RFA-DP-25-038_20241106.pdf

Centers for Disease Control and Prevention

NATIONAL CENTER FOR CHRONIC DISEASE PREVENTION AND HEALTH

PROMOTION

Epilepsy Incidence Among Children in the United States

RFA-DP-25-038

01/23/2025

Table of Contents 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

Overview

Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations Components of Participating Organizations:

National Center for Chronic Disease Prevention and Health Promotion Notice of Funding Opportunity (NOFO) Title Epilepsy Incidence Among Children in the United States Activity Code U01

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

RFA-DP-25-038

Assistance Listings Number(s) 93.068 Category of Funding Activity HL - Health NOFO Purpose The purpose of this NOFO is to:

1) Estimate overall epilepsy incidence among U.S. children 0 – 17 years of age.

2) Examine potential disparities in incidence rates of epilepsy stratified by demographic, geographic, social determinants of health, or other characteristics.

3) Identify factors that contribute to the risk of developing epilepsy and examine the association between risk factors and incidence.

Key Dates Publication Date:

To receive notification of any changes to RFA-DP-25-038, 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:

12/12/2024

Application Due Date:

01/23/2025

On-time submission requires that electronic applications be error-free and made available to CDC for processing from the NIH eRA system on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov no later than 11:59 PM U.S. Eastern Time.

Applicants will use a system or platform to submit their applications through Grants.gov and eRA Commons to CDC. ASSIST, an institutional system to system (S2S) solution, or Grants.gov Workspace are options. ASSIST is a commonly used platform because it provides a validation of all requirements prior to submission and prevents errors.

For more information on accessing or using ASSIST, you can refer to the ASSIST Online Help Site at: https://era.nih.gov/erahelp/assist. Additional support is available from the NIH eRA Service desk via http://grants.nih.gov/support/index.html.

• E-mail: commons@od.nih.gov

• Phone: 301-402-7469 or (toll-free) 1-866-504-9552

• Hours: Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding Federal holidays

Note: HHS/CDC grant submission procedures do not provide a grace period beyond the application due date time to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

Scientific Merit Review:

03/19/2025 Secondary Review:

04/30/2025 Estimated Start Date:

09/30/2025 Expiration Date:

01/24/2025 https://www.grants.gov/ http://grants.nih.gov/support/index.html mailto:commons@od.nih.gov

Required Application Instructions It is critical that applicants follow the instructions in the How to Apply - Application Guide except where instructed to do otherwise in this NOFO. Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Note:The Research Strategy component of the Research Plan is limited to 12 pages.

Page Limitations: Pages that exceed the page limits described in this NOFO will be removed and not forwarded for peer review, potentially affecting an application's score.

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

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348

Executive Summary Mechanism of Support. Cooperative agreement.

Funds Available and Anticipated Number of Awards. $1.6 million is available for this NOFO.

One award is anticipated. Awards issued under this NOFO are contingent upon availability of funds and a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of each award may also vary. The total amount awarded and the number of awards will depend upon the number, quality, duration, and cost of the applications received.

Budget and Period of Performance. The estimated total funding (direct and indirect) for the first budget period, September 30, 2025 to September 29, 2026, is $500,000. The estimated total funding (direct and indirect) for the entire Period of Performance, September 30, 2025 to September 29, 2029, is $1.6 million.

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

Eligible Project Directors/Principal Investigators (PD/PI). 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. CDC does not make awards to individuals directly. Individuals from organizations that are uniquely prepared to examine research relevant to undeserved groups, including sexual orientation and gender identity minorities as well as individuals with disabilities are always encouraged to apply.

Number of PDs/PIs. Applicants are expected to support the study design with an efficient leadership structure. If multiple PIs are proposed, applicants must provide a multiple leadership plan. https://grants.nih.gov/grants/multi_pi/

Number of Applications. Only one application per institution (normally identified by having a unique UEI number) is allowed. Effective April 4, 2022, applicants must have a Unique Entity Identifier (UEI) at the time of application submission. The UEI replaced the Data Universal Numbering System (DUNS) and is generated as part of SAM.gov registration. Current https://grants.nih.gov/grants/how-to-apply-application-guide.html

SAM.gov registrants have already been assigned their UEI and can view it in SAM.gov and Grants.gov. Additional information is available on the GSA website, SAM.gov, and Grants.gov- Finding the UEI.

Application Type. New.

Special Date(s).

Informational webinar

Date: 12-17-2024; Time: 2:00 pm (Eastern) Date and time are subject to change.

Join from a PC, Mac, iPad, iPhone or Android device.

Please click this URL to join.

https://cdc.zoomgov.com/w/1601265284?tk=GwnIQIXfvuNkZlownJ9mibRm6KIvBj2luyTBaA Eo_Gg.DQYAAAAAX3FehBZZZkNLOU96WlFHMjRwa2hOSzc4R3N3AAAAAAAAAAAA AAAAAAAAAAAAAAAAAAAAAAAAAA&pwd=ODR4d0daVnBBaEhHYWZkOHlRMjhK dz09&uuid=WN_zGxnPjRmRteJtSR5Fg1pDQ

Passcode: NDE9&ut7

Telecommunications for the hearing impaired are available at: TYT: 1-888-232-6348

Grantor Contact Name: Natalie Brown, Scientific Program Official

Contact: 404-639-4601 (Ph); nbrown3@cdc.gov

Link to Additional Information https://nap.nationalacademies.org/read/13379/chapter/1 https://pubmed.ncbi.nlm.nih.gov/32451250/

Section I. Funding Opportunity Description Statutory Authority Section 301(a) and 317 (k)(2) of the Public Health Service Act [42 USC 241(a) and 247b(k)(2), as amended.

1. Background and Purpose Epilepsy is a neurological disease characterized by recurring seizures (1). Approximately 1.2% of the U.S. population, roughly 3.4 million people, are living with active epilepsy, defined as being treated with anti-seizure medications and/or having had one or more seizures in the past year (2). Among this group, approximately 456,000 individuals are children aged 0 – 17 years (3).

Children represent one of the largest populations with newly diagnosed epilepsy (4). Epilepsy incidence among children is highest in their first year of life and declines by the end of their first decade (4). In the U.S. general population, studies of pediatric epilepsy incidence and prevalence rates are scant, and less is known about pediatric epilepsy risk factors. A 2020 CDC article analyzes progress and gaps in data since the inception of CDC's epilepsy program to develop a body of scientific understanding of epilepsy burden, CDC-supported epilepsy surveillance and https://www.gsa.gov/about-us/organization/federal-acquisition-service/technology-transformation-services/integrated-award-environment-iae/iae-systems-information-kit/unique-entity-id-is-here https://sam.gov/content/home https://grantsgovprod.wordpress.com/2021/09/14/how-to-find-an-applicants-uei-within-grants-gov/ https://grantsgovprod.wordpress.com/2021/09/14/how-to-find-an-applicants-uei-within-grants-gov/ https://grantsgovprod.wordpress.com/2021/09/14/how-to-find-an-applicants-uei-within-grants-gov/ https://cdc.zoomgov.com/w/1601265284?tk=GwnIQIXfvuNkZlownJ9mibRm6KIvBj2luyTBaAEo_Gg.DQYAAAAAX3FehBZZZkNLOU96WlFHMjRwa2hOSzc4R3N3AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA&pwd=ODR4d0daVnBBaEhHYWZkOHlRMjhKdz09&uuid=WN_zGxnPjRmRteJtSR5Fg1pDQ https://cdc.zoomgov.com/w/1601265284?tk=GwnIQIXfvuNkZlownJ9mibRm6KIvBj2luyTBaAEo_Gg.DQYAAAAAX3FehBZZZkNLOU96WlFHMjRwa2hOSzc4R3N3AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA&pwd=ODR4d0daVnBBaEhHYWZkOHlRMjhKdz09&uuid=WN_zGxnPjRmRteJtSR5Fg1pDQ https://cdc.zoomgov.com/w/1601265284?tk=GwnIQIXfvuNkZlownJ9mibRm6KIvBj2luyTBaAEo_Gg.DQYAAAAAX3FehBZZZkNLOU96WlFHMjRwa2hOSzc4R3N3AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA&pwd=ODR4d0daVnBBaEhHYWZkOHlRMjhKdz09&uuid=WN_zGxnPjRmRteJtSR5Fg1pDQ https://cdc.zoomgov.com/w/1601265284?tk=GwnIQIXfvuNkZlownJ9mibRm6KIvBj2luyTBaAEo_Gg.DQYAAAAAX3FehBZZZkNLOU96WlFHMjRwa2hOSzc4R3N3AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA&pwd=ODR4d0daVnBBaEhHYWZkOHlRMjhKdz09&uuid=WN_zGxnPjRmRteJtSR5Fg1pDQ https://nap.nationalacademies.org/read/13379/chapter/1 https://www.nap.edu/read/13379/chapter/1;%20%20https:/pubmed.ncbi.nlm.nih.gov/32451250/ epidemiologic studies: A review of progress since 1994. The article identifies that more research to determine incidence burden and associated risk factors among U.S. children is warranted (5).

Some studies have used nationwide administrative and claims data to estimate epilepsy incidence among children in 13 states (6,7); however, these studies were conducted more than a decade ago, prior to expanded Medicaid benefits under the Affordable Care Act and when there was less access to nationally representative data.

Only a few population-based estimates of epilepsy incidence among children in the United States exist, and these are also outdated. The studies focused on specific geographic areas and have small sample sizes (8-10), which limit national generalizability. Incidence disparities among child subpopulations also have not been fully explored other than studies focused on certain age groups (6-10).

Research on risk factors that may affect the development of pediatric epilepsy is also scant. Of the few known risk factors, some are preventable (e.g., brain injury, infection-related) (4). Other potential risk factors affect fetal brain development during the prenatal, perinatal, and neonatal stages such as maternal risk behaviors, asphyxia, and trauma respectively. (4,11,12).

Complications and adverse events during this time may increase the risk of developing epilepsy in childhood. Other potential risk factors for developing epilepsy in childhood may include comorbidities, environmental exposures, paternal risk behaviors, and social determinants of health (SDOH).

A promising study using large administrative and claims data, albeit not population-based, examined preexisting potential risk factors and found that neonatal seizures had the strongest independent association with the development of epilepsy after controlling for other primary variables (13). Further research using nationally representative data is needed to advance our understanding of risk factors and etiology to improve epilepsy diagnosis and prevention.

Although pediatric epilepsy research to determine national incidence rates, incidence disparities, and risk factors is limited (4,13), advancements in the past decade point to the possibility of estimating a current, national incidence burden as well as evaluating associated risk factors for children. For example, more families have health insurance, facilitating access to a health system since the Affordable Care Act was enacted; electronic health records are widely used; diagnostic tools such as genetic testing have improved; and studies demonstrate that machine learning methods are effective in diagnosing diseases and conditions (17), including population-based studies (14,15). Machine learning can be particularly useful in the field of epilepsy because the classification standard includes numerous types of seizures, epilepsies, and syndromes (16). For this NOFO, machine learning has the potential to ascertain seizures and epilepsy types, including rare forms of epilepsy, in data sets where the diagnosis is not specific or is inaccurate, as well as to generate population-based estimates (18).

The purpose of this NOFO is to use standardized definitions of epilepsies and validated methods to:

1) Estimate overall epilepsy incidence among U.S. children 0 - 17 years of age.

2) Examine potential disparities in incidence rates of epilepsy stratified by demographic, geographical, social determinants of health, and other characteristics.

3) Identify factors that contribute to the risk of developing epilepsy, as well as examine the association between these risk factors and incidence.

This NOFO will contribute to a better understanding of epilepsy incidence, incidence disparities, and associated risk factors among the general U.S. pediatric population. The knowledge obtained from this study would help health officials shape public health policies based on epilepsy incidence burden and improve the quality of life for children with epilepsy and their families.

Results will inform future research by identifying research gaps in epilepsy incidence as well as risk factors that underlie disparities.

References

1. Fisher RS, van Emde Boas W, Blume W, Elger C, Genton P, Lee P, Engel J Jr. Epileptic seizures and epilepsy: definitions proposed by the International League Against Epilepsy (ILAE) and the International Bureau for Epilepsy (IBE). Epilepsia. 2005 Apr; 46 (4):470-2.

2. Zack MM, Kobau R. National and State Estimates of the Numbers of Adults and Children with Active Epilepsy - United States, 2015. MMWR Morb Mortal Wkly Rep. 2017 Aug 11;

66 (31):821-825.

3. Child and Adolescent Health Measurement Initiative. 2022 National Survey of Children's Health (NSCH) data query. Data Resource Center for Child and Adolescent Health supported by the U.S. Department of Health and Human Services, Health Resources and Services Administration (HRSA), Maternal and Child Health Bureau (MCHB). Retrieved 6/30/2024 from www.childhealthdata.org.

4. Peter Camfield and Carol Camfield. Incidence, prevalence and etiology of seizures and epilepsy in children. Epileptic Disord 2015; 17 (2): 117-123.

5. Tian N, Janet B. Croft, Kobau R, Zack MM, Kurt JG. CDC-supported epilepsy surveillance and epidemiologic studies: A review of progress since 1994. Epilepsy & Behavior. 2020 Aug;109:107123. doi: 10.1016/j.yebeh.2020.107123. Epub 2020 May 22.

6 Helmers SL, Thurman DJ, Durgin TL, Pai AK, Faught E. Descriptive epidemiology of epilepsy in the U.S. population: A different approach Epilepsia. 2015 Jun;56(6):942-8. doi:

10.1111/epi.13001. Epub 2015 Apr 29.

7. Kim H, Thurman DJ, Durgin T, Faught E, Helmers S. Estimating Epilepsy Incidence and Prevalence in the US Pediatric Population Using Nationwide Health Insurance Claims Data Child Neurol. 2016 May;31(6):743-9. doi: 10.1177/0883073815620676. Epub 2015 Dec 29.

8. Hauser WA, Annegers, JF and Kurland LT. Incidence of epilepsy and unprovoked seizures in Rochester, Minnesota: 1935-1984 Epilepsia.1993 May-Jun;34(3):453-68. doi:

10.1111/j.1528-1157.1993.tb02586.x.

9. Wirrell EC, Grossardt BR, Wong-Kisiel LCL, and Nickels KC. Incidence and classification of new-onset epilepsy and epilepsy syndromes in children in Olmsted County, Minnesota from 1980 to 2004: a population-based study. Epilepsy Res. 2011 Jun;95(1-2):110-8. doi:

10.1016/j.eplepsyres.2011.03.009.

10. Annegers JF, Dubinsky S, Coan SP, Newmark ME and Roht L. The incidence of epilepsy and unprovoked seizures in multiethnic, urban health maintenance organizations. Epilepsia.

1999 Apr;40(4):502-6. doi: 10.1111/j.1528-1157.1999.tb00748.x.

11. Altınbezer P, Çolak R, Çalkavur S, Yılmaz U. Epilepsy Frequency and Risk Factors Three Years After Neonatal Seizures. Pediatr Neurol. 2023 Dec:149:120-126. doi:

10.1016/j.pediatrneurol.2023.09.015.

12. Burton KJ, Rogathe, J, Whittaker R, Mankad K, Hunter E, Burton MJ et al.Epilepsy in Tanzanian children: association with perinatal events and other risk factors. Epilepsia. 2012 Apr;53(4):752-60. doi: 10.1111/j.1528-1167.2011.03395.x.

13. Oh A, Thurman D J, Kim H. Comorbidities and risk factors associated with newly diagnosed epilepsy in the U.S. pediatric population. Epilepsy Behav. 2017 Oct:75:230-236.

doi: 10.1016/j.yebeh.2017.07.040.

14 Zheng C, Luo Y, Mercado C, Sy L, Jacobsen SJ, Ackerson B et al. Using natural language processing for identification of herpes zoster ophthalmicus cases to support population-based study. Clin Exp Ophthalmol. 2019 Jan;47(1):7-14. doi: 10.1111/ceo.13340.

15 Zheng C, Duffy J, Liu In-Lu Amy, Sy L, Navarro RA, Kim SS. Identifying Cases of Shoulder Injury Related to Vaccine Administration (SIRVA) in the United States:

Development and Validation of a Natural Language Processing Method. JMIR Public Health Surveill. 2022 May 24;8(5):e30426. doi: 10.2196/30426

16. Scheffer IE, Berkovic S, Capovilla G, Connolly MB, French J, Guilhoto L et al. ILAE classification of the epilepsies: Position paper of the ILAE Commission for Classification and Terminology. Epilepsia. 2017 Apr;58(4):512-521. doi: 10.1111/epi.13709.

17. Han K, Liu C, Friedman D. Artificial intelligence/machine learning for epilepsy and seizure diagnosis. Epilepsy Behav. 2024 Jun:155:109736. doi: 10.1016/j.yebeh.2024.109736.

18. Barbour K, Tian N, Yozawitz EG, Wolf S, McGoldrick PE, Sands TT, Nelson A, Basma N, Grinspan ZM. Population-based study of rare epilepsy incidence in a US urban population.

Healthy People 2030 and other National Strategic Priorities This NOFO addresses Healthy People 2030 Children-general (MICH 03) to “Reduce the rate of deaths in children and adolescents aged 1 to 19 years.”

The NOFO aligns with CDC’s strategic plan to “develop and deploy word-class data and analytics,” including to “promote seamless reporting of clinical laboratory and other essential public health data.” https://www.cdc.gov/about/priorities/index.html. Another CDC priority is to turn research into life-saving strategies to support young families.

https://www.cdc.gov/washington/testimony/2024/t20240723.htm

Public Health Impact This NOFO contributes to a comprehensive understanding of epilepsy incidence, incident-related risk factors, and incidence disparities among the general U.S. pediatric population. The knowledge obtained from this study will help health officials shape public health policies by allocating resources, planning for healthcare services, addressing disparities, and implementing preventive measures. By understanding burden and risk factors, the study results will aid researchers to delve further into early detection and intervention for epilepsy, formulate optimal https://www.cdc.gov/about/priorities/index.html https://www.cdc.gov/washington/testimony/2024/t20240723.htm treatment strategies, and enhance education and the quality of life for affected children and their families.

Relevant Work Not applicable.

2. Approach For the purposes of this NOFO, epilepsy is defined according to the Classification of Epilepsies (16), to include all types. Incidence rates are expected to be calculated based on all types, inclusive of the most common types of epilepsy, as data are available. Incidence is defined as the number of new epilepsy cases during a specified time period.

The applicant is expected to propose a research plan with the following information:

• A research team with demonstrated expertise in epidemiological methods, analysis, and pediatric epilepsy diagnosis and care, with the expertise to analyze multiple-year dataset(s) and stratify by subpopulation.

• A study design that yields findings which are nationally representative or approximate national representation.

• A timeline which includes milestones for acquiring data of sufficient quantity and quality to conduct the proposed research within the period of performance.

• A preliminary analysis of historic data (if available) to test case identification, evaluate statistical methodology, as well as assess the feasibility of achieving study objectives and identify possible obstacles to ensure a successful plan to obtain the sample.

The applicant is expected to conduct a study that meets the following data requirements:

• A representative sample that considers factors related to a balanced study population, including demographic and social determinants of health factors.

• The most recent data available.

• A description of data source(s), including sources for variables to examine potential risk factors (e.g. electronic health records [EHR]; public/commercial administrative data;

survey data).

• Dataset(s) with sufficient sample sizes relative to potential risk factors, allowing incidence rates to be stratified by these factors to examine incidence disparities.

The applicant is expected to describe the study design that includes:

• A wide range of risk factors that are based on the scientific literature and include both those related to fetal development and other factors such as comorbidity and SDOH.

• Adequate details/justification for necessary sample sizes; a power analysis may be necessary depending on the data source and sample size for subgroup analysis.

• Standardized definitions and validated methods to ascertain incident epilepsy cases. The applicant is encouraged to leverage advanced data science techniques, including machine learning, natural language processing, or other artificial intelligence tools.

Objectives/Outcomes Applicants are expected to specify measurable objectives and outcomes, including but not limited to:

• An estimated overall epilepsy incidence rate of U.S. children 0 – 17 years of age at the statistical significance level of at least 0.05. Incidence rates are expected to be inclusive of the most common epilepsies, as data are available.

• Estimated epilepsy incidence rates (at the statistical significance level of at least 0.05) stratified by demographic factors, social determinants of health, and other characteristics.

• Identified fetal brain development and other risk factors with statistically significant associations (at the statistical significance level of at least 0.05) between the identified risk factors and incident epilepsy.

• Producing and communicating findings that enable policymakers and providers to improve epilepsy prevention, screening, management, and care.

Population of Focus The population of focus is U.S. children aged 0 – 17 years. The population studied should be nationally representative, corresponding to statistical estimates of the U.S. child population by sex, race, ethnicity, and geographic distribution as defined by the U.S. Census Bureau.

Applicants should ensure the population under study is inclusive of subpopulations based on factors that might identify health disparities related to social determinants of health.

Collaboration/Partnerships Partners may include stakeholders such as professional medical groups, clinical networks, research organizations, and national or state-level epilepsy organizations. Applicants are expected to describe how key stakeholders will be involved in the research, particularly exploring risk factors and translating research findings to reduce disparities.

Evaluation/Performance Measurement The applicant is expected to include a Year 1 evaluation plan that measures SDOH, research activities, and proposed outcomes with performance measurements, milestones, and outputs aligning with the NOFO purpose. The plan is expected to include outputs such as acquiring data sets, finalizing analytical plans, and developing partnerships/collaborations; as well as preliminary analysis results (if analysis is possible). Place the evaluation/performance measurement plan in the Appendix.

The recipient is expected to finalize a full plan by the 6th month of receiving the award and update the plan yearly. Resource: www.cdc.gov/eval.

Translation Plan Applications are expected to include an outline of a detailed dissemination plan for the study findings. The outline is expected to include the anticipated dissemination strategies and timeline for recommendations to promote, enhance, or advance the translation of the research into public health and policy practice, including translating the research findings related to social determinants of health. A revised complete plan is expected within six months of award start date.

3. Funding Strategy N/A

Section II. Award Information http://www.cdc.gov/eval

Funding Instrument Type:

CA (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:

$1,600,000 The estimated total funding for the first budget period, September 30, 2025 to September 29, 2026, is $500,000. The estimated total funding for the entire four-year Period of Performance, September 30, 2025 to September 29, 2029, is $1.6 million.

Anticipated Number of Awards:

The estimated total funding for the first budget period, September 30, 2025 to September 29, 2026, is $500,000. The estimated total funding for the entire four-year Period of Performance, September 30, 2025 to September 29, 2029, is $1.6 million. The anticipated number of awards is one.

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

Award Ceiling:

$500,000 Per Budget Period

Award Floor:

$0 Per Budget Period

Total Period of Performance Length:

4 year(s)

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

HHS/CDC grants policies as described in the HHS Grants Policy Statement

(https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this NOFO.

If you are successful and receive a Notice of Award, in accepting the award, you agree that the award and any activities thereunder are subject to all provisions of 45 CFR Part 75, currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category:

00 (State governments)

01 (County governments)

02 (City or township governments)

04 (Special district governments)

05 (Independent school districts)

06 (Public and State controlled institutions of higher education)

07 (Native American tribal governments (Federally recognized))

08 (Public housing authorities/Indian housing authorities)

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

12 (Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education)

20 (Private institutions of higher education)

22 (For profit organizations other than small businesses)

23 (Small businesses)

Additional Eligibility Category:

The following types of Higher Education Institutions are always encouraged to apply for CDC support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions

Historically Black Colleges and Universities (HBCUs)

Tribally Controlled Colleges and Universities (TCCUs)

Alaska Native and Native Hawaiian Serving Institutions

Nonprofits (Other than Institutions of Higher Education):

Nonprofits (Other than Institutions of Higher Education)

Governments:

https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

U.S. Territory or Possession

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

Foreign components of U.S. Organizations are eligible to apply.

For this announcement, applicants may include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

3. Additional Information on Eligibility N/A

4. Justification for Less than Maximum Competition N/A

5. Responsiveness Access to Population of Focus

Evidence must include documentation demonstrating the applicant has access to or has requested permission to use proposed data set(s). The document must be signed and detailed, such as a memorandum of understanding or agreement, intent to contract, or other signed agreement that states the source will provide access to and facilitate data sharing. Evidence must be placed in Appendix 1.

If an applicant requests a funding amount greater than the ceiling of $500,000 as indicated in Section II of this NOFO, HHS/CDC will consider the application non-responsive, and it will not enter the review process. HHS/CDC will notify the applicant that the application does not meet the submission requirements.

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 Unique Entity Identifier (UEI) number in order to begin each of the following registrations.

PLEASE NOTE: Effective April 4, 2022, applicants must have a Unique Entity Identifier (UEI) at the time of application submission. The UEI replaced the Data Universal Numbering System (DUNS) and is generated as part of SAM.gov registration. Current SAM.gov registrants have already been assigned their UEI and can view it in SAM.gov and Grants.gov. Additional information is available on the GSA website, SAM.gov, and Grants.gov-Finding the UEI.

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: NCAGE Tool / Products / NCS Help Center (nato.int).

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

Grants.gov eRA Commons https://www.gsa.gov/about-us/organization/federal-acquisition-service/technology-transformation-services/integrated-award-environment-iae/iae-systems-information-kit/unique-entity-id-is-here https://sam.gov/content/home https://grantsgovprod.wordpress.com/2021/09/14/how-to-find-an-applicants-uei-within-grants-gov/ https://grantsgovprod.wordpress.com/2021/09/14/how-to-find-an-applicants-uei-within-grants-gov/ https://eportal.nspa.nato.int/Codification/Support/en/Products/NCAGE/ https://sam.gov/content.gov https://grants.gov https://public.era.nih.gov/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 Senior/Key Personnel (including Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing Principal Investigator (PD/PI) eRA Commons account is affiliated with the eRA commons account of the applicant organization. All registrations must be successfully completed and active before the application due date. Applicant organizations are strongly encouraged to start the eRA Commons registration process at least four (4) weeks prior to the application due date. ASSIST requires that applicant users have an active eRA Commons account in order to prepare an application. It also requires that the applicant organization's Signing Official have an active eRA Commons Signing Official account in order to initiate the submission process.

During the submission process, ASSIST will prompt the Signing Official to enter their Grants.gov Authorized Organizational Representative (AOR) credentials in order to complete the submission, therefore the applicant organization must ensure that their Grants.gov AOR credentials are active.

7. Universal Identifier Requirements and System for Award Management

(SAM)

All applicant organizations must obtain a Unique Entity Identifier (UEI) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The UEI number is a twelve-digit number assigned by SAM.gov. An AOR should be consulted to determine the appropriate number. If the organization does not have a UEI number, an AOR should register through SAM.gov. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a UEI number.

Additionally, 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.gov 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 SAM.gov and the SAM.gov Knowledge Base.

If an award is granted, the recipient organization must notify potential sub-recipients that no organization may receive a subaward under the grant unless the organization has provided its UEI number to the recipient organization.

8. Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions 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 https://www.Grants.gov https://sam.gov/content/home https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fsd.gov%2Fgsafsd_sp%3Fid%3Dgsa_kb_view2%26kb_id%3Df66d8e6cdb76d4100d73f81d0f9619c6&data=04%7C01%7Ccshifflett%40dminc.com%7C8eee7a2adab549a3b3c008d925e9a364%7Cdb7ac9ef779d46e59bca00509580ad6b%7C0%7C0%7C637582507851821018%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=UrR%2B%2FM2wWF2fZG05Z8O6JS2C3FXXSl%2F7B3%2FB45XHRrg%3D&reserved=0 support. CDC does not make awards to individuals directly. Individuals from organizations that are uniquely prepared to examine research relevant to undeserved groups, including sexual orientation and gender identity minorities as well as individuals with disabilities are always encouraged to apply.

9. Cost Sharing This NOFO does not require cost sharing as defined in the HHS Grants Policy Statement (http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf).

10. Number of Applications As defined in the HHS Grants Policy Statement, (https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf), applications received in response to the same Notice of Funding Opportunity generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit. HHS/CDC will not accept any application in response to this NOFO that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Only one application per institution (normally identified by having a unique UEI number) is allowed.

Section IV. Application and Submission Information

1. Address to Request Application Package Applicants will use a system or platform to submit their applications through Grants.gov and eRA Commons to CDC. ASSIST, an institutional system to system (S2S) solution, or Grants.gov Workspace are options. ASSIST is a commonly used platform because, unlike other platforms, it provides a validation of all requirements prior to submission and prevents errors.

To use ASSIST, applicants must visit https://public.era.nih.gov where you can login using your eRA Commons credentials, and enter the Notice of Funding Opportunity Number to initiate the application, and begin the application preparation process.

If you experience problems accessing or using ASSIST, you can refer to the ASSIST Online Help Site at: https://era.nih.gov/erahelp/assist. Additional support is available from the NIH eRA Service desk via: http://grants.nih.gov/support/index.html

• Email: commons@od.nih.gov

• Phone: 301-402-7469 or (toll-free) 1-866-504-9552.

Hours: Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding Federal holidays.

2. Content and Form of Application Submission Application guides for FORMS-H application packages are posted to the How to Apply - Application Guide page.

It is critical that applicants follow the instructions in the SF-424 (R&R) Application Guide How https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://public.era.nih.gov http://grants.nih.gov/support/index.html https://grants.nih.gov/grants/how-to-apply-application-guide.html to Apply - Application Guide except where instructed in this Notice of Funding Opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review. The package associated with this NOFO includes all applicable mandatory and optional forms. Please note that some forms marked optional in the application package are required for submission of applications for this NOFO. Follow the instructions in the SF-424 Application Guide to ensure you complete all appropriate “optional” components.

When using ASSIST, all mandatory forms will appear as separate tabs at the top of the Application Information screen; applicants may add optional forms available for the NOFO by selecting the Add Optional Form button in the left navigation panel.

3. Letter of Intent Due Date for Letter Of Intent 12/12/2024

Although a letter of intent is not required, is not binding, nor enters into the review of a subsequent application, the information allows CDC to plan the review. By the date listed above, prospective applicants are asked to email their intent to apply and include the following information: applicant institution, descriptive title of the proposed research, name and direct telephone number of the PD(s)/PI(s), names of other key personnel, and a list of proposed participating institutions.

Email the info to Natalie Brown, Scientific Program Official, at researchnofo@cdc.gov.

Place the number and title of this NOFO in the subject line: RFA CDC DP25-038, Epilepsy Incidence Among Children in the United States.

4. Required and Optional Components A complete application has many components, both required and optional. The forms package associated with this NOFO in Grants.gov includes all applicable components for this NOFO, required and optional. In ASSIST, all required and optional forms will appear as separate tabs at the top of the Application Information screen.

5. PHS 398 Research Plan Component The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that consists of components. Not all components of the Research Plan apply to all Notices of Funding Opportunities (NOFOs). Specifically, some of the following components are for Resubmissions or Revisions only. See the SF 424 (R&R) Application Guide at How to Apply

- Application Guide for additional information. Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Notice of Funding Opportunity Description).

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

https://grants.nih.gov/grants/how-to-apply-application-guide.html https://grants.nih.gov/grants/how-to-apply-application-guide.html

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

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

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

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

4. Progress Report Publication List (for Continuation ONLY)

Other Research Plan Sections

5. Vertebrate Animals

6. Select Agent Research

7. Multiple PD/PI Leadership Plan

8. Consortium/Contractual Arrangements

9. Letters of Support

10. Resource Sharing Plan(s)

11. Other Plan(s)

12. Authentication of Key Biological and/or Chemical Resources

13. Appendix

All instructions in the SF424 (R&R) Application Guide at How to Apply - Application Guide must be followed along with any additional instructions provided in the NOFO.

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

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

• A description of the data to be collected or generated in the proposed project;

• Standards to be used for the collected or generated data;

• Mechanisms for providing access to and sharing of the data (include a description of provisions for the protection of privacy, confidentiality, security, intellectual property, or other rights - this section should address access to identifiable and de-identified data);

• A statement (required) of any limitations you may encounter with sharing data collected or generated under this award with CDC (such as legal, regulatory, policy, or technical concerns);

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

• Plans for archiving and long-term preservation of the data, or explaining why long-term preservation and access are not justified (this section should address archiving and preservation of identifiable and deidentified data).

The AR-25 outlines the components of a DMP and provides additional information for investigators regarding the requirements for data accessibility, storage, and preservation.

https://www.cdc.gov/grants/additional-requirements/ar-25.html

CDC OMB approved templates may be used (e.g. NCCDPHP template https://www.cdc.gov/nccdphp/dch/media/files/Data-Management-Plan-template.docx

Other examples of DMPs may be found here: USGS, http://www.usgs.gov//products/data-and-tools/data-management/data-management-plans

Application guides for FORMS-H application packages are posted to the How to Apply - Application Guide page.

The research strategy/plan is expected to include:

• A multidisciplinary team that includes expertise in epidemiologic methods, population studies, data analysis, and pediatric epilepsy, and expertise with population-based studies of disease burden and associated risk factors.

• A study design that yields findings which are nationally representative or approximate national representation.

• A preliminary analysis of historic data (if available) to test case identification, evaluate statistical methodology, and assess the feasibility of achieving study objectives and identify possible obstacles to ensure a successful plan to obtain the sample.

• A representative sample that considers factors related to a balanced study population, including demographic and social determinants of health factors.

• A wide range of risk factors that are based on the scientific literature and include both those related to fetal brain development and other factors such as comorbidity and

SDOH).

• Standardized definitions and validated methods to ascertain incident epilepsy cases. The applicant is encouraged to leverage advanced data science techniques, including machine learning, natural language processing, or other artificial intelligence tools.

• Measurable objectives, including but not limited to:

o An estimated overall epilepsy incidence rate of U.S. children 0 – 17 years of age at the statistical significance level of at least 0.05.

o Estimated epilepsy incidence rates (at the statistical significance level of at least

0.05) stratified by demographics, social determinants of health, and other characteristics.

o Fetal brain development and other risk factors with statistically significant associations (at the statistical significance level of at least 0.05) between the identified risk factors and incident epilepsy.

https://www.cdc.gov/grants/additional-requirements/ar-25.html https://www.cdc.gov/nccdphp/dch/media/files/Data-Management-Plan-template.docx http://www.usgs.gov//products/data-and-tools/data-management/data-management-plans http://www.usgs.gov//products/data-and-tools/data-management/data-management-plans

If multiple PIs are proposed in a consortium or other arrangement, applicants must provide a multiple leadership plan.

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 publicly available. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

As applicable, applicants may provide links to publications and other information in lieu of attaching PDF documents.

7. Page Limitations All page limitations described in this individual NOFO must be followed. For this specific NOFO, the Research Strategy component of the Research Plan narrative is limited to 12 pages.

Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files with a maximum of 30 pages for all appendices. Pages that exceed page limits described in this NOFO will be removed and not forwarded for peer review, potentially affecting an application's score.

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 at .How to Apply - Application Guide.

Application guides for FORMS-H application packages are posted to the How to Apply - Application Guide page.

9. Submission Dates & Times Part I. Overview Information contains information about Key Dates. Applicants are strongly encouraged to allocate additional time and submit in advance of the deadline to ensure they have time to make any corrections that might be necessary for successful submission. This includes the time necessary to complete the application resubmission process that may be necessary, if errors are identified during validation by Grants.gov and the NIH eRA systems. The application package is not complete until it has passed the Grants.gov and NIH eRA Commons submission and validation processes. Applicants will use a platform or system to submit applications.

ASSIST is a commonly used platform because it provides a validation of all requirements prior to submission. If ASSIST detects errors, then the applicant must correct errors before their application can be submitted. Applicants should view their applications in ASSIST after submission to ensure accurate and successful submission through Grants.gov. If the submission is not successful and post-submission errors are found, then those errors must be corrected and the application must be resubmitted in ASSIST.

https://grants.nih.gov/grants/how…