CDC-RFA-GH21-2173 rev.pdf

Centers for Disease Control and Prevention

Center for Global Health

Capacity Building and Strengthening of Hospital Infection Control to detect, prevent and respond to antimicrobial resistance in India

CDC-RFA-GH21-2173

07/20/2021

Table of Contents A. Funding Opportunity Description

B. Award Information

C. Eligibility Information

D. Application and Submission Information

E. Review and Selection Process

F. Award Administration Information

G. Agency Contacts

H. Other Information

I. Glossary

Part I. Overview Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Subscribe" button link to ensure they receive notifications of any changes to CDC-RFA- GH21-2173. 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) / Agency for Toxic Substances and Disease Registry (ATSDR) B. Notice of Funding Opportunity (NOFO) Title:

Capacity Building and Strengthening of Hospital Infection Control to detect, prevent and respond to antimicrobial resistance in India C. Announcement Type: New - Type 1:

This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered. For this purpose, research is defined at https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52- 2.pdf. Guidance on how CDC interprets the definition of research in the context of public health can be found at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr- 46/index.html (See section 45 CFR 46.102(d)).

New Type 1

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-GH21-2173

E. Assistance Listings Number:

93.318 F. Dates:

1. Due Date for Letter of Intent (LOI):

https://www.grants.gov/ https://www.grants.gov/ https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html

N/A

2. Due Date for Applications:

07/20/2021 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov.

3. Due Date for Informational Conference Call:

N/A

G. Executive Summary:

1. Summary Paragraph Healthcare-associated infections (HAIs) and antimicrobial resistance (AMR) are significant public health threats around the world. India’s capacity to detect, prevent, and respond to HAIs, many caused by multi-drug resistant organisms with few therapeutic options, has been strengthened in recent years, but requires additional development.

In 2015, the Grantee in collaboration with the Indian Council for Medical Research (ICMR), established a network of tertiary-level hospitals to monitor the emergence of AMR, detect and prevent HAIs, and improve infection prevention and control (IPC) and antimicrobial stewardship practices. Data from this network show that HAIs are common in network hospitals, many of which are caused by pathogens exhibiting high levels of AMR.

This NOFO builds on CDC’s previous work with the Grantee and the ICMR to create the HAI surveillance and prevention network. The project will strengthen and expand HAI surveillance activities and IPC and antimicrobial stewardship programs in existing network sites in in order to reduce HAI rates and rapidly detect and respond to the emergence and transmission of multi-drug resistant organisms in Indian health facilities. Additional sites will be recruited and regional centers of excellence for HAI surveillance and IPC will be created to support network sites as they implement activities.

This NOFO has a required component funding structure. Please refer to Funding Strategy section.

a. Eligible Applicants:

Single

b. Funding Instrument Type:

CA (Cooperative Agreement)

c. Approximate Number of Awards

d. Total Period of Performance Funding:

$ 205,000,000

e. Average One Year Award Amount:

$ 1,000,000

f. Total Period of Performance Length:

https://www.grants.gov/

g. Estimated Award Date:

September 30, 2021

h. Cost Sharing and / or Matching Requirements:

No Part II. Full Text A. Funding Opportunity Description

1. Background

a. Overview Worldwide, over 1.4 million patients suffer from HAIs at any time. HAIs increase mortality, morbidity, adverse patient outcomes and cost of treatment. Many HAIs are caused by multi-drug resistant organisms (MDRO) with potential to spread locally and globally. India’s capacity to detect, prevent, and respond to HAIs needs to be strengthened.

This NOFO will strengthen and expand HAI surveillance, IPC, and antibiotic stewardship programs in current and additional network sites in order to demonstrably reduce HAI rates and rapidly detect and respond to the emergence and transmission of MDRO. The recipient will collaborate closely with CDC and Government of India (GoI) stakeholders to enhance surveillance and prevention programs. HAI surveillance will be implemented using standardized protocols and data entry systems to ensure consistent data are reported. A trained workforce of IPC practitioners will be created in alignment with GoI technical IPC guidelines and WHO guidance on facility-level IPC programs. Antimicrobial stewardship programs will be established at a subset of network hospitals to improve appropriate use of antibiotics. Data gathered across activities will inform development of national guidelines and policies.

Studies show, when used in conjunction, surveillance, IPC, and stewardship can sustainably reduce HAI rates.1 For this reason, WHO guidelines include them as “core components” of IPC programs.2

In 2015, in collaboration with the ICMR, a network of tertiary-level hospitals was established to identify AMR, detect and prevent HAIs, and improve infection prevention and control (IPC) and antimicrobial stewardship practices. Data shows that HAIs are common in network hospitals, many caused by AMR pathogens. Several outbreaks were identified and contained, and HAI rates decreased in hospitals implementing IPC practices.

This network was developed using funding awarded under GH15-1627: “Capacity Building and Strengthening of Hospital Infection Control to Detect and Prevent Antimicrobial Resistance in India.” As a result, 53 hospitals in 23 states began HAI surveillance and prevention activities using protocols appropriate for facilities in low- and middle-income countries. This showed high-quality, standardized HAI surveillance is possible in India. Findings from this project informed decisions to expand HAI hospital surveillance, IPC/HAI prevention activities, and surveillance data for action.

In addition to Core Global Health Security Priorities (Component 1), this NOFO will support additional activities when a disease outbreak or other public health emergency reaches a scale that requires a moderate (Component 2, Rapid Response to Small Scale Infectious Disease Outbreaks or Other Public Health Emergencies) or substantial response (Component 3, Rapid

Response to Large-Scale Infectious Disease Outbreaks or other Public Health Emergencies).

Applicants must apply for all three components.

1Pronovost PJ, Watson SR, Goeschel CA, Hyzy RC, Berenholtz SM. Sustaining Reductions in Central Line-Associated Bloodstream Infections in Michigan Intensive Care Units: A 10-Year Analysis. Am J Med Qual. 2016 May;31(3):197-202. PMID: 25609646.

2Storr J, Twyman A, Zingg W, Damani N, Kilpatrick C, Reilly J, Price L, Egger M, Grayson ML, Kelley E, Allegranzi B; WHO Guidelines Development Group. Core components for effective infection prevention and control programmes: new WHO evidence-based recommendations. Antimicrob Resist Infect Control. 2017 Jan 10;6:6. PMID: 28078082;

PMCID: PMC5223492.

b. Statutory Authorities Section 307 of the Public Health Service Act, as amended [42 USC § 242l] and Section 301(a) of the Public Health Service Act [42 USC § 241(a)]

c. Healthy People 2030 This project supports the following Healthy People 2030 topic areas:

Global Health Public Health Infrastructure Health Care Access and Quality Infectious Disease Emergency Preparedness

d. Other National Public Health Priorities and Strategies Activities funded through this cooperative agreement must align with the following United States Government (USG) and HHS/CDC strategies and policies:

CDC’s strategy for improving global health security (GHS), based on three concepts embedded in the agency’s mission to protect public health worldwide: 1) Prevent 2) Detect 3) Respond https://www.cdc.gov/globalhealth/security/index.htm

The Department of Health and Human Services’ (HHS) Global Health Strategy https://www.hhs.gov/about/agencies/oga/about-oga/why-hhs-works-globally/hhs-global-strategy/index.html

International Health Regulations (2005) (IHR) and supporting policies and frameworks https://www.who.int/topics/international_health_regulations/en/

e. Relevant Work The GoI has prioritized combating antimicrobial resistance (AMR) through a variety of actions, including improving IPC and preventing healthcare associated infections (HAIs), in its National Action Plan for AMR. This NOFO builds on CDC’s and ICMR’s work to leverage their existing https://health.gov/healthypeople/objectives-and-data/browse-objectives/global-health https://health.gov/healthypeople/objectives-and-data/browse-objectives/public-health-infrastructure https://health.gov/healthypeople/objectives-and-data/browse-objectives/health-care-access-and-quality https://health.gov/healthypeople/objectives-and-data/browse-objectives/infectious-disease https://health.gov/healthypeople/objectives-and-data/browse-objectives/emergency-preparedness https://www.cdc.gov/globalhealth/security/index.htm https://www.hhs.gov/about/agencies/oga/about-oga/why-hhs-works-globally/hhs-global-strategy/index.html https://www.hhs.gov/about/agencies/oga/about-oga/why-hhs-works-globally/hhs-global-strategy/index.html https://www.who.int/topics/international_health_regulations/en/ collaborations to create the HAI surveillance and prevention network. This network demonstrated the ability to collect HAI and AMR data across hospitals and the potential to improve IPC practices to prevent HAIs and AMR. Additional work with this network will demonstrate India’s ability to prevent infections, improve antibiotic use and to detect and contain outbreaks in participating hospitals.

2. CDC Project Description

a. Approach Bold indicates period of performance outcome.

Component 1: Core Global Health Security Priorities Strategies and Activities

Short-Term Outcomes Intermediate Outcomes

Long-Term Outcomes

Strategy 1: Expand implementation of HAI surveillance in the applicant network

Strategy 2: Develop capacity to prevent HAIs and contain AMR and other emerging infectious disease threats in applicant network hospitals by improving

IPC

Strategy 3:

Strengthen applicant network hospital laboratory systems to effectively detect

AMR

Strategy 4: Strengthen antimicrobial stewardship practices in applicant network hospitals

Increased coordination and communication among all applicant network sites

Increased regional collaboration for applicant network sites

Increased reach of HAI surveillance, infection prevention and control capacity and activities, laboratory systems strengthening, and stewardship practices by existing and new network sites

Increased number of applicant network sites participating in laboratory quality assurance schemes

Increase use HAI surveillance data to inform, monitor, and improve HAI prevention interventions

Increase number of and support for Regional HAI and IPC centers of excellence

Emerging AMR threats are rapidly identified and contained within applicant network sites

Antimicrobial stewardship practices at applicant network sites are improved

Expanded HAI surveillance network is integrated and sustained within GoI structures

HAIs are reduced and safer healthcare is delivered at applicant network sites

Approaches used to prevent HAIs and contain AMR are scaled to national level through collaborations with GoI stakeholders

Strategies and Activities

Short-Term Outcomes Intermediate Outcomes

Long-Term

Components 2, 3, and 4: Rapid Response to Small-Scale and Large-Scale Public Health Emergencies and Emerging Infectious Disease Threats (EIDT)

Strategies and Activities

Short-Term Outcomes

Intermediate

Long-Term Outcomes

Strategy 1 Intensify active surveillance, case finding, contact tracing, monitoring and other outbreak response measures at local levels

Strategy 2:

Strengthen capabilities for epidemiologic and laboratory analysis and program evaluation

Strategy 3:

Intensify social mobilization, community and professional education and engagement.

Strategy 4:

Improve outbreak case management and infection

Improved time to deploy healthcare workers

Strengthened coordination and robust emergency preparedness and response capacities

Improved disease outbreak case management and infection control

Shortened time to detect highly infectious disease outbreaks

Reduced transmission of highly infectious diseases in clinical and community settings

Increased

Reduced time to reinvigorated public health activities that have been interrupted or slowed

Improved access to health services by individuals

Increased capacity of countries for early warning, risk reduction and management of national and global health risks

• Increased number of outbreak

Sustained improvements in timeliness of achieving outbreak/epidemic/pandemic control

Reduced morbidity and mortality attributed to disease outbreaks or other public health threats

Reduced spread of infectious outbreaks into other countries

Improved preparedness for potential future outbreaks and other highly infectious diseases

Strengthen capabilities for preparedness and response to highly infectious diseases control

Strategy 5:

Strengthen non-outbreak related public health activities that are impacted by the outbreak

Strategy 6:

Increase security and logistics for local responders awareness, knowledge, and support for local disease outbreak response and prevention efforts

Rapid identification and containment of highly infectious disease outbreaks investigations and public health responses by trainees in field epidemiology training programs

i. Purpose HAIs, particularly those caused by multi-drug resistant organisms, threaten all health facilities and increase mortality, morbidity, adverse patient outcomes, and cost of treatment. India’s capacity to detect, prevent, and respond to HAIs needs to be strengthened. This NOFO aims to strengthen laboratory systems and HAI surveillance, infection control, and antimicrobial stewardship programs in the applicant surveillance and prevention network in order to reduce HAI rates and rapidly detect and respond to the emergence and AMR. This approach can be scaled for use across India.

ii. Outcomes

Component 1:Core Global Health Security Priorities Short Term Outcomes:

Increased coordination and communication among all applicant network sites Increased regional collaboration for applicant network sites Increased number of ICU and ward units within existing network sites conducting HAI surveillance Increased number of applicant network sites conducting HAI surveillance Increased number of applicant network sites with trained IPC staff in the WHO Core

Competencies for IPC professionals.

https://apps.who.int/iris/bitstream/handle/10665/335821/9789240011656-eng.pdf?ua=1

Increased number of applicant network sites implementing IPC and HAI prevention activities

Increased number of applicant network sites conducting antibiotic stewardship activities

Intermediate Outcomes:

Applicant network sites use HAI surveillance data to inform, monitor, and improve HAI prevention interventions

Regional HAI and IPC centers of excellence are identified to provide support to applicant network sites

Emerging AMR threats are rapidly identified and contained within applicant network sites

Antimicrobial stewardship practices at applicant network sites are improved

Long Term Outcomes:

HAIs are reduced and safer healthcare is delivered at applicant network sites

Components 2, 3, and 4: Rapid Response To Small-Scale and Large-Scale Public Health Emergencies and Emerging Infectious Disease Threats (EIDT) Short-Term Outcomes:

Improved time to deploy healthcare workers to respond and control the spread of infectious diseases

Strengthened coordination and robust emergency preparedness and response capacities

Improved disease outbreak case management and infection control Shortened time to detect highly infectious disease outbreaks through active surveillance and case finding Reduced transmission of highly infectious diseases in clinical and community settings Increased awareness, knowledge, and support for local disease outbreak response and prevention efforts at the community level Rapid identification of and containment of highly infectious disease outbreaks

Intermediate Outcomes:

Reduced time to reinvigorated public health activities that have been interrupted or slowed due to outbreak response Increased capacity of countries for early warning, risk reduction and management of national and global health risks

Long-Term Outcomes:

Sustained improvements in timeliness of achieving outbreak/epidemic/pandemic control Reduced morbidity and mortality attributed to disease outbreaks or other public health threats Improved preparedness for potential future outbreaks and other highly infectious diseases

iii. Strategies and Activities

Strategy 1: Expand implementation of HAI surveillance in the applicant network

Creation of applicant network technical working group to develop governance structure and mechanisms to ensure sustainability and coordination of network goals with national stakeholders

Create technical working group to coordinate activities and discuss future directions for HAI surveillance

Create regional centers of excellence to provide HAI surveillance implementation support and mentorship to network sites in the region

Expand the number of intensive care units (ICUs) reporting HAI surveillance data from existing network sites

Expand the number of hospitals enrolled and reporting HAI surveillance data to the network and contributing to national and state level HAI data

Implement data quality monitoring activities at existing and new sites reporting HAI surveillance data

Review and modify existing HAI surveillance case definitions and protocols with CDC and GoI stakeholders

Develop and pilot new HAI surveillance case definitions and protocols in collaboration with CDC and GoI stakeholders

Maintain and expand HAI surveillance data reporting and analysis systems used by network sites

Strategy 2: Develop capacity to prevent HAIs and contain AMR and other emerging infectious disease threats in applicant network hospitals by improving IPC

Create regional centers of excellence to provide IPC training, implementation support, and mentorship to network sites in the region

Develop and deliver IPC training materials for a variety of audiences, including IPC specialists and frontline healthcare workers

Develop and implement HAI prevention bundles that are appropriate for the resources available at network sites

Implement quality improvement approaches to addressing IPC gaps at network sites, focusing on prevention of HAIs

Develop approaches to rapidly identify and respond to emerging infectious disease threats, including COVID-19 and AMR, at network sites

Deliver trainings and support facility-level responses to contain to outbreaks of emerging infectious disease threats, including COVID-19 and AMR, at network sites

Develop capacity of IPC committees to detect prevent and respond to AMR and other emerging infectious disease threats.

Develop a field epidemiology training program to build IPC and HAI workforce capacity

Strategy 3: Strengthen applicant network hospital laboratory systems to effectively detect

AMR

Develop sustainable approaches to external quality assurance testing for isolation, identification, and susceptibility testing of bacteria at network sites

Enhance capacity to appropriately detect the emergence of AMR at microbiology laboratories at network sites

Enhance capacity to detect novel mechanisms of antimicrobial resistance at a subset of network sites

Develop approaches to ensure that microbiology and IPC staff at network hospitals collaborate effectively to rapidly respond to emerging infectious disease threats, including AMR

Strategy 4: Improve antimicrobial stewardship practices in applicant network hospitals Perform assessments at network sites to understand existing antimicrobial stewardship practices and opportunities for improvement Deliver training on best practices in antimicrobial stewardship to network sites in collaboration with other network stakeholders, including ICMR Identify key priorities for improving antimicrobial stewardship at network sites Develop resource-appropriate interventions to improve antimicrobial stewardship practices at a subset of network sites

Components 2, 3, and 4: Rapid Response to Small-Scale and Large-Scale Infectious Disease Outbreaks or other Public Health Emergencies and Emerging Infectious Disease Threats

(EIDT)

This component is designed to support the applicant with small-scale infectious disease outbreaks and public health emergencies if these arise during the period of performance. The applicant will indicate in the application what activities would be supported during a small-scale outbreak or emergency. Activities may include but are not limited to the following.

Strategy 1: Intensify active surveillance, case finding, contact tracing, monitoring, and other critical response efforts at local levels

Conduct and improve ongoing active surveillance, with laboratory confirmation to ensure rapid identification of missed, new or newly imported outbreak cases

Strengthen capacity for general surveillance including support for personnel required for surveillance and epidemiology activities.

Strengthen surveillance at entry points (border posts, airports and maritime ports) from countries with ongoing transmission

Strategy 2: Strengthen capabilities for epidemiologic and laboratory analysis and program evaluation

Improve operational and technical analysis, coordination and monitoring of interventions.

Assess the impact of the epidemic on health care seeking and health care provision.

Strategy 3: Intensify social mobilization, community and professional education and engagement, and psychosocial care for infected persons and their families, where applicable

Conduct intensified social mobilization and community engagement to enhance awareness and gather community support, acceptance and participation in implementation of containment measures

Provide psychosocial first aid training for community agents and their supervisors so they can provide direct psychosocial support to contact cases and their families.

Develop and conduct communications to contain the outbreaks and enforce the theme of "Staying at Zero Cases."

Develop and disseminate key health risk communication messages.

Strategy 4: Improve outbreak case management and infection control

Develop plans for patient management as community and clinical settings.

Improve infection control practices, particularly in facilities that might receive outbreak cases for example, on a border with a country with ongoing transmission

Strategy 5: Strengthen non-outbreak related public health activities that are impacted by the outbreak

Restore priority aspects of the health/public health system such as surveillance and assessment of vaccination coverage for epidemic-prone disease (e.g., measles), that are negatively impacted or stalled due to the outbreak.

Strategy 6: Increase security and logistics for local responders

Strengthen field security to ensure operational security, and protect national and international staff involved in the response

Strategy 7: Strengthen capabilities for preparedness and response to highly infectious diseases

1. Develop/implement partnership mechanisms for a more robust and responsive global health emergency workforce.

2. Train frontline responders on emerging infectious diseases.

3. Strengthen critical International Health Regulations (IHR) and health systems capacities in affected region and elsewhere.

a. With other CDC programs and CDC-funded organizations:

The recipient will also be required to work with other CDC implementing partners, including non-governmental organizations, universities, Ministry of Health and other host governmental bodies and multi-lateral organizations that receive CDC funds. The recipient should ensure their proposed activities are not duplicating activities already implemented by other CDC-funded organizations.

b. With organizations not funded by CDC:

The recipient will work primarily and directly with partner governments specifically with the Ministries of Health and other government entities who are working towards the objectives of this NOFO. In addition, the recipient will be expected to work with other in-country and global stakeholders, including but not limited to government entities, non-governmental organizations, universities, civil society, the private sector, and other USG agencies.

2. Target Populations The target population for this NOFO include those populations that fall under the following jurisdiction(s):

- India

The target populations for this NOFO include, but are not limited to, those individuals infected and affected by infectious diseases, or at risk for becoming infected by an infectious disease. The target population for this NOFO may also include at-risk population for non-communicable diseases and/or other public health emergencies.

The work under this NOFO may also target increased capacity at the national and sub-national level to implement activities in alignment with the objectives of this NOFO.

a. Health Disparities Recipients are expected to use epidemiologic, social determinants, and linked laboratory, epidemiological, and surveillance data to identify communities disproportionately affected by infectious diseases or non-communicable diseases in the target areas to ensure that program activities appropriately cover these populations. Recipients should ensure that supported services are accessible and available to all patients regardless of age, sex, race/ethnicity, sexual orientation, gender identity, or socio-economic status in order to achieve the outcomes of this

NOFO.

iv. Funding Strategy This NOFO is divided into four components. Applicants are required to apply for all components and include a separate budget and work plan for each component. The applicant’s application package should be inclusive of all component work plans and budgets; multiple applications will not be reviewed. Applicants are encouraged to submit component budgets toward the year one award ceiling for each component. However, budget proposals for year one may not exceed the year one award ceiling. Please note these amounts are subject to approval and the availability of funds. The emergency components (Components 2 – 4) follow the same logic model with identical overarching strategies and activities, however, Component 2 should support activities when a disease outbreak or other public health emergency reaches a scale that requires a moderate response, Component 3 should support activities when a disease outbreak or other public health emergency reaches a scale that requires a moderate response and Component 4 should support activities to combat COVID-19 and other emerging infectious disease threats.

Component 1: Core Global Health Security Priorities These GHS activities are intended to be funded on an annual basis. The estimated year one ceiling is $1,000,000. Future years funding level will be dependent on funding availability.

Component 2: Rapid Response to small scale infectious disease outbreaks or other Public Health Emergencies This is intended to be approved but unfunded (ABU) as a baseline practice. It would be funded to support additional activities needed within a budget period when a disease outbreak or other public health emergency reaches a scale that requires a moderate response. Estimated year one ceiling is $10,000,000.

Component 3: Rapid Response to Large Scale Infectious Disease Outbreaks or other Public Health Emergencies This is intended to be approved but unfunded (ABU) as a baseline practice. It would be funded to support additional activities needed within a budget period when a disease outbreak or other public health emergency reaches a scale that requires a substantial response. Estimated year one ceiling is $15,000,000.

Component 4: Emerging Infectious Disease Threats (EIDT) This is intended to be an approved but unfunded (ABU) component that will support activities to combat COVID-19 and other emerging infectious disease threats globally, including efforts related to global health security, global disease detection and response, global health protection, global immunization, and global coordination on public health. Expected Year 1 funding amount is $15,000,000.

Emergency Management and Response The ability to respond rapidly and effectively to public health emergencies is a key component of global health security. International public health emergencies including humanitarian crises are by nature unpredictable, requiring fulfilment of changing and often unpredictable needs that vary widely according to context. Consequently, funding for public health emergencies is also unpredictable and based on external factors. In recent years, there has been a sharp rise in the number of people living in regions of the world affected by public health emergencies, including humanitarian emergencies, which has often led to additional funding resources from the USG to respond to these threats. Given this unpredictability and the resulting need for rapid, flexible, and efficient process to award funding under an emergency situation, recipients that are selected for funding under this NOFO will be eligible to receive additional expedited supplemental funding when a public health emergency occurs to scale up activities included within the scope of work of this NOFO.

Definition of public health emergency:

In order to qualify for supplemental emergency funding, one of the following situations must apply:

1. When UN or WHO classifies the emergency as a Level 3 (L3)

2. When the US Congress appropriates funding for an international response related to humanitarian or public health crisis with the words containing “emergency” in the program title. The appropriated funding could be for CDC directly or is transferred to CDC through an Interagency Agreement (IAA) by HHS or another USG

3. When the US government (Congress, White House, National Security Council, etc.)

declares a public health emergency as national security priority

4. When the CDC Director activates Emergency Operation Center (EOC) in response to an international public health threat

5. When Department of State or U.S. Agency for International Development (USAID) transfer funds to CDC to respond to an international disaster or humanitarian assistance under 2 FAM 060 (International Disaster and Humanitarian Assistance)

If a public health emergency situation meets any one criteria listed above, then selected recipients under this NOFO will be eligible to receive supplemental emergency funding to scale up public health activities included in the scope of work of this NOFO on a single-source basis, i.e., without additional competition, within a 12-month budget period and throughout the 60-month period of performance. There is no limit on the number of emergency supplemental funding that a recipient may receive within a 12-month budget period or the 60-month period of performance under a public health emergency situation. Recipients receiving funds under a public health emergency will be eligible to receive emergency funding without constraint to the period of performance funding ceiling, annual budget period ceiling, or lack of component funding. In addition, applications for funding under a public health emergency will not need a merit review and will only require approval from the CDC Project Officer and Grants Management Officer (GMO) in order to be funded.

All reporting requirements listed under this NOFO still applies to any emergency supplemental funding.

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy

ii. Applicant Evaluation and Performance Measurement Plan Applicants must provide an evaluation and performance measurement plan that demonstrates how the recipient will fulfill the requirements described in the CDC Evaluation and Performance Measurement and Project Description sections of this NOFO. At a minimum, the plan must describe:

How the applicant will collect the performance measures, respond to the evaluation questions, and use evaluation findings for continuous program quality improvement.

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

Available data sources, feasibility of collecting appropriate evaluation and performance data, and other relevant data information (e.g., performance measures proposed by the applicant)

Plans for updating the Data Management Plan (DMP) as new pertinent information becomes available. If applicable, throughout the lifecycle of the project. Updates to DMP should be provided in annual progress reports. The DMP should provide a description of the data that will be produced using these NOFO funds; access to data;

data standards ensuring released data have documentation describing methods of collection, what the data represent, and data limitations; and archival and long-term data preservation plans. For more information about CDC’s policy on the DMP, see https://www.cdc.gov/grants/additionalrequirements/ar-25.html.

Where the applicant chooses to, or is expected to, take on specific evaluation studies, the applicant should be directed to:

Describe the type of evaluations (i.e., process, outcome, or both).

Describe key evaluation questions to be addressed by these evaluations.

https://www.cdc.gov/grants/additionalrequirements/ar-25.html

Describe other information (e.g., measures, data sources).

Recipients will be required to submit a more detailed Evaluation and Performance Measurement plan, including a DMP, if applicable, within the first 6 months of award, as described in the Reporting Section of this NOFO.

c. Organizational Capacity of Recipients to Implement the Approach The applicant should succinctly describe their capacity (skills, expertise, experience) to implement the activities proposed under this NOFO. For components 2 and 3, the applicant should detail their ability to carry out emergency operations/coordination . Applicants are encouraged to describe their experience working with the target population, ability to implement project strategies/activities, and their physical infrastructure as it applies to the NOFO.

The applicant should provide as part of their appendix the following documents:

1. Curricula vitae (CVs)/Resumes for positions related to Principal Investigator, Project Director, Business Official, and other key staff related to data analysis, program planning and implementation, finance, and monitoring and evaluation.

2. Job descriptions (maximum 1 page per job description) for key positions including:

Principal Investigator, Project Director, Business Official, and other key staff related to data analysis, program planning and implementation, finance, and monitoring and evaluation.

3. Organizational chart (maximum 1 page)

4. Financial management statement that demonstrates experience in managing USG or CDC funds that are similar in size and scope of this NOFO (maximum 1 page)

The above referenced documents to be submitted in the appendix should demonstrate the organization's capacity to address the requirements of the NOFO.

Applicants must title these documents in their appendix as follows: "CVs/Resumes," "Job Descriptions," "Organizational Chart," "Capacity," "Financial Statement" and upload as a pdf at www.grants.gov.

d. Work Plan The applicant’s application package should be inclusive of all component workplans and budgets; multiple applications will not be reviewed. Each component must have a separate work plan and budget.

Applicant must include a work plan that demonstrates how the outcomes, strategies, activities, timelines, and staffing will take place over the course of the award. Applicants must submit a detailed work plan for the first year of the project, and a high-level work plan for subsequent years. An example work plan is shown below. Applicants are not required to use this format, as long as the information above is demonstrated.

The applicant’s application package should be inclusive of all component workplans and budgets; multiple applications will not be reviewed. Each component must have a separate work plan and budget.

Period of Performance Outcome:

[from Outcomes section and/or logic model]

Outcome Measure:

[from Evaluation and Performance Measurement section]

Strategies and Activities

Process Measure [from Evaluation and Performance Measurement section]

Responsible Position / Party

Completion Date

1.

2.

3.

4.

5.

e. CDC Monitoring and Accountability Approach Monitoring activities include routine and ongoing communication between CDC and recipients, site visits, and recipient reporting (including work plans, performance, and financial reporting).

Consistent with applicable grants regulations and policies, CDC expects the following to be included in post-award monitoring for grants and cooperative agreements:

Tracking recipient progress in achieving the desired outcomes.

Ensuring the adequacy of recipient 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 deemed necessary to monitor the award:

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

Ensuring that recipients are performing at a sufficient level to achieve outcomes within stated timeframes.

Working with recipients on adjusting the work plan based on achievement of outcomes, evaluation results and changing budgets.

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

Monitoring and reporting activities that assist grants management staff (e.g., grants management officers and specialists, and project officers) in the identification, notification, and management of high-risk recipients.

The recipient(s) will be required to collaborate with CDC India and CDC headquarters offices for technical oversight of project activities to be implemented under this NOFO In addition to the CDC Project Officer, the recipient will collaborate with in-country or HQ contacts, Subject

Matter Experts (SMEs), and technical leads. The Project Officer for this award will provide relevant contacts of CDC staff and coordinate discussions with the award recipients.

B. Award Information

1. Funding Instrument Type:

CA (Cooperative Agreement) CDC's substantial involvement in this program appears in the CDC Program Support to Recipients Section.

2. Award Mechanism:

U2G

3. Fiscal Year:

4. Approximate Total Fiscal Year Funding:

$ 41,000,000

5. Total Period of Performance Funding:

$ 205,000,000 This amount is subject to the availability of funds.

Estimated Total Funding:

$ 205,000,000

6. Total Period of Performance Length:

year(s)

7. Expected Number of Awards:

8. Approximate Average Award:

$ 1,000,000 Per Budget Period

9. Award Ceiling:

$ 0 Per Budget Period

This amount is subject to the availability of funds.

10. Award Floor:

$ 0 Per Budget Period

11. Estimated Award Date:

September 30, 2021

12. Budget Period Length:

12 month(s)

Throughout the project period, CDC will continue the award based on the availability of funds, the evidence of satisfactory progress by the recipient (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 period of performance comprises the initial competitive segment and any subsequent non-competitive continuation award(s).

13. Direct Assistance Direct Assistance (DA) is not available through this NOFO.

If you are successful and receive a Notice of Award, in accepting the award, you agree that the award and any activities thereunder are subject to all provisions of 45 CFR part 75, currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

C. Eligibility Information

1. Eligible Applicants Eligibility Category:

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

2. Additional Information on Eligibility The only eligible applicant to apply for this NOFO is All India Institute of Medical Sciences.

The applicant must comply with Government of India Health Ministry’s Screening Committee (HMSC) clearance requirements if required and adhere to Government of India rules and regulations for foreign funding.

3. Justification for Less than Maximum Competition AIIMS, New Delhi has developed India’s only HAI surveillance and prevention network that uses standardized surveillance protocols and prevention approaches across sites, which allows for effective compilation of data across the network to understand trends in HAI incidence. AIIMS has developed relationships with key stakeholders in network hospitals, international organizations, and other GoI agencies over the course of the past five years. AIIMS is now seen as a national leader in HAI surveillance and prevention and a valuable source of data on the burden of HAIs and AMR. AIIMS has been designated as a center of excellence for HAI surveillance and IPC by ICMR, giving AIIMS influence within national structures to continue to expand and coordinate its efforts in HAI surveillance and prevention. As AIIMS is the only applicant that is currently doing standardized HAI surveillance and is seen as only national leader for HAI surveillance and prevention it is justifiable for a sole source NOFO.

This NOFO is a follow-on from GH15-1627, a 5-year cooperative agreement in which CDC and AIIMS collaborated to develop the plans and protocols and implementation of the AIIMS HAI surveillance and prevention network. As part of this cooperative agreement, many of the activities proposed for expansion in this NOFO, including HAI surveillance, IPC focusing on HAI prevention, laboratory capacity building for effective detection of AMR, and antimicrobial stewardship, were piloted, giving AIIMS a firm base of expanding and sustaining this work.

All-India Institute of Medical Sciences is an autonomous institution of national importance established by an Act of Parliament with the objects to develop patterns of teaching in Undergraduate and Post-graduate Medical Education .

No obvious source of GoI funding to sustain and expand the progress made by the AIIMS HAI surveillance and prevention network has been identified. Without a subsequent cooperative agreement, the network would need to dramatically downscale, removing the ability to understand the burden of HAIs and AMR in this network of large Indian hospitals and severely curtail momentum for broad acceptance in India.

4. Cost Sharing or Matching Cost Sharing / Matching Requirement:

No

5. Maintenance of Effort Maintenance of Effort is not required for this program.

D. Application and Submission Information

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-recipients, those sub-recipients 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 a recipient. 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, http://fedgov.dnb.com/webform/displayHomePage.do and registration must be renewed annually. Additional information about registration procedures may be found at https://www.sam.gov/SAM/.

c. Grants.gov:

The first step in submitting an application online is registering your organization at www.grants.gov, the official HHS E-grant Web site. Registration information is located at the "Applicant Registration" 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

Data 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 instructions 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-

System for Award Management

(SAM)

formerly Central Contractor Registration

(CCR)

1. Retrieve organizations DUNS number

2. Go to https://www.sam.gov/SAM/ 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 https://fs d.gov/ fsd-gov/ home.do Calls: 86 6-606-8220

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

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 https://www.sam.gov/SAM/ https://grants.gov/ https://www.grants.gov/ http://www.grants.gov/ https://www.grants.gov/ http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform https://www.sam.gov/SAM/ https://fsd.gov/fsd-gov/home.do https://fsd.gov/fsd-gov/home.do https://fsd.gov/fsd-gov/home.do and create new password

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

2. Request Application Package Applicants may access the application package at www.grants.gov.

3. Application Package Applicants must download the SF-424, Application for Federal Assistance, package associated with this notice of funding opportunity at www.grants.gov.

4. Submission Dates and Times If the application is not submitted by the deadline published in the NOFO, it will not be processed. Office of Grants Services (OGS) 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 OGS.

a. Letter of Intent Deadline (must be emailed or postmarked by)

b. Application Deadline

Due Date for Applications 07/20/2021

07/20/2021 11:59 pm U.S. Eastern Standard Time, at www.grants.gov. If Grants.gov is inoperable and cannot receive applications, and circumstances preclude advance notification of an extension, then applications must be submitted by the first business day on which grants.gov operations resume.

Due Date for Information Conference Call N/A

5. Pre-Award Assessments Risk Assessment Questionnaire Requirement

CDC is required to conduct pre-award risk assessments to determine the risk an applicant poses to meeting federal programmatic and administrative requirements by taking into account issues such as financial instability, insufficient management systems, non-compliance with award conditions, the charging of unallowable costs, and inexperience.