CDC-RFA-PS-24-0028 (Final).pdf

Centers for Disease Control and Prevention

NATIONAL CENTER FOR HIV, VIRAL HEPATITIS, STD AND TB PREVENTION

NCHHSTP Epidemiologic and Economic Modeling for HIV, Viral Hepatitis, STD, and TB

CDC-RFA-PS-24-0028

04/08/2024

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-PS- 24-0028. Applicants also must provide an e-mail address to www.grants.gov to receive notifications of changes.

A. Federal Agency Name:

Centers for Disease Control and Prevention (CDC)

B. Notice of Funding Opportunity (NOFO) Title:

NCHHSTP Epidemiologic and Economic Modeling for HIV, Viral Hepatitis, STD, and TB

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)).

Please note for this particular NOFO, CDC-RFA-PS-24-0028, research activities are allowable and will be subject to all applicable laws, regulations and policy requirements. Note research and human subjects protection requirements inserted throughout this NOFO. All instructions pertaining to research should be addressed and followed as indicated in this NOFO. Please refer to the Strategies and Activities (section iii) for more details.

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)

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-PS-24-0028

E. Assistance Listings Number:

93.084

F. Dates:

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

The LOI date will generate once the Synopsis is published if Days or a Date are entered.

Recommended but not Required The purpose of an LOI is to allow CDC program staff to estimate the number of and plan for the review of submitted applications.

LOI must be sent via email to:

Tamika Hoyte thoyte@cdc.gov

2. Due Date for Applications:

04/08/2024 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov.

3. Due Date for Informational Conference Call CDC will conduct a conference call for all interested applicants to provide technical assistance and respond to any questions regarding the notice of funding opportunity (NOFO) process.

Please save the date for an informational call for PS-24-0028 – NCHHSTP Epidemiologic and Economic Modeling for HIV, Viral Hepatitis, STD, and TB.

When: 03/6/2024, 1:00pm Eastern Time Conference call line:

https://cdc.zoomgov.com/j/1603997313?pwd=b253M0IrRG9yTlFOQk9JK1liWVNXQT09 Slides and notes including answers for questions received before and during the call will be posted at: https://www.cdc.gov/nchhstp/neema/index.html

G. Executive Summary:

Summary Paragraph This notice of funding opportunity (NOFO) will support modeling of disease dynamics and advanced data analytics to inform and improve HIV, viral hepatitis, STD, and TB epidemics, interventions, and programs. Epidemiologic and economic models have long been a part of NCHHSTP’s emphasis on data use for program improvement. Over 10 years (2014-2024), the Center has harnessed extramural collaborations to strengthen the use of data for understanding the efficiency, outcomes, impact, costs, quality adjusted life years (QALYs), and cost-effectiveness of programs, policies, and activities. Prior modeling efforts by NCHHSTP and collaborators have provided insights into the development of guidelines, program strategies, needs assessments, and informed piloting, implementation and scale-up of programs.

https://www.grants.gov/ https://cdc.zoomgov.com/j/1603997313?pwd=b253M0IrRG9yTlFOQk9JK1liWVNXQT09 https://www.cdc.gov/nchhstp/neema/index.html

This NOFO will incorporate new modeling approaches, continue to enhance existing models that guide informed decision-making, provide tools and data for prioritizing public interventions and programs, and to guide the allocation of scarce program resources. It will also expand the use of advanced data analytics using predictive models, causal inference, and other cutting-edge approaches, as well as allow for the development and implementation of research studies in alignment with NCHHSTP-related public health priorities. This mechanism allows NCHHSTP to strengthen its capacity to conduct scientifically valid modeling studies that promote improved health outcomes and enhance health equity.

a. Eligible Applicants:

Open Competition

b. NOFO Type:

CA (Cooperative Agreement)

c. Approximate Number of Awards

d. Total Period of Performance Funding:

$10,000,000

e. Average One Year Award Amount:

$1,000,000

f. Total Period of Performance Length:

5 year(s)

g. Estimated Award Date:

August 30, 2024

h. Cost Sharing and / or Matching Requirements:

No

Part II. Full Text

A. Funding Opportunity Description

1. Background

a. Overview Public health decision makers rely on foundational data to evaluate the effects of alternative programs, policies, and interventions. Epidemiologic data have been used in mathematical models and other advanced data analytics to guide decision making and policy for public health programs. These approaches can help to guide decision makers on evidence-based interventions that can be implemented or expanded to eradicate or reduce the burden of HIV, viral hepatitis, sexually transmitted diseases (STD), and tuberculosis (TB), and can highlight how different interventions compare with each other in terms of their health and economic outcomes.

Mathematical models and other advanced data analytics have been a component of the CDC’s toolkit, enabling the agency to fulfill its mission of supporting state and local public health efforts and evaluating the effectiveness of public health interventions. To this end, CDC and NCHHSTP have harnessed mathematical models and other advanced data analytics for assessing the value of public health interventions and evidence-based decision-making within various programs. NCHHSTP has a long history of using mathematical modeling and other advanced analytics to strengthen the use of data for understanding the efficiency, outcomes, and impact of programs, policies, and activities of the Center. Findings from two prior NOFOs supported by NCHHSTP have informed the development of guidelines for priority disease areas, produced estimates of population size, disease incidence, and prevalence, and resulted in improved understanding of the value of dollars spent for HIV, viral hepatitis, STD, and TB programs.

b. Statutory Authorities Public Health Service Act [42 U.S.C. Sections 243 and 247b(k)(2)].

c. Healthy People 2030 This NOFO addresses the following HP2030 objectives:

Reduce the number of new HIV infections (HIV-01) Increase knowledge of HIV status (HIV-02) Increase linkage to HIV medical care (HIV-04) Reduce the rate of acute hepatitis B (IID-11) Reduce the rate of acute hepatitis C (IID-12) Increase the proportion of sexually active female adolescents and young women who get screened for chlamydia (STI-01) Reduce the syphilis rate in females (STI-03) Reduce congenital syphilis (STI-04) Reduce the syphilis rate in MSM (STI-05) Reduce TB cases (IID-17) Full list at: https://health.gov/healthypeople/objectives-and-data

d. Other National Public Health Priorities and Strategies This NOFO will support the following national public health priorities and strategies:

• National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) Strategic Plan

• National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) Equity Initiative

• National HIV/AIDS Strategy

• National Strategic Plan: A Roadmap to End the Epidemic for the United States 2021-

• Viral Hepatitis National Strategic Plan

• Division of Viral Hepatitis 2025 Strategic Plan

• U.S. Department of Health and Human Services. 2020. Sexually Transmitted Infections

National Strategic Plan for the United States: 2021–2025

• DTBE strategic plan

e. Relevant Work This NOFO builds on two prior NOFOs – NCHHSTP Epidemiologic and Economic Modeling Agreement [NEEMA] – CDC-RFA-PS14-1415 and CDC-RFA-PS19-1905. A full list of NEEMA publications can be found at: Published Papers | NEEMA | NCHHSTP | CDC https://health.gov/healthypeople/objectives-and-data https://www.cdc.gov/nchhstp/strategicpriorities/default.htm https://www.cdc.gov/nchhstp/strategicpriorities/default.htm https://intranet.cdc.gov/nchhstp/od/equityinitiative/index.html https://intranet.cdc.gov/nchhstp/od/equityinitiative/index.html https://www.hiv.gov/federal-response/national-hiv-aids-strategy/national-hiv-aids-strategy-2022-2025/ https://files.hiv.gov/s3fs-public/HIV-National-Strategic-Plan-2021-2025.pdf https://files.hiv.gov/s3fs-public/HIV-National-Strategic-Plan-2021-2025.pdf https://www.hhs.gov/hepatitis/viral-hepatitis-national-strategic-plan/index.html https://www.cdc.gov/hepatitis/pdfs/DVH-StrategicPlan2020-2025.pdf https://www.hhs.gov/sites/default/files/STI-National-Strategic-Plan-2021-2025.pdf https://www.hhs.gov/sites/default/files/STI-National-Strategic-Plan-2021-2025.pdf https://www.cdc.gov/tb/about/strategic-plan-background.htm#goals-health-equity https://www.cdc.gov/nchhstp/neema/published-papers/index.html

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

CDC-RFA-PS-24-0028 Logic Model: NCHHSTP Epidemiologic and Economic Modeling for HIV, Viral Hepatitis, STD, and TB

Bold indicates period of performance outcome

Strategies & Activities Short-term Outcomes Intermediate Outcomes

Long-Term Outcomes

Strategy 1: Maximize use of models to drive public health improvement efforts for HIV, viral hepatitis, STD, TB, and related syndemics

- Identify and leverage appropriate data sources for disease models

- Conduct mathematical modeling to predict epidemics

- Conduct economic analyses to further prevention and treatment

- Develop models to inform guidelines and policy to improve public health programs

- Conduct evaluations and modeling of program integration and impact on patients and programs

Strategy 2: Support scientific discovery, program and intervention evaluation

- Increased efficiency in analysis and interpretation of surveillance, program, and other data

- Increased availability of evidence-based approaches to inform program improvement dissemination of findings from models and tools supporting NCHHSTP priorities

- Increased use of models to support development of guidelines and policies

- Increased use of models to inform program delivery and improvement

- Increased awareness and use of information from models among federal, state, and local partners

- Enhanced use of evidence-based approaches to inform prevention programs

- Improved program effectiveness, and/or decision-making about future program development and scaleup

- Reduced incidence of HIV, viral hepatitis, STIs, and

TB

- Reduced morbidity and mortality from HIV, viral hepatitis, STD, and TB infections

- Reduced health disparities and promote health equity

- Improved health outcomes for persons living with and at risk for HIV, viral hepatitis, STIs, and TB for HIV, viral hepatitis, STD, and TB

- Conduct advanced data analytics using predictive modeling, causal inference, and other cutting-edge approaches

Strategy 3: Translate findings for broader public health use and improvement efforts for HIV, viral hepatitis, STD, and TB

- Develop communication materials

- Develop and pilot tools for public health practitioner use

- Collaborate to strengthen use of models for implementation science

- Increased implementation of cost-effective, evidence-based interventions availability of tools and resources that translate model findings for public health practice

i. Purpose This NOFO will support the development of disease models and advanced data analytics to help inform and improve HIV, viral hepatitis, STD, and TB interventions and programs. It will expand (and build on) previous modeling activities by collecting needed epidemiologic and economic data, conducting additional analyses, developing new models and methodologies, standardizing methods across programs, and developing user-friendly tools. Examples of peer-reviewed publications supported by previous NEEMA NOFOs can be found here:

https://www.cdc.gov/nchhstp/neema/published-papers/index.html.

ii. Outcomes As noted in the logic model presented in the Approach section above, the outcomes expected of the recipients during the period of performance are:

Strategies 1, 2, and 3 https://www.cdc.gov/nchhstp/neema/published-papers/index.html

• Increased use of models to support development of guidelines and policies

• Increased dissemination of findings from models and tools supporting NCHHSTP priorities

• Increased availability of tools and resources that translate modeled findings for public health practice

iii. Strategies and Activities This NOFO has three strategies and four main priority areas: HIV, viral hepatitis, STD, and TB.

Applicants are required to respond to all three strategies described below and at least three of the four priority areas, and consider incorporating a syndemics approach in their proposed project narrative. A syndemic is population-level clustering of social and health problems. In the context of HIV, viral hepatitis, STDs and TB, a syndemic is when one of these infections clusters with one or more other diseases or health conditions within a specific population, driven by the contextual, structural and social factors that increases the adverse effects on the health of people and communities.

When describing strategy 3, applicants should present a clear link to activities proposed under strategies 1 and 2. Applicants may propose non-research and research activities under any of the three strategies. Examples of potential projects are presented in Table 1 below. Applicants should select three examples representing the main priority areas and provide a brief description of their approach for addressing the project ideas selected.

Strategy 1: Maximize use of models to drive public health improvement efforts for HIV, viral hepatitis, STD, TB, and related syndemics.

a. Identify and utilize appropriate data sources for disease models: Applicants should describe how they plan to utilize available or published (i.e., secondary) data or plan to obtain primary data. Applicants should describe how they will utilize available surveillance and other secondary data for informing program effectiveness, and/or decisions for future program improvement.

Applicants should describe how they will collect and maintain new streams of data on program activities, characteristics, costs, disease outcomes, and other epidemiological data. Applicants must also address how they will make data collected, generated, or obtained accessible to the public.

b. Conduct mathematical modeling to predict epidemics, disease trends, estimate health effects (e.g., health utility), and costs under programmatic interventions or alternative scenarios:

Modeling activities will be based on NCHHSTP priorities and strategies (refer to NOFO part II, section d) with details decided upon through close collaboration with CDC staff. Applicants should describe how they would approach hypothetical modeling questions (Table 1), including how they would identify and plan to target questions to the appropriate audience and ensure results are aligned with intended use by the appropriate audience.

c. Conduct economic analyses (e.g., cost, cost effectiveness, cost utility, cost benefit) to further HIV, viral hepatitis, STD, and TB prevention and treatment. Collect primary cost data if existing cost data is insufficient or inadequate. Applicants must address how they will make cost data collected, generated, or obtained accessible to the public.

d. Develop models to inform guidelines and policy recommendations to improve public health programs and/or patient outcomes: activities proposed will support current CDC guidelines or their changes and the policy development process through developing new or adapting existing models that are responsive to emerging NCHHSTP priorities.

e. Conduct evaluations and modeling of interrelated health issues, activities, and prevention strategies to promote comprehensive delivery of services, including impact on patients, specific populations and programs: Activities proposed here will address NCHHSTP’s syndemics approach, which acknowledges the opportunities a more holistic approach to individual and population health can provide by increasing collaboration between public health programs and partners to organize and blend interrelated activities and services to improve public health outcomes. Activities under this approach must include avenues for collaboration between the applicant, CDC, health department programs, and other public health partners to use models to inform program delivery and drive improvement for NCHHSTP programs. Examples include economic evaluations of technologies, interventions, and programs (Table 1). When applicable, the applicant should produce decision support tools based on their modeling for adaptation by other states or local policy and decision-making entities.

Strategy 2: Support scientific discovery, program and intervention evaluation for HIV, Viral Hepatitis, STD, and TB:

a. Conduct advanced data analytics using predictive modeling (including machine learning and artificial intelligence methods), causal inference, and other cutting edge approaches: Applicants should address how program and surveillance datasets can be leveraged to improve forecasting of disease trends and respond to emerging disease threats by providing information on when and where disease may occur, how large the impact will be, and when disease trends may shift to improve the preparation for and response to disease outbreaks. These include but are not limited to population-based modeling for forecasting trends for individual diseases and multiple infections and causal impact analysis using programmatic data to empirically estimate program impact on relevant health outcomes. Applicants should prioritize developing models and analytic tools that are simple and transparent and can quickly answer policy questions. Applicants should focus on ‘rigorous evaluation’ or ‘rigorous analytic’ approaches and are required to describe how the work will be useful for and transferrable to health departments, community-based organizations, and other relevant end-users.

Strategy 3: Translate findings for broad public health use and improvement efforts for HIV, Viral Hepatitis, STD, and TB: Applicants should describe their approach to implementing strategy 3 in relation to activities proposed under strategies 1 and 2.

a. Develop communication materials such as issue briefs and visualizations: applicants should describe how they will translate model findings in practical and easy to understand formats tailored for different policy-making and decision-making audiences. Examples of such communication materials include but are not limited to publications, issue briefs, summaries, customized analytical tools, reports, and visualizations.

b. Develop and pilot tools for public health use: Applicants should develop and/or adapt modeling tools as ‘real world’ pilots to allow state/local jurisdictions to design “what if” experiments. Applicants should describe how stakeholder (i.e., end-users and public health partner groups) collaboration will be ensured throughout the pilot. The applicant should also address potential approaches to increase awareness and use of information findings/lessons learned beyond the pilot.

c. Collaborate to strengthen use of modeling support for implementation science research:

Applicants should include plans for providing technical assistance to and collaborating with CDC staff, as needed, to improve understanding of factors contributing to or affecting successful program implementation. Applicants may propose plans for engaging with advisory groups (e.g., public health practice and public health policy advisory groups) on leveraging models and advanced data analytics for improving public health practice, decision-making, and policy.

Table 1: Examples of potential projects (this is not an exhaustive list*):

HIV

1. What is the effect of PrEP uptake on HIV incidence rates over time?

2. Estimating unmet need for PrEP by population and geography and exploring the effects of different interventions on PrEP usage and incidence.

3. Estimating effects of different testing approaches to address unmet need for knowledge of

HIV serostatus.

4. Estimating effects of multi-infection prevention and diagnosis approaches (e.g., screening and other prevention strategies including Doxy, PreP, PEP, PrEP) for HIV and syphilis among disproportionately affected populations, e.g., MSM, PWID, hetero cis-women, and others.

STIs

5. What is the impact on disease prevalence and antimicrobial resistance of post-exposure doxycycline prophylaxis?

6. Estimate the impact of using a secure patient portal for partner services (similar to those that can be used to provide test results): this project may incorporate primary data collection.

7. Estimate the impact of increasing telehealth utilization and home testing on STI incidence and prevalence. Note that studies have shown that satisfaction with telehealth vs. in-person visits varies by patient characteristics.

8. Model the impact of increasing screening for chlamydia and gonorrhea to older age groups than those currently recommended, incorporating current screening practices.

Tuberculosis

9. Primary data collection on current costs for drug-resistant and drug-susceptible TB, including hospitalization.

Viral Hepatitis

10. Assessing effects of new CDC guidelines related to hepatitis B vaccination and hepatitis B and hepatitis C screening.

11. Estimating years of potential life lost associated with differing access to hepatitis C treatment (this could be policy reasons or access reasons).

Cross-cutting

12. Collection of data to consistently measure quality-adjusted life years (QALYs) for HIV, viral hepatitis, STD, and TB in relevant populations.

13. Modeling effects of different harm reduction interventions, including vending machines, Overdose Prevention Centers, Syringe Services Programs, and a combination of those therein (may require program data collection).

14. Modeling the impact of changing Social Determinants of Health (SDOH) factors (housing, structural racism, and access to health insurance) and their intersection to determine which SDOH variables can impact incidence, treatment outcomes, and disparities in HIV, viral hepatitis, STDs, and TB.

15. State-level population estimates of transgender youth using predictive modeling.

16. Associations between policies and protocols related to confidentiality and time alone with adolescent receipt of HIV and STD testing and treatment.

17. Multilevel factors associated with temporal trends in health disparities in sexual and reproductive health among adolescents.

18. Examining racial and ethnic disparities in HIV, viral hepatitis, STDs, and TB incidence, morbidity, and mortality: exploring social and structural mediating mechanisms and interventions.

*Other project topics in collaboration with Centers external to NCHHSTP may be considered based on priorities and availability of funding.

1. Collaborations

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

Recipients will collaborate with CDC programs, state and local health departments, other federal agencies (e.g., HRSA, SAMHSA, HUD, NIH, etc.), and other CDC-funded organizations, including recipients funded through this NOFO, to support strategies and activities of this NOFO. Recipients are also encouraged to develop and strengthen collaborations with a broad range of partners, including community-based organizations, substance use treatment services, and other federal, state, and local agencies for more holistic input on social and structural factors driving NCHHSTP relevant syndemics. Applicants should demonstrate the extent of collaboration with partner(s) through letters of support, MOU, or MOA. Recipients should also collaborate with other recipients funded through this NOFO.

b. With organizations not funded by CDC:

Applicants should describe the extent to which collaborations exist that the recipient would leverage for this NOFO, including existing collaborations with other groups not funded by CDC.

2. Population(s) of Focus 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.

The program supports efforts to improve the health of populations disproportionately affected by HIV, Viral Hepatitis, sexually transmitted diseases (STDs) and TB by maximizing the health impact of public health services, reducing disease incidence, and advancing health equity. A health disparity occurs when a health outcome is seen to a greater or lesser extent between populations. Health disparities in HIV, Viral Hepatitis, STDs, and TB are inextricably linked to a complex blend of social determinants that influence which populations are most disproportionately affected by these infections and diseases. Social determinants are conditions in the places where people live, learn, work, and play that affect a wide range of health and quality-of life-risks and outcomes (https://www.cdc.gov/socialdeterminants/index.htm ). These include conditions for early childhood development; education, employment, and work; food security, health services, housing, income, and social exclusion. Health equity is a desirable goal that entails special efforts to improve the health of those who have experienced social or economic challenges.

It requires:

• Continuous efforts focused on elimination of health disparities, including disparities in health and in the living and working conditions that influence health, and

• Continuous efforts to maintain a desired state of equity after health disparities are eliminated.

Recipients should use data, including social determinants data, to identify communities within their jurisdictions that are disproportionately affected by HIV, Viral Hepatitis, STDs and TB and related diseases and conditions, and plan activities to help eliminate health disparities. In collaboration with partners and appropriate sectors of the community, recipients should consider social determinants of health in the development, implementation, and evaluation of program specific efforts and use culturally appropriate interventions and strategies that are tailored for the communities for which they are intended.

iv. Funding Strategy Not applicable

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Strategy

This NOFO emphasizes rigorous evaluation of analytic approaches, decision support methodologies and tools developed or supported. For each analytic or decision support tool or approach that is being developed, refined, piloted, integrated or implemented, the applicant should have a plan for quantitative and qualitative evaluation that includes careful documentation https://www.cdc.gov/socialdeterminants/index.htm of both successful and unsuccessful efforts. Evaluations should be defined prospectively, with input from collaborator groups, end users and implementers. While not all details of the evaluation approach will be able to be specified at the time of application, CDC will use the following 2-pronged approach of evaluation and performance measurement for this NOFO:

• Process evaluation: use to track implementation of recipient strategies and activities through output monitoring

• Outcome evaluation: determine progress on achieving the period of performance outcomes through indicator monitoring.

Applicants should propose an evaluation plan, data analysis plan (if relevant) and timeline for their specific activities. CDC will provide technical assistance on the selection of overall performance measures and implementation of the performance measures across the network.

CDC and the recipients will finalize the performance measures and identify feasible data sources for those measures within the first 9 months of the project period. Recipients are responsible for gathering and analyzing data for performance measures, which will include both qualitative and quantitative measures. Applicants are not required to use the examples provided below and are welcome to propose measures that indicate progress towards other outcomes described in their work plan and in the logical model included in this NOFO.

Increased use of models to support development of guidelines and policies

• Output 1: Number of projects supporting development of guidelines and policy recommendations at national, state or jurisdictional level.

• Indicator 1: Percentage of projects supporting the development of guidelines and policy recommendations that are referenced in guidelines and policy documents at national, state or jurisdictional level using databases such as Altmetric, Overton, or other publicly available source.

Increased availability of findings from models and tools supporting NCHHSTP priorities

• Output 2: Number of peer-reviewed articles documenting application of new modeling methods to NCHHSTP priorities.

• Indicator 2: Percentage of projects that result in articles in high-impact journals.

Increased dissemination of tools and resources that translate model findings for public health practice

• Output 3.1: Number of resources and tools tailored to a non-scientific audience base.

This can include issue briefs and visualization materials to support programs and presentations to public health practice-oriented audience base.

• Output 3.2: Number of state and local health departments, and other partner groups supported with real-world pilots of models, resources, and tools, including technical assistance provided or tool enhancements, webinars, presentations, and analytic support.

• Indicator 3: Percentage of resources and tools developed that are disseminated to state and local health departments, through usability testing, webinars, trainings, or other types of technical support.

Applicants are required to develop and submit a detailed DMP for each collection and generation of public health data.

Resource Sharing Plans: HHS and CDC policy require that recipients of grant awards make research resources and data readily available for research purposes to qualified individuals within the scientific community after publication. Please see https://www.cdc.gov/grants/additional-requirements/ar-25.html for Additional Requirement-25 (AR-25). The AR-25 outlines the components of a DMP and provides additional information for applicants regarding the requirements for data accessibility, storage and preservation. Applicants must propose a DMP in their application, for finalization within 6 months after the award. The DMP should be developed during the project planning phase prior to the initiation of data collection/generation activities and submitted for review. In the DMP, applicants will describe how they intend to manage, preserve, and make data generated or collected with CDC funding accessible. To the extent allowed under grant award and applicable under grant award and applicable regulations, CDC may request a copy of data produced under the award. Applicants may also consider the EpiForge guidelines for further considerations specific to disease modeling.

https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1003793

The DMP may be in narrative or table form and must include:

• A description of the data to be collected or generated in the proposed project;

• The standards to be used for the collected or generated data;

• Mechanisms for, or limitations to, providing access to the data, including a description for the provisions for the protection of privacy, confidentiality, security and intellectual property, or other rights;

• Statement of the use of data standards that ensure all documentation that describes the method of collection, what the data represent, and

• Plans for archiving and long-term preservation of the data, or explaining why long-term preservation and access are not justified.

The DMP will be evaluated for quality and completeness at the time of submission.

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, including, as applicable to the award, how findings will contribute to reducing or eliminating health disparities and inequities.

• 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).

• How evaluation findings will be disseminated to communities and populations of interest in a manner that is suitable to their needs.

• Plans for updating the Data Management Plan (DMP) as new pertinent information becomes available. If applicable, throughout the lifecycle of the project. Updates to https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1003793

DMP should be provided in annual progress reports. The DMP should provide a description of the data that will be produced using these NOFO funds; access to data;

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

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

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

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

• 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.

Recipients will be required to submit a more detailed evaluation plan within 12 months of initial award, including any relevant modifications to the DMP.

When developing evaluation plans, the applicant should:

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

• Describe key evaluations questions to be addressed.

• Describe other relevant information, such as indicators, measures, data sources, and stakeholder (i.e., collaborators/end-user/partner groups) engagement approach.

• Describe the approach to collaborating with diverse entities including minority serving institutions and non-academic institutions in addressing the strategies and objectives of the NOFO.

Given the wide range of approaches, activities and tools to be developed through this NOFO and because there may be a benefit for collaboration across the network of recipients and planned in collaboration with implementing partners and CDC, evaluation plans will be tailored after recipients are selected and refined in yearly work plan development. Additional guidance may be provided by CDC at a later date, as needed.

d. Work Plan Work Plan template (see example below) must be divided by strategy. Activities proposed under the respective work plans must align with the approach (logic model, strategies, activities, outcomes, and evaluation/performance measures) outlined throughout this funding announcement.

The applicant must provide a detailed work plan for the first budget period (12 months) and a high-level work plan for subsequent years. Post-award, the proposed work plan and activities may be adjusted within the scope and terms of this NOFO in collaboration with CDC to ensure compliance with applicable grant regulations and policies, to avoid duplicative work within the network of recipients and to prioritize the highest priority efforts to address the objectives of this NOFO. The workplan should address staff roles, functions and time allocation. This should https://www.cdc.gov/grants/additional-requirements/ar-25.html https://www2.ed.gov/about/offices/list/ocr/edlite-minorityinst-list.html https://www2.ed.gov/about/offices/list/ocr/edlite-minorityinst-list.html include identification of staff providing all areas of expertise referred to under the Strategies and Activities section and their respective time allocations. In addition, applicants should outline the level of effort provided by key personnel on projects.

Period of Performance Outcome:

[from Outcomes section and/or logic model]

Outcome Measure: [from Evaluation and Performance Measurement section]

Strategies and Activities

Process Measure [from Evaluation and Performance Measurement section]

Responsible Position/ Party

Completion Date

c. Organizational Capacity of Recipients to Implement the Approach Applications must have demonstrated capability in at least three of the four areas of HIV, viral hepatitis (A, B, and C), sexually transmitted diseases, and tuberculosis. Applicants should have epidemiologic, clinical, modeling, and economic expertise sufficient to define modeling questions, generate hypotheses, conduct literature searches, determine needed data inputs, collect data, and construct models in three of the four areas.

In addition, applicants should have the capacity to:

• Model epidemiologic and economic data for various United States geographic areas (regions, states, and localities).

• Work with CDC and other federal/state/local departments/health officials to identify modeling topics, strategies, and products that are of most use to them.

• Conduct data collection or research activities and secure necessary institutional review board (IRB) approvals, data use agreements, memorandum of understanding (MOU), and other administrative requirements.

• Collaborate with other organizations with expertise in developing models to address disparities in NCHHSTP's priority pathogens and populations.

• Collaborate with a diverse group of researchers including those from minority serving institutions and non-academic institutions.

• Communicate modeling activities clearly and succinctly to CDC and state/local program staff.

• Attend and give presentations to policy and scientific audiences.

Applicants should describe the organizational capacity and technical expertise that enables the applicant to successfully implement the award. Applicants must demonstrate how they are staffed, organized and managed to implement the activities in their work plan and contribute to the achievements of the outcomes defined in the logic model, with a focus on those in bold and to be achieved in the NOFO period of performance. Applicants should describe their partnership approach across sectors and within the network of recipients.

https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive-order-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government/

Key components of organizational capacity that must be provided include:

• Personnel: Curriculum vitae for key personnel should be provided in a file named “CVs/Resumes” and this file should be uploaded to www.grants.gov with the application. Collectively these key personnel should have clear and demonstrated experience and expertise that covers the range of proposed activities.

• Management: Applicants must demonstrate sufficient project management structure and experience to achieve the project outcomes, including having appropriate policies and procedures in place. This includes, but is not limited to, program and staffing management, financial reporting systems, communication, technological and data systems required to implement activities in an effective and expedited manner.

• In addition, applicants should describe their capacity to staff projects with substantial project leadership effort from key personnel.

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

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

• Tracking recipient progress in achieving the desired outcomes.

• Ensuring the adequacy of recipient systems that underlie and generate data reports.

• Creating an environment that fosters integrity in program performance and results.

Monitoring may also include the following activities deemed necessary to monitor the award:

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

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

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

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

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

For all work plans supported through this funding opportunity, recipients should strive to collaborate with CDC project officers and technical monitors to align work consistent with the scope of NCHHSTP priorities and terms of the NOFO. Additional CDC routine monitoring and accountability activities may include:

• Reviewing and approving the recipient’s annual work plan and detailed budget.

• Providing administrative support to help the recipient meet U.S. Government financial and reporting requirements.

https://www.grants.gov

• Organizing regular calls and meetings with the recipient to monitor project implementation progress.

• Organizing regular calls and meetings with the recipient to assess expenditure in relation to approved work plan and to modify as necessary.

• Ensuring all human subjects research protocols have been approved by an Office of Human Research Protections-registered IRB in accordance with the requirements of the Common Rule before human subjects work is initiated, and that IRB approvals are maintained throughout the study period, when applicable.

• Ensuring all OMB-Paperwork Reduction Act (PRA) approvals have been obtained, as necessary, throughout the lifespan of the NOFO.

• Ensuring all animal use protocols are reviewed by the CDC Animal Care and Use Program Office and Institutional Animal Care and Use Committee per CDC policies.

• Ensuring that recipient’s collaborators on activities funded by this NOFO abide by CDC policies on scientific integrity and quality.

f. CDC Program Support to Recipients

In a Cooperative Agreement, CDC and the recipients share responsibility for successfully implementing the award and meeting identified project outcomes. Recipients are required to collaborate with CDC's NCHHSTP Office of the Director and Divisions (Division of HIV Prevention [DHP], Division of Viral Hepatitis [DVH], Division of STD Prevention [DSTDP], and Division of Tuberculosis Elimination [DTBE]). The project protocols will be developed with substantial CDC involvement to assure project outcomes are consistent with NCHHSTP strategic priorities, HIV, viral hepatitis, STD, and TB specific strategic plans and in alignment with the strategies and activities stated in this NOFO. CDC will provide support to the recipients as presented below:

• Developing research questions and design of projects.

• Engaging to provide data and expert opinion (i.e., consultation on epidemiologic modeling and health economics analyses).

• Assisting in analysis and interpretation of data and disseminating results.

• Obtaining project approvals (including concept development and approval process

(CDAP ) and project determination (PD) for research or non-research from the Associate Director for Science for the respective CDC program when CDC scientists are engaged.

• Obtaining IRB approval from the CDC Institutional Review Board for research involving human subjects when CDC is engaged.

• Obtaining Office of Management and Budget approval per the Paperwork Reduction Act, if necessary.

• Facilitating and coordinating the development of information exchange with partners (i.e., collaborators/end-users/partner groups).

Because CDC and recipients share responsibility for participation in all activities and the success in meeting the outcomes, the resulting products are expected to be authored by both recipient and CDC staff who participated in the project, following CDC authorship guidelines. Hence, products will require CDC scientific review and approval before submitting to a journal, conference/meeting or other audience.

B. Award Information

1. Funding Instrument Type:

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

2. Award Mechanism:

U38 In cooperation with the states to operate a uniform national health program reporting system, which is to provide data for analytical purposes to assist health planners and health program managers in their decision-making processes.

3. Fiscal Year:

Estimated Total Funding:

$10,000,000

4. Approximate Total Fiscal Year Funding:

$2,000,000 This amount is subject to the availability of funds.

5. Approximate Period of Performance Funding:

$10,000,000

6. Total Period of Performance Length:

5 year(s)

7. Expected Number of Awards:

8. Approximate Average Award:

$1,000,000 Per Budget Period

9. Award Ceiling:

$0 Per Budget Period

10. Award Floor:

$0 Per Budget Period

11. Estimated Award Date:

August 30, 2024

12. Budget Period Length:

12 month(s)

Throughout the period of performance, 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 (period of performance) will be shown in the “Notice of Award.” This information does not constitute a commitment by the federal government to fund the entire period. The total period of performance comprises the initial competitive segment and any subsequent non-competitive continuation award(s).

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

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

C. Eligibility Information

1. Eligible Applicants

Eligibility Category:

99 (Unrestricted (i.e., open to any type of entity above),…