80% successful performance.  By collecting this data, the number of laboratories attaining ≥ 80% successful performance within specific testing areas will be identified.  This indicator can be used to target specific quality assurance needs and identify areas where EQA programs may need to increase technical assistance within the country.  The target, ≥ 80%, will serve as a baseline, it is expected that overtime this percent will increase incrementally in the future, based on overall laboratory performance within program years.

 

D.     Number of tests performed:  smear, culture and DST

 

This indicator will measure the number of tests provided by laboratories in relation to TB treatment and care.  By collecting this data, the number of laboratory tests performed can be measured.  This indicator will be able to identify the number of laboratory tests performed. This indicator may be used in conjunction with EQA measures above, in broad and very general terms, to identify and elicit discussion regarding the performance and validity of testing services in general, and may guide future areas of programmatic and laboratory focus. 

 

This announcement is for non-research activities supported by HHS/CDC.  If research is proposed, the application will not be reviewed.  For the definition of research, please see the HHS/CDC Web site at the following Internet address:  http://www.cdc.gov/od/science/regs/hrpp/researchDefinition.htm  

 

Activities:

Awardee activities for this program are as follows:

 

I.        The Awardee will assist PEPFAR in assuring the accuracy and quality of testing services in support of rapid scale-up of HIV testing and TB diagnostic capacity, and to build long term sustainability of quality laboratory systems in South Africa.  Activities will include supporting important strategic information activities to help inform the decisions of policy makers and program officials regarding their HIV prevention and ART rollout programs. These activities include: HIV-1 drug resistance transmission surveillance; sentinel surveillance of opportunistic bacterial and fungal pathogens in HIV-infected persons; microbiological etiological and antimicrobial resistance surveillance for sexually transmitted infections; training for epidemiologists and laboratory workers; collecting trend data for HIV incidence; and HIV-1 drug resistance transmission surveillance.

 

II.     The grantee will also assist PEPFAR in collaborative activities aimed to further increase national coverage of HIV and TB diagnostics and treatment monitoring capabilities; ensure uniform quality assurance measures among laboratories; support activities to initiate new and strengthen existing External Quality Assurance (EQA) programs; strengthen laboratory reporting systems and specimen transport needs in support of rural clinics and laboratories; promote efforts to synchronize infection control activities in collaboration with the National Institute of Occupation Health (NIOH); investigate, assess, validate and implement new automated laboratory diagnostic equipment and high capacity instrumentation for high burden diagnostics and service delivery needs; and to expand upon the regional support and collaboration with other PEPFAR-funded countries through the established Regional Integrated Laboratory Training Center (RILTC). 

 

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

HHS/CDC activities for this program are as follows:

 

1.      Organize an orientation meeting with the grantee for briefing on applicable U.S. Government, HHS/CDC, and PEPFAR expectations, regulations and key management requirements, as well as report formats and contents.  The orientation could include meetings with staff from HHS/CDC 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 sub-grantees to be involved in the activities performed under this agreement, as part of the PEPFAR Country Operational Plan review and approval process, managed by the Office of the U.S. Global AIDS Coordinator.

 

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

 

4.      Review and approve the grantee’s monitoring and evaluation plan, including for compliance with the strategic information guidance established by the Office of the U.S. Global AIDS Coordinator. 

 

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

 

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

 

7.      Meet on an annual basis with the 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 PEPFAR review and approval process for Country Operational Plans, managed by the Office of the U.S. Global AIDS Coordinator.

 

8.      Provide technical assistance, as mutually agreed upon, and revise annually during validation of the first and subsequent annual work plans.  This could include expert technical assistance and targeted training activities in specialized areas, such as strategic information, project management, confidential counseling and testing, palliative care, treatment literacy, and adult learning techniques.

  

9.      Provide in-country administrative support to help grantee meet U.S. Government financial and reporting requirements approved by the Office of Management and Budget (OMB) under 0920-0428 (Public Health Service Form 5161).

 

10.  Collaborate with the grantee on designing and implementing the activities listed above, including, but not limited to the provision of technical assistance to develop program activities, data management and analysis, quality assurance, the presentation and possibly publication of program results and findings, and the management and tracking of finances.

 

11.  Provide consultation and scientific and technical assistance based on appropriate, HHS/CDC and Office of the U.S. Global AIDS Coordinator documents to promote the use of best practices known at the time.

 

12.  Assist the recipient in developing and implementing quality assurance criteria and procedures.

 

II. Award Information

Type of Award: Cooperative Agreement.  HHS/CDC’s involvement in this program is listed in the Activities Section above.

Award Mechanism: U2G - Global HIV/AIDS Non-Research Cooperative Agreements                  

Fiscal Year Funds: 2008

Approximate Current Fiscal Year Funding: $10,000,000

Approximate Total Project Period Funding: $50,000,000 (This amount is an estimate, and is subject to availability of funds.)

Approximate Number of Awards: One

Approximate Average Award: $10,000,000 (This amount is for the first 12 month budget period, and includes direct costs.)

Floor of Individual Award Range: $5,000,000

Ceiling of Individual Award Range: $10,000,000 (This ceiling is for the first 12 month budget period.  [This is for direct costs only.]) 

Anticipated Award Date: September 30, 2008

Budget Period Length: 12 months

Project Period Length: Five Years

Throughout the project period, HHS/CDC’s 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 U.S. Government.

 

III. Eligibility Information

III.1. Eligible Applicants

Eligible applicants that can apply for this funding opportunity are listed below:

The South African National Health Laboratory Service.

In 2001 South Africa restructured its public sector medical laboratory services and created the National Health Laboratory System (NHLS), which is organized as a parastatal organization. The NHLS is accountable to the National Department of Health (NDOH) through its Executive Board and is responsible for public sector laboratory service delivery. The NHLS also governs activities and provides funding to the National Institute of Communicable Diseases (NICD) to provide surveillance, research and programmatic operations, as well as funding to the National Institute of Occupational Health (NIOH) for policy development activities related to occupational health.  The public service delivery arm of NHLS is comprised of approximately 300 laboratories, which include all provincial diagnostic pathology labs, tertiary level, secondary, and primary laboratories in all 9 provinces and their associated district hospital laboratories. Each district laboratory supports a network of local clinics where primary care services are provided.

 

With the continuing expansion of HIV and TB related services within NHLS, and with significant increases in MDR and XTR-TB cases within South Africa, additional support is required to strengthen HIV and TB diagnostic capacity and information management infrastructure.  To this end, NHLS is prepared and is expanding HIV diagnostics and treatment monitoring capabilities in all nine provinces.  To date, there are 46 CD4 laboratories in all 9 provinces within the NHLS system, but coverage within each health district is limited; there are only 13 laboratories in 5 provinces that are able to provide viral load testing; with only 8 laboratories in 5 provinces able to provide infant PCR diagnostics.  NHLS is driven to expand services to provide at least one CD4 laboratory per health district, as well as to expanding viral load and infant PCR services to all 9 provinces.  NHLS also recognizes their limited TB laboratory capacity due to high burden and inability to capture and report cases of MDR and XTR-TB within NHLS and the National TB Program (NTP).  There is an immediate need to provide increased access of TB culture and referral services, and to strengthen the management and reporting of MDR and XTR-TB cases, data mining activities, and surveillance analysis from the existing NHLS Data Warehouse (DISA) and to integrate data to the existing national ETR (Electronic TB Register) surveillance system.  The NHLS DISA system can be used to extract laboratory data from existing NHLS laboratory information systems (LIMS) and maybe used to import data into the ETR (Electronic TB Register) network information system.  The current system does require strengthening and NHLS is actively working to improve the capacity and utility associated with this system. 

 

National policies and standards relating to infection control programs within laboratories are currently limited.  With the National Institute of Occupation Health (NIOH) residing within the NHLS organizational structure, and with its mandate to develop policy for occupation health, activities will be leveraged to promote an infection control network and to develop robust and manageable infection control policies.  Collaboration with PEPFAR partners will assist in the development of such policies and will lead to enhancement of existing infection control measures and implementation of national infection control standards for all health care workers, including laboratory staff. 

 

With the availability of significant technical and scientific resources within South Africa, NICD and NHLS are both well placed to continue and to expand provisions for regional laboratory support within Sub-Sahara Africa.  NICD and NHLS are actively planning to expand and strengthen existing regional support mechanisms and enhance further collaboration with other PEPFAR funded countries through the established Regional Integrated Laboratory Training Center (RILTC).  Expansion of services includes, but is not limited to: extending EQA programs, TB and HIV laboratory diagnostic technical support and services, regional HIV rapid testing kit evaluations, integrated TB/HIV training programs, and other HIV and TB related laboratory technical assistance.

 

III.2. Cost Sharing or Matching

Cost sharing or matching funds are not required for this program.

 

III.3. Other

If a funding amount greater than the ceiling of the award range is requested, the application will be considered non-responsive and will not be entered into the review process.  The applicant will be notified that the application did not meet the submission requirements.

 

Special Requirements:

If the application is incomplete or non-responsive to the special requirements listed in this section, it will not be entered into the review process.  The applicant will be notified the application did not meet submission requirements.

  • Late applications will be considered 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 U.S. Government 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 the application forms package posted in Grants.gov.

 

Electronic Submission:

CDC strongly encourages the applicant to submit the application electronically by utilizing the forms and instructions posted for this announcement on www.Grants.gov, the official U.S. Government agency wide Egrant Web site.  Only applicants who apply online are permitted to forego paper copy submission of all application forms.

 

Registering the applicant’s organization through www.Grants.gov is the first step in submitting applications online. Registration information is located in the “Get Registered” screen of www.Grants.gov. While application submission through www.Grants.gov is optional, HHS\CDC strongly encourages applicants to use this online tool.

 

Please visit www.Grants.gov at least 30 days prior to filing an application to become familiar with the registration and submission processes. Under “Get Registered,” the one time registration process will take three to five days to complete; however, as part of the Grants.gov registration process, registering the applicant’s organization with the Central Contractor Registry (CCR) annually, could take an additional one to two days to complete. HHS\CDC suggest submitting electronic applications prior to the closing date so if difficulties are encountered, applicants can submit a hard copy of the application prior to the deadline.

 

Foreign organizations must include a NATO Commercial and Governmental Entity (NCAGE) Code to complete their Grants.gov registration.  Instructions for obtaining an NCAGE Code may be found at: http://www.cdc.gov/od/pgo/funding/NATO_Commercial_and_Governmental_Entity_12-18-06.doc.

 

Paper Submission:

Application forms and instructions are available on the CDC Web site, at the following Internet address: http://www.cdc.gov/od/pgo/funding/grants/app_and_forms.shtm

 

If access to the Internet is not available, or if there is difficulty accessing the forms online, contact the CDC Procurement and Grants Office Technical Information Management Section (PGOTIMS) staff at 770-488-2700 and the application forms can be mailed.

 

IV.2. Content and Form of Submission

A letter of intent is not applicable to this funding opportunity announcement.

 

Application:

A Project Abstract must be submitted with the application forms.  All electronic project abstracts must be uploaded in a PDF file format when submitting via Grants.gov.  The abstract must be submitted in the following format, if submitting a paper application:
  • Maximum of 2-3 paragraphs.
  • Font size: 12 point unreduced, Times New Roman
  • Double spaced
  • Paper size: 8.5 by 11 inches
  • Page margin size: One inch

The Project Abstract must contain a summary of the proposed activity suitable for dissemination to the public.  It should be a self-contained description of the project and should contain a statement of objectives and methods to be employed.  It should be informative to other persons working in the same or related fields and insofar as possible understandable to a technically literate lay reader.  This Abstract must not include any proprietary/confidential information. 

 

A project narrative must be submitted with the application forms.  All electronic narratives must be uploaded in a PDF file format when submitting via Grants.gov.  The narrative must be submitted in the following format, if submitting a paper application:

  • Maximum number of pages: 25.  If the narrative exceeds the page limit, only the first pages which are within the page limit will be reviewed.
  • Font size: 12 point unreduced, Times New Roman
  • Double spaced
  • Paper size: 8.5 by 11 inches
  • Page margin size: One inch
  • Printed only on one side of page.
  • Number all narrative pages; not to exceed the maximum number of pages.
  • Paper application should be held together only by rubber bands or metal clips; not bound in any other way.

 

The 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):  Describe the background and justify the need for the proposed project.  Describe the current infrastructure system; targeted geographical area(s), if applicable; and identified gaps or shortcomings of the current health systems and AIDS control projects in South Africa;
  • Project Strategy - Description and Methodologies:  Present a detailed operational plan for initiating and conducting the project.  Clearly describe the technical approach/methods for implementing the proposed project.  Describe the existence of or plans to establish partnerships necessary to implement the project.  Describe linkages, if appropriate, with programs funded by the U.S. Agency for International Development;
  • Project Goals and Objectives:  Describe the overall goals of the project, and specific objectives that are measurable and time phased, consistent with the objectives and numerical targets of PEPFAR and for this Cooperative Agreement program as provided in the “Purpose” Section at the beginning of this Announcement;
  • Project Outputs:  Be sure to address each of the program objectives listed in the “Purpose” Section of this Announcement.  Measures must be specific, objective and quantitative so as to provide meaningful outcome evaluation;
  • Project Contribution to the Goals and Objectives of PEPFAR:  Provide specific measures of effectiveness to demonstrate accomplishment of the objectives of this program; 
  • Work Plan and Description of Project Components and Activities:  Be sure to address each of the specific tasks listed in the Activities section of this Announcement.  Clearly identify specific assigned responsibilities for all key professional personnel; 
  • Performance Measures:  Measures must be specific, objective and quantitative;
  • Timeline (e.g., GANNT Chart); and
  • Management of Project Funds and Reporting.

 

Applicants may include additional information in appendices.  The appendices and budget information will not count toward the narrative page limit.  This additional information includes the following:
  • Project Budget and Justification:

With staffing breakdown and justification, provide a line item budget and a narrative with justification for all requested costs. Be sure to include, if any, in-kind support or other contributions provided by the national Government and its donors as part of the total project, but for which funding is not being requested.

 

Budgets must be consistent with the purpose, objectives of PEPFAR and the program activities listed in this announcement and must include the following:

o       Line item breakdown and justification for all personnel, i.e., name, position title, annual salary, percentage of time and effort, and amount requested.

For each contract, list the following: (1) name of proposed contractor; (2) breakdown and justification for estimated costs; (3) description and scope of activities the contractor will perform; (4) period of performance; (5) method of contractor selection (e.g., competitive solicitation); and (6) methods of accountability.  Applicants should, to the greatest extent possible, employ transparent and open competitive processes to choose contractors; 

  • Curricula vitae of current staff who will work on the activity;
  • Job descriptions of proposed key positions to be created for the activity;
  • Applicant’s Corporate Capability Statement;
  • Letters of Support; and
  • Evidence of Legal Organizational Structure.

 

The recommended guidance for completing a detailed justified budget can be found on the CDC Web site, at the following Internet address:

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

 

The agency or organization is required to have a Dun and Bradstreet Data Universal Numbering System (DUNS) number to apply for a grant or cooperative agreement from the U.S. 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 the Dun and Bradstreet website or call 1-866-705-5711. 

 

Additional requirements that may request submission of additional documentation with the application are listed in section “VI.2.  Administrative and National Policy Requirements.”

 

IV.3. Submission Dates and Times

Application Deadline Date: August 15, 2008   

 

Explanation of Deadlines: Applications must be received in the HHS/CDC Procurement and Grants Office by 5:00 p.m. Eastern Time on the deadline date. 

 

Applications may be submitted electronically at www.Grants.gov.  Applications completed online through Grants.gov are considered formally submitted when the applicant organization’s Authorizing Organization Representative (AOR) electronically submits the application to www.Grants.gov.  Electronic applications will be considered as having met the deadline if the application has been successfully submitted electronically by the applicant organization’s AOR to Grants.gov on or before the deadline date and time.

 

When submission of the application is done electronically through Grants.gov (http://www.grants.gov), the application will be electronically time/date stamped and a tracking number will be assigned, which will serve as receipt of submission.  The AOR will receive an email notice of receipt when HHS/CDC receives the application.

 

If submittal of the application is by the United States Postal Service or commercial delivery service, the applicant must ensure that the carrier will be able to guarantee delivery by the closing date and time.  The applicant will be given the opportunity to submit documentation of the carrier’s guarantee, if HHS/CDC receives the submission after the closing date 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.  If the documentation verifies a carrier problem, HHS/CDC will consider the submission as having been received by the deadline. 

 

If a hard copy application is submitted, HHS/CDC will not notify the applicant upon receipt of the submission.  If questions arise on the receipt of the application, the applicant should first contact the carrier.  If the applicant still has questions, contact the PGOTIMS staff at (770) 488-2700.  The applicant should wait two to three days after the submission deadline before calling.  This will allow time for submissions to be processed and logged.

 

This announcement is the definitive guide on application content, submission address, and deadline.  It supersedes information provided in the application instructions.  If the application submission does not meet the deadline above, it will not be eligible for review.  The application face page will be returned by HHS/CDC with a written explanation of the reason for non-acceptance.  The applicant will be notified the application 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 must be taken into account while writing the budget, are as follows:
  • Recipients may not use funds for research.

·        Needle Exchange - 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.

·        Recipients may spend funds for reasonable program purposes, including personnel, training, travel, supplies and services.  Recipients may purchase equipment and complete renovations if deemed necessary to accomplish program objectives, and if authorized by, and in accordance with, applicable federal law and HHS/CDC policy; however, recipients must request prior approval by HHS/CDC officials in writing, and conduct procurements in a transparent and competitive manner.

·        Applicants shall state all requests for funds contained in the budget in U.S. dollars.  Once HHS/CDC makes an award, foreign grantees will not be compensated for currency exchange fluctuations through the issuance of supplemental awards.

·        The costs 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, HHS/CDC will not pay indirect costs (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.

·        Recipients may contract with other organizations under this program; however, recipients must perform a substantial portion of the activities (including program management and operations, and delivery of prevention services for which funds are required) relating to the management of sub-grants to local organizations and improving their capacity, and must award any subcontracts through a competitive and transparent process.

·        Foreign recipients are subject to audit requirements specified in 45 CFR 74.26(d).  A non-Federal audit is required if, during the recipient’s fiscal year, the recipient expended a total of $500,000 or more under one or more HHS/CDC awards (as a direct recipient and/or as a sub-recipient).  The recipient either may have:  (1) a financial related audit (as defined in the Government Auditing Standards, GPO stock #020-000-00-265-4) of a particular award in accordance with Government Auditing Standards, in those cases where the recipient receives awards under only one HHS program; 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. Government 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 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 sub-agreements under this award.  These provisions must be express terms and conditions of the sub-agreement, 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.”

 

 

IV.6. Other Submission Requirements

A letter of intent is not applicable to this funding opportunity announcement.

 

Application Submission Address:

Electronic Submission:

HHS/CDC strongly encourages applicants to submit applications electronically at www.Grants.gov.  The application package can be downloaded from www.Grants.gov.  Applicants are able to complete it offline, and then upload and submit the application via the Grants.gov Web site.  Email submissions will not be accepted.  If the applicant has 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 7:00a.m. to 9:00p.m. Eastern Time, Monday through Friday. 

 

HHS/CDC recommends that submittal of the application to Grants.gov should be prior to the closing date to resolve any unanticipated difficulties prior to the deadline.  Applicants may also submit a back-up paper submission of the application.  Any such paper submission must be received in accordance with the requirements for timely submission detailed in Section IV.3. of the grant announcement. The paper submission must be clearly marked:  “BACK-UP FOR ELECTRONIC SUBMISSION.”  The paper submission must conform to all requirements for non-electronic submissions.  If both electronic and back-up paper submissions are received by the deadline, the electronic version will be considered the official submission.

 

The applicant must submit all application attachments using a PDF file format when submitting via Grants.gov.  Directions for creating PDF files can be found on the Grants.gov Web site.  Use of file formats other than PDF may result in the file being unreadable by staff.

 

Paper Submission:

Applicants should submit the original and two hard copies of the application by mail or express delivery service to:

            Technical Information Management – PS08-868

            Department of Health and Human Services       

CDC Procurement and Grants Office

2920 Brandywine Road, MS E-14

            Atlanta, GA 30341

 

V. Application Review Information

V.1. Criteria

Applicants are required to provide specific 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 the measures of effectiveness with the application, and they will be an element of evaluation.

 

HHS/CDC will evaluate the application against the following criteria:

 

Ability to Carry Out the Proposal (20 points)

Does the applicant demonstrate the local experience in South Africa and  have the institutional capacity (both management and technical) to achieve the goals of the project with documented good governance practices?  Does the applicant have the ability to coordinate and collaborate with existing PEPFAR partners and other donors, including the Global Fund and other U.S. Government Departments and agencies involved in implementing PEPFAR, including the U.S. Agency for International Development?  Is there evidence of leadership support and evidence of current or past efforts to enhance HIV prevention?  Does the applicant have the capacity to reach rural and other underserved populations in South Africa?  Does the organization have the ability to target audiences that frequently fall outside the reach of the traditional media, and in local languages?  To what extent does the applicant provide letters of support?

 

Technical and Programmatic Approach (20 points)

Does the application include an overall design strategy, including measurable time lines, clear monitoring and evaluation procedures, and specific activities for meeting the proposed objectives?  Does the applicant display knowledge of the strategy, principles and goals of PEPFAR, and are the proposed activities consistent with and pertinent to that strategy and those principles and goals?  Does the applicant describe activities that are evidence based, realistic, achievable, measurable and culturally appropriate to achieve the goals of PEPFAR?  Does the application propose to build on and complement the current national response in South Africa with evidence based strategies designed to reach underserved populations and meet the goals of the Emergency Plan?  Does the application include reasonable estimates of outcome targets?  (For example, the numbers of sites to be supported, number of clients the program will reach.)  To what extent does the applicant propose to work with other organizations?  The reviewers will assess the feasibility of the applicant's plan to meet the target goals, whether the proposed use of funds is efficient, and the extent to which the specific methods described are sensitive to the local culture.

 

Capacity Building (15 points)

Does the applicant have a proven track record of building the capacity of indigenous organizations and individuals?  Does the applicant have relevant experience in using participatory methods and approaches, in project planning and implementation?  Does the applicant describe an adequate and measurable plan to progressively build the capacity of local organizations and of target beneficiaries to respond to the epidemic?  If not a local indigenous organization, does the applicant articulate a clear exit strategy, which will maximize the legacy of this project in the intervention communities?  Does the capacity building plan clearly describe how it will contribute to (a) improved quality and geographic coverage of service delivery to achieve the "2, 7, 10" targets of the PEPFAR, and (b) (if not a local indigenous organization) an evolving role of the prime beneficiary with transfer of critical technical and management competence to local organizations/sites in support of a decentralized response?

 

Monitoring and Evaluation (15 points)

Does the applicant demonstrate the local experience and capability to implement rigorous monitoring and evaluation of the project?  Does the applicant describe a system for reviewing and adjusting program activities based on monitoring information obtained by using innovative, participatory methods and standard approaches?  Does the plan include indicators developed for each program milestone, and incorporated into the financial and programmatic reports?  Are the indicators consistent with the PEPFAR Indicator Guide?  Is the system able to generate financial and program reports to show disbursement of funds, and progress towards achieving the numerical objectives of PEPFAR?  Is the plan to measure outcomes of the intervention, and the manner in which they will be provided, adequate?  Is the monitoring and evaluation plan consistent with the principles of the "Three Ones?"  Applicants must define specific output and outcome indicators must be defined in the proposal, and must have realistic targets in line with the targets addressed in the Activities section of this announcement.

 

Understanding of the Problem (10 points)

Does the applicant demonstrate a clear and concise understanding of the current national HIV/AIDS response and the cultural and political context relevant to the programmatic areas targeted?  Does the applicant display an understanding of the Five Year Strategy and goals of PEPFAR?  To what extent does the applicant justify the need for this program within the target community?

 

Personnel (10 points)

Does the organization employ staff fluent in local languages who will work on this project?  Are the staff roles clearly defined?  As described, will the staff be sufficient to meet the goals of the proposed project?  If not an indigenous organization, does the staff plan adequately involve local individuals and organizations?  Are staff involved in this project qualified to perform the tasks described?  Curricula vitae provided should include information that they are qualified in the following:  management of HIV/AIDS prevention activities, especially confidential, voluntary counseling and testing; and the development of capacity building among and collaboration between Governmental and non-governmental partners.

 

Administration and Management (10 points)

Does the applicant provide a clear plan for the administration and management of the proposed activities, and to manage the resources of the program, prepare reports, monitor and evaluate activities, audit expenditures and produce, collect, and analyze performance data?  Is the management structure for the project sufficient to ensure speedy implementation of the project?  If appropriate, does the applicant have a proven track record in managing large laboratory budgets; running transparent and competitive procurement processes; supervising consultants and contractors; using subgrants or other systems of sharing resources with community based organizations, faith based organizations or smaller non-governmental organizations; and providing technical assistance in laboratory or pharmacy management?  The applicant must demonstrate an ability to submit quarterly reports in a timely manner to the HHS/CDC office.

 

Budget (Reviewed, but not scored)

Is the itemized budget for conducting the project, along with justification, reasonable and consistent with stated objectives and planned program activities?  Is the budget itemized, well justified and consistent with the Five-Year Strategy (2003-2008) and goals of the PEPFAR and Emergency Plan activities?  If applicable, are there reasonable costs per client reached for both year one and later years of the project?

 

V.2. Review and Selection Process

The HHS/CDC Procurement and Grants Office (PGO) staff will review applications for completeness, and for responsiveness jointly by the HHS/CDC Global AIDS Program and PGO.  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 in South Africa.   The panel may include both U.S. Government and non-U.S. Government participants. 

 

Applications will be funded in order by score and rank determined by the review panel.

CDC will provide justification for any decision to fund out of rank order.

 

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 emailed to the program director, and a hard copy 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

Successful applicants must comply with the administrative requirements outlined in 45 CFR Part 74 and Part 92, as appropriate.  The following additional requirements apply to this project:

  • AR - 4             HIV/AIDS Confidentiality Provisions.    
  • AR - 6             Patient Care.     
  • AR - 9             Paperwork Reduction Act Requirements.           
  • AR - 10           Smoke Free Workplace Requirements.               
  • AR - 12           Lobbying Restrictions.   
  • AR - 14           Accounting System Requirements.          
  • AR - 24           Health Insurance Portability and Accountability Act Requirements.          
  • AR - 25           Release and Sharing of Data.     

 

Additional information on the requirements can be found on the CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/Addtl_Reqmnts.htm.

 

CDC Assurances and Certifications can be found on the CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/grants/foamain.shtm

 

For more information on the Code of U.S. Government Regulations, see the National Archives and Records Administration at the following Internet address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html

 

VI.3. Reporting Requirements

Successful applicants must provide HHS/CDC with an annual interim progress report via www.grants.gov:

1.      The interim progress report is due no less than 90 days before the end of the budget period.  The progress report will serve as the non-competing continuation application, and must contain the following elements:

a.       Standard Form (SF) 424 form;

b.      SF-424A Budget Information Non-Construction Programs.

c.         Activities and Objectives for the Current Budget Period;

d.         Financial Progress for the Current Budget Period;

e.         Proposed Activity and Objectives for the New Budget Period Program;

f.           Budget and Supporting Budget Narrative;

g.         Measures of Effectiveness, including progress against the numerical goals of the President's Emergency Plan for AIDS Relief for South Africa; and

h.         Additional Requested Information.

 

Additionally, successful applicants must provide HHS/CDC with an original, plus two hard copies of the following reports:

2.      Semi-annual progress report, due 30 days after the end of the reporting period.  Reports should include progress against the numerical goals of the President's Emergency Plan for AIDS Relief for South Africa;

3.      Financial status report due no more than 90 days after the end of the budget period.

  1. Final Performance and Financial Status reports, no more than 90 days after the end of the project period.

These reports must be submitted to the attention of the Grants Management Specialist listed in the “VII. Agency Contacts” section of this announcement.

 

VII. Agency Contacts

CDC encourages inquiries concerning this announcement.

For general questions, contact:

            Technical Information Management Section

Department of Health and Human Services

            CDC Procurement and Grants Office

            2920 Brandywine Road, MS E-14