PKG00246859-instructions.pdf

Centers for Disease Control

National Center for Chronic Disease Prevention and Health Promotion Extramural Research

Program Office

Research to Enhance the US Vision and Eye Health Surveillance System

RFA-DP-19-005

Application Due Date: 02/14/2019

Research to Enhance the US Vision and Eye Health Surveillance System

RFA-DP-19-005

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 Research to Enhance the US Vision and Eye Health Surveillance System Activity Code U01

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

RFA-DP-19-005

Assistance Listings (CFDA) Number(s) 93.068 Category of Funding Activity:

Health NOFO Purpose The purpose of this Notice of Funding Opportunity (NOFO) is to expand the Vision and Eye Health Surveillance System (VEHSS) by identifying and incorporating new data sources and validating data and key indicators in VEHSS, maintaining the existing system, and promoting the VEHSS to stakeholders.

Key Dates Publication Date: To receive notification of any changes to RFA-DP-19-005, 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: 01/14/2019

Application Due Date: 02/14/2019

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.

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 https://www.grants.gov 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: 04/03/2019

Secondary Review: 05/15/2019

Estimated Start Date: 09/30/2019

Expiration Date: 02/15/2019 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

Executive Summary

Purpose. This NOFO solicits applications to expand the Vision and Eye Health http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf

Surveillance System (VEHSS) by identifying and incorporating new data sources and validating data and key indicators in VEHSS, maintaining the existing system, and promoting the VEHSS to stakeholders.

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

(direct and indirect) for the 3-year period of performance is $2,550,000. One award will be issued under this NOFO. The award is contingent upon availability of funds and a sufficient number of meritorious applications.

Budget and Period of Performance. The estimated total funding (direct and indirect) for the first budget period, 09/30/2019 ? 09/29/2020, is $850,000. The estimated total funding (direct and indirect) for the period of performance, 09/30/2019 ? 09/29/2022, is $2,550,000.

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. Eligible applicant institutions may submit only one application.

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 424 (R&R) Application Guide Version E.

Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: 1- 888-232-6348.

A link to this NOFO will be available Notice of Funding Opportunities | Our Programs | Natio nal Center for Chronic Disease Prevention and Health Promotion | CDC

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 http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#SectionIV http://era.nih.gov/commons/index.cfm#SectionIII1A http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm#SectionIV1 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://www.cdc.gov/chronicdisease/programs-impact/nofo/index.htm https://www.cdc.gov/chronicdisease/programs-impact/nofo/index.htm

247b (k) (2), as amended.

1. Background and Purpose This NOFO is aimed at improving the vision health of the nation by improving and strengthening the recently created Vision and Eye Health Surveillance System (VEHSS).

Surveillance is a core public health function, yielding data used to monitor the burden of disease, identify high-risk groups, inform decision makers, and evaluate the effectiveness of interventions. The United States government in Healthy People 2010 and 2020, in conjunction with the vision and eye care communities, have identified the reduction of population disparities in vision loss and access to eye care services as top public health priorities (1).

The 2016 National Academies for Sciences, Engineering, and Medicine (NASEM) report ?Making Eye Health a Population Health Imperative: Vision for Tomorrow? recommended the development of a coordinated surveillance system for vision and eye health in the United States that includes: standardizing definitions of clinical vision loss and quality of care measures;

integrating eye health outcomes; and analyzing and disseminating information in a timely manner (2).

In 2017, CDC?s Vision Health Initiative (VHI) Program convened a national panel of experts to review the NASEM recommendations and provide guidance to build VHI future strategies. One of the suggested strategies was to strengthen the national vision and eye health surveillance system (published report on the VHI website).

Vision loss is recognized as a public health problem because it affects more than 4 million people aged 40 years and older in the United States (3). It is associated with higher prevalence of multiple chronic conditions such as diabetes, cardiovascular health, falls, injuries, depression, smoking, premature mortality and overall poorer quality of life (4-9). It costs the nation more than $130 billion annually (10), and it is amenable to prevention by early detection and timely treatment (11). Vision loss is more likely to affect women, racial/ethnic minorities, and people who are older and poorer (12, 13). The most common eye diseases that may cause irreversible vision loss include age-related macular degeneration, diabetic retinopathy, and glaucoma. Other treatable forms of vision loss, such as cataract and refractive errors, affect millions of Americans. Forecasting studies indicate the number of people with eye diseases will surge in the coming decades. The population of people with glaucoma is expected to increase from 2.2-

2.7 million to 7.3 million by 2050 (14). Cataract cases are expected to increase from 20.5 million in 2010 to 30.1 million in 2020. (15) Early macular degeneration cases are expected to increase from 9.1 million in 2010 to 17.8 million in 2050 (16) and diabetic retinopathy cases will triple from 5.5 million in 2005 to 16 million in 2050 (17).

The prevalence and risk factors for some eye diseases are well documented. For example, compared to non-Hispanic Whites, the prevalence of glaucoma is substantially higher among Blacks, Hispanics/Latinos, and Asians (18, 19). Fifty percent of people with glaucoma do not know they have the disease (20). However, once detected, appropriate management can slow glaucoma progression and remaining vision can often be preserved. Lost vision, however, cannot be restored. Early macular degeneration more often occurs in Whites and males, is infrequent before age 55, and is associated with smoking (21). Diabetic retinopathy affects approximately two-fifths of those individuals who identify themselves as having diabetes mellitus - about 4.1 million in 2000. Diabetic retinopathy is more prevalent among blacks and

Hispanics compared to whites (22).

Despite the knowledge about the individual and societal burden of vision loss and eye diseases, the public health surveillance system in the United States has only just begun to systematically understand and monitor the magnitude and implications of vision loss, access to eye care, and effectiveness of services that potentially improve health and quality of life of those who are at risk of or experience vision loss (23).

Vision and eye health surveillance in the US is particularly problematic because of the concepts employed to measure vision vary and ?gold standard? survey questions are lacking. No single survey can capture all the elements needed to assess the burden of vision loss, vision function and disability, and access to eye care. Therefore, assembling a variety of existing national surveys that meet the key requirements of vision and eye health surveillance - representative sample, standard data elements, and timely access to data - may provide a basis from which to begin to assess the burden of vision health and guide interventions and policy decisions designed to address that burden.

In 2010, CDC?s VHI convened a panel of national and international experts to define surveillance approaches and metrics to capture the burden of vision health disparities and to identify properties of a surveillance system to guide public health interventions (24).

The panel outlined 6 strategies to improve vision surveillance and help reach the vision related objectives of Healthy People 2020. The strategies outlined to achieve the goal were to:

1. Link data collection and analysis with ongoing public health interventions to improve eye health disparities;

2. Effectively assess vision loss (performance-based and self-reported measures);

3. Effectively assess utilization of eye care;

4. Include defined populations to assess the disparities in vision loss and in utilization of eye care services;

5. Include and sustain ophthalmic/vision measurements and question components within national surveys; and

6. Strengthen partnerships among federal agencies and other stakeholders to establish a national vision surveillance system to monitor the nation?s eye health and eye care utilization for trends in disparity. Federal agencies and other stakeholders work together to monitor the nation?s eye health and eye care utilization.

As a result of the panel?s recommendations, CDC created an integrated vision and eye health surveillance system to improve population estimates and understanding of population trends, health disparities, as well as barriers and facilitators to access to vision care. The result of that effort was the Vision and Eye Health Surveillance System (VEHSS). The aim of this announcement is to validate, enhance, extend, and maintain the recently established VEHSS. In particular, an extensive review and reprioritization of the current vision and eye health indicators are needed to ensure that they meet rigorous scientific criteria for validity and utility.

The existing VEHSS provides access to various surveys, as well as administrative and electronic data systems. Beyond maintaining and keeping the existing system current, efforts are needed to establish the scientific validity of the indicators currently being used, identify data gaps, document and prioritize potential data sources to support key data elements for surveillance and research. Efforts are also needed to evaluate outreach, educate end users, and the VEHSS?s impact on understanding vision health population estimates, trends, and health disparities, as well as barriers and facilitators to access to vision and health care. Such efforts are vital if consumers, providers, public health, and other stake holders are to be able to use VEHSS to meet the needs of those at risk for vision impairment and the country?s visually impaired populations.

Healthy People 2020 and other National Strategic Priorities The CDC and the National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) are committed to achieving the health promotion and disease prevention objectives of "Healthy People 2020," and to measuring program performance as stipulated by the Government Performance and Review Act (GPRA). This NOFO addresses ?Healthy People 2020? focus area to ?Improve the visual health of the Nation through prevention, early detection, treatment, and rehabilitation (1). Surveillance for vision health is an important component to track and meet Healthy People Objectives. Examples of healthy vision objectives that could be monitored with the VEHSS;

V-4 Increase the proportion of adults who have a comprehensive eye exam, including dilation, within the past 2 years.

V-5 Reduce visual impairment.

V-5.1 Reduce visual impairment due to uncorrected refractive error.

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.

The announcement is in alignment with the NCCDPHP performance goal(s) to improve the lives of racial and ethnic populations who suffer disproportionately from the burdens of disease and disability, and develop tools and strategies that will enable the nation to eliminate these health disparities.

Public Health Impact The Vision and Eye Health Surveillance System will have a direct impact on vision public health by providing timely, accurate, and scientifically valid estimates of the burden of vision impairment at the national, state, and local levels. This will enable national and local public health partners to promote eye health and reduce the burden of vision impairment throughout the nation. The surveillance system will: 1) measure the burden of the vision impairment and its complications; 2) help stakeholders and researchers understand the etiology, risk factors, and natural history of vision impairment and its complications; 3) allow them to assess the impact of the vision impairment on quality of life; 4) help guide research focused on the prevention and treatment of vision impairment and its complications; and 5) effectively evaluate public health interventions.

Validation of the National Vision and Eye Health Surveillance System (VEHSS) is vital to assess progress toward meeting the healthy vision objectives in Healthy People 2020. Having such a system will further national efforts to prevent vision loss and promote eye health and will serve as an infrastructure resource to improve access and utilization of eye care services. At the end of this three-year project, the National Vision and Eye Health Surveillance System (VEHSS) will be comprehensive, up-to-date and have established scientific validity. Having met those criteria, it can then serve to provide comprehensive, integrated, and accessible information to inform academic institutions, state and national governmental agencies, and private organizations in their efforts to reduce vision loss and related disability.

Relevant Work CDC?s Vision Health Initiative (VHI) and NORC at the University of Chicago partnered to develop the National Vision and Eye Health Surveillance System (VEHSS). The current VEHSS leverages new and existing data sources to help health professionals, researchers, policy makers, and patients understand the scope of vision loss, eye disorders, and eye care services in the United States. VEHSS is intended to grow and improve over time based on input and needs of the vision health community (25).

2. Approach The purpose of this NOFO is to expand the VEHSS by identifying and incorporating new data sources and validating data and key indicators, maintain the existing VEHSS system and promote the VEHSS to stakeholders to monitor the burden of vision loss and eye diseases and ultimately to improve the vision and eye health of the nation.

The system will be extended using additional years and data sources, including surveys and administrative and electronic data sources. It will incorporate new data sources with characteristics such as representativeness, timeliness, accuracy, and geographic details and be rigorously evaluated. This project will enhance and expand dissemination and outreach to researchers, epidemiologists, decision makers, providers, and other end users for implementation and evaluation of programs aimed to improve the vision and eye health of the nation.

Objectives/Outcomes

1. Obtain expert input and review of the VEHSS?s indicators scientific validity and public health utility, and prioritize potential data sources and key indicators

2. Review and validate existing and new indicators to ensure face, construct, concurrent, and predictive validity. Indicators should address modifiable and non-modifiable risk factors and evidence-based preventive care and treatment for eye disease, major eye diseases and refractive errors, as well as indicators of quality of life and well-being.

3. Identify, test, and validate new data sources for the VEHSS, particularly those which address data gaps in disparities and for minority populations. Data sources should be evaluated with characteristics such as representativeness, timeliness, accuracy, and geographic details to accurately estimate the proportion and population of people with vision loss, major eye diseases, and access and utilization of eye care.

4. Identify and rank potential data sources to support key indicators for surveillance and research.

5. Evaluate potential sources and methods to generate county-level estimates (or alternative geographic-level variation) to identify disparities in vision loss and eye health and determine how factors such as socioeconomic status, race, and ethnicity explain geographic variability.

6. Consider analysis to calculate rates, prioritize indicators, evaluate emerging problems and monitor vision loss, major eye diseases, and access to care.

7. Plan for face-to-face meeting with CDC at the start of the project and annually thereafter to provide detailed measurable milestones for proposed project activities and distinguishable benchmarks.

8. Ensure continuation of ongoing data use agreements (if any) or establishing new DUA or mechanism to allow for public access to and use of data.

9. Collaborate with National Center for Chronic Disease Prevention and Health Promotion?s (NCCDPHP) Office of Informatics and Science Office to review data and indicators for dissemination through NCCDPHP?s open data platform. Following CDC technical and security standards, place key data and indicators into NCCDPHP?s open data platform and evaluate accessibility and usability of the data with end users such as government agencies, academic institutions, and other interested parties.

10. Develop a plan to educate end-users of vision and eye health data including but not limited to: 1) publishing in peer reviewed journals on the utility of the surveillance system; 2) presentations to end user audiences including state and local partners; and 3) a report with recommendations on the use and adoption of the National Vision and Eye Health Surveillance System; and 4) publications such as newsletters, webinars, and quick fact sheets.

11. Develop a final project report which describes the components of the VEHSS, data sources used to develop the system, development of the indicators, how the system?s data is managed (e.g., entry, editing, storage, backup, etc.) and the system?s compliance with applicable standards for data format, such as 508 compliance.

Target Population The Vision and Eye Health Surveillance System (VEHSS) should capture racial/ethnic, gender, and socioeconomic (income/education) and geographic location differences (both U. S. Census region and urban-rural) in vision status and access to and utilization of eye health care services.

Data should remain representative of the adult population so that users can draw inferences to the general population.

Collaboration/Partnerships Applicants are expected to collaborate with a variety of academic institutions, private sector organizations, and governmental agencies representing both producers and users of vision health data. The partners are expected to contribute regularly to establishing the rigor, comprehensiveness, and utility of the system as well as assuring that the content is accessible and useful to users.

The applicant is expected to establish an expert panel in vision health to review existing and new indicators, to ensure face, construct, concurrent, and predictive validity, and to explore and evaluate data collection of vision and eye health using existing surveys.

Evaluation/Performance Measurement Evaluation during the first year should be measured by the refinement and validation made to the data sets and indicators, commitments made to potential collaborators, and updated review to the current system.

In subsequent funded year, evaluation should be measured by the inclusion of additional methods for county-level estimate, identification of new indicators, timeliness of analyses, and the education of end users about the usability of the system.

Translation Plan Applicants are expected to develop a plan to target and educate end users about the usability of the system including but not limited to: 1) publishing in peer reviewed journals on the utility of the surveillance system, 2) presentations to end user audiences including state and local partners, and 3) a report with recommendations for use and adoption of the National Vision and Eye Health Surveillance System, 4) newsletters and quick fact sheets.

OMB/PRA approval may be required.

References

1. Healthy People 2020. https://www.healthypeople.gov/2020/topics-objectives/topic/visio n.

2. National Academies for Sciences, Engineering, and Medicine 2016. ?Making Eye Health a Population Health Imperative: vision for tomorrow?. Washington, DC: the National Academies Press. Doi: 10.17226/23471).

3. Varma R, Vajaranant TS, Burkemper B, et al. Visual impairment and blindness in adults in the United States: Demographic and geographic variations from 2015 to 2050. JAMA ophthalmology. 2016;134(7):802-9.

4. Klein R, Klein BE, Moss SE. Visual impairment in diabetes. Ophthalmology. 1984 Jan;91(1):1-9.

5. Patino CM, McKean-Cowdin R, Azen SP, et al. Central and peripheral visual impairment and the risk of falls and falls with injury. Ophthalmology. 2010;117(2):199-

206. e1.

6. Zhang X, Bullard KM, Cotch MF, et al. Association between depression and functional vision loss in persons 20 years of age or older in the United States, NHANES 2005- 2008. JAMA ophthalmology. 2013 May;131(5):573-81.

7. Zhang X, Kahende J, Fan AZ, et al. Smoking and visual impairment among older adults with agerelated eye diseases. Prev Chronic Dis 2011;8(4):A84.

8. McCarty CA, Nanjan MB, Taylor HR. Vision impairment predicts 5 year mortality. Br J Ophthalmol 2001;85:322?326.

9. Crews JE, Chou CF, Zhang X, Zack MM, Saaddine JB. Health-Related Quality of Life Among People Aged ?65 Years with Self-reported Visual Impairment: Findings from the 2006-2010 Behavioral Risk Factor Surveillance System. Ophthalmic Epidemiol.

2014 Oct;21(5):287-96.

10. Prevent Blindness America. The Cost of Vision Problems. Accessed September 24, 2014 from http://costofvision.preventblindness.org.

11. Saaddine JB, Narayan KM, Vinicor F. Vision loss: a public health problem?

Ophthalmology. 2003 Feb;110(2):253-4.

12. Zambelli-Weiner A, Crews JE, Friedman DS. Disparities in adult vision health in the United States. Am J Ophthalmol. 2012 Dec;154(6 Suppl):S23-30.

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

13. Zhang X, Cotch MF, Ryskulova A, Primo SA, Nair P, Chou CF, Geiss LS, Barker LE, Elliott AF, Crews JE, Saaddine JB. Vision health disparities in the United States by race/ethnicity, education, and economic status: findings from two nationally representative surveys. Am J Ophthalmol. 2012 Dec;154(6 Suppl):S53-62.

14. The Eye Diseases Prevalence Research Group. Causes and prevalence of visual impairment among adults in the United States. Arch Ophthalmol 2004;122(4):477? 485.

15. The Eye Diseases Prevalence Research Group. Prevalence of cataract and pseudophakia/aphakia among adults in the United States. Arch Ophthalmol.

2004;122(4):487-494.

16. Rein DB, Wittenborn JS, Zhang X, Honeycutt AA, Lesesne SB, Saaddine J Forecasting age-related macular degeneration through the year 2050: the potential impact of new treatments. Arch Ophthalmol. 2009 Apr;127(4):533-40.

17. Saaddine JB, Honeycutt AA, Narayan KM, Zhang X, Klein R, Boyle JP. Projection of diabetic retinopathy and other major eye diseases among people with diabetes mellitus:

United States, 2005?2050. Archives of Ophthalmology, 2008;126(12):1740?1747.

18. 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.

19. 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.

20. Saw S-M, Gazzard G, Friedman D, Foster PJ, Devereuz JG, Wong ML, Seah S.

Awareness of glaucoma, and health beliefs of patients suffering primary acute angle closure. Br J Ophthalmol. 2003 Apr;87(4):446-9.

21. Klein R, Klein BE, Linton KL. Prevalence of age-related maculopathy. The Beaver Dam Eye Study. Ophthalmology. 1992 Jun;99(6):933-43.

22. The Eye Diseases Prevalence Research Group. The prevalence of diabetic retinopathy among adults in the United States. Arch Ophthalmol. 2004;122:552-563.

23. Zambelli-Weiner A, Friedman DS. Building a basis for action: enhancing public health surveillance of vision impairment and eye health in the United States. Am J Ophthalmol.

2012 Dec;154(6 Suppl):S8-22.

24. Lee PP, West SK, Block SS, Clayton J, Cotch MF, Flynn C, Geiss LS, Klein R, Olsen TW, Owsley C, Primo SA, Rubin GS, Ryskulova A, Sharma S, Friedman DS, Zhang X, Crews JE, Saaddine JB. Surveillance of disparities in vision and eye health in the United States: an expert panel's opinions. Am J Ophthalmol. 2012 Dec;154(6 Suppl):S3-7.

25. Vision Health Initiative web site . https://www.cdc.gov/visionhealth/vehss/index.html

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.

https://www.cdc.gov/visionhealth/vehss/index.html

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: $2,550,000

Anticipated Number of Awards: 1

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

Award Ceiling: $850,000 Per Budget Period Award Floor: $0 Per Budget Period Total Period of Performance Length: 3 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 http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf 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 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

Nonprofits Other Than Institutions of Higher Education:

Nonprofits (Other than Institutions of

Higher Education)

Governments:

Eligible Agencies of the Federal

Government U.S. Territory or Possession

Other:

Native American tribal organizations

(other than Federally recognized tribal governments)

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 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 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 complete. However, it is best to start the registration process at least two weeks prior to application submission.

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.

http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform https://www.sam.gov/index.html

9. Cost Sharing This FOA 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 having a unique DUNS number) is allowed.

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.

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

3. Letter of Intent Due Date for Letter of Intent: 01/14/2019 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, MPH Scientific Program Official Extramural Research Program Operations and Services Centers for Disease Control and Prevention 4770 Buford Highway, NE Mailstop #F80 Atlanta, GA 30342 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, 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 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.

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 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

Research Plan The applicant’s research plan should address activities that will be conducted over the entire three-year period of performance and should include the following items.

Research Strategies

1. Describe plans for engaging experts to review and provide critique of the VEHSS’s data sources, indicators scientific validity and public health utility, and prioritize indicators.

2. Describe plans and appropriate methodologies to analyze the existing VEHSS data sources, indicators, and estimates to assess their validity and representativeness.

3. Describe approaches for identifying and selecting valid new and novel reliable data sources not currently part of VEHSS that are both qualitative and quantitative to assess vision loss, major eye diseases, and access and utilization of eye care services. This may include paper-based medical records, electronic medical records, and administrative data.

4. Describe plans to evaluate potential sources and methods to generate county-level estimates to identify disparities in vision loss and eye health and explain geographic variability.

5. Describe an approach to identify gaps and shortfalls in existing data sources and data elements and determine additional effective and novel approaches to accurately and more easily evaluate and monitor vision loss, eye diseases, and access to eye care.

6. Describe planned approach to overcome barriers posed by the variability of vision measures in surveys. Describe the plan to harmonize existing survey questions to capture eye health outcomes.

7. Describe planned approach to identify novel measures capturing performance-based and self-reported vision loss.

8. Describe plans to work with CDC informatics through NCCDPHP’s open data platform, place key data and indicators into the platform, and evaluate accessibility and usability of the data with end users.

9. Describe planned activities to educate researchers, government agencies, decision makers, providers, and other interested parties about how the VEHSS can be used for research and for implementation and evaluation of programs aimed to improve the vision and eye health of the nation.

Management and Staffing

1. Describe the experience and expertise of the project lead investigator including: a) leadership in project coordination; b) subject matter expertise and c) publication record in major peer reviewed journals; d) the percentage of time will devote to project activities.

2. Provide a detailed staffing plan for the three year period of performance to include: 1) staff…