RFA-DP-15-004 AMENDMENT 1.pdf

Centers for Disease Control and Prevention

National Center for Chronic Disease Prevention and Health Promotion Extramural Research Program Office

Establish a Vision and Eye Health Surveillance System for the Nation - AMENDMENT I. QUESTIONS

FROM POTENTIAL APPLICANTS AND CDC RESPONSES were added to Section VIII. as Appendix A.

on January 27, 2015

RFA-DP-15-004

Application Due Date: 02/05/2015

Establish a Vision and Eye Health Surveillance System for the Nation - AMENDMENT I. QUESTIONS FROM POTENTIAL APPLICANTS AND CDC RESPONSES were added to Section VIII. as Appendix A.

on January 27, 2015

RFA-DP-15-004

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 and Prevention Components of Participating Organizations National Center for Chronic Disease Prevention and Health Promotion Extramural Research Program Office

(NCCDPHP ERPO)

National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) Funding Opportunity Announcement (FOA) Title Establish a Vision and Eye Health Surveillance System for the Nation - AMENDMENT I. QUESTIONS FROM POTENTIAL APPLICANTS AND CDC RESPONSES were added to Section VIII. as Appendix A.

on January 27, 2015 Activity Code Applications in response to this FOA will be funded using the U01 activity code.

Funding Opportunity Announcement Type New Funding Opportunity Announcement Number

RFA-DP-15-004

Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.068 Category of Funding Activity:

Health FOA Purpose This funding opportunity announcement (FOA) solicits applications to develop, test, and implement a vision and eye health surveillance system using existing surveys, as well as administrative and electronic data sources. Such a system will be built to provide population estimates of vision loss function, eye diseases, health disparities, as well as barriers and facilitators to access vision and eye care at the national, state, and community levels. This surveillance system will provide data to prioritize new program interventions, inform policy changes, and improve public communications. The dissemination of these data to existing public health programs will encourage public health action to improve the vision and eye health of the nation.

Key Dates Publication Date: To receive notification of any changes to RFA-DP-15-004, 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: 01/05/2015

Application Due Date: 02/05/2015

On-time submission requires that electronic applications be error-free and made available to CDC for processing from eRA Commons on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov/eRA Commons no later than 5:00 PM U.S. Eastern Time. Note:

HHS/CDC grant submission procedures do not provide a period of time beyond the application due date 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).

http://www.grants.gov

Scientific Merit Review: 04/20/2015

Secondary Review: 06/05/2015

Estimated Start Date: 09/30/2015

Expiration Date: 02/06/2015 Due Dates for E.O. 12372: Executive Order 12372 does not apply to this program.

Required Application Instructions It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this FOA. Conformance to all requirements (both in the Application Guide and the FOA) 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. To develop, test, and implement a vision and eye health surveillance system using various surveys, as well as administrative and electronic data sources. Such a system will be built to provide population estimates of vision loss function, eye diseases, health disparities, as well as barriers and facilitators to access vision and eye care at the national, state, and community levels. This system will be disseminated and shared with 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.

Mechanism of Support. This funding opportunity will use the cooperative agreement funding mechanism (U-01).

Funds Available and Anticipated Number of Awards. Total funding available for this cooperative agreement is expected to be $4,000,000 over the four-year project period. $1,000,000 total direct and indirect costs, is available in FY 2015 to fund one award. The award issued under this FOA is contingent upon availability of funds and a sufficient number of meritorious applications.

Budget and Project Period. The estimated total funding (direct and indirect) for the first year is $1,000,000. The project period will run from September 30, 2015 to September 29, 2019 and the estimated total funding (direct and indirect) for the entire project period will be $4,000,000.

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 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 contain more than one PI; however, the first PI listed will be the “contact PI” for all correspondence.

Number of Applications. Eligible applicant institutions may submit more than one application, provided that each application is scientifically distinct.

Application Type. New (Type 1) http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf http://grants.nih.gov/grants/guide/pa-files/PAR-11-022.html#SectionIV http://grants.nih.gov/grants/guide/pa-files/PAR-11-022.html#SectionIII1A

Special Date(s). None Application Materials. See Section IV.1 for application materials.

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

(770) 488-2783.

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority

This program is authorized under 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

This FOA is aimed at improving the vision health of the nation by improving and strengthening the system of vision and eye health surveillance. The United States government, in conjunction with the vision and eye care communities, has identified the reduction of population disparities in vision loss and in access to eye care services as top public health priorities in Healthy People 2010 and 2020.

Background: Vision loss is recognized as a public health problem because it affects more than 3.3 million people aged 40 years and older in the United States (1): it is associated with higher prevalence of multiple chronic conditions such as diabetes (2), cardiovascular health (3), falls (4), injuries (5), depression (6), smoking (7), premature mortality (8), and overall poorer quality of life (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). Cases of cataract are expected to increase from 20.5 million in 2010 to 30.1 million in 2020 (15). Cases of early macular degeneration are expected to increase from

9.1 million in 2010 to 17.8 million in 2050 (16). Cases of diabetic retinopathy 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 disease progression and remaining vision can often be preserved, but lost vision 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 people 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, there is no public health surveillance system in the United States to systematically understand and monitor the magnitude and implications of vision loss, access to eye care, and effectiveness of services that http://grants.nih.gov/grants/guide/pa-files/PAR-11-022.html#SectionIV1 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 U.S. is particularly problematic because of the variability in the concepts employed to measure vision and the lack of “gold standard” questions employed in surveys. No single survey would be able to capture all 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 adequate information to assess the burden and guide interventions and policy decisions.

In 2010, a panel of national and international experts convened at CDC to: 1) define surveillance approaches to capture the burden of vision loss and vision health disparities; 2) identify strategies to bridge gaps in existing surveillance systems that would increase the utility for assessing and monitoring disparities in eye health, vision loss, and access to eye care; and 3) identify properties of a surveillance system to guide public health interventions (24).

The panel outlined six 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 measures 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.

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.

An integrated vision and eye health surveillance system would contribute to improved population estimates and improved understanding of population trends, and health disparities, as well as barriers and facilitators to access to vision care. Building a vision and eye health surveillance system would allow consumers, providers, public health, and other organizations to be more responsive to the particular needs of this growing population. Therefore, the aim of this announcement is to conduct research to examine the feasibility of using valid sources of existing data and analytical techniques to build a reliable and efficient, web-based, vision and eye health surveillance system for the nation.

The intended outcome of this announcement is the initial establishment and piloting of an integrated, web-based, vision and eye health surveillance system built upon various existing surveys, as well as administrative and electronic data sources, capable of determining population estimates, trends, and health disparities, as well as identifying barriers and facilitators to access to vision and health care at the national, state, and community levels.

There is a need to create an integrated eye health surveillance system that identifies how various surveys, as well as administrative and electronic data systems, contribute to an overall understanding of population estimates, trends, and health disparities, as well as barriers and facilitators to access to vision and health care. Building an eye health surveillance system would allow consumers, providers, public health, and other systems to be more responsive to the particular needs of this growing population. Therefore, the aim of this announcement is to conduct research using valid sources of data, analytical techniques, and data elements to build a reliable and efficient eye health surveillance system for the nation.

Purpose: The purpose of this announcement is to develop, test, and implement a vision and eye health surveillance system using various existing surveys, as well as traditional and non-traditional data sources, to assess population estimates, trends, and health disparities. This project will be characterized by the capacity to assess various data for inclusion and propose a plan to assemble, analyze, integrate, implement, and disseminate information from this eye health surveillance system. This system will provide necessary information to decision makers to enable government agencies, academic institutions, and other interested parties to monitor the burden and trends of vision loss; major eye diseases, risk factors for vision loss; social, economic, racial, and ethnic disparities; and to establish effective public health interventions to address problems of access and utilization. This surveillance system will also be instrumental in monitoring trends in the Healthy People 2020 healthy vision objectives.

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 RFA addresses “Healthy People 2020” focus area to “Improve the visual health of the Nation through prevention, early detection, treatment, and rehabilitation,” listed are the relevant vision objectives;

V-3 Reduce occupational eye injuries.

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

V-5 Reduce visual impairment.

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- 5.2 reduce visual impairment due to cataract.

V-6 Increase the use of personal protective eyewear.

V-6.1 Increase the use of personal protective eyewear in recreational activities and hazardous situations around the home among Children and adolescents aged 6-17 years.

V-6.2 Increase the use of personal protective eyewear in recreational activities and hazardous situations around the home among adults aged 18 years and older.

V-7 Increase rehabilitation services.

V-7.1 Increase the use of rehabilitation services by persons with visual impairment.

V-7.1 Increase the use of assistive and adaptive devices by persons with visual impairment.

V-8 Increase the proportion of Federally Qualified Health Centers (FQHCs) that provide comprehensive vision health services.

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. For more information, see www.health.gov/healthypeople and www.whitehouse.gov/omb http://www.health.gov/healthypeople http://www.whitehouse.gov/omb/mgmt-gpra/index-gpra

/mgmt-gpra/index-gpra.

Public Health Impact

A national vision and eye health surveillance system will help assess where the nation is meeting or failing to meet 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 four-year project, a proposed national vision and eye health surveillance system will be in place to provide comprehensive, integrated, and accessible information to inform academic institutions, state and national governmental agencies, and private organizations in efforts to reduce vision loss and related disability.

Relevant Work

Refer to Background and Purpose section.

2. Approach

Vision and Eye Health Surveillance System solicits applications to develop a comprehensive, integrated national eye health surveillance system to monitor vision loss, eye diseases, and access to eye care at the state and national level.

Objectives/Outcomes

The goal of this research is to build and develop a national integrated vision and eye health surveillance system to measure and monitor the burden of vision loss and eye diseases and ultimately improve the vision and eye health of the nation.

1. Determine the feasibility of establishing the National Vision and Eye Health Surveillance System using existing data sources. Applicants should identify, evaluate, test, and validate multiple existing data sources and develop an inventory of existing vision and eye related surveys, and other topic related resources. Applicants should use both traditional and nontraditional population-based national and state surveys (including NHANES and NHIS, and Behavioral Risk Factor Surveillance System [BRFSS]), census (American Community Survey), administrative data (Department of Veterans Affairs, Indian Health Service, Medicare /CMS, managed care registries, national health system registries), and non-traditional data sources (electronic health records, social media, marketing, and behavioral data) in order to establish the capacity to accurately estimate the proportion and population of people with vision loss, major eye diseases, and with access to eye care at the national and state levels as well as determine trends in each of these factors.

2. Identify, evaluate, and develop valid and reliable vision and eye health indicators that address risk factors for eye diseases (modifiable and non- modifiable, age, race/ethnicity, gender, SES, diabetes), major eye diseases and refractive errors, indicators of vision loss burden (disability, comorbid conditions, depression, falls, and death), and preventive care practices (comprehensive eye exam, awareness and education), collaborating with partners that are engaged in vision and eye health surveillance, research, and evaluation. Ensure data sources provide valid data for the selected indicators.

3. Determine the feasibility of implementing novel and effective approaches to accurately and more easily assess and monitor vision loss by testing standardized measures of visual acuity that are inexpensive and readily available to assess vision loss within surveys and across a variety of settings.

Standardized measures of visual acuity would allow for comparability across surveys and the integration of data from multiple sources into a national vision and eye health surveillance system.

http://www.health.gov/healthypeople

4. Develop, describe, and execute appropriate methodologies to assemble, analyze, and test data to provide estimates, among U.S. adults, of the burden of vision loss, major eye diseases, risk factors, measures of access and utilization of eye care, treatment, comorbid conditions, and disability.

5. Prepare and deliver final data set(s) to include data sources and all relevant and related information (e.g. data use agreements, privacy impact assessment). Ensure data use agreements (if any) allow for public access to and use of data. Collaborate with National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) Office of Informatics and Science Office to review data and indicators for dissemination through NCCDPHP’s open data platform. Load 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.

Make revisions as necessary to address accessibility and usability.

6. Evaluate the usefulness of the vision and eye health surveillance system for end users such as public health professionals, health care providers and policy makers.

7. Develop a dissemination plan that includes but is not be limited to: 1) publishing in peer-reviewed journals on the feasibility of a surveillance system, 2) presentations to end-user audiences, and 3) a report with recommendations for use and adoption of the National Vision and Eye Health Surveillance System.

8. Develop a final project report that includes but is not limited to describing the components of the system, 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.

Outcomes: At the end of this four-year award, a national vision and eye health surveillance system for vision loss, eye diseases, and eye health will be developed for implementation in the US. The system will provide valid data regarding social, economic, racial, and ethnic disparities among people reporting vision and eye health problems. The vision and eye health surveillance system will enable governmental agencies, academic institutions, private agencies, and the public to monitor the burden and trends of vision loss and its risk factors over time and to establish effective public health approaches to address this condition. It will also be instrumental in monitoring trends in the Healthy People 2020 vision health objectives. With input from stakeholders and partners, the knowledge gained from this project will add novel surveillance approaches by assembling big data systems to assess and monitor the vision health of the nation.

Target Population

The vision and eye health surveillance system 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 be representative of the U.S. adult population to enable users to draw inferences to the general population.

Collaboration/Partnerships

Applicants are expected to develop substantial collaborations and partnerships with a variety of academic institutions, private sector organizations, and governmental agencies representing both producers and users of vision health data. A variety of partners should contribute to establishing the rigor, comprehensiveness, and utility of the system as well as assuring that the content is accessible and useful to users. Establishing a national vision and eye health surveillance system needs partnerships among many stakeholders in order to monitor trends of the nation’s eye health and eye care utilization.

Evaluation/Performance Measurement

The applicant is expected to develop and implement an evaluation plan that includes the following characteristics:

I. Broad goals, objectives, and activities that are Specific, Measurable, Achievable, Realistic, and Time-limited (SMART);

II. A description of mechanisms for engaging partners and stakeholders in evaluation activities;

III. Key activity-specific evaluation questions;

IV. Evaluation methods; and V. A description of how evaluation results are intended to be used to overcome any barriers identified and to improve program effectiveness and rigor.

Translation Plan

The applicant is expected to develop and implement a translation plan that:

Describes the plan to disseminate study findings targeting users of the vision and eye health surveillance system through web sites, interactive data manipulation or portals, webinars, journal articles, professional presentations, facts sheets, etc.

Describes the plan for dissemination and translation of the research findings using collaborators and external partners.

Describes how the vision and eye health surveillance system will be integrated with health care delivery systems.

Provide recommendations for how to sustain and implement the plan beyond the funding period

OMB/PRA may apply.

References:

Congdon N, O’Colmain B, Klaver CC, et al. Causes and prevalence of visual impairment among adults in the United States. Arch Ophthalmol 2004;122(4):477– 485.

1.

Eye Diseases Prevalence Research Group. The prevalence of diabetic retinopathy among adults in the United States. Arch Ophthalmol 2004;122(4):552–563.

2.

Klein R, Marino EK, Kuller LH, et al. The relation of atherosclerotic cardiovascular disease to retinopathy in people with diabetes in the Cardiovascular Health Study. Br J Ophthalmol 2002;86(1):84 –90.

3.

Lord SR, Dayhew J. Visual risk factors for falls in older people. JAGS 2001;49:508–515. 4.

Kulmala J, Era P, Pärssinen O, et al. Lowered vision as a risk factor for injurious accidents in older people. Aging Clin Exp Res 2008;20(1):25–30.

5.

Zhang X1, Bullard KM, Cotch MF, Wilson MR, Rovner BW, McGwin G Jr, Owsley C, Barker L, Crews JE, Saaddine JB. Association between depression and functional vision loss in persons 20 years of age or older in the United States, NHANES 2005-2008.

JAMA Ophthalmol. 2013 May;131(5):573-81.

6.

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

7.

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

8.

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.

9.

Behavioral Risk Factor Surveillance System. Ophthalmic Epidemiol. 2014 Oct;21(5):287-96.

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

10.

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

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

11.

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.

12.

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.

13.

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.

14.

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.

15.

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.

16.

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.

17.

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.

18.

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.

19.

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.

20.

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

21.

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

22.

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.

23.

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.

24.

Section II. Award Information

Funding Instrument Type: Cooperative Agreement A support mechanism used when there will be substantial Federal http://costofvision.preventblindness.org/

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: $4,000,000

Total funding (direct and indirect) for the four-year project period is $4,000.000. It is anticipated that one award will be made available to a single recipient for approximately $1,000,000 in FY 2015.

If an applicant requests a funding amount greater than the ceiling of the award range for the first year ($1,000,000), HHS/CDC will consider the application non-responsive, and it will not enter into the review process. HHS/CDC will notify the applicant that the application did not meet the submission requirements.

Anticipated Number of Awards: 1

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

Award Ceiling: $1,000,000 Per Budget Period Award Floor: $0 Per Budget Period Total Project Period Length: 4 year(s) Throughout the project period, 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/ asfr/ogapa/aboutog/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this FOA.

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 http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf

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

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" when submitting via www.grants.gov.

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

None

4. Justification for Less than Maximum Competition

N/A

5. Responsiveness

The application must be received by 5:00 p.m., ET, on the due date. Failure to submit by the due date and time will result in the application being deemed non-responsive and will not be entered into the review process.

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/#1.

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.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing 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 registration process at least four (4) weeks prior to the application due date.

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 grantee 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 grantee organization.

8. Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions 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/%231 http://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 http://www.Grants.gov http://fedgov.dnb.com/webform https://www.sam.gov/index.html

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:// www.hhs.gov/ asfr/ ogapa/ aboutog/ hhsgps107.pdf).

10. Number of Applications As defined in the HHS Grants Policy Statement, (http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf), applications received in response to the same funding opportunity announcement 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 FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

Section IV. Application and Submission Information

1. Address to Request Application Package Applicants must download the SF424 (R&R) application package associated with this funding opportunity from www.Grants.gov.

If access to the Internet is not available or if the applicant encounters difficulty accessing the forms on-line, contact the HHS/CDC Procurement and Grants Office Technical Information Management Section (PGO TIMS) staff at (770) 488-2700 or pgotim@cdc.gov for further instructions. Hours: Monday - Friday, 7am – 4:30pm U.S. Eastern Standard Time. CDC Telecommunications for the hearing impaired or disabled is available at: TTY 1-888-232-6348.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/ 424/SF424_RR_Guide_General_VerC.pdf), except where instructed in this Funding Opportunity Announcement 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 forms package associated with this FOA includes all applicable components, mandatory and optional.

Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF 424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

In conjunction with the SF424 (R&R) components, CDC grants applicants should also complete and submit additional components titled “PHS398.” Note the PHS398 should include assurances and certifications, additional data required by the agency for a complete application. While these are not identical to the PHS398 application form pages, the PHS398 reference is used to distinguish these additional data requirements from the data collected in the SF424 (R&R) components. A complete application to CDC will include SF424 (R&R) and PHS398 components.

These forms can be downloaded and uploaded as Attachment A from the following link: http://www .cdc.gov/od/pgo/funding/grants/foamain.shtm http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.Grants.gov mailto:pgotim@cdc.gov http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf http://www.cdc.gov/od/pgo/funding/grants/foamain.shtm%20 http://www.cdc.gov/od/pgo/funding/grants/foamain.shtm%20

3. Letter of Intent Due Date for Letter of Intent: 01/05/2015

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.

By the date listed above and in Part 1. Overview Information, 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 National Center for Chronic Disease Prevention 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 FOA in Grants.gov includes all applicable components for this FOA, required and optional.

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 16 components. Not all 16 components of the Research Plan apply to all Funding Opportunity Announcements (FOAs). Specifically, some of the following 16 components are for Resubmissions or Revisions only. See Part I, Section 5.5 of the SF 424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf) for additional information. Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Funding Opportunity Announcement Description).

Follow the page limits stated in the SF 424 unless otherwise specified in the FOA. As applicable to and specified in the FOA, 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 FOA.

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 timeline.

4. Inclusion Enrollment Report (Renewal and Revision applications ONLY)

5. Progress Report Publication List (for Continuation ONLY)

Human Subjects Section mailto:ndarling@cdc.gov http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf

6. Protection of Human Subjects

7. Inclusion of Women and Minorities

8. Targeted/Planned Enrollment Table (for New Application ONLY)

9. Inclusion of Children

Other Research Plan Sections

10. Vertebrate Animals

11. Select Agent Research

12. Multiple PD/PI Leadership Plan.

13. Consortium/Contractual Arrangements

14. Letters of Support

15. Resource Sharing Plan(s)

16. Appendix

Component 4 (Inclusion Enrollment Report) applies only to Renewal and Revision applications for clinical research. Clinical research is that which is conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies). Follow the page limits in the SF 424 unless otherwise specified in the FOA.

All instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf) must be followed along with any additional instructions provided in the FOA.

Research Plan The applicant’s research plan should address activities that will be conducted over the entire 4-year project period, and should include the following items:

Describe the experience and expertise of the project team-including a) leadership in project coordination b) subject matter expertise, and c) publication record in major peer-reviewed journals - outlining key roles and time commitments, and expected contributions of key/collaborative partners. Describe 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.

Provide a detailed timeline, including realistic and measurable milestones for proposed project activities and distinguishable benchmarks. Include a budget plan that is linked to activities and milestones. Provide a detailed project timeline including realistic and measurable quarterly milestones for proposed project activities, with a description on how each of the proposed activities will be sequenced and scaled up over the 4-year project period.

Identify key milestones including data collection, data management, data analysis, report writing.

Describe the collaboration plan with stakeholders that include grantee collaborators and its partners, funding agency and its partner, and other experts and organizations that conduct or utilize data sources targeting the vision and eye health surveillance.

Describe how the collaboration and partnerships will be utilized throughout the four-year project period including the identification of data sources and indicators.

Include in the budget planned 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.

http://grants.nih.gov/grants/funding/424…