Foa_Content_of_RFA-DP-24-081 Final.pdf

Centers for Disease Control and Prevention

NATIONAL CENTER FOR CHRONIC DISEASE PREVENTION AND HEALTH

PROMOTION

Effectiveness of Telehealth-Based Programs to Detect Glaucoma Among High-Risk Populations in Community Health Settings

RFA-DP-24-081

02/05/2024

Table of Contents Section I. Funding Opportunity Description

Section II. Award Information

Section III. Eligibility Information

Section IV. Application and Submission Information

Section V. Application Review Information

Section VI. Award Administration Information

Section VII. Agency Contacts

Section VIII. Other Information

Overview Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations Components of Participating Organizations:

National Center for Chronic Disease Prevention and Health Promotion Notice of Funding Opportunity (NOFO) Title Effectiveness of Telehealth-Based Programs to Detect Glaucoma Among High-Risk Populations in Community Health Settings Activity Code U 01 Cooperative Agreement

Notice of Funding Opportunity Type New Agency Notice of Funding Opportunity Number

RFA-DP-24-081

Assistance Listings Number(s) 93.068 Category of Funding Activity HL - Health NOFO Purpose The purpose of this NOFO is to support comparative effectiveness trials to investigate the feasibility, effectiveness, and cost-effectiveness of telehealth-based interventions to detect and manage glaucoma among high-risk populations. This NOFO aims to support the study of replicable and scalable interventions that use real-world, payer-provider reimbursement structures within community-based, health care delivery settings in various regions of the United States. Outcomes should be relevant to clinical practice, public health, community implementation, and policy. This NOFO also supports the cost-effectiveness analyses of proposed interventions. The resulting data will assist policymakers, clinicians, and patients make informed decisions to reduce the burden of glaucoma and improve the quality of life for millions of people.

This NOFO will be accomplished through two components, Component A: Comparative effectiveness trials among high-risk populations within community-based settings, and Component B: a coordinating center to provide scientific and logistical support to Component A studies.

Key Dates Publication Date:

To receive notification of any changes to RFA-DP-24-081, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link.

An email address is needed for this service.

Letter of Intent Due Date:

01/15/2024 January 15, 2024

Application Due Date:

02/05/2024 February 5, 2024

On-time submission requires that electronic applications be error-free and made available to CDC for processing from the NIH eRA system on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov no later than 11:59 PM U.S. Eastern Time.

Applicants will use a system or platform to submit their applications through Grants.gov and eRA Commons to CDC. ASSIST, an institutional system to system (S2S) solution, or Grants.gov Workspace are options. ASSIST is a commonly used platform because it provides a validation of all requirements prior to submission and prevents errors.

For more information on accessing or using ASSIST, you can refer to the ASSIST Online Help Site at: https://era.nih.gov/erahelp/assist. Additional support is available from the NIH eRA Service desk via http://grants.nih.gov/support/index.html.

• E-mail: commons@od.nih.gov

• Phone: 301-402-7469 or (toll-free) 1-866-504-9552

• Hours: Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding Federal holidays

Note: HHS/CDC grant submission procedures do not provide a grace period beyond the application due date time to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

Scientific Merit Review:

03/19/2024 Secondary Review:

https://www.grants.gov/ http://grants.nih.gov/support/index.html mailto:commons@od.nih.gov

05/24/2024 Estimated Start Date:

09/30/2024 Expiration Date:

03/08/2024 Required Application Instructions It is critical that applicants follow the instructions in the How to Apply - Application Guide except where instructed to do otherwise in this NOFO. Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Note:The Research Strategy component of the Research Plan is limited to 12 pages.

Page Limitations: Pages that exceed the page limits described in this NOFO will be removed and not forwarded for peer review, potentially affecting an application's score.

Applications that do not comply with these instructions may be delayed or may not be accepted for review.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348

Executive Summary Purpose: The purpose of this NOFO is to support comparative effectiveness trials to investigate the feasibility, effectiveness, and cost-effectiveness of telehealth-based interventions to detect and manage glaucoma among high-risk populations. This NOFO aims to support the study of replicable and scalable interventions that use real-world, payer-provider reimbursement structures within community-based, health care delivery settings in various regions of the United States. Outcomes should be relevant to clinical practice, public health, community implementation, and policy. This NOFO also supports the cost-effectiveness analysis of proposed interventions. The resulting data will assist policymakers, clinicians, and patients make informed decisions to reduce the burden of glaucoma and improve the quality of life for millions of people.

This NOFO will be accomplished through two components, Component A: Comparative effectiveness trials among high-risk populations within community-based settings, and Component B: a coordinating center to provide scientific and logistical support to Component A studies.

Mechanism of Support: Cooperative Agreement

Funds Available and Anticipated Number of Awards: The amount available for the five-year period of performance, September 30, 2024 to September 29, 2029, is $15,000,000 for both components. Awards issued under this NOFO are contingent upon availability of funds and a sufficient number of meritorious applications. The total amount awarded and the number of awards will depend upon the number, quality, and budgets of the applications received.

Budget and Period of Performance: The estimated total funding (direct and indirect) for the first budget period, September 30, 2024 - September 29, 2025, is $3,000,000.

https://grants.nih.gov/grants/how-to-apply-application-guide.html

Number of Applications: Only one application per institution is allowed, as indicated by a unique entity identifier (UEI) at the time of submission. An organization may apply for Component A or Component B, not both.

Application Type: NEW

Special Date(s): A pre-application informational webinar will be held tentatively on December 19, 2023 at 2 pm. Details and any changes will be posted on Grants.gov.

Section I. Funding Opportunity Description Statutory Authority Sections 301(a) and 317(k)(2) of the Public Health Service Act, (42 U.S.C. section 241(a) and 247b(K)(2), as amended.

1. Background and Purpose The purpose of this NOFO is to support comparative effectiveness trials to investigate the feasibility, effectiveness, and cost-effectiveness of telehealth-based interventions to detect and manage glaucoma among high-risk populations. This NOFO aims to support the study of replicable and scalable interventions that use real-world, payer-provider reimbursement structures within community-based, health care delivery settings in various regions of the United States. Outcomes should be relevant to clinical practice, public health, community implementation, and policy. The resulting data will assist policymakers, clinicians, and patients make informed decisions to reduce the burden of glaucoma and improve the quality of life for millions of people.

The interventions under study to detect and manage glaucoma are likely to detect other ocular conditions (e.g., age-related macular degeneration, cataract, diabetic retinopathy, uncorrected refractive error). These may form part of the study and its outcomes; however, the primary focus should be to detect and manage glaucoma. The purpose of this NOFO is also to support cost-effectiveness analyses of proposed interventions in a real-world setting as well as to improve vision-related quality of life.

Background

Glaucoma is one of the leading causes of irreversible blindness in the United States. About 3 million Americans have the disease, and this is expected to increase to 7.3 million by 2050 (1).

Currently, 50% of those who have glaucoma are unaware of their condition; if current methods to reach and care for patients remain in use, there will be about 3.5 million Americans with undiagnosed glaucoma in 2050 (1-2).

The prevalence and risk factors for glaucoma are well-documented. Compared to non-Hispanic Whites, the prevalence of glaucoma is substantially higher among Black, Hispanics/Latino, and Asian individuals (2-4). Prevalence increases with age among all ethnic groups. Risk factors for glaucoma include race (Black, Asian), ethnicity (Hispanic) and age, as well as a family history of glaucoma and diagnosis of diabetes (5).

Treatments to slow the progression of glaucoma and avoid vision loss are available, therefore timely examination and follow-up are recommended for people at high risk for glaucoma (4).

However, national and state data suggest that only about half of people at high risk for serious vision loss have visited an eye doctor in the past 12 months. Despite the preferred practice patterns of eye care professional communities and Medicare’s glaucoma screening benefit for high-risk patients, access to glaucoma care among vulnerable populations falls short of recommendations (5-6). The Medicare benefit is underutilized among “high-risk patients,” defined by Medicare as those with a family history of glaucoma, those with diabetes, Black adults over age 50, and Hispanic adults over age 65 (7).

In the past decade, technology has advanced, and innovative tools such as telemedicine have enhanced glaucoma screening and early diagnosis, especially in underserved populations and rural settings. Peer-reviewed studies demonstrate the potential of such tools to reach large populations of vulnerable individuals cost-effectively (8-11).

In 2016, the National Academies of Sciences, Engineering, and Medicine published the landmark report Making Eye Health a Population Health Imperative: Vision for Tomorrow, defining vision and eye health problems as a growing public health concern for the nation. The report recommended an agenda that includes efforts to focus on innovative models of care to improve access to appropriate diagnosis and follow-up treatment, and to address eye care disparities (12).

The Agency for Healthcare Research and Quality, Effective Health Care Program sponsored a comparative effectiveness review of glaucoma screening published in 2012 (13). This and a subsequent 2013 and a 2022 statement by the US Preventive Services Task Force conclude that the current evidence is insufficient to assess the balance of benefits and harms of screening for primary open-angle glaucoma in the general adult population, noting: “This recommendation applies to adults who do not have vision symptoms and are seen in a primary care setting” (14).

However, given the known risk factors for glaucoma, the American Academy of Ophthalmology, in its Primary Open Angle Glaucoma Preferred Practice Pattern, citing several studies, concluded that “Screening may be more useful and cost-effective when it is targeted at populations at high risk for glaucoma” (15). These expert recommendations and evidence of the effectiveness of treatment, as well as new potential screening tests, justify further evaluation of the comparative effectiveness of different real-world approaches to detecting and managing glaucoma among high-risk populations (16).

The Centers for Disease Control and Prevention/Vision Health Initiative has been engaged in numerous community-based studies over the past 12 years — conducted in geographically diverse settings — demonstrating that targeted screening in high-risk populations has a high sensitivity for identifying those with both early and later stages of glaucoma (5-7). In 2012, CDC’s Vision Health Initiative demonstrated that reaching people at high risk for glaucoma by either a mobile eye health program or telemedicine program provided useful information for wider implementation in public health clinics and optometry clinics located in retail outlets.

These glaucoma screening programs in underserved communities have identified glaucoma and glaucoma suspect cases at much higher rates than within the general population.

The current project, Screening and Interventions for Glaucoma and Eye Health through Telemedicine (SIGHT) Studies, taking place in Michigan, New York City, and Alabama (SIGHTSTUDIES.org), is detecting higher rates of glaucoma among high-risk populations than are found in the general population. These studies are operating in a variety of settings including federally qualified health centers, community health centers, and primary care locations in rural areas. These studies find that interventions are improving glaucoma and other major eye diseases detection and management among groups at high-risk (9).

https://sightstudies.org/

To maximize public health impact and acknowledging the low prevalence of glaucoma in the general population, CDC intends to fund studies that include an intervention group and control group with an acceptable standard of care within real-world, payer-provider structures. SIGHT studies have demonstrated that well-funded demonstration projects increase detection of glaucoma in resource-poor settings; however, there is a knowledge gap in the applicability of these study findings to real world settings in which detection and management of eye disease is governed by existing reimbursement structures.

Many people with glaucoma are likely to have other eye diseases. Since eye diseases and vision impairment affect large numbers of people, especially older-age and disadvantaged populations, an intervention design that can identify other eye diseases and general vision impairment is desired. Community-based detection and management programs with standard, measurable outcomes have the capacity to improve quality of vision, eye health, and quality of life for millions of people every year.

References:

1. Vajaranant TS, Wu S, Torres M, Varma R. The changing face of primary open-angle glaucoma in the United States: demographic and geographic changes from 2011 to 2050.

AJO, 2012 Apr;154(2):303-314

2. Susanna R, De Moraes CG, Cioffi GA, et al. Why do people (still) go blind from glaucoma? Transl Vis Sci Technol. 2015;4:1.

3. Tielsch JM, Sommer A, Katz J, et al. Racial variations in the prevalence of primary open-angle glaucoma. The Baltimore Eye Survey. JAMA 1991;266:369–74.

4. Leske MC, Heijl A, Hussein M, et al. Factors for glaucoma progression and the effect of treatment: the early manifest glaucoma trial. Arch Ophthalmol 2003;121: 48-56

5. Gower EW, Whiteside-De Vos J, Cassard SD, Shekhawat NS, Friedman DS. The Medicare glaucoma screening benefit a critical program that misses its target. American Journal of Ophthalmology, 2013;156(2):211-212.

6. Kim S, Stewart JF, Emond MJ, Reynolds AC, Leen MM, Mills RP. The effect of a brief education program on glaucoma patients. Journal of Glaucoma 1997.

7. Glaucoma Test Coverage (medicare.gov) accessed 9/14/2023

8. It is time to rethink adult glaucoma screening recommendations. Newman-Casey PA

MD, MS; Hark LA PHD, MBA; Rhodes LA MD, MSPH. J Glaucoma 2023;32:69-71

9. Kolomeyer NN, Katz LJ, Hark LA, et al. Lessons learned from 2 large community-based glaucoma screening studies. J Glaucoma. 2021;30:875–877.

10. Hark L, Waisbourd M, Myers JS. Improving access to eye care among persons at high-risk of glaucoma in Philadelphia: design and methodology: the Philadelphia Glaucoma Detection and Treatment Project. Ophthalmic Epidemiol. 2016;23:122–130.

11. Home Page – Sight (sightstudies.org) accessed 9/14/2023

12. National Academies of Sciences, Engineering, and Medicine, Health and Medicine

Division, Board on Population Health and Public Health Practice. Committee on Public Health Approaches to Reduce Vision Impairment and Promote Eye Health. National Academies Press (US); 2016.

13. Ervin, A. M., Boland, M. V., Myrowitz, E. H., Prince, J., Hawkins, B., Vollenweider, D., ... & Robinson, K. A. (2012). Screening for glaucoma: comparative effectiveness.

https://www.medicare.gov/coverage/glaucoma-tests https://sightstudies.org/

14. US Preventive Services Task Force. Mangione CM, Barry MJ, et al. Screening for primary open-angle glaucoma: US Preventive Services Task Force Recommendation Statement. JAMA. 2022;327:1992–1997.

15. American Academy of Ophthalmology Glaucoma Panel. Preferred Practice Pattern® Guidelines. Primary Open Angle Glaucoma. San Francisco, CA: American Academy of Ophthalmology; 2010.

16. Moyer VA. U.S. Preventive Services Task Force. Screening for glaucoma: U.S.

Preventive Services Task Force Recommendation Statement. Ann Intern Med.

2013;159:484–489.

Healthy People 2030 and other National Strategic Priorities This NOFO supports these three topics outlined in Healthy People 2030, a national disease prevention initiative that identifies opportunities to improve the health of all Americans.

Objective V-02 calls to “Increase the proportions of adults who have had a comprehensive eye exam in the last two years” to improve early detection and timely treatment of eye conditions leading to vision impairment.

Objective V-05 specifically calls for the reduction of vision impairment due to glaucoma, “Reduce visual impairment due to glaucoma”

Objective V-R01 calls to “Increase access to comprehensive vision services in community health centers.” “This objective currently has research status, meaning it is a high-priority public health issue that doesn’t yet have evidence-based interventions developed to address it. It may or may not have reliable baseline data available. If both baseline data and evidence-based interventions become available, this objective may become a core Healthy People 2030 objective.”

Other National Public Health Priorities and Strategies

• This NOFO supports a CDC/Division of Diabetes Translation objective to promote health equity by reducing disparities that affect vision loss and eye diseases.

• The National Academies of Sciences, Engineering, and Medicine calls for transforming vision impairments from common to rare, and eliminating correctable and avoidable vision impairments in the U.S. by 2030. The NASEM Board on Population Health and Public Health Practice has called on CDC to develop a comprehensive surveillance system for eye and vision health coupled with a common research agenda and coordinated research and demonstration grant programs that target eye conditions and diseases that contribute the greatest public health burden to provide evidence of effective policies, practices, and interventions (8).

Public Health Impact Fifty percent of people with glaucoma do not know they have it (2), and many people are not familiar with the disease and its potential to cause severe vision impairment and blindness.

Additionally, there is a lack of access to eye care for those at high-risk for glaucoma in the United States, making office visits and medications necessary to diagnose, treat, and monitor glaucoma out-of-reach for many populations.

By testing the comparative effectiveness of interventions in this study to clinical standards of care, the public health community will gain knowledge about the feasibility (clinical, patient quality-of-life improvement, and cost-effectiveness) of real-world implementation. Community-https://health.gov/healthypeople/objectives-and-data/browse-objectives/preventive-care/increase-proportion-adults-who-have-had-comprehensive-eye-exam-last-2-years-v-02 https://health.gov/healthypeople/objectives-and-data/browse-objectives/sensory-or-communication-disorders/reduce-vision-loss-glaucoma-v-05 https://health.gov/healthypeople/objectives-and-data/browse-objectives/sensory-or-communication-disorders/increase-access-vision-services-community-health-centers-v-r01 https://nap.nationalacademies.org/author/BPH https://nap.nationalacademies.org/author/BPH based detection and management programs with standard, measurable outcomes have the capacity to improve quality of vision, eye health, and quality of life for millions of people every year. The resulting interventions will have sufficient rigor and fidelity to be replicated and scaled-up in communities across the nation. The results of this research will generate information that will assist patients, policymakers, and clinicians make informed decisions about glaucoma and vision health.

Relevant Work CDC has been engaged in coordinated research and demonstration grant programs that target glaucoma detection and management to provide evidence of effective policies, practices, and interventions since 2012 (CDC-RFA-DP12-1207; CDC-RFA-DP14-002, SIGHT Studies CDC-

RFA-DP19-004).

CDC’s Vision Health Initiative and NORC at the University of Chicago partnered to develop the National Vision and Eye Health Surveillance System. VEHSS leverages new and existing data sources to help health professionals, researchers, policymakers, and patients understand the scope of vision loss, eye disorders, and eye care services. It reports the prevalence of glaucoma, use of eye health services, and eye health disparities in treatments and outcomes nationally and at the state level whenever available.

2. Approach This NOFO will be accomplished through two components, Component A: Comparative effectiveness trials among high-risk populations, and Component B: A coordinating center to provide logistics and scientific support to the funded research studies under Component A.

Applicants may apply for either Component A or Component B. Applications from one institution for both components will not be accepted.

Strategies and Activities

Component A: Comparative effectiveness trials in high-risk populations

• Test the real-world efficacy of the intervention compared to usual care that is well-described and justified. The proposed study should have an intervention and a control arm, and should be conducted in a real-world setting(s) (e.g., Federally Qualified Health Centers).

• Fully leverage existing community settings, such as retail, clinical infrastructure, and payer-provider structures.

• Study settings should be in geographic locations in the United States with high proportions of people living at or below the federal poverty level, in communities that are predominantly comprised of minority groups, and among communities that are less likely to access eye care services.

• Demonstrate how the methods to perform glaucoma detection in a real-world setting can generate evidence for detecting other eye diseases, functional vision loss, and vision impairment.

• Conduct an economic analysis of the costs and benefits of the proposed intervention, cost-per-case detected, and cost-effectiveness of the intervention vs. usual care. An economic analysis should account for existing reimbursement structures for detection and management of glaucoma.

https://www.cdc.gov/visionhealth/index.htm https://Vision%20and%20Eye%20Health%20Surveillance%20System%20(VEHSS)%20Explore%20by%20Indicator%20|%20DDT%20|%20CDC

Component B: Coordinating Center

The coordinating center will play a critical role in facilitating collaboration between Component A recipients, which will independently implement their interventions. The Component B recipient will serve as a logistical and organizing hub, accelerating information exchange between the studies and with stakeholders. It will provide a strong organizational foundation and accommodate the needs of Component A recipients.

Strategies and activities include:

• Collaborate with Component A recipients to develop common, standardized protocols that will enable the comparison of outcomes across Component A studies, including the cost-effectiveness assessment. Assist recipients to refine their study designs.

• Establish the infrastructure and implement processes to support collaboration. Organize, facilitate, and develop the governance for a steering committee (and work groups); ensure it has primary responsibility for developing common study protocols, indicators, manuals, and reporting standards.

• Maintain study-wide timeline management. Coordinate logistics for study meetings including planning agendas, securing facilities for face-to-face meetings, and preparing minutes.

• Facilitate the exchange of abstracts, manuscripts, presentations, fact sheets, and other scientific materials and drafts among the recipients and CDC. Facilitate the development of guidelines for presentations at scientific meetings, and for writing and publishing materials about the findings.

• Develop and maintain a study website with internal and external access.

Objectives/Outcomes Outcomes should be relevant to clinical practice, public health, community implementation, providers, and policy.

This NOFO is expected to include the following outcomes from Component A:

• An innovative, telehealth-based intervention for detection and management of glaucoma among high-risk population(s) in one or more real-world setting(s).

• A protocol that uses or modifies the intervention to detect other eye diseases and vision impairment.

• Outcome measures that identify and assess reductions in health disparities.

• A description of the prevalence of glaucoma, glaucoma suspect, vision impairment, and other potentially blinding eye diseases among the study population.

• Patient-centered outcome measures such as vision-related quality of life, patient satisfaction, functional status, adherence to follow-up, and if possible, improved vision.

• An assessment of participant retention strategies.

• A cost-effectiveness analysis of the proposed intervention, accounting for existing payer-provider reimbursement structures.

• Sufficient evidence of the cost benefit of glaucoma detection compared to "usual care.”

• Transition of the intervention to a program in the community.

• A blueprint for future scaling and replication of the intervention to decrease disparities in glaucoma care and minimize glaucoma-related vision impairment beyond the study setting.

This NOFO is expected to include the following outcomes from Component B:

• Standardized measurements that will enable comparison of outcomes across Component A studies.

• Timely logistical and scientific communications via a study website with both internal-only access and external pages.

• An effective steering committee that produces collaborative protocols and guidelines.

Target Population The study population is people in the US at high-risk for and disproportionally affected by glaucoma, including people 65 and older, those with a family history of glaucoma, those with diabetes, non-Hispanic Black and Hispanic adults aged 50 and older, and/or those living in poverty and lacking access, resources, and/or education regarding vision and eye health.

Included among this population are those affected by disparities such as, but not limited to, race, ethnicity, gender, geography, and socioeconomic status.

Collaboration/Partnerships Collaborations and strategic partnerships are crucial to implement program strategies and sustain outcomes. They allow for more efficient use of existing resources and exchange of information between experts working in various areas of public health and other sectors. Applicants are encouraged to form and expand existing community partnerships to maximize the capacity of their intervention, as well as to possibly transition the intervention to community vision care services once the study is complete.

Suggested partners include health care systems, retail vision services, non-profit organizations, community organizations, and professional organizations.

Evaluation/Performance Measurement Applicants should propose a rigorous evaluation framework for key milestones that establishes high-priority process and outcome measures for activities/strategies. Evaluation efforts should include measurable outputs; short-term, intermediate, and long-term outcomes and their indicators; and a strategy for using the results to improve the study.

Recipients will have six months to finalize the performance measures and plan. The evaluation plan may be updated throughout the period of performance. Recipients are expected to continuously implement the evaluation plan to measure and track the process (e.g., implementation, quality, and reach) and incorporate rapid feedback provided by CDC.

Recipients' performance milestones related to the NOFO activities in the annual RPPR work plan allows CDC to monitor the recipients’ activities and their achievement of the project goals, objectives, and activities.

For Component A, this plan must include methods to:

• identify, track, and report qualitative and quantitative indicators.

• identify and assess reductions in health disparities.

• access data and continuously monitor data quality.

• engage community partners to achieve the outcome of eventual transition of the program into the community/community health systems.

• develop measures for replicating and scaling-up in communities/public health systems.

For component B, this plan must include measurements of quality related to facilitating a multi-site, collaborative environment; execution of communication and information exchange; and documenting, tracking, and coordinating steering committee activities.

Translation Plan Applicants for Components A and B are expected to outline a translation and dissemination plan to guide future efforts to expand and implement glaucoma screening and management programs in real-world settings that include other eye diseases and vision loss detection. Award recipients are expected to collaborate and submit a full translation and dissemination plan to CDC within six months. The plan should include how the information will be shared with key stakeholders, including public health practitioners, academic researchers, governmental agencies, patient advocacy groups, eye care providers, insurance providers, the target population, and the public at large.

The plan should include a variety of approaches for sharing research findings and how it measures audience impact (e.g., website, webinars, podcasts, media relations, reports, fact sheets, and electronic manuals), as well as materials to guide replication and expansion of interventions.

Recipients are expected to communicate the findings throughout the study to the larger scientific and public health communities in peer-reviewed journals presentations at professional meetings and conferences. Topics should include recruitment strategies, analysis of provider-payer structures applicable to the intervention, methods, protocol, measurements, and scalability.

Translations should define setting, partners, scope, economic considerations (e.g., engagement of payers, upfront costs, and financial benefits to provider organization), and outcome measures.

Materials should be finished products during the fifth year of the period-of-performance.

3. Funding Strategy N/A

Section II. Award Information Funding Instrument Type:

CA (Cooperative Agreement) A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed:

New - An application that is submitted for funding for the first time. Includes multiple submission attempts within the same round.

Estimated Total Funding:

$15,000,000

The estimated total funding (direct and indirect) for the entire five-year period of performance, September 30, 2024 to September 29, 2029, is $15,000,000 to fund up to 5 awards in two components. CDC will award one applicant for Component B, a coordinating center. The remaining awards will be for Component A.

Applicants may apply for either Component A or Component B. Applications from one institution applying for both components will not be accepted.

Anticipated Number of Awards:

The estimated total funding (direct and indirect costs) for the first budget period is $3,000,000.

Component A:

Number of Awards: four (4)

Estimated Funding: $2,750,000

Component B: Coordinating Center

Number of Awards: One (1)

Estimated Funding: $250,000

Applicants may apply for either Component A or Component B. Applications from one institution applying for both components will not be accepted.

Awards issued under this NOFO are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

Award Ceiling:

$950,000 Per Budget Period

Award Floor:

$0 Per Budget Period

Total Period of Performance Length:

5 year(s)

Throughout the Period of Performance, CDC's commitment to continuation of awards will depend on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and CDC’s determination that continued funding is in the best interest of the Federal government.

HHS/CDC grants policies as described in the HHS Grants Policy Statement (https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this NOFO.

https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

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.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category:

00 (State governments)

01 (County governments)

02 (City or township governments)

04 (Special district governments)

05 (Independent school districts)

06 (Public and State controlled institutions of higher education)

07 (Native American tribal governments (Federally recognized))

08 (Public housing authorities/Indian housing authorities)

11 (Native American tribal organizations (other than Federally recognized tribal governments))

12 (Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education)

20 (Private institutions of higher education)

22 (For profit organizations other than small businesses)

23 (Small businesses)

99 (Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility")

Additional Eligibility Category:

The following types of Higher Education Institutions are always encouraged to apply for CDC support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions

Historically Black Colleges and Universities (HBCUs)

Tribally Controlled Colleges and Universities (TCCUs)

Alaska Native and Native Hawaiian Serving Institutions

Governments:

U.S. Territory or Possession

Other:

Faith-based or Community-based Organizations

Regional Organizations

Bona Fide Agents: A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with "Other Attachment Forms."

2. Foreign Organizations Foreign components of U.S. Organizations are not eligible to apply.

For this announcement, applicants may not include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

3. Additional Information on Eligibility This is a new, competitive NOFO. Prior agreements, funding, collaborations, and other arrangements with CDC are not evidence of eligibility for this NOFO.

The purpose of this NOFO is to support comparative effectiveness trials to investigate the feasibility, effectiveness, and cost-effectiveness of telehealth-based interventions to detect and manage glaucoma among high-risk populations. This NOFO aims to support the study of replicable and scalable interventions that use real-world, payer-provider reimbursement structures within community-based, health care delivery settings in various regions of the United States. Outcomes should be relevant to clinical practice, public health, community implementation, and policy. This NOFO also supports the cost-effectiveness analyses of proposed interventions. The resulting data will assist policymakers, clinicians, and patients make informed decisions to reduce the burden of glaucoma and improve the quality of life for millions of people.

This NOFO will be accomplished through two components, Component A: Comparative effectiveness trials among high-risk populations within community-based settings, and Component B: a coordinating center to provide scientific and logistical support to Component A studies.

4. Justification for Less than Maximum Competition N/A

5. Responsiveness If your application is incomplete or non-responsive to these requirements, it will not enter into the review process.

Component A

1. Geographical location

Applications must define a geographical study location(s) that includes the target population.

Evidence must be submitted in tables and include timely and specific data that align the proposed geographical area with the target population characteristics. Sources of evidence may include data from the U S. Census Bureau; National Vision and Eye Health Surveillance System; Places:

Local Data for Better Health; and state/local government data.

2. Access to target population

Applications must provide evidence of access to the target population in a real-world community setting.

Evidence must include an official document, such as a signed letter of commitment, memorandum of agreement, or memorandum of understanding that states that the proposed community-based entity will provide access and facilitate recruitment of participants.

Applications for Component A must place evidence in Appendix 1.

Component B

N/A

6. Required Registrations Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Unique Entity Identifier (UEI) number in order to begin each of the following registrations.

PLEASE NOTE: Effective April 4, 2022, applicants must have a Unique Entity Identifier (UEI) at the time of application submission. The UEI replaced the Data Universal Numbering System (DUNS) and is generated as part of SAM.gov registration. Current SAM.gov registrants have already been assigned their UEI and can view it in SAM.gov and Grants.gov. Additional information is available on the GSA website, SAM.gov, and Grants.gov-Finding the UEI.

• (Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: NCAGE Tool / Products / NCS Help Center (nato.int).

• System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, SAM.gov.

• Grants.gov

• eRA Commons

All applicant organizations must register with Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes. The one-time registration process will take three to five days to complete.

However, it is best to start the registration process at least two weeks prior to application https://www.cdc.gov/places/ https://www.cdc.gov/places/ https://www.gsa.gov/about-us/organization/federal-acquisition-service/office-of-systems-management/integrated-award-environment-iae/iae-systems-information-kit/unique-entity-identifier-update https://sam.gov/content/home https://grantsgovprod.wordpress.com/2021/09/14/how-to-find-an-applicants-uei-within-grants-gov/ https://grantsgovprod.wordpress.com/2021/09/14/how-to-find-an-applicants-uei-within-grants-gov/ https://eportal.nspa.nato.int/Codification/Support/en/Products/NCAGE/ https://eportal.nspa.nato.int/Codification/Support/en/Products/NCAGE/ https://sam.gov/content.gov https://grants.gov https://public.era.nih.gov/commons https://www.Grants.gov submission.

All Senior/Key Personnel (including Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing Principal Investigator (PD/PI) eRA Commons account is affiliated with the eRA commons account of the applicant organization. All registrations must be successfully completed and active before the application due date. Applicant organizations are strongly encouraged to start the eRA Commons registration process at least four (4) weeks prior to the application due date. ASSIST requires that applicant users have an active eRA Commons account in order to prepare an application. It also requires that the applicant organization's Signing Official have an active eRA Commons Signing Official account in order to initiate the submission process.

During the submission process, ASSIST will prompt the Signing Official to enter their Grants.gov Authorized Organizational Representative (AOR) credentials in order to complete the submission, therefore the applicant organization must ensure that their Grants.gov AOR credentials are active.

7. Universal Identifier Requirements and System for Award Management (SAM) All applicant organizations must obtain a Unique Entity Identifier (UEI) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The UEI number is a twelve-digit number assigned by SAM.gov. An AOR should be consulted to determine the appropriate number. If the organization does not have a UEI number, an AOR should register through SAM.gov. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a UEI number.

Additionally, organizations must maintain the registration with current information at all times during which it has an application under consideration for funding by CDC and, if an award is made, until a final financial report is submitted or the final payment is received, whichever is later.

SAM.gov is the primary registrant database for the Federal government and is the repository into which an entity must provide information required for the conduct of business as a recipient.

Additional information about registration procedures may be found at SAM.gov and the SAM.gov Knowledge Base.

If an award is granted, the recipient organization must notify potential sub-recipients that no organization may receive a subaward under the grant unless the organization has provided its UEI number to the recipient organization.

8. Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for HHS/CDC support.

https://sam.gov/content/home https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fsd.gov%2Fgsafsd_sp%3Fid%3Dgsa_kb_view2%26kb_id%3Df66d8e6cdb76d4100d73f81d0f9619c6&data=04%7C01%7Ccshifflett%40dminc.com%7C8eee7a2adab549a3b3c008d925e9a364%7Cdb7ac9ef779d46e59bca00509580ad6b%7C0%7C0%7C637582507851821018%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=UrR%2B%2FM2wWF2fZG05Z8O6JS2C3FXXSl%2F7B3%2FB45XHRrg%3D&reserved=0

9. Cost Sharing This NOFO does not require cost sharing as defined in the HHS Grants Policy Statement (http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf).

10. Number of Applications As defined in the HHS Grants Policy Statement, (https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf), applications received in response to the same Notice of Funding Opportunity generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit. HHS/CDC will not accept any application in response to this NOFO that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Only one application per institution (normally identified by its UEI number) is allowed.

Section IV. Application and Submission Information

1. Address to Request Application Package Applicants will use a system or platform to submit their applications through Grants.gov and eRA Commons to CDC. ASSIST, an institutional system to system (S2S) solution, or Grants.gov Workspace are options. ASSIST is a commonly used platform because, unlike other platforms, it provides a validation of all requirements prior to submission and prevents errors.

To use ASSIST, applicants must visit https://public.era.nih.gov where you can login using your eRA Commons credentials, and enter the Notice of Funding Opportunity Number to initiate the application, and begin the application preparation process.

If you experience problems accessing or using ASSIST, you can refer to the ASSIST Online Help Site at: https://era.nih.gov/erahelp/assist. Additional support is available from the NIH eRA Service desk via: http://grants.nih.gov/support/index.html

• Email: commons@od.nih.gov

• Phone: 301-402-7469 or (toll-free) 1-866-504-9552.

Hours: Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding Federal holidays.

2. Content and Form of Application Submission Applicants must use FORMS-G application packages for due dates on or before January 24, 2023 and must use FORMS-H application packages for due dates on or after January 25, 2023.

Application guides for FORMS-G and FORMS-H application packages are posted to the How to Apply - Application Guide page.

It is critical that applicants follow the instructions in the SF-424 (R&R) Application Guide How to Apply - Application Guide except where instructed in this Notice of Funding Opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://public.era.nih.gov http://grants.nih.gov/support/index.html https://grants.nih.gov/grants/how-to-apply-application-guide.html https://grants.nih.gov/grants/how-to-apply-application-guide.html accepted for review. The package associated with this NOFO includes all applicable mandatory and optional forms. Please note that some forms marked optional in the application package are required for submission of applications for this NOFO. Follow the instructions in the SF-424 Application Guide to ensure you complete all appropriate “optional” components.

When using ASSIST, all mandatory forms will appear as separate tabs at the top of the Application Information screen; applicants may add optional forms available for the NOFO by selecting the Add Optional Form button in the left navigation panel.

Please use the form and instructions for SF424 (R&R) FORMS-H for applications due on or after January 25, 2023.

3. Letter of Intent Due Date for Letter Of Intent 01/15/2024

01/15/2024 Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information it contains allows CDC to plan the review. By the date listed above, prospective applicants are asked to provide a letter of intent by email that includes:

Name of the Applicant Institution

Descriptive title of proposed research

Contact information of the PI/PD, including co-PIs/PDs

Names of key personnel

Participating institutions and any co-PIs/PDs

Please provide the number, title of this funding opportunity, and the component in the subject line of the email. Send the email to:

Alison Amoroso, Scientific Program Official, at researchnofo@cdc.gov

4. Required and Optional Components A complete application has many components, both required and optional. The forms package associated with this NOFO in Grants.gov includes all applicable components for this NOFO, required and optional. In ASSIST, all required and optional forms will appear as separate tabs at the top of the Application Information screen.

5. PHS 398 Research Plan Component The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that consists of components. Not all components of the Research Plan apply to all Notices of Funding Opportunities (NOFOs).