rfa-oh-26-016_v4b.pdf

Notice of Funding Opportunity

Application due February 20, 2026

National Institute for Occupational Safety and Health (NIOSH) World Trade Center Health Program

Extension of the World Trade Center Health Registry (U50) Opportunity number: RFA-OH-26-016

Contents

Step 1: Review the Opportunity 4

Basic information 5

Eligibility 7

Program description 10

Step 2: Get Ready to Apply 21

Find the application package 22

Get registered 22

Help applying 23

Step 3: Build Your Application 24

Application checklist 25

Application contents and format 26

Step 4: Understand Review, Selection, and Award 31

Application review 32

Award notices 40

Step 5: Submit Your Application 41

Submission requirements and deadlines 42

Step 6: Learn What Happens After Award 44

Post-award requirements and administration 45

Contacts and Support 49

Before you begin 3

Contents 2

Before you begin If you believe you are a good candidate for this funding opportunity, secure your SAM.gov and Grants.gov registrations now. If you are already registered, make sure your registrations are active and up-to-date.

SAM.gov registration (this can take several weeks) You must have an active account with SAM.gov. This includes having a Unique Entity Identifier (UEI).

See Step 2: Get Ready to Apply

Grants.gov registration (this can take several days) You must have an active Grants.gov registration. Doing so requires a Login.gov registration as well.

See Step 2: Get Ready to Apply

Apply by the application due date Applications are due by 11:59 p.m. Eastern Time on February 20, 2026.

To help you find what you need, this NOFO uses internal links. In Adobe Reader, you can go back to where you were by pressing Alt + Left Arrow (Windows) or Command + Left Arrow (Mac) on your keyboard.

Before you begin 3 https://sam.gov/ https://grants.gov/

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1:

Review the Opportunity

In this step

Basic information 5

Eligibility 7

Program description 10

Basic information Centers for Disease Control and Prevention (CDC)

National Institute for Occupational Safety and Health (NIOSH)

World Trade Center Health Program

Providing a central, unified, and up-to-date database for the study and improvement of the health and well-being of those impacted by the 9/11 attacks.

Have questions?

See Contacts and Support.

Key facts

Opportunity name:

Extension of the World Trade Center Health Registry (U50)

Opportunity number:

RFA-OH-26-016

Assistance listing: 93.262

NOFO version: original

Key dates

Application submission deadline:

February 20, 2026

Optional letter of intent deadline:

January 22, 2026

Expected scientific review dates:

April 2026

Expected secondary review dates:

May 2026

Expected award date:

June 26, 2026

Expected start date:

July 1, 2026

Expiration date:

February 20, 2026

See Submit Your Application for other submission requirements and deadlines that may apply to this NOFO.

Summary This notice of funding opportunity (NOFO) is to extend the World Trade Center (WTC) Health Registry to meet the statutory mandate. This is a cooperative agreement between the recipient and the WTC Health Program within the National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC). It will provide a total of $47.4 million for a performance period of five years. The recipient will expand the current Registry’s work to ensure it continues to provide a central, unified database for the study and improvement of health and well-being of those impacted by the 9/11 attacks.

To apply for this award, follow all the instructions listed in this NOFO. In your responses, describe appropriate strategies and methodologies you will use to meet the specific objectives and outcomes within the period of performance.

These include:

• Maintain the Registry as a public health resource.

• Expand knowledge about the physical and mental health effects of 9/11.

• Conduct community activities to respond to concerns and specific healthcare needs of those with 9/11 exposure.

• Maintain and extend the 9/11 Treatment Referral Program.

• Collaborate with the WTC Health Program and its entities at various levels.

Include an evaluation and performance measurement plan for each objective in your application. Briefly describe how research findings may be translated into practice or may inform strategies to improve health and well-being of people impacted by the 9/11 attacks.

Step 1: Review the Opportunity 5

We will review how directly your application responds to this NOFO. Non-federal scientists and senior federal scientists will review and score only responsive applications. We will award the application with the highest score.

Funding details Funding type: Cooperative agreement

Expected awards: 1

The number of awards is subject to available funds and program priorities.

Period of performance: Five years in 12-month budget periods.

Application type: New and Renewal

Expected total program funding over the performance period: $47.4 million

Expected total program funding per budget period: $9.48 million

Expected funding per applicant per budget period: $9.48 million

Maximum award amount per budget period: $9.48 million

Minimum award amount per budget period: $0

Funding strategy NIOSH intends to commit over a five-year period approximately $47,400,000 in total costs (direct and indirect) to fund one award. The estimated FY2026 funding is $9,480,000. It is possible that additional funds in later budget periods would be based on increases in the cost-of-living Consumer Price Index if available and approved by the WTC Health Program.

Step 1: Review the Opportunity 6

Eligibility Eligible applicants Only these types of organizations may apply:

• State governments.

• County governments.

• City or township governments.

• Special district governments.

• Independent school districts.

• Public and state-controlled institutions of higher education.

• Native American tribal governments (federally recognized).

• Public housing authorities and Indian housing authorities.

• Native American tribal organizations, other than federally recognized tribal governments.

• Nonprofits having a 501(c)(3) status, other than institutions of higher education.

• Nonprofits without 501(c)(3) status, other than institutions of higher education.

• Private institutions of higher education.

• For-profit organizations other than small businesses.

• Small businesses.

• Federally Funded Research and Development Centers.

• Faith-based or community-based organizations.

• Regional organizations.

• Bona fide agents applying on behalf of state, territorial, local, and tribal government organizations.

Bona fide agents must submit documentation that demonstrates their arrangement with the eligible applicant. See Other attachments form.

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.

Step 1: Review the Opportunity 7

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 criteria We will review your application to make sure it meets these requirements.

These are the basic requirements you must meet to move forward in the competition. We won’t consider an application that:

• Is from an organization that doesn’t meet all eligibility criteria. See requirements in Eligibility.

• Is submitted after the application deadline.

• Exceeds the five-year period of performance limit.

• Has a proposed budget for any fiscal year more than the maximum funding amount for each budget period of $9.48 million as outlined in the Funding details section.

See the Application checklist to understand which elements of your application are part of the responsiveness criteria.

Application limits You must follow these limits on the number of applications your organization can submit.

You may submit more than one application per institution if each application is scientifically distinct. The principal investigator (PI) must be different for each application you submit.

Qualifications for principal investigator or project director We invite anyone who has the skills, knowledge, and resources needed to carry out the proposed research as a project director or principal investigator (PD/PI) to work with their organization or institution to apply.

If there are multiple PDs/PIs, we require one PD/PI to serve as the “Contact” PI. The “Contact” PI will be responsible for all communications between the PDs/PIs and NIOSH, for assembling the application materials, and for coordinating progress reports.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 8 https://grants.nih.gov/grants/guide/url_redirect.htm?id=11118

Cost sharing and matching funds This program has no cost-sharing requirement, meaning you do not need to contribute to the costs of this project.

If you choose to include cost-sharing funds, we won’t consider it during review. If you receive an award, we will include your voluntary commitment in the award, and you must report on the funds.

Post-award requirements

Before you apply, make sure you understand the requirements that come with an award.

See Step 6: Learn What Happens After Award for information on regulations that apply, reporting, and more.

Step 1: Review the Opportunity 9

Program description Background The Agency for Toxic Substances and Disease Registry (ATSDR) and the New York City Department of Health and Mental Hygiene (NYC DOH) established the World Trade Center (WTC) Health Registry (the Registry) in 2002. The Registry’s goal was to monitor the health of people directly exposed to the 9/11 attacks. The Registry has received federal funding to begin operations since then, and it has collaborated with the National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC) since May 2009.

The Registry is the largest health registry in U.S. history to monitor people’s health related to exposure to a large disaster. Over 71,000 people have voluntarily enrolled. The Registry’s population includes those who performed 9/11-related rescue and recovery work, or lived, worked, or attended school in lower Manhattan on 9/11/2001.

Since its establishment, the Registry has completed five major health survey waves between 2003-2024 and has launched a sixth wave. Between these waves, the Registry has also conducted focused surveys on specific topics such as Hurricane Sandy impact, autoimmune disease, health and employment, COVID-19, and multiple chemical sensitivity. You can find more information about these surveys on its survey material website. The Registry also prepares annual reports for enrollees and the public. These reports include information on key activities, accomplishments, and recent findings on the health impacts of the 9/11 attacks.

The Registry’s work helps the WTC Health Program by:

• Identifying physical and mental health effects from exposure to the 9/11 attacks and related healthcare needs.

• Disseminating findings and recommendations to a broad community.

• Sharing information about 9/11-related resources and services.

• Informing healthcare policy and future disaster response planning.

The Registry is currently managed by the NYC DOH and funded through a cooperative agreement with CDC/NIOSH. This NOFO is to provide funding to extend the WTC Health Registry.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 10 https://www.atsdr.cdc.gov/index.html https://www.nyc.gov/site/doh/index.page https://www.nyc.gov/site/doh/index.page https://www.nyc.gov/site/911health/index.page https://www.cdc.gov/niosh/index.htm https://www.cdc.gov/niosh/index.htm https://www.cdc.gov/index.htm https://www.cdc.gov/index.htm https://www.nyc.gov/site/911health/researchers/survey-materials.page https://www.nyc.gov/site/911health/researchers/annual-reports.page

Related work You can find related information and work at the following websites:

• WTC Health Program Research webpage

• Current and completed NIOSH-funded 9/11 research studies: WTC Health Program Funded Projects

• All publications related to 9/11 exposure: 9/11 Health Research Publications

• The Registry’s key activities, accomplishments, and recent findings:

Annual reports

• More information about the current Registry: World Trade Center Health Registry

Purpose This NOFO is to extend the Registry to ensure that it continues to provide a central, unified database for the study and improvement of health and well-being of those impacted by the 9/11 attacks. This work includes:

• Follow-up survey waves.

• Focused surveys or studies of specific topics.

• In-depth studies of subgroups.

• Linkage to other data sources.

• Emerging health condition identification and investigation.

• Research facilitation with external researchers.

• Healthcare facilitation for people enrolled in the Registry.

• Support to the WTC Health Program on surveillance, research, and administration.

• Research translation.

• Community outreach and engagement.

Public health impact The WTC Health Program’s mission is to provide high-quality, compassionate medical monitoring and treatment for WTC-related conditions to those directly affected by the 9/11 attacks. Although the full scope of 9/11-related health problems is unknown, increasing evidence suggests that significant health conditions may be associated with the 9/11 attacks among those directly exposed. The Registry serves as a central, unified database to assess short-term and long-term health effects among this population. It facilitates

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 11 https://www.cdc.gov/wtc/research.html https://www.cdc.gov/wtc/fundingdashboard.html https://www.cdc.gov/wtc/fundingdashboard.html https://www.cdc.gov/wtc/researchpublications.html https://www.cdc.gov/wtc/researchpublications.html https://www1.nyc.gov/site/911health/researchers/annual-reports.page https://www.nyc.gov/site/911health/index.page https://www.nyc.gov/site/911health/index.page studies on health impacts of the 9/11 attacks conducted by external researchers and serves as a valuable tool for the WTC Health Program.

The Registry’s research, along with other NIOSH-funded research, provides scientific evidence to healthcare professionals to diagnose WTC-related conditions earlier. This leads to more effective treatment for WTC Health Program members. Although it is challenging 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.

CDC priorities CDC is committed to gold-standard science and ensuring trust, transparency, and credibility.

Approach We expect that your application includes plans for the major tasks below to accomplish the goal of the WTC Health Registry:

• Align with the WTC Health Program Research Agenda: Establish a procedure that allows the WTC Health Program to review all proposed projects (whether internal or external) to ensure they align with the research needs, priorities, and goals of the WTC Health Program. The WTC Health Program’s areas of interest include:

◦ Linking 9/11 exposure to health conditions.

◦ Characterizing and treating established WTC-related diseases and comorbidities.

◦ Health services research and value-based care that addresses disaster-related injury and illness for chronic disease.

◦ Characterizing the work-ability and occupational outcomes for those impacted by the 9/11 attacks.

◦ Medical, public health, emergency preparedness research, as well as other scientific research relevant to the WTC Health Program.

• Continue Registry follow-up survey wave(s): Plan and conduct continuing follow-up surveys and analysis of the long-term health effects of the 9/11 attacks, building on previous surveys.

• Expand focused or in-depth studies: Explore, plan, and conduct studies focusing on specific topics or subgroups (e.g., emerging health concerns, healthcare service needs and utilizations, youth survivors, and second-generation individuals of enrollees exposed to the 9/11 attacks).

Step 1: Review the Opportunity 12

• Explore and conduct data linkage studies: Explore, plan, and conduct data linkage with other data sources, such as linking enrollees with cancer registries, hospitalization data, Medicare/Medicaid data, MarketScan data, U.S. Renal Data System, and vital records. Perform appropriate analyses and disseminate findings.

• Support external Registry studies: Establish and maintain protocols to permit and facilitate other researchers to use the Registry or de-identified Registry data for research related to the health impact of the 9/11 attacks. Establish a clear process to contact consented enrollees about external studies they may participate in.

• Build and maintain database and analysis infrastructure: Ensure that data are prepared for analysis within defined, optimal timeframes;

develop mechanisms for sharing appropriate data elements with other related organizations serving people exposed to the 9/11 attacks.

Develop and implement protocols for data security and database backup and recovery.

• Disseminate and translate research findings: Prepare regular reports or peer-reviewed publications on surveys and studies conducted by the Registry. Participate in scientific conferences and disseminate research findings to the scientific community or disaster research/preparedness community. Disseminate results and findings to state and local public health officials, community residents, and other concerned individuals and organizations.

• Be responsive to public information needs and requests: Support and maintain a call system for questions and concerns from the public about the WTC Health Registry (NYC DOH call center). Create and maintain an accessible and updated website about the Registry.

• Engage in outreach: Engage in broad community outreach. Use existing contacts with businesses, community groups, and organizations to facilitate outreach. Build and maintain a strong liaison with the community, state and local governments, and other stakeholders.

• Retain and engage enrollees: Plan and manage resources to follow up with enrollees and keep their contact information updated. Include plans and ways (e.g., website, reports, and direct communications) to sustain enrollees’ interest and help keep enrollees involved with the Registry.

Step 1: Review the Opportunity 13

• Respond to enrollees’ health needs and concerns: Maintain and extend the treatment referral program to help enrollees identify care sources.

Identify and assist enrollees who may benefit from treatment referral based on survey data. Work with the WTC Health Program and its entities to identify the overlap of Registry enrollees and WTC Health Program members. Identify and assist enrollees who are potentially eligible to apply for the WTC Health Program. Provide support to share exposure information if requested.

• Integrate project evaluation: Include measures to assess process and outcomes. Plan and conduct evaluations of each proposed project to assess the relevance and the impact of the project activities in terms of improving the health and wellness of those exposed to the 9/11 attacks.

Measure contributions of the project in terms of outputs and outcomes (intermediate or final) that result from project activities; use and explain quantitative measures in such assessments.

• Provide consultation services: Develop science-based capacity for conducting epidemiological and demographic research related to the Registry under separate funding; consult with Registry external researchers or interested parties on 9/11-attack or disaster related research, surveillance, and outreach activities.

• Engage in collaboration: Collaborate with WTC Health Program and its entities (e.g., data centers) on surveillance, research, and other activities relevant to the WTC Health Program; attend and participate in WTC Health Program’s research meetings and webinars.

Objectives and outcomes This section includes the outcomes we expect you to report progress on and achieve within the period of performance if you receive funding.

The specific objectives of this award are to:

• Maintain the Registry as a public health resource to allow health professionals to track and investigate possible trends in illness and recovery related to the 9/11 attacks.

• Conduct and facilitate surveillance activities and research activities relevant to the WTC Health Program to expand knowledge about the physical and mental health effects of the 9/11 attacks.

• Conduct community activities to respond to the physical and mental health concerns and specific healthcare needs of those exposed to the 9/11 attacks.

Step 1: Review the Opportunity 14

• Maintain and extend the 9/11 Treatment Referral Program to help those exposed to the 9/11 attacks find care sources. This includes encouraging and helping enrollees to apply to the WTC Health Program and sharing enrollees’ exposure information with WTC Health Program to facilitate their enrollment or WTC-related health condition certification.

• Collaborate with WTC Health Program and its entities (e.g., Data Centers and Clinical Centers of Excellence), as needed, through appropriate data use agreements and protections (e.g., business associate agreement) to conduct activities relevant to the WTC Health Program. These activities include but are not limited to:

◦ Identifying the overlap of Registry enrollees and WTC Health Program members.

◦ Exploring surveillance signals and treatment outcomes as follows:

▪ Linkage between 9/11 exposure and uncommon health conditions, such as rare cancers, autoimmune diseases, neurological, and neurocognitive diseases (including age at diagnosis).

▪ Treatment outcomes for selected conditions linked to 9/11 exposure.

▪ Emerging WTC Health Program priorities regarding health and wellness issues among those exposed to the 9/11 attacks.

We expect you to plan and implement corresponding activities and report the outcomes related to each of these objectives in each performance year.

Collaborations Interdisciplinary and transdisciplinary collaborations are essential to achieving all the objectives. We expect to see the recipient collaborate with:

• NIOSH and the WTC Health Program at various levels.

• The network of WTC Health Program Data Centers, clinicians, scientists, and internal and external experts for active and passive surveillance activities on emerging health conditions related to the 9/11 attacks.

• External researchers for studies related to the 9/11 attacks.

• Other entities as needed for research or healthcare related to the 9/11 attacks, or for the purposes of informing healthcare policy and future disaster response planning.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 15 https://www.hhs.gov/hipaa/for-professionals/covered-entities/sample-business-associate-agreement-provisions/index.html

Evaluation and performance measurement You should include an evaluation and performance measurement plan for each specific objective as listed in the “Objectives and outcomes” section.

Evaluations provide information for management and improve program effectiveness. You can refer to the CDC document Framework for Program Evaluation for help. 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.

Paperwork Reduction Act Any activities involving information collection from 10 or more individuals or organizations may require the Paperwork Reduction Act (PRA) approval. The PRA requires review and approval of the information collection by the White House Office of Management and Budget.

To determine if a proposed activity requires PRA approval, contact your scientific and research contact. Collections include items like surveys and questionnaires. If you have collections requiring PRA approval, CDC is responsible for working with OMB to gain the approval.

For more information about CDC’s requirements under PRA see CDC Paperwork Reduction Act Compliance.

Translation plan You should describe briefly how the research findings may be translated into practice or may be used to inform public health policy, especially in terms of improving health and well-being of people exposed to the 9/11 attacks.

Funding policies and limitations Changes in HHS regulations As of October 1, 2025, HHS will adopt 2 CFR 200, with some exceptions included in 2 CFR 300. These regulations replace those in 45 CFR 75. You can find details in HHS Summary of Regulatory Changes, which is posted in the Grants.gov Related Documents tab for this opportunity.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 16 https://www.cdc.gov/evaluation/php/about/?CDC_AAref_Val=https://www.cdc.gov/evaluation/ https://www.cdc.gov/evaluation/php/about/?CDC_AAref_Val=https://www.cdc.gov/evaluation/ https://www.cdc.gov/scientific-integrity/php/public-information-collection/?CDC_AAref_Val=https://www.cdc.gov/os/integrity/reducepublicburden/index.htm https://www.ecfr.gov/current/title-2/part-200

General guidance

• You may use funds only for reasonable program purposes consistent with the award, its terms and conditions, and federal laws and regulations that apply to the award. If you have questions about these purposes, ask the grants management contact.

• Your budget is arranged in eight categories: salaries and wages, fringe benefits, travel, equipment, supplies, contractual, other (includes consultant costs), and indirect costs.

• Support beyond the first budget year will depend on:

◦ Appropriation of funds.

◦ Satisfactory progress in meeting your project’s objectives.

◦ A decision that continued funding is in the government’s best interest.

• Generally, you may not use funds to purchase furniture or equipment.

Clearly identify and justify any such proposed spending in the budget.

• You should plan and budget two WTC Health Program research meetings each year. These research meetings usually last two days and are held in New York City. These may alternate between virtual and in-person meetings.

Unallowable costs You may not use funds for:

• Clinical care, except as allowed by law.

• Pre-award costs, unless we give you prior written approval.

• Other than for normal and recognized executive-legislative relationships:

◦ Publicity or propaganda purposes, including preparing, distributing, or using any material designed to support or defeat the enactment of legislation before any legislative body.

◦ The salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence the enactment of legislation, appropriations, regulation, administrative action, or executive order proposed or pending before any legislative body.

See Anti-Lobbying Restrictions for CDC Recipients.

For guidance on some types of costs that we restrict or do not allow, see 2 CFR 200.420, Considerations for Selected Items of Cost.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 17 https://www.cdc.gov/grants/documents/Anti-Lobbying-Restrictions.pdf https://www.ecfr.gov/current/title-2/section-200.420

Indirect costs Indirect costs are those shared across multiple projects and not easily separated. Learn more at CDC Budget Preparation Guidelines.

To charge indirect costs you can select one of two methods:

Method 1 — Approved rate. If you currently have an indirect cost rate approved by your cognizant federal agency, you may use that rate.

Enclose a copy of the current approved rate agreement in your Other Attachments Form.

Method 2 — De minimis rate. If you have never received a negotiated indirect cost rate, you may elect to charge a de minimis rate (see 2 CFR 200.414(f)). This rate is 15% of modified total direct costs (MTDC). See the definition of MTDC (2 CFR 200.1). You can use this rate indefinitely.

Other indirect cost policies As described in 2 CFR 200.403(d), you must consistently charge items as either indirect or direct costs and may not double charge.

Indirect costs may include the cost of collecting, managing, sharing, and preserving data.

Salary rate limitation The salary rate limitation in the current appropriations act applies to this program. As of January 2025, the salary rate limitation is $225,700. We update this limitation when it changes.

Program income If you earn any money from your award-supported project activities (known as program income), you must use it for the purposes and under the conditions of the award. Find more about program income at 2 CFR 200.307.

Expanded authority For more information on expanded authority and pre-award costs, see the HHS Grants Policy Statement and speak to the grants management contact.

Pre-award costs may be allowable as an expanded authority, but only if we authorize the costs.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 18 https://www.cdc.gov/grants/documents/budget-preparation-guidance.pdf https://www.ecfr.gov/current/title-2/section-200.414 https://www.ecfr.gov/current/title-2/section-200.414 https://www.ecfr.gov/current/title-2/part-200#p-200.1(Modified%20Total%20Direct%20Cost%20(MTDC)) https://www.ecfr.gov/current/title-2/part-200#p-200.403(d) https://www.ecfr.gov/current/title-2/section-200.307 https://www.hhs.gov/sites/default/files/hhs-grants-policy-statement-october-2024.pdf

Public health data We require that awards include the needed costs and methods to share public health data. You may include the reasonable cost of sharing or archiving public health data as part of your requested budget for first-time or continuation awards. For more information, see Data Management and Access.

Human subjects We will restrict funds related to conducting research involving human subjects until the appropriate assurances and Institutional Review Board (IRB) approvals are in place. To lift the restrictions, we require copies of all current local IRB approval letters, local IRB-approved protocols, and CDC IRB approval letters, when applicable.

If the proposed research project involves more than one institution and will be conducted in the United States, we expect you to:

• Use a single Institutional Review Board (sIRB) to conduct the required ethical review.

• Include a single IRB plan in your research plan and PHS Human Subjects and Clinical Trials Information form, unless either of the following is true:

◦ Review by an sIRB would be prohibited by a federal, tribal, or state law, regulation, or policy.

◦ You provide a compelling justification based on ethical or human subject protection issues or other well-justified reasons.

Do not duplicate information in the research plan form and the PHS Human Subjects and Clinical Trials Information form.

In your research plan, discuss the overall strategy, methodology, and analyses of your proposed research. Use the PHS Human Subjects and Clinical Trials Information form to provide detailed information for human subjects studies and clinical trials.

We will review and approve exceptions in accordance with 45 CFR part 46 and, as applicable, 21 CFR part 50 and 21 CFR part 56, or we may place a restriction on the award.

Note: The sIRB requirement applies to participating sites in the United States.

Foreign sites participating in CDC-funded, cooperative research studies do not need to follow the requirement for sIRB.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 19 https://www.cdc.gov/grants/additional-requirements/ar-25.html https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46 https://www.ecfr.gov/current/title-21/part-50 https://www.ecfr.gov/current/title-21/part-56

For more information, please consult the scientific and research contact listed for this NOFO.

Statutory authority The World Trade Center Health Program was established by Title I of the James Zadroga 9/11 Health and Compensation Act of 2010, Pub. L. 111-347, as amended by Pub. L. 114-113, Pub. L. 116-59, Pub. L. 117-328, and Pub. L.

118-31 adding Title XXXIII to the Public Health Service (PHS) Act (codified at 42 U.S.C. 300mm - 300mm-64). The authority for this specific research is found in Sections 3342 and 3351 of the Zadroga Act, as amended (42 U.S.C. 300mm-52 and § 300mm-61).

For the purpose of ensuring ongoing data collection relating to victims of the September 11, 2001, terrorist attacks, the WTC Health Program Administrator shall ensure that a registry of such victims is maintained that is at least as comprehensive as the WTC Health Registry maintained under the arrangements in effect as of January 1, 2015, with the New York City Department of Health and Mental Hygiene. (42 U.S.C 300mm-52)

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 20 https://www.congress.gov/111/plaws/publ347/PLAW-111publ347.pdf https://www.congress.gov/114/plaws/publ113/PLAW-114publ113.pdf https://www.congress.gov/116/plaws/publ59/PLAW-116publ59.pdf https://www.congress.gov/117/bills/hr2617/BILLS-117hr2617enr.pdf https://www.congress.gov/bill/118th-congress/house-bill/2670/text

Step 2:

Get Ready to Apply

In this step

Find the application package 22

Get registered 22

Help applying 23

Find the application package The application package has all the forms you need to apply. You can find it online. Go to Grants Search at Grants.gov or eRA ASSIST and search for opportunity number RFA-OH-26-016. After opening the opportunity, select the “package” tab to see the forms.

We recommend that you select the Subscribe button from the View Grant Opportunity page for this NOFO to get updates.

If you can’t use Grants.gov to download application materials or have other technical difficulties, including issues with application submission, contact Grants.gov for help.

Get registered You must be registered in both SAM.gov and Grants.gov to apply. You can review the requirements and get started on developing your application before your registrations are complete.

SAM.gov You must have an active account with SAM.gov to apply. SAM.gov registration can take several weeks. Begin that process today.

To register:

• Go to SAM.gov Entity Registration and select Get Started. From the same page, you can also select the Entity Registration Checklist for the information you will need to register.

• You must agree to the financial assistance general certifications and representations specifically. Those for contracts are different.

When you register, you will also receive your required Unique Entity Identifier (UEI).

Once you register:

• You will have to maintain your registration throughout the life of any award.

• If your organization has multiple UEIs, use the one associated with your physical location.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 2: Get Ready to Apply 22 https://grants.gov/search-grants https://public.era.nih.gov/assist/public/login.era?TARGET=https%3A%2F%2Fpublic.era.nih.gov%3A443%2Fassist%2F https://www.grants.gov/support https://www.grants.gov/support https://sam.gov/content/entity-registration https://www.hhs.gov/sites/default/files/financial-assistance-general-certification-representations.pdf https://www.hhs.gov/sites/default/files/financial-assistance-general-certification-representations.pdf

Grants.gov You must also have an active account with Grants.gov. You can see step-by step instructions at the Grants.gov Quick Start Guide for Applicants.

eRA Commons You must register in eRA Commons. Your senior and key personnel must also register and affiliate their accounts with your organization’s account.

Register at least four weeks before the application deadline.

Need help? See Contacts and Support.

Help applying For help with the application process and tips for preparing your application, see How to Apply on our website and the Research Instructions for NIH and Other PHS Agencies.

If any instructions differ from those in this NOFO, follow the instructions in this NOFO.

For other questions, see Contacts and Support.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 2: Get Ready to Apply 23 https://grants.gov/applicants/applicant-registration http://www.grants.gov/quick-start-guide/applicants https://public.era.nih.gov/commonsplus/public/login.era?TARGET=https%3A%2F%2Fpublic.era.nih.gov%3A443%2Fcommons https://www.cdc.gov/grants/applying/index.html https://grants.nih.gov/grants/how-to-apply-application-guide/forms-i/research-forms-i.pdf

Step 3:

Build Your Application

In this step

Application checklist 25

Application contents and format 26

Application checklist You must follow the research instructions to complete your application. In this section, we also provide NOFO-specific guidance for some forms.

Make sure that you have everything you need to apply:

Form Required for

PHS 398 Research Plan form All applications.

SF424 (R&R) All applications.

PHS 398 Cover Page Supplement Form

All applications.

SF424 (R&R) Other Project Information

All applications.

SF424 (R&R) Project/ Performance Site Locations

All applications.

SF424 (R&R) Senior/Key Person Profile

All applications.

R&R Budget Form or PHS 398 Modular Budget Form

All applications.

• Include only one of these forms, not both, in your application.

• The modular form is typically used by domestic organizations requesting $250,000 or less per budget period in direct costs.

R&R Subaward Budget Attachments Form

If your application proposes subawards.

PHS Human Subjects and Clinical Trials Information

All applications.

PHS Assignment Request Form

Optional.

Other Attachments Form All applications.

Report on overlap If applicable.

Bona fide agents documentation

If applicable.

Indirect cost agreement If applicable.

See Submission requirements and deadlines to see if there are other requirements beyond the application itself.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 3: Build Your Application 25

Important: public information

When filling out your SF-424 form, pay attention to Box 15: Descriptive Title of Applicant’s Project.

We share what you put there with USAspending. This is where the public goes to learn how the federal government spends their money.

Instead of just a title, insert a short description of your project and what it will do.

See instructions and examples.

Application contents and format You must follow the research instructions in the How to Apply: Application Guide unless this NOFO says otherwise. We strictly enforce these requirements. If you do not follow them, we may delay or not accept your application for review.

See responsiveness criteria to make sure you meet all requirements.

As you build your application, keep the review criteria in mind.

PHS 398 Research Plan form You will use the PHS 398 Research Plan form to complete your research plan.

You will upload each of the following parts of the form as a separate attachment.

Some parts may not be required for your application. We provide guidance here and in the Application Guide.

Follow all instructions beginning on page 81 of the research instructions. We note additional instructions in this NOFO.

Introduction This section only applies to resubmission or revision applications. Do not include this section if you are submitting a new or renewal application.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 3: Build Your Application 26 https://www.usaspending.gov/ https://www.hhs.gov/sites/default/files/hhs-writing-award-descriptions.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-i/research-forms-i.pdf https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400 https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400 https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400 https://grants.nih.gov/grants/how-to-apply-application-guide/forms-i/research-forms-i.pdf#page=81

Research plan section To complete this section use the instructions beginning on page 83 of the research instructions. The parts for this section include:

Parts Required for Page limit

Specific aims All applications. 1 page

Research strategy All applications. 75 pages

Progress report publication list Renewal applications only. None

To complete this section use the instructions beginning on page 87 of the research instructions. The parts for this section include:

Parts Required for Page limit

Vertebrate animals If you answer “Yes” to the question “Are Vertebrate Animals Used?” on the R.220 - R&R Other Project Information Form.

None

Select agent research If your proposed activities involve the use of select agents at any time during the proposed period of performance.

None

Multiple PI/PD leadership plan If you designate multiple PD/PIs (on the R.240 - R&R Senior/Key Person Profile (Expanded) Form).

None

Consortium and contractual arrangements

If you include any consortiums or contracts in your budget.

None

Letters of support All applications. None

Resource sharing plans All applications. None

Other plans All applications. None

Authentication of Key Biological and/or Chemical Resources

All applications. None

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 3: Build Your Application 27 https://grants.nih.gov/grants/how-to-apply-application-guide/forms-i/research-forms-i.pdf#page=83 https://grants.nih.gov/grants/how-to-apply-application-guide/forms-i/research-forms-i.pdf#page=87

Other plans: Data management plan For all public health data you plan to collect, a data management plan (DMP) is required. For a definition of “public health data” and other key information, see Data Management and Access on our website.

Submit your DMP in the Other Plans section of your PHS 398 Research Plan and include:

• The data you will collect or generate and what its sources will be.

• Whether there are reasons why you cannot share data collected or generated under the award with CDC. These could include legal, regulatory, policy, or technical concerns.

• Who can access data and how you will protect it.

• Data standards that explain what documentation released data will have.

That documentation should describe collection methods, what the data represent, and data limitations.

• Archival and long-term data preservation plans.

• How you will update the DMP as new information becomes available over the life of the project. You will provide updates to the DMP in annual reports. For more information about CDC’s policy on the DMP, see Data Management and Access Requirement at CDC’s website.

• Use USGS DMP template for your DMP.

Appendix We allow only limited appendix materials. Follow all the appendix instructions detailed on page 94 of the research instructions.

Do not use the appendix to get around page limits. You may attach up to 10 PDF documents in the appendix. Additionally, you can include up to three publications that are not publicly available.

Use these guidelines to decide if you need to include a PDF appendix titled “WTC Health Program funded projects and publications”:

• If you have received funding as a PI or co-PI for any research project(s) from the WTC Health program, you should include this appendix. In this appendix, please list the funded project(s) and provide citations for any related papers published or submitted for publication in peer-reviewed journals.

• If you have been supported (not as a PI or co-PI) by any research funding from the WTC Health Program, it is OPTIONAL for you to include this

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 3: Build Your Application 28 https://www.cdc.gov/grants/additional-requirements/ar-25.html https://www.cdc.gov/grants/additional-requirements/ar-25.html https://www.cdc.gov/grants/additional-requirements/ar-25.html https://www.usgs.gov/data-management/data-management-plans appendix in your application to list the supporting project(s) and provide citations for any related papers published or submitted for publication in peer-reviewed journals that you authored or co-authored.

• If you have never received research funding from the WTC Health Program, you don’t need to include this appendix in your application.

Reviewers will consider this information when evaluating the investigator’s past performance or contribution to WTC Health Program funded research when applicable.

Budget form To develop your budget, see CDC’s Budget Preparation Guidelines.

Be sure to follow the guidance in funding policies and limitations.

The budget can include both direct costs and indirect costs as allowed.

Other attachments form You will use the Other Attachments form to upload the following attachments.

Report on overlap File name: Report on overlap

You must provide this attachment only if you have submitted a similar request for a grant, cooperative agreement, or contract to another funding source in the same fiscal year and that request may result in any of the following types of overlap:

Programmatic

• They are substantially the same project.

• A specific objective and the project design for accomplishing it are the same or closely related.

Budgetary

• You request duplicate or equivalent budget items that are already funded by another source or requested in the other submission.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 3: Build Your Application 29 https://www.cdc.gov/grants/documents/Budget-Preparation-Guidance.pdf

Commitment

• Given all current and potential funding sources, an individual’s time commitment exceeds 100%, which is not allowed.

• We will discuss the overlap with you and resolve the issue before award.

Bona fide agent documentation File name: Bona fide agent

A bona fide agent is an organization eligible to submit an application on behalf of another organization.

If you are applying as a bona fide agent of a state, territorial, tribal, or local government, you must attach a legal, binding agreement from the government as documentation of your status as their agent.

Indirect cost agreement File name: Indirect cost agreement

If you include indirect costs in your budget using an approved rate, include a copy of your current agreement approved by your cognizant agency for indirect costs (2 CFR 200.1). If you use the de minimis rate, you do not need to submit this attachment.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 3: Build Your Application 30 https://www.ecfr.gov/current/title-2/part-200#p-200.1(Cognizant%20agency%20for%20indirect%20costs) https://www.ecfr.gov/current/title-2/part-200#p-200.1(Cognizant%20agency%20for%20indirect%20costs)

Step 4:

Understand Review, Selection, and Award

In this step

Application review 32

Award notices 40

Application review Initial review We will review your application to make sure that it meets the responsiveness criteria. If your application does not meet these criteria, we will not move it to the merit review phase.

We will not review any pages over the page limit.

Scientific merit review We use a two-level merit review process:

• External scientists with expertise in relevant scientific disciplines and research areas perform the first level.

• Internal senior federal scientists with broad scientific and programmatic experience perform the second level.

First level of merit review Reviewers will consider each of the following review criteria to determine scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that is not innovative may be essential to advance a field.

The reviewers use the following criteria. Overall impact and criterion scores (1-to-9-point scale: 1 = exceptional; 9 = poor).

Reviewers will provide an overall impact score. This score indicates how likely they think it is that the project will have a sustained, powerful influence on the research fields involved. They consider the following scored criteria and additional review criteria.

We will average the eligible reviewers’ impact scores for each application (calculated to one decimal point) and multiply it by 10 to determine the final overall impact score. The final overall impact score ranges from 10 (high impact) to 90 (low impact).

Step 4: Understand Review, Selection, and Award 32

Scored criteria Reviewers will evaluate the five individual criteria (significance, investigators, innovation, strategy, and environment) and consider the application’s strengths and weaknesses within each criterion. The impact score for the application is not intended to be an average of these scored criteria.

Significance

• Does your application further develop the concept and usefulness of a

WTC Health Registry? Does your application clearly show that the extended WTC Health Registry will continue to provide a central, unified database for the study and improvement of health and well-being of those impacted by the 9/11 attacks?

• Does your application address an important problem or a critical barrier to help determine physical and mental health impacts and healthcare needs that have emerged in people exposed to the 9/11 attacks?

• If your project is successful, how will scientific knowledge, technical capability, or clinical practices be improved for care of the population exposed to 9/11?

• How will successful completion of your proposed project change the concepts, methods, technologies, treatments, services, or preventative interventions used in the WTC Health Program, occupational health, or public health?

• Will your proposed project further enhance access of the clinical research science community to WTC Health Program data resources?

• What is the potential impact of your…