CDC-RFA-GH20-2086.pdf

Centers for Disease Control and Prevention

Center for Global Health

Technical Collaboration to Strengthen and Expand Capacity to Assess, Prevent, and Mitigate the Effects of Public Health Threats of National and Global Importance with the Ministry of

Health in Lao PDR

CDC-RFA-GH20-2086

Application Due Date: 09/15/2020

Technical Collaboration to Strengthen and Expand Capacity to Assess, Prevent, and Mitigate the Effects of Public Health Threats of National and Global Importance with the Ministry of

Health in Lao PDR

CDC-RFA-GH20-2086

TABLE OF CONTENTS

Part I. Overview Information A. Federal Agency Name B. Funding Opportunity Title C. Announcement Type D. Agency Funding Opportunity Number E. Assistance Listings (CFDA) Number F. Dates G. Executive Summary

Part II. Full Text 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 Information 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- GH20-2086. 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:

Technical Collaboration to Strengthen and Expand Capacity to Assess, Prevent, and Mitigate the Effects of Public Health Threats of National and Global Importance with the Ministry of Health in Lao PDR 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-GH20-2086

E. Assistance Listings (CFDA) Number:

93.283 F. Dates:

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

2. Due Date for Applications: 09/15/2020, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov.

3. Date for Informational Conference Call:

N/A

G. Executive Summary:

1. Summary Paragraph:

This cooperative agreement will strengthen the public health systems in the country of Lao PDR with a focus on three public health topics: 1. Global Health Security (Component 1) 2.

Accelerate Ending HIV/AIDS (Component 2), and 3. Pandemic Preparedness and Vaccine Systems Strengthening (Component 3). The cooperative agreement will provide both technical and financial assistance to strengthen Lao PDR Ministry of Health’s capacity in Global Health Security by improving influenza surveillance, response, and control for both human and animal health. The cooperative agreement will also focus on strengthening of surveillance, treatment, and control of HIV/AIDS through the PEPFAR initiative. The anticipated outcome is for Lao PDR to be better prepared to detect, respond, and prevent infectious diseases within its borders, 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.grants.gov including both human and animal disease. Another outcome is for the Lao PDR government to conduct effective surveillance and response efforts as it relates to HIV/AIDS. The public health impact on global health security and international capacity in the health and well-being of people not only affects the government of Lao PDR, but also the Southeast Asia region, the United States, and the world. This cooperative agreement will involve the collection of data for the primary purposes of applying proven public health tools, global initiatives for disease control and public health training and capacity building.

a. Eligible Applicants: Single

b. NOFO Type: Cooperative Agreement

c. Approximate Number of Awards: 1

d. Total Period of Performance Funding: $40,000,000

e. Average One Year Award Amount: $8,000,000

f. Total Period of Performance Length: 5

g. Estimated Award Date: 09/30/2020

h. Cost Sharing and / or Matching Requirements: N Cost sharing or matching funds are not required for this program. Although no statutory matching requirement for this NOFO exists, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged

Part II. Full Text A. Funding Opportunity Description

Part II. Full Text

1. Background

a. Overview This NOFO has three components: Global Health Security (Component 1), Accelerate Ending HIV/AIDS (Component 2), and Pandemic Preparedness and Vaccine Systems Strengthening (Component 3).

Component 1: Global Health Security is a global initiative to detect, respond, and prevent emerging and re-emerging infectious diseases, both human and zoonotic. Infectious diseases are continually a public health challenge in South East Asia due to an inefficient linkage between human health, animal health and environmental health sectors. In Lao PDR, one of the major public health concerns is related to One Health, which includes threats of avian influenza and other zoonotic diseases related to illegal wildlife trading and a cross border livestock trading. These public health concerns place the country at risk of disease outbreaks.

Component 2: CDC, Division of Global HIV/AIDS and Tuberculosis (DGHT) in Thailand and Lao PDR provide TA to the Department of Communicable Disease Control, Center for

HIV/AIDS and STI (CHAS) and other Lao PDR partners focusing on promoting early detection of people living with HIV (PLHIV), improving linkages to treatment, retention and viral load suppression, promoting innovative interventions, and strengthening efficient use of HIV surveillance and clinical data for the strategic planning and improving quality of services. Over the past years, the Lao PDR political environment has increasingly supported the national HIV response and updated the National Strategic Plan for HIV/AIDS and STI Prevention and Control 2021-2030 (NSAP) aiming to end HIV transmission by 2030. Expected outcomes are to promote and demonstrate sustainable HIV epidemic-control solutions that can be replicated, integrated, and scaled-up into existing health systems by the Government of Lao PDR, expand the health care workforce capacities to improve quality of HIV services (prevention, treatment, laboratory), implement acceleration of HIV epidemic control strategies such as PrEP, Recency testing, Index Partner testing, Case-Based Surveillance, strategic use of HIV information for public health actions and promote collaboration with local community partners to provide high quality community-based outreach, testing, referrals, and counselling.

Component 3: Seasonal influenza preparedness is also a critical component of global health security as sentinel monitoring systems are critical to monitoring epidemics and pandemics of respiratory illnesses; and countries with seasonal influenza vaccine infrastructures have the policies and logistical mechanisms in place to rapidly disseminate pandemic vaccines to those in need. This NOFO will address infectious disease detection, response, and prevention in Lao PDR including zoonotic diseases, and vaccination programs. CDC understands the importance of working across the various sectors of health to ensure there are positive working relationships solidified before an outbreak occurs. This NOFO will seek to provide technical assistance (TA) in the human and animal sectors through a One Health approach. This NOFO aligns with the current CDC strategic priorities including strengthening surveillance, epidemiology and laboratory services; enhancing vaccine and prevention programs; supporting public health activities; increasing global health impact; increasing impact on public health policy; and preventing illness, injury disability and death.

b. Statutory Authorities This program is authorized under the Public Health Service Act, Sections 301(a)[42 U.S.C.

241(a)], 307 [42 U.S.C. 2421], as amended.

GHSA: Public Health Service Act sections 301(a) and 307, as amended,42 U.S.C. §§ 241 and 242l.

PEPFAR has called for immediate, comprehensive and evidence-based action to turn the tide on the global HIV/AIDS epidemic through Public Law 108-25 (the United States Leadership Against HIV/AIDS, Tuberculosis and Malaria At of 2003) [22 U.S.C. 7601, et seq.] and Public Law 110-293 (the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis and Malaria Reauthorization Act of 2008) [42 U.S.C. 300cc-40a et seq] The overarching purpose of this NOFO is to fund activities to prevent or control disease to improve health, and public health program services.

c. Healthy People 2030

• Global health priority of Healthy People 2020: Improve public health and strengthen U.S.

national security through global disease detection, response, prevention, and control strategies.

https://www.healthypeople.gov/2020/topics-objectives/topic/global-health

• The PEPFAR strategy for accelerating HIV/AIDS epidemic control will be achieved through working in collaboration with host government. Through joint collaboration, PEPFAR expects the epidemic will be controlled and future costs required to sustain the HIV/AIDS response will decline. https://www.healthypeople.gov/2020/topics-objectives/topic/global-health

d. Other National Public Health Priorities and Strategies This NOFO supports The U.S. Department of Health and Human Services (HHS) Global Strategy.

https://www.hhs.gov/about/agencies/oga/about-oga/why-hhs-works-globally/hhs-global-strat egy/index.html https://www.hiv.gov/federal-response/pepfar-global-aids/pepfar https://www.hiv.gov/federal-response/pepfar-global-aids/pepfar

e. Relevant Work The Global Health Security Initiative seeks to support countries to have the ability to detect, respond, and prevent emerging infectious diseases. CDC coordinates with local, regional, and global human, animal and environment health partners to generate important data on a burden of a broad range of infectious diseases, including the risk factors associated with public health emerging diseases to strengthen public health capacity within multi-sectoral partners.

Since 2011, the DGHT/PEPFAR has provided TA to the Lao PDR MoH by improving health systems and quality of HIV services. DGHT aims to advance previous gains through continued support to the Lao PDR during implementation of the NSAP 2021-2030, which is in line with PEPFAR goals of maximizing prevention and treatment activities for key populations (KP) while ensuring all populations benefit from effective interventions.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

Component 1 – Global Health Security

Strategies and Activities

Short-term Outcomes Intermediate Outcomes

Long-Term Outcomes

· Global Health Security Strategy:

https://www.healthypeople.gov/2020/topics-objectives/topic/global-health https://www.healthypeople.gov/2020/topics-objectives/topic/global-health 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.hiv.gov/federal-response/pepfar-global-aids/pepfar%20https://www.hiv.gov/federal-response/pepfar-global-aids/pepfar https://www.hiv.gov/federal-response/pepfar-global-aids/pepfar%20https://www.hiv.gov/federal-response/pepfar-global-aids/pepfar

1) Surveillance Information System Assessment

2) Surveillance System and Capacity

3) Lab Capacity

4) Assessment of One Health Coordination in Lao

PDR

5) Disease Prioritization Methodology Developed

Improved ability of partners to create an organized information system for animal surveillance activities

Improved ability to identify and address knowledge gaps in disease surveillance capacity at central and provincial levels

Surveillance samples are tested and reported in a timely manner

Increased knowledge of One Health coordination among different sectors in Lao PDR

Increased knowledge of disease prioritization process among public health stakeholders

Increased ability to conduct disease prioritization among public health stakeholders

Improved ability of partners to conduct surveillance activities, compile and analyze data to examine public health needs Improved quality of surveillance activities that meet international standards

Improved laboratory capacity to test infectious diseases within Lao PDR.

One Health stakeholders are aware of one another’s plans and find synergies where possible.

Lao PDR allocates appropriate resources to prioritized diseases.

Well-established information system surveillance in Lao PDR which leads to policy development.

Disease surveillance is a trusted source for situational awareness in Lao

PDR

Streamlined and synergized efforts to address infectious diseases in the country

Laboratory workforce capacity to provide surveillance services sustained through government support

Resources are optimized to prevent, detect and respond to emerging infectious diseases and other public health issues of concern in Lao

PDR

Lao PDR establishes sustainable resources to maintain surveillance and response efforts

Component 2 – Accelerate ending HIV/AIDS

Activities

Short-Term Outcomes Intermediate Outcomes

Long-Term Outcomes

· Accelerate ending HIV/AIDS strategy

6) Capacity building of health care providers to scale up Effective Prevention Strategies

7) Strengthen laboratory system to expand access to viral load (VL) testing and integrate Recency testing into the HIV case-based surveillance

8) Capacity building of health care providers to deliver high quality, client centered HIV testing and ART

Increased implementation of Pre- Exposure Prophylaxis (PrEP) to prevent HIV in high burden provinces

Increased number of sites providing index partner testing and social network strategies Increased viral load (VL) coverage and reduced results turnaround time at antiretroviral therapy (ART) sites via implementation of point of care (POC) X-pert VL testing and other diagnostic network optimization strategies

Increased awareness of distribution of HIV recent infection through integration of Recency testing in the HIV case-based surveillance

Increased number of ART clinics providing high-quality patient-friendly HIV counseling, testing, same-day results and ART

Increased uptake of PrEP among Key Populations in HIV high burden provinces through policy change

All partners of PLHIV receive HIV testing and know their HIV status

Increased the national VL coverage to >90%

Improved national HIV monitoring program for recent infection for public health responses

More than 90% of

Decreased new HIV infections

Decreased

AIDS

morbidity

Decreased AIDS mortality

Increased ART coverage and VL suppression among PLHIV services

9) Establishment, decentralization, and expansion of ART sites to improve client-centered care including multi-month ARV drug dispensing services

10) Strengthening data utilization and data quality for program planning at national, sub-national and site levels initiation

Improved ability of clinics to provide high quality HIV services including Index partner testing, antiretroviral therapy (ART) adherence/lost to follow up, TB preventative therapy (TPT), tenofovir/lamivudine/dolutegravir (TLD) transition, differentiated care, stigma & discrimination to improve retention

Increased routine use of continuous quality improvement (CQI) at facilities to improve impact of HIV program at all levels of the health system Improved HIV program data collection, reporting, and quality through a single national HIV database District Health Information Software (DHIS 2) Improved national HIV database, reports and HIV case based surveillance for HIV program monitoring using the national DHIS 2 HIV database

PLHIV satisfied with services received at ART clinics

More than 98% PLHIV linked to same day ART and retained in ART clinics

Increased national competency of quality improvement strategies, ART services and client-centered services among HIV program staff

Improved quality of HIV data for strategic planning and monitoring of HIV epidemic and public health response Increased capacity of health care workers and public health technical officers in analysing, interpreting and using program and surveillance data for service quality improvement and program planning at sites, sub-national and national level

Component 3 – Pandemic Preparedness and Vaccine Systems Strengthening

Activities

Short-term Outcomes Intermediate Outcomes

Long-term Outcomes

11) Pandemic preparedness and vaccine systems strengthening

Increased pandemic preparedness.

Improved capacity of multidisciplinary rapid response teams and field epidemiologists trained to respond to a pandemic.

Increased capacity to evaluate vaccine programs

Pandemic plans are exercised and result stakeholders having an increased capacity to respond to pandemics.

New vaccine programs for respiratory pathogens sustained by Lao PDR in priority target groups with only technical assistance from CDC and external partners.

Pandemic preparedness enhanced through improved JEE evaluations.

Vaccine programs for respiratory pathogens integrated into routine budgeting of the Government of Lao PDR.

i. Purpose The purpose of this NOFO is to build capacity in Lao PDR to detect, respond, and prevent infectious diseases which may infect both animals and humans. Also, to strengthen the existing public health systems in Lao PDR with sustainable capacity to deliver comprehensive, effective, and high-quality HIV-related services that reduce the annual number of new HIV infections and AIDS deaths, especially among priority populations, and improve the impact of their national HIV/AIDS programs to accomplish UNAIDS 95-95-95 goals.

ii. Outcomes Component 1 – Global Health Security Short-term Outcomes

• Surveillance samples are tested and reported in a timely manner

• Increased knowledge of One Health coordinating among different sectors in Lao PDR

• Increased knowledge of disease prioritization process among public health stakeholders Intermediate Outcomes

• Improved quality of surveillance activities that meet international standards

• Improved laboratory capacity to test infectious diseases within Lao PDR.

• Lao PDR allocates appropriate resources to prioritized diseases.

Long-Term Outcomes

• Disease surveillance is a trusted source for situational awareness in the Lao PDR

• Laboratory workforce capacity to provide surveillance services sustained through government support

• Resources are optimized to prevent, detect and respond to emerging infectious diseases and other public health issues of concern in Lao PDR Component 2 – Accelerate Ending HIV/AIDS Short-term Outcomes

• Increased implementation of Pre-Exposure Prophylaxis (PrEP) to prevent HIV in high burden provinces

• Increased number of sites providing index partner testing and social network strategies

• Increased number of ART clinics providing high-quality patient-friendly HIV counselling, testing, same-day results and ART initiation

• Improved ability of clinics to provide high quality HIV services including Index partner testing, ART adherence/lost to follow up, TPT, TLD transition, differentiated care, stigma & discrimination to improve retention

• Increased routine use of CQI at facilities to improve impact of HIV program at all levels of the health system

• Improved HIV program data collection, reporting, and quality through a single national HIV database DHIS 2

• Improved national HIV database, reports and HIV case based surveillance for HIV program monitoring using the national DHIS 2 HIV database Intermediate Outcomes

• Increased uptake of PrEP among Key Populations in HIV high burden provinces through policy change

• All partners of PLHIV receive HIV testing and know their HIV status

• Increased the national VL coverage to >90%

• Improved national HIV monitoring program for recent infection for public health responses

• More than 90% of PLHIV satisfied with services received at ART clinics

• More than 98% PLHIV linked to same day ART and retained in ART clinics

• Increased national competency of quality improvement strategies, ART services and client-centered services among HIV program staff

• Improved quality of HIV data for strategic planning and monitoring of HIV epidemic and public health response Long-Term Outcomes

• Decreased new HIV infections

• Decreased AIDS morbidity

• Decreased AIDS mortality

• Increased ART coverage and VL suppression among PLHIV Component 3 -Pandemic Preparedness and Vaccine Systems Strengthening Intermediate Outcome

• New vaccine programs for respiratory pathogens sustained by Lao PDR in priority target groups with only technical assistance from CDC and external partners.

iii. Strategies and Activities The recipient is expected to carry out the strategies and activities listed under all three components.

Component 1 – Global Health Security

1) Surveillance Information System Assessment

a. Assess data needs and surveillance information system through an assessment of the current human and animal health information systems available in Lao PDR. The assessment would include information shared by partners, timeliness of information sharing, quality of data reporting and surveillance data management.

b. Improve information systems according to the needs identified in the assessment.

2) Surveillance System and Capacity Assessment

a. Assess the current diseases surveillance system in Lao PDR. The assessment would include resources, partners contributing to surveillance activities, information sharing, and technical capacity.

b. Provide training to address gaps in public and animal health officers conducting surveillance.

Based on the assessment of surveillance capacity, list the gaps and how the gaps can be addressed through training of officers.

3) Lab Capacity Assessment

a. Assess lab capacity for disease detection. The assessment should include the current testing capacity within Lao PDR.

b. Manage current test supplies and materials. The current lab testing being conducted should be documented, including which partner/agency is responsible for purchasing which test supplies.

c. Provide training to address gaps in lab staff. Based on the assessment of lab capacity, list the gaps and how the gaps can be addressed through training of lab staff.

4) Assessment of One Health Coordination in Lao PDR

a. Provide questionnaire to both animal and human health and environmental partners. The questionnaire would be sent to donors, government agencies, and other one health partners working in Lao PDR. The questionnaire should cover identified strengths, weaknesses, and suggestions---allowing for qualitative data.

b. Provide a platform (e.g. regular meeting) for One Health partners in Lao PDR to coordinate, share information, develop joint work plans to maximize resource utilization to address zoonotic diseases of concern.

5) Disease Prioritization Methodology Developed

a. Present guidelines developed by partners to related stakeholders. The guidelines utilized in other countries will be presented and the methodology will be agreed upon by all partners working in Lao PDR.

b. Provide training to in-country facilitators. Training will be offered to Lao PDR-based facilitators to ensure the prioritization goes as planned.

c. Develop One Health coordinating platform in Lao PDR.

Component 2 – Accelerate ending HIV/AIDS

6) Capacity building of health care providers to scale up effective Prevention Strategies

a. Strengthen active case finding activities including partner testing and HIV self-testing

b. Promote and advocate for PrEP for high risk KPs

c. Strengthen and scale up a successful index partner test services to improve case finding yields.

d. Provide TA on the development of national tools, and monitoring system

e. Capacity building including through coaching and monitoring webinar led by CHAS to monitor index testing and other services for QI

f. Strengthen and scale up a successful index partner testing services to improve case finding yields

7) Strengthen laboratory system to expand access to VL testing and integrate Recency testing into the HIV case-based surveillance

a. Promote and pilot POC Xpert VL testing to improve VL coverage and optimize the efficient use of the machines before implementation in al ART sites

b. Strengthen the national EQA program for HIV and HIV related testing

c. Integration of Recency testing in the HIV case-based surveillance to identify geographic location of recent infection to support the national HIV surveillance program

d. Pilot implementation of recent infection surveillance in 5 ART sites before nationwide implementation

e. Strengthen laboratory systems and quality assurance program to support and promote integration of Recency testing into the HIV case-based surveillance

f. Strengthen laboratory systems and quality assurance program to support and promote integration of Recency testing into the HIV case-based surveillance

g. Capacity building and system preparation for introduction of Recency testing at all HIV testing sites

h. Geographical mapping of recent infection cases for HIV prevention and treatment prioritizations and planning

i. Establish and expand decentralization of HIV VL testing using POC VL

j. Establishment of decentralization of POC VL testing system

k. Capacity building on using POC Xpert VL testing and QA systems

l. Promotion and collaboration with key partners and HQ for POC Xpert VL EQA program

8) Capacity building of health care providers to deliver high quality, client centered HIV testing and ART services

a. Development of National quality improvement guidelines.

b. QI lesson learned sharing and promotion of quality Improvement coaching at all ART facilities

c. Implementation of CQI to improve, Index partner testing, ART adherence/lost to follow up, TPT, TLD transition, differentiated care, stigma & discrimination and retention.

d. Identify service gaps in both public health care facilities, and community-based services in high burdened areas to expand cost-effective interventions

e. Strengthen the national QI program and QI coaching system to integrate into routine program

f. Develop and implement innovative and effective interventions to improve ART retention/viral load suppression, differentiated care, MMD etc.

g. Promote and monitor uptake and quality of TPT and TLD transition

h. capacity development on HIV quality improvement (QI) systems through development of national quality improvement guidelines and coaching curriculum

i. interventions to address sdART initiation, ART adherence/lost to follow up, TPT, TLD transition, differentiated care MMD, stigma & discrimination and improve retention

9) Expansion of diversified ART services network though establishment and decentralization of ART POC to improve client-centered care including multi-month ARV drug prescription services in selected provinces and district

a. establishment and decentralization of ART POC

b. improvement of client-centered approaches for multi-month ARV drug prescription services in selected provinces and districts

c. Expansion of ART POC in provinces with high case load and no ART sites

d. Lessons learnt sharing for POC ART sites and outcomes of PLHIV receiving care

e. POC ART sites expansion in additional provinces where needed in accordance to the national plan.

10) Promote Data Utilization and Data Quality For Program Planning At National And Site Levels

a. Develop and implement a standardized surveillance system to determine the burden of disease and monitor HIV epidemic and risk behaviors among key populations;

b. Strengthen a harmonized and streamlined monitoring and evaluation system to describe ongoing interventions, characteristics, and outcomes across various stakeholders and different levels of program implementation

c. Improve and sustain management of an effective implementation through building capacity of the decentralized provincial surveillance and monitoring and evaluation network

d. Build human capacity for analysis and interpretation of SI to identify programmatic bottlenecks, identification of areas where programmatic improvement is needed, and use of evidence to facilitate rapid scale-up of high impact interventions

e. Strengthen the capacity of the country to harmonize HIVCAM Plus and DHIS2 data for streamlined management of national data reports in DHIS2 (GFATM e-cascade) using the UIC system and utilize for national and subnational program planning and improving the quality of HIV services.

Component 3 – Pandemic Preparedness and Vaccine Systems Strengthening

11) Pandemic preparedness and vaccine systems strengthening

a. Update and exercise pandemic plans

b. Review and evaluate influenza and other respiratory pathogen vaccine programs

c. Improve implementation of influenza and other respiratory vaccine programs in priority target groups.

1. Collaborations

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

CDC is responsible for providing technical assistance and support conducted by global programs including disease detection and response, health systems and laboratory strengthening. CDC-Thailand works closely with the Center for Global Health, Division of Global HIV and Tuberculosis, Global One Health Office in CDC’s National Center for Emerging and Zoonotic Infectious Disease (NCEZID) and the Influenza Division in the

National Center for Immunization and Respiratory Diseases (NCIRD) to provide expertise to address the challenges of global health and works in concert with domestic and international partners to improve health and well-being around the world. The recipient is expected to work with other CDC-funded implementing partners and public health authorities to implement immediate, comprehensive and evidence-based actions to turn the tide of the HIV/AIDS epidemic in Lao PDR.

The recipient is required to collaborate with CDC Thailand and CDC Lao PDR staff, USG subject matter experts and Project Officer for project management and technical oversight of project activities under each technical area and evaluation. The project office for this award will provide all relevant contacts and coordinate discussions with the award recipient.

The recipient is also encouraged to collaborate with various CDC Divisions and programs to ensure the activities and material meet CDC standards, maximize resources, avoid duplication, and concur with CDC published recommendations and disease specific information.

b. With organizations not funded by CDC:

The recipient may be required to collaborate with other U.S. Government agencies such as but not limited to the United States Agency for International Development (USAID), U.S.

Department of Defense (DOD), U.S. Department of State, Health and Human Services of Global Affairs, as well as the Food and Agriculture of the United Nations (FAO), World Health Organization (WHO), The Joint United Nations Programme on HIV/AIDS (UNAIDS), The Global Fund to Fight AIDS, Tuberculosis and Malaria (GF) and other One Health Partners.

2. Target Populations Components 1, 2, 3 are focused on the people of Lao PDR. All components will also focus on vulnerable populations and Component 2 activities, primarily PLHIV, MSM, and TG women, but also sex workers and injecting drug users in geographic areas where those populations are concentrated.

a. Health Disparities N/A

iv. Funding Strategy Applicant is required to apply for all three components.

Component 1: Global Health Security - $ 5,000,000 These activities are intended to be partially funded at the beginning of each budget period with additional funding components processed throughout the budget period on an annual basis.

Future years funding level will be dependent on funding availability.

Component 2: Accelerate ending HIV/AIDS - $ 1,000,000 These activities are intended to be partially funded at the beginning of each budget period with additional funding components processed throughout the budget period on an annual basis.

Future years funding level will be dependent on funding availability.

Component 3: Pandemic Preparedness and Vaccine Systems Strengthening - $2,000,000

These activities are intended to be partially funded at the beginning of each budget period with additional funding components processed throughout the budget period on an annual basis.

Future years funding level will be dependent on funding availability.

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy In addition, the recipient(s) may be required to conduct a costing analysis or economic evaluation of implemented interventions or activities at the end of project to determine:

• Cost and/or unit costs, and cost drivers of interventions or activities

• Cost-effectiveness of interventions or activities Evaluations are expected to align with national, PEPFAR, and agency priorities and programmatic gaps, and will be reviewed and approved as part of the Country Operational Plan (COP). As such, the evaluation questions listed in this announcement may be amended based on feedback from OGAC during the annual COP review process.

CDC Approaches for Performance Measurement:

Throughout the five-year NOFO period, CDC will work with the recipient to measure implementation performance. Note that:

- CDC will use results of performance measures to continuously determine whether NOFO activities and outcomes were achieved as planned.

- CDC will provide technical assistance to the recipient to support routine data collection, analysis of key performance indicators, and quarterly reporting to CDC.

- CDC will review the monitoring results and provide feedback, noting any necessary corrective and/or improvement actions, according to the performance measurement standard.

- Quarterly, CDC, in partnership with the recipient, will hold Program Implementation Reviews in order to review financial information, status of activities and key successes and challenges to achieve. Performance measures will include both PEPFAR (MER) and non- PEPFAR indicators. The recipient is required to provide performance reports and additional relevant PEPFAR and non-PEPFAR indicators as part of their Evaluation and Performance Management Strategy to monitor the impact of initiatives in this NOFO.

- At the end of NOFO period (annually), CDC, in partnership with the recipient, will conduct site monitoring using program specific monitoring tools in order to (1) demonstrate accountability of the NOFO investments, and (2) prioritize quality improvement actions needed to achieve program accomplishment as planned. Site monitoring reports will be distributed to the recipient.

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 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), if applicable, for accuracy throughout the lifecycle of the project. 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, they 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.

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.

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:

1. How applicant will collect the performance measures, respond to the evaluation questions, and use evaluation findings for continuous program quality improvement. The Paperwork Reduction Act of 1995 (PRA): Applicants are advised that any activities involving information collections (e.g., surveys, questionnaires, applications, audits, data requests, reporting, record keeping and disclosure requirements) from 10 or more individuals or non-Federal entities, including State and local governmental agencies, and funded sponsored by the Federal Government are subject to review and approval by the Office of Management and Budget.

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

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

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

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

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

• Describe key evaluation questions to be addressed by these evaluations.

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

The recipient will be required to submit a more detailed Evaluation and Performance Measurement plan 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 Applicant must demonstrate the ability to execute the CDC strategies and activities and meet period of performance outcomes. Applicants should demonstrate relevant experience and capacity (management, administrative, and technical) to implement the activities. Applicants must also be fully capable of managing the required procurement efforts, including the ability to write and award contracts in accordance with applicable grants regulations.

Applicant must be able to manage program performance, evaluation, performance monitoring, financial reporting, and must have capacity to manage the required funds in accordance with the HHS Grants Policy Statement, which can be found at:

https://www.hhs.gov/grants/grants/grants-policies-regulations/index.html 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 program planning and implementation.

2) Organizational chart (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.

CDC must provide maximum flexibility to enable applicants to implement NOFO requirements based on their own organization design and approach, unless otherwise required by statute.

The applicant should save the required files as pdfs and upload them to http://www.grants.gov.

d. Work Plan The work plan allows the CDC project officer to monitor implementation of activities and progress on period of performance outcomes. Applicants must apply for all three components and provide a work plan for each component. Work plans should be detailed and focused on the first year of the period of performance. Applicants should be instructed to provide a detailed work plan for the first year of the project and a high-level work plan for subsequent years.

Work plans should demonstrate alignment among the outcomes, strategies, activities, timelines and staffing. Applicants are strongly encouraged to utilize SMART, measurable indicators to ensure the outcomes are met during the performance period..

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.

https://www.hhs.gov/grants/grants/grants-policies-regulations/index.html http://www.grants.gov

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.

f. CDC Program Support to Recipients (THIS SECTION APPLIES ONLY TO

COOPERATIVE AGREEMENTS)

CDC will provide support to the cooperative agreement recipient through conference calls, site visits, and at a minimum quarterly technical and financial monitoring utilizing a performance review process which includes a written report and financial audit. The calls will serve as an opportunity for the project officer and recipient to share information related to their progress, challenges, and successes. During the quarterly performance review, both the technical and financial activities and outcomes will be assessed, keeping in mind the timeline specified in the monitoring and performance plan.

CDC will provide technical assistance utilizing the CDC offices in both Lao PDR and Thailand.

Subject matter experts from CDC-Atlanta, FAO, USAID, and WHO may also be utilized for trainings and other consultations, if needed.

Specific to component 2, a cooperative agreement, CDC staff is substantially involved in the program activities. CDC activities for this program include, but are not limited to, the following:

1. Organize an orientation meeting with the recipient for a briefing on applicable U.S.

Government, HHS/CDC, and PEPFAR expectations, regulations, and key management requirements, as well as report formats and contents. The orientation could include meetings with staff from HHS agencies and OGAC.

2. Review and make recommendations as necessary to the process used by the recipient to select key personnel and/or post-award sub-contractors and/or sub-recipients to be involved in the activities performed under this agreement, as part of the PEPFAR COP review and approval process, managed by OGAC.

3. Review and approve recipient’s annual work plan and detailed budget, as part of the PEPFAR COP review and approval process, managed by OGAC.

4. Review and approve the recipient’s monitoring and evaluation plan, including for compliance with the strategic information guidance established by OGAC.

5. Meet on a regular basis with the recipient to assess expenditures in relation to approved work plan and modify plans as necessary.

6. Meet on a quarterly basis with the recipient to assess quarterly technical and financial progress reports and modify plans as necessary.

7. Meet on an annual basis with the recipient to review annual progress report for each U.S.

Government Fiscal Year, and to review annual work plans and budgets for the subsequent year, as part of the PEPFAR COP review and approval process, managed by OGAC.

8. Provide technical assistance, as mutually agreed upon, and revise annually during validation of the first and subsequent annual work plans. This could include expert technical assistance and targeted training activities in specialized areas, such as strategic information, project management, and confidential counseling and testing.

9. Provide in-country administrative support to help the recipient meet U.S. Government financial and reporting requirements approved by the Office of Management and Budget

(OMB).

10. Collaborate with the recipient on designing and implementing the activities listed above, including, but not limited to: the provision of technical assistance to develop program activities, data management and analysis, quality assurance, the presentation and possibly publication of program results and findings, and the management and tracking of finances.

11. Provide technical assistance or advice on any data collections on 10 or more people that are planned or conducted by the recipient. All such data collections-- where CDC staff will be or are approving, directing, conducting, managing, or owning data-- must undergo OMB project determinations by CDC and may require OMB Paperwork Reduction Act of 1995 (PRA) clearance prior to the start of the project.

12. Provide consultation and scientific and technical assistance based on appropriate HHS/CDC and OGAC documents to promote the use of best practices known at the time.

13. Assist the recipient in developing and implementing quality-assurance criteria and procedures.

14. Facilitate in-country planning and review meetings for technical assistance activities.

15. Provide technical oversight for all activities under this award.

16. Conduct site visits through the Site Improvement through Monitoring System (SIMS), in compliance with PEPFAR requirements, to monitor and evaluate clinical and community service delivery site capacity to provide high-quality HIV/AIDS services in all program areas and 'above-site' capacity to perform supportive or systemic functions, by assessing and scoring key program area elements of site performance and work with the recipient on identified gaps and continuous quality improvement, which might include more thorough data quality or service quality assessments as indicated.

17. Ensure the recipient’s Evaluation and Performance Measurement Plan is aligned with the strategic information guidance established by OGAC and other HHS/CDC requirements, including PEPFAR’s Monitoring, Evaluation, and Reporting (MER) strategy, PEPFAR’s Evaluation Standards of Practice, and CDC’s Data for Partner Monitoring Program (DFPM).

18. Provide ethical reviews, as necessary, for evaluation activities, including from HHS/CDC headquarters. Evaluations can be process, outcome, or impact.

A. Process Evaluation: measures how the intervention was delivered, what worked/did not, differences between the intended population and the population served, and access to the intervention.

B. Outcome Evaluation: determines effects of intervention in target population(s) (e.g., change in knowledge, attitudes, behavior, capacity, etc.).

C. Economic Evaluation: justifies the investment, and determines the efficiency and economic impact of interventions.

19. Supply the recipient with protocols for related evaluations.

B. Award Information

1. Funding Instrument Type: 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: 2020

4. Approximate Total Fiscal Year Funding: $8,000,000

5. Approximate Period of Performance Funding: $40,000,000

This amount is subject to the availability of funds.

Estimated Total Funding: $40,000,000

6. Approximate Period of Performance Length: 5 year(s)

7. Expected Number of Awards: 1

8. Approximate Average Award: $8,000,000 Per Budget Period

9. Award Ceiling: $0 Per Budget Period

This amount is subject to the availability of funds.

There is no award ceiling for this NOFO

10. Award Floor: $0 Per Budget Period

11. Estimated Award Date: 09/30/2020

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.

C. Eligibility Information

1. Eligible Applicants Eligibility Category: Others (see text field entitled "Additional

Inform…