dp15009amendpublication.pdf

Centers for Disease Control and Prevention

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

Improving Surveillance and Prevention of Epilepsy Burden in US Communities

RFA-DP-15-009

Application Due Date: 02/26/2015

Improving Surveillance and Prevention of Epilepsy Burden in US Communities

RFA-DP-15-009

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 Improving Surveillance and Prevention of Epilepsy Burden in US Communities Activity Code AMENDMENT I. QUESTIONS FROM POTENTIAL APPLICANTS AND CDC RESPONSES added to Section VIII. Other Information, February 11, 2015

Activity Code: U01

Funding Opportunity Announcement Type New Funding Opportunity Announcement Number

RFA-DP-15-009

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

Health FOA Purpose The purpose of this FOA is to use standardized definitions and methods to assess epilepsy burden to expand the knowledge of: 1) the prevalence and/or incidence of epilepsy among various U.S. populations or subpopulations, and 2) risk factors or other determinants that affect epilepsy incidence, prevalence or other epilepsy outcomes to guide interventions or services aimed at prevention, treatment, or rehabilitation that, if implemented, would minimize health disparities in people with epilepsy.

Key Dates Publication Date: To receive notification of any changes to RFA-DP-15-009, 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: 01/26/2015

Application Due Date: 02/26/2015

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).

Scientific Merit Review: 04/20/2015 http://www.grants.gov

Secondary Review: 06/05/2015

Estimated Start Date: 09/30/2015

Expiration Date: 02/27/2015 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. The purpose of this FOA is to use standardized definitions and methods to assess epilepsy burden to expand the knowledge of: 1) the prevalence and/or incidence of epilepsy among various U.S. populations or subpopulations, and 2) risk factors or other determinants that affect epilepsy incidence, prevalence or other epilepsy outcomes to guide interventions or services aimed at prevention, treatment, or rehabilitation that, if implemented, would minimize health disparities in people with epilepsy.

Mechanism of Support. This funding opportunity announcement (FOA) solicits applications to conduct epilepsy research and surveillance through a cooperative agreement.

Funds Available and Anticipated Number of Awards. NCCDPHP intends to commit an approximate total of $600,000 to fund first-year activities for up to two projects under this FOA. Awards under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

Budget and Project Period. The anticipated start-date for new awards is September 30, 2015.

The project period will run from 09/30/2015 to 09/29/2018. First-year funding is estimated in the range of $200,000-$300,000, including direct and indirect costs. The average award is anticipated to be $250,000. An applicant may request a project period of up to 3 years.

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

Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.

Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. NOTE: CDC does not make awards to individuals directly. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply.

Number of PDs/PIs. Applications may 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 http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf

Application Type. New 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.

This FOA will be posted at http://www.cdc.gov/chronicdisease/about/foa.htm .

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority

This program is authorized under the sections 301(a) and 317(k)(2) of the Public Health Service Act, 42 U.S.C. 241(a) and 247b(k)(2), as amended.

1. Background and Purpose

Epilepsy is a chronic neurological condition characterized by recurrent seizures. Epilepsy affects about 2 million Americans. About 10% of people will experience a seizure sometime during their lifetime and about 3% will have had a diagnosis of epilepsy by age 80. In 2010, nearly 140,000 new cases of epilepsy were diagnosed in the United States. Epilepsy results in an estimated annual cost of $15.5 billion in medical costs and lost or reduced earnings and production. The CDC Epilepsy Program began in 1994 at Congressional direction. The CDC epilepsy program has activities in the areas of promoting patient self-management, conducting epidemiologic and prevention research, increasing public awareness and knowledge, and strengthening partnerships (http://www.cdc.gov/epilepsy/index.htm ). Since 1994 the Epilepsy Program has supported a number of epidemiologic research studies defining the prevalence and incidence of the disorder, its risk factors, and determinants of outcome. Research supported by CDC has provided evidence of the substantial variability in the prevalence of epilepsy among different populations within the United States, with estimates ranging from 5.0 to 11.5 cases of active epilepsy per thousand population (http://www.cdc.gov /epilepsy/publications.htm). CDC-supported research on quality-of-care, quality of life, and health outcomes research in U.S. populations have identified substantial disparities among people with epilepsy—limitations in their health care access and quality of care among those with low incomes, impairments in their quality of life, high rates of comorbidity, and a higher prevalence of poverty.

Epidemiologic studies that describe the occurrence of epilepsy in general populations are important for policy makers and health care providers to identify risk factors and populations at higher risk, plan and provide prevention programs, and ensure appropriate care and services for those affected.

Seminal reports from consensus conferences on epilepsy and the recent (2012) Institute of Medicine Report on epilepsy, Epilepsy across the Spectrum, (http://iom.edu/Reports/2012/Epilepsy-Across-the -Spectrum.aspx) recognize the gap in epidemiologic studies of epilepsy incidence, prevalence and associated burden. Because epilepsy is a spectrum of disorders, gaps occur with respect to epilepsy incidence and prevalence in population subgroups, causes, risk factors and comorbidities, health status and quality of life, health disparities, quality of care, and access to utilization of health care and community services and costs (IOM 2012). Except for the National Health Interview Survey and the National Survey on Children’s Health, questions on epilepsy are not routinely asked on public health surveillance systems, limiting what is known about epilepsy burden based on representative samples of community-dwelling people with epilepsy. Data sources used in previous http://www.cdc.gov/chronicdisease/about/foa.htm http://www.cdc.gov/epilepsy/index.htm http://www.cdc.gov/epilepsy/publications.htm http://www.cdc.gov/epilepsy/publications.htm http://iom.edu/Reports/2012/Epilepsy-Across-the-Spectrum.aspx http://iom.edu/Reports/2012/Epilepsy-Across-the-Spectrum.aspx studies often provide inadequate estimates of epilepsy burden because of small sample sizes, limiting study of disparities in population subgroups (e.g., age, sex, racial/ethnic groups). The lack of use of standardized methods and epilepsy case definitions in some prior studies, further, limits how comparable and actionable epilepsy data are. Thus, available data are insufficient to guide health care provision and services for community-dwelling people with epilepsy.

The purpose of this FOA is to use standardized definitions and methods to assess epilepsy burden to expand the knowledge of: 1) the prevalence and/or incidence of epilepsy among various U.S. populations or subpopulations, and 2) risk factors or other determinants that affect epilepsy incidence, prevalence or other epilepsy outcomes to guide interventions or services aimed at prevention, treatment, or rehabilitation that, if implemented, would minimize health disparities in people with epilepsy.

Healthy People 2020 and other National Strategic Priorities

This RFA addresses “Healthy People 2020“ Disability and Health Objective 6 (DH-6) to “Increase the proportion of people with epilepsy and uncontrolled seizures who receive appropriate medical care,” and is in alignment with CDC’s strategic priorities for “Excellence in surveillance, epidemiology, and laboratory science and services” and “Prevent illness, injury, disability, and premature death.”

Public Health Impact

By identifying risk factors or other determinants that affect epilepsy incidence, prevalence or other epilepsy outcomes, study findings can guide interventions or services aimed at prevention, treatment, or rehabilitation that, if implemented, would minimize health disparities in people with epilepsy.

Relevant Work

Refer to Background and Purpose section.

2. Approach

The goal is to expand the knowledge base on epilepsy incidence and prevalence in subpopulations (e.g., a study population representing a base population such as a district, city, county, state, or other geopolitical unit within the United States or its territories), and to identify preventable risk factors that can guide interventions for epilepsy to reduce epilepsy burden. The awardee may elect to study epilepsy occurrence and associated risk factors in all age groups or in restricted age groups (e.g., children only) especially if higher incidence has been previously demonstrated in the restricted stratum.

Objectives/Outcomes

1) Design and implement a study that would examine the association between epilepsy (prevalence and incidence) and any one or more of the following types of risk factors, determinants, or outcomes:

(a) Clinical risk factors and comorbidities;

(b) Demographic risk categories including socioeconomic strata, race, or ethnicity;

(c) Preventable risk factors in persons with epilepsy (e.g., before epilepsy onset in children: maternal reproductive and pregnancy history, maternal risky behaviors during and after pregnancy, birth weight, feeding difficulties, paternal risky behaviors, parental occupations, and dietary history; before epilepsy onset in adults: risky behaviors, occupational history, dietary history, and medical history);

(d) Epilepsy history associated with study outcomes (e.g., age at first seizure; age diagnosed);

(e) Access to and quality of care (primary or specialty care); or

(f) Determinants of outcomes such as disability, mortality, quality of life, and other consequences of concern to public health.

2) Align study design with proposed information to be collected and based on gaps identified by previous research. Identify short- and long-term outcomes to assess project benchmarks and success.

3) Develop plans for analysis and dissemination. The dissemination plan should include approaches to develop one or more manuscripts describing study outcomes and should also address recommendations to promote, enhance, or advance translation of the research to policy or practice.

Target Population

The target population should include people with epilepsy within a defined geographic area (e.g., a study population representing a base population such as a district, city, county, state, or other geopolitical unit within the United States or its territories). The awardee may elect to study epilepsy occurrence and associated risk factors in all age groups or in restricted age groups (e.g., children only) especially if higher incidence has been previously demonstrated in the restricted stratum.

Collaboration/Partnerships

To achieve these objectives, it is expected that the awardee will collaborate with state health departments (e.g., state offices of epidemiology and state vital records registrars); academic researchers in neurology/epileptology, epidemiology; behavioral scientists, neuroscience nurses and others as needed. In addition, in developing methods and protocols, the awardee is expected to consult, as needed, with national experts, which may include CDC scientists, in these research disciplines.

Evaluation/Performance Measurement

The applicant will be expected to develop a project timeline with project milestones and short- and long-term outputs, and outcomes to ensure proposed project objectives are met.

Translation Plan

The dissemination plan should include approaches to develop one or more manuscripts describing study outcomes and should also address recommendations to promote, enhance, or advance translation of the research to policy or practice.

Section II. Award Information

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

Application Types Allowed:

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

Estimated Total Funding: $1,800,000

Anticipated Number of Awards: 2

Up to two awards are anticipated over the entire project period. First-year funding is estimated in the range of $200,000-$300,000, including direct and indirect costs. The average award is anticipated to be $250,000. An applicant may request a project period of up to 3 years.

If an applicant requests a funding amount greater than the ceiling of the award range for the first year ($300,000), 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.

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

Award Ceiling: $300,000 Per Budget Period Award Floor: $0 Per Budget Period Total Project Period Length: 3 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 higher education Private institutions of higher education For profit organizations other than small businesses Small businesses Others (see text field entitled "Additional Information on Eligibility" for clarification)

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

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

To ensure that awardees can promptly design and conduct population-based surveillance in a population of adequate size to achieve the public health intent of this funding opportunity, eligible applicants for an award must meet the following criteria:

Established researchers with a principal investigator (PI) who has documented expertise in either neurologic or epidemiologic research;

A research team with documented expertise in both neurology and epidemiology;

Evidence (in the form of letters of support or other documentation) ensuring access to a study population of sufficient size to provide reasonable precision in statistical estimates of critical outcome measures.

4. Justification for Less than Maximum Competition

Not applicable.

5. Responsiveness

The PI’s expertise in either neurologic or epidemiologic research and proposed team members’ experience in neurology and epidemiology should be reflected in the Research and Related Senior/Key Person Section of the SF424 (R&R).

Evidence in the form of letters of support or other documentation confirming access to the proposed study population. Include a description of the study population (e.g., estimated size, socio-demographic characteristics).

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 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 grantee organization.

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

9. Cost Sharing This FOA does not require cost sharing as defined in the HHS Grants Policy Statement (http:// 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.

3. Letter of Intent 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

Due Date for Letter of Intent: 01/26/2015

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 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 and Health Promotion (NCCDPHP) Extramural Research Program Operations and Services (ERPOS) 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) mailto:zgx7@cdc.gov

5. Progress Report Publication List (for Continuation ONLY)

Human Subjects Section

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 three

(3) year project period and should include at least the following items:

The qualifications and relevant experience of the research team, including epidemiologists and neurologists. Other relevant institutional resources, including evidence that the applicant has the staffing and facilities to conduct the proposed study.

Characteristics and size of base population, the estimated number of people with epilepsy to be enrolled from that population, and any selection criteria (e.g., age).

Operational case definition(s) of epilepsy.

Methods of case ascertainment, sources of data, and, where appropriate, any measures or methods to ensure complete or representative case enrollment.

Scientific questions to be studied.

Data variables to be collected pertaining to areas of specific interest in epilepsy (e.g., intrinsic clinical risk factors, etiologies, genetics, and/or co-morbidities; demographic risk categories including age, socioeconomic strata, race or ethnicity, access to and quality of care); or determinants or early predictors of longer term outcomes of epilepsy including outcomes such as disability, mortality, quality of life, and other consequences of concern to public health.

Other methods essential to the success of the proposal.

Methods of data analysis. Also include sample size calculations to estimate precision of key measures of interest.

Letters of support from collaborating partners specifying the commitment of the parties involved, including descriptions of access to data and populations. These letters should be included in the appendices.

appendices.

Procedures for data management and quality control, including methods for assuring privacy and maintaining confidentiality.

A dissemination plan for abstracts, presentations, or publications describing research findings, and as needed, guidelines for collaborating scientists interested in proposing abstracts, presentations or manuscripts based on study findings.

6. 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.

7. Page Limitations All page limitations described in this individual FOA must be followed. For this specific 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.

8. 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. Applicants should ensure that all attachments are uploaded to the system.

CDC requires 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/funding/424/ SF424_RR_Guide_General_VerC.pdf).

9. Submission Dates & 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).

http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf http://grants.nih.gov/grants/guide/url_redirect.htm?id=11128 http://www.grants.gov/ 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 at 770-488-2700; www.pgotim@cdc.gov for guidance at least 3 calendar days before the deadline date.

After submission of your application package, applicants will receive a “submission receipt” email generated by Grants.gov. Grants.gov will then generate a second e-mail message to applicants which will either validate or reject their submitted application package. This validation process may take as long as two (2) business days. A third and final e-mail message is generated once the applicant’s application package has passed validation and the grantor has confirmed receipt of the application.

Unsuccessful Submissions:

If an application submission was unsuccessful, the applicant must:

1. Track his/her submission and verify the submission status (tracking should be done initially regardless of rejection or success).

a. If the status states “rejected,” do #2a or #2b.

2. Check his/her emails from both Grants.gov and eRA Commons for rejection notices.

a. If the deadline has passed, he/she should email the Grant Management Specialist listed in the FOA (pgotim@cdc.gov) explaining why the submission failed.

b. If there is time before the deadline, he/she should correct the problem(s) and resubmit as soon as possible.

Due Date for Applications: 02/26/2015

Electronically submitted applications must be submitted no later than 5:00 p.m., ET, on the listed application due date.

10. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review (http:// www. whitehouse.gov/ omb/ grants_spoc).

11. Funding Restrictions mailto:support@grants.gov mailto:www.pgotim@cdc.gov http://www.whitehouse.gov/omb/grants_spoc

11. 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. Pre-award costs may be allowable as an expanded authority, but only if authorized by CDC.

For more information on expanded authority and pre-award costs, go to: http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf.

Up to 25% of the budget may be restricted until all applicant IRB approvals, if warranted, are confirmed.

Applicants are advised that any activities involving standard information collection (i.e., surveys, questionnaires, data requests, etc.) from 10 or more non-federal individuals/entities are subject to Paperwork Reduction Act (PRA) requirements and may require the CDC to coordinate an OMB/PRA approval request.

12. 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.6 "Required Registrations" 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 System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

If the applicant has an FWA number, enter the 8-digit number. Do not enter the letters “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 the SF 424 (R&R) 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/ Electronic Receipt /avoiding _errors.htm or http:// grants. nih.gov/grants/ Electronic Receipt/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 http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://grants.nih.gov/grants/guide/url_redirect.htm?id=11144 http://grants.nih.gov/grants/ElectronicReceipt/avoiding_errors.htm http://grants.nih.gov/grants/ElectronicReceipt/avoiding_errors.htm http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm

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 improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

If successful, do the research results have the potential to be scalable and reach a large portion of the population at risk?

Does the work align with an IOM recommendation on epilepsy surveillance and prevention?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project? Have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Do the investigators have a successful track record in epidemiologic studies on epilepsy or similar low prevalence disorders?

Is there evidence of past collaborations with the proposed research team?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

http://www.cdc.gov/about/organization/mission.htm

Is the proposed research innovative and yet offer reasonable potential for concrete applications of interest and value to CDC and other epilepsy stakeholders?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are there plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Does the application describe how the results from the research will be disseminated and ultimately used?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Does the project utilize critical partnerships or collaborations?

2. Additional Review Criteria As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects If the research involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46 , the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the HHS/CDC Requirements under AR-1 Human Subjects Requirements

(http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar1).

If your proposed research involves the use of human data and/or biological specimens, you must provide a justification for your claim…