gh-13-006 haiti final amend i 3 .11.13.doc

Amendment I (03/11/2013)

1. Page 3, 5 – change of application deadline to March 25, 2013 Table of Contents

Part 1. Overview Information Key Dates

Required Application Instructions

Executive Summary…………………………………………………………………………..4

Part 2. Full Text Section I. Funding Opportunity Announcement 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

Funding Opportunity Announcement Type

New

Key Dates

Publication Date

To receive notification of any changes to RFA-GH-13-006 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 11:59 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).

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 25 pages.

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 the cooperative agreement is to conduct assessments and surveys to support critical disease control activities. A key tenet of these activities is that MSPP will work to build capacity to conduct, interpret, disseminate, and respond to assessments, surveys and other evaluations.

· Mechanism of Support: Cooperative Agreement

· Funds Available and Anticipated Number of Awards. The total level for funding for this award is $5,000,000.00. 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.

· Budget and Project Period. The estimated total funding for the first year (12 month budget) is $500,000.00 and the estimated total funding for the entire project period is $5,000,000.00. The project period will run from 06/01/2013 to 05/31/2018.

· Application Research Strategy Length: 25 pages

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

· Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. NOTE: CDC does not make awards to individuals directly. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply.

· Number of PDs/PIs: One PI per application

· Number of Applications. Eligible applicant institutions may submit more than one application, provided that each application is scientifically distinct.

· Application Type. Identify and state the type of application being solicited and any additional instructions/requirements. See question #15 on FOA Checklist for definitions of applications types.

· Special Date(s). LOI date: Feb 15, 2013; Receipt date: March 25, 2013; Review date: May 2013; Award date: Sep 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. 2421], “317 [42 U.S.C. 247b (k)(1),(2)], as amended as well as under Public Law 108-25 (the United States Leadership Against HIV/AIDS, Tuberculosis and Malaria At of 2003) [22 U.S.C. 7601, et seq.] and Public Law 110-293 (the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis and Malaria Reauthorization Act of 2008)

1. Background and Purpose Background

Haiti suffers from a broad range of health threats. Rates of HIV are the highest outside of Africa; access to safe water and appropriate sanitation are poor, and immunization rates are low. Historically, Haiti has had poor health outcomes with infant mortality at 57/1,000 live births, maternal mortality of 630/100,000 and life expectancy at birth only 54.4 years. On January 12, 2010, Haiti was struck by a powerful earthquake, resulting in nearly 300,000 deaths, and badly damaging an already fragile public health infrastructure.

Substantial resources have been committed from within and outside Haiti to mount an intensified response to these health threats. To date the US Government has provided broad support to the Ministry of Health (Ministère de la Santé Publique et de la Population MSPP) efforts to re-establish infrastructure, provide health care services and implement priority public health activities.

Specific public health challenges at this time include infectious diseases (HIV, tuberculosis, cholera and other food/water borne diseases, vaccine preventable disease, vector borne diseases such as rabies, lymphatic filariasis, dengue fever, and malaria, respiratory pathogens, and fungal infections), obstetrical complications, injuries, and other non-communicable diseases. MSPP, in collaboration with other government programs and local partners and with support from multilateral and bilateral organizations, is implementing a wide range of prevention and treatment programs.

Purpose

The global response to reconstruction efforts and the cholera epidemic is the largest public health commitment made in Haiti to date. It offers a unique opportunity to address research priority questions, using large scale public health evaluation programs. The purpose of the program is to conduct assessments and surveys to support critical disease control activities. A key tenet of these activities is that MSPP will work to build capacity to conduct, interpret, disseminate, and respond to assessments, surveys and other evaluations.

Priorities

Priority interventions for this cooperative agreement will be those that have the greatest capacity to improve the impact of the public health response in Haiti. Priority may be determined based on factors such as the morbidity and mortality attributable to a specific health threat, the availability of/potential for effective interventions, and the anticipated long term impact of an intervention. Projects developed for this Research Cooperative Agreement should include research and evaluations addressing public health priorities in Haiti.

Possible project proposals are not limited to the examples provided below (which are in no specific order) as long as they are of public health importance to Haiti, have the potential to reduce burden of disease and recommendations derived from the studies will result in the implementation of control and prevention activities. It is not expected that the applicant respond to all of the illustrative project proposals listed below, rather concentrate on three to four proposals that aligned with the health priorities in country and the capacity of the applicant to support their execution.

A. HIV and its complications, and other sexually transmitted infections. Illustrative activities include:

a. Surveys of HIV incidence, prevalence, risk factors in general populations and in specific risk populations relevant in Haiti such as mobile populations, commercial sex workers, persons who inject drugs and men who have sex with men.

b. Evaluations of the effectiveness of interventions to prevent HIV, including evaluations of the impact of efforts to expand access to HIV treatment.

c. Evaluations of the effectiveness of interventions to identify persons with HIV, link them to care services.

d. Evaluations of the accuracy of data describing HIV treatment program implementation.

e. Evaluations of the effectiveness of interventions designed to retain persons in care and ensure timely initiation of, and adherence to treatments including antiretroviral drugs.

f. Evaluations of the prevalence of opportunistic infections and other complications of HIV. Evaluations of the effectiveness of implementation strategies to identify, prevent, and treat these infections.

g. Surveys of prevalence of syphilis and other sexually transmitted infections, evaluations of the performance of new rapid tests for syphilis, evaluations of interventions to prevent and treatment STIs.

h. Survey of prevalence of Herpes Simples Virus among pregnant women in Haiti.

B. Tuberculosis. Illustrative activities include:

a. Evaluations of the prevalence of tuberculosis or prevalence of drug-resistant tuberculosis in the general population or in specific at-risk populations such as persons living in densely-populated urban settings (camps for internally displaced populations, urban slums, and prisons) or persons with HIV.

b. Evaluations of the effectiveness of strategies to identify persons with tuberculosis disease or tuberculosis infection, including evaluations of new technologies such as GeneXpert or interferon gamma release assays.

c. Evaluations of the effectiveness of strategies to prevent and treat tuberculosis.

C. Cholera and other causes of diarrhea illness/other food- and water-borne diseases. Illustrative activities include:

a. Surveys of disease prevalence, diarrhea etiology, mortality, risk factors for mortality, and knowledge, attitudes and practices related to prevention and treatment of diarrhea and other food- and water-borne disease.

b. Evaluation of key prevention strategies related to improving the safety of drinking water, and sanitation (“WASH activities)—for example evaluation of knowledge, attitudes and practices related to point-of-use or point-of purchase chlorination strategies, and evaluations of the acceptability and effectiveness of implementation strategies, as measured by disease prevalence and or residual chorine/water safety measures.

c. Evaluation of other prevention strategies such as immunization and interventions intended to reduce risk behaviors.

d. Evaluations of the effectiveness of strategies to diagnose and reduce morbidity and mortality of diarrhea, including interventions related to community strategies for rehydration, and approaches to ensuring availability of appropriate treatment.

D. Respiratory infections and other vaccine preventable diseases. Illustrative activities include:

a. Sero surveys, coverage surveys, and other efforts to assess rates of vaccination and levels of protective immunity against various pathogens.

b. Assessments of the acceptability of vaccination and other factors associated with receipt of immunizations, and the impact of integration of immunization efforts and other health efforts on overall health outcomes.

c. Assessments of efficacy and effectiveness of immunizations.

d. Assessments of interventions to diagnose, prevent, and treat respiratory disease and other vaccine preventable diseases.

E. Vector-borne diseases including dengue fever, malaria, lymphatic filariasis, and rabies. Illustrative activities include:

a. Assessments of disease and vector prevalence, including assessments of drug resistance or pesticide resistance

b. Evaluations of risk factors for disease burden.

c. Evaluations of interventions related to diagnosis, prevention and treatment and communication campaigns of these diseases.

d. Assessments of knowledge, attitudes and practices related to these infections.

e. Participation and evaluation of pilot rabies vaccination projects.

f. Strengthen and evaluate malaria surveillance through the implementation of effective malaria diagnostic practices and case reporting at sentinel sites.

F. Non-communicable and chronic disease threats including Environmental Health Issues, Chronic Diseases, Bio-safety, and Injury Control and Prevention. Illustrative activities include:

a. Surveys of prevalence of chronic or non-communicable health conditions in general or specific at-risk populations.

b. Assessments of risk factors for chronic or non-communicable health conditions

c. Evaluation of interventions meant to diagnose, prevent ameliorate the burden of, or treat chronic or non-communicable health conditions.

d. Assessment of the economic impact of chronic and non-communicable health conditions.

G. Maternal morbidity, mortality and reproductive health. Illustrative activities include:

a. Assessments of key contributors to maternal mortality, surveillance for these key causes of maternal mortality.

b. Survey of knowledge, attitude and practices related to breastfeeding, complementary feeding, nutrition, reproductive health, family planning and WASH behaviors of enrolled pregnant women attending antenatal clinics.

c. Assessments of risk factors for maternal mortality

d. Evaluations of interventions to reduce the risks of maternal mortality.

H. Pediatric morbidity and mortality

a. Assessments of key contributors to pediatric mortality, surveillance for these key causes of pediatric mortality.

b. Evaluations of the effectiveness of prevention of mother to child transmission programs through assessment of infection rates in HIV-exposed infants.

c. Assessments of risk factors for pediatric mortality

d. Evaluations of interventions to reduce the risks of pediatric mortality.

I. Nutrition, under nutrition, and malnutrition. Illustrative activities include:

a. Surveys of nutritional status in at risk groups, including children, pregnant women attending antenatal clinics, persons with HIV etc. at baseline and following implementation of interventions.

b. Assessment of interventions and survey of knowledge, attitude and practices related to breastfeeding, complementary feeding, nutrition, reproductive health, family planning and WASH behaviors of enrolled pregnant women attending antenatal clinics

c. Follow-up surveys of nutritional status of enrolled mothers postnatal, 6 and 12 months postnatal and then yearly up to 5 years

d. Nutritional status assessment of children; at birth and monthly up to 2 years and then yearly up to 5 years. At birth, a low birth weight of less than 2,500 g is a good marker of the mother's weight gain and the fetus' development during pregnancy

e. Qualitative survey to examine factors influencing changes in knowledge, attitude and practices related to breastfeeding, complementary feeding, family planning and WASH behaviors of enrolled women

f. Evaluation of income-generating activities

J. Integrated research and evaluations related to the above priorities or other key health threats in Haiti. Illustrative activities include:

a. Population based or household based surveillance for various health threats. Where needed, this could include population enumerations.

b. Evaluations of the acceptability, uptake, and effectiveness of interventions meant to address multiple disease threats, including for example evaluation of the effectiveness of providing packages of services in community or clinical settings.

c. Assessment of the effectiveness, capacity of health systems including the acceptability and accessibility of health services, quality of health services, and capacity to implement and oversee key public health response efforts.

d. Incorporate the results of research into operational health promotion, disease prevention and control programs in Haiti and ensure the sharing of expertise and research findings with other nations, non-governmental agencies and academic institutions

Applicant may propose a variety of projects that address these priorities, but should be limited to three or four project proposals. Within each project, applicant must submit separate Research Plans and Budgets. While priorities should be in line with international and CDC priorities as outlined above, national and community priorities should also drive the choice of projects. Proposed projects must be culturally appropriate, conducted in locally appropriate languages, will need to be approved by appropriate regulatory authorities in Haiti (e.g., the ethical review board), and should incorporate elements such as community advisory boards that demonstrate the efforts to ensure buy-in from involved/affected communities.

Issues related to the sustainability of any evaluated interventions should also be considered; where appropriate, this should involve collection of cost data and conduct of analyses of cost effectiveness /other economic analyses.

Public Health Impact

Evaluation is critical to the success of this response. Interventions need to be informed by data on background rates of disease, risk factors, and the effectiveness and impact of interventions. CDC has a number of funding agreements to support public health efforts in Haiti, but these are chiefly focused on health services implementation. This funding announcement is focused on assessments of health and health services that will assist MSPP in their planning and implementation of effective public health programs and interventions.

2. Approach Objectives/Outcomes – This project is to support Haiti’s Ministry of Health (Ministère de la Santé Publique et de la Population MSPP) and to establish its lead role in the post-earthquake and cholera response activities by providing critical technical assistance for the implementation of surveillance surveys for public health decision making. This FOA will also allow technical assistance and research activities and evaluations to respond to other conditions and diseases that may occur during the project period.

Target population -Haitians Collaboration/Partnerships –MSPP is the single award for this g cooperative agreement and we would support collaboration with other partners, but it is not a requirement.

Evaluation/Performance measurement – The awardee’s performance will be evaluated on their ability to improve the impact of the public health response priorities in Haiti. Depending on the specific project proposal, the awardee performance will be be determined based on factors such as the morbidity and mortality attributable to a specific health threat, the availability of/potential for effective interventions, and the anticipated long term impact of an intervention. The awardee will be measured by their ability to perform research and evaluations addressing public health priorities in Haiti, the research has the potential to reduce burden of disease, and recommendations derived from the studies will result in the implementation of control and prevention activities.

Transition plan – The research is to improve health outcomes for the people of Haiti, so one would expect significant findings to help shape intervention choices and potentially, public health policy. Throughout the five years of the award this cooperative agreement will provide the awardee with technical assistance and resources that will enhance technical abilities as lead in critical public health activities in Haiti. As their capacity to conduct their own studies increases, Global Fund and others will consider expanding specific support directly to the awardee.

Section II. Award Information

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New

Funds Available and Anticipated Number of Awards

Approximate Fiscal Year Funding: $500,000.00

Approximate Total Project Period Funding: $5,000,000.00 Anticipated Number of Awards: One

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

Ceiling of Individual Award Range: $1,000,000.00

Throughout the project period, CDC's commitment to continuation of awards will depend on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and CDC’s determination that continued funding is in the best interest of the Federal government.

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.

1. Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Eligibility for this program is limited to the Ministry of Public Health Haiti - Ministère de la Santé Publique et de la Population (MSPP). No other applications are solicited. MSPP is the most appropriate and qualified agency to conduct the activities specified under this cooperative agreement. The MSPP is the government agency responsible for safeguarding public health in the country and an established CDC partner in Haiti. The MSPP has a presence in the 10 geographic departments of the country and capable of supporting research and surveillance activities on a nationalized basis. The MSPP has the statutory authority to develop, implement, oversee and assure compliance to regulations related to research and quality assurance/quality controls in the country.

2. Foreign Organizations Foreign Organizations are eligible to apply.

Foreign components of U.S. Organizations are/are not eligible to apply. N/A

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:The applicant must have the authority, madate, and ability to oversee and influence public health in Haiti. They must be able to obtain, analyze and dissiminate a variety of information on multiple heallth issues. The eligible applicant will have scientific and technical expertise, the infrastructure capacity, and authority to address public health issues in Haiti. Finally, it is cruicial that the eligible applicant have in place existing central, departmental, and municipal based structures required to immediately engage in priority public health activities.

Justification for Less than Maximum Competition:

The Ministry of Public Health Haiti - Ministère de la Santé Publique et de la Population (MSPP) is the most appropriate and qualified partner to conduct the research activities specified under this cooperative agreement for the following reasons:

1. The MSPP is uniquely positioned – in terms of constitutional authority, mandate and ability – to oversee and safeguard public health, and to collect and analyze information and disseminate research reports related to multiple health issues. They have the ability to utilize existing public health networks and other partners to assure the accomplishment of research goals as required in this cooperative agreement.

2. The MSPP is the only organization in Haiti that possesses the requisite scientific and technical expertise and the infrastructure capacity, and who has the primary responsibility within the Haitian government to address public health issues. These combined attributes make them uniquely qualified as the only organization in country capable of effectively conducting the research activities proposed for this cooperative agreement.

3. The MSPP has in place the central, departmental and municipal based structures required to immediately engage in the activities listed in this announcement.

4. The MSPP is the key governmental agency that will enable CDC to execute its health strategy in Haiti. Specifically, CDC will broaden its strong partnership with MSPP to assure the implementation and evaluation of public health research programs that will result in the prevention and control of diseases both communicable and non-communicable in Haiti.

5. CDC currently has a non-research cooperative agreement with MSPP and is in the process of developing a new 5 year agreement which covers activities related to HIV, TB, malaria, maternal health, rabies, nutrition, immunizations, lymphatic filariasis, etc. This new cooperative agreement will give MSPP an opportunity to engage on research topics in priority health areas.

4. Responsiveness: Applicant may propose a variety of projects that address the previously outlined priorities, but should be limited to three or four project proposals. Within each project, applicant must submit separate Research Plans and Budgets. While priorities should be in line with international and CDC priorities as outlined above, national and community priorities should also drive the choice of projects. Proposed projects must be culturally appropriate, conducted in locally appropriate languages, will need to be approved by appropriate regulatory authorities in Haiti (e.g., the ethical review board), and should incorporate elements such as community advisory boards that demonstrate the efforts to ensure buy-in from involved/affected communities. Issues related to the sustainability of any evaluated interventions should also be considered; where appropriate, this should involve collection of cost data and conduct of analyses of cost effectiveness /other economic analyses.

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.

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).

8. 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

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:

Daphne B. Moffett, PhD

Deputy Director – Health Systems Reconstruction Office

Division of Global Disease Detection and Emergency Response – Center for Global Health

Centers for Disease Control and Prevention

1600 Clifton Road, MS A05

Atlanta, GA 30033

Telephone: 404-718-4562 Email: zzc0@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 project please complete all the applicable components in the SF 424 and label them appropriately for each of the project. Please label each of the project with the priority title ( eg. Infectious Diseases, HIV/AIDS, etc ) as listed under the Part II, Section 1.

2. Purpose.

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 to this 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.

4. Inclusion Enrollment Report (Renewal and Revision applications ONLY)- not applicable to this FOA

5. Progress Report Publication List (for Continuation ONLY)- not applicable to this FOA

Human Subjects Section

6. Protection of Human Subjects

7. Inclusion of Women and Minorities

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

9. Inclusion of Children

Other Research Plan Sections

10. Vertebrate Animals

11. Select Agent Research

12. Multiple PD/PI Leadership Plan.

13. Consortium/Contractual Arrangements

14. Letters of Support

15. Resource Sharing Plan(s)

16. Appendix

Follow the page limits in the SF 424 unless otherwise specified in the FOA.

Project Budget 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 the applicant is not requesting funding.

If included under the SF424 application/PHS Form 398– Budget Section, the budget justification will not count toward the Appendix page limit.

Budgets must be consistent with the purpose and must include the following: line item break down and justification for all personnel, i.e., name, position title, annual salary, percentage of time and effort, and amount requested.

The application must be assembled and paginated as one complete document from beginning to end. Begin page numbering with the first PHS 398 face page, followed by a comprehensive Table of Contents for the entire application beginning with the Executive Summary, Administrative Core Plan and continuing through each Project and any Appendices.

The Table of Contents should provide enough detail to readily locate specific sections/information pertinent to the application.

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 ( this may include pre-printed questionnaires or surveys). 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.

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 25 pages.

Supporting materials for the Research Plan narrative included as appendices may not exceed 5 PDF files with a maximum of 15 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; www.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).

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

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

a. 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.

b. 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.

· The applicant may contract with other organizations under this program; however the applicant must perform a substantial portion of the activities (including program management and operations, and delivery of prevention services for which funds are required.)

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

· 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 that involve the collection of information from 10 or more individuals with direct engagement of CDC staff may be subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act PRA. All such information collection projects need to be reviewed by the Center for Global Health PRA Contact for determining if OMB PRA approval is required.

The applicant can obtain guidance for completing a detailed justified budget on the CDC website, at the following Internet address:

http://www.cdc.gov/od/pgo/funding/budgetguide.htm Other Submission Requirements and Information

Application Submission

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11144).

Important reminders:

All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to CDC.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR).