Amendment (6/17/14)

Page 2: The purpose of this amendment is to cancel the conference call for potential applicants.

Page 8: Update the funding ceiling for Project C: Global Health Security for Project C: Global Health Security: The new funding amount has been increased to $150,000 to $1,500,000.

Part I. Overview Information

Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the “Send Me Change Notifications Emails” link to ensure they receive notifications of any changes to FOA# CGH-GH14-1418. Applicants also must provide an e-mail address to www.grants.gov to receive notifications of changes.

A. Federal Agency Name

Centers for Disease Control and Prevention (CDC)

B. Funding Opportunity Title

Protecting and Improving Public Health Globally: Building and Strengthening Public Health Impact, Systems, Capacity and Security

C. Announcement Type: New—Type 1

This announcement is only for non-research international activities supported by CDC. If research is proposed, the application will not be considered. Research for this purpose is defined at:

http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf.

D. Agency Funding Opportunity Number

CGH-GH14-1418

E. Catalog of Federal Domestic Assistance Number

93.318

Protecting and Improving Health Globally Page 1

F. Dates

1. Letter of Intent Deadline Date: N/A

2. Application Deadline Date: July 7,2014, 11:59 p.m. U.S. Eastern Standard Time, on www.grants.gov

G. Executive Summary

1. Summary paragraph:

This FOA supports the implementation of programs and activities that focus on protecting and improving health globally through regional, national, and local partnerships. Its purpose is to develop, implement and strengthen public health surveillance, health information (including monitoring and evaluation), and public health laboratory systems. It is intended to support workforce development and build capacities to prevent, detect, respond, and control infectious and non-communicable diseases, injuries, and public health emergencies. Projects considered for this FOA should consider building upon existing public health infrastructure focusing on country priorities that are of mutual interest in order to strengthen regional and national partnerships, public health capacity, leadership, strategic collaboration and integrated health programming through ministries of health. In addition, projects must also consider monitoring and evaluation of overall program performance and the progress of projects or activities.

a. Eligible Applicants (select one): Limited Eligibility. Ministries of Health and their bona fide agents

b. FOA Type (select one): Cooperative agreementc. Approximate Number of Awards: 32d. Total Project Period Funding: $175,000,000 (5-year period, all countries)e. Average One Year Award Amount: $1,000,000 (per country)f. Number of Years of Award: 5g. Approximate Date When Awards will be Announced: 08/30/2014h. Cost Sharing and /or Matching Requirement: N/A

Part II. Full Text

Full Text is the CDC Description of the project and must thoroughly describe the project including specific requirements for applicants.

A. Funding Opportunity DescriptionInsert narrative for each header below based on content outlined in the Guidance.

Protecting and Improving Health Globally Page 2

1. Background:Maximum of 2 pages, single-spaced, Calibri 12 point, 1-inch margins

a. Statutory Authorities: Public Health Service Act Sections 301(a), 307, and 317 as amended [42 U.S.C. §§ 241, 242l, and 247b]

b. Healthy People 2020:N/A

c. Other National Public Health Priorities and Strategies:This FOA supports CDC’s Global Health Strategy, which focuses on: improving the health and well-being of people around the world; improving capabilities to prepare for and respond to infectious diseases, other emerging health threats and public health emergencies; building country public health capacity as a means to achieve lasting health improvements; and maximizing the potential of CDC’s global programs to achieve public health impact.

Additionally, this FOA supports The Department of Health and Human Services’ (HHS) Global Health Strategy, which articulates three strategic goals that support HHS’ global health vision of a healthier, safer world: protect and promote the health and well-being of Americans through global health action; provide leadership and technical expertise in science, policy, programs and practice to improve global health; and advance United States interests in international diplomacy, development, and security through global health action.

This FOA also supports CDC’s Winnable Battles, public health priorities with large-scale impact on health and known, effective strategies to address them. CDC’s global Winnable Battles include: global immunization, motor vehicle injuries, mother-to-child transmission of HIV and syphilis globally, and tobacco use.

CDC’s World Health Organization Collaborating Center (WHO CC) for Implementation of International Health Regulations, National Surveillance and Response Capacities works in partnership with WHO and Ministries of Health and has a mandate to assist WHO member states in greatest need of support to build national core capacities for surveillance and response as required by the International Health Regulations.

d. Relevant Work:This FOA will cover a number of specific categorical areas to strengthen public health systems and build specific public health capacities with multiple discrete projects and funding from a variety of programs at CDC. See Part III: Program Specific Global Health Activities for further details on relevant work for each discrete project.

Protecting and Improving Health Globally Page 3

2. CDC Project Description

a. Approach:

The Global Health Logic Model Overview depicts the FOA’s general approach. It shows “if-then” relationships between the CDC’s global health strategies and the intended outcomes that result from implementing them. That is, “if” an activity is completed, “then” the following outcome is expected.

The strategies and outcomes of the Logic Model Overview are stated broadly to capture the variety of activities and outcomes that are associated with the discrete projects supported by this FOA (outlined in Part III: Program Specific Global Health Activities). Activities listed in each of the projects are associated with one or more of the strategies described in the Logic Model Overview.

Protecting and Improving Health Globally Page 4

Logic Model Overview

Strategies and Actvities Short-term Outcomes Intermediate Outcomes Long-term Outcomes

1. Strengthen Epidemiological Capacity Enhance investigation response and

reporting Improve surveillance to drive public health

action Implement and evaluate epidemiologic

public health practice, and prevention and control strategies

Coordinate and collaborate

2. Enhance Laboratory Capacity Sustain and enhance laboratory diagnostic

capacity Improve laboratory coordination and

outreach/information flow

3. Enhance Public Health Systems Capacity Develop Public Health Workforce Sustain and enhance and innovate

integrated information systems

4. Develop and Implement Evidence-based Practices

• Trained workforce better prepared to respond• Better coordination and exchange of data• Improved surveillance• Improved completeness and timeliness of reporting• More timely and efficient efforts:

o Detection of outbreakso Response to outbreakso Investigation of outbreakso Implementation of control

measures

• Increased use of evidence-based practices

Data used to: Improve PH response and

control Improve public health practice Inform clinical medicine/

treatment Set priorities Inform program and policy

development

Development and implementation of strong: Public health interventions Prevention guidelines

Earlier detection of outbreaks and other public health priorities/emergenciesIncreased awareness of: Public re: disease and chronic

conditions risks and protective action

Providers re: appropriate action

Increased compliance with the IHR

Improved treatment and prevention of diseases

Minimized transmission of diseases

Future outbreaks prevented Increased detection Reduction in incidence/

prevalence of preventable diseases and conditions

Decreased morbidity/ mortality Improved health outcomes,

quality, and equity

Protecting and Improving Health Globally Page 5

i. Problem Statement:In 2010, CDC established the Center for Global Health (CGH) recognizing that domestic and global health are indivisible and that no country can protect the health of its citizens in isolation from the rest of the world. CDC engages internationally to protect the health of the American people and save lives worldwide in the belief that healthy societies are more just, stable, and prosperous.

CDC’s future successes in global health work depend upon efforts to leverage existing public health infrastructure and investments, develop and support country capacity in public health, and build upon the agency’s standing as a trusted partner to shape global health strategy and policy based on sound science.

CDC relies on strong regional, national, and local partnerships to address current global health concerns and to investigate and respond to emerging risks. This FOA will build and strengthen partnerships to enhance epidemiological, laboratory, and health systems capacity and to develop and implement evidence-based practices that protect and improve health.

ii. Purpose:The purpose of this FOA is to support the implementation of programs and activities focusing on protecting and improving health globally through regional, national, and local partnerships to develop, implement and strengthen public health surveillance, health information systems (including monitoring and evaluation), public health laboratory capacity, workforce development, and systems and capacities for the prevention, detection, response, and control of infectious and non-communicable diseases, injury prevention efforts and public health emergencies. Projects considered for this FOA should consider building upon existing public health infrastructure and focusing on country priorities that are of mutual interest in order to strengthen regional and national partnerships, public health capacity, leadership, strategic collaboration and integrated health programming through ministries of health. In addition, projects must also consider monitoring and evaluation of overall program performance and the progress of projects or activities.

Projects considered under this FOA aim to leverage CDC and U.S. government interests and initiatives in order to address the following areas:

1. Health Impact: Improving the health and well-being of people2. Health Security: Improving capabilities to prepare for and respond to infectious diseases, other

emerging public health threats, and public health emergencies3. Health Capacity: Building and strengthening country public health capacities

Activities to accomplish the goals of this FOA are outlined in program-specific funding opportunity descriptions in Part III: Program Specific Global Health Activities. These projects may focus on a specific

Protecting and Improving Health Globally Page 6

disease, capacity, or objective of the broad FOA.

iii. Outcomes:As reflected in the Global Health Logic Model Overview, awardees are expected to show measurable progress toward the short-term and intermediate outcomes for this five-year project period.

The specific outcomes awardees are expected to demonstrate progress for will depend on the projects funded. Each of the discrete projects focuses on one or more of these outcomes, which are specified in the ‘Outcomes’ section of each project in Part III: Program Specific Global Health Activities.

On a general level, the following short-term outcomes will be achieved: (1) A trained workforce that is better prepared to respond; (2) Better coordination and exchange of data; (3) Improved surveillance for driving public health action; (4) Improved completeness and timeliness of reporting to appropriate surveillance networks; and (5) More timely and efficient efforts in the detection, response, investigation, and implementation of control measures for outbreaks and (6) increased use of evidence-based practices.

The intermediate outcomes will also be achieved during this project period: (1) Data used for improving public health response and control, improving public health practice, informing clinical medicine/treatment, setting priorities, and informing program and policy development; (2) Development and implementation of strong public health interventions and prevention guidelines; (3) Increased awareness of disease risks and protective actions among the public; (4) Increased awareness of appropriate actions among providers; and (5) Earlier detection of outbreaks and other public health priorities/emergencies.

Long term, projects will contribute to the: (1) Improved treatment and prevention of diseases; (2) Minimized transmission of diseases; (3) Prevention of future outbreaks; (4) Reduction in incidence and prevalence of preventable diseases and conditions; (5) Decreased morbidity and mortality; (6) Improved overall health outcomes and quality of life; and (7) Compliance with the International Health Regulations (IHR).

iv. Funding Strategy:Direct CDC appropriations will fund these activities. It is possible that additional funds designated to support global health security and/or global public health strengthening and capacity building efforts strengthening CDC’s investments in public health may also support additional projects under this FOA.

Anticipated average award (per country):

Project A : Birth Defects COUNT: $25,000-$50,000

Protecting and Improving Health Globally Page 7

Project B : Influenza: $25,000-$50,000 Project C : Global Health Security: $150,000-$1,500,000 Project D : Global Non-communicable Diseases and Injuries: $200,000 Project E : Strengthening Global Public Health Capacity to Prevent and Control Emerging and

Zoonotic Infectious Diseases: $100,000-$400,000 Project F : Global Civil Registration and Vital Statistics Improvement Program: $25,000-$100,000

This funding is subject to change based on CDC budgets and priorities and emerging public health issues and outbreaks.

v. Strategies and Activities:While global health activities span many different programmatic areas and discrete projects, this FOA focuses on several overlapping key strategies: strengthening and enhancing epidemiological and laboratory capacity, enhancing public health systems capacity and developing and implementing evidence-based practices (see Logic Model in Section A.2.a). These strategies and the activities associated with them are further described in Part III: Program Specific Global Health Activities. Below you will find an overview of these projects.

Project A: Birth Defects COUNT: Support the strengthening of birth defects surveillance, capacity building, evidence-informed practices, and program monitoring and evaluation.

Project B: Influenza: Support and strengthen influenza surveillance systems, maintain capacity to detect, monitor, and respond to changes in influenza viruses, and contain or mitigate transmission of novel influenza among humans.

Project C: Global Health Security: Strengthen capacity to detect and report outbreaks when they occur and build an interconnected global network that can respond effectively to limit the spread of infectious disease outbreaks worldwide.

Project D: Global Noncommunicable Diseases and Injuries: Support surveillance, capacity building, and program implementation and evaluation to address noncommunicable diseases, including injuries.

Project E: Strengthening Global Public Health Capacity to Prevent and Control Emerging and Zoonotic Infectious Diseases: Develop sustainable surveillance, response and laboratory systems that can work collaboratively to detect, prevent, and control emerging and zoonotic infectious diseases.

Project F: Global Civil Registration and Vital Statistics Improvement Program: Obtain essential information on births and deaths, including causes of death, needed to plan health, education, and government services and allocate health resources. Provide citizens with the documents required to

Protecting and Improving Health Globally Page 8

participate in national activities such as school, work, international travel, and collection of inheritance and life insurance benefits.

1. Collaborations: left blank intentionally

a. With CDC funded programs:Each activity that appears in Part III: Program Specific Global Health Activities has its own program guidance that provides collaboration (if applicable) information specific to that CDC program.

b. With organizations external to CDC:Each activity that appears in Part III: Program Specific Global Health Activities has its own program guidance that provides collaboration (if applicable) information specific to that CDC program.

2. Target Populations:

Each activity that appears in Part III: Program Specific Global Health Activities has its own program guidance that provides target population (if applicable) information specific to that CDC program.

Inclusion:N/A

b. Evaluation and Performance Measurement:i. CDC Evaluation and Performance Measurement Strategy:

The purpose of evaluation and performance measurement is to help CDC awardees: (1) Monitor the extent to which activities planned were successfully completed (e.g., Were activities implemented correctly?); (2) Demonstrate how capacity building activities contribute towards program outcomes (e.g., Were outcomes of interest achieved?); and (3) Inform decisions about future programming that drive continuous program improvement for more efficient and effective program performance (e.g., What and how could things be improved?).

While each project will have a detailed Evaluation and Performance Measurement Strategy described in their individual attachment (i.e., requirements for annual reporting of performance measures), the overall CDC Evaluation and Performance Measurement Strategy will focus on both process and outcome evaluation. Process evaluation is conducted to monitor activities during the implementation and operation of a program while an outcome evaluation examines the longer-term successes and accomplishments of a program. Potential data sources will include awardee applications and progress reports (e.g., work plans, performance measures, and success stories), surveys and interviews with select public health agencies.

While each project’s Evaluation and Performance Measurement Strategy will differ, below are

Protecting and Improving Health Globally Page 9

some examples of the key evaluation questions to be addressed by the FOA during this project period. The evaluation questions reflect priorities of stakeholders, and assess contributions that span across the Protecting and Improving Global Health Logic Model Overview from strategies and activities employed by awardees to outcomes accomplished by the overall program.

Process Evaluation Questions

1) What are the major activities conducted by awardees that contributed towards achieving program outcomes?

2) What were the major outputs (milestones or deliverables) accomplished by awardees that contributed towards achieving program outcomes?

3) To what extent were awardees’ proposed activities implemented as planned?

Outcome Evaluation Questions

1) To what extent has the flow and exchange of data to drive public health action improved at the district, national and international levels (e.g., improving treatment and prevention of diseases, minimized transmission of disease, decreased morbidity and mortality, increased compliance with IHR, etc.)?

2) To what extent were surveillance systems to drive public health action improved at the district, national and international levels (e.g., improving public health response and control, informing public health practice, inform program policy and development, etc.)?

3) To what extent has reporting to appropriate surveillance networks improved at the district, national and international levels (e.g., timelier, more complete)?

4) To what extent was (e.g., timelier, more efficient) the detection, response, and investigation of outbreaks, and implementation of appropriate control measures improved?

5) To what extent did this project increase district, national and international awareness and knowledge around risks and protective actions of diseases and conditions among the public?

6) To what extent did this project increase awareness and knowledge about appropriate actions of diseases and conditions among providers?

7) How does this project promote the use of data to improve district, national and international public health response and control, practice, inform clinical medicine/treatment, set priorities, and inform program and policy development?

8) How has this project contributed to the implementation and/or development of strong district, national and international level public health interventions or prevention guidelines?

9) How has this project strengthened the country’s health system or core capacities?

ii. Applicant Evaluation and Performance Measurement Plan:Applicants must provide one jurisdiction- or community-specific evaluation and performance

Protecting and Improving Health Globally Page 10

measurement plan per project applied for that is consistent with the CDC strategy. At a minimum, the plan must:

Describe how key program partners will participate in the evaluation and performance measurement planning processes.

Describe the type of evaluations (i.e., process, outcome, or both) to be conducted. Describe key evaluation questions. Describe other information (e.g., performance measures

to be developed by the applicant), as determined by the CDC program, that must be included.

Describe potentially available data sources and feasibility of collecting appropriate evaluation and performance data.

Describe how evaluation findings will be used for continuous program quality improvement. Describe how evaluation and performance measurement will contribute to developing an

evidence base for programs that employ strategies lacking a strong effectiveness evidence base.

c. Organizational Capacity of Awardees to Execute the Approach:A successful grantee must demonstrate core organizational capacity to manage and conduct the activities for which awards are made.

d. Work Plan:Each project the applicant is applying for (see Part III: Program Specific Global Health Activities) must include a work plan. Work plans should be detailed and focus on the first year of the project period with a framework for subsequent years. Work plans should demonstrate alignment among the outcomes, strategies, activities, timelines and staffing. Additional information on performance measures, data sources and target population(s) can also be included.

e. CDC Monitoring and Accountability Approach:Monitoring activities include routine and ongoing communication between CDC and awardees, site visits, and awardee reporting (including work plans, performance, and financial reporting). HHS grants policy specifies the following HHS expectations for post-award monitoring for grants and cooperative agreements:

Tracking awardees progress in achieving the desired outcomes. Insuring the adequacy of awardee systems that underlie and generate data reports. Creating an environment that fosters integrity in program performance and results.

Monitoring may also include the following activities: Ensuring that work plans are feasible based on the budget and consistent with the intent of the

award. Ensuring that awardees are performing at a sufficient level to achieve objectives within stated

timelines.

Protecting and Improving Health Globally Page 11

Working with awardees on adjusting the work plan based on achievement of objectives and changing budgets.

Monitoring performance measures (both programmatic and financial) to assure satisfactory performance levels.

Other activities deemed necessary to monitor the award, if applicable.

These may include monitoring and reporting activities as outlined in HHS grants policy that assists grants management staff (e.g., grants management officers and specialists, and project officers) in the identification, notification, and management of high-risk grantees.

f. CDC Program Support to Awardees:CDC will support programs by providing:

1. Technical assistance in the following: evaluation, performance measurement, work plan development, program planning, and specific subject matter expertise for global health projects.

2. Coordination of activities where appropriate with ministries of health.3. Targeted technical assistance (TA) to ministries of health (or their bona fide agents), national

public health institutes, and/or national public health labs to help advance global health capabilities.

B. Award Information

Insert narrative for each header based on content outlined in the Guidance.

1. Type of Award: Cooperative AgreementCDC’s substantial involvement in this program is indicated in the “CDC Program Support to Awardees” section of this document.

2. Award Mechanism: U19 - Non-research cooperative agreement3. Fiscal Year: 2014

4. Approximate Total Fiscal Year Funding: $1,000,000 (per country)

5. Approximate Total Project Period Funding: $175,000,000 (5-year period, all countries)

6. Total Project Period Length: 5 years

7. Approximate Number of Awards: 32

8. Approximate Average Award: $ $1,000,000

Protecting and Improving Health Globally Page 12

9. Floor of Individual Award Range: None

10. Ceiling of Individual Award Range: None

11. Anticipated Award Date: August 30, 2014

12. Budget Period Length: 12 monthsThroughout the project period, CDC will continue the award based on the availability of funds, the evidence of satisfactory progress by the awardee (as documented in required reports), and the determination that continued funding is in the best interest of the federal government. The total number of years for which federal support has been approved (project period) will be shown in the “Notice of Award.” This information does not constitute a commitment by the federal government to fund the entire period. The total project period comprises the initial competitive segment and any subsequent non-competitive continuation award(s).

Funding is subject to change based on CDC budgets and priorities and emerging public health issues and outbreaks.

13. Funds Tracking:Proper fiscal oversight is critical to maintaining public trust in the stewardship of federal funds. Effective October 1, 2013, a new HHS policy on subaccounts requires the CDC to set up payment subaccounts within the Payment Management System (PMS) for all new grant awards. Funds awarded in support of approved activities and drawdown instructions will be identified on the Notice of Award in a newly established PMS subaccount (P subaccount). Grantees will be required to draw down funds from award-specific accounts in the PMS. Ultimately, the subaccounts will provide grantees and CDC a more detailed and precise understanding of financial transactions.

14. Direct Assistance:Direct assistance is not available through this FOA

15. Indirect Costs:Indirect costs are not an allowable cost through this FOA

C. Eligibility Information

Insert narrative for each header below based on content outlined in the Guidance.

1. Eligible Applicants: Eligibility is limited to Ministries of Health (or bona fide agents) in countries where there is existing partnership with CDC, but is not limited to countries where CDC has a physical presence.

Protecting and Improving Health Globally Page 13

2. Special Eligibility Requirements:Funding for Project B: Influenza (see Part III: Program Specific Global Health Activities) is only available to countries that have successfully completed both influenza Capacity Building and Sustainability Cooperative Agreements from Influenza Division, CDC (India, Indonesia, Thailand, China, Philippines, Pakistan, and Mongolia).

Other projects may have additional eligibility requirements associated with them. If so, these will be noted in Part III: Program Specific Global Health Activities.

3. Justification for Less than Maximum Competition:Eligibility for this FOA is limited to Ministries of Health (or their bona fide agents) in countries where there is existing partnership with CDC, but is not limited to countries where CDC has a physical presence.

Ministries of Health are uniquely qualified to set country public health priorities and to impact and strengthen health systems on a national scale. They have the ability and authority to mobilize and direct public health personnel to prepare for and respond to outbreaks, to gather national level public health data, to implement significant interventions to treat and control diseases, to improve laboratory networks, and to conduct training programs that build country workforce capacity.

Ministries of Health are the primary partners of CDC in building and strengthening global public health impact, systems, capacity, and security. CDC continues to work with ministries, in some cases based on decades-old relationships, to protect and improve public health through a focus on a broad spectrum of activities, including epidemiology and surveillance, laboratory, emergency management, workforce development and training, outbreak response, disease treatment and control, vaccination and eradication, and non-communicable diseases.

It is expected that projects under this FOA will leverage, compliment, or synergize with existing CDC-funded work around the world. The purpose of this broad FOA with limited eligibility to Ministries of Health is to ensure that CDC is approaching its global work in a coordinated way in order to be efficient with limited funding and eliminate any potential duplication efforts by CDC, USG, or other international partners. While it is not possible to list every potential relationship to ongoing CDC-funded activities, it is conceivable that new projects would relate to CDC's work in emerging infections, influenza surveillance and pandemic preparedness, field epidemiology training, International Health Regulations, global health security, risk communication, emergency management, laboratory capacity, and non-communicable diseases.

Specific activities may have additional eligibility requirements associated with them, which are described in the Program Specific Global Health Activity (PSGHA) appendices of the FOA. If eligible as a bona fide agent of a Ministry of Health, documentation of the bona fide agent status must be provided by the Ministry of Health.

4. Other:N/A

5. Cost Sharing or Matching:

Protecting and Improving Health Globally Page 14

Cost sharing or matching funds are not required for this program. However, although there is no statutory match requirement for this FOA, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged. Awards may be prioritized based on the ability of a country to demonstrate commitment to long-term capacity building through cost sharing and/or matching funds for projects that align with country priorities.

6. Maintenance of Effort:Maintenance of effort is not required for this program.

D. Application and Submission InformationAdditional materials that may be helpful to applicants: http://www.cdc.gov/od/pgo/funding/docs/FinancialReferenceGuide.pdf.

1. Required Registrations:An organization must be registered at the three following locations before it can submit an application for funding at www.grants.gov.

a. Data Universal Numbering System: All applicant organizations must obtain a Data Universal Numbering System (DUNS) number. A DUNS number is a unique nine-digit identification number provided by Dun & Bradstreet (D&B). It will be used as the Universal Identifier when applying for federal awards or cooperative agreements.

The applicant organization may request a DUNS number by telephone at 1-866-705-5711 (toll free) or internet at http://fedgov.dnb.com/webform/displayHomePage.do. The DUNS number will be provided at no charge.

If funds are awarded to an applicant organization that includes sub-awardees, those sub-awardees must provide their DUNS numbers before accepting any funds.

b. System for Award Management (SAM): The SAM is the primary registrant database for the federal government and the repository into which an entity must submit information required to conduct business as an awardee. All applicant organizations must register with SAM, and will be assigned a SAM number. All information relevant to the SAM number must be current at all times during which the applicant has an application under consideration for funding by CDC. If an award is made, the SAM information must be maintained until a final financial report is submitted or the final payment is received, whichever is later. The SAM registration process can require 10 or more business days, and registration must be renewed annually. Additional information about registration procedures may be found at www.SAM.gov .

c. Grants.gov : The first step in submitting an application online is registering your organization at

Protecting and Improving Health Globally Page 15

www.grants.gov, the official HHS E-grant Web site. Registration information is located at the “Get Registered” option at www.grants.gov.

All applicant organizations must register at www.grants.gov. The one-time registration process usually takes not more than five days to complete. Applicants should start the registration process as early as possible.

Step System Requirements Duration Follow Up

1Data Universal

Number System (DUNS)

1. Click on http://fedgov.dnb.com/webform

2. Select Begin DUNS search/request process

3. Select your country or territory and follow the instruction to obtain your

DUNS 9-digit #4. Request appropriate staff member(s)

to obtain DUNS number, verify & update information under DUNS

number

1-2 Business Days

To confirm that you have been issued a new DUNS number check online at

(http://fedgov.dnb.com/webform) or call 1-866-705-5711

2

System for Award

Management (SAM) formerly

Central Contractor

Registration (CCR)

1. Retrieve organizations DUNS number

2. Go to www.sam.gov and designate an E-Biz POC (note CCR username will not work in SAM and you will need to have an active SAM account before

you can register on grants.gov)

3-5 Business Days but up to 2 weeks

and must be renewed once a

year

For SAM Customer Service Contact www.fsd.gov/US Calls: 866-606-8220

3 Grants.gov

1. Set up an individual account in Grants.gov using organization new

DUNS number to become an authorized organization representative

(AOR) 2. Once the account is set up the E-BIZ

POC will be notified via email 3. Log into grants.gov using the

password the E-BIZ POC received and create new password

4. This authorizes the AOR to submit applications on behalf of the

organization

Same day but can take 8

weeks to be fully registered and

approved in the system (note,

applicants MUST obtain a DUNS

number and SAM account before

applying on grants.gov)

Register early! Log into grants.gov and check AOR status until it shows you have

been approved

2. Request Application Package:Download the application package from www.grants.gov

3. Application Package:

Protecting and Improving Health Globally Page 16

Applicants must download the SF-424 application package associated with this funding opportunity from www.grants.gov. If Internet access is not available, or if the online forms cannot be accessed, applicants may call the CDC PGO staff at 770-488-2700 or e-mail PGO PGOTIM@cdc.gov for assistance. Persons with hearing loss may access CDC telecommunications at TTY 1-888-232-6348.

4. Submission Dates and Times:If the application is not submitted by the deadline published in the FOA, it will not be processed. PGO personnel will notify the applicant that their application did not meet the deadline. The applicant must receive pre-approval to submit a paper application (see Other Submission Requirements section for additional details). If the applicant is authorized to submit a paper application, it must be received by the deadline provided by PGO.

If Grants.gov cannot receive applications due to an emergency or other unanticipated event (and circumstances preclude advance notification of an extension), then applications must be submitted by the first business day on which government operations resume.

a. Letter of Intent (LOI) Deadline Date: N/A

b. Application Deadline Date: 60 days after publication, 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov

If Grants.gov cannot receive applications due to an emergency or other unanticipated event (and circumstances preclude advance notification of an extension), then applications must be submitted by the first business day on which government operations resume.

5. CDC Assurances and Certifications:

All applicants are required to sign and submit CDC Assurances and Certifications documents that can be found on the CDC Web site: http://www.cdc.gov/od/pgo/funding/grants/foamain.shtm

Applicants may follow either of the following processes:

Applicants must name this file “Assurances and Certifications” and upload as a PDF on www.grants.gov.

Complete the applicable assurances and certifications and submit them directly to CDC on an annual basis at http://www.cdc.gov/od/pgo/funding/grants/foamain.shtm

Assurances and certifications submitted directly to CDC will be kept on file for 1 year and will apply to all applications submitted to CDC within one year of the submission date.

6. Content and Form of Application Submission:Applicants are required to submit all of the documents outlined below as their application package on

Protecting and Improving Health Globally Page 17

www.grants.gov.

7. Letter of Intent (LOI):LOI is not requested or required as part of the application for this FOA.

8. Table of Contents: (No page limit, not included in project narrative page limit)Provide a detailed table of contents for the entire submission package that includes all of the documents in the application and headings in the “Project Narrative” section(s). Name the file “Table of Contents” and upload it as a PDF file under “Other Attachment Forms” at www.grants.gov.

9. Project Abstract Summary: (Maximum of 1 page)A project abstract is included on the mandatory documents list and must be submitted at www.grants.gov. The project abstract must be a self-contained, brief summary of the proposed project including the purpose and outcomes. This summary must not include any proprietary or confidential information. Applicants must enter the summary in the “Project Abstract Summary” text box at www.grants.gov.

10. Project Narrative: (Maximum of 18 pages per project, single spaced, Calibri 12 point, 1-inch margins, number all pages, content beyond 18 pages will not be reviewed).The Protecting and Improving Global Health application must be written according to the following outline. Each applicant may only submit one application, but may apply for multiple projects. Applicants must specify for which project(s) they are applying (see Part III: Program Specific Global Health Activities). For each project they apply for, applicants must submit a complete Project Narrative that includes ‘Organizational Capacity of Awardees to Implement the Approach,’ and all of the bolded headings shown in this section. The Project Narrative must be succinct, self-explanatory, and in the order outlined in this section. It must address outcomes and activities to be conducted over the entire project period as identified in Part III: Program Specific Global Health Activities.

Applicants must submit one Project Narrative per project applied for with the application forms. Applicants must name this file “[Project Name] Project Narrative” and upload it at www.grants.gov.

a. Background: Applicants should provide a description of relevant background information that includes the context of the problem (see CDC Background).

i. List of the project component activities being addressed in the application.ii. Provide information on your jurisdiction’s population size, demographic characteristics,

and morbidity and mortality related to infectious diseases (e.g., priority infectious diseases in your jurisdiction).

iii. Describe your health department’s organizational structure (e.g., local, centralized, regional health departments) with a special emphasis of how this structure impacts your activities. Additionally, describe your jurisdiction’s organizational capacity in relation to program planning and performance management.

iv. Describe organizational, fiscal, administrative, and/or programmatic challenges or limitations you expect to face, and measures to overcome them, associated with the

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implementation of the activities you are proposing in this application.v. Describe plans to assure that planning is adequate and that activities (e.g., hiring,

contracting, procurement, collaborations, etc.) are implemented quickly with rigorous tracking and oversight to avoid delays and reduce the potential for unobligated funds remaining at the end of the budget and project period.

vi. Success Stories: Please provide stories to capture recent accomplishments that highlight the impact of this program in your jurisdiction. They will be used to educate stakeholders, decision makers, and policymakers about the impact of Protecting and Improving Global Health activities.

b. Approach

i. Problem Statement: Applicants must describe the core information relative to the problem for the jurisdictions or populations they serve. The core information should help reviewers understand how the applicant’s response to the FOA will address the public health problem and support public health priorities (See CDC Project Description).

ii. Purpose: Applicants must describe specifically how their application will address the problem as described in the CDC Project Description.

iii. Outcomes: Applicants must clearly identify the outcomes they expect to achieve by the end of the project period. Refer to outcomes listed in the component project’s ‘outcomes’ section. Outcomes are the results that the program intends to achieve. All outcomes should indicate the intended direction of change (i.e., increase, decrease, maintain, complete). See the Global Health Logic Model Overview in the Approach section of the CDC Project Description. In addition to the project period outcomes required by CDC, applicants should include any additional outcomes they anticipate.

iv. Strategy and Activities: For each project applied for, the applicant must provide a clear and concise description of the strategies and activities they will use to achieve the project period outcomes. Briefly introduce the activity/ies being proposed and describe what the expected outputs and outcomes will be over the first 12-month budget period. Whenever possible, applicants should use evidence-based program strategies as identified by the Community Guide1 (or similar reviews) and reference it explicitly as a source. Applicants may propose additional strategies and activities to achieve the outcomes. Applicants should select existing evidence-based strategies that meet their needs, or describe the rationale for developing and evaluating new strategies or practice-based innovations. (See Part III: Program Specific Global Health Activities).

1. Collaborations: Applicants must describe how they will collaborate with CDC funded programs as well as with organizations external of CDC, in the case of eligibility as a bona fide agent. A bona fide agent is an agency/organization identified by the Ministry of Health as eligible to submit an application under their eligibility in lieu of a MoH application. If eligible as a bona fide agent of a Ministry of Health, documentation of the

1 http://www.thecommunityguide.org/index.html

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bona fide agent status must be provided by the Ministry of Health. Applicants must provide MOUs/MOAs and name the file “MOUs/MOAs” and upload as PDF files at www.grants.gov.

Alternately, applicants must file letters of support, as appropriate, name the file “Letters of Support”, and upload it as a PDF file at www.grants.gov.

2. Target Populations: Applicants must describe the specific target population(s) to be addressed in their jurisdiction to allocate limited resources, target those at greatest health risk, and achieve the greatest health impact. Applicants should use data, including social determinants data, to identify communities within their jurisdictions or communities served that are disproportionately affected by the public health problem, and plan activities to reduce or eliminate these disparities. Disparities by race, ethnicity, gender identity, sexual orientation, geography, socioeconomic status, disability status, primary language, health literacy, and other relevant dimensions (e.g., tribal communities) should be considered.Inclusion: If applicable, applicants must address how they will be inclusive of how specific populations, i.e. who can benefit from the program. Refer back to the CDC Project Description, Approach, Inclusion, if applicable.

c. Applicant Evaluation and Performance Measurement Plan: Applicants must provide a jurisdiction or community-specific evaluation and performance measurement plan that is consistent with the CDC Evaluation and Performance Measurement Strategy section of the CDC Project Description of this FOA. Data collected must be used for ongoing monitoring of the award to evaluate its effectiveness, and for continuous program improvement.

The plan must:

Describe how key program partners will be engaged in the evaluation and performance measurement planning processes.

Describe the type of evaluations to be conducted (i.e. process and/or outcome).

Describe key evaluation questions to be answered.

Describe other information, as determined by the CDC program (e.g., performance measures to be developed by the applicant) that must be included.

Describe potentially available data sources and feasibility of collecting appropriate evaluation and performance data.

Describe how evaluation findings will be used for continuous program and quality improvement.

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Describe how evaluation and performance measurement will contribute to development of the evidence base, where program strategies are being employed that lack a strong evidence base of effectiveness.

Describe how major activities conducted, the progress of those activities, and highlight significant milestones accomplished as a result of those activities

Specifically address progress against each performance measure written in your proposal

In the description for each activity, describe any barriers encountered, and how the barriers were addressed

d. Evaluation and Performance Measurement Strategy: Describe in a brief narrative (2-3 pages maximum) a plan to monitor activities, demonstrate progress towards program outcomes and inform future program decisions over the five-year project period. The plan should be consistent with the CDC Evaluation and Performance Measurement Strategy. Reporting on this plan will occur on an annual basis and at the end of the project period. CDC will work with awardees during the first six months of the project period to finalize an evaluation and performance measurement plan to better monitor the progress of the activities implemented and outcomes achieved.

This plan, at a minimum, must address the following points:i. Identify key program partners and describe how they will participate in the

development, implementation and reporting of performance measures as described within this FOA. These include persons involved in or affected by the program and primary users of the evaluation (e.g., program staff from epidemiology, laboratory, and health information systems; program coordinators; partners (if applicable), etc.)

ii. Consider the evaluation questions outlined in the CDC Evaluation and Performance Measurement Strategy. These questions will establish the scope and focus of the evaluation. Identify which of these questions apply to your set of projects and modify them based on your portfolio. Applicants may also choose to develop other evaluation questions, in addition to those defined by the CDC strategy.

iii. Describe how your performance measures (and associated data) could help answer your chosen evaluation questions.

iv. Discuss any barriers or challenges expected for collecting data (i.e., responding to performance measures) or assurances that data can be collected. In addition, applicants may also describe other measures to be developed or additional data sources and data collection methods that applicants will use to answer the evaluation questions stated above.

v. Describe how evaluation findings will be used for continuous program quality improvement at the applicant level. Discuss how data collected (i.e., performance

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measurement data) will be used and shared by the key program partners.vi. Describe how evaluation and performance measurement will contribute to developing

an evidence base for strategies lacking a strong effectiveness evidence base. If applicants are demonstrating or employing new or innovative strategies, applicants should describe how evaluation and performance measurement (e.g., adding more rigor in analysis of data) will be used to determine if these strategies are effective.

Awardees will be required to submit a more detailed evaluation and performance measurement plan within the first six months of the project, as outlined in the reporting section of the FOA.

e. Organizational Capacity of Awardees to Execute the Approach:Applicant must address the organizational capacity requirements as described in the CDC Project Description. Applicants must name this file “CVs/Resumes” or “Organizational Charts” and upload it at www.grants.gov.]

11. Work Plan: Maximum page limit 25 pages per project, single spaced, Calibri 12 point, 1-inch marginsApplicants must prepare one work plan per project applied for that is consistent with the CDC Project Description Work Plan section. The work plan integrates and delineates more specifically how the awardee plans to carry out achieving the project period outcomes, strategies, and activities, evaluation and performance measurement, including key milestones.

Applicants must name this file “[Project Name] Work Plan” and upload it as a PDF file at www.grants.gov .

12. Budget Narrative:Applicants must submit an itemized, line-item budget per project applied for, which may be scored as part of the Organizational Capacity of Awardees to Execute the Approach. When developing the budget narrative, applicants should consider whether the proposed budget is reasonable and consistent with the purpose, outcomes and program strategy outlined in the project narrative. The budget must include:

Salaries and wages Fringe benefits Consultant costs Equipment Supplies Travel Alterations and Renovations Other categories Contractual costs Total Direct costs

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Total Indirect costs

For guidance on completing a detailed budget, see Budget Preparation Guidelines at: http://www.cdc.gov/od/pgo/funding/budgetguide.htm.

Applicants should name this “[Project Name] Budget Narrative” and upload as a PDF file to www.grants.gov. If requesting indirect costs in the budget, a copy of the indirect cost rate agreement is required. If the indirect cost rate is a provisional rate, the agreement must have been made less than 12 months earlier. Applicants should name this file “Indirect Cost Rate” and upload to www.grants.gov.

13. Tobacco and Nutrition Policies:Awardees are encouraged to implement tobacco and nutrition policies.

Unless otherwise explicitly permitted under the terms of a specific CDC award, no funds associated with this FOA can be used to implement the optional policies, and no applicants will be evaluated or scored on whether they choose to participate in implementing these optional policies.

The CDC supports implementing evidence-based programs and policies to reduce tobacco use and secondhand smoke exposure, and to promote healthy nutrition. CDC encourages all awardees to implement the following optional recommended evidence-based tobacco and nutrition policies within their own organizations. This builds upon the current federal commitment to reduce exposure to secondhand smoke, which includes The Pro-Children Act, 20 U.S.C. 7181-7184, that prohibits smoking in certain facilities that receive Federal funds in which education, library, day care, health care, or early childhood development services are provided to children.

Tobacco Policies:

1. Tobacco-free indoors – no use of any tobacco products (including smokeless tobacco) or electronic cigarettes in any indoor facilities under the control of the awardee

2. Tobacco-free indoors and in adjacent outdoor areas – no use of any tobacco products or electronic cigarettes in any indoor facilities, within 50 feet of doorways and air intake ducts, and in courtyards under the control of the awardee

3. Tobacco-free campus – no use of any tobacco products or electronic cigarettes in any indoor facilities and anywhere on grounds or in outdoor space under the control of the awardee

Nutrition Policies:

1. Healthy food service guidelines should at a minimum, align with Health and Human Services and General Services Administration Health and Sustainability Guidelines for Federal Concessions and Vending Operations for cafeterias, snack bars, and vending machines in any facility under the control of the awardee and in accordance with contractual obligations for these services (http://www.gsa.gov/graphics/pbs/Guidelines_for_Federal_Concessions_and_Vending_Operations.p

Protecting and Improving Health Globally Page 23

df)2. The following are resources for healthy eating and tobacco free workplaces:

http://www.cdc.gov/nccdphp/dnpao/hwi/toolkits/tobacco/index.htmhttp://www.thecommunityguide.org/tobacco/index.html

http://www.cdc.gov/chronicdisease/resources/guidelines/food-service-guidelines.htm

14. Intergovernmental Review:Executive Order 12372 does not apply to this program.

15. Funding Restrictions:Restrictions that must be considered while planning the programs and writing the budget are:

Awardees may not use funds for research.

Awardees may not use funds for clinical care except as allowed by law.

Awardees may only use funds for reasonable program purposes, including personnel, travel, supplies, and services (such as contractual).

Generally, awardees may not use HHS/CDC/ATSDR funding for the purchase of furniture or equipment. Any such proposed spending must be clearly identified in the budget in accordance with CDC’s budget guidelines.

Reimbursement of pre-award costs is not allowed.

Other than for normal and recognized executive-legislative relationships, no funds may be used for:

Publicity or propaganda purposes, for the preparation, distribution, or use of any material designed to support or defeat the enactment of legislation before any legislative body

The salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence the enactment of legislation, appropriations, regulation, administrative action, or Executive order proposed or pending before any legislative body

See Additional Requirement (AR) 12 for detailed guidance on this prohibition and additional guidance on lobbying for CDC awardees.

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

Protecting and Improving Health Globally Page 24

16. Other Submission Requirements:a. Electronic Submission: Applications must be submitted electronically at www.grants.gov. The

application package can be downloaded from www.grants.gov. Applicants can complete the application package off-line, and then submit the application by uploading it at www.grants.gov website. All application attachments must be submitted using a PDF file format. Directions for creating PDF files can be found at www.grants.gov. File formats other than PDF may not be readable by PGO TIMS staff.

Applications must be submitted electronically by using the forms and instructions posted for this funding opportunity on www.grants.gov.

If Internet access is not available or if the forms cannot be accessed on-line, applicants may contact the PGO TIMS staff at 770- 488-2700 or by e-mail at pgotim@cdc.gov, Monday through Friday, 7:30 am–4:30 pm Eastern Standard Time (EST), except federal government holidays. Electronic applications will be considered successful if they are available to PGO TIMS staff for processing from www.grants.gov on the deadline date.

Do not use “special characters (i.e. %, &, * etc.) on the cover page of your application (form SF 424 – Application for Federal Assistance) as special characters are not recognized by the electronic system. Use of special characters may result in your application being rejected. When copy/paste is used on application documents, the grantee should ensure that text only is pasted. When extra, blank spaces at the end of the original are pasted into the new document it causes the system to reject the document.

b. Tracking Number: Applications submitted through www.grants.gov, are time/date stamped electronically and assigned a tracking number. The Authorized Organization Representative (AOR) will receive an email notice of receipt when www.grants.gov receives the application. The tracking number serves to document that the application has been submitted and initiates the electronic validation process before the application is made available to CDC.

c. Validation Process: Application submission is not concluded until successful completion of the validation process. After submission of the application package, applicants will receive a “submission receipt” email generated by www.grants.gov. A second email message to applicants will then be generated by www.grants.gov that will either validate or reject the submitted application package. This validation process may take as long as two (2) business days. Applicants are strongly encouraged to check the status of their application to ensure submission of their package is complete and no submission errors have occurred. Applicants also are strongly encouraged to allocate ample time for filing to guarantee that their application can be submitted and validated by the deadline published in the FOA. Non-validated applications will not be accepted after the published application deadline date.

If you do not receive a “validation” e-mail within two business days of application submission,

Protecting and Improving Health Globally Page 25

please contact www.grants.gov. For instructions on how to track your application, refer to the e-mail message generated at the time of application submission or the Application User Guide, Version 3.0, page 57.

d. Technical Difficulties: If the applicant encounters technical difficulties with www.grants.gov, the applicant should contact www.grants.gov Customer Service. The www.grants.gov Contact Center is available 24 hours a day, 7 days a week, with the exception of Federal Holidays. You can reach the www.grants.gov Contact Center at 1-800-518-4726 or by email at support@www.grants.gov. Submissions sent by email, fax, CD’s or thumb drives of applications will not be accepted. Please note that www.grants.gov is managed by HHS.

e. Paper Submission: If technical difficulties are encountered at www.grants.gov, applicants should call the www.grants.gov Contact Center at 1-800-518-4726 or e-mail them at support@www.grants.gov for assistance. After consulting with the Contact Center, if the technical difficulties remain unresolved and electronic submission is not possible, applicants may e-mail or call CDC GMO/GMS, before the deadline, and request permission to submit a paper application. Such requests are handled on a case-by-case basis.

An applicant’s request for permission to submit a paper application must:

1. Include the www.grants.gov case number assigned to the inquiry;2. Describe the difficulties that prevent electronic submission and the efforts taken with the

www.grants.gov Contact Center to submit electronically; and3. Be postmarked at least three calendar days before the application deadline. Paper applications

submitted without prior approval will not be considered. If a paper application is authorized, PGO will advise the applicant of specific instructions for submitting the application (e.g., original and two hard copies of the application by U.S. mail or express delivery service).

E. Application Review Information

2. Review and Selection Process:Applications will be reviewed in three phases

b. Phase I Review:All applications will be reviewed initially for completeness by the CDC’s Procurement and Grants Office (PGO) staff and will be reviewed jointly for eligibility by the CDC, CGH and PGO. Incomplete applications and applications that are non-responsive to the eligibility criteria will not advance to Phase II review. Applicants will be notified that the application did not meet eligibility and/or published submission

Protecting and Improving Health Globally Page 26

requirements.

d. Phase II Review:Review panels will evaluate complete, eligible applications in accordance with the “Criteria” included in each project description in Section III: Program Specific Global Health Activities.

Not more than thirty days after the Phase II review is completed, applicants will be notified electronically if their application does not meet eligibility or published submission requirements.

f. Phase III Review:Applications will be funded in order by score and rank determined by the review panel unless funding preferences or other considerations stated in this FOA apply. Final selection and approval of activities will be prioritized in collaboration with CDC.

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

2. 3. Anticipated Announcement and Award Dates:The applicant will receive a telephone call from PGO and the project officer to advise the awardee that the application for funds was acceptable. This communication will be followed with an official notice of grant award (NOA) which will include the financial details and the reporting requirements. The expected award date is August 30, 2014.

G. Award Administration Information

The following text is required – see additional information in [brackets] that must be inserted by CDC programs :

1. 2. Award Notices:Awardees will receive an electronic copy of the Notice of Award (NoA) from the CDC PGO. The NoA shall be the only binding, authorizing document between the awardee and CDC. The NoA will be signed by an authorized GMO and emailed to the awardee program director.

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration and Federal Funding Accountability And Transparency Act Of 2006 (FFATA) requirements.

Unsuccessful applicants will receive notification of the results of the application review by email with delivery receipt or by mail.

3. 4. Administrative and National Policy Requirements:Awardees must comply with the administrative requirements outlined in 45 Code of Federal Regulations (CFR) Part 74 or Part 92, as appropriate. To view brief descriptions of relevant provisions visit the CDC website at: http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm

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The following administrative requirements apply to this project:

[Generally applicable administrative requirements (ARs):

AR-9: Paperwork Reduction Act AR-10: Smoke-Free Workplace AR-11: Healthy People 2020 AR-12: Lobbying Restrictions AR-13: Prohibition on Use of CDC Funds for Certain Gun Control Activities AR-14: Accounting System Requirements AR-16: Security Clearance Requirement AR-21: Small, Minority, And Women-owned Business AR-24: Health Insurance Portability and Accountability Act AR-25: Release and Sharing of Data AR-26: National Historic Preservation Act of 1966 AR-29: Compliance with EO13513, “Federal Leadership on Reducing Text Messaging while Driving,”

October 1, 2009 AR-30: Compliance with Section 508 of the Rehabilitation Act of 1973 AR- 32: Executive Order 131410: Promoting Quality and Efficient Health Care in Federal

Government (If applicable applicants should be aware of the program’s current business needs and how they align with nationally adopted Public Health Information Network (PHIN) standards, services, practices, and policies when implementing, acquiring, and updating public health information systems.)

AR-33: Plain Writing Act of 2010 AR-34: Patient Protection and Affordable Care Act (e.g. a tobacco-free campus policy and a

lactation policy consistent with S4207)

ARs applicable to HIV/AIDS Awards:

AR-4: HIV/AIDS Confidentiality Provisions AR-5: HIV Program Review Panel AR-6: Patient Care

ARs applicable to ATSDR Awards:

AR-18: Cost Recovery – ATSDR AR-19: Third Party Agreements – ATSDR

ARs applicable to Conference Awards:

AR-20: Conference Support AR-27: Conference Disclaimer and Use of Logos

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Organization Specific ARs:

AR-8: Public Health System Reporting (Community-based non-governmental organizations) AR-15: Proof of Non-profit Status (Non-profit organizations) AR 23: Compliance with 45 C.F.R. Part 87 (Faith-based organizations)]

Pilot Program for Enhancement of Employee Whistleblower Protections: All applicants will have a condition of award that applies to 48 CFR section 3.908 requiring grantees to inform their employees in writing of employee whistleblower rights and protections under 41. U.S.C 4712 in the predominant native language of the workforce.

If applicable, award recipients will be required to submit an electronic version of the final, peer-reviewed manuscript of any work developed under this award upon acceptance for publication. Additional information will be provided in the award terms.

For more information on the Code of Federal Regulations, visit the National Archives and Records Administration at: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html

3. Reporting:

a. CDC Reporting Requirements:

Reporting allows for continuous program monitoring and identifies successes and challenges that awardees encounter throughout the project period. Also, reporting is a requirement for awardees who want to apply for yearly continuation of funding. Reporting helps CDC and awardees because it:

Helps target support to applicants, particularly for cooperative agreements; Provides CDC with periodic data to monitor awardee progress towards

meeting the FOA outcomes and overall performance; Allows CDC to track performance measures and evaluation findings for

continuous program improvement throughout the project period and to determine applicability of evidence-based approaches to different populations, settings, and contexts; and

Enables the assessment of the overall effectiveness and impact of the FOA.

As described in the following text, awardees must submit an annual performance report, ongoing performance measures data, administrative reports, and a final performance and financial report. A detailed explanation of any additional reporting requirements will be provided in the Notice of Award to successful applicants.

b. Specific reporting requirements:

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i. Awardee Evaluation and Performance Measurement Plan: Awardees must provide a more detailed evaluation and performance measurement plan within the first six months of the project. This more detailed plan should be developed by awardees as part of first-year project activities, with support from CDC. This more detailed plan should build on the elements stated in the initial plan, and should be no more than 25 pages. At a minimum, and in addition to the elements of the initial plan, this plan must:

Indicate the frequency that evaluation and performance data are to be collected.

Describe how data will be reported. Describe how evaluation findings will be used to ensure continuous

quality and program improvement. Describe how evaluation and performance measurement will yield

findings that will demonstrate the value of the FOA (e.g., effect on improving public health outcomes, effectiveness of FOA as it pertains to performance measurement, cost-effectiveness, or cost-benefit).

Describe dissemination channels and audiences (including public dissemination).

Describe other information requested and as determined by the CDC program.

When developing evaluation and performance measurement plans, applicants are encouraged to use the Introduction to Program Evaluation for Public Health Programs: A Self-Study Guide, available at: http://www.cdc.gov/eval/guide/index.htm

ii. Annual Performance Report (due no later than 120 days before the end of the budget period and serves as a continuation application).

This report must not exceed 35 pages excluding work plan and administrative reporting. Attachments are not permitted, but web links are allowed. The awardee must submit the Annual Performance Report via www.grants.gov no later than 120 days before the end of the budget period. In addition, the awardee must submit an annual Federal Financial Report within 90 days after the end of the calendar quarter in which the budget year ends.

This report must include the following:

Performance Measures (including outcomes) – Awardees must report on performance measures for each budget period and update

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measures, if needed

Evaluation Results –Awardees must report evaluation results for the work completed to date (including any impact data)

Work Plan (maximum of 25 pages) – Awardees should update work plan each budget period

Successes Awardees must report progress on completing activities

outlined in the work plan Awardees must describe any additional successes (e.g.,

identified through evaluation results or lessons learned) achieved in the past year

Awardees must describe success stories Challenges

Awardees should describe any challenges that hinder achievement of both annual and project period outcomes, performance measures, or their ability to complete the activities in the work plan

Awardees must describe any additional challenges (e.g., identified through evaluation results or lessons learned) encountered in the past year

CDC Program Support to Awardees Awardees should describe how CDC could assist them in

overcoming any challenges to achieve both annual and project period outcomes and performance measures, and complete activities outlined in the work plan

Administrative Reporting (not subject to page limits) SF-424A Budget Information-Non-Construction Programs Budget Narrative – Must use the format outlined in Section IV.

Content and Form of Application Submission, Budget Narrative Section

Indirect Cost Rate Agreement

For year 2 and beyond of the award awardees may request up to 75% of their estimated unobligated funds to be carried forward into the next budget period.

The carryover request must: Express a bona fide need for permission to use an unobligated balance Include a signed, dated, and accurate FFR for the budget period from

which the fund will be transferred (can request up to 75% unobligated

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balances) Include a list of proposed activities, an itemized budget, and a narrative

justification of those activities

iii. Performance Measure Reporting: CDC programs must require awardees to submit performance measures annually at a minimum, and may require reporting more frequently. Performance measure reporting should be limited to the collection of data. When funding is awarded initially, CDC programs should specify reporting frequency, required data fields, and format.

iv. Federal Financial Reporting: The annual FFR form (SF-425) is required and must be submitted through eRA Commons2 within 90 days after the end of the calendar quarter in which the budget year ends. The report should include only those funds authorized and disbursed during the timeframe covered by the report. The final report must indicate the exact balance of unobligated funds, and may not reflect any unliquidated obligations. The final FFR expenditure data and the Payment Management System’s (PMS) cash transaction data must correspond; no discrepancies between the data sets are permitted. Failure to submit the required information by the due date may affect adversely the future funding of the project. If the information cannot be provided by the due date, awardees are required to submit a letter of explanation and include the date by which the information will be provided.

v. Final Performance and Financial Report: At the end of the project period, awardees must submit a final report to include a final financial and performance report. This report is due 90 days after the end of the project period.

At a minimum, this report must include the following: Performance Measures (including outcomes) – Applicants must report

final performance data for all performance measures for the project period.

Evaluation results – Applicants must report final evaluation results for the project period

Impact of Results – Applicants must describe the effects or results of the work completed over the project period, including success stories.

Additional forms as described in the Notice of Award, including Equipment Inventory Report and Final Invention Statement.

FFR (SF-425)

2https://commons.era.nih.gov/commons/

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Awardees should e-mail the report to the CDC PO and the GMS listed in the “Agency Contacts” section of the FOA.

4. Federal Funding Accountability and Transparency Act of 2006:

Federal Funding Accountability And Transparency Act Of 2006 (FFATA), Public Law 109-282, the Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), requires full disclosure of all entities and organizations receiving Federal funds including awards, contracts, loans, other assistance, and payments through a single publicly accessible Web site, www.USASpending.gov.

Compliance with this law is primarily the responsibility of the Federal agency. However, two elements of the law require information to be collected and reported by applicants: 1) information on executive compensation when not already reported through the SAM, and 2) similar information on all sub-awards/subcontracts/consortiums over $25,000.

For the full text of the requirements under the FFATA and HHS guidelines, go to:

http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi? dbname=109_cong_bills&docid=f:s2590enr.txt.pdf,

https://www.fsrs.gov/documents/ffata_legislation_110_252.pdf http://www.hhs.gov/asfr/ogapa/aboutog/Grants%20Management

%20Information/ffata_guidelines.html.

H. Agency Contacts

The following text is required – see additional information in [brackets] that must be inserted by CDC programs:

CDC encourages inquiries concerning this announcement.For programmatic technical assistance, contact:

Elizabeth O’Mara, Project OfficerDepartment of Health and Human ServicesCenters for Disease Control and Prevention

1600 Clifton Rd MS E-29

Atlanta, GA 30333

Telephone: 404-639-4263

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Email: eco1@cdc.gov

For financial, awards management, or budget assistance, contact:

Hector Buitrago, Grants Management Specialist

Department of Health and Human Services

CDC Procurement and Grants Office

2920 Brandywine Road, Colgate Building, Rm 2710

Atlanta, GA 30341

Telephone: 770.488.2921

Email: gmf2@cdc.gov

For assistance with submission difficulties related to www.grants.gov, contact:

www.grants.gov Contact Center: 1-800-518-4726.

Hours of Operation: 24 hours a day, 7 days a week. Closed on Federal holidays.

For all other submission questions, contact:

Technical Information Management Section

Department of Health and Human Services

CDC Procurement and Grants Office

2920 Brandywine Road, MS E-14

Atlanta, GA 30341

Telephone: 770-488-2700

Email: pgotim@cdc.gov

CDC Telecommunications for individuals with hearing loss is available at: TTY 1.888.232.6348

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I. Other Information

[Insert internet web links to the CDC Program’s CIO website, any other applicable web links, and any required attachments.]

Following is a list of acceptable attachments that applicants can upload as PDF files part of their application at www.grants.gov. Applicants may not attach documents other than those listed; if other documents are attached, applications will not be reviewed.

Project Abstract Project Narrative Budget Narrative CDC Assurances and Certifications Work Plan Table of Contents for Entire Submission

[Insert optional attachments as appropriate]

Resumes/CVs Letters of support Organizational Charts Non-profit organization IRS status forms, if applicable Indirect cost rate , if applicable Memorandum of Agreement (MOA) Memorandum of Understanding (MOU) Bona Fide Agent status documentation, if applicable

J. Glossary

Administrative and National Policy Requirements, Additional Requirements (ARs): outline the Administrative requirements found in 45 CFR Part 74 and Part 92 and other requirements as mandated by statute or CDC policy. CDC programs must indicate which ARs are relevant to the FOA. All ARs are listed in the template for CDC programs. Awardees must then comply with the ARs listed in the FOA. To view brief descriptions of relevant provisions visit the CDC website at: http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm .

Authority: Legal authorizations that outline the legal basis for the components of each individual FOA. An Office of Global Council (OGC) representative may assist in choosing the authorities appropriate to any given program.

Award: Financial assistance that provides support or stimulation to accomplish a public purpose. Awards include grants and other agreements (e.g., cooperative agreements) in the form of money, or property in lieu of money,

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by the Federal Government to an eligible recipient.

Budget Period/Year: the duration of each individual funding period within the project period. Traditionally, budget period length is 12 months or 1 year.

Carryover: Unobligated Federal funds remaining at the end of any budget period that, with the approval of the GMO or under an automatic authority, may be carried forward to another budget period to cover allowable costs of that budget period (whether as an offset or additional authorization). Obligated, but unliquidated, funds are not considered carryover.

Catalog of Federal Domestic Assistance (CFDA): A catalog published twice a year which describes domestic assistance programs administered by the federal government. This government-wide compendium of Federal programs lists projects, services, and activities which provide assistance or benefits to the American public. https://www.cfda.gov/index?s=agency&mode=form&id=0bebbc3b3261e255dc82002b83094717&tab=programs&tabmode=list&subtab=list&subtabmode=list

CDC Assurances and Certifications: Standard government-wide grant application forms.

CFDA Number: The CFDA number is a unique number assigned to each program/FOA throughout its lifecycle that enables data and funding tracking and transparency.

Competing Continuation Award: An award of financial assistance which adds funds to a grant and extends one or more budget periods beyond the currently established project period.

Continuous Quality Improvement: A system that seeks to improve the provision of services with an emphasis on future results.

Contracts: An award instrument establishing a binding legal procurement relationship between CDC and a recipient obligating the latter to furnish a product.

Cooperative Agreement: An award of financial assistance that is used to enter into the same kind of relationship as a grant; and is distinguished from a grant in that it provides for substantial involvement between the Federal agency and the awardee in carrying out the activity contemplated by the award.

Cost Sharing or Matching: Refers to program costs not borne by the Federal government but required of awardees. It may include the value of allowable third-party in-kind contributions, as well as expenditures by the awardee.

Direct Assistance: assistance given to an applicant such as federal personnel or supplies. See http://www.cdc.gov/stltpublichealth/GrantsFunding/direct_assistance.html.

Federal Funding Accountability And Transparency Act Of 2006 (FFATA): Requires information on Federal awards, including awards, contracts, loans, and other assistance and payments, be made available to the public

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on a single website, www.USAspending.gov.

Fiscal Year: The year that budget dollars are allocated to fund program activities. The fiscal year starts October 1st and goes through September 30th.

Grant: A legal instrument used by the Federal government to enter into a relationship, the principal purpose of which is to transfer anything of value to a recipient to carry out a public purpose of support or stimulation authorized by statute. The financial assistance may be in the form of money, or property in lieu of money. The term does not include: a Federal procurement subject to the Federal Acquisition Regulation; technical assistance (which provides services instead of money); or assistance in the form of revenue sharing, loans, loan guarantees, interest subsidies, insurance, or direct payments of any kind to individuals. The main difference between a grant and a cooperative agreement is that there is no anticipated substantial programmatic involvement by the Federal Government under an award.

Grants.gov: A "storefront" web portal for use in electronic collection of data (forms and reports) for Federal grant-making agencies through the www.grants.gov site, www.grants.gov.

Health Disparities: are differences in health outcomes and their determinants between segments of the population, as defined by social, demographic, environmental, and geographic attributes.

Healthy People 2020: Provides national health objectives for improving the health of all Americans by encouraging collaborations across sectors, guiding individuals toward making informed health decisions, and measuring the impact of prevention activities.

Inclusion: Inclusion refers to both the meaningful involvement of community members in all stages of the program process, and maximum involvement of the target population in the benefits of the intervention. An inclusive process assures that the views, perspectives, and needs of affected communities, care providers, and key partners are actively included.

Indirect Costs: Those costs that are incurred for common or joint objectives and therefore cannot be identified readily and specifically with a particular sponsored project, program, or activity but are nevertheless necessary to the operations of the organization. For example, the costs of operating and maintaining facilities, depreciation, and administrative salaries are generally treated as indirect costs.

International public health work: For purposes of this template, is defined as work conducted internationally for the benefit of a foreign entity or jurisdiction.

Lobbying: Direct lobbying includes any attempt to influence legislation, appropriations, regulations, administrative actions or Executive Orders (“legislation or other orders”), or other similar deliberations at all levels of government through communications that directly express a view on proposed or pending legislation or other orders and which are directed to members of staff, or other employees of a legislative body or to government officials or employees who participate in the formulation of legislation or other orders. Grass Roots lobbying includes efforts directed at inducing or encouraging members of the public to contact their elected

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representatives at the Federal, State or local levels to urge support of, or opposition to, proposed or pending legislative proposals.

Maintenance of Effort: A requirement contained in authorizing legislation, regulation stating that to receive Federal grant funds a recipient must agree to contribute and maintain a specified level of financial effort for the award from its own resources or other non-Federal sources. This requirement is typically given in terms of meeting a previous base-year dollar amount.

Memorandum of Understanding (MOU)/Memorandum of Agreement (MOA): is a document describing a bilateral or multilateral agreement between parties. It expresses a convergence of will between the parties, indicating an intended common line of action. It is often used in cases where parties either do not imply a legal commitment or in situations where the parties cannot create a legally enforceable agreement.

New FOA: Any FOA that is not a continuation or supplemental award.

Non-Governmental Organization: A non-governmental organization (NGO) is any non-profit, voluntary citizens' group which is organized on a local, national or international level.

Notice of Award: The only binding, authorizing document between the recipient and CDC confirming issue of award funding. The NoA will be signed by an authorized Grants Management Officer, and provided to the recipient fiscal officer identified in the application.

Objective Review: A process that involves the thorough and consistent examination of applications based on an unbiased evaluation of scientific or technical merit or other relevant aspects of the proposal. The review is intended to provide advice to the individuals responsible for making award decisions.

OGC: Office of the General Counsel (OGC) is the legal team for the Department of Health and Human Services (HHS), providing representation and legal advice on a wide range of national issues. OGC supports the development and implementation of HHS's programs by providing legal services to the Secretary of HHS and the organization's various agencies and divisions.

Outcome: The observable benefits or changes for populations and/or public health capabilities that will result from a particular program strategy.

Performance Measures: Performance measurement is the ongoing monitoring and reporting of program accomplishments, particularly progress toward pre-established goals. It is typically conducted by program or agency management. Performance measures may address the type or level of program activities conducted (process), the direct products and services delivered by a program (outputs), or the results of those products and services (outcomes). A “program” may be any activity, project, function, or policy that has an identifiable purpose or set of objectives.

Plain Writing Act of 2010: The Plain Writing Act requires federal agencies to communicate with the public in plain language to make information and communication more accessible and understandable by intended users,

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especially people with limited health literacy skills or limited English proficiency. www.plainlanguage.gov

Procurement and Grants Office (PGO): PGO is the only entity within CDC which can obligate federal funds. PGO provides non-programmatic management for all CDC financial assistance activities (grants and cooperative agreements) and manages and awards all CDC contracts.

Program Strategies: Public health interventions or public health capabilities.

Program Official: The person responsible for developing the FOA – whether a project officer, program manager, branch chief, division leadership, policy official, center leadership, or similar staff member.

Project Period Outcome: An outcome that will result by the end of the FOA period of funding.

SAM: The System for Award Management (SAM) is the primary vendor database for the U.S. Federal Government. SAM validates applicant information and electronically shares the secure and encrypted data with the Federal agencies' finance offices to facilitate paperless payments through Electronic Funds Transfer (EFT). The SAM stores organizational information, allowing www.grants.gov to verify your identity and to pre-fill organizational information on grant applications.

Statute: An act of a legislature that declares, proscribes, or commands something; a specific law, expressed in writing. A statute is a written law passed by a legislature on the state or federal level. Statutes set forth general propositions of law that courts apply to specific situations.

Statutory Authority: A legal statute that provides the authority to establish a Federal financial assistance program or award.

Technical Assistance: The providing of advice, assistance, and training pertaining to the development, implementation, maintenance, and/or evaluation of programs.

Work Plan: The summary of annual strategies and activities, personnel and/or partners who will complete them, and the timeline for completion. The work plan will outline the details of all necessary activities that will be supported through the approved budget.

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Part III: Program Specific Global Health Activities

Project A: Birth Defects COUNT

Project Name

Birth Defects COUNT (Countries and Organizations United for Neural Tube Defects Prevention)

Funding Opportunity DescriptionInsert narrative for each header below based on content outlined in the Guidance provided.

Background

a. Background Overview

Many countries have made progress in reducing under-5 mortality due to infectious diseases. However, mortality due to birth defects has remained constant and assumes a larger proportion of under-5 mortality. Neural tube defects (NTDs) are serious birth defects of the brain and spine and are a significant cause of death and lifelong disability worldwide. It is well established that folic acid, consumed prior to and during the first few weeks of pregnancy, can significantly reduce the risk of having a NTD-affected pregnancy. Increasing folic acid intake among women of reproductive age to reduce the risk of NTDs can be achieved at the population level through fortification with folic acid of common food products. The US saw a 36% decline in NTD rates following mandatory fortification and other countries (e.g., Canada, Chile and South America) also saw significant decreases in rates. Some experts estimate that only 25% of folic acid-sensitive NTDs globally are currently being prevented. One of the key barriers to implementing effective country-level prevention strategies is the scarcity of birth defects data and the need for more systematic collection of these data, which can lead to moving prevention efforts forward. With more than 300,000 babies born with NTDs each year, a great prevention opportunity remains.

b. National Public Health Priorities and Strategies:

This program activity aligns with Objective 1.4 of the CDC Global Health Strategy, 2012-2015 and with Objective 2.3 of the CDC Global Maternal and Child Health Strategy 2013-2016

CDC Project DescriptionMaximum 2 pages, single-spaced, Calibri 12 Point, 1-inch margins.

a. Approach

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Birth Defects COUNT Logic Model Overview

Strategies and Activities Short-term Outcomes Intermediate Outcomes Long-term Outcomes

(a) Improve surveillance to drive public health action

(b) Develop and implement evidence-informed practices

(c) Enhance laboratory and technical capacity

(d) Develop and conduct program monitoring and evaluation

• Increased and improved surveillanceo Integration or enhancement of

systemso Trained workforceo Data collectedo Improved efficiencies

Increased use of evidence-informed strategieso Assessments conductedo Strategic plan(s) developed

Improved laboratory and technical capacityo Protocols/standards developedo Harmonized methodso Trained workforce

Improved monitoring and evaluation of programso Assessments conductedo Monitoring and evaluation plans

developed

Increased awareness of:o Evidence-informed practiceso Burden of birth defectso NTD prevention opportunitieso Birth defects surveillance importanceo Increased awareness of the need for

birth defects prevention and effective prevention strategies

Quality surveillance data used to:o Increase efficiencieso Improve qualityo Improve public health

practiceo Set prioritieso Inform program and

policy development and decision making

Development and implementation of effective:o Birth defects prevention

plans and strategieso Laboratory methods to

assess and monitor prevention strategies

o Data collection systemso Monitor programso Evaluate programso Use and dissemination of

monitoring and evaluation outcomes

Increased identification of birth defects

Improved quality and use of birth defects data

Established systems-level prevention strategies

Reduced morbidity and mortality associated with birth defects/NTDs

More low- and middle-resource countries with population-level NTD prevention strategies

Bold indicates project period outcomes

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i. Problem Statement:

Birth defects continue to be a cause of significant death and disability worldwide, exacting considerable social and economic burden on the families and systems of care that are ill-prepared to address them. Neural tube defects (NTDs) can result in death, lifelong disability, cognitive impairment and numerous costly medical interventions. The lifetime direct cost of care for one child born with spina bifida (a common NTD) in the US is estimated to be US$706,000. Though the majority of NTDs are preventable, worldwide, more than 300,000 babies are born with NTDs each year. Many countries do not have surveillance systems that capture NTDs and other birth defects, nor do they have the laboratory capacity to analyze blood folate concentrations to assess risk and monitor effectiveness of intervention strategies. Strengthening country-level capacity for birth defects surveillance and blood folate monitoring can have a significant impact on reducing disability and under-5 mortality and improving the health of children worldwide. In addition, having such data generated and available will enable CDC to develop interventions that may be generalizable to the United States populations and to future public health interventions.

ii. Purpose:

The purpose of this program activity is to assist country-level NTD prevention efforts by supporting the strengthening of birth defects surveillance, capacity building, evidence-informed practices and program monitoring and evaluation. Priority will be given to countries in South-East Asia, Africa and Western Pacific WHO-delineated regions.

iii. Outcomes:

Note: Bolded outcomes denote project period outcomes

Short-term• Increased and improved surveillance

o Integration or enhancement of systemso Trained workforceo Data collectedo Improved efficiencies

Increased use of evidence-informed strategieso Assessments conductedo Strategic plan(s) developed

Improved laboratory and technical capacityo Protocols/standards developedo Harmonized methods

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o Trained workforce

Improved monitoring and evaluation of programso Assessments conductedo Monitoring and evaluation plans developed

Increased awareness of:o Evidence-informed practiceso Burden of birth defectso NTD prevention opportunitieso Birth defects surveillance importanceo Increased awareness of the need for birth defects prevention and effective prevention strategies

Intermediate Quality surveillance data used to:

o Increase efficiencieso Improve qualityo Improve public health practiceo Set prioritieso Inform program and policy development and decision making

Development and implementation of effective:o Birth defects prevention plans and strategieso Laboratory methods to assess and monitor prevention strategieso Data collection systemso Monitor programso Evaluate programso Use and dissemination of monitoring and evaluation outcomes

Long-term Increased identification of birth defects Improved quality and use of birth defects data Established systems-level prevention strategies Reduced morbidity and mortality associated with birth defects/NTDs More low- and middle-resource countries with population-level NTD prevention strategies

iv. Funding Strategy:

CDC’s National Center on Birth Defects and Developmental Disabilities, Division of Birth Defects and Developmental Disabilities will provide funding support for the execution of activities resulting in

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outcomes, as stated above. Funds should be utilized for personnel, travel, supplies and equipment, or contractual support for proposed activities. Funding decisions for activities will be based on CDC’s Birth Defect priorities, existing global collaborations, ongoing activities, and the availability of funds. Applicants may apply for one or more strategy.

v. Strategies and Activities:

To achieve the outcomes and to drive country-level public health action, any or all of the following strategies and corresponding activities would be implemented:

(a) Strategy: Improve surveillance to drive public health action

Activities:

Assess existing birth defects surveillance systems and related indicators Explore the feasibility of integrating birth defects surveillance into other surveillance

systems Develop, enhance or integrate birth defects surveillance Analyze existing birth defects surveillance data and disseminate findings to aid public health

decision making Develop and conduct trainings on birth defects surveillance

(b) Strategy: Develop and implement evidence-informed practices

Activities:

Develop and conduct an in-country assessment of current or previous birth defects/NTD prevention activities

Develop and implement a strategic plan for population-level birth defects/NTD prevention to inform and advance prevention in the areas of policy, science, partnerships and communication

Promote and implement evidence-informed birth defects/NTD prevention strategies (e.g., folic acid fortification), including increasing awareness of healthcare providers and public health personnel on prevention strategies

(c) Strategy: Enhance laboratory and technical capacity

Activities:

Coordinate and collaborate with country and global experts to harmonize the use of assay

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methods for blood folate and related biomarkers Develop and disseminate protocols/standards for the collection and assessment of blood

folate and related biomarkers consistent with harmonized international standards Support mechanisms to improve the use of data to support birth defects prevention Develop and conduct training on appropriate laboratory methods

(d) Strategy: Develop and conduct program monitoring and evaluation

Activities:

Assess current methods to monitor and evaluate birth defects/NTD prevention programs Develop or enhance monitoring and evaluation of birth defects/NTD prevention programs Conduct monitoring and/or evaluation of birth defects surveillance systems, biomarkers,

policies or other appropriate measures Disseminate monitoring and evaluation results to decision makers, researchers and others,

as appropriate (including, but not limited to, submissions to peer-reviewed journals) Utilize findings to improve effective implementation of birth defects prevention programs

1. Collaborations –a. With CDC funded programs:

The applicant is encouraged to work closely with other CDC-funded programs to implement all strategies and activities, particularly the technical areas including providing expert guidance and consultation.

b. With organizations external to CDC:

The applicant is encouraged to build and expand collaborative relationships with strategic partners and donors at the international, regional and national levels to achieve greater impact and sustainability, avoid duplication of efforts, leverage funds, and expand working relationships. For example, the applicant could collaborate with experts at the regional, national, local levels located in academic centers, clinical institutions, Ministries of Health and other non-CDC governmental and non-governmental institutes and organizations whose work centers on maternal, child or perinatal health.

2. Target Populations:

Women of reproductive age

b. Evaluation and Performance Measurement:

CDC Evaluation and Performance Measurement Strategy:CDC will work with the awardees to demonstrate program impact through process and outcome/impact

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evaluation of funded activities.

Depending on what activities are funded, performance measures may include:

Process: Quantitative and qualitative reporting of process measures is expected. For each measure, reporting will include descriptions of how the work was done, what the successes and challenges were, and how problems and challenges were resolved and overcome.

Number of in-country assessments conducted Number of surveillance systems developed, enhanced or integrated Number of trainings conducted and the number and public health role of individuals who

attended Number of analyses conducted and reports/papers written Number of strategic plans developed (e.g., national, state, local) Number of birth defects/NTD prevention strategies implemented (e.g., programs, initiatives,

policies) Number of protocols and/or standards developed and disseminated

Outcome/Impact:

Increase identification of birth defects through improved surveillance systems Improve the quality and use of birth defects data to drive prevention efforts Improve efficiencies of data collection Establish systems-level, evidence-informed birth defects prevention strategies to reduce birth

defects/NTDs Increase capacity to accurately assess blood folate and related biomarkers to monitor the

impact of birth defects prevention programs Improve effective implementation of birth defects prevention programs using evaluation data

Performance measures should be reported annually. Performance measures and evaluation findings will be used to demonstrate advances in preventing birth defects/NTDs and for program quality improvement. The awardees are encouraged to work with CDC to disseminate findings from their activities and from this evaluation through reports, manuscripts, presentations and other appropriate means.

Application Review Information

a. Criteria

A review panel will evaluate complete, eligible applications for this project in accordance with the

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criteria below. See Part II, Section E, Application Review Information for further details on the review and selection process.

Ability to Carry Out the Proposal (15 points)Does the applicant demonstrate the local experience and institutional capacity (both management and technical) to achieve the goals of the FOA with documented good governance practices? (5 points)

Does the applicant have the ability to coordinate and collaborate with existing partners and other donors? Does the applicant demonstrate the ability and support to reach out to new strategic partners? To what extent does the applicant propose to work with other relevant organizations? (10 points)

Technical and Programmatic Approach (20 points)The reviewers will assess the feasibility of the applicant’s plan to meet the outcomes, congruency of application with the logic model, whether the proposed use of funds are efficient and the extent to which the specific methods described are justified as appropriate for the local culture. Does the application include an overall strategy, including measurable objectives, timelines, clear monitoring and evaluation procedures, and specific activities for meeting the proposed outcomes? (10 points) Does the applicant describe activities that are evidence-informed, realistic, achievable, measurable and culturally appropriate to achieve the goals of the FOA? (5 points) Does the application include reasonable estimates of output targets? (For example, the numbers of trainings, in-country assessments and analyses conducted.) (5 points)

Understanding of the Problem (5 points)Does the applicant demonstrate a clear and concise understanding of the current public health problem and the cultural and political context relevant to the programmatic areas targeted? (2 points) To what extent does the applicant justify the need for this FOA within the target community? (3 points)

Capacity Building (20 points)Does the applicant have a proven track record of building the capacity of indigenous organizations and individuals to accomplish similar objectives? Does the applicant have relevant experience in using participatory methods, and approaches, in project planning and implementation? Does the applicant describe an adequate and measurable plan to progressively build and/or strengthen the capacity of local organizations and target audiences to respond to the public health problem? Does the capacity building plan clearly describe how it will contribute to an evolving role to build and strengthen capacity at the local level?

Monitoring and Evaluation (15 points)Does the applicant demonstrate the local experience and capability to implement performance monitoring and rigorous evaluation of the project? Does the evaluation and performance measurement

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plan appropriately address the components specified in this announcement (i.e. key evaluation questions, types of evaluations to be conducted, performance measures (i.e., indicators), how often performance measures must be reported, how evaluation and performance measurement will track how target populations are affected by FOA strategies, how evaluation findings and performance measures will be used and yield findings to demonstrate the value of the FOA, and how results will be disseminated). Does the applicant describe the development and use of a performance monitoring system to be used to routinely review data and adjust program activities accordingly? Are there performance measures (i.e. indicators) developed for each program milestone, and incorporated into the financial and programmatic reports?

Personnel (10 points)Does the applicant provide documentation that professional personnel involved in the project are qualified and have skills and past experience needed to administer and operate this program (as evidenced by curricula vitae, publications, etc.)? Does the staff plan adequately involve local individuals and organizations?

Administration and Management (15 points)Does the applicant provide a clear plan for the administration and management of the proposed activities, and to manage the resources of the program, prepare reports, monitor and evaluate activities, audit expenditures and produce collect and analyze performance data? Is the management structure for the project sufficient to ensure speedy implementation of the project? Does the applicant describe adequate resources and facilities (both technical and administrative) for conducting the project?

Budget (Reviewed Not Scored)Is the itemized budget for conducting the project, along with justification, reasonable and consistent with stated objectives and planned program activities? Is the budget itemized, well justified and consistent with the goals of the program? If applicable, are there reasonable costs per client reached for both year one and later years of the project?

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Project B: Influenza

Project Name:

Influenza

Funding Opportunity DescriptionInsert narrative for each header below based on content outlined in the Guidance provided.

Background

a. Background Overview: The purpose of this funding is to support foreign governments through their Ministries of Health or other responsible Ministries for human health or public-health emergency preparedness to maintain and improve capacity to conduct routine influenza surveillance and detect and respond to pandemic influenza. In November 2005, the U.S. National Strategy for Pandemic Influenza was announced and the HHS Pandemic Influenza Plan was released. One of the primary objectives of both documents is to leverage global partnerships to increase preparedness and response capabilities around the world “with the intent of stopping, slowing or otherwise limiting the spread of a pandemic to the United States.” The National Strategy sets out clear goals of ensuring the rapid reporting of outbreaks and containing outbreaks beyond the borders of the United States. Through this award, CDC will support routine influenza surveillance and the maintenance of international capacity to detect, and respond to an influenza pandemic.

b. National Public Health Priorities and Strategies:

Measurable outcomes of the program will be in alignment with the HHS Pandemic Influenza Operational Plan and the President’s National Strategy for Pandemic Influenza, the principles of the International Partnership on Avian and Pandemic Influenza, and the following performance goal for the National Center for Immunization and Respiratory Diseases (NCIRD): Protect Americans from infectious diseases.

CDC Project DescriptionMaximum 2 pages, single-spaced, Calibri 12 Point, 1-inch margins.

a. Approach:

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Influenza Logic Model Overview

Strategies and Activities Short-Term Outcomes Intermediate Outcomes Long-Term Outcomes

1. Maintain the capacity of epidemiologists in routine influenza surveillance, analysis, and outbreak response

Use of trained epidemiologists to strengthen the quality of influenza surveillance and response to outbreaks.*

Use of trained epidemiologists to strengthen estimates of influenza seasonality, disease burden, and economic burden in the country*

Improved estimates of influenza disease burden in the region

Enhanced response to abnormal or irregular disease in the country.

Improved estimates of the economic burden of seasonal influenza and influenza outbreaks in the country

Improved use of influenza data/experience to formulate country-specific influenza prevention andcontrol policies

Impact of long term outcomes: Reduce health, social, and economic impacts of an influenza pandemic and other public-health emergencies

2. Maintain an information management system for influenza surveillance data

Use of an information system to improve the integration of epidemiologic and virologic information*

Maintained weekly reporting of needed influenza data in a timely manner

3. Maintain sentinel surveillance for SARI and ILI

Improved representativeness and quality of viruses/specimens sent to laboratories for analysis*

Improved national influenza data*

4. Maintain influenza testing and reporting capacity at the national laboratory

Improved detection of seasonal influenza viruses and viruses with pandemic potential*

Strengthened sharing of viruses/specimens with WHO CCs.

Strengthened participation in WHO GISRS.

Enhanced testing of other emerging respiratory viruses

5. Maintain and enhance national routine influenza surveillance reporting

Strengthened system for communicating influenza surveillance results*

Increased awareness of seasonal patterns of influenza and influenza events in the country

6. Build or enhance surveillance for outbreaks of severe respiratory and febrile illnesses

Improved communication and reporting protocol for handling suspected outbreaks *

Improved awareness among health-care, animal and community-based workers, in how to identify and report unusual cases or clusters of respiratory disease in humans or animals

Improved reporting of suspected outbreaks of severe respiratory and febrile illnesses in a timely manner.

*Indicates project period outcomes

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i. Problem Statement:

An influenza pandemic has greater potential than any other naturally occurring infectious disease event to cause large and rapid global and domestic increases in deaths and serious illnesses. Preparedness is the key to substantially reducing the health, social, and economic impacts of an influenza pandemic and other public-health emergencies. The rapid detection of influenza viruses with pandemic potential and assessment of potential impact requires both a good routine influenza surveillance system for seasonal influenza, understanding of the epidemiology of influenza in different settings and pandemic preparedness. International effort to contain and mitigate the effects of an outbreak of pandemic influenza is a central component of the overall U.S. strategy. In many ways, the character and quality of the U.S. response and that of its international partners will play a determining role in the severity of a pandemic. Gathering relevant epidemiologic data as soon as possible wherever a pandemic emerges will allow for more effective response. This project is only available to countries that have successfully completed both influenza Capacity Building and Sustainability Cooperative Agreements from Influenza Division, CDC (India, Indonesia, Thailand, China, Philippines, Pakistan, Mongolia). The support provided in this project is intended to provide funding to augment eligible countries’ national funding to maintain and strengthen influenza surveillance and detection activities, and to ensure ongoing technical assistance.

ii. Purpose:

The principal intent of this assistance is to support and strengthen existing routine influenza surveillance systems and to maintain capacity to detect, monitor and respond to and contain or mitigate transmission of novel influenza viruses among humans. A second intent is to continue support for the development of epidemiologic, virologic, and related capacity to detect, respond to, and monitor changes in influenza viruses, as well as identify outbreaks of any severe respiratory illness syndromes. A third intent is to help strengthen the ability of national institutions in different countries, especially National Influenza Centers, to more fully participate in the WHO Global Influenza Surveillance and Response System (GISRS), including sharing specimens and clinical and epidemiologic data on disease related to the circulation of influenza.

iii. Outcomes:

1. Maintain the capacity of epidemiologists in routine influenza surveillance, analysis, and outbreak response

*Short Term Outcome: Use of trained epidemiologists to strengthen the quality of influenza surveillance and response to outbreaks.

*Intermediate Outcome: Demonstrated use of epidemiologists to strengthen estimates of influenza

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seasonality, disease burden, and economic burden in the country

2. Maintain an information management system for influenza surveillance data*Short-term Outcome: Maintained use of an information system to improve the integration of epidemiologic and virologic information (See Activities 2.1-2.2)

Intermediate Outcome: Maintained weekly reporting of needed influenza data in a timely manner

3. Maintain sentinel surveillance for SARI and ILI

*Short Term Outcome: Maintained representativeness and quality of viruses/specimens sent to laboratories for analysis (See Activities 3.1-3.4)

*Intermediate Outcome: Improved national influenza data

**Note: Where resources are limited, countries may exclusively collect SARI surveillance data.

4. Maintain influenza testing and reporting capacity at the national laboratory

*Short Term Outcome: Improved detection of seasonal influenza viruses and viruses with pandemic potential (See Activities 4.1-4.7)

Intermediate Outcome: Strengthened sharing of viruses/specimens with WHO CCs. (See Activities 4.8-4.9)

Intermediate Outcome: Strengthened participation in WHO GISRS. (Activity 4.10)

Intermediate Outcome: Enhanced testing of other emerging respiratory viruses

5. Maintain national routine influenza surveillance reporting

*Short Term Outcome: Strengthened system for communicating influenza surveillance results (See Activities 5.1-5.3)

Intermediate Outcome: Increased awareness of seasonal patterns of influenza and influenza events in the country

6. Build or enhance surveillance for outbreaks of severe respiratory and febrile illnesses

*Short Term Outcome: Improved communication and reporting protocol for handling suspected outbreaks (See Activities 6.1-6.3)

Short Term Outcome: Improve awareness among health-care, animal and community-based

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workers, in how to identify and report unusual cases or clusters of respiratory disease in humans or animals

Intermediate Outcome: Improved reporting of suspected outbreaks of severe respiratory and febrile illnesses in a timely manner. Measurable Outcome : (See Activities 6.2-6.3)

* Indicates project period outcomes

iv. Funding Strategy:

Funds will be used to support foreign governments through their Ministries of Health or other responsible Ministries in countries who successfully completed five year Capacity Building and Sustainability cooperative agreements with Influenza Division, CDC. The funds can augment an established and functioning influenza surveillance system, but should be a small portion of the overall cost of the influenza surveillance program.

Approximate average award per year: $25,000 - $50,000 Eligible Countries are: India, Indonesia, Thailand, Mongolia, Philippines, Pakistan, China Approximate number of awards and amount will be based on funds available Funding decisions will be based on:

o Capacity for detecting novel viruseso Laboratory testing capacityo Evidence of past reporting of data to WHO and sharing specimenso Completeness of influenza surveillance reporting, including weekly reports to MOH and

sharing with WHO and CDC

v. Strategies and Activities:

1. Maintain the capacity of epidemiologists in routine influenza surveillance, analysis, and outbreak response

1.1. Train epidemiologists in the knowledge, skills and abilities they need to:

1.1.1.Establish and maintain sentinel sites for SARI and ILI.

1.1.2.Analyze data for weekly and annual influenza reporting.

1.1.3.Detect, investigate, respond to, and contain outbreaks of influenza

1.2. Conduct table-top exercises for epidemiologists to practice outbreak response.

2. Maintain an information management system for influenza surveillance data

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2.1. Determine information-management system needs giving consideration to sentinel site, national and WHO (including FluNet) reporting requirements

2.2. Train staff responsible for data management in the use of the information management system.

3. Maintain sentinel surveillance for SARI and ILI

3.1. Maintain at least three influenza sentinel sites with good geographic and demographic representation.

3.2. Maintain standardized data collection instruments and specimen collection, storage, packaging and transport protocols consistent with global standards for the collection of epidemiological and virological data at all SARI and ILI sites..

3.3. Maintain collection of specimens on a weekly basis from each ILI site.3.4. Maintain collection of all specimens from SARI patients at each SARI site if feasible given

laboratory constraints

4. Maintain influenza testing and reporting capacity at the national laboratory

4.1. Maintain routine and on-going influenza testing in the national laboratory

4.2. Train laboratory staff in molecular and virological techniques for influenza detection, typing and sub-typing and keep protocols up to date for evolving situations.

4.3. Use RT-PCR to identify influenza-positive specimens.4.4. Perform influenza virus isolation and typing using current WHO reagents and techniques.4.5. Maintain biosafety and biosecurity of laboratories according to national and international

standards.4.6. Participate in the WHO EQAP for influenza A detection by RT-PCR and CDC’s Performance

Evaluation Panels for influenza testing by RT-PCR.4.7. Use PCR or appropriate BSL-3 laboratories to test for H5N1 virus or novel influenza virus

subtypes and other non-influenza respiratory diseases that potentially pose a global threat.4.8. On an ongoing basis, report any novel or unsubtypable influenza A to national authorities and

WHO and ship specimens or isolates within one week to a WHO Collaborating Center.4.9. Send virus isolates or RT-PCR positive specimens to a WHO Collaborating Center at least

twice a year. Ship all isolates or a sub-set of isolates that represent a variety of sub-types, responded with low reactivity to HAI testing and are geographically and demographically representative.

4.10. Provide WHO FluNet indicators on a weekly basis to WHO GISRS4.11. Maintain regular communication with animal health laboratories that detect influenza

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viruses.

5. Maintain and enhance national routine influenza surveillance reporting

5.1. Analyze combined sentinel site data and produce a standard report on a weekly basis

5.1.1. For ILI only: number and proportion of outpatient consultations due to ILI.5.2. Distribute weekly reports to sentinel sites, the Ministry of Health, partners within the country,

WHO FluNet and CDC.

5.3. Analyze surveillance data collected throughout the year and produce an annual report.

6. Build or enhance surveillance for outbreaks of severe respiratory and febrile illnesses

6.1. Develop a system, with written protocols, for the rapid dissemination of information between different levels of government for the purposes of reporting suspect cases or clusters of severe respiratory and febrile illnesses.

6.2. Maintain communication materials to alert health-care, animal workers and community based workers in how to identify and report unusual cases or clusters of respiratory disease in humans or animals. Include information on high risk patients or situations.

6.3. Participate in the WHO Global Influenza Surveillance and Response System (GISRS) to share specimens and/or virus isolates from suspect cases or clusters of severe respiratory and febrile illness in a timely manner.

1. Collaborations –a. With CDC funded programs:

Not applicable

b. With organizations external to CDC:

Not applicable

2. Target Populations:

Not applicable

b. Evaluation and Performance Measurement:

CDC Evaluation and Performance Measurement Strategy:Measurable goals and evaluation criteria for receipt of these funds are as follows:

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1. Capacity of Epidemiologists for routine influenza surveillance, analysis, outbreak responsea. Number of trainings held on routine influenza surveillance and outbreak responseb. Number of table top exercises held on outbreak responsec. Number of influenza outbreaks for which a response was conductedd. Number of manuscripts produced by country epidemiologists

2. Information Management Systema. Number of weeks/year for which virological data is available for the country on

theWHOFluNet websiteb. Ability of national authorities and sentinel sites to access up-to-date influenza

summary data3. Sentinel Surveillance

a. Epidemiological and virological data collected, analyzed, and published to MOH, WHO (including FluNet) and CDC, preferably on a weekly basis

b. Coverage of sentinel sites (Number of sites by region, population, etc)per yearc. Number of specimens collected from ILI and SARI sites per month

4. Influenza Testing and Reporting Capacitya. Number of specimens tested for influenza and percent positive specimens identified by

RT-PCRb. Number of influenza viruses isolated and subtyped and shared with WHOc. Participation and score in WHO EQAP for Influenza A detection by RT-PCRd. Number of unsubtypable or novel viruses reported to WHO

5. National Routine Influenza Surveillance Reportinga. Number of weekly reports produced and distributed to CDC, WHO and national

authoritiesb. Production of annual report on influenza surveillance

6. Surveillance for Outbreaksa. System and protocols in place for information sharing during potential outbreaksb. Suspect cases and clusters of severe respiratory and febrile illness reported to WHO

Application Review Information

a. Criteria

A review panel will evaluate complete eligible applications for this project in accordance with the criteria below. See Part II, Section E, Application Review Information for further details on the review and selection process.

Technical and Programmatic Approach (30 points)The reviewers will assess the feasibility of the applicant’s plan to meet the outcomes, congruency of application with the logic model, and whether the proposed use of funds is efficient. Does the application present a clear and detailed plan for maintaining and strengthening the existing routine

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influenza surveillance system? Does the plan clearly and appropriately address all recipient activities? Does the applicant describe specific objectives of the proposed program consistent with the purpose and measurable outcomes of this announcement, and which are specific and measurable? (10 points)Does the applicant clearly identify specific persons responsible for each key activity? Does the plan clearly describe the applicant’s technical approach/methods for developing and conducting the proposed program, and does it appear feasible and adequate to accomplish the objectives? Does the applicant describe funding received or anticipated from other sources to perform the same or similar activities? (10 points) Does the applicant describe the existence of or plans to establish partnerships needed to accomplish objectives? Does the applicant describe adequate and appropriate collaborations with other international organizations, other national health agencies, as well as national Government authorities responsible for public health emergency preparedness and animal health? (10 points)

Background and Need (10 points)Does the applicant adequately discuss the background for the proposed project and the progress made during the previous cooperative agreements with CDC Influenza Division? (5 points) Does the applicant illustrate and justify the need for the proposed project, consistent with the purpose and objectives of this program? (5 points)

Capacity (30 points)Does the applicant have the necessary laboratory testing capacity to achieve the goals and objectives of the program? Does the applicant have a track record of using RT-PCR to identify influenza-positive specimens? Does the applicant have a track record of performing influenza virus isolation and typing using current WHO reagents and techniques? (10 points) Does the applicant provide evidence of past reporting of data to WHO and sharing specimens with a WHO Collaborating Center? Does the applicant demonstrate the capacity to detect novel viruses? Does the applicant provide a clear plan to report any novel or unsubtypable influenza A to national authorities and WHO and to ship specimens or isolates within one week to a WHO Collaborating Center? (10 points) Does the applicant demonstrate the capacity to produce and distribute influenza surveillance reports, including a proven track record of distributing reports to sentinel sites, the Ministry of Health, partners within the country, WHO FluNet and CDC? (10 points)

Monitoring and Evaluation (20 points)Does the applicant demonstrate the capability to implement performance monitoring and rigorous evaluation of the project? Does the evaluation and performance measurement plan appopriately address the components specified in this announcement (i.e. key evaluation questions, types of evaluations to be conducted, performance measures (i.e., indicators), how often performance measures must be reported, how evaluation findings and performance measures will be used and yield findings to demonstrate the value of the FOA, and how results will be disseminated). Does the applicant describe a performance monitoring system used to routinely review data and adjust program activities accordingly? Are there performance measures (i.e. indicators) developed for each program milestone,

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and incorporated into the financial and programmatic reports?

Administration and Management (10 points)Does the applicant provide a clear plan for the administration and management of the proposed activities, and to manage the resources of the program, prepare reports, monitor and evaluate activities, audit expenditures and produce collect and analyze performance data? Is the management structure for the project sufficient to ensure speedy implementation of the project? Does the applicant describe adequate resources and facilities (both technical and administrative) for conducting the project? Does the applicant provide documentation that professional personnel involved in the project are qualified and have skills and past experience needed to administer and operate this program (as evidenced by curricula vitae, publications, etc.)?

Budget (Reviewed Not Scored)Is the itemized budget for conducting the project, along with justification, reasonable and consistent with stated objectives and planned program activities? Is the budget itemized, well justified and consistent with the goals of the program?

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Project C: Global Health Security

Project Name

Global Health Security

Funding Opportunity DescriptionInsert narrative for each header below based on content outlined in the Guidance provided.

Background

a. Background Overview

An interconnected world is increasing the opportunities for human, animal and zoonotic diseases to emerge and spread globally. Today’s health security threats arise from at least 5 sources: the emergence and spread of new microbes; the globalization of travel and food supply; the rise of drug-resistant pathogens; the acceleration of biological science capabilities and the risk that these capabilities may cause the inadvertent or intentional release of pathogens; and continued concerns about terrorist acquisition, development, and use of biological agents. Since the emergence of Severe Acute Respiratory Syndrome in 2003, the world has made great progress in strengthening local, regional, and international capacity to prevent, detect and respond to emerging infectious disease threats. Yet, despite important accomplishments, much remains to be done. The recent emergence of the H7N9 influenza virus and Middle East Respiratory Syndrome Coronavirus underscore infectious disease as a serious global threat. Ongoing vulnerabilities include geographic areas with limited disease surveillance systems, reluctance to share outbreak information or biological samples, emergence of new pathogens and development of drug-resistance, and the specter of intentional or accidental release of biological agents. Multi-sectoral collaboration and the combined resources and expertise of the health and security sectors will be required to efficiently match resources to needs, avoid redundant efforts, and identify gaps.

b. National Public Health Priorities and Strategies:

The Global Health Security Branch (GHSB), in partnership with other U.S. government agencies, helps countries meet key WHO International Health Regulation requirements through Global Health Security

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implementation activities. GHSB supports U.S. commitments under Article 44 of the International Health Regulations, as well the international priorities of Presidential Policy Directive #2 “National Strategy for Countering Biological Threats”.

CDC Project DescriptionMaximum 2 pages, single-spaced, Calibri 12 Point, 1-inch margins.

a. Approach:

CDC’s approach to global health security is based on prevention, detection and response. These three concepts are embedded in our agency’s history, collaborations, and mission to protect public health worldwide.

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Global Health Security Logic Model Overview* During the project period awardees are expected to achieve the short-term outcomes.

Strategies and Activities Short-Term Outcomes Long-Term OutcomesLaboratory Systems:

Strengthen the nationwide laboratory system’s capacity for detection, specimen referral, and laboratory confirmation of an agreed upon number of priority pathogens.

Develop infrastructure to obtain and transport specimens from any part of the country.

Develop Multi-hazard National Public Health Emergency Preparedness and Response Plan

Information Systems: Integrate data sources from disease

surveillance, laboratory information systems and EOC dashboards to improve public health decisions during emergencies.

Workforce Development: Train and deploy an effective biosurveillance

workforce including physicians, veterinarians, biostatisticians, laboratory scientists, and field epidemiologists, who can systematically cooperate to meet relevant International Health Regulations (IHR) and Performance of Veterinary Services (PVS) core competencies

Train field epidemiologists (at least 1 per 200,000 population) whose data analysis informs evidence-based policy, investigating outbreaks and conducting event-based surveillance

Emergency Operations Centers: Establish a central point for epidemic response

and information exchange Strengthen existing information channels and

reduce response times.

Improved laboratory diagnostic capabilities to identify a range of emerging pathogens using a broad spectrum of laboratory testing methodologies, and an established mechanism for further characterization of critical unknowns.

Improved ability to monitor and slow Antimicrobial Resistance (AMR) and report results as appropriate to international or IHR focal points.

Improved ability to identify, hold, secure, and monitor collections of especially dangerous pathogens in a minimal number of facilities with biosafety and biosecurity best practices in place

Strengthened surveillance information systems capable of detecting potential Public Health Event of International Concern (PHEIC) in any part of the country are established and functioning.

Information systems able to reliably detect and respond to disease outbreaks, including zoonotic, food safety, chemical, and radiological emergencies

Trained public health personnel able to detect at least three of five syndromes indicative of a potential PHEIC

Increased coordination among relevant personnel from multiple sectors to implement IHR core capacity requirements

Increased adoption of behaviors, policies and/or practices that minimize the spillover of zoonotic diseases into human populations

National Focal Point functions and operations are in place

Effective implementation of Multi-hazard National Public Health Emergency Preparedness and Response Plan

Adequate numbers of trained personnel available to support the response to a PHEIC

Established mechanisms for effective risk communication during a public health emergency are in place

Improved coordination to detect and respond to PHEICs among relevant sectors (agriculture, security, human health)

GLOBAL HEALTH SECURITY Prevent avoidable epidemics

through− Evidence-based policies and

decision making− More secure labs working with

dangerous pathogens− Decreased drug resistance− Ensuring a safe food and drug

supply

Detect threats early by− Providing technical expertise

and mentoring to MoH staff− Improving surveillance systems− Strengthening lab systems to

characterize pathogens

Respond rapidly and effectively to public health events of international concern by

− Ensuring host country detection efforts guide response

− Building local emergency response expertise

− Creating interconnected emergency operations centers

− Strengthening the public health workforce

− Improving information management and technology infrastructure to support decision making

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i. Problem Statement:

The world is a dangerous place, full of old and new pathogens that can move great distances in less time than ever before. People all over the world are vulnerable to the emergence and spread of new microbes, facilitated by the globalization of travel and trade, the rise of drug resistance, and the potential of laboratories to make and release, intentionally or not, dangerous pathogens.

ii. Purpose:

The purpose of this funding is to promote a world safe and secure from global health threats where we can prevent or mitigate the impact of naturally occurring outbreaks and intentional or accidental releases of dangerous pathogens, rapidly detect and transparently report outbreaks when they occur, and employ an interconnected global network that can respond effectively to limit the spread of infectious disease outbreaks in humans and animals, mitigate human suffering and the loss of human life, and reduce economic impact.

iii. Outcomes:

Eligible applicants are encouraged to request funding only for those strategies and activities which are achievable in their country during the project period. Depending upon what is requested by the applicant, awardees will be expected to achieve corresponding short-term outcomes from the following list:

Improved laboratory diagnostic capabilities to identify a range of emerging pathogens using a broad spectrum of laboratory testing methodologies, and an established mechanism for further characterization of critical unknowns.

Improved ability to monitor and slow Antimicrobial Resistance (AMR) and report results as appropriate to international or IHR focal points.

Improved ability to identify, hold, secure, and monitor collections of especially dangerous pathogens in a minimal number of facilities with biosafety and biosecurity best practices in place

Strengthened surveillance information systems capable of detecting potential Public Health Event of International Concern (PHEIC) in any part of the country are established and functioning.

Information systems able to reliably detect and respond to disease outbreaks, including zoonotic, food safety, chemical, and radiological emergencies

Trained public health personnel able to detect at least three of five syndromes indicative of a potential PHEIC

Increased coordination among relevant personnel from multiple sectors to implement IHR core

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capacity requirements Increased adoption of behaviors, policies and/or practices that minimize the spillover of zoonotic

diseases into human populations National Focal Point functions and operations are in place

Effective implementation of Multi-hazard National Public Health Emergency Preparedness and Response Plan

Adequate numbers of trained personnel available to support the response to a PHEIC Established mechanisms for effective risk communication during a public health emergency are in

place Improved coordination to detect and respond to PHEICs among relevant sectors (agriculture,

security, human health)

It is expected that achieving the short-term outcomes will lead to the long-term outcomes identified below and in the logic model. Awardees are expected to make progress toward the long-term goals, but not achieve all of them by the end of the project period.

Prevent avoidable epidemics through− Evidence-based policies and decision making− Improving the safety and security of labs working with dangerous pathogens− Decreased drug resistance− Ensuring a safe food and drug supply

Detect threats early by− Strengthening and developing technical expertise of MoH staff− Improving surveillance systems− Strengthening lab systems to characterize pathogens

Respond rapidly and effectively to public health events of international concern by− Ensuring host country detection efforts guide response− Building local emergency response expertise− Creating interconnected emergency operations centers− Strengthening the public health workforce− Improving information management and technology infrastructure to support decision making

iv. Funding Strategy:

Funds should be used for personnel, travel, supplies and equipment, or contractual support for proposed activities.

v. Strategies and Activities:

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Laboratory Systems: Strengthen the nationwide laboratory system’s capacity for detection, specimen referral,

and laboratory confirmation of an agreed upon number of priority pathogens. Develop infrastructure to obtain and transport specimens from any part of the country. Develop Multi-hazard National Public Health Emergency Preparedness and Response Plan

Information Systems: Integrate data sources from disease surveillance, laboratory information systems and EOC

dashboards to improve public health decisions during emergencies.

Workforce Development: Train and deploy an effective biosurveillance workforce including physicians, veterinarians,

biostatisticians, laboratory scientists, and field epidemiologists, who can systematically cooperate to meet relevant International Health Regulations (IHR) and Performance of Veterinary Services (PVS) core competencies

Train field epidemiologists (at least 1 per 200,000 population) whose data analysis informs evidence-based policy, investigating outbreaks and conducting event-based surveillance

Emergency Operations Centers: Establish a central point for epidemic response and information exchange Strengthen existing information channels and reduce response times.

1. Collaborations –a. With CDC funded programs:

Collaborations and synergies with other CDC programs are encouraged.

b. With organizations external to CDC:

Collaborations and synergies with external organizations and other donors are encouraged.

2. Target Populations:

n/a

b. Evaluation and Performance Measurement:

CDC Evaluation and Performance Measurement Strategy:

Monitoring activities include routine and ongoing communication between CDC and awardees, site visits, and awardee reporting (including work plans, performance, and financial reporting). The HHS Grants Policy Administration Manual (GPAM) specifies the following HHS expectations for post-award monitoring for grants and cooperative agreements:

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Tracking awardees progress in achieving the desired outcomes. Insuring the adequacy of awardee systems that underlie and generate data reports. Creating an environment that fosters integrity in program performance and results.

Monitoring may also include the following activities:

Ensuring that work plans are feasible based on the budget and consistent with the intent of the award.

Ensuring that awardees are performing at a sufficient level to achieve objectives within stated timelines.

Working with awardees on adjusting the work plan based on achievement of objectives and changing budgets.

Monitoring performance measures (both programmatic and financial) to assure satisfactory performance levels.

Other activities deemed necessary to monitor the award, if applicable.

Application Review Information

a. Criteria

A review panel will evaluate complete, eligible applications for this project in accordance with the criteria below. See Part II, Section E, Application Review Information for further details on the review and selection process.

Ability to Carry Out the Proposal (15 points)Does the applicant demonstrate the local experience and institutional capacity (both management and technical) to achieve the goals of the FOA with documented good governance practices? (5 points) Does the applicant have the ability to coordinate and collaborate with existing partners and other donors? To what extent does the applicant provide letters of support? (5 points) Where applicable, does the applicant have the capacity to reach rural and other underserved populations? Where applicable, does the organization have the ability to target audiences that frequently fall outside the reach of the traditional media, and in local languages? (5 points)

Technical and Programmatic Approach (20 points)The reviewers will assess the feasibility of the applicant’s plan to meet the outcomes, congruency of application with the logic model, whether the proposed use of funds is efficient and the extent to which the specific methods described are appropriate for the local culture. Does the application include an

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overall strategy, including measurable timelines, clear monitoring and evaluation procedures, and specific activities for meeting the proposed outcomes? (5 points) Does the applicant describe activities that are evidence-based, realistic, achievable, measurable and culturally appropriate to achieve the goals of the FOA? (10 points) Does the application include reasonable estimates of output targets? (For example, the numbers of sites to be supported, number of clients the program will reach.) To what extent does the applicant propose to work with other organizations? (5 points)

Understanding of the Problem (10 points)Does the applicant demonstrate a clear and concise understanding of the current public health problem and the cultural and political context relevant to the programmatic areas targeted? (5 points) To what extent does the applicant justify the need for this FOA within the target community? (5 points)

Capacity Building (15 points)Does the applicant have a proven track record of building the capacity of indigenous organizations and individuals? Does the applicant have relevant experience in using participatory methods, and approaches, in project planning and implementation? Does the applicant describe an adequate and measurable plan to progressively strengthen the capacity of local organizations and target beneficiaries to respond to the public health problem? If not a local indigenous organization, does the applicant articulate a clear exit strategy which will maximize the sustainability of project results in the intervention communities? Does the capacity building plan clearly describe how it will contribute to (if not a local indigenous organization) an evolving role of the prime beneficiary with transfer of critical technical and management competence to local organizations/sites in support of a decentralized response?

Monitoring and Evaluation (20 points)Does the applicant demonstrate the local experience and capability to implement performance monitoring and rigorous evaluation of the project? Does the evaluation and performance measurement plan appopriately address the components specified in this announcement (i.e. key evaluation questions, types of evaluations to be conducted, performance measures (i.e., indicators), how often performance measures must be reported, how evaluation and performance measurement will track how target populations are affected by FOA strategies, how evaluation findings and performance measures will be used and yield findings to demonstrate the value of the FOA, and how results will be disseminated). Does the applicant describe a performance monitoring system used to routinely review data and adjust program activities accordingly? Are there performance measures (i.e. indicators) developed for each program milestone, and incorporated into the financial and programmatic reports?

Personnel (10 points)Does the organization employ staff fluent in local languages who will work on this project? Are the staff roles clearly defined? As described, will the staff be sufficient to meet the goals of the proposed project? If not an indigenous organization, does the staff plan adequately involve local individuals and organizations? Are staff involved in this project qualified to perform the tasks described?

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Administration and Management (10 points)Does the applicant provide a clear plan for the administration and management of the proposed activities, and to manage the resources of the program, prepare reports, monitor and evaluate activities, audit expenditures and produce collect and analyze performance data? Is the management structure for the project sufficient to ensure speedy implementation of the project? If appropriate, does the applicant have a proven track record in managing large budgets; running transparent and competitive procurement processes; supervising consultants and contractors; using subgrants or other systems of sharing resources with community based organizations, faith based organizations or smaller non-governmental organizations; and where appropriate providing technical assistance in health system stregnthening activities such as laboratory management?

Budget (Reviewed Not Scored)Is the itemized budget for conducting the project, along with justification, reasonable and consistent with stated objectives and planned program activities? Is the budget itemized, well justified and consistent with the goals of the program? If applicable, are there reasonable costs per client reached for both year one and later years of the project?

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Project D: Global Noncommunicable Diseases and Injuries

Project Name

Global Noncommunicable Diseases (NCDs) and Injuries

Funding Opportunity Description

Background

a. Background Overview

This program activity will address the substantial and growing global public health problem of noncommunicable diseases (NCDs), which include chronic diseases and injuries such as those caused by motor vehicle crashes, by supporting NCD surveillance, capacity building, and program implementation and evaluation.

b. National Public Health Priorities and Strategies:

This program activity aligns with Objective 1.8 of the CDC Global Health Strategy, 2012-2015: Reduce Burden of Non-communicable Diseases; and supports the U.S. Department of Health and Human Service’s Global Strategy, specifically, Strategy Objective 1: Enhance Global Health Surveillance and Objective 8: Address the Changing Global Pattern of Death, Illness and Disability.

CDC Project DescriptionMaximum 2 pages, single-spaced, Calibri 12 Point, 1-inch margins.

a. Approach:

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Global Non-Communicable Disease (NCD) and Injury Logic Model Overview

Strategies and Activities Short-Term Outcomes Intermediate Outcomes Long-term OutcomesNCD/Injury Surveillance Develop NCD/Injury surveillance indicators

and systems Evaluate and enhance existing NCD/Injury

surveillance systems Support analysis and interpretation of

surveillance data, and disseminate findings

Improved NCD/Injury surveillance systems*

Better quality NCD/Injury surveillance data*

More information available for decision-making on NCD/Injury priorities and activities

Sustained NCD/Injury surveillance systems

NCD/Injury Capacity Building Develop and conduct trainings on NCD/Injury

prevention and control Develop and disseminate tool kits, case

studies, and other capacity building materials Support mechanisms to improve mentorship

for NCD/Injury trainees Support FE(L)TP programs to enhance

NCD/Injury activities Develop and conduct in-country assessments

of NCD/Injury capacity

Stronger materials and strategies to train local staff on NCD/Injury prevention and control*

More NCD/Injury mentors engaged in training*

Trained workforce that is better able to address NCDs and injuries in their country*

Sufficient workforce to address NCDs and injuries

NCD/Injury Project Implementation and Evaluation Promote and implement NCD/Injury

prevention and control strategies Evaluate NCD/Injury prevention programs,

initiatives, policies, and systems Develop and disseminate NCD/Injury

treatment and control protocols Develop strategic plans to address NCD/Injury

prevention and control Support communication strategies and plans

that address NCDs and injuries

Better understanding of the effectiveness of ongoing NCD/Injury prevention and control strategies*

More availability of standardized NCD/Injury treatment and control protocols*

More countries with population-level NCD/Injury strategic plans*

Increased use of evidence-based NCD/Injury prevention and control strategies*

Decreases in NCD/Injury risk factors on the population level

Sustained NCD/Injury prevention and control programs and initiatives

More effective utilization of resources

Increased recognition by high-level country leadership that NCDs and injury are critical public health priorities

Decrease in NCD/Injury morbidity and mortality

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* Indicates project period outcomes

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i. Problem Statement:

Noncommunicable diseases (NCDs) are responsible for almost three quarters of all deaths worldwide. These include deaths caused by injuries such as motor vehicle injuries and chronic diseases, such as cardiovascular disease, cancer, diabetes, and chronic respiratory diseases. More than 80 percent of NCD-related deaths are in low- and middle-income countries, where health systems are often not equipped to respond, and nearly a third of those deaths occur before age 60. The enormous social and economic toll of NCDs worldwide calls for an integrated strategic approach to reduce illnesses and deaths due to NCDs globally.

ii. Purpose:

This program activity will address the global problem of NCDs (including injuries) by supporting surveillance, capacity building, and program implementation and evaluation. Outcomes, findings, and experiences from country-specific work could be used by other countries to inform their own NCD strategies and activities.

iii. Outcomes:

Improved NCD/injury surveillance systems Better quality NCD/injury surveillance data Stronger materials and strategies to train local staff on NCD/injury prevention and control More NCD/Injury mentors engaged in training Trained workforce that is better able to address NCDs and injuries in their country Increased use of evidence-based NCD/injury prevention and control strategies Better understanding of the effectiveness of ongoing NCD/injury prevention and control

strategies More availability of standardized NCD/injury treatment and control protocols More countries with population-level NCD/injury strategic plans

iv. Funding Strategy:

The NCD Unit in CDC’s Center for Global Health will provide funding support for the execution of activities resulting in outcomes, as stated above. Funds should be utilized for personnel, travel, supplies and equipment, or contractual support for proposed activities. Funding decisions for activities will be based on CDC’s NCD priorities, existing global collaborations, ongoing NCD activities, and the availability of funds.

v. Strategies and Activities:

NCD/Injury Surveillance

Develop population-based NCD surveillance indicators and systems

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Assess, evaluate, and enhance existing NCD surveillance systems Support analysis and interpretation of existing surveillance data, and disseminate findings to aid

public health decision making

NCD/Injury Capacity Building

Develop and conduct trainings on NCD prevention and control Develop and disseminate tool kits, case studies, and other capacity building materials that

promote NCD prevention and control Support mechanisms to improve mentorship for NCD trainees Support FE(L)TP programs to enhance NCD activities Develop and conduct in-country assessments of NCD capacity

NCD/Injury Project Implementation and Evaluation

Promote and implement evidence-based NCD prevention and control strategies Systematically evaluate NCD prevention and control programs, initiatives, policies, and systems Develop and disseminate NCD treatment and control protocols Develop strategic plans to address population-level NCD prevention and control Support communication strategies and plans that address NCDs

1. Collaborations –a. With CDC funded programs:

The applicant is encouraged to work closely with other CDC-funded programs to implement all strategies and activities, particularly the technical areas including providing expert guidance and consultation and developing scientific manuscripts and other dissemination products.

b. With organizations external to CDC:

The applicant is encouraged to foster and strengthen collaborative relationships with strategic partners at the international and regional levels to achieve greater impact and sustainability, avoid duplication of efforts, leverage funds, and expand working relationships. For example, the applicant could collaborate with experts at the regional, national, and local levels, academic centers, clinical institutions, Ministries of Health and other non-CDC governmental and non-governmental institutes and organizations whose work centers on prevention of NCDs and injuries.

2. Target Populations:

Not applicable

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b. Evaluation and Performance Measurement:

CDC Evaluation and Performance Measurement Strategy:CDC will work with the awardees to demonstrate program impact through process and outcome evaluation of funded activities.

Depending on what activities are funded, performance measures may include:

Number of surveillance systems supported Number of analyses conducted and reports/papers written Number of capacity building trainings conducted and the number of individuals who attended Number of tool kits, case studies, and capacity building materials developed Number of in-country capacity assessments conducted Number of NCD/injury prevention and control strategies (e.g., programs, initiatives, policies)

supported Number of protocols and strategic plans developed

Performance measures should be reported annually. Performance measures and evaluation findings will be used to demonstrate advances in preventing and controlling NCDs and for program quality improvement. The awardees are encouraged to work with CDC to disseminate finding from their activities and from this evaluation through reports, manuscripts, and presentations.

Application Review Information

a. Criteria

A review panel will evaluate complete, eligible applications for this project in accordance with the criteria below. See Part II, Section E, Application Review Information for further details on the review and selection process.

Ability to Carry Out the Proposal (15 points)Does the applicant demonstrate the local experience in [country] and institutional capacity (both management and technical) to achieve the goals of the FOA with documented good governance practices, specific to noncommunicable disease (NCD)/injuryprojects and surveillance systems? (5 points) Does the applicant have the ability to coordinate and collaborate with existing partners and other donors? To what extent does the applicant provide letters of support? (5 points) Where applicable, does the applicant have the capacity to reach rural and other underserved populations in [Country]? Where applicable, does the organization have the ability to target audiences that frequently fall outside the reach of the traditional media, and in local languages? (5 points)

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Technical and Programmatic Approach (20 points)The reviewers will assess the feasibility of the applicant’s plan to meet the outcomes, congruency of application with the logic model, whether the proposed use of funds is efficient and the extent to which the specific methods described are appropriate for the local culture. Does the application include an overall strategy, including measurable timelines, clear monitoring and evaluation procedures, and specific activities for meeting the proposed outcomes? (5 points) Does the applicant describe activities that are evidence-based, realistic, achievable, measurable and culturally appropriate to achieve the goals of the FOA? (5 points) Does the application include reasonable estimates of output targets? (For example, the numbers of sites to be supported, number of clients the program will reach.) Are output targets aligned with project period outcomes? To what extent does the applicant propose to work with other organizations? (5 points) Does the applicant have experience developing and conducting country assessment of NCD or injury capacity? (5 points)

Understanding of the Problem (10 points)Does the applicant demonstrate a clear and concise understanding of the current public health problem and the cultural and political context relevant to the programmatic areas targeted? (5 points) To what extent does the applicant justify the need for this FOA within the target community? (5 points)

Capacity Building (15 points)Does the applicant have a proven track record of building the capacity in-country by improving mentorship of traniees or experience in programs such as FE(L)TP specific to NCD or injury ? (2 points) Does the applicant have relevant experience in using participatory methods, and approaches, in project planning and implementation? (2 points) Does the applicant have the relevant experience to conduct trainings and develop and disseminate toolkits, guidelines, case studies and other capacity building materials? (2 points) Does the applicant describe an adequate and measurable plan to progressively strengthen the capacity of local organizations and target beneficiaries to respond to the public health problem? (5 points) If not a local indigenous organization, does the applicant articulate a clear exit strategy which will maximize the sustainability of project results in the intervention communities? (2 points) Does the capacity building plan clearly describe how it will contribute to (if not a local indigenous organization) an evolving role of the prime beneficiary with transfer of critical technical and management competence to local organizations/sites in support of a decentralized response? (2 points)

Monitoring and Evaluation (20 points)Does the applicant demonstrate the local experience and capability to implement performance monitoring and rigorous evaluation of the project? (5 points) Does the evaluation and performance measurement plan appopriately address the components specified in this announcement (i.e. key evaluation questions, types of evaluations to be conducted, performance measures (i.e., indicators), how often performance measures must be reported, how evaluation and performance measurement will track how target populations are affected by FOA strategies, how evaluation findings and performance measures will be used and yield findings to demonstrate the value of the FOA, and how results will be disseminated). (5 points) Does the applicant describe a performance monitoring system

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used to routinely review data and adjust program activities accordingly? (5 points) Are there performance measures (i.e. indicators) developed for each program milestone, and incorporated into the financial and programmatic reports? (5 points)

Personnel (10 points)Does the organization employ staff fluent in local languages who will work on this project? Are the staff roles clearly defined? As described, will the staff be sufficient to meet the goals of the proposed project? If not an indigenous organization, does the staff plan adequately involve local individuals and organizations? Are staff involved in this project qualified to perform the tasks described?

Administration and Management (10 points)Does the applicant provide a clear plan for the administration and management of the proposed activities, and to manage the resources of the program, prepare reports, monitor and evaluate activities, audit expenditures and produce collect and analyze performance data? Is the management structure for the project sufficient to ensure speedy implementation of the project? If appropriate, does the applicant have a proven track record in managing large budgets; running transparent and competitive procurement processes; supervising consultants and contractors; using subgrants or other systems of sharing resources with community based organizations, faith based organizations or smaller non-governmental organizations; and where appropriate providing technical assistance in health system stregnthening activities such as laboratory management?

Budget (Reviewed Not Scored)Is the itemized budget for conducting the project, along with justification, reasonable and consistent with stated objectives and planned program activities? Is the budget itemized, well justified and consistent with the goals of the program? If applicable, are there reasonable costs per client reached for both year one and later years of the project?

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Project E: Strengthening Global Public Health Capacity to Prevent and Control Emerging and Zoonotic Infections Diseases

Project Name

NCEZID: Strengthening Global Public Health Capacity to Prevent and Control Emerging and Zoonotic Infectious Diseases

Funding Opportunity Description

Background

a. Overview:

The National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) is one of the CDC’s principal sources of epidemiologic and laboratory expertise about bacterial, viral, and fungal pathogens as well as infectious diseases of unknown origin. Because pathogens can quickly spread across the globe, NCEZID works with countries to enhance public health capacity, increase health security, and reduce the spread and importation of disease. NCEZID seeks to improve global public health by protecting people from:

Foodborne and waterborne illnesses Deadly infectious diseases Diseases that can be spread by animals and vectors Infections in healthcare facilities or drug-resistant threats Pathogens that can be used as agents of bioterrorism Illnesses that cross borders and affect refugees, immigrants, and travelers

b. National Public Health Priorities and Strategies:

Projects funded by NCEZID will support its mission to reduce illness and death associated with emerging and zoonotic infectious diseases and to protect against the unintentional or intentional spread of infectious diseases nationally and globally.Additionally, this work contributes to accomplishing the objectives of the 2014 U.S. Department of State 5-Year Global Health Security Agenda across the following areas:

1. Domestic and regional commitments, including activities undertaken to improve domestic global health security capacity and commitments across borders that bring together nations and/or organizations to achieve a larger national or regional global health security objectives; and

2. Transparent sharing of information commitments, including efforts to share lessons learned and

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to foster transparency and information sharing when outbreaks occur.

This work also contributes to accomplishing the CDC ‘Healthy People 2020’ Global Health and Preparedness objectives across the following areas:

1. Improve public health and strengthen U.S. national security through global disease detection, response, prevention, and control strategies; and

2. Improve the Nation’s ability to prevent, prepare for, respond to, and recover from a major health incident.

CDC Project Description

a. Approach:

Strategies and Activities Short-Term Outcomes Long-Term Outcomes

Strengthen public health fundamentals in infectious disease surveillance, laboratory science, and epidemiologic investigation

Increased capacity to collect, analyze, and share infectious disease data for local public health action

Improved integration of epidemiologic and laboratory data

Improved public health communication and training

A solid foundation of systems for laboratory, surveillance, and epidemiologic investigation necessary for public health decision-making

Support the implementation of evidence-based interventions to prevent and control infectious diseases

Increased use of tools and interventions that will reduce infectious diseases and improve infection control and treatment

Reduced illness and death associated with infectious diseases

Strengthen public health preparedness, safety, and biosecurity as related to the spread of high-consequence infectious diseases as well as to emerging pathogens

Increased ability to detect, assess, and contain public health threats when and where they occur

Improved planning and operational preparedness

Global capacity to rapidly detect and respond to outbreaks of public health significance

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to disease threats

i. Problem Statement:

The regular emergence of new pathogens and the rise in antimicrobial resistance underscore the importance of national and global preparedness to understand and detect the transmission of pathogens where they naturally occur. The revised International Health Regulations (IHR) addressed the need for countries to develop strong health systems capable of detection of and response to public health threats having potential cross border impact. NCEZID seeks to aid developing countries to comply with IHR in the core capacities critical to preventing the dissemination of infectious agents and protecting public health - surveillance, response, and laboratory.

ii. Purpose:

The purpose of this FOA is to enable NCEZID to support countries in strengthening core capacity in surveillance, response, and laboratories to work collaboratively to develop sustainable systems that can detect, prevent, and control emerging and zoonotic infectious diseases across a range of non-research projects in the following major areas of interest:

1. Preventing diseases caused by contaminated food or water and detecting and containing fungal infections.

2. Reducing the spread of antimicrobial resistant pathogens and promoting safety in healthcare settings.

3. Preventing illness and death caused by highly lethal, contagious, or unexplained diseases.4. Preventing the spread of infectious disease in globally mobile populations and in those with

increased risk for acquiring or transmitting infections5. Identifying and responding to diseases spread by vectors.6. Detecting and responding to infectious disease threats, with a special focus on emerging

pathogens and biological warfare agents.7. Developing and applying technology that will result in faster identification of bacteria, viruses,

fungi, and other pathogens.

iii. Outcomes:

At the end of the project period, grantees are expected to demonstrate measurable progress toward one or more of NCEZID’s short-term outcomes. Specific short -term outcomes will vary among projects.

1. Increase capacity to collect, analyze, and share infectious disease data for local public health action.

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2. Improve integration of epidemiologic and laboratory data3. Improve public health communication and training4. Increase use of tools and interventions that will reduce infectious diseases and improve

infection control and treatment5. Increase ability to detect, assess, and contain public health threats when and where they occur6. Improve planning and operational preparedness to disease threats.

Long-term outcomes will occur as a result of individual project efforts and will contribute toward: 1) building a solid foundation of systems for laboratory, surveillance, and epidemiologic investigation necessary for public health decision-making; 2) reducing illness and death associated with infectious diseases; 3) building global capacity to rapidly detect and respond to outbreaks of public health significance; and 4) achieving compliance with the IHR.

iv. Funding Strategy:

NCEZID will award projects based on scientific merit of proposed projects and activities, specified criteria of funding source (when applicable), and Center/Division priorities. One or more of NCEZID’s seven divisions may provide funding through this FOA:

Division of Foodborne, Waterborne, and Environmental DiseasesDivision of Global Migration and QuarantineDivision of Healthcare Quality PromotionDivision of High-Consequence Pathogens and PathologyDivision of Preparedness and Emerging InfectionsDivision of Scientific ResourcesDivision of Vector-Borne Diseases

Projects may be supported from 1-5 years based on availability of funds.

v. Strategies and Activities:

NCEZID will be substantially involved with countries in a wide-range of activities that are aligned with its three strategies. Following are examples that illustrate the range of projects and activities that may be considered for funding by NCEZID divisions:

1. Strengthen public health fundamentals in infectious disease surveillance, laboratory science, and epidemiologic investigation.

Projects should seek to increase capacity to collect, analyze, investigate, and communicate data for decision making.

Develop mechanisms and tools to build infectious disease surveillance and response

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systems. Develop and apply diagnostic tools and methods that will strengthen and improve core

laboratory capacity for early detection of emerging diseases, including rapid diagnostic tests for use in remote, low-resource areas of the country.

Develop and conduct training programs for scientists and health professionals in epidemiology, surveillance, methods for data collection and analysis, and evidence-based program planning, implementation and evaluation.

Develop educational materials for the public and health professionals promoting prevention and outbreak control.

Incorporate new technologies such as mobile devices for gathering public health data during outbreaks.

Develop and test strategies and tools for monitoring pathogens in the environment.

2. Support the implementation of evidence-based interventions to prevent and control infectious diseasesProjects should use scientific data and proven approaches to develop and guide local and national public heath action and evaluate impact. Conduct, coordinate, and evaluate public health efforts and interventions for infectious

disease control and prevention. Identify risk factors and disease burdens and develop and implement public health

programs, practices, and policies for infectious disease prevention and control. Implement activities and practices that will improve the quality and safety of healthcare

through efforts to reduce healthcare associated infection and antimicrobial resistant and ensure the safety of medical products.

Conduct activities to improve the safety of food and water and reduce related enteric illnesses, including expanding efforts into existing school and healthcare settings.

Conduct activities to improve the health of migrating population and reduce cross-border disease spread.

3. Strengthen public health preparedness, safety, and biosecurity as related to the spread of high-consequence infectious diseases as well as to emerging pathogensProjects should seek to improve public health preparedness at the local, national, and regional levels through cross-cutting and specialized programs. Conduct activities that will improve scientific and response planning and preparedness for

bioterrorism, emerging infections, and other infectious disease emergencies. Develop and conduct workforce training on biosafety/biosecurity and bioterrorism agent

detection and response. Develop and validate tools and test to aid laboratory detection and identification of new,

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unknown, emerging, or bioterror disease threats. Develop and conduct activities that will improve collaborations among law enforcement and

public health agencies.

Substantial NCEZID programmatic involvement with the awardees is anticipated during the performance of activities.

2. Collaborations –a. With CDC funded programs:

Collaboration and leveraging of resources with other CDC-funded projects in areas of mutual interest is encouraged.

b. With organizations external to CDC:

NCEZID promotes multidisciplinary collaboration among public health, government, and private sector experts in identifying broad-based solutions to public health problems at the local and regional levels. Key partners should be identified and a description of how they will be engaged in the project should be included in the proposal.

3. Target Populations:

N/A

b. Evaluation and Performance Measurement:

CDC Evaluation and Performance Measurement Strategy:

Evaluation and Performance Measurement Strategy plans will vary by project; however, all plans should focus on both process and outcome evaluation. Projects should provide a detailed evaluation plan that clearly describes how progress toward achieving the project goals will be measured. At a minimum the evaluation plan must:

1. Provide clear intended outputs and short-, mid-, and long-term outcomes;2. Describe how the process of implementation will be monitored;3. Provide indicators of progress and measures of effectiveness for the proposed activities; and4. Describe how the utility and public health impact of the project activities will be assessed.

Application Review Information

a. Criteria

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A review panel will evaluate complete, eligible applications for this project in accordance with the criteria below. See Part II, Section E, Application Review Information for further details on the review and selection process.

Ability to Carry Out the Proposal (15 points)Does the applicant demonstrate the local experience and institutional capacity (both management and technical) to achieve the goals of the FOA with documented good governance practices? (5 points) Does the applicant have the ability to coordinate and collaborate with existing partners and other donors? To what extent does the applicant provide letters of support? (5 points) Where applicable, does the applicant have the capacity to reach rural and other underserved populations? Where applicable, does the organization have the ability to target audiences that frequently fall outside the reach of the traditional media, and in local languages? (5 points)

Technical and Programmatic Approach (20 points)The reviewers will assess the feasibility of the applicant’s plan to meet the outcomes, congruency of application with the logic model, whether the proposed use of funds is efficient and the extent to which the specific methods described are appropriate for the local culture. Does the application include an overall strategy, including measurable timelines, clear monitoring and evaluation procedures, and specific activities for meeting the proposed outcomes? (5 points) Does the applicant describe activities that are evidence-based, realistic, achievable, measurable and culturally appropriate to achieve the goals of the FOA? (10 points) Does the application include reasonable estimates of output targets? (For example, the numbers of sites to be supported, number of clients the program will reach.) To what extent does the applicant propose to work with other organizations? (5 points)

Understanding of the Problem (10 points)Does the applicant demonstrate a clear and concise understanding of the current public health problem and the cultural and political context relevant to the programmatic areas targeted? (5 points) To what extent does the applicant justify the need for this FOA within the target community? (5 points)

Capacity Building (15 points)Does the applicant have a proven track record of building the capacity of indigenous organizations and individuals? Does the applicant have relevant experience in using participatory methods, and approaches, in project planning and implementation? Does the applicant describe an adequate and measurable plan to progressively strengthen the capacity of local organizations and target beneficiaries to respond to the public health problem? If not a local indigenous organization, does the applicant articulate a clear exit strategy which will maximize the sustainability of project results in the intervention communities? Does the capacity building plan clearly describe how it will contribute to (if not a local indigenous organization) an evolving role of the prime beneficiary with transfer of critical technical and

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management competence to local organizations/sites in support of a decentralized response?

Monitoring and Evaluation (20 points)Does the applicant demonstrate the local experience and capability to implement performance monitoring and rigorous evaluation of the project? Does the evaluation and performance measurement plan appopriately address the components specified in this announcement (i.e. key evaluation questions, types of evaluations to be conducted, performance measures (i.e., indicators), how often performance measures must be reported, how evaluation and performance measurement will track how target populations are affected by FOA strategies, how evaluation findings and performance measures will be used and yield findings to demonstrate the value of the FOA, and how results will be disseminated). Does the applicant describe a performance monitoring system used to routinely review data and adjust program activities accordingly? Are there performance measures (i.e. indicators) developed for each program milestone, and incorporated into the financial and programmatic reports?

Personnel (10 points)Does the organization employ staff fluent in local languages who will work on this project? Are the staff roles clearly defined? As described, will the staff be sufficient to meet the goals of the proposed project? If not an indigenous organization, does the staff plan adequately involve local individuals and organizations? Are staff involved in this project qualified to perform the tasks described?

Administration and Management (10 points)Does the applicant provide a clear plan for the administration and management of the proposed activities, and to manage the resources of the program, prepare reports, monitor and evaluate activities, audit expenditures and produce collect and analyze performance data? Is the management structure for the project sufficient to ensure speedy implementation of the project? If appropriate, does the applicant have a proven track record in managing large budgets; running transparent and competitive procurement processes; supervising consultants and contractors; using subgrants or other systems of sharing resources with community based organizations, faith based organizations or smaller non-governmental organizations; and where appropriate providing technical assistance in health system stregnthening activities such as laboratory management?

Budget (Reviewed Not Scored)Is the itemized budget for conducting the project, along with justification, reasonable and consistent with stated objectives and planned program activities? Is the budget itemized, well justified and consistent with the goals of the program? If applicable, are there reasonable costs per client reached for both year one and later years of the project?

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Project F: Global Civil Registration and Vital Statistics Improvement Program

Project Name

Global Civil Registration and Vital Statistics Improvement Program

Funding Opportunity DescriptionInsert narrative for each header below based on content outlined in the Guidance provided.

Background

a. Background OverviewCivil registration and vital statistics (CRVS) systems provide essential information to public health programs on births and deaths, in particular regarding causes of death. This information is critically needed in low-income countries (LICs), where high levels of communicable disease are now being compounded by a rapid rise in chronic non-communicable diseases. Despite this need, LICs have poorly functioning CRVS systems, especially regarding the production of health information – what is referred to as the “information paradox” of the developing world. This project will implement demonstration projects in selected LICs to test and evaluate methods and procedures to improve CRVS functions. Following project completion, countries will be encouraged to apply successful methods to other areas to produce improved national systems.

b. National Public Health Priorities and Strategies:

Not applicable.

CDC Project DescriptionMaximum 2 pages, single-spaced, Calibri 12 Point, 1-inch margins.

a. Approach:

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Global Civil Registration and Vital Statistics Improvement Program Logic Model Overview

Strategies andActivities

Short-TermOutcomes

Medium-TermOutcomes

Long-TermOutcomes

Improve reporting of births and deaths, including home events

Improved sensitivity among community leaders of the importance of improved reporting of births, deaths*

25% increase in number of home events reported*

Improved completeness of vital event reporting, including home events

Facilitate certificate request process for individuals, improve production & delivery of birth and death certificates

Residents of selected areas can request certificates locally (without travel to district where event occurred, thanks to central electronic database of birth & death records)*

All urban residents can request certificates locally, receive certificates promptly*

Urban & rural Individuals can request certificates locally, receive event certificates in timely manner

Improve accuracy and completeness of information for births and deaths, including causes of death

Civil registration and health personnel trained on statistical reporting*

Improved accuracy of demographic data items and causes of death*

Evaluation program documents significant improvement in data accuracy and completeness, including causes of death

Design data processing and data flow system to reduce duplication of effort and ensure return of information to health system

Work completed with electronic health data systems to establish quality checks, minimize duplication of effort (capture data once, use many times)*

Data flow system ensures return of relevant vital statistics data to health system*

Quality vital statistics data relevant to health facilities are regularly provided

Develop capacity for analysis of vital statistics data and preparation of reports

Vital statistics staff are trained to carry out data analysis, preparation of annual report*

Initial annual report prepared; repeat/revise analysis training as required*

Data users receive regular annual vital statistics reports

Promote use of vital statistics data for specialized purposes

Potential government users of vital statistics data interviewed to determine needs*

Initial specialized reports distributed; comments used to revise future versions*

Customized reports and electronic data provided to specific government and other

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users*Indicates project period outcomes

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i. Problem Statement:

Civil registration and vital statistics systems provide valuable services to governments and individuals, including essential health information. CRVS systems exist to address the needs of individuals for identification, inheritance, etc. but provide an ideal vehicle for the collection of additional information on births and deaths, including causes of death. CRVS systems In low-income countries however, do not function well for a variety of reasons: authority for CRVS systems is typically divided among several ministries; systems are designed to be passive, requiring individuals to visit registration offices to report events; many individuals in LICs do not have a perceived need for proof of identity (i.e., birth certificate); many births and deaths still take place at home in LICs; and the network of registration offices often is sparse and hence far from the location of events. The resulting poor performance of CRVS systems leads to lack of central government interest and funding; the lack of government interest and support impedes improvement efforts, in a vicious circle that ensures stagnant, low-performing systems.

ii. Purpose:

To support national Ministries of Health and Ministries of Home Affairs in their efforts to:1) obtain essential information on births and deaths, including causes of death, needed for planning health services, allocation of health resources, as well as planning for education and other government services; and2) provide citizens with the documents required to participate in national activities such as school attendance, work permits, international travel, and collection of inheritance and life insurance benefits.

iii. Outcomes:

At the end of the project period, grantees are expected to show measurable progress towards one or more of the following short-term and intermediate outcomes:

Improved sensitivity of community leaders to the importance of improved reporting of births, deaths

Residents of selected areas can request certificates locally (without travel to district where event occurred, thanks to central electronic database of birth & death records

Civil registration and health personnel trained on statistical reporting Work completed with electronic health data systems to establish quality checks, minimize

duplication of effort (capture data once, use many times) Vital statistics staff are trained to carry out data analysis, preparation of annual report Potential government users of vital statistics data interviewed to determine needs 25% increase in number of home events reported

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All urban residents can request certificates locally, receive certificates promptly Improved accuracy of demographic data items and causes of death Data flow system ensures return of relevant vital statistics data to health system Initial annual report prepared; repeat/revise analysis training as required Initial specialized reports distributed; use comments to revise future versions

It is expected that achieving the short-term and intermediate outcomes will lead to the long-term outcomes identified below and in the logic model. Awardees are expected to make progress toward the long-term goals, but not achieve all of them by the end of the project period.

Improved completeness of vital event reporting, including home events Urban & rural Individuals can request certificates locally, receive event certificates in timely

manner Evaluation program documents significant improvement in data accuracy and completeness,

including causes of death Quality vital statistics data relevant to health facilities are regularly provided Data users receive regular annual vital statistics reports Customized reports and electronic data provided to specific government and other users-

iv. Funding Strategy:

Funds will be used for demonstration area-specific and some national-level activities in each country, including personnel, training, travel, supplies and equipment, and contractual support. Funding amounts will be decided at a later date.

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v. Strategies and Activities:

The project will develop demonstration sites in selected countries to test and evaluate improvement methods including the following:

Improve reporting of births and deaths including home events. Identify strategy for identification and reporting of home events Use publicity campaign to increase public awareness of need to report events Create technical working group to improve collaboration across government ministries as

well as with NGOs and international/donor agencies Engage government and other members of society in reporting births and deaths Utilize existing resources such as community health workers to report home events Use verbal autopsy to collect cause of death information for home deaths Devise mobile IT system for reporting home deaths to improve timeline, avoid use of paper,

and eliminate need for data entry in registration office in demonstration site Facilitate certificate request process for individuals, improve production & delivery of birth

and death certificates Develop electronic database to facilitate certificate requests, printing/delivery of certificates Devise plan for delivery of certificates to distant households, including use of community

health workers, immunization personnel, or others Improve accuracy and completeness of information for births, deaths, and causes of death

Develop continuous training program for registration officials and health facility personnel on registration procedures and importance of accurate vital statistics data

Training course for physicians on proper procedures for reporting causes of death Develop plan for refresher training, including use of CMEs Convince local medical schools to add certification training to their curriculum Review cause of death reporting form; if not in compliance with WHO standards,

recommend modifications Training course for medical coders on use of ICD for coding causes of death

Monitor quality of coding on continuous basis, retrain as required Design data processing and data flow system to reduce duplication of effort and ensure return

of information to health system Verify data entry of information from reporting forms For health facilities with electronic data systems, devise modification to minimize

duplication of effort (i.e., enter data once, use for many purposes) Ensure that data flow design includes return of relevant information to health facilities

Develop capacity for analysis of vital statistics data and preparation of reports Train staff in district registration office within demonstration site Prepare annual statistical reports on births, deaths, and causes of death in demo area

Promote use of vital statistics data for specialized purposes Devise plan for distribution of vital statistics to relevant government officials/offices of

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health, education, planning, elections, etc. in demonstration area Include in plan the return of information to individual health facilities and local officials

including traditional officials Customize reports to present data in ways useful to specific organizations

1. Collaborations –a. With CDC funded programs:

Global Immunization Division, CGH

b. With organizations external to CDC:

The applicant is encouraged to collaborate with the organizations listed, if appropriate. WHO UNICEF UNECA UNESCAP Plan International

2. Target Populations:

All ages, both sexes in demonstration areas

b. Evaluation and Performance Measurement:

CDC Evaluation and Performance Measurement Strategy:Measurable goals and evaluation criteria:

1. Monitor percent of births and deaths registered; goal is ≥ 90%;2. Number of stakeholders in Technical Work Group; number of meetings annually.3. Number of birth/death certificates provided;4. Delay between receipt of request for certificate and date of delivery;5. Percent of registration forms with missing/inaccurate information;6. Percent of facility deaths with ill-defined cause of death;7. Percent of facility deaths requiring query back to physician to clarify causes of death;8. Certification training implemented in local medical schools; CME certification training

established;9. Percent of home deaths with cause of death obtained via verbal autopsy;10. Percent of death reports with cause of death coding errors;11. Average delay between date of event and date of reporting to registration office;12. Interval between end of calendar year and date of publication of annual statistical report for

demonstration project;13. Number of local government offices receiving annual vital statistics report;

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14. Number/percent of health facilities receiving reports on their vital events;15. Interval between end of calendar year and date of delivery of facility-specific report;

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