RFA-OH-25-001 NIH Guide.pdf

RFA-OH-25-001: Exploratory/Developmental Research for World Trade Center Health Program Evidence-based Strategies to Improve Treatment Effectiveness, Di...

https://grants.nih.gov/grants/guide/rfa-files/RFA-OH-25-001.html[5/8/2024 5:02:09 PM]

Department of Health and Human Services Part 1. Overview Information Participating Organization(s)

Centers for Disease Control and Prevention (CDC)

The policies, guidelines, terms, and conditions of the HHS Centers for Disease Control and Prevention (CDC) stated in this Notice of Funding Opportunity (NOFO) might differ from those used by the HHS National Institutes of Health (NIH). If written guidance for completing this application is not available on the CDC website, then CDC will direct applicants elsewhere for that information.

Components of Participating Organizations

National Institute for Occupational Safety and Health (NIOSH)

Notice of Funding Opportunity (NOFO) Title

Exploratory/Developmental Research for World Trade Center Health Program Evidence-based Strategies to Improve Treatment Effectiveness, Diagnostic Practices, and Program Evaluation (R21)

Activity Code

R21 Exploratory/Developmental Research Grant

Announcement Type

New

Related Notices None

Funding Opportunity Number (FON)

RFA-OH-25-001

Companion Notice of Funding Opportunity

None http://www.cdc.gov/ https://www.cdc.gov/niosh/index.htm https://grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=r21&Search.x=0&Search.y=0&Search_Type=Activity

RFA-OH-25-001: Exploratory/Developmental Research for World Trade Center Health Program Evidence-based Strategies to Improve Treatment Effectiveness, Di...

Number of Applications

Eligible applicant institutions may submit more than one application, provided that each application is scientifically distinct. See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.262

Funding Opportunity Purpose

NIOSH supports exploratory and developmental research (R21) which addresses diagnostic or treatment uncertainty with respect to individuals receiving monitoring and/or treatment under subtitle C of the James Zadroga 9/11 Health and Compensation Act of 2010 as amended.

The Zadroga Act lists three broad research areas:

Physical and mental health conditions that may be related to the September 11, 2001, terrorist attacks;

Diagnosing WTC-related health conditions for which there has been diagnostic uncertainty; and

Treating WTC-related health conditions for which there has been treatment uncertainty.

The World Trade Center (WTC) Health Program intends to increase opportunities for research on innovative approaches, interventions, techniques, or methods to improve treatment and diagnostic effectiveness through intervention, and support program evaluation.

The WTC Health Program seeks to achieve a suitable mix of scientifically robust research projects which assess the feasibility of enhancing interventions and program evaluations to improve diagnosis, treatment, care, and well-being of 9/11-exposed populations.

Research areas of interest include clinical, screening, diagnostic, epidemiological, treatment, prevention, translation, and program evaluation. WTC responders, screening-eligible WTC survivors, and certified-eligible WTC survivors comprise the populations of interest.

The research should consider health equity initiatives in design, where possible. Opportunities for future health effects research involving vulnerable groups of persons (e.g., minorities, women, children, and other potentially disadvantaged groups) who were exposed to the 9/11 attacks and aftermath are of special interest. Research is needed to identify at-risk groups, characterize the health burden, and to inform care.

This WTC Health Program R21 Notice of Funding Opportunity (NOFO) is intended to encourage exploratory/developmental research by providing support for the early and conceptual stages of project development which assess the feasibility of new areas of investigation with the potential to enhance treatment effectiveness and diagnostic practices.

These studies may lead to breakthroughs in a particular area, or to the development of new

RFA-OH-25-001: Exploratory/Developmental Research for World Trade Center Health Program Evidence-based Strategies to Improve Treatment Effectiveness, Di...

Key Dates interventions, techniques, agents, methodologies, models, or approaches with major clinical impacts. These studies are expected to break new ground or extend prior discoveries toward new directions or uses. Applicants are expected to propose research for which there is likely to be minimal or no preliminary data.

The WTC Health Program Research webpage provides comprehensive information and tools for researchers. The research agenda, publication library, and other resources, including the Funding Dashboard, can also be found there (e.g., awarded project details such as publications, topics, populations, funding awarded, and the principal investigators and their institutions).

Posted Date

May 7, 2024

Open Date (Earliest Submission Date)

June 3, 2024

Letter of Intent Due Date(s)

September 27, 2024 (LOI recommended but not required)

Application Due Date(s)

October 29, 2024

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

Eastern Time.

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 https://www.era.nih.gov/need-help.

E-mail: commons@od.nih.gov

Phone: 301-402-7469 or (toll-free) 1-866-504-9552 https://www.cdc.gov/wtc/research.html https://era.nih.gov/erahelp/assist https://www.era.nih.gov/need-help mailto:commons@od.nih.gov

RFA-OH-25-001: Exploratory/Developmental Research for World Trade Center Health Program Evidence-based Strategies to Improve Treatment Effectiveness, Di...

Required Application Instructions It is critical that applicants follow the Research (R) 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 6 pages.

Page Limitations: Pages that exceed the page limits described in this NOFO will be removed and not forwarded for peer review.

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

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).

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

March 2025

Advisory Council Review

April 2025

Earliest Start Date

July 1, 2025

Expiration Date

November 28, 2024

Due Dates for E.O. 12372

Not Applicable https://grants.nih.gov/grants/how-to-apply-application-guide.html https://grants.nih.gov/grants/how-to-apply-application-guide.html http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward

RFA-OH-25-001: Exploratory/Developmental Research for World Trade Center Health Program Evidence-based Strategies to Improve Treatment Effectiveness, Di...

for review.

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

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.

2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.

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

Section I. Notice of 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 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Statutory Authority The World Trade Center (WTC) Health Program was established by Title I of the James Zadroga 9/11 Health and Compensation Act of 2010, Pub. L. 111-347, as amended by Pub. L. 114-113, Pub. L. 116-59, Pub. L. 117-328, and Pub. L. 118-31 adding Title XXXIII to the Public Health Service (PHS) Act (codified at 42 U.S.C. 300mm - 300mm-64). The authority for this specific research is found in Section 3341 of the Zadroga Act, as amended (42 U.S.C. 300mm-51).

Background https://public.era.nih.gov/commons/ https://grants.gov/search-grants?oppStatuses=closed|archived|posted|forecasted&fon=RFA-OH-25-001 http://public.era.nih.gov/commons/ https://www.congress.gov/111/plaws/publ347/PLAW-111publ347.pdf https://www.congress.gov/114/plaws/publ113/PLAW-114publ113.pdf https://www.congress.gov/116/plaws/publ59/PLAW-116publ59.pdf https://www.congress.gov/117/bills/hr2617/BILLS-117hr2617enr.pdf https://www.congress.gov/118/plaws/publ31/PLAW-118publ31.pdf

RFA-OH-25-001: Exploratory/Developmental Research for World Trade Center Health Program Evidence-based Strategies to Improve Treatment Effectiveness, Di...

The World Trade Center (WTC) Health Program is administered by the National Institute for Occupational Safety and Health (NIOSH). Program information is available at the WTC Health Program website. The James Zadroga 9/11 Health and Compensation Act of 2010, Public Law 111-347 (hereafter referred to as the Zadroga Act ) was signed by President Obama on January 2, 2011, and was re-authorized on December 18, 2015 (the Consolidated Appropriations Act, 2016, Public Law 114-113), and further amended by Public Laws 116-59, 117-328, and 118-31. The Zadroga Act established monitoring and treatment activities for responders and survivors of the September 11, 2001, terrorist attacks and requires the establishment (under Subtitle C) of a research program on health conditions resulting from the attacks.

The Zadroga Act lists the following broad research areas (42 U.S.C. 300mm-51):

Physical and mental health conditions that may be related to the September 11, 2001, terrorist attacks;

Diagnosing WTC-related health conditions for which there has been diagnostic uncertainty; and Treating WTC-related health conditions for which there has been treatment uncertainty.

Research conducted under the Zadroga Act includes epidemiologic and other research studies on WTC-related health conditions or emerging conditions among (1) WTC responders, certified-eligible WTC survivors under treatment, and individuals who were exposed within a geographic area related to the September 11, 2001, terrorist attacks in a manner similar to the exposure within such geographic area experienced by individuals meeting the eligibility criteria under section 3311(a)(2) or 3321(a)(1)(B); and (2) sampled populations outside the New York City disaster area in Manhattan as far north as 14th Street and in Brooklyn, along with control populations, to identify potential for long-term adverse health effects in less exposed populations.

The Zadroga Act established the requirement for a WTC Health Program Scientific/Technical Advisory Committee and states that the WTC Program Administrator shall consult with the committee in carrying out research activities related to the September 11, 2001, terrorist attacks.

Purpose NIOSH supports exploratory and developmental research projects (R21) that address issues related to diagnostic or treatment uncertainty with respect to individuals receiving monitoring and/or treatment under subtitle C of the James Zadroga 9/11 Health and Compensation Act of 2010 (Public Law 111-347, as amended by Public Laws 114-113, 116-59, 117-328, and 118-31).

The WTC Health Program intends to increase opportunities for research on new, innovative approaches, interventions, techniques, or methodologies to improve treatment and diagnostic effectiveness through intervention, as well as support program evaluation.

The WTC Health Program seeks to achieve a suitable mix of scientifically robust research projects which assess the feasibility of enhancing interventions and program evaluations https://www.cdc.gov/wtc/ https://www.cdc.gov/wtc/ https://www.congress.gov/111/plaws/publ347/PLAW-111publ347.pdf http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title42-chapter6A-subchapter31&edition=prelim https://www.congress.gov/114/plaws/publ113/PLAW-114publ113.pdf https://www.congress.gov/116/plaws/publ59/PLAW-116publ59.pdf https://www.congress.gov/117/bills/hr2617/BILLS-117hr2617enr.pdf https://www.congress.gov/118/plaws/publ31/PLAW-118publ31.pdf https://www.govinfo.gov/content/pkg/USCODE-2010-title42/html/USCODE-2010-title42-chap6A.htm https://www.govinfo.gov/content/pkg/USCODE-2010-title42/html/USCODE-2010-title42-chap6A.htm https://www.cdc.gov/wtc/stac.html https://www.cdc.gov/wtc/stac.html https://www.congress.gov/111/plaws/publ347/PLAW-111publ347.pdf https://www.congress.gov/114/plaws/publ113/PLAW-114publ113.pdf https://www.congress.gov/116/plaws/publ59/PLAW-116publ59.pdf https://www.congress.gov/117/bills/hr2617/BILLS-117hr2617enr.pdf https://www.congress.gov/118/plaws/publ31/PLAW-118publ31.pdf

RFA-OH-25-001: Exploratory/Developmental Research for World Trade Center Health Program Evidence-based Strategies to Improve Treatment Effectiveness, Di...

to improve diagnosis, treatment, care, and well-being of 9/11-exposed populations.

Research areas of interest include clinical, screening, diagnostic, epidemiological, treatment, prevention, translation, and program evaluation. WTC responders, screening-eligible WTC survivors, and certified-eligible WTC survivors comprise the populations of interest.

The research should consider health equity initiatives in design, where possible.

Opportunities for future health effects research involving vulnerable groups of persons (e.g., minorities, women, children, and other potentially disadvantaged groups) who were exposed to the 9/11 attacks and aftermath are of special interest. Research is needed to identify at-risk groups, characterize the health burden, and to inform care.

This WTC Health Program R21 Notice of Funding Opportunity (NOFO) is intended to encourage exploratory/developmental research by providing support for the early and conceptual stages of project development which assess the feasibility of new areas of investigation with the potential to enhance treatment effectiveness and diagnostic practices. These studies may lead to breakthroughs in a particular area, or to the development of new interventions, techniques, agents, methodologies, models, or approaches with major clinical impacts. These studies are expected to break new ground or extend prior discoveries toward new directions or uses. Applicants are expected to propose research for which there is likely to be minimal or no preliminary data.

Research funded by the WTC Health Program is primarily intended for the benefit of the 9/11-exposed population. It is not required that project findings be generalizable to other populations.

The WTC Health Program Research webpage provides comprehensive information and tools for researchers. The research agenda, publication library, and other resources, including the Funding Dashboard, can also be found there (e.g., awarded project details such as publications, topics, populations, funding awarded, and the principal investigators and their institutions).

Major areas of research interest Research areas of interest include clinical, screening, diagnostic, epidemiological, treatment, prevention, translation, and program evaluation. WTC responders, screening-eligible WTC survivors, and certified-eligible WTC survivors comprise the population targeted for the research project.

NIOSH is soliciting exploratory and developmental research grant applications (R21) to increase support and focus on assessing the feasibility, development, and effectiveness of methods, practices, interventions, and programs related to evidence-based strategies to improve treatment effectiveness, diagnostic practices, and program evaluation. In the following areas:

https://www.cdc.gov/wtc/research.html

RFA-OH-25-001: Exploratory/Developmental Research for World Trade Center Health Program Evidence-based Strategies to Improve Treatment Effectiveness, Di...

Health Services Research: Projects that examine how people get access to health care and care management services, how much care costs, and what happens to patients as a result of this care. Research projects in this area have the potential to identify improved methods/procedures to organize, manage, finance, and deliver health care.

Implementation Research: Projects that study the processes whereby WTC Health Program research outputs are disseminated, adopted, implemented, sustained, and scaled up equitably in real-world settings for affected populations.

Screening Research: Projects that evaluate current, or facilitate the development of, new/improved, methods to detect certain disorders or health conditions.

Diagnostic Research: Projects that evaluate current, or facilitate the development of, new/improved, methods to identify diseases, disorders, or conditions.

Treatment Research: Projects that evaluate/identify improved treatment interventions/methods (e.g., medication, psychotherapy, dietary/nutritional, care management and coordination etc.) or promote the development of new or novel treatment approaches, e.g., telemedicine.

Prevention Research: Projects that identify/evaluate new methods and interventions (e.g., medicine(s), psychotherapy, vaccines, nutrition, or lifestyle changes) that prevent or mitigate the development or reoccurrence of various diseases/disorders.

Proposed projects should consider health equity initiatives in design, where possible.

Opportunities for future health effects research involving vulnerable groups of persons (e.g., minorities, women, children, and other potentially disadvantaged groups) who were exposed to the 9/11 attacks and aftermath are of special interest. Research is needed to identify at-risk groups, characterize the health burden, and inform care.

Applications should clearly state:

how the design, content, format and dissemination of outreach efforts will be tailored to the needs of WTC populations from diverse backgrounds;

how cultural competence of research and linguistically appropriate dissemination of findings and solutions will be ensured; and how historically underrepresented groups can be included in research projects, e.g., though participation on advisory boards, as researchers/staff, and though partnerships.

Relevant diseases or conditions include, but are not limited to:

Respiratory diseases Cancer (including detection/diagnosis of pre-malignant changes) Cardiovascular Disease Psychological resilience and well-being Persistent psychiatric conditions such as posttraumatic stress, anxiety and depressive disorders Cognitive changes Aging the impacts of aging on those impacted by 9/11 illness and injury (e.g., premature aging, optimizing adaptation for productivity)

RFA-OH-25-001: Exploratory/Developmental Research for World Trade Center Health Program Evidence-based Strategies to Improve Treatment Effectiveness, Di...

Neurological Diseases Aerodigestive health Birth and Reproductive Outcomes Multisystem or auto-immune diseases Emerging conditions identified by WTC Health Program surveillance activities. Includes diseases/conditions requiring further program consideration. A list of these diseases/conditions is found at https://www.cdc.gov/wtc/received.html, in the section titled, Petitions Received and WTC Health Program Responses.

The WTC Health Program Research webpage provides comprehensive information and tools for researchers. The research agenda, publication library, and other resources, including the Funding Dashboard, can also be found there (e.g., awarded project details such as publications, topics, populations, funding awarded, and the principal investigators and their institutions).

Objectives The overall objective of this announcement is to solicit meritorious and scientifically rigorous research applications to help:

improve diagnosis and treatment activities of the WTC Health Program;

expand knowledge about health effects related to the September 11, 2001, terrorist attacks;

answer critical questions about physical and mental health conditions related to the September 11, 2001, terrorist attacks; and apply lessons learned from 9/11 to improve response to and mitigation of health effects from future disasters.

The WTC Health Program seeks to achieve a suitable mix of scientifically robust research projects which assess the feasibility of enhancing interventions and program evaluations to improve diagnosis, treatment, care, and well-being of 9/11-exposed populations.

Research areas of interest include clinical, screening, diagnostic, epidemiological, treatment, prevention, translation, and program evaluation. WTC responders, screening-eligible WTC survivors, and certified-eligible WTC survivors comprise the population targeted for the research project.

The research should consider health equity initiatives in design, where possible.

Opportunities for future health effects research involving vulnerable groups of persons (e.g., minorities, women, children, and other potentially disadvantaged groups) who were exposed to the 9/11 attacks and aftermath are of special interest. Research is needed to identify at-risk groups, characterize the health burden, and to inform care.

WTC Health Program applicants are strongly encouraged to review the WTC Health Program Research webpage which provides comprehensive information and tools for researchers. The research agenda, publication library, and other resources, including the Funding Dashboard, can also be found there (e.g., awarded project details such as publications, topics, populations, funding awarded, and the principal investigators and their institutions).

https://www.cdc.gov/wtc/received.html

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Healthy People 2030 and other National Strategic Priorities The WTC research program funded by this NOFO will contribute to the CDC strategic goal, in alignment with an HHS strategic goal and objectives found in Healthy People 2030, to increase the number of communities that protect and promote health and safety and prevent illness and injury to improve the safety, quality, affordability, and accessibility of health care.

Public Health Impact A growing body of evidence suggests that significant health conditions have emerged which are associated with the disaster, particularly for those exposed during the collapse of the towers and those who participated substantially in rescue, recovery, and clean-up operations.

Research conducted under the Zadroga Act includes epidemiologic and other research studies on WTC-related health conditions or emerging conditions among (1) WTC responders, certified-eligible WTC survivors under treatment, and individuals who were exposed within a geographic area related to the September 11, 2001, terrorist attacks in a manner similar to the exposure within such geographic area experienced by individuals meeting the eligibility criteria under section 3311(a)(2) or 3321(a)(1)(B); and (2) sampled populations outside the New York City disaster area in Manhattan as far north as 14th Street and in Brooklyn, along with control populations, to identify potential for long-term adverse health effects in less exposed populations.

Scientific research may inform health care professionals and allow earlier diagnoses of WTC conditions, which may lead to more effective treatment. However, scientifically identifying the causes of health problems or conditions is typically very difficult. While it is often not possible to determine the specific cause of an individual's illness or condition, it is critical to promote scientifically rigorous studies and reviews of potential health problems or risk factors among the affected population.

The WTC Health Program Research webpage provides comprehensive information and tools for researchers. The research agenda, publication library, and other resources, including the Funding Dashboard, can also be found there (e.g., awarded project details such as publications, topics, populations, funding awarded, and the principal investigators and their institutions).

Relevant Work Information about current and completed NIOSH-funded research studies pertaining to the World Trade Center can be found on the WTC Health Program Research webpage (including two publications from the WTC Health Program: First Decade of Research and a Workshop on Cognitive Aging and Impairment in the 9/11-Exposed Population). The WTC Health Registry's annual reports, prepared for enrollees and the public, include https://health.gov/healthypeople https://health.gov/healthypeople https://www.cdc.gov/wtc/research.html https://www.cdc.gov/wtc/research.html https://www.mdpi.com/1660-4601/17/19/7290 https://www.mdpi.com/1660-4601/18/2/681 https://www1.nyc.gov/site/911health/researchers/annual-reports.page

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information on its key activities and accomplishments, and details on recent findings about the health consequences of 9/11.

Note: Interested applicants are strongly encouraged to visit the WTC Health Program Research webpage for additional information.

Population of Focus The population of focus for research funded under this NOFO are individuals exposed to the September 11, 2001, terrorist attacks, including responders and community members (also referred to as survivors).

Responder cohorts or populations include:

local responders (FDNY and others) who were exposed and (a) still live in the NYC area or (b) have since moved away from the NYC area; and responders who came from outside the NYC area to assist with the response and subsequently returned to their respective home areas.

Screening-eligible and certified-eligible WTC survivors (adults and children) include individuals who lived, worked, went to school, or attended child or adult day care in the New York City (NYC) Disaster Area, as defined in 42 CFR 88.1, on September 11, 2001, or in the following days, weeks, or months and those otherwise meeting the eligibility criteria in 42 CFR 88.7 or 88.8.

Additionally, proposed research can include sampled populations outside the NYC disaster area in Manhattan as far north as 14th Street and in Brooklyn, along with control populations, to identify potential for long-term adverse health effects in less exposed populations.

Collaboration/Partnerships Interdisciplinary and transdisciplinary collaborations that share expertise are essential to advance WTC Health Program efforts to 1) evaluate linkages between WTC exposures and uncommon health conditions, 2) improve diagnostic and treatment outcomes, and 3) support activities to address emerging WTC Health Program health and well-being priorities.

The WTC Health Program recognizes that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. There are many benefits which flow from a diverse scientific workforce, including fostering scientific innovation, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in and benefit from research, and enhancing public trust.

Ancillary Studies/Secondary Analysis of Existing Data

Applicants considering projects that depend on interaction or collaboration with the Data https://www1.nyc.gov/site/911health/researchers/published-research-publications.page https://www.cdc.gov/wtc/research.html https://www.cdc.gov/wtc/define.html https://ecfr.federalregister.gov/current/title-42/chapter-I/subchapter-G/part-88/section-88.1 https://ecfr.federalregister.gov/current/title-42/chapter-I/subchapter-G/part-88/section-88.1 https://ecfr.federalregister.gov/current/title-42/chapter-I/subchapter-G/part-88/section-88.7 https://ecfr.federalregister.gov/current/title-42/chapter-I/subchapter-G/part-88/section-88.8

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Centers, or the 9/11 Health Registry associated with the WTC Health Program ( Data Center and WTC Health Registry Contacts , below) must coordinate in advance with the respective Directors or Administrators of the Data Centers to ensure access to data and/or availability of adequate numbers of potential participants are feasible to conduct the proposed research. Documentation of the study recruitment plan and agreement on this coordination must be included in the application, along with any budgetary needs for the coordination activities, by providing both a letter from the investigator to the Data Center/Health Registry/WTC Health Program and a response letter from the Data Center/Health Registry/WTC Health Program to the investigator.

Data Center and WTC Health Registry Contacts

Fire Department of New York

Medical Director Dr. David Prezant, 718-999-2696, David.Prezant@fdny.nyc.gov

Administrative Director Ms. Jessica Weakley, 718-999-0412, Jessica.Weakley@fdny.nyc.gov

Associate Director, WTC FDNY Data Center Dr. Rachel Zeig-Owens, 718-403-4416, Rachel.Zeig-Owens@fdny.nyc.gov

Icahn School of Medicine at Mount Sinai

Director Dr. Andrew C. Todd, 212-824-7053, Andrew.Todd@mssm.edu

Data Requests Mr. Christopher R. Dasaro, 332-323-2806, Christopher.Dasaro@mssm.edu

NYC Health and Hospitals Corporation

Medical Director Dr. Joan Reibman, 212-263-6479, Joan.Reibman@nychhc.org

Executive Director Mr. Scott VanOrden, 646-458-2711, Scott.VanOrden@nychhc.org

Data Center Director Ms. Michelle Hyde, 212-788-0949, Michelle.Hyde@nychhc.org

WTC Health Registry

Public Affairs Manager Paul Gambino, 718-786-4481, pgambino1@health.nyc.gov

Evaluation/Performance Measurement Evaluations provide information for management and improve program effectiveness. The CDC document Framework for Program Evaluation can be helpful.

Effective program evaluation is a systematic way to improve and account for public health actions by involving procedures that are useful, feasible, ethical, and accurate.

Understanding and applying the elements of this framework for research projects may enhance planning effective public health strategies, improving existing programs including mailto:David.Prezant@fdny.nyc.gov mailto:Jessica.Weakley@fdny.nyc.gov mailto:Rachel.Zeig-Owens@fdny.nyc.gov mailto:Andrew.Todd@mssm.edu mailto:Christopher.Dasaro@mssm.edu mailto:Joan.Reibman@nychhc.org mailto:Scott.VanOrden@nychhc.org mailto:Michelle.Hyde@nychhc.org mailto:pgambino1@health.nyc.gov https://www.cdc.gov/eval/framework/index.htm

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evidence-based activities, and demonstrating beneficial results and impact of federal funding.

Translation Plan When relevant to the goals of the research project, applicants should describe briefly how the findings may be used to promote, enhance, or advance translation of the research into practice or may be used to inform public health policy. See A Way Forward: The Translational Impacts of World Trade Center Health Program Research.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information Funding Instrument

Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New

The OER Glossary and the How to Apply - Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s)

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

Estimated total funding (direct and indirect) available for this program is expected to be $4.0M; and assumes a 2-year period of performance.

Anticipated number of awards is 4 to 8.

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

Award Budget

Up to $500,000 in total costs (direct and indirect costs; including consortium F&A costs) for the 2-year period of performance.

No more than $365,000 in total costs may be requested in either year.

https://blogs.cdc.gov/niosh-science-blog/2021/10/26/wtchp-translational-impacts/ https://blogs.cdc.gov/niosh-science-blog/2021/10/26/wtchp-translational-impacts/ https://grants.nih.gov/grants/guide/url_redirect.php?id=11116 https://grants.nih.gov/grants/guide/url_redirect.php?id=82400 https://grants.nih.gov/grants/guide/url_redirect.php?id=82400 https://grants.nih.gov/grants/guide/url_redirect.php?id=82370 https://grants.nih.gov/grants/guide/url_redirect.php?id=82370

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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 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 Eligible Organizations Higher Education Institutions

Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education

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

Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

Small Businesses For-Profit Organizations (Other than Small Businesses)

Local Governments

State Governments County Governments

Award Project Period

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

RFA-OH-25-001: Exploratory/Developmental Research for World Trade Center Health Program Evidence-based Strategies to Improve Treatment Effectiveness, Di...

City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

Eligible Agencies of the Federal Government U.S. Territory or Possession

Other

Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations 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."

Federally Funded Research and Development Centers (FFRDCs): FFRDCs are operated, managed, and/or administered by a university or consortium of universities, other not-for-profit or nonprofit organization, or an industrial firm, as an autonomous organization or as an identifiable separate operating unit of a parent organization. A FFRDC meets some special long-term research or development need which cannot be met as effectively by an agency's existing in-house or contractor resources. FFRDCs enable agencies to use private sector resources to accomplish tasks that are integral to the mission and operation of the sponsoring agency. For more information on FFRDCs, go to https://gov.ecfr.io/cgi-bin/searchECFR.

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

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

For this announcement, applicants may not include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

Responsiveness Applications that exceed the 2-year period of performance limit, the total cost limit of $500,000 (including consortium F&A costs) for the 2-year period of performance or the total cost limit of $365,000 in either year will be considered non-responsive and will not proceed to peer review. In these cases, CDC/NIOSH will notify the applicant and request that the application be withdrawn.

The Research Strategy component of the Research Plan is limited to 6 pages. This page limit includes all text, tables, graphs, figures, diagrams, and charts in this component.

Upon receipt, applications will be evaluated for completeness by NIH/CSR and CDC/NIOSH. CDC/NIOSH will screen all applications for responsiveness. Incomplete or https://gov.ecfr.io/cgi-bin/searchECFR https://grants.nih.gov/grants/guide/url_redirect.php?id=11118 https://grants.nih.gov/grants/guide/url_redirect.php?id=11118

RFA-OH-25-001: Exploratory/Developmental Research for World Trade Center Health Program Evidence-based Strategies to Improve Treatment Effectiveness, Di...

non-responsive applications will not be reviewed. Applicants will be requested to withdraw non-responsive applications.

Special Requirements You must specify the WTC subpopulation(s) under study (see Section I. Population of Focus for descriptions) or a combination of these populations. If you propose to study a combination of these populations, you must clearly state the percentages of each population.

You must also include the primary diseases or conditions listed in Section I of this announcement that you propose to study, followed by a brief description.

The WTC Subpopulation(s) under study and Primary Diseases/Conditions must be included as one attachment titled "Study Information" in the "12. Other Attachments" section of the "R&R Other Project Information" component of the application. Please note there are other requirements specific to this announcement that must be included in this section of your application: Project Dissemination Plan and Project Evaluation Plan (see Section V, Additional Review Considerations for information), as well as Duplication of Efforts (see Section IV, Other Submission Requirements and Information for instructions).

Applicants who plan to collect public health data must submit a Data Management Plan (DMP) in the "11. 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. CDC OMB-approved templates may be used (e.g., NCCDPHP template). Other examples of DMPs may be found at USGS. See Section IV, Content and Form of Application Submission for information.

Note to Applicants Pre-application Public Information Sessions will be conducted in mid-September to address questions from prospective applicants regarding current research funding opportunities published by the WTC Health Program. During the sessions, CDC, NIOSH, and WTC Health Program staff will provide information on the scope of this and other relevant announcements, the application process, the peer review process, and answer questions about the NOFOs (note the staff will not take comments). Interested applicants wanting to learn more about the NOFOs and ask questions, please check the OEP website for dates, times and call-in methods, which will be posted no later than August 1.

WTC Health Program Reference Documents Interested applicants are strongly encouraged to review the WTC Health Program Research webpage, which provides comprehensive information and tools for researchers.

The research agenda, publication library, and other resources, including the Funding Dashboard, can also be found there (e.g., awarded project details such as publications, topics, populations, funding awarded, and the principal investigators and their institutions).

https://www.cdc.gov/chronicdisease/pdf/nofo/DMP-Template-508.docx https://www.usgs.gov/data-management/data-management-plans https://www.cdc.gov/niosh/oep/default.html#newsandnotices https://www.cdc.gov/niosh/oep/default.html#newsandnotices

RFA-OH-25-001: Exploratory/Developmental Research for World Trade Center Health Program Evidence-based Strategies to Improve Treatment Effectiveness, Di...

The WTC Health Program Research Publication Library

A regularly updated comprehensive listing of 9/11 health research publications from 2001 to present. Publications can be searched by study population, WTC cohort (responders, survivors, both), year of publication, outcome studied (WTC covered and non-covered conditions), and year published.

The WTC Research Grant Project Information Dashboard

The funding dashboard includes all research projects awarded since 2011 (the year that the Zadroga 9/11 Health and Compensation Act was signed into law). Project-specific information includes research institution, Principal Investigator, year awarded, and topic area (respiratory disease, mental health, cancer, cardiovascular disease, emerging conditions, and WTC youth).

Required Registrations Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) How to Apply - Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission. 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.

System for Award Management (SAM) (the replacement system for the Central Contractor Registration) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.

eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.

Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration. All applicant organizations must register with Grants.gov. Please visit www.Grants.gov at https://www.cdc.gov/wtc/researchpublications.html https://www.cdc.gov/wtc/fundingdashboard.html https://grants.nih.gov/grants/guide/url_redirect.php?id=82400 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://grants.nih.gov/grants/guide/url_redirect.php?id=82390 https://grants.nih.gov/grants/guide/url_redirect.php?id=82390 https://grants.nih.gov/grants/guide/url_redirect.php?id=11123 https://grants.nih.gov/grants/guide/url_redirect.php?id=82300

RFA-OH-25-001: Exploratory/Developmental Research for World Trade Center Health Program Evidence-based Strategies to Improve Treatment Effectiveness, Di...

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.

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…