EH20-001 Amendmnet FINAL.pdf

Centers for Disease Control and Prevention

National Center for Environmental Health Extramural Research Program Office

Environmental Health Specialists Network (EHS-Net) - Practice based research to improve food safety

RFA-EH-20-001

Application Due Date: 03/06/2020

Environmental Health Specialists Network (EHS-Net) - Practice based research to improve food safety

RFA-EH-20-001

TABLE OF CONTENTS

Part 1. Overview Information Key Dates Required Application Instructions Executive Summary

Part 2. Full Text Section I. Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 1. Overview Information Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations National Center for Environmental Health Notice of Funding Opportunity (NOFO) Title Environmental Health Specialists Network (EHS-Net) - Practice based research to improve food safety Activity Code Applications in response to this NOFO will be funded using the U01 activity code.

Notice of Funding Opportunity Type New Agency Notice of Funding Opportunity Number

RFA-EH-20-001

Assistance Listings (CFDA) Number(s) 93.070 Category of Funding Activity:

Health NOFO Purpose The Environmental Health Specialists Network (EHS-Net) is a collaborative forum of environmental health specialists who work together to improve environmental health practice.

EHS-Net seeks to improve the practice of environmental health service programs by developing and sustaining a network of environmental health specialists (EHS) who collaborate with epidemiologists, laboratorians and other public health professionals to conduct practice-based research to identify and prevent environmental risk factors contributing to foodborne illness. This announcement will fund EHS-Net-related research projects for food safety activities under the jurisdiction of departments of health or other agencies responsible for regulatory oversight of retail food service including restaurants, delis, cafeterias, schools, etc.

For information on EHS-Net activities, please visit our web page at: https://www.cdc.gov/nceh /ehs/ehsnet .

The purpose of Amendment 1 to this NOFO is to update the application submission deadline to no later than 5:00 PM U.S. Eastern Time on March 6, 2020, to update the expected project start date to September 30, 2020, and to provide additional clarifying information based on questions received from potential applicants during the Pre- Application Conference Call held on January 7, 2020. A summary of these questions and answers can be found in Section VIII. Other Information, of the amended NOFO.

Key Dates Publication Date: To receive notification of any changes to RFA-EH-20-001, return to the synopsis page of this announcement at www.grants.gov and click on the http://www.cdc.gov/nceh/ehs/EHSNet/ http://www.cdc.gov/nceh/ehs/EHSNet/ https://www.grants.gov

"Send Me Change Notification Emails" link. An email address is needed for this service.

Letter of Intent Due Date: 01/28/2020

Application Due Date: 03/06/2020

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

Eastern Time. Applications must be submitted using the Application Submission System & Interface for Submission Tracking (ASSIST) module which is a web-based service used for the preparation and submission of grant applications to CDC through Grants.gov. ASSIST provides the ability for applicants to prepare their applications online, and offers the applicant additional capabilities including the ability to preview the application image, validate the application against required business rules, and prepopulate data from an applicant organization's records, therefore identifying issues earlier in the application submission process.

Note: HHS/CDC grant submission procedures do not provide a grace period beyond the application due date time to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

Scientific Merit Review: 06/03/2020 This is an approximate date.

Secondary Review: 07/16/2020 This is an approximate date.

Estimated Start Date: 09/30/2020 This is an approximate date.

Expiration Date: 04/30/2020 Due Dates for E.O. 12372: Due no later than 60 days after the application receipt date.

Required Application Instructions

**ELECTRONIC APPLICATION SUBMISSION VIA ASSIST IS PREFERRED**

It is recommended that applicants use ASSIST for the electronic preparation and submission of applications through Grants.gov to CDC. ASSIST is an alternative method to prepare and submit applications, and provides many features to facilitate the application submission process which improves data quality (e.g., pre-population of organization data, pre-submission validation of business rules, and preview of the application image used for review). Use of the Grants.gov downloadable Adobe application packages and submission process will still be supported.

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this NOFO. Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Note: The Research Strategy component of the Research Plan is limited to 20 pages.

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

Pages that exceed page limits described in this NOFO will be removed and not forwarded for peer review, potentially affecting an application's score.

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

Executive Summary Purpose:

The Environmental Health Specialists Network (EHS-Net) is a collaborative forum of environmental health specialists who work together to improve environmental health practice.

EHS-Net seeks to improve the practice of environmental health service programs by developing and sustaining a network of environmental health specialists (EHS) who collaborate with epidemiologists, laboratorians and other public health professionals to conduct practice-based research to identify and prevent environmental risk factors contributing to foodborne illness. This announcement will fund EHS-Net-related research projects for food safety activities under the jurisdiction of departments of health or other agencies responsible for regulatory oversight of retail food service including restaurants, delis, cafeterias, schools, etc.

For information on EHS-Net activities, please visit our web page at: https://www.cdc.gov/nceh /ehs/ehsnet .

This Environmental Health Specialists Network (EHS-Net) research opportunity seeks to develop and sustain a network of environmental health program staff, in collaboration with epidemiologists and other public health professionals, to identify retail food safety research practice-based priorities focused on identifying and preventing foodborne illness risk factors, and to conduct the research. EHS-Net research will contribute to:

Identification of foodborne illness risk factors associated with retail food establishments, Identification of interventions to address those risk factors and reduce foodborne outbreaks (including food safety policies), Improvement of environmental health practice in the area of retail food safety.

This research opportunity will require three primary activities for those sites participating in EHS-Net. These are:

Identifying and conducting multisite retail food safety practice-based research projects;

all EHS-Net sites will participate in developing and conducting these projects.

Identifying and conducting single-site retail food safety practice-based projects; these projects will be unique to each site and will address the needs and priorities of the site.

http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf

Collecting and reporting data from the environmental health component of foodborne outbreak investigations to NCEH’s National Environmental Assessment Reporting System (NEARS). These data, when aggregated and analyzed, provide valuable information about the causes and prevention of foodborne illness outbreaks.

Mechanism of Support. Cooperative agreement; an assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Funds Available and Anticipated Number of Awards. NCEH intends to commit approximately $1,540,700 in FY 2020 to fund up to eight applications. The maximum amount per award for the first 12-month budget period is $192,587 (direct and indirect costs). Awards issued under this NOFO are contingent upon availability of funds and a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the amount of each award may also vary.

The total amount awarded and the number of awards will depend upon the number, quality, and proposed cost of the applications received and approved.

Budget and Project Period. The estimated total funding (direct and indirect costs) for the first 12-month budget period is expected to be $1,540,700 (direct and indirect costs) and the estimated total funding for the entire project period is expected to be $7,703,500 (direct and indirect costs). The project period is expected to run from 09/01/2020 to 08/31/2025.

Application Research Strategy Length: Page limits for the Research Strategy are clearly specified in Section IV. Application and Submission Information of this announcement.

Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.

Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. NOTE: CDC does not make awards to individuals directly. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply.

Number of PDs/PIs Co-principal investigators are allowed for this NOFO; their names must appear on the face page of the application. However, one principal investigator must be designated as the contact PI. All PD/PIs must include their eRA Commons Identification in the Credential Field of the Senior/Key Person Profile Component of the SF424 (R&R) Application Package. For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

Number of Applications. Eligible applicant institutions may submit more than one application, provided that each application is scientifically distinct. However, applicant institutions can submit only one grant application with the same principal investigator. Only one application per principal investigator will be funded under this announcement.

Application Type. See Section IV.1 for application materials.

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#SectionIV http://era.nih.gov/commons/index.cfm#SectionIII1A http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm#SectionIV1

Special Date(s).

A pre-application teleconference call will be conducted on January 7, 2020 to address questions from prospective applicants regarding NOFO RFA-EH-20-001, "Environmental Health Specialists Network (EHS-Net)". The call will begin at 1:00 PM Eastern Standard Time (EST) and end at 2:00 PM Eastern Standard Time (EST), or sooner if all participant questions are addressed. Questions and answers from the discussion will be included in an amended NOFO to be published approximately 2 weeks after the call.

Participant Access Information

Call Date: January 7, 2020 Call Start Time: 1:00 PM Eastern Standard Time (EST) Call End Time: 2:00 PM Eastern Standard Time (EST) Call Leader: Daniel Holcomb, Scientific Program Official Toll-Free Number: 1-866-916-0413 Conference Passcode: 52108552

Application Materials. See Section IV.1 for application materials.

Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: (770) 488-2783.

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority Awards are made under the authorization of Section 301 (a) [42 U.S.C. 241(a)] of the Public Health Service Act, and section 391 (a) [42 U.S.C. 280 b(a)] of the Public Service Health Act, as amended.

1. Background and Purpose Background:

CDC/NCEH first funded EHS-Net in 1999, with the goal of establishing a consortium of federal, state, and local environmental health and epidemiological staff to identify and address retail foodborne illness risk factors. CDC/NCEH has funded state and local health departments to participate in EHS-Net in five-year cycles. Thus, the state and local EHS-Net sites change with each cycle. Together with CDC, U.S. Department of Agriculture USDA), and Food and Drug Administration (FDA) representatives, EHS-Net sites identify its retail food safety priorities for the funding cycle, and conduct practice-based research activities to address those priorities.

EHS-Net is unique in its ability to collect real-time data on food safety policies and practices in retail food establishments. It relies on staff from environmental health programs; these staff are http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm#SectionIV1 experienced and invested in retail food safety and are best-positioned to identify retail food safety research priorities, conduct the research, analyze and interpret the data, and disseminate research findings. Indeed, since its founding in 2000, EHS-Net has published 43 scientific articles based on both individual and multisite studies.(See the Revelant Work section for more detail.)

Findings from EHS-Net research projects have influenced retail food safety and foodborne illness and outbreak prevention; EHS-Net findings have been used to inform significant, national food safety policy and practice guidelines, including the FDA Food Code and USDA- FSIS guidance on controlling Listeria monocytogenes. (See the Revelant Work section for more detail.)

Because of EHS-Net’s continuing ability to address important gaps in retail food safety, and its ongoing effectiveness in collecting, analyzing, interpreting and disseminating food safety data, NCEH wishes to support another EHS-Net five-year cooperative agreement.

For more information, www.cdc.gov/winnablebattles/foodsafety/index.html, www.healthypeo ple.gov, http://www.cdc.gov/foodsafety/fsma.html

Purpose:

This Environmental Health Specialists Network (EHS-Net) research opportunity seeks to develop and sustain a network of environmental health program staff, in collaboration with epidemiologists and other public health professionals, to identify retail food safety research practice-based priorities focused on identifying and preventing foodborne illness risk factors, and to conduct the research. EHS-Net research will contribute to:

Identification of foodborne illness risk factors associated with retail food establishments, Identification of interventions to address those risk factors and reduce foodborne outbreaks (including food safety policies), Improvement of environmental health practice in the area of retail food safety.

This research opportunity will require three primary activities for those sites participating in EHS-Net. These are:

Identifying and conducting multisite retail food safety practice-based research projects;

all EHS-Net sites will participate in developing and conducting these projects.

Identifying and conducting single-site retail food safety practice-based projects; these projects will be unique to each site and will address the needs and priorities of the site.

Collecting and reporting data from the environmental health component of foodborne outbreak investigations to NCEH’s National Environmental Assessment Reporting System (NEARS). These data, when aggregated and analyzed, provide valuable information about the causes and prevention of foodborne illness outbreaks.

Healthy People 2020 and other National Strategic Priorities This program of research addresses the established CDC Food Safety Winnable Battle for Food http://www.cdc.gov/winnablebattles/foodsafety/index.html http://www.healthypeople.gov/ http://www.healthypeople.gov/ http://www.cdc.gov/foodsafety/fsma.html

Safety, “Healthy People 2020” priority areas of food safety and public health infrastructure, and the Food Safety Modernization Act.

Public Health Impact CDC has identified reducing foodborne diseases as a winnable battle. With additional effort and support for evidence-based, cost-effective strategies that we can implement now, we can have a significant impact on our nation's health. Measurable outcomes of the program will be in alignment with the following performance goals for the National Center for Environmental Health: Prevent or reduce illness, injury and death related to environmental risk factors and build and enhance effective partnerships to improve environmental health capacity.

Relevant Work NCEH’s Water, Food, and Environmental Health Services Branch has a 20-year history of funding state and local public health programs to successfully develop and conduct individual and multisite research projects related to food safety. EHS-Net was first funded in 2000; since then, EHS-Net has published 43 scientific articles based on both individual and multisite projects. A select few of these articles are listed below.

Brown L, Hoover E, Faw B, Hedeen N, Nicholas D, Wong M, et al. Food safety pract ices linked with proper refrigerator temperatures in retail delis. Foodborne Pathog Disease. 2018;15(5):300-7

Cates SC, Muth MK, Karns SA, Penne MA, Stone CN, Harrison JE. Certified kitchen managers: do they improve restaurant inspection outcomes? J Food Prot.

2009;72(2):384-91.

Green L, Radke V, Mason R, Bushnell L, Reimann D, Mack J, Motsinger M, Stigger T,Selman C. Factors related to food worker hand hygiene practices. J Food Prot.

2007;70(3):661-666.

Radke T, Brown LG, Faw B, Hedeen N, Matis B, Perez P, et al. Restaurant food allergy practices – six selected sites, United States, 2014. MMWR. 2017;66(15);404-7

Sumner S, Brown LG, Frick R, Stone C, Carpenter LR, Bushnell L, et al. Factors assoc iated with food workers working while experiencing vomiting or diarrhea. J Food Prot.

2011;74(2):215-20.

Wong M, McKelvey W, Ito K, Schiff C, Jacobson JB, Kass D. Impact of a letter-grade program on restaurant sanitary conditions and diner behavior in New York City. Am J Public Health. 2015;105(3):e81-7

Findings from EHS-Net research projects have influenced retail food safety and foodborne illness and outbreak prevention; EHS-Net findings have been used to inform significant, national food safety policy and practice guidelines. Specifically:

EHS-Net findings on links between kitchen manager certification and food safety were used to support changes to the 2017 FDA Food Code that strengthened certification requirements.

The CDC-funded Council to Improve Foodborne Outbreak Response’s (CIFOR) used EHS-Net findings on investigation practices linked to outbreak contributing factor identification to inform their Guidelines for Foodborne Disease Outbreak Response, a https://www.liebertpub.com/doi/10.1089/fpd.2017.2358 https://www.liebertpub.com/doi/10.1089/fpd.2017.2358 https://www.cdc.gov/nceh/ehs/ehsnet/docs/JFP_Certified_Kitchen_MGRs.pdf https://www.cdc.gov/nceh/ehs/ehsnet/docs/JFP_Certified_Kitchen_MGRs.pdf https://www.cdc.gov/nceh/ehs/ehsnet/docs/JFP_Food_Worker_Hand_Hygiene.pdf https://www.cdc.gov/mmwr/volumes/66/wr/mm6615a2.htm https://www.cdc.gov/mmwr/volumes/66/wr/mm6615a2.htm https://www.cdc.gov/nceh/ehs/ehsnet/docs/JFP_ill_food_workers.pdf https://www.cdc.gov/nceh/ehs/ehsnet/docs/JFP_ill_food_workers.pdf https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4330857/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4330857/ comprehensive best-practices resource for federal, state, and local agencies that investigate foodborne outbreaks.

EHS-Net’s investigation practice findings also informed the development of CDC’s new version of Epi-Ready, an influential training on foodborne outbreak investigation for environmental and public health professionals.

USDA’s Food Safety and Inspection Service (FSIS) used EHS-Net findings on retail deli food safety practices in the development of their Best Practices Guidance for Controlling Listeria monocytogenes (Lm) in Retail Delicatessens, a guidance document for retailers.

These findings were also used in the development of the Interagency (CDC, FDA, USDA-FSIS) Retail LM Action Plan to reduce the risk of listeriosis via promotion of best practices in retail delis.

USDA-FSIS used EHS-Net study findings to inform the development of a new rule that requires retail establishments to maintain beef grinding logs to improve FSIS’s ability to trace the source of foodborne outbreaks.

NCEH’s website on Food Safety (http://www.cdc.gov/nceh/ehs/topics/foodsafety.htm) highlights a number of their efforts to conduct surveillance of foodborne illness outbreaks, investigate the cause of foodborne illness outbreaks, and conduct research to develop best management practices to prevent foodborne outbreaks.

2. Approach Outcomes will be achieved through three primary approaches. First, successful applicants will collaborate with other applicants and EHS-Net partners to identify, develop, and conduct practice-based retail food safety multisite research projects. Second, successful applicants will identify, develop, and conduct practice-based retail food safety projects unique to their site.

Both multisite and individual site projects could involve a variety of approaches. Examples include:

Collecting interview and observation descriptive data on food workers’ food safety practices in retail establishments.

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

Evaluating food safety program activities, such as retail inspection and outbreak investigation practices.

Collecting linking, and analyzing environmental health epidemiologic data to identify relationships between food safety policies and regulations and outbreak occurrence and size.

Because of its prevalence in retail establishments, project activities focused on norovirus investigation and prevention are encouraged. Likewise, activities focused on the most frequent contributing factors to retail-related outbreaks, including contamination of food by ill workers and improper use of time as temperature control, are encouraged. Projects focused on the use of environmental sampling as an investigative tool are also encouraged.

A third approach will be used to achieve primary outcomes--successful applicants will conduct environmental assessments when investigating foodborne outbreaks and will report these http://www.cdc.gov/nceh/ehs/topics/foodsafety.htm assessment data to CDC’s National Environmental Assessment Reporting System (NEARS).

These environmental assessment data, when aggregated and analyzed, will provide valuable information about the causes and prevention of foodborne illness outbreaks.

Objectives/Outcomes Research Objectives:

Staffing

1. Establish and maintain a qualified full-time senior staff position in the agency’s food safety programs (i.e., one full-time equivalent per program), with full responsibility for implementation and coordination of activities of the EHS-Net related to food safety. The person in this position must report directly to a senior environmental health official who has agency (State and/or local) authority to participate in EHS-Net activities. The person in this position also must have demonstrated leadership skills; technical knowledge and program experience with the food safety program; knowledge and understanding of the appropriate State environmental health program for food safety; and communication skills necessary to effectively promote and facilitate network activities. The person will be involved in study design; data collection, analysis, and interpretation; and publication of findings. The person will also be responsible for the accuracy, quality, and timely reporting of all data submitted to CDC.

2. Identify an existing staff position in the health agency’s program with responsibilities and organizational authority for foodborne disease surveillance. The individual should know and understand the epidemiology and surveillance of foodborne illnesses;

knowledgably conduct the epidemiology and surveillance of foodborne disease; inform and guide decisions concerning specific activities of the network; lead and coordinate proposed activities; and possess knowledge of and coordinate with the agency’s environmental service program for food. The individual should be active in study design; data collection, analysis, and interpretation; and publication of findings.

3. Identify existing staff position(s) in State and/or local agencies with responsibility for carrying out specific EHS-Net activities. These persons should have the technical program experience needed to implement proposed activities; an understanding of the State food program; and the communication skills necessary to effectively implement proposed activities. State and/or local agencies are encouraged to have resources available to proficiently translate EHS-Net activities into other languages (e.g. Spanish or Chinese).

State Agency/Locality Collaboration and Planning

1. Strengthen the partnership between food safety, disease surveillance, and laboratory authorities in the State (i.e., departments of health, departments of agriculture; agencies for institutional care, education, environmental protection, etc.) by establishing an interagency plan that identifies complementary responsibilities and support functions to carry out planned EHS-Net activities. The interagency plan should address policies and programs, technical assistance, and resources; and identify participating local agencies.

2. Define the geographical boundaries of the EHS-Net site. An EHS-Net site may include an entire State or a geographically defined area (or areas) within a State that, ideally, represents both rural and urban communities. Geographically defined areas may be represented as cities, urban and rural counties, townships, parishes, or districts as defined by the applicant or other partnering agency. Within this geographically defined area, local health agencies and/or other local agencies with regulatory responsibility for food must be identified as partners.

3. Within the State or geographically defined area, develop partnerships with State and/or local agencies and others to provide in-kind assistance or other cost-sharing support to complement the basic assistance obtained from CDC to support network activities.

4. Establish and/or sustain effective partnerships with other public or private organizations interested in addressing environmental health services issues related to their effectiveness in preventing disease (e.g., universities, schools of public health, standard-setting organizations, multi-jurisdictional commissions with environmental responsibilities, community-based organizations, other Federal and State government agencies, research organizations, nongovernmental organizations and foundations).

Organize the network to:

1. Maintain the ability to accommodate changes in specific activities and priorities as the public health system’s need for information changes, or as new and/or reemerging health problems or environmental issues emerge.

2. Include both rural and urban populations.

3. Have the capacity to conduct multiple, concurrent projects.

4. Enlist participation of local public health departments and/or other related agencies (i.e.

departments of agriculture, environmental protection agencies) or private organizations with a role in protecting the public’s health.

Operate the network as a consortium to function effectively as part of a national network of EHS-Net sites. Collaborate with CDC and other EHS-Net sites, through the EHS-Net steering committee and EHS-Net working groups, to establish priorities, coordinate and monitor projects, and ensure that projects address existing and emerging infections issues.

Ensure all potential interactions with study participants are properly reviewed to meet all appropriate federal, state and local requirements for protection of human subjects. Provide documentation of Institutional Review Board (IRB) approval for all relevant research projects involving human subjects. (See Common Rule Requirements in Section VI (4)) Collect and submit samples (i.e., food or environmental samples) as part of network activities to designated laboratories for evaluation. Laboratories may include State, Federal, or academic facilities, as appropriate for the study proposed and approved by the EHS-Net.

Manage, analyze, and interpret data from network activities; and publish and disseminate findings. Dissemination of findings includes, but is not limited to, presentations at local, regional and national public health and food conferences, such as the International Association of Food Protection, Conference for Food Protection, etc., and publication of articles in peer reviewed journals, and information on the EHS-Net website.

Propose and conduct activities subject to public health priorities identified at the annual EHS- Net grant recipient meetings in collaboration with CDC and appropriate partner agencies or organizations. Collaborate with CDC and other EHS-Net network sites to develop and finalize protocols for activities. Obtain the appropriate IRB approvals for research involving human subjects for all participating sites.

Categories of food safety activities:

1) Practice-based retail food safety research projects. These projects should be aimed at identifying foodborne illness risk factors associated with retail food establishments, identifying interventions to address those risk factors and reduce foodborne outbreaks (including food safety policies), and evaluating or improving environmental health programs and practice in retail food safety. These projects can include applied behavioral, food safety, or environmental epidemiological approaches. Examples of such projects include, but are not limited to:

Describing or improving retail establishments’ active managerial control over food safety or food safety management systems.

Describing or improving practices that pose foodborne illness risk in retail food establishments, such as poor worker hand hygiene, workers working while ill, inadequate temperature control of food, and inadequate cleaning and sanitizing of food surfaces and equipment.

Identifying gaps in formal food safety policies in retail food establishments.

Identifying retail establishment characteristics associated with retail food safety.

Identifying and evaluating interventions to reduce retail foodborne illness risk/improve food safety.

Identifying gaps in retail inspection or outbreak investigation practices.

Investigating and preventing norovirus transmission and outbreaks.

Developing and evaluating environmental sampling protocols and methods.

Assessing effectiveness of food safety programs in reducing foodborne illness risk factors.

2) Conducting environmental assessments during foodborne illness outbreak investigations.

Data from these environmental assessments will inform continued improvements in the collection, reporting, analysis, and use of environmental assessment data in the identification, development, and improvement of foodborne illness prevention activities. This includes reporting data collected to CDC through the National Environmental Assessment Reporting System (NEARS) (See (see https://www.cdc.gov/nceh/ehs/nears/) and may also involve collection of food or environmental surface samples and submission to state, CDC, or other laboratories.

References: See "Relevant Work", and Food Safety Projects http://www.cdc.gov/nceh/ehs /EHSNet/foodsafety.htm) Outcomes will be achieved through three primary approaches. First successful applicants will collaborate with other applicants and EHS-Net partners to identify, develop, and conduct practice-based retail food safety multi-site research projects. Second, successful applicants will identify, develop, and conduct practice-based retail food safety projects unique to their site.

Primary Outcomes to be achieved with funded research:

Expected outcomes of this project include http://www.cdc.gov/nceh/ehs/EHSNet/foodsafety.htm http://www.cdc.gov/nceh/ehs/EHSNet/foodsafety.htm identification of retail foodborne illness factors and gaps in retail food safety policies and practices, identification of interventions to address those risk factors and reduce foodborne outbreaks, and improvement of environmental health practice in the area of retail food safety.

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.

Retail establishment characteristics associated with retail food safety. For example, past EHS-Net research has consistently found that retail establishments with food safety certified kitchen managers have better food safety practices.

Identified methods to reduce retail foodborne illness risk/improve food safety. For example, EHS-Net has recently begun a study designed to evaluate the effectiveness of an education intervention to improve retail practices concerning employees working while ill.

Identified improvements in environmental public health practice. An example:

development and delivery of training to food safety program staff, informed by findings about gaps in food safety program staff’s inspection practices, on identifying food safety violations on parasite destruction in sushi restaurants.Identification of gaps in outbreak investigation practices, based on collection and analysis of outbreak environmental assessment data reported to NEARS.

Target Population NOFO applicants will be conducting research that can inform retail safety interventions and policies and improve food safety practices in retail food establishments. The majority of the population is impacted by retail food safety; 61% of U.S. adults recently reported they ate dinner at a restaurant at least once in the past week. Some members of the population are at greater risk from foodborne illness; these include children, older people, and those with reduced immunity.

Collaboration/Partnerships This announcement seeks to continue the Environmental Health Specialists Network (EHS-Net) practice-based research studies 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. In order to conduct this critical research, successful collaboration 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. Applicants are expected to develop collaborations pertinent to the proposed research plan. Applications are expected to include documentation of 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 the applicant’s proposed activities.

Environmental health, epidemiology, and laboratory programs within health departments all play a critical role in retail food safety, particularly in the area of outbreak investigation. Thus, successful applicants 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, successful applicants 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. Applicants must submit documentation of all partnerships and collaborations with the application and include the documentation in the appendix.

Evaluation/Performance Measurement Applicants are expected to provide an evaluation and performance measurement plan with measures of effectiveness. The plan should demonstrate the feasibility of accomplishing proposed project objectives. Effectiveness measures should relate to the goals in the Purpose section of this announcement and measure the intended outputs and outcomes described.

Outcomes to be evaluated should be clearly described. Performance measures could include the number of participants in a study, study participation rates, and types of data collected.

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, applicants will be expected to participate in work groups focused on disseminating and translating the research. Applicants are encouraged to consider other methods and venues to disseminate findings, such as infographics and convened meetings of stakeholders. A key outcome of this research will be to translate findings into actionable public health efforts; therefore, applicants should provide a description of how findings could be translated into policies and practices.

Section II. Award Information Funding Instrument Type: Cooperative Agreement A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed:

New - An application that is submitted for funding for the first time. Includes multiple submission attempts within the same round.

Estimated Total Funding: $7,703,500

Anticipated Number of Awards: 8 NCEH intends to commit approximately $1,540,700 for direct and indirect costs in FY2020 to fund up to nine (8) awards. The maximum amount per award for the first 12-month budget period is $192,587 (direct and indirect costs). The project period is expected to be five years.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award may also vary. The total amount awarded and the number of awards will depend upon the number, quality, duration and cost of the applications received and approved.

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

Award ceiling and floor are for the first 12-month budget period only.

Award Ceiling: $192,587 Per Budget Period Award Floor: $0 Per Budget Period Total Period of Performance Length: 5 year(s)

Throughout the Period of Performance, CDC's commitment to continuation of awards will depend on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and CDC’s determination that continued funding is in the best interest of the Federal government.

HHS/CDC grants policies as described in the HHS Grants Policy Statement (http://www.hhs.gov/ sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this NOFO.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility" http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

Additional Eligibility Category:

2. Foreign Organizations Foreign Organizations are not eligible to apply.

Foreign components of U.S. Organizations are not eligible to apply.

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

3. Additional Information on Eligibility

N/A

4. Justification for Less than Maximum Competition N/A

5. Responsiveness The Letters of Support section must include evidence of effective and well-defined working relationships between the awardee institution and any organizations or outside entities expected to partner in the proposed research, particularly those partners providing access to needed data.

This should be evidenced by letters of support, or memoranda of understanding or agreement detailing the nature and extent of the involvement from the recipient organization and outside entities. Applications that do not meet this requirement will be considered nonresponsive and will not be forwarded for review.

The biosketch of the PI must include documentation of an advanced degree (Masters or doctorate) in environmental or public health, epidemiology or other related science, and experience in retail food safety. Applications that do not meet this requirement will be considered non-responsive and will not be forwarded for peer review.

6. Required Registrations Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: https:// eportal.nspa.nato. int/ AC135Public/ Docs/ US%20Instructions%2 0for%20NSPA%20NCAGE.pdf

System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, https://www.sam.gov/portal/SAM/.

https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://www.sam.gov/portal/SAM

Grants.gov eRA Commons

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

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing Principle Investigator (PD/PI) eRA Commons account is affiliated with the eRA commons account of the applicant organization. All registrations must be successfully completed and active before the application due date. Applicant organizations are strongly encouraged to start the eRA Commons registration process at least four (4) weeks prior to the application due date. ASSIST requires that applicant users have active eRA Commons account in order to prepare an application. It also requires that the applicant organization's Signing Official have an active eRA Commons Signing Official account in order to initiate the submission process. During the submission process, ASSIST will prompt the Signing Official to enter their Grants.gov Authorized Organizational Representative (AOR) credentials in order to complete the submission, therefore the applicant organization must ensure that their Grants.gov AOR credentials are active.

7. Universal Identifier Requirements and System for Award Management (SAM) All applicant organizations must obtain a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number is a nine-digit number assigned by Dun and Bradstreet Information Services. An AOR should be consulted to determine the appropriate number. If the organization does not have a DUNS number, an AOR should complete the US D&B D-U-N-S Number Request Web Form or contact Dun and Bradstreet by telephone directly at 1-866-705-5711 (toll-free) to obtain one. A DUNS number will be provided immediately by telephone at no charge. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a DUNS number.

Additionally, all applicant organizations must register in the System for Award Management (SAM). Organizations must maintain the registration with current information at all times during which it has an application under consideration for funding by CDC and, if an award is made, until a final financial report is submitted or the final payment is received, whichever is later. SAM is the primary registrant database for the Federal government and is the repository into which an entity must provide information required for the conduct of business as a recipient. Additional information about registration procedures may be found at the SAM internet site at https://www.sam.gov/index.html.

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

8. Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions https://www.Grants.gov https://public.era.nih.gov/commons/public/login.do?TYPE=33554433&REALMOID=06-1edb031f-46c7-44b3-b803-60b537de74d2&GUID=&SMAUTHREASON=0&METHOD=GET&SMAGENTNAME=-SM-938PYmoLVb4VrDeXo04LZUDVDvc%2b3899ByInEAjuSUvWNIGfB2zRpWiCivYGCogG&TARGET=-SM-http%3a%2f%2fpublic%2eera%2enih%2egov%2fcommons https://www.grants.gov http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform https://www.sam.gov/index.html

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

9. Cost Sharing This FOA does not require cost sharing as defined in the HHS Grants Policy Statement (http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf).

10. Number of Applications As defined in the HHS Grants Policy Statement, (https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf), applications received in response to the same Notice of Funding Opportunity generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit. HHS/CDC will not accept any application in response to this NOFO that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

As defined in the HHS Grants Policy Statement,(https://www.hhs.gov/sites/default/files/grants /grants/policies-regulations/hhsgps107.pdf), applications received in response to the same Notice of Funding Opportunity generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit. HHS/CDC will not accept any application in response to this NOFO that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Applicant institutions may not submit applications with the same, or similar, proposed research to two or more funding opportunities from CDC. Eligible applicant organizations may submit more than one application to this NOFO, provided that each application is scientifically distinct.