foa gh15 008.pdf

Centers for Disease Control and Prevention

Center for Global Health Extramural Research Program Office

Conducting Operational Research to Identify Numbers and Rates, Determine Needs, and Integrate Services to

Mitigate Morbidity and Mortality Among Internally Displaced Persons Affected by Emergencies

RFA-GH-15-008

Application Due Date: 04/20/2015

Conducting Operational Research to Identify Numbers and Rates, Determine Needs, and Integrate Services to Mitigate Morbidity and Mortality Among Internally Displaced Persons Affected by Emergencies

RFA-GH-15-008

TABLE OF CONTENTS

Part 1. Overview Information

Key Dates Required Application Instructions Executive Summary

Part 2. Full Text

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 Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations Center for Global Health Extramural Research Program Office (CGH ERPO) Center for Global Health (CGH) Funding Opportunity Announcement (FOA) Title Conducting Operational Research to Identify Numbers and Rates, Determine Needs, and Integrate Services to Mitigate Morbidity and Mortality Among Internally Displaced Persons Affected by Emergencies Activity Code U01

Funding Opportunity Announcement Type New Funding Opportunity Announcement Number

RFA-GH-15-008

Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.269 Category of Funding Activity:

Health FOA Purpose This research is needed to determine: first, best methods for determining a) the population size and vulnerabilities, such as mortality rate and b) the specific needs of these IDPs, especially in urban settings, and second, determine best practices for integrating programs across sectors, such as a) gender-based violence and protection or mental health services, b) access to potable water and improved sanitation and impact on nutrition or water-borne diseases, c) combining mental health and primary healthcare services. The programs should be proven to be effective individually so that the synergy of them is what is investigated.

Key Dates Publication Date: To receive notification of any changes to RFA-GH-15-008, 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.

Letter of Intent Due Date: N/A

Application Due Date: 04/20/2015

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).

Scientific Merit Review: 05/01/2015

Secondary Review: 06/01/2015 http://www.grants.gov

Estimated Start Date: 09/01/2015

Expiration Date: 08/31/2020 Due Dates for E.O. 12372: Executive Order 12372 does not apply to this program.

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 12 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

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. This research is needed to determine: first, find best methods for determining a) the population size and vulnerabilities, such as mortality rate and b) the specific needs of these IDPs, especially in urban settings, and second, determine best practices for integrating programs across sectors, such as a) gender-based violence and protection or mental health services, b) access to potable water and improved sanitation and impact on nutrition or water-borne diseases, c) combining mental health and primary healthcare services. The programs should be proven to be effective individually so that the synergy of them is what is investigated.

Mechanism of Support. Cooperative agreement Funds Available and Anticipated Number of Awards. The estimated total funding for the first year (12 month budget period) will be $500,000 and the estimated total funding for the entire project period will be approximately $2,500,000. There will be up to five awards a year.

Awards issued under this FOA are contingent upon availability of funds.

Budget and Project Period. Budget period 09/01/2015 to 08/30/2016; Project period 09-01-2015 to 08-31-2020.

Application Research Strategy Length: The Research Strategy page limit is 12 pages.

Eligible Institutions/Organizations: Foreign entities only, specifically located in any country affected by emergencies, conflict or natural disaster, such as countries in Africa or the Middle East, with at least 5 years of proven experience working with displaced populations. The foreign entity in the affected country may be U.S. based. Section III.

Eligibility Information 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 http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf file://cdc/project/COGH_Office_of_Science_and_Public_Health_Practice/Extramuaral%20Program/PROGRAMS/2015/GH12-008%20ERRB/AM%20FOA/RFA-GH-15-008%20FOA_10-%2021%20verison%20HS%2010212014.docx#_Section_III._Eligibility file://cdc/project/COGH_Office_of_Science_and_Public_Health_Practice/Extramuaral%20Program/PROGRAMS/2015/GH12-008%20ERRB/AM%20FOA/RFA-GH-15-008%20FOA_10-%2021%20verison%20HS%2010212014.docx#_Section_III._Eligibility racial and ethnic groups as well as individuals with disabilities are always encouraged to apply.

Number of PDs/PIs. All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 week s.

PDs/PIs should provide letters of support from the head of their institution as well as curriculum vitas to show previous work in the subject matter/location of work to be conducted.

Number of Applications. Eligible applicant institutions may submit only one application Application Type. New 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 Description

Statutory Authority

Sections 301 and 307 (k) (1) and (k) (2) of the Public Health Service Act (42 U.S.C. 242 and 247 b

(k) (1) and (k) (2)), as amended.

1. Background and Purpose

By the end of 2013, there were over 33 million internally displaced persons (IDPs, UNHCR. Global trends, 2013); persons uprooted from their homes by conflict and/or natural disaster. An ever increasing number of these persons are living in urban settings, with one estimate being half of all IDPs (Jacobsen K. Feinstein International Center, 2008). Although these persons are similar to non-IDP poor, whether urban, peri-urban or rural, IDPs arrive more impoverished, often traumatized, and lack documentation, support networks, and knowledge of their new surroundings compared with non-IDP poor of the host community. Furthermore, IDPs are not afforded the same protection as refugees by United Nations agencies or international law. As a result, who they are and what their basic needs and vulnerabilities, and protection problems are may be different and greater than the poor of the host population (Davies A. & Jacobsen K. Forced Migration Review, 2010).

IDPs are often a hidden population and difficult to identify through the standard methods developed for refugees in closed camp settings.

Furthermore, ability to identify hidden populations, of whom IDPs can be considered one such group, and determine their vulnerabilities, such as mortality rates, and their needs has been broached by partners using many different sampling methods. However, the methods to identify these populations and determine their mortality rates are varied and the methods’ validity for emergency purposes has not been documented. There is currently limited evidence to support one method over another, especially in an emergency setting.

Measuring the overall vulnerabilities or impact of programs during acute humanitarian emergencies requires robust mortality data. Prospective mortality data allow observation of trends and therefore the ability to modify programs while single cross-sectional surveys do not. Mortality data in humanitarian emergencies is particularly constrained by opportunity cost, especially if obtained on a file://cdc/project/COGH_Office_of_Science_and_Public_Health_Practice/Extramuaral%20Program/PROGRAMS/2015/GH12-008%20ERRB/AM%20FOA/RFA-GH-15-008%20FOA_10-%2021%20verison%20HS%2010212014.docx#_Section_IV._Application community basis. Few studies have looked at compared the accuracy, feasibility, usefulness and cost-effectiveness of different methods of community-based mortality surveillance (Caleo GM et al.

Pop Hlth Metrics 2012). More evidence-based research is needed to determine best methods, determine costs both monitory and in terms of human resources, and establish lessons learned prospectively during an acute emergency affecting internally displaced persons (Working Group for Mortality Estimation in Emergencies. Emerg Themes Epi 2007).

For IDPs, tailored programs are desired. However, the programing and treatment initiatives must avoid the perception of favoring IDPs over the host population. Among existing healthcare services, IDPs are rarely integrated into national healthcare strategy or system. If one considers the potential consequences of epidemic disease in the larger community, IDP and host, it is critical to protect the health security of the whole community. However, often healthcare services for IDPs are seen as competing for limited resources that should be invested in the host community. This perception prevents IDPs from enjoying the same rights to those basic health services as the remaining civilian population (UNHCR, 2006http://www.unhcr.org/4c2355229.pdf).

Core reasons for limited access to basic health services among IDPs are financial and legal (Davies A. & Jacobsen K. Forced Migration Review, 2010). IDPs lack of capacity to pay for healthcare service. These poor financial resources of IDP make it often impossible for them to access existing local healthcare services, which heavily depend on private healthcare service when there is a weak public healthcare system. In addition, public healthcare system, often require proof of health and social insurance that IDPs may lack. By law, many nations take responsibility of protecting health among vulnerable populations. However, lack of documentation and identification make it difficult to access those public healthcare systems. IDPs’ specific needs include access to public healthcare, clean water, housing, livelihood, education and legal protection. Therefore, careful evaluation of legal, social and cultural barriers of IDPs should be undertaken in the regional context.

In this context, emergency response aid should facilitate a window of chance for local communities to think or plan differently from the past to allocate their resources with the help from outside. Some issues to consider include impact of internally displacement on the local health system, resilience of the local health system to response to the overlapped health needs of IDPs, improved integration in protection, education and mental health in the community housing IDPS. The importance of evidence on effective programming that tries to integrate across different sectors is ever greater. The evaluation of programs needs to include the consideration of sustainability, including financing;

legal authority; and social and cultural barriers, which can be critical to advise health professionals and policy makers to make a salient decision. Guidance can be found in the Framework for program evaluation in public health: A checklist of steps and standards (available at www.wmich.edu/evalctr /checklists/evaluation-checklists). Furthermore, in light of today’s limited resources, great needs, and competing interests, it is important to design programing and treatment for IDPs that are not siloed but integrated across sectors and populations.

Positive effects have been reported when safe drinking water and improved sanitation and hygiene is integrated into other programs, such as maternal–child health, nutrition, diarrhea and respiratory diseases control, control of other neglected tropical disease, and public health in non-emergency settings (Platt. WASH Advocates, January 23, 2013). USAID has endorsed the integration of WASH into nutrition programming in their Bureau for Global Health five-year project (http://www .washplus.org/sites/default/files/wash_nutrition2013.pdf ). However for improved WASH effects on nutritional status, one systematic review found that few studies had provided information on intervention adherence, attrition or cost nor had few used high quality methods or been of sufficient duration (Dangour et al. The Cochrane Library, 2013).

http://www.wmich.edu/evalctr/checklists/evaluation-checklists http://www.wmich.edu/evalctr/checklists/evaluation-checklists http://www.washplus.org/sites/default/files/wash_nutrition2013.pdf http://www.washplus.org/sites/default/files/wash_nutrition2013.pdf

Newborn survival is intricately linked to maternal survival. A newborn is 3-10 times more likely to die within its first two years of life without its mother. CDC’s current programmatic approach places emphasis on interventions to enhance the survival of the mother and newborn. However, there is limited data on the effectiveness of neonatal health interventions in humanitarian settings.

Humanitarian researchers have called attention to the need to advance neonatal healthcare programming (Spiegel et al. Lancet 2010; Salama et al. Lancet 2004; Moss et al. WHO Bulletin 2006).Additionally, preventing a mother’s death can be considered a very effective intervention for the assuring the well-being and survival of a child and is critical for achieving child survival goals.

There is a need to adopt a more comprehensive approach to neonatal and child survival by improving pregnancy outcomes and investment in interventions to improve pregnancy outcomes that are likely to improve neonatal and child survival.

Proper hand washing is critical both in the delivery room and the nursery. The rationale for hand washing /hand rubbing is reduction of transient micro flora. Besides maternal-child transmission, environmental organisms in the delivery room and the nursery may place a role in neonatal sepsis cases (Zaidi AKM, et al., Ped Infect Dis J Jan 2009); the organisms in the environment of the delivery room and the nursery may be transmitted to the neonates due to breaches in the infection control precautions. A re-emphasis on improving pregnancy outcomes is thus critical to reduce maternal and neonatal mortality and the role hygiene plays needs further investigation.

Therefore research is needed for how can we best integrate specific sectors, improved water, sanitation and hygiene (WASH); food security and nutrition; and different aspects of health action, to increase the individual IDP and public health impact given the resource constraints of today. The programs should be proven to be effective individually so that the synergy of them is what is investigated.

Although ERRB continues to work to address the medical needs of displaced populations, mental health needs often go unaddressed (Prince M, et al.,The Lancet 2007). Displaced populations worldwide are at particularly high risk for developing mental health problems. Surveys of displaced populations have demonstrated prevalence of posttraumatic stress disorder symptoms (PTSD) from 5% to almost 40% and of depressive symptoms from 30% to almost 70%. (Mollica RF, et al., The Lancet 2004;Lopes Cardozo B, et al., JAMA, 2004;Lopes Cardozo, et al., JAMA, 2000; Husain F,et al., JAMA 2011; Mollica RF,et al., JAMA. 1993).

The World Health Organization (WHO) Mental Health Gap Action Programme (mhGAP) aims at scaling up services for mental, neurological and substance use disorders; they estimate that as many as 75% of people with those disorders remain under-treated (WHO. Mental Health GAP Action Programme (mhGAP) 2002; WHO. mhGAP 2012, http://www.who.int/mental_health/mhgap/mhGAP _forum_2012.pdf?ua=1). The approach to use primary health care providers to deliver basic mental health services could be used among displaced populations where there is often a lack of mental health providers and services but where basic medical needs are provided. WHO has proposed the mhGAP as part of the humanitarian response, to provide a relatively low-cost sustainable answer to the mental health needs of extremely vulnerable populations. One example is among the 10.8 million Syrians in need of humanitarian assistance, roughly a third of the population, who are displaced by the violent civil conflict (UN, June 2014). Mental health screening instruments for use by primary care providers and training manuals for primary care providers to address mental health issues during humanitarian response have been developed by the International Medical Corps (IMC) (World Health Organization, 2010. http://www.who.int/mental_health/publications/mhGAP_intervent ion_guide/en/;http://www.youtube.com/playlist?list=PL8EFD1932C0CF4C96&;feature=plcp). Research is needed to evaluate the effectiveness and impact of integration of basic mental health services into http://www.who.int/mental_health/mhgap/mhGAP_forum_2012.pdf?ua=1 http://www.who.int/mental_health/mhgap/mhGAP_forum_2012.pdf?ua=1 http://www.who.int/mental_health/publications/mhGAP_intervention_guide/en/;http:/www.youtube.com/playlist?list=PL8EFD1932C0CF4C96&feature=plcp http://www.who.int/mental_health/publications/mhGAP_intervention_guide/en/;http:/www.youtube.com/playlist?list=PL8EFD1932C0CF4C96&feature=plcp primary health care in displaced populations.

As noted, IDPs suffer from violent conflict and are victims to gender-based violence. However, recent global review of gender-based violence (GBV) prevention and response efforts in humanitarian settings reveals a dearth of evidence-based programs in this arena as well (Asgary, R.

et al, International Health, 2013). As part of their mandate to provide guidance on prevention and response to GBV in emergencies, the Gender-based Violence Area of Responsibility (GBV AoR, www.gbvaor.net ) has revised and updated the Inter-agency Standing Committee (IASC) Guidelines on GBV Programming in Emergency Settings which will be finalized in early 2015. The overall goal of the Guidelines is to support humanitarian stakeholders across all sectors to fulfill their responsibility to protect all those affected by crises. The rollout of these guidelines provides an opportunity to build capacity and evaluate the effectiveness of integration of GBV efforts across all humanitarian sectors.

Priority areas to consider for research and some of the topics to address (only one priority focus area and research topic per application) could include, but not be limited to:

1. Identify sampling methods for surveys of displaced persons living in urban settings,

a. Assess current methods and possible future sampling methods of urban displaced persons to determine population size

2. Develop a feasible and useful method to collect prospective mortality data among displaced persons early on in acute emergencies

3. Improve growth and reduce morbidity through integrating WASH and nutrition interventions

a. Impact of integrating WASH programming on nutritional status of acutely malnourished children in CMAM program

4. Improve health and reduce morbidity through integrating WASH and healthcare activities

a. Impact on diarrhea or respiratory diseases control with providing WASH measures as a part of primary healthcare delivery

5. Reduce maternal and neo-natal mortality with integrated hygiene interventions

a. Impact of ensuring hand washing facilities and promoting use of hand disinfectant on maternal and neonatal outcomes

b. Impact of the Inter-agency Newborn Health Field Package on neonatal mortality and health

6. Reduce morbidity associated with mental health problems among displaced persons

a. Effectiveness and impact of the integration of basic mental health services into primary health

7. Improve implementation and integration of gender-based violence (GBV) programs in other sectors

a. Effectiveness and impact of integration of psychological first aid training for health sector personnel as part of capacity building for GBV response

b. Effectiveness and impact of the integration of the GBV Guidelines into humanitarian sectors

Healthy People 2020 and other National Strategic Priorities

Public Health Impact

Relevant Work

1) List at least 5 countries where you currently work: the area of country-camp, urban, peri-urban; size and characteristics of displaced populations; and length of time in each country by months and years (must have at least 5 years of experience in the field of emergency response).

2) Include what sectors (environmental health, nutrition, and health such as infectious diseases, reproductive health, mental health) this work involves and demonstrate that work by existing letter, agreements, website, etc.

3) Provide letter of intent or other form of communication between government and/or United Nations agency where you are working in listed countries.

2. Approach

Objectives/Outcomes

Objectives/Outcomes – Any one applicant should address integration across or within sectors of WASH, food security/nutrition, or health action.The outcomes are to determine the best practices for integrating programs across sectors picking programs already proven to be effective individually and determining the synergetic effect of integration. An applicant may also address best methods for determining size and vulnerabilities of displaced population(s) or for determining their needs.

Target Population

The population is IDPs in a variety of locations, urban, peri-urban or rural

Collaboration/Partnerships

Given that this is a cooperative agreement, substantial involvement from CDC is expected from both scientific or program staff to assist, guide, coordinate, or participate in project activities as indicated in this FOA under Section VI 2. Additional Policy Requirements/ Cooperative agreement terms and condi tions. Additionally, partnership involves collaboration with local governments and humanitarian organizations in the methods to implement scientific measurement of needs and outcomes;

operational research related to program implementation, integration, and evaluation. Letters of support from partnership collaborations are requested.

Evaluation/Performance Measurement

Process and outcome evaluation of integrated programs will be needed following guidance found in the Framework for program evaluation in public health: A checklist of steps and standards (available at www.wmich.edu/evalctr/checklists/evaluation-checklists).

Translation Plan file://cdc/project/COGH_Office_of_Science_and_Public_Health_Practice/Extramuaral%20Program/PROGRAMS/2015/GH12-008%20ERRB/AM%20FOA/RFA-GH-15-008%20FOA_10-%2021%20verison%20HS%2010212014.docx#_CDC_Administrative_Requirements file://cdc/project/COGH_Office_of_Science_and_Public_Health_Practice/Extramuaral%20Program/PROGRAMS/2015/GH12-008%20ERRB/AM%20FOA/RFA-GH-15-008%20FOA_10-%2021%20verison%20HS%2010212014.docx#_CDC_Administrative_Requirements

Awardee may participate in conference with CDC project official(s) and research team; and attend in-person or conference call meetings with CDC co-investigators.

• CDC will provide technical assistance in the analysis and dissemination of information, data and findings from the project, facilitating dissemination of results.

• In collaboration with CDC, awardee may present at national or international meetings and publish research findings in peer-reviewed scientific journals.

Section II. Award Information

Funding Instrument Type: 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 - An application that is submitted for funding for the first time. Includes multiple submission attempts within the same round.

Estimated Total Funding: $2,500,000

The estimated total funding for the first year (12 month budget period) will be $500,000 and the estimated total funding for the entire project period will be approximately $2,500,000. Awards issued under this FOA are contingent on the availability of funds. To include Direct and Indirect Costs

Anticipated Number of Awards: 5

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

Award Ceiling: $500,000 Per Budget Period Award Floor: $150,000 Per Budget Period Total Project Period Length: 5 year(s) 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://www.hhs.gov/ asfr/ogapa/aboutog/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: Public and State controlled institutions of higher education

Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Others (see text field entitled "Additional Information on Eligibility" for http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf

Others (see text field entitled "Additional Information on Eligibility" for clarification)

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. Delete when Foreign Organizations are not allowed to apply

2. Foreign Organizations Foreign Organizations are eligible to apply.

Foreign (non-US) organizations must follow policies described in the HHS Grants Policy Statement (http ://www.hhs.gov/asfr/ogapa/aboutog/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: https ://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf .

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

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

3. Special Eligibility Requirements

Foreign Organizations are eligible to apply.

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

1. List at least 5 countries where you currently work: the area of country-camp, urban, peri-urban; size and characteristics of displaced populations; and length of time in each country by months and years (must have at least 5 years of experience in the field of emergencies).

2. Include what sectors (environmental health, nutrition, and health such as infectious diseases, reproductive health, mental health) this work involves and demonstrate that work by existing letter, agreements, website, etc.

3. Provide letter of intent or other form of communication between government and/or United Nations agency where you are working in listed countries.

•This agreement builds on work that CDC/CGH/DGHP/ERRB has been developing. Over that time, successful ERRB technical partners with proven experience in their respective fields have been almost exclusively non-governmental organizations and universities with a presence in at least 5 (five) countries. It is important to maintain this consistency, and ensure that the successful recipient has the related capacity and experience to continue the effort.

• Successful recipient must have a demonstrable record and existing staff, both domestically and internationally, trained in public health and science related to environmental health, nutrition, infectious diseases, mental health, and/or reproductive health. CDC/CGH/DGHP/ERRB has worked with numerous organizations in humanitarian emergencies and natural disasters, and considers that only those http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf mailto:ccrhelp@dnb.com https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf non-governmental organizations, universities, colleges or research institutions with a proven track record of at least 5 years on-the-ground experience would be qualified to complete the required tasks.

• Successful recipient must have a significant global presence, allowing it to coordinate with local governments, and non-governmental and international organizations in the implementation of operational research related to program implementation and evaluation, scientific measurement of needs and outcomes for emergency-affected, conflicts and natural disasters, populations.

• The limited duration of this grant requires that a successful vendor begin work immediately upon receipt of the award. CDC/CGH/DGHP/ERRB considers that this can only be accomplished by an established non-governmental organization, university, college, or research institution with experience operating in humanitarian emergencies, conflicts and natural disasters.

• Successful recipient must have an intimate knowledge of the non-governmental and international organizations related to program implementation and evaluation, scientific measurement of needs and outcomes for emergency-affected, conflicts and natural disasters, populations. CDC/CGH/DGHP/ERRB believes that the most experienced potential recipients are those which have established themselves as active participants in the international non-governmental community as providers of support to individuals, families, and communities affected by conflict and natural disasters. This essential connection will provide the successful grant recipient the resources and contacts to implement the program.

4. Justification for Less than Maximum Competition

5. Responsiveness

Applicant should meet criteria in eligibility and should stay within the scope of the FOA.

6. 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: https://eportal.nspa.nato. int/AC135Public/Docs/US%20Instructions%2 0for%20NSPA%20NCAGE.pdf System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, https://www.sam.gov/portal/SAM/#1.

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.

7. Universal Identifier Requirements and System for Award Management (SAM) https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://www.sam.gov/portal/SAM/%231 http://www.Grants.gov https://public.era.nih.gov/commons/public/login.do?TYPE=33554433&REALMOID=06-1edb031f-46c7-44b3-b803-60b537de74d2&GUID=&SMAUTHREASON=0&METHOD=GET&SMAGENTNAME=-SM-938PYmoLVb4VrDeXo04LZUDVDvc%2b3899ByInEAjuSUvWNIGfB2zRpWiCivYGCogG&TARGET=-SM-http%3a%2f%2fpublic%2eera%2enih%2egov%2fcommons http://www.Grants.gov

7. Universal Identifier Requirements and System for Award Management (SAM) 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).

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.

8. 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.

9. Cost Sharing This FOA does not require cost sharing as defined in the HHS Grants Policy Statement (http:// www.hhs.gov/ asfr/ ogapa/ aboutog/ hhsgps107.pdf).

10. Number of Applications As defined in the HHS Grants Policy Statement, (http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf), 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.

Applicant organizations may submit only one application per priority area.

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.

2. Content and Form of Application Submission http://fedgov.dnb.com/webform https://www.sam.gov/index.html http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.Grants.gov mailto:pgotim@cdc.gov

2. 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/funding/ 424/SF424_RR_Guide_General_VerC.pdf), 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.

3. Letter of Intent Due Date for Letter of Intent:

N/A

4. 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.

5. 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/funding/424/SF424_RR_Guide_General_VerC.pdf) 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. 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) - 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.

4. Inclusion Enrollment Report (Renewal and Revision applications ONLY)

5. Progress Report Publication List (for Continuation ONLY)

Human Subjects Section

6. Protection of Human Subjects

7. Inclusion of Women and Minorities

8. Targeted/Planned Enrollment Table (for New Application ONLY) http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf

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

Component 4 (Inclusion Enrollment Report) applies only to Renewal and Revision applications for clinical research. Clinical research is that which is conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies). Follow the page limits in the SF 424 unless otherwise specified in the FOA.

All instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf) must be followed along with any additional instructions provided in the FOA.

6. 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.

7. 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 12 pages. Supporting materials for the Research Plan narrative included as appendices may not exceed 5 PDF files with a maximum of 40 pages for all appendices.

8. 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/funding/424/ SF424_RR_Guide_General_VerC.pdf).

9. Submission Dates & 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 http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf http://grants.nih.gov/grants/guide/url_redirect.htm?id=11128 http://www.grants.gov/

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 http://grants.nih.gov/grants/guide/url_redirect.htm?id=11123 mailto:support@grants.gov mailto:www.pgotim@cdc.gov

(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.

Due Date for Applications: 04/20/2015

Electronically submitted applications must be submitted no later than 5:00 p.m., ET, on the listed application due date.

10. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review (http:// www. whitehouse.gov/ omb/ grants_spoc).

11. 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.