Revised Foa_Content_of_CDC-RFA-GH-24-0096.pdf

Centers for Disease Control and Prevention

Center for Global Health

Strengthening Mozambique’s Capacity to Integrate and Sustain High-Quality Laboratory Services and Systems under the President's Emergency Plan for AIDS Relief (PEPFAR)

CDC-RFA-GH-24-0096

02/21/2024

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- GH-24-0096. 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:

Strengthening Mozambique’s Capacity to Integrate and Sustain High-Quality Laboratory Services and Systems under the President's Emergency Plan for AIDS Relief (PEPFAR) 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 purposes of this NOFO, research is defined as set forth in 45 CFR 75.2 and, for further clarity, as set forth in 42 CFR 52.2 (see eCFR :: 45 CFR 75.2 -- Definitions and https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR- 2007-title42-vol1-sec52-2.pdf. In addition, for purposes of research involving human subjects and available exceptions for public health activities, please see 45 CFR 46.102(l) (https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section- 46.102#p-46.102(l)).

Applicants should note that a Letter of Intent (LOI) is not requested or required as part of the application for this NOFO or for any CDC PEPFAR FY24 NOFO. Applicants should not submit LOIs.

Amendment 1: Questions and Answers (Q&A), Application Due Date Extension, Letter of Intent (LOI) Clarification, NOFO Formatting and Searchability, and Additional Updates 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.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section-46.102#p-46.102(l) https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section-46.102#p-46.102(l)

The purpose of this amendment is to include the updates as listed below.

• There was no Q&A for this NOFO.

• The purpose of this amendment is to extend the Application Due Date from February 12, 2024 (2/12/2024) to February 21, 2024 (2/21/2024).

• Applicants should note that a Letter of Intent (LOI) is not requested or required as part of the application for this NOFO or for any CDC PEPFAR FY24 NOFO. Applicants should not submit LOIs. There may be dates populated in some NOFOs in the LOI fields (1. Due Date for Letter of Intent (LOI) under Part I. Overview, and a. Letter of Intent Deadline under D. Application and Submission Information), but this is an error CDC is working to fix. These sections should be blank to reflect that LOIs are not requested or required.

• There may be some NOFOs uploaded under the “Related Documents” tab of www.grants.gov with the search and copy/paste functions disabled, but this is an error CDC is working to fix. In the meantime, applicants may also access the NOFO document by clicking on the “Package” tab of the opportunity on www.grants.gov, clicking the “Preview” button under the “Actions” column of the Opportunity Package, and then clicking on the “Download Instructions” button. This should allow applicants to download the full NOFO PDF document with the search and copy/paste functions enabled.

• CDC has retired the Risk Assessment Questionnaire Requirement and applicants are no longer required to submit the CDC Risk Questionnaire as part of their NOFO application.

CDC continues to conduct the review of risk posed by applicants described in Phase III Review and may ask for additional information prior to the award based on the results of the review. Risk Questionnaires that are submitted will not be included in this risk review.

• In F. Award Administration Information, 2. Administrative and National Policy Requirements, CDC has added AR-38: Health Information Technology (IT) Interoperability to the list of Organization Specific Administrative Requirements.

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-GH-24-0096

E. Assistance Listings Number:

93.067 F. Dates:

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

2. Due Date for Applications:

02/21/2024 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 https://www.grants.gov/

High-quality laboratory systems and services are essential for accurate diagnosis, treatment, and management of HIV and opportunistic infections (OI) amongst people living with HIV (PLHIV).

Mozambique has made tremendous progress toward building technical capacity and optimizing the laboratory network to provide timely access to early infant diagnosis (EID) and viral load (VL) testing services for all eligible clients. VL coverage has rapidly increased from 67% in 2018, to 83% in 2022, contributing to improved patient monitoring and outcomes for PLHIV.

This NOFO plans to build upon current accomplishments and support government institutions in Mozambique to strengthen and sustain laboratory systems and services towards achieving the UNAIDS 95-95-95 goals.

The NOFO aims to attain comprehensive coverage for both VL and EID testing, facilitate the expansion of HIV testing for enhanced case detection, strengthen the diagnosis of TB and other OI, enhance the governance of laboratory systems, build technical, scientific, and managerial capabilities, and implement robust laboratory data and quality management systems (QMS). This approach encompasses comprehensive quality assurance (QA) and continuous quality improvement (QI) programs essential for HIV rapid test site certification and laboratory accreditation. This NOFO seeks to strengthen integration of laboratory systems and services to support multi-disease testing and improve responsiveness to emerging public health threats.

a. Eligible Applicants:

Open Competition

b. Funding Instrument Type:

CA (Cooperative Agreement)

c. Approximate Number of Awards The expected number of awards is 1-2.

d. Total Period of Performance Funding:

$0 The Approximate Project Period of Performance Funding/Estimated Total Funding for the Total 5 year Project Period is None. The Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award amount for years 2-5 will be set at continuation.

e. Average One Year Award Amount:

$7,000,000 The Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award amount for Year 1 is $7,000,000. The expected number of awards is 1-2. Exact amounts for each award under this NOFO will be determined at the time of award. Applicants are encouraged to apply to the Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award amount.

f. Total Period of Performance Length:

5 year(s)

g. Estimated Award Date:

September 30, 2024

h. Cost Sharing and / or Matching Requirements:

No 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

1. Background

a. Overview Access to timely, quality laboratory testing and diagnostic services for the effective diagnosis, treatment, and management if HIV, TB, and other diseases of public health importance is a cornerstone of successful public health efforts. Consequently, robust laboratory systems remain essential for the achievement of UNAIDS 95-95-95 targets and control of emerging public health threats.

In collaboration with the Ministry of Health (MOH) and the National Institute of Health (INS), Mozambique has made incredible progress scaling up and increasing access to quality-assured diagnostic networks and systems for HIV. These networks have also strengthened overall health system capabilities and diagnostic services across various diseases, preparing the nation to respond to outbreaks and pandemics effectively. For example, during the COVID-19 pandemic, PEPFAR-supported VL/EID laboratory systems were leveraged for SARS-COV-2 testing. As Mozambique continues to respond to the second-highest HIV epidemic in the world, with 12.5% (approximately 2.1 million individuals) of its population aged 15-49 living with HIV, further scale-up to attain and sustain optimal coverage and universal access to efficient diagnostic services is essential to achieving HIV epidemic control. Mozambique must continue to scale-up EID, VL, and OI testing services. This will ensure that every patient receives a timely diagnosis and necessary linkage to treatment, at least one VL test a year to monitor treatment efficacy, and ensure a timely switch to second-line treatment where a patient is failing treatment. Timely access to OI testing services for will improve clinical outcomes amongst patients with advanced HIV disease (AHD). To support new clinical care needs and be responsive to global health security, scale-up of resilient laboratory systems must be integrated and support multi-disease testing.

PEPFAR investments have supported adequate infrastructure and testing capacity to meet improved VL and EID coverage. Supporting systems, including sample referral, laboratory information management systems (LIMS), and QA/QI programs, have also been implemented;

however, optimal coverage is still to be achieved, and programs are largely managed by implementing partners (IP). To sustain these systems, integration of diagnostic networks and systems and increased MOH leadership and oversight are required. Furthermore, local organizations must be established to provide laboratory systems, strengthening support to the government.

This NOFO aims to build national-level capacity to support the establishment of integrated, resilient, and responsive HIV diagnostic networks that have capability to support multi-disease testing and respond to emerging public health threats. Furthermore, this NOFO aims to support the development and implementation of policies that promote increased and improved government oversight fostering the expansion and long-term viability of LIMS, QMS and QA/QI programs, and continued capacity building for new and innovative HIV-related diagnostics.

Anticipated outcomes include increased MOH and INS leadership which will contribute significantly to the the sustainability of integrated diagnostic networks that are responsive to changes in HIV management, and achievement of UNAIDS’ 95-95-95 targets.

b. Statutory Authorities This program is authorized under Public Law 108-25 (the United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act 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), and Public Law 113-56 (PEPFAR Stewardship and Oversight Act of 2013).

The President’s Emergency Plan for AIDS Relief (PEPFAR) has called for immediate, comprehensive and evidence-based action to turn the tide of global HIV/AIDS. The overarching purpose of this NOFO is to fund activities to prevent or control disease or injury and improve health, or to improve a public health program or service.

c. Healthy People 2030 N/A

d. Other National Public Health Priorities and Strategies Under the leadership of the Global Health Security and Diplomacy Bureau (GHSD Bureau), as part of PEPFAR, the U.S. Department of Health and Human Services’ Centers for Disease Control and Prevention (HHS/CDC) works in partnership with host country governments and other key partners to assess the needs of each country and design a customized program of assistance that fits within the host nation's strategic plan in a manner consistent with the purposes of this NOFO. Goals and priorities include the following:

• Reducing the prevention and treatment gaps for adolescent girls and young women (AGYW), children, and key populations (KPs);

• Strengthening national and local programmatic, financial, and community leadership;

• Designing new partnerships with key private, public, and multi sector entities that can complement existing programs and expand reach;

• Utilizing the PEPFAR platform for broader disease surveillance and public health programming, consistent with the PEPFAR legislative and funding authority;

• Investing in the scale-up of cutting edge behavioral and implementation science to bend the curve on new infections;

• Improving the care and treatment of HIV/AIDS, sexually transmitted infections (STIs), and related opportunistic infections by improving STI management; enhancing laboratory diagnostic capacity and the care and treatment of opportunistic infections; interventions for intercurrent diseases impacting HIV infected patients including tuberculosis (TB); and initiating programs to provide anti-retroviral therapy (ART);

• Strengthening the capacity of countries to collect, use, and share surveillance data and manage national HIV/AIDS programs by expanding HIV/STI/TB surveillance programs and strengthening laboratory support for surveillance, diagnosis, treatment, disease monitoring, and HIV screening for blood safety; and

• Developing, validating, and/or evaluating public health programs to inform, improve, and target appropriate interventions, as related to the prevention, care and treatment of HIV/AIDS, TB, and opportunistic infections.

In an effort to ensure maximum cost efficiencies and program effectiveness, HHS/CDC also supports coordination with and among relevant partners. Recipients may be requested to participate in the following programmatic activities:

• Scale-up evidence-based programs to identify and close the major HIV gaps among AGYW, children, and KPs;

• Increase impact through strategic coordination and integration;

• Strengthen and leverage key multilateral organizations, global health partnerships, and private sector engagement;

• Encourage country ownership and invest in country-led plans, putting our national and local partners in the lead and actively enabling their growth through design of the program at all phases;

• Build sustainability through investments in health systems;

• Enhance health equity and reduce disparities in access to and uptake of HIV services;

• Improve performance metrics, monitoring and evaluation and the quality of related data;

and

• Promote research, development, and innovation to develop a body of knowledge, enhance awareness and increase the skills and abilities of stakeholders (research is not supported by this NOFO).

PEPFAR defines national HIV epidemic control as the point at which the number of new infections falls below the declining number of deaths among people living with HIV (PLHIV).

This definition of epidemic control does not suggest near-term elimination or eradication of HIV as may be possible with other infectious diseases, but rather suggests a decline of HIV-infected persons in a population, achieved through the reduction of new HIV infections when mortality among PLHIV is steady or declining, consistent with natural aging. Critically, however, a country will not be able to maintain epidemic control if program efforts are not sufficiently sustained and new infections are allowed to rebound or death rates to increase.

In addition to the specific activities listed in the Strategies and Activities section of this NOFO, all CDC PEPFAR cooperative agreements resulting from this NOFO may address the following activities, where and when appropriate, that focus U.S. government resources and activities toward achieving and sustaining the HIV/AIDS epidemic:

• Optimize HIV testing and treatment strategies to reach undiagnosed populations living with HIV, especially young adults, men, and KP. These strategies may include or build upon traditional methods and activities related to outbreak detection, investigation, and response, including efforts to reduce or remove evidenced barriers to services such as stigma and discrimination and inequitable gender norms. Responding to recent infections or ongoing patterns of transmission will be prioritized.

• Focus on prevention among children, adolescents, young adults, and members of vulnerable and key populations.

• Support surveillance activities and programs, along with information systems, that improve understanding of HIV epidemiology, help identify inequities and remaining gaps (e.g., societal impediments to HIV services), and inform future programming.

• Support efforts to maintain quality for laboratory systems and activities, including diagnostics and viral load measurement.

• Actively use epidemiologic, program, and financial/cost data to ensure implementation of high quality, cost-effective programs to improve partner performance and increase epidemiologic impact.

• Support country-led, sustainable programming by working with and implementing activities through local partners, including faith communities and faith-based organizations (FBOs), HIV network organizations and community-based organizations (CBOs) directly servicing communities and populations at-risk and most affected by HIV to build local capacity.

• Strengthen programmatic, financial, and community contributions by partner governments in the HIV/AIDS response.

• Support activities, interventions, and programs (e.g., including those intended to reduce or remove evidenced societal impediments to services such as stigma, discrimination, and inequitable gender norms) to find, treat, and prevent TB among PLHIV and to identify and treat HIV among people infected with TB.

• Support efforts to prevent, detect, respond, and treat infectious and non-infectious diseases that impact PLHIV and populations affected by HIV.

Any activities outside of HIV or TB activities will be consistent with the direction set forth in PEPFAR’s Five-Year Strategy, PEPFAR’s annual Country/Regional Operational Plan (COP/ROP) Guidance, annual COPs/ROPs, or other similar forthcoming strategy, guidance, or planning documents as may be consistent with applicable law.

Geographic prioritization may change over the course of the period of performance based on the burden of disease and changing program and PEPFAR priorities.

If the scope of activities to be conducted by the recipient(s) of funds under this NOFO includes work with KP, the recipient(s) will be expected to collaborate with KP organizations in the design and delivery of appropriate optimal and quality HIV services to KP.

Any Personally Identifiable Information (PII) collected for continuity of service provision should be managed in a manner that ultimately protects individual-level data to the extent allowed by applicable law.

In addition, PEPFAR is committed to protecting children from abuse, exploitation, and neglect in order to decrease their vulnerability to HIV/AIDS. Consistent with underlying authorities, PEPFAR seeks to ensure that children and youth obtaining services through PEPFAR programming are also protected from abuse, exploitation, and neglect in CDC PEPFAR-supported programs.

To that end, because activities to be funded under this NOFO may involve children or personnel coming into contact with children, Recipients of CDC PEPFAR funds agree to ensure compliance with host country and local child welfare and protection legislation or international standards, whichever gives greater protection, and with U.S. law, where applicable. Further, Recipients of CDC PEPFAR funding are strongly encouraged to: 1) have in place policies and procedures that prohibit recipient personnel from engaging in child abuse, exploitation, or neglect; 2) consider child safeguarding in project planning and implementation to determine potential risks to children that are associated with project activities and operations; 3) apply measures to reduce the risk of child abuse, exploitation, or neglect, including, but not limited to, limiting unsupervised interactions with children; prohibiting exposure to pornography; and complying with applicable laws, regulations, or customs regarding the photographing, filming, or other image-generating activities of children; 4) promote child-safe screening procedures for personnel, particularly personnel whose work brings them in direct contact with children; and 5) have a process for ensuring that personnel and others recognize child abuse, exploitation, or neglect, report allegations, investigate and manage allegations, and take appropriate action in response to such allegations. It is also strongly encouraged that Recipients include the above provisions in any applicable code of conduct for its personnel implementing PEPFAR-funded activities.

In its work with partners, CDC seeks to help control HIV epidemics and to achieve and maintain low levels of HIV incidence and mortality. Now and in the future, viable, capable, durable, and successful local partners will play an important role in achieving and sustaining control of national HIV epidemics. To that end, CDC strongly encourages direct applications from local organizations (i.e., institutions located, registered, and managed in the country and/or sub-region where work occurs and led by national of that country and/or sub-region). U.S.-based partners working in international settings also offer unique capabilities and will continue to make important contributions. Partnerships between local organizations and U.S.-based organizations may also offer benefits and are encouraged in such cases.

This NOFO is only for non-research activities supported by CDC. Recipients may not use funds for research. Certain activities that may require human subjects review due to institutional requirements but that are generally considered not to constitute research (e.g., formative assessments, surveys, disease surveillance, program monitoring and evaluation, field evaluation of diagnostic tests, etc.) may be funded through this mechanism. If research is proposed, the application will not be reviewed. For the definition of research, please see the CDC Web site at the following Internet address: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/revised-common-rule-regulatory-text/index.html#46.102

e. Relevant Work This NOFO builds on current, past, and program activities carried out under CDC-RFA-GH19- 1938 to support Mozambique’s MOH to strengthen an integrated national laboratory network for https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/revised-common-rule-regulatory-text/index.html#46.102 https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/revised-common-rule-regulatory-text/index.html#46.102 the provision of quality clinical diagnosis, screening, and surveillance services towards achievement of the UNAIDS 95-95-95 goals. The NOFO was designed to address governance and management of the integrated laboratory network, strengthening institutions to build and retain a quality workforce, building technical and scientific capacity, and implementing QMS towards accreditation. Laboratory accreditation has been achieved for six reference laboratories;

however, to date, no Central or Provincial Hospital laboratories have achieved accreditation.

Increased focus and mentorship are required to move clinical laboratories toward meeting this goal. Additionally, the current policy environment and inadequate staff limit MOH oversight for laboratory programs.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

Strategies and Activities

Short-Term Outcomes

Intermediate Outcomes

Long-Term Outcomes

Strategy 1: Build and expand sustainable and adaptable QA/QI programs to achieve international accreditation and adherence to national laboratory quality standards at all tiers of the laboratory system

Strategy 2: Expand and integrate LIMS within laboratories to optimize laboratory operations for efficient, timely patient management, and evidence-based decision-making

Strategy 3:

Develop, adapt, and optimize, capacity building initiatives for laboratory staff to implement

Increased operationalization of national QA/QI policies, procedures, and programs

Increased national and sub-national use of standardized indicators that measure the performance of the integrated diagnostic network

Increased competency of technical staff at all levels

Increased implementation of laboratory-based surveillance systems

Increased accuracy of laboratory results for client-centered decision-making

Increased adherence of laboratories to international and national QA/QI laboratory standards

Improved oversight of laboratory programs, systems, and networks

Increased availability of quality laboratory data for evidence-based decision-making

Increased implementation of policies for rapid uptake of global regulatory-approved diagnostics and population-appropriate testing algorithms

Sustained access to essential HIV, TB, and other disease diagnostics

Improved governance of laboratory programs, systems, and networks

Sustained maintenance of laboratory accreditation status by ISO-accredited laboratories

Increased efficient and timely client management

Increased capacity to detect, investigate, and respond to emerging public health threats for all populations affected by HIV innovative diagnostic and surveillance approaches for TB, HIV, and emerging public health threats

Strategy 4: Build local organizations and governmental capacity to manage and sustain laboratory programs, systems, and networks for TB, HIV, and emerging public health threats

Improved understanding of the roles and responsibilities needed to manage laboratory systems and networks

Increased capability of local organizations and government to manage laboratory programs, systems, and networks

i. Purpose The purpose of this NOFO is to build national capacity and to strengthen MOH and INS leadership to build and sustain policy governed, integrated laboratory systems and programs that support access to innovative and quality-assured laboratory diagnostics. This NOFO aims to support LIMS to guarantee timely and efficient results delivery for persons living with HIV/AIDS and the general Mozambique population.

ii. Outcomes CDC may require or allow applicants to propose additional related project period outcomes other than those identified in the NOFO.

Short-Term Outcomes:

• Increased operationalization of national QA/QI policies, procedures, and programs

• Increased national and sub-national use of standardized indicators that measure performance of the integrated diagnostic network

• Increased competency of technical staff at all levels

• Increased implementation of laboratory-based surveillance systems

• Increased accuracy of laboratory results for client-centered decision-making

• Improved understanding of the roles and responsibilities needed to manage laboratory systems and networks

Intermediate Outcomes:

• Increased adherence of laboratories to international and national QA/QI laboratory standards

• Improved oversight of laboratory programs, systems, and networks

• Increased availability of quality laboratory data for evidence-based decision making

• Increased implementation of policies for rapid uptake of global regulatory-approved diagnostics and population-appropriate testing algorithms

• Increased capability of local organizations and government to manage laboratory programs, systems, and networks

Long-Term Outcomes:

• Improved governance of laboratory programs, systems, and networks

• Sustained maintenance of laboratory accreditation status by ISO-accredited laboratories

• Increased capacity to detect, investigate, and respond to emerging public health threats for all populations affected by HIV

iii. Strategies and Activities CDC may require or allow applicants to propose additional related strategies and activities other than those identified in the NOFO to achieve the expected Outcomes.

Strategy 1: Build and expand sustainable and adaptable QA/QI programs to achieve international accreditation and adherence to national laboratory quality standards at all tiers of the laboratory system

• Provide technical assistance for revision of Mozambique’s laboratory policy and strategic plans

• Support implementation of QMS mentorship and TA to achieve ISO 15189 accreditation of reference, central, and provincial laboratories and ensure external quality assurance (EQA) compliance

• Develop and implement a comprehensive national QA/QI certification program that defines national requirements and standards for different levels of the laboratory system

• Ensure the sustainability and institutionalization of QA/QI programs (including Strengthening Laboratory Management towards Accreditation (SLMTA) and Rapid Test Continuous Quality Improvement (RTCQI)

• Expand national proficiency testing (PT) programs to incorporate newly adopted diagnostic tests and support MOH guidelines for decentralization of PT programs

• Review current systems and develop innovative approaches, processes, and policies to increase and sustain participation in PT programs

• Support ISO 17043 accreditation for the national PT program

Strategy 2: Expand and integrate LIMS within laboratories to optimize laboratory operations for efficient, timely patient management, and evidence-based decision-making

• Develop laboratory policies, strategies, and standards that will regulate the implementation and management of LIMS across different levels of the laboratory system

• Develop and implement management structures and strategies to institutionalize LIMS system under MOH management

• Support the installation and maintenance of LIMS in new PEPFAR-supported laboratories

• Expand LIMS, electronic patient tracking system (EPTS) integration at the health facility (HF) level, and integration with other systems where relevant

• Build and integrate automated QA processes to monitor and evaluate laboratory operations.

• Collaborate with PEPFAR partners to monitor and evaluate the sample referral processes using innovative LIMS-related technological approaches

• Collaborate with PEPFAR partners to develop, implement, and operationalize appropriate modules and dashboards within LIMS to address service gaps as needed

• Develop and implement routine LIMS training and capacity-building activities with contextually appropriate technological advancements

• Collaborate with laboratory and PEPFAR partners to develop, implement, and operationalize procedures to track LIMS data QA

• Improve LIMS data security, privacy and confidentiality of client results

• Improve data analysis and data dissemination to inform program priorities and evidence-based decision-making

Strategy 3: Develop, adapt, and optimize capacity building initiatives for laboratory staff to implement innovative diagnostic and surveillance approaches for TB, HIV, and emerging public health threats

• Work with MOH and other key stakeholders to develop, implement, and operationalize resilient testing algorithms that are adaptable to the changing landscape of HIV, TB, and other diagnostics as needed

• Identify and implement innovative diagnostic approaches across TB, HIV, and other diseases of public health importance using innovative capacity-building approaches (across in-service training, mentorship, and continuing education needs)

• Develop and implement technologically adaptable virtual and in-person training activities for laboratory staff to ensure a competent workforce across the laboratory network

• Develop, implement, and maintain systematic competency evaluation practices for laboratory staff

• Expand and strengthen HIV surveillance systems to inform public health response to HIV, TB, and emerging public health threats

• Build and expand the capacity for genomic sequencing and bioinformatics to improve timely detection and response to emerging public health threats

Strategy 4: Build local organizations and governmental capacity to manage and sustain laboratory programs, systems, and networks for TB, HIV, and emerging public health threats

• Collaborate with local organizations, INS and MOH to develop, implement, and operationalize national laboratory policies and strategic plans that stipulate structures and positions that need to be in place to manage laboratory systems

• Build human resources for health capacity within management structures at national and subnational levels, where relevant collaborate with CDC’s health information system trainings

• Work with MOH to improve the capacity to sustain laboratory programs using diversified financial resources

• Implement innovative capacity building approaches to enhance competency and management skills to facilitate implementation, monitoring, and evaluation of programs

In furtherance of the underlying purposes of this NOFO, Recipient is expected to provide copies of and/or access to all data, software, tools, training materials, guidelines, and systems developed under this NOFO to Ministry of Health and other relevant stakeholders, including HHS/CDC, for appropriate use consistent with underlying authorities.

1. Collaborations

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

To achieve the goals of the NOFO, the recipient(s) will be expected to collaborate with relevant MOH counterparts including the INS, the National Directorates for Public Health, Medical Assistance and for Human Resources. Additionally, the recipient(s) is expected to work with CDC-funded clinical partners supporting laboratory services in the provinces and CDC-funded laboratory, strategic information, and health systems strengthening partners, and any other CDC headquarters-funded technical assistance mechanisms and partners.

b. With organizations not funded by CDC:

The recipient(s) will be expected to collaborate with non-CDC funded US Government agencies and programs, under PEPFAR, Global Health Security and other potential initiatives, including collaborations with e.g. USAID and USAID implementing partners, and non-governmental organizations supporting laboratory systems strengthening initiatives. Other non-CDC funded partners that the recipient(s) will be expected to collaborate with include, but are not limited to, Global Fund, and WHO.

2. Population(s) of Focus The population(s) of focus for this NOFO include laboratory staff of all cadres, public health employees, clinicians, Government of Mozambique employees, PLHIV, and the general population of Mozambique.

This NOFO, including funding and eligibility, is not limited based on, and does not discriminate on the basis of race, color, national origin, disability, age, sex (including gender identity, sexual orientation, and pregnancy) or other constitutionally protected statuses.

a. Health Disparities The goal of health equity is for everyone to have a fair and just opportunity to attain their highest level of health. Achieving this requires focused and ongoing societal efforts to address historical and contemporary injustices; overcome economic, social, and other obstacles to health and healthcare; and eliminate preventable health disparities.

Broadly defined, social determinants of health are non-medical factors that influence health outcomes. They are the conditions in which people are born, grow, work, live, and age, and the wider set of forces and systems shaping the conditions of daily life. These forces (e.g., racism, climate) and systems include economic policies and systems, development agendas, social norms, social policies, and political systems. See content below and in other sections (e.g., Approach, Collaborations, Populations of Focus) for information on how this specific NOFO affects social determinants of health.

A health disparity is a preventable difference in the burden of disease, injury, violence, or opportunities to achieve optimal health that are experienced by populations that have been socially, economically, geographically, and environmentally disadvantaged. Health disparities are inextricably linked to a complex blend of social determinants that influence which populations are most disproportionately affected by these diseases and conditions.

In an effort to assure that activities funded through this NOFO (1) affirm and advance, as appropriate, the role of health equity and an equitable, diverse, and inclusive workforce as core principles, and (2) advance the reduction of stigma and discrimination through the promotion, consistent with applicable laws, of civil and human rights to improve the health outcomes of persons at risk of, or living with, HIV and/or TB infection, CDC PEPFAR awards resulting from this NOFO may address the following activities, where and when appropriate:

• Community involvement in the design, implementation, and monitoring of HIV and TB services.

• Training for implementing partners involved in the design, implementation, and/or monitoring of activities on stigma, discrimination, gender equitable norms, human rights, and community engagement to minimize the likelihood for activities to unintentionally increase stigma and discrimination directed towards PLHIV, people with TB, and other

KP.

• Programs to address evidenced health disparities and social barriers (e.g., HIV-related stigma) to HIV and TB services.

• Use of data to monitor disparities and implement strategies to improve access, service use, and outcomes.

iv. Funding Strategy Applicants to this NOFO are encouraged to apply to the Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award amount. Applications must not exceed this amount.

Component Funding: It is required that all PEPFAR-funded cooperative agreements be formulated for component funding. A component is a discrete set of activities with an associated budget. CDC will use component funding to provide funding for activities proposed in an application that received merit review but were not selected for funding in the initial award (i.e., at the onset of budget period 1) but may be funded at a later point in the budget period as programmatically necessary and as funding becomes available. Please review the following key points about component funding:

• Component funding must be setup at the time of the application. While preparing the application, applicants should review the expectations listed in the NOFO for Year 1 activities and group them under the anticipated components listed below. Only activities planned for Year 1 should be grouped into components; applicants do not need to group activities in the high-level plan for the subsequent years 2-5 of the award into components. Funding amounts and components for years 2-5 will be determined at continuation.

• Each component must be a discrete set of activities with an associated budget.

Distinguishable component budget narratives are required. Setting up components based on time (i.e., quarterly) is an appropriate distinction of activities, provided activities are clearly outlined.

• Applicants should submit the anticipated components on an SF-424A form as part of their application which shows all components for the budget period. The amounts should exactly match what is being requested for funding. Each component has its own approved amount and cannot be funded above the established amount. The combined total of all components must total the requested amount.

• If more than 4 components are proposed, multiple SF-424As will be needed. Applicants may include the first 4 components on one SF-424A form and the remaining components on a second SF-424A form. Applicants may download additional SF-424A forms and upload them as PDFs under “Budget Narrative Attachment Form” or “Other Attachments Form.” These should be clearly labeled for easy identification and included in the Table of Contents for the entire submission.

• If possible, applicants are encouraged to submit a separate budget justification for each component, but it is not a requirement. Applicants will not be deemed incomplete if separate budget justifications are not provided with the submission. A separate budget justification will ultimately be required for all components that are funded.

• Any component that is not funded at the time of a new award may be deemed “Approved but Unfunded (ABU)”. There is no guarantee that all components will be funded in a budget period as ABU components are subject to the availability of funds and the underlying legal authority for the work.

o Components may not be awarded in order. All ABU components are eligible to receive funding once (and if) funds become available.

o If funding becomes available, multiple components can be funded through the same funding action (single NOA).

o If funding is awarded for an amount less than the ABU component approved amount, it is not possible to fund the difference at a later time. Components can only be funded once.

• If, during the funding confirmation, the Program Office approves a budget that differs from what was submitted at the time of application (reflected in the budget markup), a revised budget may be required in addition to the technical review responses. If required, the revised budget is due within thirty (30) days of the start of the budget period. If required, technical review responses will also be due within thirty (30) days of the start of the budget period and must be submitted separately from revised budget applications.

Future funding for ABU components will not be awarded until a revised budget, if required, is submitted and approved by CDC.

• Once components are awarded, funds cannot be redirected between components.

However, funds may be redirected within a component between object class categories.

It is critical to ensure accountability, transparency, and programmatic performance of all U.S.

taxpayer dollars. When developing the annual work plan, please be advised that the annual

COP/ROP guidance requires that CDC take decisive action if an implementing partner is underperforming programmatically during any quarter of a fiscal year.

Applicants are encouraged to consider the following in the development of their budgets and budget narratives:

For Year 1, CDC anticipates an Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award of $7,000,000 with the below listed components:

• Component 1 – COP Q1 Targets/Activities;

• Component 2 – COP Q2 Targets/Activities;

• Component 3 – COP Q3 Targets/Activities;

• Component 4 – COP Q4 Targets/Activities;

• Component 5 – COP Additional Targets/Activities.

Applicants must specify a descriptive title for each corresponding column shown on the SF- 424A, followed by the total (cumulative) in the column to the far right of the SF-424A.

Applicants are encouraged to use the components listed above, but may propose alternative budget components so long as the general component funding guidance is followed.

Funding provided under this NOFO is subject to the availability of funds. The total number of years for which federal support has been programmatically 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. All future year funding will be based on satisfactory programmatic progress and the availability of funds.

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy

CDC expects that the routine performance data is reviewed, cleaned, and used for program management. To this effect, the recipient(s) should hold regular review meetings to discuss performance and use data in program quality improvement activities.

The recipient(s) should allocate funds made available under this NOFO for both evaluation activities and performance monitoring. While the final funding amount will be agreed upon by both CDC and the recipient, a minimum of 5% of funds should be allocated for monitoring activities and 5% of funds should be used for evaluation activities. These are estimates for the total funding over the 5-year project.

PERFORMANCE MONITORING

Some anticipated PEPFAR (MER) and non-MER indicators, targets, and reporting frequencies corresponding to Year 1 of the NOFO are shown below. Applicants should also propose any additional relevant PEPFAR MER and non-MER indicators as part of their initial Evaluation and Performance Measurement Strategy.

Applicants should note that these may be adjusted, or new targets and indicators may be identified in subsequent years based on implementation of HIV/AIDS epidemic control strategies and program priorities. Any gaps or unmet needs not fulfilled in the first year may affect the targets of the subsequent years.

Unless otherwise indicated, the reporting periods for MER indicators will mirror the PEPFAR MER indicator reporting frequency (quarterly, semi-annually, and annually). Additional information regarding MER reporting is included in the MER Guidance and resource materials, available at the following link (copy/paste into web browser to access):

https://datim.zendesk.com/hc/en-us/articles/360000084446-MER-Indicator-Reference-Guides.

PEPFAR MER Process and Outcome Measures:

• TX_PVLS: Percentage of ART patients with a VL result documented in the medical record and/or laboratory information system (LIS) with a suppressed VL (<1000 copies/ml) [Target: 95%; Reporting Frequency: Quarterly]

• LAB_PTCQI: Number of PEPFAR Supported laboratory-based testing and/or Point-of- Care Testing (POCT) sites engaged in CQI and proficiency testing activities [Target:

3,000; Reporting Frequency: Annually]

Non-MER: Additional Performance Measures (Custom Indicators)

Applicants should propose additional custom performance measures to monitor achievement of outcomes not directly measured by PEPFAR (MER) indicators. Custom indicators should include process and outcome measures directly correlated with the logic model. Below are examples of additional process and outcome measures for the strategies/activities and outcomes previously discussed in the logic model and associated sections.

• Number of policies developed by MOH that lead to hiring of staff [Target: Not assigned;

Reporting Frequency: Annual]

• Number of SOPs developed by MOH that lead to hiring of staff [Target: Not assigned;

Reporting Frequency: Annual]

• Proportion of PEPFAR supported laboratories using the government-endorsed LIMS [Target: 100%; Reporting Frequency: Annual]

• Proportion of HF where LIMS is integrated with EPTS [Target: 75%; Reporting Frequency; Annual]

• Proportion of integrated (LIMS and EPTS) HF that achieve a data upload rate of >98% [Target: 100%; Reporting Frequency Quarterly]

• Number of PEPFAR-supported laboratories participating in a CQI program to achieve national accreditation [Target: 130; Reporting Frequency: Annually]

• Proportion of PEPFAR-supported laboratories that have achieved documented progress towards ISO 15189 accreditation [Target: 75%; Reporting Frequency: Annually]

• Number of accumulated PEPFAR-supported laboratories that have achieved ISO 15189 accreditation [Target: 18; Reporting Frequency: Annually]

Data Sources for MER and Custom Indicators: Data sources may include registers, tally sheets, electronic and paper laboratory and records, QA/QI data bases, quarterly progress reports, surveillance and survey reports, and other program monitoring tools.

Evaluation https://datim.zendesk.com/hc/en-us/articles/360000084446-MER-Indicator-Reference-Guides

The evaluation topics below are examples of areas that the recipient may be expected to answer through process or outcome evaluation(s). Applicants should include at least 1, but no more than 3 potential evaluation topic areas. Recipients will be expected to conduct a mid-term and/or end-year evaluation.

Sample Evaluation Topics:

• Fidelity of the national laboratory CQI certification program [Process Evaluation]

• Assessing achievement of LIMS integration and interoperability [Outcome Evaluation]

• Facilitators and barriers to the government’s role in managing laboratory systems

[Process Evaluation]

Evaluation Data Sources: Data sources may include registers, tally sheets, electronic and paper laboratory and patient records, QA/QI data bases, recipient progress reports, focus groups, in-depth interviews, surveys, and other program monitoring tools.

Dissemination of Evaluation Results: Dissemination channels may include local and international conferences and forum abstract presentations, conference poster displays, manuscripts, bulletins, reports, presentations to technical working groups and stakeholder meetings, and other approved products in print and electronic media. The primary intended users of evaluation results and findings will be the wider program stakeholders. All evaluation reports will be publicly available on PEPFAR resource sites. CDC and stakeholders will use overall evaluation findings during the five-year NOFO period to share and implement key recommendations to strengthen program implementation and effectiveness, sustainability, and continued program improvement upon completion of the award.

Evaluations and strategy should align with national, PEPFAR, and agency requirements and priorities, and will be reviewed and may require approval as part of the COP/ROP. As such, the example evaluation topics listed in this NOFO may be amended based on feedback from the GHSD Bureau during the annual COP/ROP review process.

ii. Applicant Evaluation and…