RFA-OH-24-003 R21 Survivors Only NIH.pdf

RFA-OH-24-003: Exploratory/Developmental Grants Related to the World Trade Center Survivors (R21-No Applications with Responders Accepted) https://grants.nih.gov/grants/guide/rfa-files/RFA-OH-24-003.html[8/17/2023 3:09:34 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)

Funding Opportunity Title

Exploratory/Developmental Grants Related to the World Trade Center Survivors (R21-No Applications with Responders Accepted)

Activity Code

R21 Exploratory/Developmental Research Grant

Announcement Type

Reissue of RFA-OH-22-004

Related Notices

None

Notice of Funding Opportunity (NOFO) Number

RFA-OH-24-003

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 https://grants.nih.gov/grants/guide/rfa-files/RFA-OH-22-004.html

RFA-OH-24-003: Exploratory/Developmental Grants Related to the World Trade Center Survivors (R21-No Applications with Responders Accepted)

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 projects (R21) that address issues related to diagnostic or treatment uncertainty with respect to individuals receiving monitoring and/or treatment under subtitle B 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 and 117-328).

To help address the Zadroga Act research mandate, as supported by the World Trade Center (WTC) Health Program and in consultation with the WTC Health Program Scientific/Technical Advisory Committee, NIOSH is soliciting applications for scientifically rigorous research (42 U.S.C. §300mm–51) among screening-eligible and certified-eligible WTC survivors and similarly exposed populations in New York City in Manhattan between Houston Street and 14th Street and in Brooklyn to help answer critical questions about:

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.

A major area of research interest of this announcement also includes improving the healthcare and well-being of at-risk survivor populations including minority groups, women exposed while pregnant or of reproductive age, the elderly, adolescents, and other minor children. 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.

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.

In addition to screening-eligible and certified-eligible WTC survivors, 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.

The NIOSH/WTC Health Program R21 grant is intended to encourage https://www.congress.gov/111/plaws/publ347/PLAW-111publ347.pdf 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.cdc.gov/wtc/stac.html https://www.cdc.gov/wtc/stac.html 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/define.html https://www.cdc.gov/wtc/define.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

RFA-OH-24-003: Exploratory/Developmental Grants Related to the World Trade Center Survivors (R21-No Applications with Responders Accepted)

Key Dates 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 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 approaches 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

August 16, 2023

Open Date (Earliest Submission Date)

November 1, 2023

Letter of Intent Due Date(s)

November 1, 2023 (LOI recommended but not required)

Application Due Date(s)

December 5, 2023

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 on the listed application due date.

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 https://www.cdc.gov/wtc/research.html https://era.nih.gov/erahelp/assist

RFA-OH-24-003: Exploratory/Developmental Grants Related to the World Trade Center Survivors (R21-No Applications with Responders Accepted)

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.

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

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

Applicants are strongly encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Note: HHS/CDC grant submission procedures do not provide a 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 2024

Advisory Council Review

April 2024

Earliest Start Date

July 1, 2024

Expiration Date

January 4, 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 https://www.era.nih.gov/need-help mailto:commons@od.nih.gov 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-24-003: Exploratory/Developmental Grants Related to the World Trade Center Survivors (R21-No Applications with Responders Accepted)

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 not accepted 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 Health Program is authorized under Section 301 of the Public Health Service Act as amended (42 U.S.C. 241) and the James Zadroga 9/11 Health and Compensation Act of 2010 (Public Law 111–347, as amended by Public Laws 114–113, https://public.era.nih.gov/commons/ https://www.grants.gov/web/grants/applicants/download-application-package.html#search=true&oppNum=RFA-OH-24-003 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

RFA-OH-24-003: Exploratory/Developmental Grants Related to the World Trade Center Survivors (R21-No Applications with Responders Accepted)

116–59 and 117-328); codified in Title XXXIII of the Public Health Service Act at 42 U.S.C.

§§ 300mm – 300mm–62. The authority for this specific research is found in Section 3341 of the Zadroga Act, as amended (42 U.S.C. §§ 300mm–51).

Background 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 and 117-328. 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, screening-eligible WTC survivors, and 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 B 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 and 117-328).

https://www.congress.gov/116/plaws/publ59/PLAW-116publ59.pdf https://www.congress.gov/117/bills/hr2617/BILLS-117hr2617enr.pdf 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.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

RFA-OH-24-003: Exploratory/Developmental Grants Related to the World Trade Center Survivors (R21-No Applications with Responders Accepted)

To help address the Zadroga Act research mandate, as supported by the WTC Health Program and in consultation with the WTC Health Program Scientific/Technical Advisory Committee, NIOSH is soliciting applications for scientifically rigorous research (42 U.S.C.

§300mm–51) among screening-eligible and certified-eligible WTC survivors and similarly exposed populations in New York City in Manhattan between Houston Street and 14th Street and in Brooklyn to both address critical questions about physical and mental health conditions and provide practical treatment and diagnostic benefits for enrollees.

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.

In addition to screening-eligible and certified-eligible WTC survivors, proposed research can include 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.

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 NIOSH/WTC Health Program R21 grant 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 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. Applications for long-term projects requiring preliminary data are solicited under other grant mechanisms (e.g., R01 or U01 projects) and will not be accepted for the R21 funding mechanism.

Major areas of WTC Survivor research interest include, but are not limited to, the following:

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.

A major area of research interest of this announcement also includes improving the healthcare and well-being of at-risk survivor populations including minority groups, women exposed while pregnant or of reproductive age, the elderly, adolescents, and other minor children.

https://www.cdc.gov/wtc/stac.html https://www.cdc.gov/wtc/stac.html 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/define.html https://ecfr.federalregister.gov/current/title-42/chapter-I/subchapter-G/part-88/section-88.1

RFA-OH-24-003: Exploratory/Developmental Grants Related to the World Trade Center Survivors (R21-No Applications with Responders Accepted)

Health Equity: Proposed projects should include discussions describing how research questions, data collection methods and analysis, and dissemination of results will be inclusive of the diversity in the WTC populations, especially those from historically underrepresented groups including women, minorities, foreign-born individuals, and individuals of all ages, including appropriate representation of older adults and individuals exposed to the WTC disaster prior to 18 years of age.

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.

Types of clinical research areas that will be considered for potential projects include, but are not limited to:

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.

Quality of Life Research: Projects that identify, develop, or evaluate, methods/interventions that improve comfort and the quality of life for individuals with a chronic illness or multimorbidity.

Omics Research: Projects that facilitate improvement in methods/procedures for the prediction of disorders by identifying and understanding how genes and illnesses may be related (e.g., identification of phenotypes and biomarkers). Research in this area may explore ways in which a person’s genes make him or her more or less likely to develop a disorder or respond to a medication.

Epidemiological/Clinical Research: Projects that seek to identify the patterns, causes, and control of disorders among the WTC population, including women and those exposed to 9/11 as children. These projects will also identify, implement, and improve research

RFA-OH-24-003: Exploratory/Developmental Grants Related to the World Trade Center Survivors (R21-No Applications with Responders Accepted) methods.

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.

Health Equity Research: Projects that identify/develop methods to systematically determine whether there are unique vulnerabilities and health disparities among individuals exposed to the 9/11 attacks and aftermath. Vulnerable groups include but are not limited to, women, minorities, foreign-born individuals, and individuals of all ages, with appropriate representation of older adults and individuals exposed to the WTC disaster prior to 18 years of age.

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 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 productive aging) Neurological Diseases Aerodigestive health Birth and Reproductive Outcomes Multisystem or auto-immune diseases Other Emerging conditions – research supported by evidence from existing surveillance, research, or concerns raised by the 9/11-exposed population, which point to either a new appearance of a WTC-related health condition or a new understanding of an existing WTC-related health condition.

Among many health conditions that may be explored, there are several conditions that have come to light because of concerns expressed by the affected population. These health conditions include, but are not limited to, endocrine-related disorders, including metabolic syndrome; reproductive health outcomes, such as polycystic ovary syndrome (PCOS), endometriosis, and infertility; autoimmune and neurodegenerative diseases; and cancer among individuals exposed to the WTC disaster at younger ages (18 years of age or younger).

In response to health equity initiatives, 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 September 11, 2001, terrorist

RFA-OH-24-003: Exploratory/Developmental Grants Related to the World Trade Center Survivors (R21-No Applications with Responders Accepted) attacks and aftermath are of special interest. Research is needed to identify at-risk groups, characterize the health burden, and inform care. Potential projects include (but are not limited to) research targeted to:

Develop and apply methods for identifying a cohort of eligible young adult study subjects (exposed and control groups) and determine their willingness to participate in future health effects research. These methods include, but are not limited to, community-based approaches to recruitment that engage existing outreach and education partners and mixed methods research to assess health concerns and interests in research participation.

Develop methods to systematically determine whether there are unique vulnerabilities and health disparities in groups within the population of individuals exposed to the 9/11 attacks and its aftermath.

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 exploratory/developmental 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;

improve the healthcare and well-being of the at-risk survivor populations including minority groups, women exposed while pregnant or of reproductive age, the elderly, adolescents, and other minor children; and apply lessons learned from 9/11 to improve response to and mitigation of health effects from future disasters.

NIOSH seeks to achieve a suitable mix of projects that help advance treatment effectiveness and the understanding of health and well-being impacts related to the September 11, 2001, terrorist attacks among WTC survivors.

Increased knowledge of the characteristics of WTC-related illnesses and disorders, such as pathology, prognosis, latency, and the effects of other risk factors and comorbidities, is critical for achieving improved treatment and intervention protocols. Scientific evaluation of the translation of WTC Health Program research outputs into practical benefits enhances research integration and expedites research-to-care program objectives.

Researchers are encouraged to review WTC Health Program funded projects and publications by visiting the Program Research webpage to assist with an assessment of research gaps and needs.

Healthy People 2030 and other National Strategic Priorities The WTC research program funded by this NOFO will contribute to the CDC strategic

RFA-OH-24-003: Exploratory/Developmental Grants Related to the World Trade Center Survivors (R21-No Applications with Responders Accepted) 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, screening-eligible WTC survivors, and 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.

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).

CDC/NIOSH solicited public comments regarding research priorities for WTC Health Program research projects on WTC survivors (adults and children) and similar survivor populations south of 14th street in Manhattan and in Brooklyn. The WTC Health Program's research program helps answer critical questions about potential 9/11-related physical https://health.gov/healthypeople https://health.gov/healthypeople

RFA-OH-24-003: Exploratory/Developmental Grants Related to the World Trade Center Survivors (R21-No Applications with Responders Accepted) and mental health, as well as diagnosing and treating health outcomes on the List of WTC-Related Health Conditions.

The public comments (closed August 23, 2021) are shared in Docket CDC-2021-0071 at https://www.regulations.gov/document/CDC-2021-0071-0001.

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 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.

Target Population The target population for research funded under this NOFO are individuals exposed to the September 11, 2001, terrorist attacks, specifically community members (also referred to as survivors).

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.

In addition to screening-eligible and certified-eligible WTC survivors, 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.

Ancillary Studies/Secondary Analysis of Existing Data

Applicants considering projects that depend on interaction or collaboration with the Data https://www.regulations.gov/document/CDC-2021-0071-0001 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 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

RFA-OH-24-003: Exploratory/Developmental Grants Related to the World Trade Center Survivors (R21-No Applications with Responders Accepted)

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

RFA-OH-24-003: Exploratory/Developmental Grants Related to the World Trade Center Survivors (R21-No Applications with Responders Accepted) 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 support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New Resubmission

The OER Glossary and the SF424 (R&R) 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 meritorious 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 any single 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.htm?id=11116 https://grants.nih.gov/grants/guide/url_redirect.htm?id=82370 https://grants.nih.gov/grants/guide/url_redirect.htm?id=82370

RFA-OH-24-003: Exploratory/Developmental Grants Related to the World Trade Center Survivors (R21-No Applications with Responders Accepted)

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 City or Township Governments

Award Project Period

2 years.

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.

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

RFA-OH-24-003: Exploratory/Developmental Grants Related to the World Trade Center Survivors (R21-No Applications with Responders Accepted)

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 Institutions Non-domestic (non-U.S.) Entities (Foreign Institutions) 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 HHS 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 See Section I. Target Population for descriptions of allowed WTC subpopulation. No applications with responders are accepted for this NOFO.

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 any single 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.

https://gov.ecfr.io/cgi-bin/searchECFR

RFA-OH-24-003: Exploratory/Developmental Grants Related to the World Trade Center Survivors (R21-No Applications with Responders Accepted)

Upon receipt, applications will be evaluated for completeness by NIH/CSR and CDC/NIOSH. CDC/NIOSH will screen all applications for responsiveness. Incomplete or non-responsive applications will not be reviewed. Applicants will be requested to withdraw non-responsive applications.

Note to Applicants You must specify the WTC Subpopulation under study (WTC survivors; see Section I.

Target Population for descriptions). No applications with responders are accepted for this

NOFO.

You must also include the primary diseases or conditions (e.g., respiratory disease, adult mental health, cancer, children’s research or emerging conditions) that you propose to study, with a brief description of the diseases or conditions.

The WTC Subpopulation 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 CDC Risk Questionnaire with supporting documentation and 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 Resource Sharing Plan 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). See Section IV, Content and Form of Application Submission and Section V, Additional Review Considerations for information.

The NIOSH Secondary Review Committee (SRC) may categorize and prioritize projects by WTC subpopulation and relevant diseases/conditions listed in Section I of this announcement based on program needs.

WTC Health Program Reference Documents

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 https://www.cdc.gov/chronicdisease/pdf/nofo/DMP-Template-508.docx https://www.cdc.gov/wtc/researchpublications.html https://www.cdc.gov/wtc/fundingdashboard.html

RFA-OH-24-003: Exploratory/Developmental Grants Related to the World Trade Center Survivors (R21-No Applications with Responders Accepted) 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).

Public Input on the Scope of WTC Health Program Research Activities on WTC Survivors (Docket CDC-2021-0071)

CDC/NIOSH solicited public comments regarding research priorities for WTC Health Program research projects on WTC survivors (adults and children) and similar survivor populations south of 14th street in Manhattan and in Brooklyn. The WTC Health Program's research program helps answer critical questions about potential 9/11-related physical and mental health, as well as diagnosing and treating health outcomes on the List of WTC-Related Health Conditions. The public comments for Docket CDC-2021-0071 closed on August 23, 2021.

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

Required Registrations Applicant Organizations

Applicant organizations must complete and maintain 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. 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. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

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)– 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 https://www.regulations.gov/document/CDC-2021-0071-0001 https://www.cdc.gov/wtc/research.html https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-039.html…