gh-13-002 rev. final-foa 12.19.12.docx

Table of Contents

Part 1. Overview Information Part 2. Full Text of the Announcement Section I. Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 1. Overview Information

Components of Participating Organizations

Center for Global Health (CGH)

Activity Code

U01 Research Project Cooperative Agreements

Funding Opportunity Announcement Type

New

Key Dates Publication Date

To receive notification of any changes to RFA-GH-13-002, return to the synopsis page of this announcement at www.grants.gov and click on the “Send Me Change Notification Emails” link An email address is needed for this service.

On-time submission requires that electronic applications be error-free and made available to CDC for processing from eRA Commons on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov/eRA Commons no later than 5:00 PM U.S. Eastern Time. Note: HHS/CDC grant submission procedures do not provide a period of time beyond the application due date to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

Due Dates for E.O. 12372

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

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar7

Required Application Instructions It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this FOA. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Note: The Research Strategy component of the Research Plan is limited to 16 pages per objective

Applications that do not comply with these instructions may be delayed or not accepted for review.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348 Executive Summary

· Purpose. The purpose of this research announcement is to identify partners who can collaborate with CDC in settings in Africa, Asia, and the Americas to : (1) promote and strengthen NTD control and elimination efforts, (2) improve monitoring and evaluation (M&E) tools for measuring program impact and performance of international NTD programs, and (3) determine how best to use currently available and new M&E tools to measure the impact of single disease and integrated NTD programs. This program addresses the “Healthy People 2020” focus on improving public health and strengthening U.S. national security through global disease detection, response, prevention, and control strategies.

· Mechanism of Support. Cooperative Agreement

· Funds Available and Anticipated Number of Awards. CGH/DPDM intends to provide approximately US $ 9 million in total CGH/DPDM funding to be allocated over a five year period, starting in September of 2013. The expected number of award will be: up to seven awards in objective 1, up to three awards for objective 2, and up to two awards for objective 3. Budget amounts for each objective are specified under the description of the objective in Section 1/ Approach

· Budget and Project Period: Up to $1.8 million in funding for the first year of the cooperative agreement, and up to $ 9 million dollars over a 5-year period, from August 2013 –July 2017. The awards issued under this FOA are contingent upon availability of funds and a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of each award may also vary. The total amount awarded and the number of awards will depend upon the number, quality, duration and cost of the applications received.

· Application Research Strategy Length: 16 pages per objective

· Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.

· Eligible Project Directors/Principal Investigators (PDs/PIs). Open to all.

· Number of PDs/PIs. One per submission

· Number of Applications. Eligible applicants are required to submit applications by research objective as this FOA includes multiple research objectives. Eligible applicants can also submit applications for more than one research objective but each submitted application must have a distinct research plan and include all the 16 components as specified in Section IV. 1

· Application Type. New

· Special Date(s). Letter of Intent (February 2013), Application Deadline (March 2013), Scientific Merit Review (May 2013), Award (August 2013).

· Application Materials. See Section IV.1 for application materials.

· Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: (770) 488-2783.

Part 2. Full Text

Section I. Funding Opportunity Announcement Description

Statutory Authority

This program is authorized under the Public Health Service Act sections 301(a),(c) [42 U.S.C. 241(a),(c)], 307 [42 U.S.C. 242l], and 317(k) (2) [42 U.S.C. 247b (k)(2)].” Note that “42 U.S.C. 242l.

1. Background and Purpose

Purpose:

The purpose of this research announcement is to identify partners who can collaborate with CDC in settings in Africa, Asia, and the Americas to : (1) promote and strengthen NTD control and elimination efforts, (2) improve monitoring and evaluation (M&E) tools for measuring program impact and performance of international NTD programs, and (3) determine how best to use currently available and new M&E tools to measure the impact of single disease and integrated NTD programs.

Background:

The Center for Global Health/Division of Parasitic Diseases and Malaria (CGH/DPDM) of the Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) is committed to achieving the “Healthy People 2020” objective to improve public health and strengthen U.S. national security through global disease detection, response, prevention, and control strategies.

Neglected Tropical Diseases (NTDs) are a group of parasitic and bacterial diseases that cause substantial illness for more than one billion people globally. Affecting the world’s poorest people, NTDs impair physical and cognitive development, contribute to mother and child illness and death, and limit productivity in the workplace. NTDs are a major cause of disease burden, resulting in approximately 57 million years of life lost due to premature disability and death. Much of CDC's current work focuses on the seven NTDs – lymphatic filariasis (LF), onchocerciasis, schistosomiasis, infections from soil-transmitted helminths (hookworm, Ascaris, whipworm), and trachoma – that can be controlled or eliminated by providing safe and effective medicines to individuals in affected communities through mass drug administration (MDA). MDAs have achieved tremendous success by reducing the prevalence and intensity of NTDs. According to WHO, 668 million persons were treated through MDA for one or more NTDs in 2009. While a remarkable achievement, less than half of the global population at risk of NTDs is currently receiving treatment. The similarity of MDA implementation strategies for NTDs has led to the rapid adoption of integrated NTD programs both by countries and donor communities. Despite efforts to integrate programs, additional resource mobilization and advocacy will be needed to close this gap. Increased donor support for the implementation of NTD programs requires better routine monitoring of program impacts.

The CDC has more than 20 years’ experience with planning, conducting, and implementing NTD projects in Africa, the Americas, and Southeast Asia, as well as developing laboratory diagnostic tools to support these projects. CDC has provided much of the evidence-based science including laboratory tests that is the basis for current global policies and programs for NTDs such as lymphatic filariasis (LF) and onchocerciasis. With its long standing history and expertise in working on NTDs, CDC is well-placed to be at the forefront to develop strategies to achieve NTD elimination, to continue providing leadership for NTD programs, and to assist in scale-up efforts in the implementation of effective NTD prevention and control programs around the world.

Onchocerciasis:

The optimal tools for detecting onchocerciasis infection will vary with the programmatic settings and needs. During the scale-up of MDA, detection of the parasite in skin snips was the gold standard diagnostic method. Because of the time and expense involved in performing skin snips, rapid assessment methods were developed (rapid epidemiologic mapping and rapid epidemiologic assessment). This approach met program needs for identifying the communities at highest risk. However, as the prevalence of infection is reduced through MDA, more sensitive and specific tools are required to define endpoints (e.g. interruption of transmission) and conduct surveillance for recrudescence of infection.

There are currently several markers of infection used to evaluate program impact, such as skin snips and the OV-16 antibody. Although a few studies have used one or more of these impact markers in sites where MDA has been conducted for more than a decade, our understanding of how these markers perform in African program settings is inadequate. Furthermore, the optimal population sampling strategies most appropriate for each marker is yet to be defined. Data are needed to determine which markers perform well at key programmatic endpoints, which markers perform well in settings of co-endemic filarial infections, and which age-group(s) of community members provide(s) the best information on program impact and the status of parasite transmission.

Effect of ivermectin MDA for onchocerciasis on LF:

As the programs to control or eliminate lymphatic filariasis (LF) continue to scale up, there is growing interest to determine the impact of ivermectin MDA for onchocerciasis on reducing and possibly interrupting LF transmission where the two diseases are co-endemic. For example, more than 17 million people are being treated for onchocerciasis in the Democratic Republic of the Congo (DRC) in areas likely to be co-endemic for LF and more than 25 million Nigerians are receiving ivermectin for onchocerciasis in co-endemic areas. It is possible that many years of ivermectin MDA for onchocerciasis may have eliminated LF in certain settings across Africa. Evaluating the status of LF where MDA occurs in DRC, Nigeria and Ethiopia alone could potentially reduce the need for LF MDA by approximately 50 million persons. One difficulty in assessing the impact of MDA for onchocerciasis on LF is the difference in the implementation unit (IU) used by the two programs. For onchocerciasis the IU is the village or community as transmission of the parasite is focal and is related to the distance from the blackfly breeding site on the nearby river, and for LF the IU is most commonly the district and is not related to river-based breeding sites.

Integrated NTD programs:

Public health programs aimed at NTDs collect data on reported coverage as a proxy for program impact and have, in general, failed to capture the complete package of health benefits associated with integrated NTD programs. This is a significant oversight, particularly in light of the fact that synergistic interactions are likely to occur as a result of co-implementation of NTD programs in terms of reductions in anemia, improved nutritional status and increased growth among children. Very few studies have focused on combined therapy; none have included both helminth infections and trachoma.

The absence of information documenting the broader program impacts leads to an underestimate of the public health value of integrated NTD programs; consequently, donors and countries place a low priority on NTD interventions despite their remarkably low cost. Having a better understanding of the health benefits associated with integrated NTD programs could lead to the selection of different indicators that that would capture program impact more effectively and without having to monitor a basket of disease-specific indicators, each requiring a different biological specimen and sampling strategy. WHO’s Strategic Technical and Advisory Group noted that development of new indicators to evaluate the impact of integrated NTD programs should be a research priority.

Public Health Impact:

More than one billion people are affected by at least one NTD. NTDs disproportionately affect neglected and marginalized populations and inflict significant morbidity on some of the poorest people on the planet. . This funding opportunity announcement aims to collaboratively develop evidence based recommendations which can be used to improve the well-being of affected population either by contributing to the improved control of these infections or to the elimination of the transmission of these infections.

Relevant work:

CDC is a partner in the United States Government NTD and Global Health Initiatives. CDC scientists’ contribution includes scientific research to guide programs and policies, such as the evaluation of diagnostic tests and protocols for assessing NTD transmission. CDC scientists also provide technical expertise related to monitoring and evaluation of programs’ progress, and consultation and training to ministries of health and other partners to help build global and national capacity to control and eliminate NTDs.

2. Approach

Specific Areas of Research

The applicant may propose an implementation science research project focusing on one or more of the topics described below, to the extent that it can be justified within the context of the country’s NTD program. Applicants may address multiple objectives in one country, one objective in multiple countries, or a combination of the two. The topics described below provide examples of priority research areas that would be considered responsive to this funding announcement. The topics were identified and selected because they reflect needs in countries where NTD programs are beginning to shift from a focus on NTD control to a focus on NTD elimination.

For objective 1a, sites have to be those specified in the objective.

For objectives 1b, 2 and 3, preferred sites are mentioned. However, applications for other countries where the study objectives could be fully accomplished will also be considered.

Objective 1: Measuring the impact of onchocerciasis control and elimination programs

Budget for objective 1a: ceiling USD $90,000 per country, though we expect most proposals would range between USD $25,000 and USD $62,500. Amounts above USD $62,500 will be considered if sufficiently justified in the proposal.

Budget for objective 1b: ceiling USD $150,000 per country.

Preferred sites for 1a: Uganda, Democratic Republic of Congo, Ethiopia and Guatemala Preferred sites for 1b: Sites in Africa that meet the criteria specified below.

Number of awards: Up to 4 for objective 1a and up to 3 for objective 1b.

DPDM would like to provide a framework that describes the process and procedures for determining whether interruption of transmission of onchocerciasis has occurred and MDA can be stopped, for conducting surveillance for the detection of recrudescence of infection after MDA has been stopped, and for certification of onchocerciasis elimination in African foci. Providing this framework will require evaluation of diagnostic tests or other impact measures in different epidemiologic settings in Africa, with particular attention to performance of such measures in areas with co-endemic filarial infections.

Two specific sub-objectives should be addressed:

Objective 1a: Evaluation of the evolution of biomarkers of onchocercal infection (e.g. antibody tests or cytokines) as MDA with ivermectin progresses

· This objective should be addressed through longitudinal studies of changes in biomarkers in areas where MDA has been weak or recently started, except for the site in Guatemala which has already interrupted transmission.

· Priority countries include Uganda (Kitgum/Lamwo), Democratic Republic of Congo (DRC) (Banalia/Tshopo Project in the Orientale Province), Ethiopia (newly identified endemic area near Jimma), and Guatemala (Central Endemic Zone) where DPDM has previously conducted baseline studies.

· Proposal should include the collection of physical exam data, serologic samples and parasitologic samples.

Objective 1b: Evaluation of the performance of diagnostic tools for onchocercal infection in areas that are approaching the interruption of transmission

· This objective should be addressed through cross-sectional studies of the performance of diagnostic tools for onchocerciasis in areas where the onchocerciasis elimination programs are approaching interruption of transmission (e.g at least 10 rounds of MDA with high rates of coverage have been completed) in a variety of age groups.

· The countries and specific sites should be selected based on: a) the documented duration and effectiveness of MDA program implementation; b) the likelihood that the program is near an endpoint; and c) a commitment to operational research by the program and local health officials. Although sites for these studies might be identified in Uganda, Ethiopia or the Democratic Republic of Congo, other countries (e.g. Ghana, Cameroon, and Togo) may provide more suitable sites.

· Sites with co-endemic loiasis or lymphatic filariasis are highly desirable.

· Proposal should include the collection of physical exam data, serologic samples and parasitologic samples

Applicants may submit proposals for work in one or more countries (though for projects in Africa, preference will be given to those who submit proposals for three countries). For objective 1a, the target population is 500 in each site, except for Guatemala where the target population is 150. For objective 1b, the target population is 500 – 1000 people.

Objective 2: Impact of ivermectin MDA for onchocerciasis on co-endemic LF Budget: $200,000 per country Preferred sites: DRC, Ethiopia, Nigeria Awards: up to 3 for this objective

Implementation units (IU) are the administrative areas that countries use to make decisions about implementing MDA. We want to evaluate the prevalence and transmission of LF in an IUs (most likely districts) where all or some of their communities have been treated with ivermectin for the control of onchocerciasis, and where preventive chemotherapy (PCT) for LF (ivermectin and albendazole) has not yet been started. Preferred countries for these evaluations are Ethiopia, Nigeria and DRC. The proposed studies and methodology will vary based on the availability of baseline data for LF (historical data, prevalence of LF (clinical disease) and the progress of programs to control and/or eliminate onchocerciasis (number and frequency of MDAs and program coverage) in the proposed study areas. All methodologies shall follow the published WHO and APOC guidelines for monitoring and evaluation of the programs towards the elimination and control of LF and onchocerciasis. Information on how many people have participated in CDTI for onchocerciasis would need to be obtained either in the form of reported covered or surveyed coverage.

The objectives of this work include:

a. To develop a standardized protocol to evaluate the status of LF in the areas of onchocerciasis and LF overlap.

b. To evaluate the impact of mass drug administration of ivermectin for the control of onchocerciasis on reducing the prevalence and transmission of lymphatic filariasis (LF).

c. In LF implementation units (district), compare prevalence of LF between communities that have received ivermectin MDA with those that have not received it.

d. Preferred sites may be in in DRC, Ethiopia and Nigeria; however, other countries may provide suitable sites with a high likelihood of project success. Up to three awards are anticipated. Funding ceilings will be USD $200,000 per country.

Applicants may submit an application for work on all countries, or by individual country (e.g. sampling of several IU in three countries, or sampling of one IU in DRC only).

Objective 3: Impact indicators for integrated NTD programs, and development of an integrated NTD surveillance platform Budget: USD $ 250,000 per country Preferred sites: Tanzania and Mozambique Awards: up to 2 for this objective Approaches to NTD programs that integrate drug delivery more efficiently may improve the overall health benefits to populations at risk. A key component to any integration work is the use of adequate mechanisms or methods that can measure the progress of the program. The impact and efficacy of program interventions should be based on public health data from solid and robust diagnostic tools. To accomplish this objective, we need to

· Identify partners that can assist in the development and validation of new diagnostic tools and strategies to monitor and evaluate integrated programs for NTDs targeted by preventive chemotherapy strategies endorsed by WHO. The applicant should be able and willing to collaborate as necessary with other organizations involved in NTD program work in the selected study country.

· Identify field settings appropriate for in-depth assessments of the public health benefits of integrated NTD programs; appropriate field settings include sentinel sites with a target population of 1-2,000 people

· Develop a robust protocol to capture longitudinal or cross-sectional impact data, that can lead to the population-based assessments of the public health benefits of integrated NTD programs.

· Identify and validate indicators which will capture the public health impact of integrated NTD programs, including the investigation of new tools that can be used for NTD monitoring, evaluation and surveillance.

Specific country sites were also selected based on a) the duration and effectiveness of MDA program implementation, b) the likelihood that the program is near an endpoint (based on pre-control level of endemicity); and c) a commitment to operational research by the program and local health officials. Applicants may submit an application for work in either or both countries, (e.g. integrated monitoring in both Mozambique and Tanzania, or integrated monitoring in Mozambique only.

Section II. Award Information

Application Types Allowed

New

Funds Available and Anticipated Number of Awards

Total funding available for year-1 period: 1.8 million dollars.

Total funding available for 5-year period: 9 million dollars.

Indirect costs are inclusive of the funds requested and shall not exceed 15% of the research costs. (not applicable for foreign institutions)

Awards issued under this FOA are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

Ceiling for one year : 1.8 million Total project period ceiling – 9 million Specific ceilings per country per project are specifically described under each objective Indirect costs are limited to 15%, and must be included in the total funds requested. ( not eligible for foreign institutions)

HHS/CDC grants policies as described in the HHS Grants Policy Statement (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html) will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information Eligible Applicants

Eligible Organizations

Higher Education Institutions:

· Public/State Controlled Institutions of Higher Education

· Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for CDC support as Public or Private Institutions of Higher Education:

· Hispanic-serving Institutions

· Historically Black Colleges and Universities (HBCUs)

· Tribally Controlled Colleges and Universities (TCCUs)

· Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education Nonprofits (Other than Institutions of Higher Education) Eligible Agencies of the Federal Government

Other

· Foreign Organizations: a Foreign Organization is a public or private organization, whether non-profit or for-profit, located in a country other than the United States (U.S.) and its territories that is subject to the laws of the country in which it is located, irrespective of the citizenship of project staff or place of performance.

· Federally Funded Research and Development Centers (FFRDCs): FFRDCs are operated, managed, and/or administered by a university or consortium of universities, other not-for-profit or nonprofit organization, or an industrial firm, as an autonomous organization or as an identifiable separate operating unit of a parent organization. A FFRDC meets some special long-term research or development need which cannot be met as effectively by an agency’s existing in-house or contractor resources. FFRDC's enable agencies to use private sector resources to accomplish tasks that are integral to the mission and operation of the sponsoring agency. For more information on FFRDCs, go to http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=512ff78311f427c00454772dcf21523a&rgn=div8&view=text&node=48:1.0.1.6.34.0.1.18&idno=48.

2. Foreign Organizations Foreign Organizations are eligible to apply.

Foreign components of U.S. Organizations are eligible to apply.

Foreign (non-US) organizations must follow policies described in the HHS Grants Policy Statement (http://dhhs.gov/asfr/ogapa/grantinformation/hhsgps107.pdf), and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide. International registrants can confirm DUNS by sending an e-mail to ccrhelp@dnb.com , including Company Name, D-U-N-S Number, and Physical Address, and Country. Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: http://www.dlis.dla.mil/Forms/Form_AC135.asp.

Program should indicate if it is permissible to use foreign consultants or collaborators below.

For this announcement, applicants may include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

3. Special Eligibility Requirements:

Eligibility is open to public and nonprofit private institutions and agencies working with host-country investigators or in the countries and/or sites of interest for the NTD objectives described in this FOA.

Applicants are not required to currently or previously have received CDC funding.

4. Responsiveness:

a. If the application does not meet the scope of the FOA it will not be acceptable.

b. Budget limits should be met.

c. Requesting beyond the allowed budget will be unacceptable.

Applicants should specifically address the research objectives outline in the FOA. If an applicant suggests working in sites other than the priority sites mentioned, specific reasons with supporting evidence to justify site selection should be included in the protocol. Applicants who submit proposals for objective 1 should specify what is known about co-endemic filarial infections for any proposed site (whether it is a priority site or not). Applicants who submit proposals for objective 1b must propose site in Africa only.

5. Required Registrations Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: http://www.dlis.dla.mil/Forms/Form_AC135.asp System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, http://www.grants.gov/applicants/org_step2.jsp.

Grants.gov eRA Commons

All applicant organizations must register with Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes. The “one-time” registration process will take three to five days to complete. However, it is best to start the registration process at least two weeks prior to application submission.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization. All registrations must be successfully completed and active before the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

6. Universal Identifier Requirements and Central Contractor Registration All applicant organizations must obtain a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number is a nine-digit number assigned by Dun and Bradstreet Information Services. An AOR should be consulted to determine the appropriate number. If the organization does not have a DUNS number, an AOR should complete the US D&B D-U-N-S Number Request Web Form or contact Dun and Bradstreet by telephone directly at 1-866-705-5711 (toll-free) to obtain one. A DUNS number will be provided immediately by telephone at no charge. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a DUNS number.

Additionally, all applicant organizations must register in the System for Award Management (SAM), the replacement system for the Central Contractor Registration (CCR) database. Organizations must maintain the registration with current information at all times during which it has an application under consideration for funding by CDC and, if an award is made, until a final financial report is submitted or the final payment is received, whichever is later. SAM is the primary registrant database for the Federal government and is the repository into which an entity must provide information required for the conduct of business as a recipient. Additional information about registration procedures may be found at the SAM internet site at https://www.sam.gov/index.html.

If an award is granted, the grantee organization must notify potential sub-recipients that no organization may receive a subaward under the grant unless the organization has provided its DUNS number to the grantee organization.

7. Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for HHS/CDC support.

8. Cost Sharing This FOA does not require cost sharing as defined in the HHS Grants Policy Statement (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html).

9. Number of Applications Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

As defined in the HHS Grants Policy Statement, (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html), applications received in response to the same funding opportunity announcement generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit. HHS/CDC will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Section IV. Application and Submission Information

1. Address to Request Application Package Applicants must download the SF424 (R&R) application package associated with this funding opportunity from www.Grants.gov.

If access to the Internet is not available or if the applicant encounters difficulty accessing the forms on-line, contact the HHS/CDC Procurement and Grants Office Technical Information Management Section (PGO TIMS) staff at (770) 488-2700 or pgotim@cdc.gov for further instructions. Hours: Monday - Friday, 7am – 4:30pm U.S. Eastern Standard Time. CDC Telecommunications for the hearing impaired or disabled is available at: TTY 1-888-232-6348.

Content and Form of Application Submission It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/guide/url_redirect.htm?id=12000), except where instructed in this Funding Opportunity Announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF 424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

In conjunction with the SF424 (R&R) components, CDC grants applicants should also complete and submit additional components titled “PHS398.” Note the PHS398 should include assurances and certifications, additional data required by the agency for a complete application. While these are not identical to the PHS398 application form pages, the PHS398 reference is used to distinguish these additional data requirements from the data collected in the SF424 (R&R) components. A complete application to CDC will include SF424 (R&R) and PHS398 components. These forms can be downloaded and uploaded as Attachment A from the following link: http://www.cdc.gov/od/pgo/funding/grants/foamain.shtm Letter of Intent The only acceptable modifications to this section are those related to the staff contact information. Current policy does not allow any changes to the type of information requested in the Letter of Intent..

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CIO staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Name of the Applicant Descriptive title of proposed research Name, address, and telephone number of the PD(s)/PI(s) Names of other key personnel Participating institutions Number and title of this funding opportunity

The letter of intent should be sent to:

Lata Kumar MPH, MBA Health Scientist CGH Science Office Center for Global Health MS D-69, 1600, Clifton Road Atlanta, GA 30033 lek7@cdc.gov

Required and Optional Components A complete application has many components, both required and optional. The forms package associated with this FOA in Grants.gov includes all applicable components for this FOA, required and optional.

PHS 398 Research Plan Component The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that consists of 16 components. Not all 16 components of the Research Plan apply to all Funding Opportunity Announcements (FOAs). Specifically, some of the following 16 components are for Resubmissions or Revisions only. See Part I, Section 5.5 of the SF 424 (R&R) Application Guide (http://grants.nih.gov/grants/guide/url_redirect.htm?id=12000) for additional information. Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Funding Opportunity Announcement Description). Follow the page limits stated in the SF 424 unless otherwise specified in the FOA.

For each of the proposed objective please complete all the 16 applicable components in the SF 424 and label them appropriately. We suggest labeling each objective with the title and country where work is to be implemented. When an applicant submits proposal for more than one objective, each of the objective would be required to submit all the components of the SF 424 and a separate budget with budget justification for each of the objective.

Research plan page limit is 16 pages for each of the objectives.

As applicable to and specified in the FOA, the application should include the bolded headers in this section and should address activities to be conducted over the course of the entire project, including but not limited to:

1. Introduction to Application (for Resubmission and Revision ONLY) - not applicable for new applications provide a clear description about the purpose of the proposed research and how it addresses the specific requirements of the FOA.

2. Specific Aims – state the problem the proposed research addresses and how it will result in public health impact and improvements in population health.

3. Research Strategy – the research strategy should be organized under 3 headings: Significance, Innovation and Approach. Describe the proposed research plan, including staffing and timeline.

Human Subjects Section

4. Protection of Human Subjects

5. Inclusion of Women and Minorities

6. Targeted/Planned Enrollment Table (for New Application ONLY)

7. Inclusion of Children

Other Research Plan Sections

13. Consortium/Contractual Arrangements

14. Letters of Support

15. Resource Sharing Plan(s)

16. Appendix

All instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Adobe_VerB.pdf) must be followed along with any additional instructions provided in the FOA.

Appendix Do not use the appendix to circumvent page limits. A maximum of 10 PDF documents are allowed in the appendix. Additionally, up to 3 publications may be included that are not publically available. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

· Publications in press: Include only a publication list with a link to the publicly available on-line journal article or the HHS/NIH Pub Med Central (PMC) submission identification number; do not include the entire article.

· Manuscripts accepted for publication, but not yet published: Applicants may submit the entire article electronically as a PDF attachment.

· Manuscripts published, but a publicly available online journal link is not available: Applicants may submit the entire article electronically as a PDF attachment.

· Surveys, questionnaires, data-collection instruments, clinical protocols, and informed-consent documents.

Graphic images of gels, micrographs, etc, provided the image (may be reduced in size) is within the (stated) page limit of Items 2-5 of the Research Plan component. Applicants may not include any images in the Appendix that do not also appear within the Research Plan Please note the following restriction on appendix attachments: The Research Plan Appendix attachments are limited to 10 attachments. Appendices are uploaded as attachments in the HHS/PHS 398 Research Plan form, in field #18, within the electronic application package. An applicant will receive an error message if the number of appendix attachments exceeds 10, which will result in an unsuccessful submission of the application. You may include more than one publication, or other allowable appendix material, within one attachment; however, do not let your attachments exceed 10.

Do not use the Appendix to circumvent the page limitations of the Research Plan component. HHS/CDC will not review an application that does not observe the relevant policies and procedures. Applicants must review specific FOAs for any additional program-specific guidance on Appendix material and other application requirements

Page Limitations All page limitations described in this individual FOA must be followed. For this specific FOA, the Research Strategy component of the Research Plan narrative is limited to 16 pages.

Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files with a maximum of 50 pages for all appendices.

Format for Attachments Designed to maximize system-conducted validations, multiple separate attachments are required for a complete application. When the application is received by the agency, all submitted forms and all separate attachments are combined into a single document that is used by peer reviewers and agency staff. Applicants should ensure that all attachments are uploaded to the system.

CDC requires all text attachments to the Adobe application forms be submitted as PDFs and that all text attachments conform to the agency-specific formatting requirements noted in the SF424 (R&R) Application Guide (Part I, Section 2) (http://grants.nih.gov/grants/guide/url_redirect.htm?id=12000).

Submission Dates and Times Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov (http://www.grants.gov/), the online portal to find and apply for grants across all Federal agencies. The eRA Commons systems retrieve the application from Grants.gov and check the application against CDC business rules. If no errors are found, the application will be assembled in the eRA Commons for viewing by the applicant before moving on for further CDC processing.

If errors are found, the applicant will be notified in the eRA Commons. They must make required changes to the local copy of their application and submit again through Grants.gov. Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Once you can see your application in the Commons, be sure to review it carefully as this is what the reviewer will see. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11123).

Information on the submission process is provided in the SF424 (R&R) Application Guide.

Note: HHS/CDC grant submission procedures do not provide a period of time beyond the grant application due date to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e. error correction window).

The application package is not complete until it has passed the Grants.gov/eRA Commons validation process. This process and email notifications of receipt, validation or rejection may take two (2) business days.

Applicants are strongly encouraged to allocate additional time prior to the submission deadline to submit their applications and to correct errors identified in the validation process. Applicants are encouraged also to check the status of their application submission to determine if the application packages are complete and error-free. Applicants who encounter system errors when submitting their applications must attempt to resolve them by contacting the Grants.gov Contact Center (1-800-518-4726; support@grants.gov). If the system errors cannot be resolved, applicants must contact CDC PGO TIMS at 770-488-2700; pgotim@cdc.gov for guidance at least 3 calendar days before the deadline date.

After submission of your application package, applicants will receive a “submission receipt” email generated by Grants.gov. Grants.gov will then generate a second e-mail message to applicants which will either validate or reject their submitted application package. This validation process may take as long as two (2) business days. A third and final e-mail message is generated once the applicant’s application package has passed validation and the grantor has confirmed receipt of the application.

Unsuccessful Submissions:

If an application submission was unsuccessful, the applicant must:

1. Track his/her submission and verify the submission status (tracking should be done initially regardless of rejection or success).

0. If the status states “rejected,” do #2a or #2b.

1. Check his/her emails from both Grants.gov and eRA Commons for rejection notices.

1. If the deadline has passed, he/she should email the Grant Management Specialist listed in the FOA (pgotim@cdc.gov) explaining why the submission failed.

1. If there is time before the deadline, he/she should correct the problem(s) and resubmit as soon as possible.

Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11142).

Funding Restrictions All HHS/CDC awards are subject to the terms and conditions, cost principles, and other requirements described in the HHS Grants Policy Statement. Pre-award costs may be allowable as an expanded authority, but only if authorized by CDC.

Restrictions, which must be taken into account while writing the budget, are as follows:

· Recipients may only expend funds for reasonable program purposes, including personnel, travel, supplies, and services, such as contractual.

· The direct and primary recipient in a cooperative agreement program must perform a substantial role in carrying out project objectives and not merely serve as a conduit for an award to another party or provider who is ineligible.

· Reimbursement of pre-award costs is not allowed.

· 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.

· 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.

· Foreign grantees are subject to audit requirements specified in 45 CFR 74.26(d). A non-Federal audit is required, if during the grantees fiscal year, the grantee expended a total of $500,000.00 or more under one or more HHS awards (as a direct grantee and/or as a sub-grantee). The grantee 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 case where the grantee receives awards under only one HHS program; or, if awards are received under multiple HHS programs, a financial related audit of all HHS awards in accordance with Government Auditing Standards; or (2) An audit that meets the requirements contained in OMB Circular A-133.

· A fiscal Grantee 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.

· If research involves human subjects, funds will be restricted until a Federal Wide Assurance (FWA) and Institutional Review Board Approvals (IRB) are in place.

· Projects, if directed by CDC staff and involve the collection of information from 10 or more individuals, and are funded by a grant/cooperative agreement, will be subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act.

Other Submission Requirements and Information

Application Submission Applications must be submitted electronically following the instructions described in…