PKG00246744-instructions.pdf

Centers for Disease Control

National Center for Chronic Disease Prevention and Health Promotion Extramural Research

Program Office

Improving Detection and Management of Glaucoma and Other Eye Diseases Among High Risk

Populations

RFA-DP-19-004

Application Due Date: 02/11/2019

Improving Detection and Management of Glaucoma and Other Eye Diseases Among High Risk

Populations

RFA-DP-19-004

TABLE OF CONTENTS

Part 1. Overview Information Key Dates Required Application Instructions Executive Summary

Part 2. Full Text 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

Part 1. Overview Information Participating Organization(s) Centers for Disease Control Components of Participating Organizations National Center for Chronic Disease Prevention and Health Promotion Extramural Research Program Office (NCCDPHP ERPO) Notice of Funding Opportunity (NOFO) Title Improving Detection and Management of Glaucoma and Other Eye Diseases Among High Risk Populations Activity Code U01

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

RFA-DP-19-004

Assistance Listings (CFDA) Number(s) 93.283 Category of Funding Activity:

Health NOFO Purpose The purpose of this Notice of Funding Opportunity (NOFO) is to study innovative strategies to better engage populations most at risk, most vulnerable, and least likely to have access to eye care to detect and manage glaucoma and other eye diseases in community-based settings, for replication and scaling in the US. This NOFO has two components, Component A: Community- Based Interventions with Vulnerable Populations and Component B: Coordinating Center to provide logistics and support to the research study.

Key Dates Publication Date: To receive notification of any changes to RFA-DP-19-004, 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: 01/11/2019

Application Due Date: 02/11/2019

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 5:00 PM U.S.

https://www.grants.gov

Eastern Time. Applications must be submitted using the Application Submission System & Interface for Submission Tracking (ASSIST) module which is a web-based service used for the preparation and submission of grant applications to CDC through Grants.gov. ASSIST provides the ability for applicants to prepare their applications online, and offers the applicant additional capabilities including the ability to preview the application image, validate the application against required business rules, and prepopulate data from an applicant organization's records, therefore identifying issues earlier in the application submission process.

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: 04/12/2019

Secondary Review: 05/14/2019

Estimated Start Date: 09/30/2019

Expiration Date: 02/12/2019 Due Dates for E.O. 12372: Executive Order 12372 does not apply to this program.

Required Application Instructions

**ELECTRONIC APPLICATION SUBMISSION VIA ASSIST IS PREFERRED**

It is recommended that applicants use ASSIST for the electronic preparation and submission of applications through Grants.gov to CDC. ASSIST is an alternative method to prepare and submit applications, and provides many features to facilitate the application submission process which improves data quality (e.g., pre-population of organization data, pre-submission validation of business rules, and preview of the application image used for review). Use of the Grants.gov downloadable Adobe application packages and submission process will still be supported.

It is critical that applicants follow the instructions in the SF 424 (R&R) 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 25 pages.

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

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348 http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf

Executive Summary

Purpose. The purpose of this NOFO is to study innovative strategies to better engage populations most at risk, most vulnerable, and least likely to have access to eye care to detect and manage glaucoma and other eye diseases in community-based settings, for replication and scaling in the US. This NOFO has two components, Component A:

Community-Based Interventions with Vulnerable Populations and Component B:

Coordinating Center to provide logistics and support to the research study.

Mechanism of Support. Cooperative Agreement Funds Available and Anticipated Number of Awards. The estimated total funding

(direct and indirect) for the five-year period of performance, September 30, 2019 to September 29, 2024 is $11,750,000, to fund up to four (4) awards in two Components.

Component A: Community-Based Interventions with Vulnerable Populations Number of Awards: Up to three (3) Estimated Funding: $10,500,000 Component B: Coordinating Center Number of Awards: One (1) Estimated Funding: $1,250,000

Budget and Period of Performance. The estimated total funding for the first 12-month budget period is $2,350,000 (direct and indirect), and the estimated total funding for the five year period of performance, September 30, 2019 to September 29, 2024, is $11,750,000 (direct and indirect).

Estimated funding for the first 12-month budget period.

Component A: $ 2,100,000 (direct and indirect) Component B: $ 250,000 (direct and indirect)

Application Research Strategy Length. Page limits for the Research Strategy are clearly specified in Section IV. Application and Submission Information of this announcement.

Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A.

are eligible to apply.

Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. NOTE:

CDC does not make awards to individuals directly. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply.

Number of PDs/PIs. Applications may include more than one PI; however, the first PI listed on the application will be the “contact PI” for all correspondence. Any additional PIs are permitted, but would be referred to as Co-PIs.

Number of Applications. Only one application per institution (normally identified by having a unique DUNS number) is allowed for each Component.

Application Type. New Special Date(s). None Application Materials. See Section IV.1 for application materials. Please note that

Form E is to be used when downloading the application package. https://grants.nih.gov /grants/how-to-apply-application-guide/forms-e/research-forms-e.pdf.

Hearing Impaired. Telecommunications for the hearing impaired are available at:

TTY: 1-888-232-6348.

A link to this announcement is available at https://www.cdc.gov/chronicdisease/programs-impact/nofo/index.htm

Part 2. Full Text 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 Glaucoma is the leading cause of irreversible blindness among African Americans and the second leading cause of blindness worldwide. An estimated 2.2 to 2.7 million people in the Unites States have the disease (REF 1). Due to its asymptomatic nature, half of people with glaucoma are unaware of their condition (REF 2), increasing the severity of the disease.

However, once detected, appropriate treatment and management can slow glaucoma progression and preserve the remaining vision, but cannot restore lost vision.

The prevalence and risk factors for glaucoma are well documented. Compared to non-Hispanic whites, the prevalence of glaucoma is substantially higher among Blacks, Hispanics/Latinos, and Asians (REF 3, 4). Prevalence increases with age among all ethnic groups. Risk factors for glaucoma include race (Blacks, Asians), ethnicity (Hispanics) and age, as well as a family history of glaucoma and diagnosis of diabetes (REF 5).

In addition to individual risk factors, many system features could influence delivery of high-quality eye care such as health insurance coverage, patient and provider education, organizational characteristics, poor coordination between primary care providers and specialists within the health care system, and cost-shifting strategies. System-level factors may also include legislation and health system or community-based initiatives that aim to influence access to and quality of eye care.

The Agency for Healthcare Research and Quality (AHRQ) Effective Health Care Program sponsored a comparative effectiveness review (CER) of glaucoma screening published in 2012 (REF 6). This and a subsequent 2013 statement by the US Preventive Services Task Force (USPSTF) concluded that the current evidence is insufficient to assess the balance of benefits and harms of screening for primary open-angle glaucoma, noting “This recommendation applies to adults who do not have vision symptoms and are seen in a primary care setting” (REF 7).

However, given the known risk factors for glaucoma, the American Academy of Ophthalmology in its Primary Open Angle Glaucoma Preferred Practice Pattern, citing several https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/research-forms-e.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/research-forms-e.pdf https://www.cdc.gov/chronicdisease/programs-impact/nofo/index.htm https://www.cdc.gov/chronicdisease/programs-impact/nofo/index.htm studies, concluded “Screening may be more useful and cost-effective when it is targeted at populations at high risk for glaucoma” (REF 8). In addition, evidence on the effectiveness of treatment and new potential screening tests justify further evaluation of the success of programs aimed at reaching high-risk populations, detecting and managing glaucoma among high-risk populations (REF 9) In 2016, the National Academies of Sciences, Engineering, and Medicine (NASEM) 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 included efforts to focus on innovative models of care to improve access to appropriate diagnosis and follow-up treatment (REF 10).

Efforts to improve the identification and detection of glaucoma have been proposed at multiple levels of the individuals, community, and health care system. According to a National Eye Institute (NEI) survey, more than 90 percent of Americans have heard of glaucoma, yet 50% of glaucoma cases are undiagnosed due to the asymptomatic nature of early glaucoma and only 8% are aware glaucoma has no early symptoms (REF 13). Barriers to care include patient knowledge, adherence to eye care recommendations, lower education, lack of medical home, and lack of vision insurance (REF 14-15).

Medicare provides glaucoma screening as a benefit for “high risk patients”— that includes those with a family history of glaucoma, those with diabetes, Blacks over age 50, and Hispanics over age 65. Despite efforts to incentivize access to glaucoma care among vulnerable groups, the benefit has been underutilized (REF 15).

Acknowledging the known risk factors for glaucoma, the asymptomatic character of the disease, the lack of a single test to identify glaucoma, limitations in access to eye care, and the low prevalence of glaucoma in the broad community, the focus of this NOFO is to identify and implement innovative strategies to engage populations most at risk, most vulnerable, and least likely to have access to eye care to detect and manage glaucoma and other major eye diseases.

Purpose The purpose of this NOFO is to identify and implement innovative strategies to better engage populations most at risk, most vulnerable, and least likely to have access to eye care to detect and manage glaucoma and other eye diseases in community-based settings, for replication and scaling in the US. This NOFO will be accomplished with two components, Component A: Community-Based Interventions with Vulnerable Populations and Component B: Coordinating Center to provide logistics and support to the research study.

Given the low general population prevalence of glaucoma, broad general population screening appears not to be cost-effective, and the marginal results from glaucoma screenings in high-risk population (REF 11), it is reasonable to reach out to groups with higher prevalence (African Americans over age 40, Asians, older people [aged 65+ years] especially older Hispanics, those with a family history of glaucoma, and those with diabetes).

Healthy People 2020 and other National Strategic Priorities This project supports Healthy People 2020 vision objectives, a national disease prevention initiative that identifies opportunities to improve the health of all Americans. In 2010 and 2020 a vision chapter was included to “improve the visual health of the nation through prevention, early detection, treatment, and rehabilitation.” The chapter addresses vision impairment specifically due to diabetic retinopathy, glaucoma, cataract, age-related macular degeneration, and refractive errors (Healthy People 2020).

Objective V-4 of vision chapter of HP 2020 addresses access to eye care “Increase the propo rtion of adults who have a comprehensive eye examination, including dilation, within the past 2 years” to improve early detection and timely treatment of eye conditions leading to vision impairment.

Objective V-5 of vision chapter of HP 2020 addresses visual impairment due to major eye diseases such as diabetic retinopathy, age-related macular degeneration, glaucoma, cataract, and refractive error, noting "visual impairment is associated with loss of personal independence, decreased quality of life, and difficulty maintaining employment. For older adults, visual problems have a pronounced negative impact on quality of life, equivalent to that of life-threatening conditions such as heart disease and cancer." Objective V-5.3 specifically calls for the reduction of vision impairment due to glaucoma.

V-5.1 Reduce visual impairment due to uncorrected refractive errors V-5.2 Reduce visual impairment due to diabetic retinopathy V-5.3 Reduce visual impairment due to glaucoma V-5.4 Reduce visual impairment due to cataract V-5.5 Reduce visual impairment due to age-related macular degeneration (AMD)

Public Health Impact In order to avoid permanent vision loss among the estimated 2.2 to 2.7 million Americans who have glaucoma, early detection and proper management of the disease is critical. In order to detect eye diseases and protect vision, effective measures to improve eye care access and utilization are important. This project will improve our knowledge and understanding of how best to identify, reach and engage populations at risk, and address barriers to access and appropriate utilization of preventive, high quality eye care. It will result in the establishment of a comprehensive protocol that has been tested and proven to have sufficient rigor to be replicated and available to be used by other communities across the nation.

Relevant Work In 2012, CDC’s Vision Health Initiative funded two institutions to improve glaucoma detection, referral, and sustained eye care by identifying and engaging high-risk people in underserved communities. Both programs demonstrated that reaching people at high risk for glaucoma by either mobile eye health program or telemedicine program provided useful information for wider implementation in public health clinics and in optometrist clinics located in retail outlets.

Currently, and since 2014, two institutions are funded to refine and optimize approaches to detect glaucoma among specific high-risk communities and provide successful follow-up care, while operating through a variety of settings including federally qualified health centers, community centers, primary care locations, and pharmacy chains. (REF 11, 12). This NOFO builds upon that funding (CDC-RFA-DP14-002 and CDC-RFA-DP12-1207) to further refine and develop innovative strategies for glaucoma detection and management among high-risk https://www.healthypeople.gov/2020/topics-objectives/topic/Vision/objectives#5377 https://www.healthypeople.gov/2020/topics-objectives/topic/Vision/objectives#5377 https://www.healthypeople.gov/2020/topics-objectives/topic/Vision/objectives#5377 populations.

2. Approach The purpose of this NOFO is to study innovative strategies to better engage, detect, and manage glaucoma and other eye diseases among vulnerable populations, in community-based settings, for replication and scaling in the US. This NOFO will be accomplished with two components, Component A: Community-Based Interventions with Vulnerable Populations and Component B: Coordinating Center to provide logistics and support to the research study funded under Component A. To be funded for Component B: Coordinating Center, applicants must apply for and receive funding for Component A: Community-Based Interventions with Vulnerable Populations.

Objectives/Outcomes The NOFO’s objectives are to: 1) identify and implement interventions to increase engagement, detection, and management of glaucoma and other eye diseases; 2) identify modifiable pathways and implement interventions to address the geographic disparities in engaging and reaching high-risk populations; and 3) conduct an economic evaluation of the costs and benefits of proposed approaches.

Component A: Community-Based Interventions with Vulnerable Populations

1. Work with other Component A awardees and Component B awardee to develop and implement a standardized evaluation protocol.

2. Identify and implement interventions to reach and engage individuals within populations at high-risk for glaucoma. The proposed research should focus on identifying geographic regions in the United States with high proportions of people living at or below the federal poverty level and communities that are predominantly comprised of minority groups. Model designs should seek to target populations most at risk who are also vulnerable populations and less likely to access eye care services.

3. Identify and implement an algorithm for glaucoma detection using innovative approaches such as optic disc / computerized imagery, telemedicine, and mobile units.

4. Determine and track patient reported outcome measures such as vision-related quality of life, functional status, adherence, and patient satisfaction.

5. Identify and describe barriers contributing to delayed diagnosis and reduced disease management across levels of the socio-ecological model, a theory-based framework for understanding the multifaceted and interactive effects of personal and environmental factors that determine behaviors.

6. Implement a protocol to detect eye diseases and vision impairment and demonstrate how the methods to perform glaucoma detection can be modified to detect other eye diseases or functional vision loss.

7. Develop an economic framework to assess the cost-effectiveness of the proposed approach to detect and mange glaucoma, other major eye diseases, and vision impairment.

8. Develop and design materials to guide replication and expansion of glaucoma and other eye diseases/vision impairment detection programs. This objective should include creation of electronic handbooks for developing or replicating eye disease and functional vision loss detection interventions that define setting, partners, scope, intensity, reporting, and outcome measures.

Component B: Coordinating Center The objective of this component is to facilitate the interaction and communication to maximize study quality and impact.

1. Awardee for Component B will work with Component A awardees to:

Identify the interventions and develop a common evaluation protocol;

Assist the awardees in refining study designs and proposals;

Facilitate linkages between awardees and other partners;

Provide a coordinated forum for communication and transfer of methodological themes in study designs and analyses;

Facilitate the formation of a steering committee consisting of the principal investigators from each study site;

Work with awardees and the funding agency to prepare meeting logistics for the study including agendas, securing meeting facilities for annual face-to-face meetings, and planning and preparing regular committee meeting minutes, etc.; and

Establish and maintain a study website and organize the steering committee meetings.

At the end of the funding cycle the coordinating center will also be responsible for the preparation of reports documenting the results of the research study.

2. Awardee shall have sufficient staff available to plan, coordinate, and resolve day-to-day issues of the network; to maintain study-wide timeline management; and to facilitate the exchange of abstracts, manuscripts, presentations, fact sheets, and other scientific materials among the collaborating centers and the funding agency.

Target Population The target population for this NOFO is people at high-risk for glaucoma including African Americans over age 40 years, Asians, older people [aged 65+ years] especially older Hispanics, those with a family history of glaucoma, and those with diabetes.

The applicant should consider disparities by race, ethnicity, gender, geography, and socioeconomic status using innovative approaches. Identifying the populations is important to learning about the applicability of the resulting strategies in different populations.

Collaboration/Partnerships The applicants for this project are encouraged to form and expand partnerships to maximize the capacity of the interventions. Partnerships may occur at the community level to ensure broadest reach and ownership of the proposed intervention. Collaborations and a strategic partnerships are crucial to implement program strategies, sustain outcomes, and allow for more efficient use of existing resources and exchange of information between experts working in various areas of public health and other sectors.

Evaluation/Performance Measurement

Component A: Community-Based Interventions with Vulnerable Populations Applicants will identify standard proximal (six month) and distal (about 2-4 years) outcomes measuring vision impairment, patient reported vision-related quality of life, functional status, and patient satisfaction. Evaluation efforts should include measurable outputs and refinement to the study design, commitments to professional staffing and potential collaborators, and the execution of the study protocol. Evaluation should also address the multi-center collaborative efforts among the award recipients and the execution of the collaborative activities.

Component B: Coordinating Center Evaluation should address measurements of quality of promoting and facilitating a multi-center and collaborative environment among the award recipients, providing the coordination of study meetings, conference calls, development and execution of a communication plan including development of a study website, distribution of meeting reports, tracking and management of and coordination of committee activities.

Translation Plan Awardees will be expected to develop a translation and dissemination plan outlining the steps that will be taken to share research finding with public health practitioners, academic researchers, government agencies, private organizations, and the public. Awardees are expected to submit results to peer-reviewed journals and present findings at professional meetings and conferences, and to disseminate aspects of their work through diverse approaches such as a study website, webinars, and briefs. The translation plan should include plans for translating the intervention to scalable program with associated costs.

OMB/PRA is not expected to apply.

References

1. The Eye Diseases Prevalence Research Group. Prevalence of open-angle glaucoma among adults in the United States. Arch Ophthalmology 2004;122:532-538.

2. 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.

3. Varma R, Ying-Lai M, Francis BA, Nguyen BB-T, Deneen J, Wilson MR, Azen SP.

Prevalence of open-angle glaucoma and ocular hypertension in Latinos: The Los Angeles Latino Eye Study. Ophthalmology 2004;111:1439–1448.

4. Stein JD, Kim DS, Niziol LM, Talwar N, Nan B, Musch DC, Richards JE. Differences in Rates of Glaucoma among Asian Americans and Other Racial Groups, and among Various Asian Ethnic Groups, Ophthalmology 2011;118:1031–1037.

5. Francis BA, Varma R, Chopra V, Lai MY, Shtir C, Azen SP. Intraocular pressure, central corneal thickness, and prevalence of open-angle glaucoma: the Los Angeles Latino Eye Study. Am J Ophthalmol. 2008 Nov;146(5):741-6.

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

7. Moyer VA. Screening for glaucoma U. S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2013.

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

9. Burr, J. M., Mowatt, G., Hernández, R., Siddiqui, M. A., Cook, J., Lourenco, T., ... & Deeks, J. (2007). The clinical effectiveness and cost-effectiveness of screening for open angle glaucoma: a systematic review and economic evaluation. Health technology assessment (Winchester, England), 11(41), 1-190.

10. National Academies of Sciences, Engineering, and Medicine. (2017). Making eye health a population health imperative: vision for tomorrow. National Academies Press.

11. Hark, L., Waisbourd, M., Myers, J. S., Henderer, J., Crews, J. E., Saaddine, J. B., ... & Suleiman, A. (2016). 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 epidemiology, 23(2), 122-130.

12. Zhao, D., Guallar, E., Gajwani, P., Swenor, B., Crews, J., Saaddine, J., ... & Sosa-Ebert, A. (2017). Optimizing glaucoma screening in high-risk population: design and 1-year findings of the Screening to Prevent (SToP) Glaucoma study. American journal of ophthalmology, 180, 18-28.

13. National Eye Health Education Program, National Eye Institute, Lions Clubs International Foundation. 2005 Survey of public knowledge, attitudes, and practices related to eye health and disease. 2007.

14. Livingston PM, Lee SE, De Paola C, Carson CA, Guest CS Taylor HR. Knowledge of glaucoma, and its relationship to self-care practices, in a population sample. Aust N Z J Ophthalmol. 1995 Feb;23(1):37-41.

15. 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.

16. 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.

Section II. Award Information Funding Instrument Type: 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: $11,750,000

Anticipated Number of Awards: 4

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

Award Ceiling: $700,000 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 (http://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.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: State governments

County governments City or township governments Special district governments Independent school districts Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education For profit organizations other than small businesses Small businesses Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

Information on Eligibility"

Additional Eligibility Category:

2. Foreign Organizations Foreign Organizations are not eligible to apply.

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. Special Eligibility Requirements

NA

4. Justification for Less than Maximum Competition

NA

5. Responsiveness

NA

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 Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: https:// eportal.nspa.nato. int/ AC135Public/ Docs/ US%20Instructions%2 0for%20NSPA%20NCAGE.pdf

System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, https://www.sam.gov/portal/SAM/.

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 submission.

https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://www.sam.gov/portal/SAM https://www.Grants.gov https://public.era.nih.gov/commons/public/login.do?TYPE=33554433&REALMOID=06-1edb031f-46c7-44b3-b803-60b537de74d2&GUID=&SMAUTHREASON=0&METHOD=GET&SMAGENTNAME=-SM-938PYmoLVb4VrDeXo04LZUDVDvc%2b3899ByInEAjuSUvWNIGfB2zRpWiCivYGCogG&TARGET=-SM-http%3a%2f%2fpublic%2eera%2enih%2egov%2fcommons https://www.grants.gov

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing Principle 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 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 DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number is a nine-digit number assigned by Dun and Bradstreet Information Services. An AOR should be consulted to determine the appropriate number. If the organization does not have a DUNS number, an AOR should complete the US D&B D-U-N-S Number Request Web Form or contact Dun and Bradstreet by telephone directly at 1-866-705-5711 (toll-free) to obtain one. A DUNS number will be provided immediately by telephone at no charge. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a DUNS number.

Additionally, all applicant organizations must register in the System for Award Management (SAM). 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 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 the SAM internet site at https://www.sam.gov/index.html.

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 DUNS 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.

9. Cost Sharing This FOA does not require cost sharing as defined in the HHS Grants Policy Statement http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform https://www.sam.gov/index.html

(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 having a unique DUNS number) is allowed for each Component.

Section IV. Application and Submission Information

1. Address to Request Application Package In order to use ASSIST, applicants must visit https://public.era.nih.gov/assist 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:

· E-mail: http://grants.nih.gov/support/index.html

· Phone: 301-402-7469 or (toll-free) 1-866-504-9552. The NIH eRA Service desk is available Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding federal holidays.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the SF-424 (R&R) Application Guide http://grants.nih.gov/grants/how-to-apply-application-guide.htm and here: https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf, 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 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 (R&R) 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.

3. Letter of Intent Due Date for Letter of Intent: 01/11/2019 http://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/assist http://grants.nih.gov/grants/how-to-apply-application-guide.htm https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CIO staff to estimate the potential review workload and plan the review.

Prospective applicants are asked to submit a letter of intent that includes the following information:

Name of the Applicant Descriptive title of proposed research Name, address, and telephone number of the PD(s)/PI(s) Names of other key personnel Participating institutions Number and title of this funding opportunity

The letter of intent should be sent to:

Sue Shaw National Center for Chronic Disease and Health Promotion Extramural Research Program Operations and Services Centers for Disease Control and Prevention 4770 Buford Highway, NE M/S F-80 Atlanta, GA 30341 Telephone: (770) 488-6142 / Email: zgx7@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). Specifically, some of the following components are for Resubmissions or Revisions only. See the SF 424 (R&R) Application Guide https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/generalforms-e.pdf and https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf for additional information. Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Notice of Funding Opportunity Description).

Follow the page limits stated in the SF 424 unless otherwise specified in the NOFO. As applicable to and specified in the NOFO, the application should include the bolded headers in this section and should address activities to be conducted over the course of the entire project, including but not limited to:

1. Introduction to Application (for Resubmission and Revision ONLY) - provide a clear description about the purpose of the proposed research and how it addresses the specific requirements of the NOFO.

https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf

2. Specific Aims – state the problem the proposed research addresses and how it will result in public health impact and improvements in population health.

3. Research Strategy – the research strategy should be organized under 3 headings:

Significance, Innovation and Approach. Describe the proposed research plan, including staffing and time line.

4. Progress Report Publication List (for Continuation ONLY)

Other Research Plan Sections

5. Vertebrate Animals

6. Select Agent Research

7. Multiple PD/PI Leadership Plan.

8. Consortium/Contractual Arrangements

9. Letters of Support

10. Resource Sharing Plan(s)

11. Authentication of Key Biological and/or Chemical Resources

12. Appendix

All instructions in the SF424 (R&R) Application Guide https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf and here:

https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf must be followed along with any additional instructions provided in the NOFO.

Applicants that plan to collect public health data must submit a Data Management Plan (DMP) in the Resource Sharing Plan section of the PHS 398 Research Plan Component of the application. A DMP is required for each collection of public health data proposed. Applicants who contend that the public health data they collect or create are not appropriate for release must justify that contention in the DMP submitted with their application for CDC funds.

The DMP may be outlined in a narrative format or as a checklist but, at a minimum, should include:

• Descriptions of the data to be produced in the proposed project

• How access will be provided to the data (including provisions for protection of privacy, confidentiality, security, intellectual property, or other rights)

• Use of data standards that ensure all released data have appropriate documentation that describes the method of collection, what the data represent, and potential limitations for use

• Plans for archival and long-term preservation of the data, or explaining why long-term preservation and access cannot be justified Examples of DMPs may be found here: University of California https://dmp.cdlib.org/, or USGS, http://www.usgs.gov/datamanagement/plan/dmplans.php

Research Plan

To be funded for Component B: Coordinating Center, applicants must apply for and receive funding for Component A: Community-Based Interventions with Vulnerable Populations.

Applicants must submit a separate application for each Component.

https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf https://dmp.cdlib.org/ http://www.usgs.gov/datamanagement/plan/dmplans.php

For each Component, the applicant’s research plan should address activities that will be conducted over the entire 5-year period of performance, and should include the following items.

Component A: Community-Based Interventions with Vulnerable Populations

1. Describe approaches to engage the high risk populations using data to identify communities that are disproportionately affected by glaucoma and other major eye diseases.

2. Describe the rationale for the selected geographic area where the study will be performed and provide an explanation for why the results from this area may be applicable to other geographic areas within the USA.

3. Describe the sequence of activities proposed to engage population at risk, including outreach; education/ training/ awareness; detection/ identification of glaucoma, glaucoma suspect, other eye disease, and vision impairment; follow-up/loss to follow-up; measurement of proximal and distal outcomes.

4. Describe approaches(s) to identify and collaborate with appropriate partners such as university medical centers, non-profit organizations, health systems, professional organizations and other agencies or organizations relevant to the study to request their cooperation for this project.

5. Describe plans for data collection, management, quality assurance, and analysis including information on sample size calculations for the study.

6. Describe plans for the economic study to; estimate the effectiveness of the proposed protocol in terms of number of cases detected and follow-up care of the identified cases of glaucoma, other major eye diseases, and vision impairment; estimate the total and additional costs associated with expanding glaucoma detection to include other major eye diseases and vision impairment; and assess the cost-effectiveness of expanding glaucoma detection protocol, compared with no expansion program or status quo.

7. Describe the core components of the intervention (reporting, outcome measures, and training) that require fidelity in order to replicate the intervention.

8. Describe expected contributions to public health (e.g., further understanding of glaucoma detection, potential for dissemination of and sustainability of the proposed intervention in the public health care system).

9. Describe plans for sharing the results of the study(s) and proposed dissemination strategies for project results. These may include outreach of information to targeted audiences, such as research scientists, behavioral or educational professional organizations, or state and federal policy makers; web postings or other web-based activities such as webinars and other educational activities; and publication in peer reviewed literature.

Management and Staffing

1. Provide a detailed staffing plan to include: 1) staff experience designing, implementing, and evaluating public health strategies including, experience identifying geographic disparities, geospatial mapping, working with partners and local communities; 2) describe the multi-disciplinary experience of the research team (including, but not limited to epidemiologists, statisticians, survey methodologists, demographers, health services researchers, informaticians, and analysts), and how the members of the research team will complement each other’s skills and work together; 3) the research team member’s contributions to similar studies and publications in peer-reviewed journals and presentations made at professional and scientific conferences; and 4) description of how the team members will complement each other’s skills and work together. Include the percentage of time each person will devote to project activities.

2. Provide detailed description of the experience and expertise of the project lead including; a) leadership in project coordination; b) subject matter expertise; and c) publication record in major peer reviewed journals.

3. Provide detailed plan for the coordination and communication approach for working with CDC. Include plans to participate in monthly program monitoring, and provide information as requested by the program.

Timeline

1. Provide a detailed timeline, including realistic and measurable milestones for proposed project activities and distinct benchmarks with a description on how each of the proposed activities will be sequenced and scaled up over the period of performance.

2. Provide a timeline for conducting follow-up assessments and data collection at baseline and subsequent time points during a minimum follow-up period of 12 and 24-36 months after delivery. Provide outcome measures such as health and quality of life.

Budget

1. Include a detailed budget and justification that is linked to proposed activities and milestones.

2. Include travel each year for two key staff (including the PI) to attend an annual meeting in Atlanta, GA to discuss study progress and any issues related to accomplishing project objectives.

Evaluation

1.…