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Part I Overview Information


United States Department of Health and Human Services (HHS)

Issuing Organization

Centers for Disease Control and Prevention (Malaria Branch/ DPD/ NCZVED/ CDC), at http://www.cdc.gov/malaria


Participating Organizations

Centers for Disease Control and Prevention (CDC) at http://www.cdc.gov/


Components of Participating Organizations

Malaria Branch, Division of Parasitic Diseases, National Center for Zoonotic, Vector-Borne, and Enteric Diseases (NCZVED/ CDC), at http://intranet.cdc.gov/ccid/nczved/

Title: Strengthening National Capacity in

Malaria and Other Infectious Disease

Operations Research (U01)

The policies, guidelines, terms, and conditions of the HHS Centers for Disease Control and Prevention (CDC) stated in this announcement might differ from those used by the HHS National Institutes of Health (NIH). If written guidance for completing this application is not available on the CDC website, then CDC will direct applicants elsewhere for that information.


Authority: This program is authorized under sections 301(a) and 317(k)(2) of the Public Health Service Act, [42 U.S.C. sections 241(a) and 247b(k)(2)], as amended.

Announcement Type: New

Instructions for Submission of Electronic Research Applications:

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance may be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

This FOA must be read in conjunction with the application package instructions included with this announcement on Grants.gov/Apply for Grants (hereafter referred to as, Grants.gov/Apply.)

A registration process is necessary before submission, and applicants are strongly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Two steps are required for on time submission:

1) The application must be successfully received by Grants.gov no later than 5:00 p.m. Eastern Standard Time on the application submission receipt date (see “Key Dates” below.)

2) Applicants must complete a verification step in the Electronic Research Administration (eRA Commons) within two business days of notification. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the eRA Commons.

Funding Opportunity Announcement (FOA) Number: RFA-CK-09-004

Catalog of Federal Domestic Assistance Number(s): 92.283

Key Dates

Release/Posted Date: February 2, 2009
Letter of Intent Receipt Date: Not applicable
Application Submission Receipt Date(s): April 2, 2009
Peer Review Date(s): May 2009
Council Review Date(s): June 2009

Earliest Anticipated Start Date(s): September 1, 2009

Additional Information to Be Available Date: Not Applicable

Expiration Date: TBD

Due Date for E.O. 12372

Due no later than 60 days after the application receipt date.

Additional Overview Content


Funding Opportunity Announcement Glossary: FOA Glossary Terminology

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions

2.Cost Sharing or Matching
3.Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application to CDC
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources

3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement

1. Recipient Rights and Responsibilities
2. HHS/CDC Responsibilities
3. Collaborative Responsibilities

3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

4. General Questions Contact(s)

Section VIII. Other Information - Required Federal Citations


Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

The National Center for Zoonotic, Vector-Borne, and Enteric Diseases (NCZVED) of CDC within HHS is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010" and to measuring program performance as stipulated by the Government Performance and Review Act (GPRA). This RFA addresses “Healthy People 2010” priority area(s) of Immunization and Infectious Diseases and Global Public Health and is in alignment with NCZVED’s performance goal(s) to protect Americans from infectious diseases, provide assistance to endemic-country ministries of health and research partners, and conduct public health diplomacy. For more information www.healthypeople.gov. and

http://intra-apps.cdc.gov/fmo/.

In addition this FOA addresses the specific goals of the CDC Malaria Branch: to (1) implement and evaluate malaria program intervention activities, including those supported by the President’s Malaria Initiative, (2) conduct agreed upon operational research strategically important to Malawi for malaria as well as other infectious diseases of importance in Malawi, (3) link the training of students to operations research important to preventing and controlling infectious diseases with a focus on malaria prevention and care, and (4) help design and implement monitoring and evaluation activities in support of the Malawi Ministry of Health strategic plans for Malaria, and other important infectious diseases agreed upon by the Ministry, the College of Medicine, and CDC.

Strengthening National Capacity in Operations Research.

At the start of the 21st century, malaria remained the single most important infectious pathogen for child survival in sub-Saharan Africa. CDC and its research partners in malaria-endemic countries have been at the forefront of establishing the efficacy of proven malaria control interventions including: insecticide-treated bed nets (ITN), intermittent preventive treatment of malaria for pregnant women (IPTp), and artemisinin-containing combination treatments (ACT) for symptomatic malaria cases. If implemented broadly, it is estimated that these interventions together could reduce the malaria-attributable mortality among African children by as much as 50%. Assuring high coverage of these interventions was identified as a priority in the Global Malaria Control Strategy of 1993, the African Region’s Accelerated Plan for Malaria Control in 1997, the Abuja Declaration for Roll Back Malaria in 2000, and the US President’s Malaria Initiative in 2005. However, reaching coverage targets of 60 to 80% has been elusive without the benefit of scientific evidence to direct program managers in the best ways forward.

New global initiatives for malaria control have also emphasized interventions such as indoor residual spraying (IRS), which had fallen out of favor. Researchers in Malawi and elsewhere in the malaria-endemic world have championed interventions that might be available in the next five to 10 years including partially effective malaria vaccines, artemisinin-containing combination treatments, new insecticides for residual application, and new approaches to vector management and control. In late 2007, the Roll Back Malaria Partnership called on endemic-countries to develop strategies for elimination and post-elimination scenarios. This renewed emphasis on malaria elimination carries with it an obligation for malaria control programs and their research partners to investigate carefully and to document the ideal mix of malaria control interventions across settings of diverse and rapidly declining malaria transmission, to identify and document the effectiveness of newly recognized and once disqualified interventions, and to maximize opportunities for integrated delivery and management of malaria control in the context of other child survival and infectious disease control programs. This RFA represents an important opportunity to address these deficiencies and priorities in the context of a long-standing partnership with the Malawi Ministry of Health and CDC.

The applicant must address all of the objectives below in their research plan:

Objective 1: Assist the Malawi Ministry of Health in the conduct of program activities on human infectious diseases, with an emphasis on malaria.

Objective 2: Determine the optimal mix of currently validated malaria control interventions across malaria transmission zones and diverse epidemiological and cultural settings.

Objective 3: Develop and evaluate the impact of revised, enhanced or novel interventions that will contribute to effective malaria control at scale.

Objective 4: Establish the most feasible and effective opportunities for integration of malaria interventions with other child survival, environmental health, vector control, and infectious disease programs.

Malawi is well-positioned as a setting for exploring how the introduction and scale up of established malaria control interventions (ITNs, IPTp, and facility-based case management with ACT) affect the level of malaria transmission in areas formerly subjected to intense, perennial transmission. The introduction and widespread use of ITNs in Malawi, and other socioeconomic and environmental changes appear to have reduced the malaria entomological inoculation rate. This FOA presents an opportunity to explore additional questions about scaling up existing interventions and the optimal mix of malaria prevention and treatment initiatives in settings of declining malaria transmission.

Research supported by this program will specifically address the CDC Malaria Branch goal of addressing the optimal mix of currently validated malaria control interventions across malaria transmission zones and diverse epidemiological and cultural settings in the first funding year. Furthermore it will support the program’s objective of identifying and exploiting opportunities to integrate delivery, management and monitoring and evaluation of malaria control with other public health interventions. As new or revised interventions are proposed for contributing to effective malaria control at scale, additional activities may be developed in subsequent funding years.

All of the following 6 research activities must be addressed in order to add scientific knowledge to the first-level priority areas. During the first project year the applicant will propose to:

1) Conduct household and community cross-sectional studies to demonstrate the level of anemia and malaria parasitemia prevalence in the presence of scaled up malaria control interventions.

2) Conduct sentinel surveillance in selected areas to assess the impact of scaled up malaria control interventions.

3) Conduct mosquito vector behavior studies and routine entomologic surveillance examining the impact of deploying synthetic pyrethroid and alternative insecticides for indoor spraying or long-lasting ITNs.

4) Conduct national and sub-national level trainings for Ministry of Health health workers in malaria prevention, control, and treatment.

5) Conduct evaluations of long-lasting insecticide treated nets in a variety of epidemiologic and field settings.

6) Examine the effectiveness of introducing routine diagnostic testing for malaria with blood slide microscopy or RDTs.

7) Enhance access to effective malaria treatment through community-and retail-sector outlets.

As funding becomes available, the research plan should include additional topics as supported by current scientific evidence. The applicant will address these second-level priority issues by proposing to:

· Conduct a comparative evaluation of strategies to assess trends in childhood mortality.

· Conduct policy and advocacy mapping to document decision-making for scaling up malaria control interventions.

· Conduct a focused evaluation of newly recommended interventions (including rectal artesunate and intramuscular artemether, as well as interventions not yet recognized) to enhance pre-referral and definitive care of severe febrile illness in children.

· Pilot test novel technologies such as cellular telephone and personal data assistants for collecting and transmitting malaria surveillance information.

· Pilot test new strategies for active case detection and treatment of malaria infections.

· Conduct studies assessing the impact of novel interventions for preventing malaria in pregnancy on pregnancy outcome.

· Assess new pharmaceutical regimens for intermittent preventive treatment in pregnant women, infants, children, or other risk groups.

· Conduct field studies of mass drug administration and gametocytocidal treatments for malaria illness.

Third-level activities may also be possible and should thus be included as potential future activities in the research plan:

· Comprehensively describe (through clinical and laboratory cross-sectional surveys with laboratory confirmation) the non-malarial causes of fever and the effectiveness of the new treatment algorithms for sick children.

· Conduct in vivo and in vitro cohort studies on the efficacy of currently recommended and likely alternative first line malaria treatment drugs in children and pregnant women, according to World Health Organization criteria for clinical efficacy and the SYBR green assay for in vitro culture of malaria parasites.

· Evaluate the cost and cost-effectiveness of scaling up proven malaria treatments at district and national level.

· Conduct qualitative studies of health seeking behavior for malaria and malaria-like illness and perceptions of scaled up prevention and treatment interventions. These could include focus group discussion and individual interviews with community members, health care worker, traditional and lay healers, and drug retailers.

· Establish the frequency and distribution of known molecular markers for antimalarial drug resistance in community and facility-based studies.

· Develop and pilot test integrated pharmacovigilance systems for detecting adverse drug events.

· Assess the impact of malaria vector control interventions (IRS, ITNs and larval control, where appropriate) on other insect vectors of public health importance and related illnesses including lymphatic filariasis.

· Conduct studies of malaria prevention and treatment in HIV-infected and exposed individuals.

· Conduct demographic surveillance to document long-term trends in all-cause and malaria-specific childhood mortality in the context of scaling up malaria control interventions.

The applicant should anticipate and address future collaborations within CDC's various Centers and Divisions to identify opportunities where malaria prevention and treatment interventions or their monitoring and management systems can overlap with those for other major public health problems. The research plan should include and address childhood bacterial diseases such as respiratory infection and meningitis, which can be difficult to distinguish from severe malaria and which contribute to co-morbidity. In addition, scaled up malaria control interventions may provide opportunities for other public health interventions delivered either at the household or health facility. Studies to explore these opportunities should also be considered.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the U01 activity code.

The HHS/CDC U01 is a cooperative agreement assistance instrument. Under the U01 assistance instrument, the Recipient Organization retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, and with HHS/CDC staff is substantially involved as a partner with the Recipient Organization, as described in Section VI.2.A., "Cooperative Agreement”.