dd12-003 amendment i 1.23.12.doc

Amendment I made on January 23, 2012:

· Section III: Eligibility Information, Page 14: Number of Applications

· Questions and Answers (Attachment 1), page 34 Table of Contents

Part 1. Overview Information Part 2. Full Text of the Announcement 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

Division of Human Development and Disability (DHDD)

Announcement Type

New

Examine and address unmet need in health related areas for people with intellectual disabilities by researching valid and reliable data sources and analytic techniques to better understand risk factors associated with health disparities among people with and without intellectual disabilities.

Component B

Evaluate promising practices that have the potential to reduce health disparities in selected key health indicators for people with intellectual disabilities.

Key Dates Publication Date

December 19, 2011

To receive notification of any changes to RFA-DD-12-003, 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.

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).

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 or in a Notice from the NIH Guide for Grants and Contracts). 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 Part 2. Full Text

Section I. Funding Opportunity Description

Statutory Authority

This program is authorized under Section 301(a) and 317C of the Public Health Service Act, (42 U.S.C. Sections 241(a) and 247b-4 as amended).

Background

Research demonstrates that people with intellectual disabilities experience numerous health disparities resulting in poorer health outcomes (e.g., Horowitz et al., 2001; Surgeon General, 2002; Krahn, Hammond and Turner, 2006). They are more likely to have complex health conditions, reduced access to quality health care and more limited exposure and participation in health promotion programs. Some specific concerns include inadequate cancer screening, poor management of epilepsy (Bowley & Kerr, 2000) and being at higher risk for other chronic conditions (Janicki et al., 2002), including obesity (Rimmer and Yamaki, 2006), poor vision (Woodhouse, et al., 2004), and mental health problems with potential misuse of psychotropic medications (Lewis et al., 2002). While this evidence has led to certain countries taking targeted steps to build a surveillance system that can better assess and understand the health of their citizens with intellectual disabilities (Ouellette-Kuntz, 2007; Emerson and Hatton, 2008; Walsh, Kerr Lantmane-deValk, 2003), including a consortium of 13 countries of the European Union engaged in the Pomona project (Walsh, 2008), no such dedicated surveillance system is as yet in place in the U.S.

Part of the reason for this relates to the complexity associated with constructing a surveillance system like this at the national level. Population-based health information for this population is difficult to identify. Adults with intellectual disabilities “age out” of the educational system and its records, and may be missing from or unidentifiable on social services rolls. Perceived stigma and past discrimination results in a reluctance of many affected individuals from affiliating with terminology associated with intellectual disabilities. While people with intellectual disabilities are frequently connected to social service programs that can be tracked, these administrative data are not population-based and may present a service population profile that is not characteristic of the population as a whole.

Nearly 4 million Americans currently are estimated to have intellectual disabilities. They face significant challenges to maintaining health and wellness at different points in their lives. As a group, adults with an intellectual disability experience poorer health outcomes than people without an intellectual disability and have mental health problems and potential overuse of psychotropic medications. The Surgeon General’s National Blueprint to Improve the Health of Persons with Mental Retardation (http://www.nichd.nih.gov/publications/pubs/closingthegap/) draws attention to these longstanding health disparities and lack of good surveillance in an attempt to narrow the gap between this population’s health needs and their use of health services.

Purpose Given that the existence of health disparities suggest a differential receipt of services among people with intellectual disabilities compared to the rest of the population, identify and address unmet need (e.g., inadequate cancer screening, poor management of epilepsy, higher risk for other chronic conditions, poor vision, and mental health problems with potential misuse of psychotropic medications) associated with service use in health related areas for people with intellectual disabilities by:

· Researching valid and reliable data sources and analytic techniques to understand risk factors associated with health disparities between people with and without intellectual disabilities (Component A);

· Evaluating promising practices that have the potential to reduce these disparities in key health indicators for people with intellectual disabilities (Component B).

This program addresses the “Healthy People 2020” focus area(s) of

DH-2

Increase the number of Tribes, States, and the District of Columbia that have public health surveillance and health promotion programs for people with disabilities and caregivers.

DH-5

Increase the proportion of youth with special health care needs whose health care provider has discussed transition planning from pediatric to adult health care.

DH-9

(Developmental) Reduce the proportion of people with disabilities who encounter barriers to participating in home, school, work, or community activities.

HYPERLINK "http://www.healthypeople.gov/2020/topicsobjectives2020/objectiveslist.aspx?topicId=9"(Developmental) Reduce the proportion of people with disabilities who encounter barriers to participating in home, school, work, or community activities.

DH-14

Increase the proportion of children and youth with disabilities who spend at least 80 percent of their time in regular education programs.

DH-15

Reduce unemployment among people with disabilities

This project supports the strategic goal of both the National Center on Birth Defects and Developmental Disability (NCBDDD) and Division of Human Development and Disability (DHDD) of reducing disparities in health indicators, including obesity in children, youth and adults with disabilities. In addition, it supports the additional DHDD priority of identifying and reducing disparities in health care for persons with disabilities.

Scientific Knowledge to be Achieved through this Funding Opportunity Through this announcement, the CDC intends to fund applications that have the potential to yield high impact research results by reducing overall burden and, thereby, improving population on a large scale.

Component A of this FOA involves research that provides improved understanding of factors associated with disparities and unmet need within the intellectual disabilities population. These may include programs, policies and practices that contribute to improved health and well-being such as behavioral interventions, federal, state or community program participation, health delivery system enhancements or redesign, policies that promote social capital and integration, the role of training, and public health campaigns that may target or include intellectual disabilities populations.

Component B of this FOA involves research to determine best practices that already may exist that appear effective in reducing disparities for this population. In building upon Component A, this research is intended to play a translational role in contributing to the adaptation of wider public health strategies that improve the health and well-being of people with intellectual disabilities by improving our understanding of risk factors contributing to unmet need (Component A) and developing a knowledge repository of programs, policies and practices that show evidence or promise of addressing these needs (Component B).

This FOA has two Components, A and B: Applicants must specify which Component they are applying. Component A solicits applications to conduct data research using valid sources of data, analytical techniques, and data elements in order to understand the associated risk factors between people with and without intellectual disabilities. Component B solicits applications to evaluate promising practices, through systematic review, that have the potential to reduce disparities in key health indicators for people with intellectual disabilities.

Indicate which component you are applying for in number 11 of the SF424 (R&R) Application Guide “Descriptive Title of Applicant’s Project” Example: Component A: Title of Project or Component B: Title of Project. Applicants may apply for Component A, Component B, or both; however, applicants should submit separate applications for each component.

Research Objectives and Approach:

Component A: Research Objective: While disparities in health indicators are known to exist for people with intellectual disparities, factors that may either be associated with or contribute to these disparities, many of which are presumed to relate to differential receipt of health or other services for portions of the intellectual disability population that lead to unmet need, are largely unknown. The objective of Part A, therefore, is to examine and address risk and protective factors associated with health disparities for selected key health indicators and areas of unmet need among people with intellectual disabilities. These indicators shall include those identified in the 3/2011 IOM Report, Leading Health Indicators for Healthy People 2020 - Letter Report (http://www.iom.edu/Reports/2011/Leading-Health-Indicators-for-Healthy-People-2020.aspx): access to care and quality of health care services, healthy behaviors, injury, physical and social environments, chronic disease, mental health, responsible sexual behavior, substance abuse, tobacco use, and healthy births. A person is considered to have unmet need if he or she did not get or delayed medical care due to cost in the past year.

1: Identify valid and reliable data sources

The approach for identifying and selecting data sources that are valid and reliable should be thoroughly described. Both qualitative and quantitative data should be included. However, qualitative data must be from representative subsets of the intellectual disabilities population that allow for meaningful extrapolation of subsequent findings. Quantitative data should be identified from population-based national surveys or administrative data that offer robust sample sizes and reliable coding, so that data can be reliably analyzed longitudinally (i.e., over multiple years).

2: Identify data elements from data sources that will be used as independent (predictive) and dependent (outcome) variables

Outcomes (dependent) variables should be identified from among at least five leading health indicators and/or areas of unmet need (as defined in the research objective). Predictive (independent) variables should include factors from domains such as demographics, environment, service use (health and other), and others as available from the selected data.

3: Analyze data

Using valid and reliable statistical techniques specific to either qualitative or quantitative analysis, identify risk factors associated with health disparities among health determinants and unmet need for people with intellectual disabilities through comparisons that include samples with and without people with intellectual disabilities.

4: Summarize findings and disseminate new knowledge that informs policy Prepare a detailed dissemination plan that ensures information is provided to key public health practitioners and academic researchers. Include a description of how data will be stored, potential for future analysis and plans for data sharing. The plan should also include a variety of approaches for sharing research findings, including at a minimum an electronic chart book summarizing key findings and at least two peer-reviewed journal articles.

Component B: Research Objective: Conduct a systematic review process to evaluate critical success factors (e.g., independent living, increased screening rates, etc..) associated with programs, policies or procedures that appear influential in reducing health disparities for people with intellectual disabilities.

The goal of the systematic review is to develop a knowledge repository of programs, policies and practices that show evidence or promise of addressing the unmet needs of people with intellectual disabilities.

The proposed research project should address:

(1) one or more priority research gaps that exist in the evidence base for community interventions in programs, policies and practices related to improving the health and well-being of people with intellectual disabilities. This work should be informed by resources such as the Guide to Community Preventive Services (The Community Guide – www.thecommunityguide.org) or other relevant systematic reviews. In addition, the work should be able to contribute to building the evidence base for public health prevention strategies that increase public health impact by informing public health practice on ways to promote health and prevent disease that are evidence-based, implementable and scalable. Research results are expected to help inform activities of public health programs supporting prevention strategies.

(2) The analytic framework, which is the conceptual approach for evaluating the interventions, should include:

i. How all relevant studies will be identified.

ii. How the systematic review will be conducted to reduce bias in the conclusions and assure power and precision of the results; include the criteria for inclusion and exclusion of studies.

iii. How the evidence will be summarized to address the public health problem.

(3) A detailed dissemination plan to ensure that information is provided to key public health practitioners and academic researchers. Provide a detailed plan and timeline for the study over a three year project period. Identify potential partners for dissemination and translation of the systematic review results. Describe relationship and shared project activities, such as with state or local health departments and other community groups involved in promoting the health of people with intellectual disabilities.

A systematic review usually involves the following sequence of steps:

a) carefully defining the literature topic for review, based on existing knowledge of intellectual disability and health, specific public health applications of this knowledge, and potential service use scenarios;

b) developing an analytic framework and framing the specific questions for which evidence is collected and reviewed, including questions related to the analytic validity, clinical validity, and clinical utility of the service, contextual factors, ethical, legal and social issues, and both benefits and harms;

c) gathering technical experts and content reviewers; outlining the process that will be used for the systematic review of project materials and approaches to determine critical success factors for programs, policies, and procedures that may reduce health disparities for people with intellectual disabilities;

d) identifying data sources and searching for evidence using explicitly stated strategies and study inclusion/exclusion criteria;

e) specifying criteria for assessing quality of studies and conducting the assessment;

f) abstracting data into evidence tables;

g) synthesizing findings;

h) conducting clinical decision modeling studies as needed to address issues for which data are not conclusive;

i) conducting economic analyses as needed for evaluation of contextual issues;

j) evaluating the overall quality of evidence related to the analytic framework or “chain of evidence”;

k) assessing the overall balance of benefits and harms from using the test based on available evidence and information from modeling studies; and

l) identifying gaps in knowledge and identifying research questions for which research is most needed.

References:

Bowley, C., and Kerr, M. Epilepsy and intellectual disability. Journal of Intellectual Disability Research, 2000, 44(5): 529-543.

Emerson, E., and Hatton, C. Self-reported well-being of women and men with intellectual disabilities in England. American Association on Intellectual and Developmental Disabilities, 2008, 113(2): 143-155.

Horowitz S., Kerker B., Owens P. and Zigler E. 2000. The health status and needs of individuals with mental retardation. New Haven: Yale University.

Institute of Medicine. The Future of Disability in America. Washington, DC: National Academies Press, 2007.

Janicki, M.P., Davidson, P.W., Henderson, C.M., et al. Health characteristics and health services utilization in older adults with intellectual disability living in community residences. Journal of Intellectual Disabilities Research, 2002, 46: 287-298.

Krahn, G.L., Hammond, L., and Turner, A. A cascade of disparities: Health and health care access for people with intellectual disabilities. Mental Retardation and Developmental Disabilities Research Reviews, 2006, 12: 22-27.

Lewis, M.A., Lewis, C.E., Leake, B., et al. The quality of health care for adults with developmental disabilities. Public Health Reports, 2002, 117: 174-184.

Ouellette-Kuntz, H. Commentary: Comprehensive health assessments for adults with intellectual disabilities. International Journal of Epidemiology, 2007, 36: 147-148.

Rimmer, J. and Yamaki. Obesity and intellectual disability, Mental Retardation and Developmental Disabilities Research Reviews, 2006, 12: 70-82.

USDHHS. Closing the gap: A national blue-print for improving the health of individuals with mental retardation. Report of the Surgeon General’s Conference on Health Disparities and Mental Retardation. 2002. Washington, D.C.: U.S. Department of Health and Human Services, Office of the Surgeon General.

USDHHS. The Surgeon General’s call to action to improve the health and wellness of persons with disabilities. 2005. Washington, D.C.: U.S. Department of Health and Human Services, Office of the Surgeon General.

Walsh, P.N. Health indicators and intellectual disability. Current opinion in Psychiatry, 2008: 21: 474-478.

Walsh, P.N., Kerr, M., Van Schrojenstein Lantman-deValk, H.M.J. Health indicators for people with intellectual disabilities: A European perspective. European Journal of Public Health, 2003: 13(3 Supplement): 47-50.

Woodhouse, J.M., Adler, P., and Duignan, A. Vision in athletes with intellectual disabilities: The need for improved eye care. Journal of Intellectual Disabilities Research, November 2004, 48: 736-745.

Section II. Award Information

Application Types Allowed

New

Funds Available and Anticipated Number of Awards

Component A It is anticipated that one award will be made to a single recipient for this component. It is anticipated that the award will be $250,000 for each of Budget Years 1, 2 and 3.

These estimates include direct and indirect costs.

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

Component B (Systematic Review)

It is anticipated that one award will be made to a single recipient for this component. It is anticipated that the award will be $200,000 for each of Budget Years 1, 2 and 3.

These estimates include direct and indirect costs.

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

Applications with budget requests greater than the ceiling will be considered non-responsive and will not be reviewed.

The ceiling of the award for Component B will be $200,000 (including direct and indirect costs) for the first year.

Applications with budget requests greater than the ceiling will be considered non-responsive and will not be reviewed.

The project period for Component B will be 3 years.

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

HHS/CDC grants policies as described in the HHS Grants Policy Statement (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html) will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions:

· Public/State Controlled Institutions of Higher Education

· Private Institutions of Higher Education

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)

For- Profit Organizations

· Small Businesses

· For-Profit Organizations (Other than Small Businesses)

Governments

· State Governments

· County Governments

· City or Township Governments

· Special District Governments

· Indian/Native American Tribal Governments (Federally Recognized)

· Indian/Native American Tribal Governments (Other than Federally Recognized)

· Eligible Agencies of the Federal Government

· U.S. Territory or Possession

Other

· Independent School Districts

· Public Housing Authorities/Indian Housing Authorities

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

· Faith-based or Community-based Organizations

· Regional Organizations

· Non-domestic (non-U.S.) Entities (Foreign 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.

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Foreign (non-U.S.) components of U.S. Organizations are not allowed.

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.

· Central Contractor Registration (CCR) – must maintain current registration in CCR to be renewed annually.

· Grants.gov

· eRA Commons

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.

Central Contractor Registration and Universal Identifier Requirements

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 Central Contractor Registry (CCR) and 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. CCR 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 CCR internet site at www.ccr.gov (https://www.bpn.gov/ccr/default.aspx).

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.

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.

2. Cost Sharing

This FOA does not require cost sharing as defined in the HHS Grants Policy Statement (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html). Based on authorization language, this section should only be included in the FOA, if applicable.

3. Other

Additional Information on Eligibility

As defined in the HHS Grants Policy Statement (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html), 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.

If your application is incomplete or non-responsive to the requirements listed in this section, it will not enter into the review process.

Number of Applications

Applicants may apply for Component A, Component B, or both; however, applicants should submit separate applications for each component. Applicants may submit only one application per component.

Indicate which component you are applying for in #11 of the 424 "Descriptive Title of Applicant's Project" followed by the title of your project Example: Component A: Title of project or Component B: Title of Project 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. HHS/CDC will not accept any application that is essentially the same as one already reviewed.

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 Email: pgotim@cdc.gov for further instruction Hours: Monday - Friday, 7am – 4:30pm U.S. Eastern Standard Time. CDC Telecommunications for the hearing impaired or disable is available at: TTY 1-888-232-6348.

If the applicant encounters technical difficulties with Grants.gov, the applicant should contact Grants.gov Customer Service. The Grants.gov Contact Center is available 24 hours a day, 7 days a week, with the exception of all Federal Holidays. The Contact Center provides customer service to the applicant community. The extended hours will provide applicants support around the clock, ensuring the best possible customer service is received any time it is needed. You can reach the Grants.gov Support Center at 1-800-518-4726 or by email at support@grants.gov. Submissions sent by email, fax, CD’s or thumb drives of applications will not be accepted.

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/guide/url_redirect.htm?id=12000), 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 Letter of Intent 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 in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information for Component A or B:

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, and specification of the component (A, B or both components)

The letter of intent should be sent to:

Natalie J. Darling, MPH National Center for Chronic Disease and Health Promotion

Extramural Research Program Office

Centers for Disease Control and Prevention

4770 Buford Highway, NE M/S F-46 Atlanta, GA 30341 Telephone: (770) 488-5740 Email: ndarling@cdc.gov 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.

Research Plan Components/Attachments

The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that consist of 16 components. Not all 16 components of the Research Plan apply to all Funding Opportunity Announcements (FOAs). See Part I, Section 5.5 of the SF 424 (R&R) Application Guide (http://grants.nih.gov/grants/guide/url_redirect.htm?id=12000) for additional information. Please attach applicable sections of the following Research Plan components:

1. Introduction to Application

2. Specific Aims

3. Research Strategy

4. Inclusion Enrollment Report

5. Progress Report Publication List

Human Subjects Section

6. Protection of Human Subjects

7. Inclusion of Women and Minorities

8. Targeted/Planned Enrollment Table

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

The Research Plan narrative is comprised of components 2, 3, and 4 above. Component 4 (Inclusion Enrollment Report) applies only to renewal and revision applications for clinical research. Note that the Research Strategy is divided into three parts: 1) Significance, 2) Innovation, and 3) Approach.

All instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Adobe_VerB.pdf) must be followed, with the following additional instructions: Add text in the space below (before Appendix) to supply any additional instructions related to the Research Plan, but only include information that is different from application guide.

Research Plan

The research plan should include:

Component A

1. Describe the approach for identifying and assessing data sources including quantitative and qualitative information. Describe how data sources and data elements will be selected. Include a rationale for selection of the leading health indicators or areas of unmet need for the research study.

2. Describe the roles of key partners, their qualifications, and evidence of their commitment and cooperation with this research (e.g., recent letters of support, memoranda of understanding, and documentation of prior collaborations)

3. Describe any data access requirements for each identified data source (e.g., data use agreements (DUAs) or other data sharing mechanisms employed)

4. Evidence of existing partnerships or previous work with population based data inclusive of people with intellectual disabilities

5. Evidence of sufficient institutional support (e.g., space, equipment, etc.) and a staffing plan and other resources that will enable the achievement of this objective within the project period.

6. Describe the overall analytic plan

a. Specific, measurable, time-framed sub-objectives for the three year funding period.

b. Analytic timeline.

c. Benchmarks of adequate and timely progress.

d. Key staff who will be devoted to this activity. For each key personnel, describe their demonstrated knowledge, experience, and ability in population level surveillance, data management, analytic techniques and subject matter expertise related to the health and well-being of people with intellectual disabilities. Include the percentage of time each person will devote to project activities.

e. Describe outcome variables from the list of leading health indicators and unmet needs and independent variables proposed in the analysis. Describe analytic approaches that will be employed. Include descriptive and multivariate methods.

7. Provide a description of relationship(s) with the greater intellectual disability community and also local and state health department agencies and other partners that may be relevant to the research. Describe the roles of relevant partners in dissemination and translation of study findings.

8. Describe proposed dissemination strategies for project results. These may include outreach of information to targeted audiences, such as research scientists, behavioral or educational professional organizations, or state and federal policy makers; web postings or other web based activities such as webinars and other educational activities; publication in both peer review and grey area literature.

Component B:

1. Describe the literature topics for review, based on existing knowledge of intellectual disability and health, specific public health applications of this knowledge, and potential service use scenarios;

2. Describe an analytic framework and frame the specific questions for which evidence is collected and reviewed, including questions related to the analytic validity, clinical validity, and clinical utility of the service, contextual factors, ethical, legal and social issues, and both benefits and harms;

3. Describe the approach for identifying and recruiting technical experts and content reviewers. Outline the process that will be used for systematic review of project materials and approaches for assessment and determination of critical success factors for programs, policies and procedures that appear influential in reducing health disparities for people with intellectual disabilities.

4. Describe proposed approach to identify data sources to be used in the literature review. Include a description of strategies to be employed and specific inclusion/exclusion criteria that will be used.

5. Specify criteria for assessing quality of studies and conducting the assessment. Identify process by which selection criteria are selected and how metrics are constructed that evaluate and assess quality of studies;

6. Develop a plan to abstract data into coded or categorically-based evidence tables and synthesize findings in ways that aggregate key findings from these summary tables into critical success factors for programs, policies and procedures. In addition to determining overall effectiveness, these summary tables should identify gradients of effectiveness where possible ranging from relative certainty of ineffectiveness to relative certainty of effectiveness;

7. Describe approaches to address equivocal findings (neither evidence of ineffectiveness or effectiveness), including use of clinical decision modeling that incorporates assumptions to project effectiveness for particular programs, practices or policies described in studies. Also describe clinical decision modeling approaches for data that may include economic variables where these factors may be important in determining overall effectiveness for particular programs, policies or procedures.

8. Develop a plan that summarizes and describes findings in ways that evaluate the overall quality of evidence related to the analytic framework or “chain of evidence.” This should include identifying apparent critical success factors associated with effectiveness.

9. Broadly assess strengths and weakness of the systematic review process through an assessment of the overall balance of benefits and harms from using criteria developed based on available evidence and information from modeling studies. Identify gaps in knowledge and future research questions for which research is most needed.

10. Describe the staffing plan. Describe each member’s training, expertise and role in carrying out the systematic review. Describe how the team members will complement each other’s skills and work together.

11. Identify tasks and a timeline for key review activities for the 3 year project period.

Appendix

Do not use the appendix to circumvent page limits. A maximum of 10 PDF documents are allowed in the appendix. Additionally, up to 3 publications may be included that are not publically available. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Page Limitations

All page limitations described in this individual FOA must be followed. For this FOA, the

Research Strategy component of the Research Plan narrative is limited to 25 pages.

Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files with a maximum of 35 pages for all appendices.

Format for Attachments

Designed to maximize system-conducted validations, multiple separate attachments are required for a complete application. When the application is received by the agency, all submitted forms and all separate attachments are combined into a single document that is used by peer reviewers and agency staff.

CDC require all text attachments to the Adobe application forms be submitted as PDFs and that all text attachments conform to the agency-specific formatting requirements noted in the SF424 (R&R) Application Guide (Part I, Section 2) (http://grants.nih.gov/grants/guide/url_redirect.htm?id=12000).

Failure to follow these requirements may lead to rejection of the application during agency validation or delay in the review process.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov (http://www.grants.gov/), the online portal to find and apply for grants across all Federal agencies. The eRA Commons systems retrieve the application from Grants.gov and check the application against CDC business rules. If no errors are found, the application will be assembled in the eRA Commons for viewing by the applicant before moving on for further CDC processing.

If errors are found, the applicant will be notified in the eRA Commons. They must make required changes to the local copy of their application and submit again through Grants.gov. Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Once you can see your application in the Commons, be sure to review it carefully as this is what the reviewer will see. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11123).

Information on the submission process is provided in the SF424 (R&R) Application Guide.

Note: HHS/CDC grant submission procedures do not provide a period of time beyond the grant 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).

The application package is not complete until it has passed the Grants.gov/eRA Commons validation process. This process and email notifications of receipt, validation or rejection may take two (2) business days.

Applicants are strongly encouraged to allocate additional time prior to the submission deadline to submit their applications and to correct errors identified in the validation process. Applicants are encouraged also to check the status of their application submission to determine if the application packages are complete and error-free. Applicants who encounter system errors when submitting their applications must attempt to resolve them by contacting the Grants.gov Contact Center (1-800-518-4726; support@grants.gov). If the system errors cannot be resolved, applicants must contact CDC PGO TIMS for guidance at least 3 calendar days before the deadline date.

4. Intergovernmental Review (E.O. 12372) This initiative is not subject to intergovernmental review (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11142).

5. Funding Restrictions

All HHS/CDC awards are subject to the terms and conditions, cost principles, and other requirements described in the HHS Grants Policy Statement.

Funds for research involving human subjects will be restricted until a Federal wide Assurance and Institutional Review Board Approval are in place.

6. Other Submission Requirements and Information

Application Submission

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11144).

Important reminders:

All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to CDC.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

Applicants are reminded to enter the approved Federal Wide Assurance (FWA) that the applicant has on file with the Office for Human Research Protections, if available. If the applicant has a FWA number, enter the 8-digit number. Do not enter the FWA before the number. If a Project/Performance Site is engaged in research involving human subjects, the applicant organization is responsible for ensuring that the Project/Performance Site operates under and appropriate Federal Wide Assurance for the protection of human subjects and complies with 45 CFR Part 46 and other CDC human subject related policies described in Part II of this Application Guide and in the HHS Grants Policy Statement.

See more resources to avoid common errors and submitting, tracking, and viewing applications: http://grants.nih.gov/grants/ElectronicReceipt/avoiding_errors.htm or http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm Upon receipt, applications will be evaluated for completeness by the CDC Procurement and Grants Office (PGO) and responsiveness by PGO and the Center, Institute or Office of the CDC. Applications that are incomplete and/or nonresponsive will not be reviewed.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the CDC mission (http://www.cdc.gov/about/organization/mission.htm), all applications submitted to the CDC in support of public health research are evaluated for scientific and technical merit through the CDC peer review system.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be…