rfa-eh-25-011_v5.pdf

Division of Environmental Health Science and Practice

Notice of Funding Opportunity

Application due December 2, 2024

Environmental Health Specialists Network (EHS-Net) Practice-based Research to Improve Food Safety Opportunity number: RFA-EH-25-011

Contents Before you begin 3

Step 1: Review the Opportunity 4

Basic information 5

Eligibility 7

Program description 10

Step 2: Get Ready to Apply 20

Get registered 21

Step 3: Prepare Your Application 23

Application contents and format 24

Step 4: Learn About Review and Award 29

Application review 30

Award notices 38

Step 5: Submit Your Application 39

Application submission and deadlines 40

Step 6: Learn What Happens After Award 43

Post-award requirements and administration 44

Contacts and Support 48

Endnotes 51

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 December 2, 2024 Applications are due by 11:59 p.m. Eastern Time on December 2, 2024.

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/

Jump to a step

1. Review 2. Get Ready 3. Prepare 4. Learn 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

National Center for Environmental Health

Division of Environmental Health Science and Practice

Advancing research on improving food safety practices to reduce foodborne illness.

Have questions?

See Contacts and Support.

Key facts

Opportunity name:

Environmental Health Specialists Network (EHS- Net) Practice-based Research to Improve Food Safety

Opportunity number: RFA-

EH-25-011

Federal assistance listing:

93.070

Key dates

Application deadline:

December 2, 2024

Optional letter of intent deadline: November 4, Informational call: October 15, 2024 at 3 p.m. ET

Expected scientific review date: April 22, 2025

Expected secondary review date: June 6, 2025

Expected award date:

August 29, 2025

Expected start date:

September 30, 2025

Expiration date: March 9, Summary The Environmental Health Specialists Network (EHS-Net) supports programs in public health departments to:

• As a funded member of EHS-Net, collaborate with other EHS-Net recipients and partners to develop and conduct multisite research projects focused on improving retail food safety.

• Develop and conduct individual research projects focused on improving retail food safety. These projects will be unique to each recipient’s needs.

• Include an environmental health component in foodborne outbreak investigations and report data from outbreak investigations to CDC’s National Environmental Assessment Reporting System (NEARS).

You must be able to collaborate with epidemiology and laboratory staff in your health departments or in other agencies that conduct foodborne outbreak investigations.

Environmental health programs are typically responsible for retail food safety in their jurisdictions; foodborne outbreaks commonly occur in retail food establishments such as restaurants, delis, and caterers. Thus, the focus of these research and investigation efforts is retail food safety.

We will award recipients for the first 12 months. We expect to award four more separate 12-month budget periods after that. Those separate budget period awards depend on whether funds are available and whether the recipient’s progress is satisfactory.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 5 https://www.cdc.gov/restaurant-food-safety/php/investigations/nears.html

Key activities

• Practice-based research with a focus on retail food establishments.

• Foodborne outbreak investigation.

• Collaboration with other EHS-Net recipients.

Topics of interest

• Food safety management systems.

• Foodborne illness risk factors and practices that contribute to outbreaks, such as sick workers, inadequate temperature control of food, and inadequate cleaning and sanitizing.

• Interventions to reduce foodborne illness risk factors.

• Norovirus prevention and investigation.

• Cottage food and food freedom regulations.

• Restaurant inspection and outbreak investigation practices.

Funding details Instrument type: Cooperative Agreement

Application type: New

Expected total program funding over the performance period: Up to $10,000,000

Expected total program funding per budget period: Up to $2,000,000

Expected number of awards: Up to 10

Maximum funding per applicant per budget period: Up to $200,000

Expected average award amount per budget period: Up to $200,000

We plan to award projects for 12-month budget periods for a five-year period of performance.

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

Number of applications You may submit more than one application if each application is scientifically distinct.

Step 1: Review the Opportunity 6

Eligibility Eligible applicants Only the following types of organizations may apply. State, territorial, local, and tribal government organizations may also opt to select a bona fide agent to apply on their behalf.

• State governments.

• County governments.

• City or township governments.

• Special district governments.

• Independent school districts.

• Public and state-controlled institutions of higher education.

• Private 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.

• For-profit organizations other than small businesses.

• Small businesses.

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

Other required responsiveness factors You must address these additional factors in your application to qualify for funding under this NOFO. Applications that do not meet these requirements will be considered nonresponsive and will not be forwarded for review.

• Demonstrate governmental authority and responsibility to regulate and oversee retail food service establishments in your jurisdiction. The success of this research is directly related to your ability and capacity to implement public policies and regulations to protect communities from

Step 1: Review the Opportunity 7 foodborne outbreaks and to provide communities with safe food. You should illustrate how your organization is structured to regulate retail food service establishments including citing of regulatory policy in your jurisdiction in an Application attachment titled ‘Governmental Authority’.

• Demonstrate support by your epidemiology program for EHS-Net. This partnership can be shown with a letter of support or memorandum of understanding in an Application attachment titled ‘Epidemiology Support’.

• Demonstrate the principal investigator (PI) has an advanced degree (master’s or doctorate) in environmental or public health, epidemiology, or other related science, and experience in retail food safety. The SF-424 Biographical Sketch for the PD, PI or Co-Investigator(s) must include documentation of expertise in food safety that is reflected in the application’s research strategy section. The knowledge, experience, and expertise necessary to conduct this research and achieve proposed objectives must be documented with either of the following:

◦ At least one co-authored, peer-reviewed publication as defined by the NIH National Library of Medicine in a relevant area of food safety.

◦ By serving as a PD, PI, or co-PI on a research grant in food safety.

• Experience requirements may be demonstrated through the combined experiences of a PI and co-PI (if applicable). The citation of the relevant publication(s) or research experience must be clearly identified (by bold text or highlight) in the appropriate SF 424 Biographical Sketch.

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

We encourage people from underrepresented groups to apply, such as people from underrepresented racial, ethnic, sexual orientation and gender identity groups, and those with disabilities.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 8 https://www.nlm.nih.gov/nichsr/stats_tutorial/section3/mod6_peer.html

Cost sharing and matching funds This program has no cost-sharing or matching funds requirement. We will not consider cost-sharing fund contributions during your application review.

However, if you choose to submit voluntary cost-sharing funds in your application, and we fund the award, we will require you to report on these funds.

Step 1: Review the Opportunity 9

Program description Background and purpose Most foodborne outbreaks in the U.S. are linked with retail food establishments.[1] These outbreaks are often caused by unsafe practices in the establishments (i.e., risk factors).[2] To reduce outbreaks, we need to find ways to identify and prevent these unsafe practices in retail food establishments.

This funding opportunity supports recipients to improve retail food safety by:

• Developing and conducting food safety research that identifies foodborne illness risk factors in retail food establishments and ways to reduce those risk factors.

• Conducting foodborne outbreak investigations that identify the risk factors that led to the outbreaks.

The Environmental Health Specialists Network (EHS-Net) brings together federal, state, and local food safety professionals to conduct practice-based research that meets these goals. Previous EHS-Net recipients are environmental health programs; they are unique in their ability to collect real-time data on food safety practices and policies in retail establishments.

Healthy People 2030 This opportunity supports the Healthy People 2030 goal of preventing foodborne illnesses by improving food safety practices in retail establishments.

Public health impact About one in six people in the U.S. get foodborne illnesses every year.[3] Most of the U.S. population is impacted by retail food safety; almost half of Americans eat out at least once a week.[4] This opportunity will identify evidence-based strategies for reducing risk factors in retail food establishments. It will also support improved foodborne outbreak investigations, which will support better retail food safety. Measurable program outcomes will align with the following performance goals for the National Center for Environmental Health (NCEH):

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 10 https://health.gov/healthypeople/objectives-and-data/browse-objectives/foodborne-illness https://www.cdc.gov/nceh/information/docs/nceh-atsdr-strategic-framework-508.pdf

• Prevent or reduce illness, injury, and death related to environmental risk factors.

• Build and enhance effective partnerships to improve environmental health capacity.

Related work The NCEH Water, Food, and Environmental Health Services Branch has a 25-year history of funding state and local public health programs to develop and conduct individual and multisite research projects related to retail food safety. EHS-Net was first funded in 2000; since then, EHS-Net has published more than 40 scientific articles based on both individual and multisite projects.

A recent review highlights the impact of EHS-Net research on national food safety guidelines.[5] For example, research on links between kitchen manager certification and food safety supported changes to the 2017 FDA Food Code that strengthened certification requirements. The review also highlights how individual site EHS-Net projects support food safety. For example, Minnesota identified effective methods for cooling food quickly to prevent pathogen growth.

Recent publications highlight the value of EHS-Net projects. A recent paper found that outbreak investigations are most successful when epidemiological, environmental health, and laboratory staff work together.[6] Another recent publication found that the risk factors of sick workers preparing food and lack of sick leave policies were key contributors to outbreaks.[7] A 2020 review identified key restaurant actions linked with food safety: policies and procedures; training; and monitoring.[8] NCEH’s EHS-Net website highlights previous EHS-Net recipients’ successful efforts to identify outbreak risk factors and ways to reduce them, improve outbreak investigation practices, and identify environmental health practices that improve retail food safety.[9]

Approach Objectives and outcomes Recipients’ research and activities will achieve outcomes through three primary approaches.

The first two approaches involve retail food safety research and recipients should detail their approach in the application’s research strategy section.

Recipients will:

Step 1: Review the Opportunity 11

1. As a funded member of EHS-Net, collaborate with other EHS-Net cooperative agreement recipients, CDC, and other federal partners, through the EHS-Net Steering Committee and work groups, to:

◦ Identify EHS-Net multisite (i.e., all EHS-Net funded recipients) retail food safety research project priorities at the annual EHS-Net recipient meetings, in collaboration with CDC and other appropriate partner agencies or organizations.

◦ Develop and implement identified research projects.

◦ Manage, analyze, and interpret data from projects.

◦ Publish and disseminate findings from these projects.

2. Conduct environmental assessments during foodborne outbreak investigations in retail establishments. Report outbreak environmental assessment data to CDC’s National Environmental Assessment Reporting System (NEARS).

3. Develop and conduct individual site retail food safety projects that address your agency’s needs; manage, analyze and interpret data from these projects; and disseminate findings from these projects.

Topics of particular interest for research projects include:

• Food safety management systems.

• Foodborne illness risk factors and practices that contribute to outbreaks, such as sick workers, inadequate temperature control of food, and inadequate cleaning and sanitizing.

• Interventions to reduce foodborne illness risk factors.

• Norovirus prevention and investigation.

• Cottage food and food freedom regulations.

• Restaurant inspection and outbreak investigation practices.

Both multisite and individual site research projects could involve a variety of approaches, including:

• Collecting interview and observation data on food worker and manager food safety policies and practices in retail establishments.

• Developing, implementing, and evaluating interventions to improve retail food safety.

• Evaluating food safety program activities (for example, inspection and investigation practices).

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 12 https://www.cdc.gov/restaurant-food-safety/php/investigations/environ-assess.html?CDC_AAref_Val=https://www.cdc.gov/nceh/ehs/nears/environmental-assessment.htm

Approaches focused on understanding how to translate research on reducing and preventing foodborne illness risk factors into practice (implementation science) are particularly welcome.

The third approach to achieve expected outcomes involves conducting foodborne outbreak investigations focused on identifying the risk factors that led to the outbreaks. This requires recipients to conduct environmental assessments as part of their outbreak investigations.

Environmental assessments help identify the risk factors that led to the outbreak and the root causes of those risk factors. These data provide valuable information about the causes and prevention of outbreaks.

Recipients will report their outbreak environmental assessment data to CDC’s National Environmental Assessment Reporting System (NEARS).

Expected outcomes of cooperative agreement activities include:

• Identification of foodborne illness risk factors for outbreaks in retail establishments.

• Identification of methods and interventions for reducing those foodborne illness risk factors and improving retail food safety.

• Identifying methods to improve environmental health practice in retail food safety.

• Strengthening relationships between environmental health, epidemiology, and laboratory programs within funded agencies.

• Reporting data from the environmental assessment component of foodborne outbreak investigations to NEARS.

Example outcomes include:

• Identified prevalence of food preparation practices that pose foodborne illness risk in retail food establishments, such as poor worker hand hygiene, inadequate temperature control of food, and inadequate cleaning and sanitizing of food surfaces and equipment.

• Identified prevalence of the lack of formal food safety policies in retail food establishments.

• Identified methods to reduce retail foodborne illness risk/improve food safety. For example, EHS-Net has identified the most effective methods for cooling food quickly.

• Identified improvements in environmental public health practice. For example: development and delivery of training to food safety program staff, informed by findings about gaps in food safety program staff’s inspection practices.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 13

• Identification of gaps in outbreak investigation practices, based on collection and analysis of outbreak environmental assessment data reported to NEARS.

Organizational capacity Applicants will need to provide a plan for the following staffing and organizational requirements at the time of application to support their activities. Please describe your plan for meeting these requirements in “Other Attachments Form” entitled “Organizational Capacity Plan” (see the applications components checklist).

• Plan to employ a qualified full-time senior staff person in your agency’s food safety regulatory program who will lead EHS-Net activities. This person will:

◦ Have demonstrated leadership and communication skills and technical knowledge and food safety program experience.

◦ Coordinate their agency’s EHS-Net study design, data collection, analysis, interpretation, and dissemination activities.

◦ Ensure the quality and timeliness of all data reported to CDC.

• Discuss a plan to strengthen the partnerships among environmental health, epidemiology, and laboratory regulatory and public health programs in your agency. This plan should include responsibilities and support functions of the programs in relation to EHS-Net activities.

• Describe planned partnerships with state and local agencies and others in the EHS-Net site to obtain in-kind or other cost-sharing support in support of EHS-Net activities, as appropriate.

• Identify an agency epidemiologist who will work with the EHS-Net staff member to support EHS-Net activities. This person should have experience with epidemiology and surveillance of foodborne illnesses and outbreaks. They will provide epidemiological expertise and be active in study design, data collection, analysis, and interpretation and dissemination, as appropriate.

Given that partnership between epidemiology and environmental health is critical to the success of EHS-Net, applicants will need to demonstrate support by their epidemiology program for EHS-Net.

Focus populations Recipients will conduct research that can inform retail safety interventions and policies and improve food safety practices in retail food establishments.

Step 1: Review the Opportunity 14

Much of the population is impacted by retail food safety; almost half of Americans eat out at least once a week.[10] Some members of the population are at greater risk from foodborne illness; these include children, older people, and those with reduced immunity.

Equal opportunities This NOFO, including funding and eligibility, is not limited based on, and does not discriminate on the basis of, race, color, national origin, disability, age, sex (including gender identity, sexual orientation, and pregnancy) or other constitutionally protected statuses.

Health disparities The goal of health equity is for everyone to have a fair and just opportunity to attain their highest level of health. Health disparities are often caused by social determinants that influence which populations are most disproportionately affected by health conditions.

A health disparity is a difference in health burdens between groups of people with differing social determinants of health.

Social determinants of health are conditions in the environments where people are born, live, learn, work, play, worship, and age. These determinants affect a wide range of health, functioning, and quality-of-life outcomes and risks.

We encourage you to consider working with communities or populations disproportionately affected by foodborne illness in your research. These might include:

• People who speak languages other than English.

• People with reduced economic stability.

• People with limited education attainment, access, or quality.

• People with limited healthcare access or quality.

• Geographically underserved areas.

• Racial and ethnic minority groups.

Collaborations and partnerships This announcement seeks to continue the EHS-Net practice-based research projects to provide regulatory officials with science and data to implement policies and regulations that protect communities from foodborne illness outbreaks and to provide communities with safe food. Research collaboration

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 15 https://www.cdc.gov/about/priorities/why-is-addressing-sdoh-important.html?CDC_AAref_Val=https://www.cdc.gov/about/sdoh/index.html between both public health and regulatory agencies is required. Previous EHS-Net sites have modeled the necessary level of collaboration across multiple state and local agencies to accomplish this goal. We expect you to develop collaborations pertinent to the proposed research plan. We expect your application to document effective and well-defined working relationships with any organization and/or outside entity expected to participate in the proposed research. Collaborations and documentation of the collaborations are expected to ensure implementation and sustainability of your proposed activities.

Environmental health, epidemiology, and laboratory programs within health departments all play a critical role in retail food safety, particularly in outbreak investigations. Thus, you need to have and maintain collaborative partnerships among these three programs. Additionally, in some states, collaboration among local and state health departments is important to retail food safety. For example, in some states, local health department staff are responsible for conducting retail food safety inspections, while state health department staff are responsible for investigating outbreaks. As such, successful applicants need to have and maintain collaborative partnerships within their state.

Finally, EHS-Net success is dependent upon the ability of its members to collaborate with one another to identify retail food safety research priorities, conduct the multisite research, analyze the data, and interpret and disseminate findings from the research. Thus, you need to be able to develop and maintain collaborative partnerships within the network.

Documentation of collaboration(s) must be illustrated by letters of support, memoranda of understanding or agreement, or interagency plans that detail the nature and extent of the involvement from the performing organization and outside entities. You must submit documentation of all partnerships and collaborations with the application and include the documentation in the appendix.

Translation plan Research findings should be disseminated through publications, including journal articles, for diverse audiences, and presentations at professional conferences and other venues. For multisite research projects, you will be expected to participate in work groups focused on disseminating and translating the research. You are encouraged to consider other methods and venues to disseminate findings, such as infographics and partner meetings. A key outcome of this research will be to translate findings into actionable

Step 1: Review the Opportunity 16 public health efforts; therefore, you should describe how findings could be translated into policies and practices.

Funding policies and limitations General guidance

• Your budget is arranged in eight categories: salaries and wages, fringe benefits, consultant costs, equipment, supplies, travel, other, and contractual. Any research study incentives should be categorized under the “other” category and sufficient justification provided.

• 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. Questions about this determination should be posed to the grants management specialist.

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

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

Unallowable costs You may not use funds for:

• Clinical care except as allowed by law.

• Pre-award costs unless CDC gives 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.

Indirect costs Indirect costs are those for a common or joint purpose across more than one project and that can’t be easily separated by project. Learn more at 45 CFR 75.414, Indirect Costs and CDC Budget Preparation Guidelines.

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

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 17 http://www.cdc.gov/grants/documents/Anti-Lobbying_Restrictions_for_CDC_Grantees_July_2012.pdf https://www.ecfr.gov/current/title-45/section-75.414 https://www.ecfr.gov/current/title-45/section-75.414 https://www.cdc.gov/grants/documents/budget-preparation-guidance.pdf

Method 1 – Approved rate. You currently have an indirect cost rate approved by your cognizant federal agency.

Justification: Provide a summary of the rate. Enclose a copy of the current approved rate agreement in the Attachments.

Method 2 – De minimis rate. Per 45 CFR 75.414(f), if you have never received a negotiated indirect cost rate, you may elect to charge a de minimis rate. If you are awaiting approval of an indirect cost proposal, you may also use the de minimis rate for your application budget. If you choose this method, costs included in the indirect cost pool must not be charged as direct costs.

This rate is 10% of modified total direct costs (MTDC). See 45 CFR 75.2 for the definition of MTDC. You can use this rate indefinitely.

Other indirect cost policies As described in 45 CFR 75.403(d) and 45 CFR 75.414, 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.

• Indirect costs on grants awarded to foreign organizations and foreign public entities and performed fully outside of the territorial limits of the U.S. may be paid to support the costs of compliance with federal requirements. The indirect cost rate is fixed at eight percent of modified total direct costs.

• Negotiated indirect costs may be paid to the American University, Beirut, and the World Health Organization.

• Indirect costs on training grants are limited to a fixed rate of eight percent of MTDC exclusive of tuition and related fees, direct expenditures for equipment, and sub-awards in excess of $25,000.

• If requesting indirect costs in the budget based on a federally negotiated rate, you must attach a copy of the indirect cost rate agreement. See other attachments form.

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 authorized by CDC.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 18 https://www.ecfr.gov/current/title-45/part-75#p-75.414(f) https://www.ecfr.gov/current/title-2/part-200#p-200.1(Modified%20Total%20Direct%20Cost%20(MTDC)) https://www.ecfr.gov/current/title-45/part-75#p-75.403(d) https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-75/subpart-E/subject-group-ECFR1eff2936a9211f7/section-75.414 https://www.ecfr.gov/current/title-45/part-75#p-75.2(Modified%20Total%20Direct%20Cost) https://www.ecfr.gov/current/title-45/part-75#p-75.2(Modified%20Total%20Direct%20Cost) https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

Public health data We require that awards include mechanisms for, and the costs of, public health data sharing. You may also include the reasonable cost of sharing or archiving public health data as part of the total budget requested for first-time or continuation awards. For more information, please see Additional Requirement – 25 | Grants | CDC.

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 will 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 review by a sIRB would be prohibited by a federal, tribal, or state law, regulation, or policy or 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 and Public Health Service Act (PHSA) section 301(d) (42 USC 241(d)), or we may place a restriction on the award.

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

Statutory authority Awards are made under the authorization of Section 301 (a) [42 U.S.C. 241(a)] of the Public Health Service Act, as amended.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 19 https://www.cdc.gov/grants/additional-requirements/ar-25.html https://www.cdc.gov/grants/additional-requirements/ar-25.html https://www.ecfr.gov/current/title-45/part-46 https://www.ecfr.gov/current/title-21/part-50 https://www.ecfr.gov/current/title-21/part-56 https://www.govinfo.gov/content/pkg/USCODE-2022-title42/html/USCODE-2022-title42-chap6A-subchapII-partA-sec241.htm

Step 2:

Get Ready to Apply

In this step

Get registered 21

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

SAM.gov You must have an active account with SAM.gov. This includes having a Unique Entity Identifier (UEI). 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.

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.

Need help? See Contacts and Support.

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.

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-EH-25-011.

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.

To get updates on changes to this NOFO, select Subscribe from the View Grant Opportunity page for this NOFO on Grants.gov.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 2: Get Ready to Apply 21 https://sam.gov/content/entity-registration 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://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

Help applying For help on 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.

Join the informational call Get more information about this opportunity.

A pre-application webinar call will be conducted on October 15, 2024, to address questions from prospective applicants regarding NOFO RFA- EH-25-011. The call will begin at 3 p.m. Eastern Time (ET) and end at 3:50 p.m.

ET, or sooner if all questions are addressed. Questions and answers from the discussion will be included in an amended NOFO approximately 3 weeks after the call.

Date and Time: October 15, 2024, from 3 p.m. ET to 3:50 p.m. ET

Join the webinar in Zoom.

Passcode: 5K0E%T22

If you are not able to join through your computer, you can call in:

Join by phone:

Phone numbers:

• +1 646 828 7666 US (New York)

• +1 646 964 1167 US (US Spanish Line)

• +1 669 254 5252 US (San Jose)

• +1 551 285 1373 US (New Jersey)

• +1 415 449 4000 US (US Spanish Line)

• +1 669 216 1590 US (San Jose)

Meeting ID: 161 834 1589

Passcode: 32477154

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 2: Get Ready to Apply 22 https://www.cdc.gov/grants/applying/index.html https://grants.nih.gov/grants/how-to-apply-application-guide/forms-h/research-forms-h.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-h/research-forms-h.pdf https://cdc.zoomgov.com/j/1618341589?pwd=TkprQUVicGxOM2RrL3ZqTWhDQzlnQT09

Step 3:

Prepare Your Application

Application contents and format 24

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. You are encouraged to submit your application in advance of deadlines.

Application components You must follow the instructions for each of the following components in the Research Instructions. We also provide NOFO-specific guidance for some forms in this section. All the components you need are listed in the following checklist.

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.

SF424 (R&R) Biosketch for each proposed senior/ key personnel and other significant contributors

All applications

R&R Budget Form All applications.

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.

Duplication of efforts If applicable.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 3: Prepare Your Application 24 https://grants.nih.gov/grants/how-to-apply-application-guide/forms-h/research-forms-h.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/forms/biosketch.htm

Form Required for

Bona fide agent documentation If applicable.

Indirect cost agreement If applicable.

Organizational Capacity Plan All applications.

Responsiveness Requirements All applications.

Governmental Authority All applications.

Epidemiology Support All applications.

SF2424 (R&R) Biosketch All applications.

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 listed in the appropriate section of the form as a separate attachment. Not all parts may be required for your application. We provide guidance here and in the Application Guide.

Follow all instructions beginning on page 82 of the Research Instructions.

Added instructions are also noted here.

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

Research plan section The parts for this section include:

Parts Required for Page limit

Specific aims All applications. 1

Research strategy All applications. 12

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 3: Prepare Your Application 25

Other research plan section The parts for this section include:

Parts Required for Page limit

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/memoranda of understanding (MOU)(include mandatory letter of support or MOU demonstrating epidemiology support)

All applications. None

Resource sharing plans All applications. None

Other plans All applications. None

Data management If you plan to collect public health data, you must submit a Data Management Plan (DMP) in the Other Plans section of your PHS 398 Research Plan. We require a DMP for each collection of public health data you propose. If you contend that the public health data you collect or create are not appropriate for release, you must justify that contention in the DMP submitted with your application. You can directly download a sample template.

For all public health data you plan to collect as part of this NOFO, please describe:

• The data you plan to collect and their available data sources.

• The feasibility of collecting appropriate evaluation and performance data.

• A data management plan (DMP) that includes:

◦ The data you will collect or generate.

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

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

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 3: Prepare Your Application 26 https://www.cdc.gov/injury-violence-prevention/media/files/2024/06/NCEH-ATSDR-Extramural-DMP-Template-508.docx

◦ Data standards that ensure released data have documentation that describes 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 is 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.

• Other relevant data information, such as performance measures you propose.

For a definition of “public health data” and other key information, see AR 25:

Data Management and Access on our website.

Appendix We allow only limited appendix materials. Follow all instructions for the appendix in the Research Instructions.

Do not use the appendix to circumvent page limits. You may attach up to 10 PDF documents in the appendix. Additionally, up to three publications may be included that are not publicly available.

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 provide the following attachments by uploading them to the Other Attachments form.

Duplication of efforts 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 it may result in any of the following types of overlap:

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 3: Prepare Your Application 27 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.cdc.gov/grants/documents/Budget-Preparation-Guidance.pdf

Programmatic:

• They are substantially the same project, or

• 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 already are provided by another source or requested in the other submission.

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.

File name: Report on overlap

Bona fide agent documentation A bona fide agent is an organization identified as eligible to submit an application on behalf of another organization. If 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.

File name: Bona fide agent

Indirect cost agreement If you include indirect costs in your budget using an approved rate, include either a copy of your:

• Current agreement approved by your cognizant agency for indirect costs.

• Cost allocation plan approval letter.

If you use the de minimis rate, you do not need to submit this attachment.

File name: Indirect cost agreement

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 3: Prepare Your Application 28 https://www.ecfr.gov/current/title-45/part-75#p-75.2(Cognizant%20agency%20for%20indirect%20costs)

Step 4:

Learn About Review and Award

In this step

Application review 30

Award notices 38

Application review Initial review We review each application to make sure it meets responsiveness requirements. These are the basic requirements you must meet to move forward in the competition. We will not consider an application that:

• Is from an organization that does not meet eligibility criteria. See requirements in eligibility.

• Is submitted after the deadline.

• Does not include how your organization is structured to regulate retail food service establishments including citing of regulatory policy in your jurisdiction in an Application attachment titled ‘Governmental Authority’.

• Does not demonstrate support by your epidemiology program for EHS- Net with a letter of support or memorandum of understanding in an Application attachment titled ‘Epidemiology Support’.

• Does not demonstrate the principal investigator (PI) has an advanced degree (master’s or doctorate) in environmental or public health, epidemiology, or other related science, and experience in retail food safety via the SF-424 Biographical Sketch. Experience should be documented via at least one of the following:

◦ At least one co-authored, peer-reviewed publication as defined by the NIH National Library of Medicine in the relevant area of food safety.

◦ By serving as a PD,PI, or co-PI on a research grant in food safety.

Experience requirements may be demonstrated through the combined experiences of a PI and co-PI (if applicable).

The citation of the relevant publication(s) or research experience must be clearly identified (by bold text or highlight) in the appropriate SF 424 Biographical Sketch.

Additionally, we will not review any pages that exceed the page limit.

Scientific merit review We use a two-level merit review process. The first level of merit review is carried out by non-federal scientists who have expertise in relevant scientific disciplines and research areas. The second level of review is performed by senior federal scientists with broad scientific and programmatic experience or

Step 4: Learn About Review and Award 30 by advisory boards that may include public members with general knowledge of, and interest in, the mission of the CDC.

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 (1 to 9 scale) Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research fields involved. They consider the following review criteria, including the additional review criteria as applicable for each project proposed.

We average the overall impact scores from all eligible reviewers for a given application (calculated to one decimal point) and multiply by 10 to determine the final overall impact score. The overall impact score ranges from 10 to 90.

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

Significance

• Does the project address an important problem or a critical barrier to progress in the field?

• How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

• How well does the application’s Organizational Capacity Plan address the roles and responsibilities of participation in the EHS-Net?

• If the applicant achieves the application’s aims, how well will it advance scientific knowledge, food safety, or public health practice?

• How well does the proposal enlist local public health departments and/or other appropriate government agencies or private organizations to improve food safety?

Step 4: Learn About Review and Award 31

Investigators

• To what extent are the PD/PIs, collaborators, and other researchers well suited to the project?

• To what extent have they shown an ongoing record of accomplishments that have advanced their field?

• If the project is collaborative or multi-PD/PI, to what extent do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project?

• To what extent is the work proposed appropriate to the experience level of the principal investigator and other researchers?

• To what extent does the investigative team bring complementary and integrated expertise to the project?

• To what extent has the applicant identified both internal key professional personnel and support staff, as well as external personnel (e.g., participating or collaborating institutions, agencies, and organizations outside the applicant’s agency) to assign to the EHS-Net and network projects?

• How much experience do the applicant’s key personnel have working as part of a national network of EHS-Net sites?

Innovation

• To what extent does the application challenge and seek to shift current…