RFA-OH-23-001 NIH Guide 2022Aug.pdf

RFA-OH-23-001: Exploratory/Developmental Grants Related to the World Trade Center Health Program (R21) https://grants.nih.gov/grants/guide/rfa-files/RFA-OH-23-001.html[8/24/2022 3:59:41 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 funding opportunity announcement (FOA) 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 Health Program (R21)

Activity Code

R21 Exploratory/Developmental Research Grant

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-OH-23-001

Companion Funding Opportunity

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

RFA-OH-23-001: Exploratory/Developmental Grants Related to the World Trade Center Health Program (R21)

Key Dates

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 and 116–59). Enrolled WTC responders and certified-eligible WTC survivors will be included in the research project.

Lifestyle medicine is a highly valuable, evidence-informed clinical approach, focused on managing and reversing many of the types of chronic diseases certified as WTC-related health conditions by the WTC Health Program. By focusing on sustainable health behaviors and lifestyle factors (including six pillars: nutrition and diet, sleep hygiene, stress management and positive psychology, physical activity, social connectedness, and avoidance of substance misuse), lifestyle medicine has the potential to limit disease progression; to prevent development of additional chronic diseases; and to improve health outcomes, overall member well-being, quality of life, and member satisfaction with the Program.

To establish the scope of the WTC Health Program FY2023 lifestyle medicine research, NIOSH seeks to achieve a suitable mix of projects and interventions focusing on sustainable health behaviors and the lifestyle factors described above. All of these sustainable health behaviors and lifestyle factors influence quality of life, disease progression and recurrence, survival, adverse events, and other health-related outcomes among WTC Health Program members.

NIOSH/WTC Health Program R21 grants support the early and conceptual stages of research projects that assess the feasibility of novel areas of investigation, with the potential to enhance the effectiveness of treatment and diagnostic practice. These studies may lead to breakthroughs in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that have a major clinical impact. These studies should break new ground or extend previous discoveries toward new directions or applications.

Applicants are expected to propose research approaches for which there is likely to be minimal or no preliminary data.

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

RFA-OH-23-001: Exploratory/Developmental Grants Related to the World Trade Center Health Program (R21)

Posted Date

August 23, 2022

Open Date (Earliest Submission Date)

November 1, 2022

Letter of Intent Due Date(s)

November 1, 2022 (LOI recommended but not required)

Application Due Date(s)

December 6, 2022

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 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 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 https://era.nih.gov/erahelp/assist https://www.era.nih.gov/need-help mailto:commons@od.nih.gov

RFA-OH-23-001: Exploratory/Developmental Grants Related to the World Trade Center Health Program (R21)

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 FOA. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Note: The Research Strategy component of the Research Plan is limited to 6 pages.

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

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

March 2023

Advisory Council Review

March 2023

Earliest Start Date

July 1, 2023

Expiration Date

December 12, 2022

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://public.era.nih.gov/commons/ 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-23-001: Exploratory/Developmental Grants Related to the World Trade Center Health Program (R21)

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. 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. Funding Opportunity Description Statutory Authority The World Trade Center (WTC) Health Program is authorized under the James Zadroga 9/11 Health and Compensation Act of 2010 (Public Law 111–347, as amended by Public Laws 114–113 and 116–59); codified in Title XXXIII of the Public Health Service Act at 42 U.S.C. §§ 300mm – 300mm–61, 124 Stat. 3623).

Background The World Trade Center (WTC) Health Program is administered by the National Institute for Occupational Safety and Health (NIOSH). Information on this program is available at the NIOSH 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 Law 116–59. 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.

https://www.grants.gov/web/grants/applicants/download-application-package.html#search=true&oppNum=RFA-OH-23-001 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 http://www.cdc.gov/niosh/topics/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.govinfo.gov/content/pkg/USCODE-2010-title42/html/USCODE-2010-title42-chap6A.htm

RFA-OH-23-001: Exploratory/Developmental Grants Related to the World Trade Center Health Program (R21)

Research to be conducted under the Zadroga Act includes epidemiologic and other research studies on WTC-related health conditions or emerging conditions among (1) enrolled WTC responders and certified-eligible WTC survivors under treatment; and (2) 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 Zadroga Act establishes a WTC Health Program Scientific/Technical Advisory Committee and indicates 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 and 116–59). Enrolled WTC responders and certified-eligible WTC survivors will be included in the research project.

Lifestyle medicine is a highly valuable, evidence-informed clinical approach, focused on managing and reversing many of the types of chronic diseases certified as WTC-related health conditions by the WTC Health Program. By focusing on sustainable health behaviors and lifestyle factors (including six pillars: nutrition and diet, sleep hygiene, stress management and positive psychology, physical activity, social connectedness, and avoidance of substance misuse), lifestyle medicine has the potential to limit disease progression; to prevent development of additional chronic diseases; and to improve health outcomes, overall member well-being, quality of life, and member satisfaction with the Program.

To establish the scope of the WTC Health Program FY2023 lifestyle medicine research, NIOSH seeks to achieve a suitable mix of projects and interventions focusing on sustainable health behaviors and the lifestyle factors described above. All of these sustainable health behaviors and lifestyle factors influence quality of life, disease progression and recurrence, survival, adverse events, and other health-related outcomes among WTC Health Program members.

NIOSH/WTCHP R21 grants support the early and conceptual stages of research projects that assess the feasibility of novel areas of investigation, with the potential to enhance the effectiveness of treatment and diagnostic practice. These studies may lead to breakthroughs in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that have a major clinical impact. These studies should break new ground or extend previous discoveries toward new directions or 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

RFA-OH-23-001: Exploratory/Developmental Grants Related to the World Trade Center Health Program (R21) applications. Long-term projects requiring preliminary data are solicited under other grant mechanisms (e.g., R01 or U01 projects) and will not be considered for R21 awards.

Major areas of research interest NIOSH is soliciting exploratory and developmental research projects (R21) that support and facilitate the feasibility, development, and evaluation of methods, practices, interventions, and programs related to Lifestyle Medicine within the following clinical research areas:

Treatment Research: Projects that develop and implement behavioral lifestyle interventions as an essential therapeutic approach to addressing chronic diseases certified by the Program, either as WTC-related condition or medically associated condition (MAC). Lifestyle treatment interventions can include but are not limited to psychotherapy, diet/nutrition, physical activity, care management and coordination, pharmaceutical optimization, stress management and identification of motivational metrics/interventions for achieving and maintaining lifestyle medicine goals. These treatment interventions should provide practical benefits for WTC Health Program enrollees.

Program Evaluation: Projects that evaluate WTC Health Program Lifestyle medicine interventions, programs, and outcomes. Projects can focus on the identification of improved methods/procedures to organize, manage, finance, and deliver lifestyle health care interventions designed to prevent or mitigate the development or reoccurrence of various diseases/disorders.

These include, but are not limited to:

cost analyses (e.g., treatment and pharmaceutical interventions), sustainability, assessment of socioecological and health inequities impact and mitigation strategies, assessment of various care delivery models (e.g., virtual and hybrid, etc.), assessment of staffing, training, and technology management needs, and treatment interventions (e.g., medicine(s), psychotherapy, stress management, socialization, nutrition, care management and coordination etc.).

Screening Research: Projects that evaluate current or facilitate the development of new/improved methods to identify and detect at-risk groups (e.g., individuals with a chronic illness, disorders or conditions influenced by lifestyle factors). Lifestyle care plan development, education and assessment of interest and the identification of common areas of health focus/concern.

Relevant focus areas include, but are not limited to:

nutrition and diet, sleep quality/hygiene, stress management and positive psychology, physical activity, RFA-OH-23-001: Exploratory/Developmental Grants Related to the World Trade Center Health Program (R21) social connectedness, avoidance of risky substances, and optimization of medication usage and reduction in polypharmacy

Relevant lifestyle issues/focus areas related to the following outcomes:

Respiratory diseases Cancer (including detection/diagnosis of pre-malignant changes) Cardiovascular disease Persistent psychiatric conditions such as posttraumatic stress, anxiety and depressive disorders Cognitive reserve, resilience or decline Aging – the impacts of aging on those impacted by 9/11 illness and injury (e.g., premature aging, optimizing adaptation for productivity) Neurological and neurodegenerative diseases/conditions Aerodigestive health 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 the WTC website, in the section titled, Petitions Received and WTC Health Program Responses.

Health Equity: Project proposals should include discussion 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.

Applicant research proposals should demonstrate:

how the design, content, format and dissemination of outreach efforts will be tailored to the needs of WTC populations from diverse backgrounds; and how historically underrepresented groups can be included in research projects, e.g., though participation on advisory boards, as researchers/staff, and though partnerships.

Objectives The overall objective of this announcement is to solicit meritorious and scientifically rigorous research applications that will 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 future disasters (see WTCHP Research- to- Care logic model).

Researchers can review WTC Health Program funded projects and publications by visiting the WTC Health Program Research Compendium to assist with an assessment of research gaps/needs.

Healthy People 2030 and other National Strategic Priorities The WTC research program funded by this FOA will contribute to the CDC strategic goal, https://www.cdc.gov/wtc/received.html https://www.cdc.gov/wtc/pdfs/research_to_care.pdf https://www.cdc.gov/wtc/pdfs/research_to_care.pdf https://www.cdc.gov/wtc/pdfs/research_to_care.pdf https://wwwn.cdc.gov/ResearchGateway/Publications/CompendiumArchive

RFA-OH-23-001: Exploratory/Developmental Grants Related to the World Trade Center Health Program (R21) 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 that 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 to be conducted under the Zadroga Act includes epidemiologic and other research studies on WTC-related health conditions or emerging conditions (1) among enrolled WTC responders and certified-eligible WTC survivors under treatment; and (2) in sampled populations outside the New York City disaster area in Manhattan (as far north as 14th Street) and in Brooklyn, along with (3) 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.

NIOSH's Research Compendium outlines the research goals and accomplishments of the WTC Health Program, program stakeholders, and research grantees. The compendium provides the research mission as defined by the James Zadroga 9/11 Health and Compensation Act of 2010 (Public Law 111–347, as amended by Public Laws 114–113 and 116–59). It gives a brief history of the program, an overview of the research goals, and a bibliography of all WTC Health Program-funded research project publications and links to constituent Primary Investigators and program-related websites and resources.

CDC/NIOSH solicited public comments regarding research interests in lifestyle medicine (such as sustainable health behaviors and lifestyle interventions) used to optimize management and improve outcomes of WTC-related health conditions. The WTC Health Program's research program helps answer critical questions about potential WTC-related physical and mental health, as well as diagnosing and treating health conditions on the List of WTC-Related Health Conditions.

The public comments (closed May 26, 2022) are shared in Docket CDC-2022-0055 at https://www.regulations.gov/document/CDC-2022-0055-0001.

Relevant Work https://health.gov/healthypeople https://wwwn.cdc.gov/ResearchGateway/Publications/CompendiumArchive http://www.gpo.gov/fdsys/pkg/PLAW-111publ347/pdf/PLAW-111publ347.pdf https://www.congress.gov/114/plaws/publ113/PLAW-114publ113.pdf https://www.regulations.gov/document/CDC-2022-0055-0001

RFA-OH-23-001: Exploratory/Developmental Grants Related to the World Trade Center Health Program (R21)

Information about current and completed NIOSH-funded research studies pertaining to the World Trade Center can be found at WTC Health Program Research Gateway and 9/11 Health Update (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 Registry's annual reports, prepared for enrollees and the public, include information on its key activities and accomplishments, as well as details on recent findings about the health consequences of 9/11.

The Research-to-Care Logic Model used by the WTC Health Program staff to evaluate the effectiveness of the WTC research program can be found at https://www.cdc.gov/wtc/pdfs/research_to_care.pdf.

More information can be found in the Research Compendium and public comments as described above.

Note: Interested applicants are strongly encouraged to review the Research Compendium, information on current and completed WTC research, and the Registry's annual reports.

Target Population The target population for research funded under this FOA 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.

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 who have been identified as eligible for medical monitoring and treatment as described in 42 CFR 88.1 or 88.12(b).

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 https://wwwn.cdc.gov/researchgateway https://www.cdc.gov/wtc/news.html#feb1021 https://www.cdc.gov/wtc/news.html#feb1021 https://www.mdpi.com/1660-4601/17/19/7290 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/pdfs/research_to_care.pdf https://wwwn.cdc.gov/ResearchGateway/Publications/CompendiumArchive https://www.regulations.gov/document/CDC-2022-0055-0001 https://wwwn.cdc.gov/ResearchGateway/Publications/CompendiumArchive https://wwwn.cdc.gov/ResearchGateway/Publications/CompendiumArchive 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 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-88.12

RFA-OH-23-001: Exploratory/Developmental Grants Related to the World Trade Center Health Program (R21) 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 wellness priorities.

Ancillary Studies/Secondary Analysis of Existing Data

Applicants considering projects that depend on interaction or collaboration with the Data 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

Mount Sinai School of Medicine

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 – Ms. Angeles Pai, 212-788-3466, paia@nychhc.org

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

WTC Health Registry

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

Evaluation/Performance Measurement 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:paia@nychhc.org mailto:Michelle.Hyde@nychhc.org mailto:pgambino1@health.nyc.gov

RFA-OH-23-001: Exploratory/Developmental Grants Related to the World Trade Center Health Program (R21)

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 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 WTC Health Program Research-to-Care logic model.

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 Renewal Revision 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 FOA.

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.

https://www.cdc.gov/eval/framework/index.htm https://www.cdc.gov/wtc/pdfs/research_to_care.pdf https://www.cdc.gov/wtc/pdfs/research_to_care.pdf https://grants.nih.gov/grants/guide/url_redirect.htm?id=11116 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-23-001: Exploratory/Developmental Grants Related to the World Trade Center Health Program (R21)

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/NIOSH 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

Awards issued under this FOA 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.

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.

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 FOA.

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.

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

RFA-OH-23-001: Exploratory/Developmental Grants Related to the World Trade Center Health Program (R21)

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 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. FFRDC's 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 NIH Grants Policy Statement, are not allowed.

For this announcement, applicants may include collaborators or consultants from foreign institutions.

All applicable federal laws and policies apply.

Responsiveness https://gov.ecfr.io/cgi-bin/searchECFR https://grants.nih.gov/grants/guide/url_redirect.htm?id=11118 https://grants.nih.gov/grants/guide/url_redirect.htm?id=11118 https://grants.nih.gov/grants/guide/url_redirect.htm?id=11118

RFA-OH-23-001: Exploratory/Developmental Grants Related to the World Trade Center Health Program (R21)

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 be reviewed. 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. These page limits are the totals for 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 non-responsive applications will not be reviewed. Applicants will be requested to withdraw non-responsive applications.

Note to Applicants

You must list the Study Design of your proposed study, followed by a brief description.

You must specify the WTC Subpopulation(s) under study (see Section I. Target Population 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 relevant Lifestyle Issues/Focus Areas listed in Section I of this announcement that you propose to study, followed by a brief description.

The Study Design, WTC Subpopulation(s) under study and relevant Lifestyle Issues/Focus Areas should be included as one attachment titled "Study Information" in the "12. Other Attachments" section of the "R&R Other Project Information" section of the application. Please note there are other requirements specific to this announcement that must be included in your application: Project Dissemination Plan, Project Evaluation Plan, Resource Sharing Plan and Data Management Plan (see Section IV, 2. Content and Form of Application Submission for information and place to upload the contents), as well as CDC Risk Questionnaire and if applicable, Duplication of Efforts (see Section IV, 7. Other Submission Requirements and Information for instructions).

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

Diseases/Conditions Requiring Further Program Consideration

Applicants may propose to study Other 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.

WTC Health Program Reference Documents

The WTC Health Program Research Compendium

NIOSH's Research Compendium outlines the research goals and accomplishments of the WTC Health https://www.cdc.gov/wtc/received.html

RFA-OH-23-001: Exploratory/Developmental Grants Related to the World Trade Center Health Program (R21)

Program, program stakeholders, and research grantees. The compendium provides the research mission as defined by the James Zadroga 9/11 Health and Compensation Act of 2010. It gives a brief history of the program, an overview of the research goals, and a bibliography of all WTC Health Program-funded research project publications and links to constituent Primary Investigators and program-related websites and resources.

Public Input on Research Interests in Lifestyle Medicine

CDC/NIOSH solicited public comments regarding research interests in lifestyle medicine (such as sustainable health behaviors and lifestyle interventions) used to optimize management and improve outcomes of WTC-related health conditions. The WTC Health Program's research program helps answer critical questions about potential WTC-related physical and mental health, as well as diagnosing and treating health conditions on the List of WTC-Related Health Conditions.

The public comments (closed May 26, 2022) are shared in Docket CDC-2022-0055 at https://www.regulations.gov/document/CDC-2022-0055-0001.

Note: Interested applicants are strongly encouraged to review the WTC Health Program Research Compendium, information on current and completed WTC research, and the Registry's annual reports.

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 successfully completed and active prior to the application due date. 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.

NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.

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.

Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

https://www.regulations.gov/document/CDC-2022-0055-0001 https://wwwn.cdc.gov/ResearchGateway/Publications/CompendiumArchive https://wwwn.cdc.gov/ResearchGateway/Publications/CompendiumArchive https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-039.html https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-039.html https://www.gsa.gov/about-us/organization/federal-acquisition-service/office-of-systems-management/integrated-award-environment-iae/iae-systems-information-kit/unique-entity-identifier-update 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.htm?id=82390 https://grants.nih.gov/grants/guide/url_redirect.htm?id=82390 https://grants.nih.gov/grants/guide/url_redirect.htm?id=11176 https://grants.nih.gov/grants/guide/url_redirect.htm?id=11176 https://www.gsa.gov/about-us/organization/federal-acquisition-service/office-of-systems-management/integrated-award-environment-iae/iae-systems-information-kit/unique-entity-identifier-update https://www.gsa.gov/about-us/organization/federal-acquisition-service/office-of-systems-management/integrated-award-environment-iae/iae-systems-information-kit/unique-entity-identifier-update https://grants.nih.gov/grants/guide/url_redirect.htm?id=82300

RFA-OH-23-001: Exploratory/Developmental Grants Related to the World Trade Center Health Program (R21) eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; 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.

All applicant organizations must register with Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes. The one-time registration process will take three to five days to complete. However, it is best to start the registration process at least two weeks prior to application submission.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. All Senior/Key Personnel (including PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing PD/PI eRA Commons account is affiliated with the eRA commons account of the applicant organization. Obtaining an eRA Commons account can take up to 2 weeks. 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.

If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. 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 https://grants.nih.gov/grants/guide/url_redirect.htm?id=11123 https://grants.nih.gov/grants/guide/url_redirect.htm?id=11123 https://www.grants.gov/

RFA-OH-23-001: Exploratory/Developmental Grants Related to the World Trade Center Health Program (R21) at SAM.gov and the SAM.gov Knowledge Base.

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

Eligible Individuals (Program Director/Principal Investigator) in Organizations/Institutions This FOA invites applications from both experienced researchers and researchers who are at the early stage of their independent careers or have not had substantial prior NIH/CDC funding.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for CDC/NIOSH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

When multiple PDs/PIs are proposed, NIOSH requires one PD/PI to be designated as the "Contact" PI, who will be responsible for all communications between the PDs/PIs and the NIOSH, for assembling the application materials outlined below, and for coordinating progress reports. The Contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs.

NOTE: The CDC does not make awards to individuals directly.

2. Cost Sharing This FOA does not require cost sharing as defined in the HHS Grants Policy Statement.

3. Additional Information on Eligibility Number of Applications Applicant organizations may submit more than one application, provided that each application is scientifically distinct.