rfa-eh15-001 amend 1.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-15-001

Application Due Date: 04/10/2015

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

RFA-EH-15-001

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 Extramural Research Program Office (NCEH ERPO) National Center for Environmental Health (NCEH) Funding Opportunity Announcement (FOA) Title Environmental Health Specialists Network (EHS-Net) - Practice based research to improve food safety Activity Code Applications in response to this FOA will be funded using the U01 activity code.

Funding Opportunity Announcement Type New Funding Opportunity Announcement Number

RFA-EH-15-001

Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.070 Category of Funding Activity:

Health FOA 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. For information on EHS-Net activities, please visit http://www.cdc.gov /nceh/ehs/EHSNet/ index.htm.

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.

The purpose of this FOA is to provide additional clarifying information based on questions received from potential applicants during the Pre-Application Conference Call or as a result of direct communication with the Scientific Program Official. A summary of the "questions and answers" and a list of changes made to the original FOA begins on page 32.

Key Dates Publication Date: To receive notification of any changes to RFA-EH-15-001, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link. An email address is needed for this service.

Letter of Intent Due Date: 03/12/2015

Application Due Date: 04/10/2015 http://www.cdc.gov/nceh/ehs/EHSNet/ http://www.cdc.gov/nceh/ehs/EHSNet/ http://www.grants.gov

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

HHS/CDC grant submission procedures do not provide a period of time beyond the application due date 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: 07/01/2015 An approximate date; however, the review will be conducted in July, 2015

Secondary Review: 07/22/2015 An approximate date; however, the review will be conducted between July and August, 2015

Estimated Start Date: 09/30/2015 An approximate date; however, the start date is planned for September 2015

Expiration Date: 04/11/2015 Due Dates for E.O. 12372: Due no later than 60 days after the application receipt date.

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

Note: The Research Strategy component of the Research Plan is limited to 25 pages.

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

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

The Research Strategy component of the Research Plan is limited to 25 pages.

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. For information on EHS-Net activities, please visit http ://www.cdc.gov/nceh/ehs/EHSNet/ index.htm.

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.

The purpose of this FOA is to provide additional clarifying information based on questions received from potential applicants during the Pre-Application Conference Call or as a result of direct communication with the Scientific Program Official. A summary of the "questions and answers" and a list of changes made to the original FOA begins on page 32.

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

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 $1,425,000 in FY 2015 to fund up to eight applications. The maximum amount per award for the first 12-month budget period is $178,125 (direct and indirect costs). Awards issued under this FOA 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 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.

Budget and Project Period. The estimated total funding (direct and indirect costs) for the first 12-month budget period is expected to be $1,425,000 (direct and indirect costs) and the estimated total funding for the entire project period is expected to be $7,125,000 (direct and indirect costs). The project period will run from 09/30/2015 to 09/29/2020.

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 FOA; their names must appear on the face page of the application. However, one principal investigator must be designated as the contact PI. 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.

Special Date(s).

Letter of intent, if it is submitted, is due 30 days after publication.

A pre-application teleconference call will conducted on February 27, 2015, from 2:00 – 3:30 pm Eastern Time to address prospective applicants’ questions regarding FOA EH15-001, Environmental Health Specialists Network (EHS-Net) - Practice based research to improve food safety.

PARTICIPANT ACCESS INFORMATION

CALL DATE: February 27, 2015 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

CALL TIME: 2:00 Eastern Time CALL DURATION: 1 hour 30 minutes CALL LEADER: Susan Neurath Toll-Free Number: (855)-644-0229 Passcode: 8636049 #

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 Sections of the Public Health Service Act as amended and under the Code Federal Regulations. Awards are made under the authorization of Section 301 of the Public Health Service Act [42 U.S.C. Section 241], as amended.

1. Background and Purpose

Background and Purpose The National Center for Environmental Health (NCEH) of CDC within HHS is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2020" and to measuring program performance as stipulated by the Government Performance and Review Act (GPRA). This program of research addresses the CDC Winnable Battles for Food Safety, “Healthy People 2020” priority areas of food safety and public health infrastructure, and the Food Safety Modernization Act.

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 will 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.

CDC specific roles in the implementation of the Food Safety Modernization Act include enhancing foodborne disease surveillance systems by improving the collection, analysis, reporting and usefulness of associated data. These roles are to be implemented through governmental coordination and integration, evaluating and improving surveillance systems, and external stakeholder collaboration.

For more information, www.cdc.gov/winnablebattles/foodsafety/index.html, www.healthypeople.gov, http ://intra-apps.cdc.gov/fmo/, http://www.cdc.gov/foodsafety/fsma.html

Environmental Health Specialists Network (EHS-NET) Research Opportunity Description The focus of EHS-Net is to:

http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm#SectionIV1 http://www.cdc.gov/winnablebattles/foodsafety/index.html http://www.healthypeople.gov/ http://intra-apps.cdc.gov/fmo/ http://intra-apps.cdc.gov/fmo/ http://www.cdc.gov/foodsafety/fsma.html

Identify retail food safety issues Develop appropriate projects to address these issues Propose interventions and/or best practices based on the findings Disseminate findings

EHS-Net food safety activities include conducting applied behavioral and environmental epidemiologic research to identify environmental factors that contribute to disease transmission.

The focus of this research is to:

Identify and understand environmental factors associated with retail food safety, including food related illness and outbreaks.

1.

Evaluate food safety service programs, providers and their activities; 2.

Develop and disseminate the findings from EHS-Net projects to the environmental public health and food safety communities.

3.

Research Objectives:

Staffing

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’s Environmental Health Specialists Network Information System (EHSNIS) ( http ://www.cdc.gov/nceh/ehs/EHSNet/resources/ehsnis.htm)

1.

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.

2.

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).

3.

State Agency Collaboration and Planning http://www.cdc.gov/nceh/ehs/EHSNet/resources/ehsnis.htm http://www.cdc.gov/nceh/ehs/EHSNet/resources/ehsnis.htm

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.

1.

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.

2.

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.

3.

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).

4.

Organize the network to:

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.

1.

Include both rural and urban populations.2.

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

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.

4.

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.

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 Grantee 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. Conducting environmental assessments when investigating foodborne illness outbreaks to inform continued improvements in the collection, reporting, analysis and use of assessment data in the identification and/or improvement or development of foodborne illness prevention activities or policies. This includes reporting data collected to CDC through the EHS-Net Web-based information system (see http://www.cdc .gov/nceh/ehs/EHSNet/ehsnis.htm), the National Voluntary Environmental Assessment Information System (see http://www.cdc.gov/nceh/ehs/NVEAIS/index.htm ), and may also involve collection of food and/or environmental surface samples and submission to State, CDC, or other laboratories.

2. Building on previous EHS-Net research activities and findings (see http://www.cdc.gov/nceh/ehs /EHSNet), develop, implement, and evaluate interventions designed to identify and understand environmental factors associated with retail food safety, including foodborne illness. Possible activities that fall under this category include applied behavioral, food safety and environmental epidemiologic research.

Other possible activities include conducting behavioral research on preventing restaurant workers from working when ill; improving hand-washing behaviors and minimizing bare hand contact with foods; and requiring trained, certified kitchen managers to be present during all hours of operation. Examples of other potential behavioral projects include identification of risky food preparation practices and environmental factors related to those practices; barriers and facilitators for implementation of intervention strategies by food workers or managers; barriers and facilitators for EHS as risk communicators and risk managers;

barriers and facilitators for food safety programs in enforcing regulatory requirements; and development and evaluation of training materials or prevention messages for EHS, industry, or the public. Examples of potential environmental epidemiologic projects include descriptive epidemiology projects to determine the level of control of risk factors and status of food safety policies, and other studies to determine what factors and policies or combination prevent outbreaks of foodborne illness. Examples of potential food safety research may include development or evaluation of environmental sampling techniques for norovirus or other pathogens of interest; development or evaluation of pathogen-specific environmental sampling techniques or policies for investigations of foodborne illness outbreaks, or for use during routine evaluations to establish baseline levels of pathogen-specific contamination; or projects to assess the route of pathogen-specific cross-contamination.

3. Evaluating food safety programs and their activities. Potential projects would attempt to assess the effectiveness of food safety programs and/or specific activities in reducing risk factors for disease in the population served. Implementation and evaluation of pilot prevention and intervention projects (i.e., evaluation of integrated communication projects designed to increase hand washing by food workers in restaurants, or evaluation of hand washing behaviors and the impact on infectious diseases in institutional http://www.cdc.gov/nceh/ehs/EHSNet/ehsnis.htm http://www.cdc.gov/nceh/ehs/EHSNet/ehsnis.htm http://www.cdc.gov/nceh/ehs/NVEAIS/index.htm http://www.cdc.gov/nceh/ehs/EHSNet http://www.cdc.gov/nceh/ehs/EHSNet restaurants, or evaluation of hand washing behaviors and the impact on infectious diseases in institutional food service). Potential projects could include evaluation of the effects of food workers’ or managers’ food safety training programs on active managerial control of risk factors to foodborne illness outbreaks.

References: Food Safety Projects (see http://www.cdc.gov/nceh/ehs/EHSNet/foodsafety.htm)

Healthy People 2020 and other National Strategic Priorities

This program of research addresses the CDC Winnable Battles for Food 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 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

Objectives/Outcomes

Applications are expected to propose efforts designed to:

Conduct foodborne outbreak environmental assessments and report findings to the National Voluntary Environmental Assessment Information System.

Identify and improve our understanding of environmental factors associated with retail food safety.

Evaluate food safety service programs, providers and their activities;

Develop and disseminate findings from EHS-Net projects to the environmental public health and food safety communities.

Target Population

The research will be conducted in retail food establishments (e.g., restaurants, delis, cafeterias, schools, nursing homes, grocery stores). Specifically, the retail establishment kitchens will be observed and managers and workers will be interviewed. Thus, the target population of the research is retail food establishments.

http://www.cdc.gov/nceh/ehs/EHSNet/foodsafety.htm http://www.cdc.gov/nceh/ehs/topics/foodsafety.htm

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. Documentation of collaboration is 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 measures of effectiveness that will demonstrate the accomplishment of the proposed project objectives. Measures of effectiveness must relate to the goals stated in the “Purpose” section of this announcement. Measures must be objective and quantitative and must measure the intended outcome.

Translation Plan

Research findings should be disseminated through publications, including articles in peer reviewed journals and “Research Briefs” for diverse audiences, as well as presentations at professional conferences and other venues. Applicants are encouraged to include other avenues of dissemination of findings other than publications and presentations to reach as diverse an audience as possible. An explanation for how the scientific findings could be translated into public health programs, policies or practice should be included.

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: $1,425,000

Anticipated Number of Awards: 8

NCEH intends to commit approximately $1,425,000 in FY 2015 to fund up to eight applications. The maximum amount per award for the first 12-month budget period is $178,125 (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 FOA are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

Award Ceiling: $178,125 Per Budget Period Award Floor: $0 Per Budget Period Total Project Period Length: 5 year(s) Throughout the project period, 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/ asfr/ogapa/aboutog/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: State governments

County governments City or township governments Native American tribal governments (Federally recognized)

Governments:

U.S. Territory or Possession

Other:

Bona Fide Agents: a Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with "Other Attachment Forms" when submitting via www.grants.gov.

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.

http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf

3. Special Eligibility Requirements

Eligibility for this funding announcement is limited to applicants from governmental agencies that have the authority and responsibility to regulate and oversee retail food service including restaurants, delis, cafeterias, schools, etc. for food safety. These include State Governments or their Bona Fide Agents (includes the District of Columbia); Local Governments (County, City or Township) or their Bona Fide Agents; American Indian or Alaska Native Tribal Governments (federally-recognized or state-recognized); and Territorial Governments or their Bona Fide Agents in the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau Governments.

Eligibility is limited to the agencies described above because this announcement seeks to continue the Environmental Health Specialists Network (EHS-Net) research activities. EHS-Net was developed to provide regulatory officials with science and data to implement policies and regulations that protect communities from foodborne outbreaks and to provide communities with safe food.

All applicants that include a partnership between various agencies must have or establish a Memorandum of Understanding (MOU) documenting the responsibilities and proposed activities of each organization that will contribute to the research efforts, public health evaluations, and retail food regulatory practices. This is important to ensure that the applicable state and local agencies responsible for governing, setting policies and regulating food are involved in the projects from the beginning. Having the responsible agencies involved in the research activities will help ensure that we are maximizing our ability to reduce foodborne illness. The MOU must be submitted with the application and be included in the appendix. If your application is incomplete or non-responsive to the special requirements listed in this section, it will be considered ineligible and will not be forwarded for review.

4. Justification for Less than Maximum Competition

Eligibility is only offered to agencies that have the governmental authority and responsibility to regulate and oversee retail food service. These agencies have the unique capacity to implement public policies and regulations to protect communities from foodborne outbreaks and to provide communities with safe food.

Additionally, these agencies are uniquely positioned to establish the necessary level of collaboration across multiple agencies to accomplish the purpose and goals of EHS-Net, and the research objectives of this FOA.

No other business, university, organization, etc. will be able to lead collaborative efforts to change or improve the delivery of environmental health programs developed for this purpose.

5. Responsiveness

Applications will be considered nonresponsive if they exceed the page limitations or attachment limitations specified in this announcement.

Applications that include proposals to collaborate with other federal, state, or local agency or organization, must include a memorandum of understanding (MOU) detailing the nature and extent of the working relationships and involvement that can be expected from each organization outside of the grantee's agency. This documentation must be included in the appendix.

Applications will be considered nonresponsive if they do not meet the other criteria specified in this announcement.

6. Required Registrations

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/#1.

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 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 registration process at least four (4) weeks prior to the application due date.

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 grantee 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 grantee organization.

8. Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions 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 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/%231 http://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 http://www.Grants.gov http://fedgov.dnb.com/webform https://www.sam.gov/index.html

This FOA does not require cost sharing as defined in the HHS Grants Policy Statement (http:// www.hhs.gov/ asfr/ ogapa/ aboutog/ hhsgps107.pdf).

10. Number of Applications As defined in the HHS Grants Policy Statement, (http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf), applications received in response to the same funding opportunity announcement 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 FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Applicant organizations 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.

Section IV. Application and Submission Information

1. Address to Request Application Package Applicants must download the SF424 (R&R) application package associated with this funding opportunity from www.Grants.gov.

If access to the Internet is not available or if the applicant encounters difficulty accessing the forms on-line, contact the HHS/CDC Procurement and Grants Office Technical Information Management Section (PGO TIMS) staff at (770) 488-2700 or pgotim@cdc.gov for further instructions. Hours: Monday - Friday, 7am – 4:30pm U.S. Eastern Standard Time. CDC Telecommunications for the hearing impaired or disabled is available at: TTY 1-888-232-6348.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/ 424/SF424_RR_Guide_General_VerC.pdf), except where instructed in this Funding Opportunity Announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

The forms package associated with this FOA includes all applicable components, mandatory and optional.

Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF 424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

In conjunction with the SF424 (R&R) components, CDC grants applicants should also complete and submit additional components titled “PHS398.” Note the PHS398 should include assurances and certifications, additional data required by the agency for a complete application. While these are not identical to the PHS398 application form pages, the PHS398 reference is used to distinguish these additional data requirements from the data collected in the SF424 (R&R) components. A complete application to CDC will include SF424 (R&R) and PHS398 components.

3. Letter of Intent Due Date for Letter of Intent: 03/12/2015 http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.Grants.gov mailto:pgotim@cdc.gov

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CIO staff to estimate the potential review workload and plan the review.

By the date listed above and in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Name of the Applicant

Descriptive title of proposed research

Name, address, and telephone number of the PD(s)/PI(s)

Names of other key personnel

Participating institutions

Number and title of this funding opportunity

The letter of intent should be sent to:

Jane Suen, DrPH

Scientific Research Official for the National Center for Environmental Health, ATSDR, and NCIPC

Centers for Disease Control and Prevention (CDC) 4770 Buford Hwy, NE Mailstop F-63 Atlanta, GA 30341 Telephone: 770-488-4281 Email: JXS8@cdc.gov

4. Required and Optional Components A complete application has many components, both required and optional. The forms package associated with this FOA in Grants.gov includes all applicable components for this FOA, required and optional.

5. PHS 398 Research Plan Component The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that consists of 16 components. Not all 16 components of the Research Plan apply to all Funding Opportunity Announcements (FOAs). Specifically, some of the following 16 components are for Resubmissions or Revisions only. See Part I, Section 5.5 of the SF 424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf) for additional information. Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Funding Opportunity Announcement Description).

Follow the page limits stated in the SF 424 unless otherwise specified in the FOA. As applicable to and specified in the FOA, the application should include the bolded headers in this section and should address activities to be conducted over the course of the entire project, including but not limited to:

1. Introduction to Application (for Resubmission and Revision ONLY) - provide a clear description about the purpose of the proposed research and how it addresses the specific requirements of the FOA.

2. Specific Aims – state the problem the proposed research addresses and how it will result in public health impact and improvements in population health.

3. Research Strategy – the research strategy should be organized under 3 headings: Significance, mailto:SFN8@cdc.gov

Innovation and Approach. Describe the proposed research plan, including staffing and timeline.

4. Inclusion Enrollment Report (Renewal and Revision applications ONLY)

5. Progress Report Publication List (for Continuation ONLY)

Human Subjects Section

6. Protection of Human Subjects

7. Inclusion of Women and Minorities

8. Targeted/Planned Enrollment Table (for New Application ONLY)

9. Inclusion of Children

Other Research Plan Sections

10. Vertebrate Animals

11. Select Agent Research

12. Multiple PD/PI Leadership Plan.

13. Consortium/Contractual Arrangements

14. Letters of Support

15. Resource Sharing Plan(s)

16. Appendix

Component 4 (Inclusion Enrollment Report) applies only to Renewal and Revision applications for clinical research. Clinical research is that which is conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies). Follow the page limits in the SF 424 unless otherwise specified in the FOA.

All instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf) must be followed along with any additional instructions provided in the FOA.

6. Appendix Do not use the appendix to circumvent page limits. A maximum of 10 PDF documents are allowed in the appendix. Additionally, up to 3 publications may be included that are not publically available. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

7. Page Limitations All page limitations described in this individual FOA must be followed. For this specific FOA, the Research Strategy component of the Research Plan narrative is limited to 25 pages. Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files with a maximum of 60 pages for all appendices.

8. Format for Attachments Designed to maximize system-conducted validations, multiple separate attachments are required for a complete application. When the application is received by the agency, all submitted forms and all separate attachments are combined into a single document that is used by peer reviewers and agency staff. Applicants should ensure that all attachments are uploaded to the system.

CDC requires all text attachments to the Adobe application forms be submitted as PDFs and that all text attachments conform to the agency-specific formatting requirements noted in the SF424 (R&R) Application Guide (Part I, Section 2) (http://grants.nih.gov/ grants/funding/424/ SF424_RR_Guide_General_VerC.pdf).

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

9. Submission Dates & Times Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov (http://www.grants.gov), the online portal to find and apply for grants across all Federal agencies. The eRA Commons systems retrieve the application from Grants.gov and check the application against CDC business rules. If no errors are found, the application will be assembled in the eRA Commons for viewing by the applicant before moving on for further CDC processing.

If errors are found, the applicant will be notified in the eRA Commons. They must make required changes to the local copy of their application and submit again through Grants.gov.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Once you can see your application in the Commons, be sure to review it carefully as this is what the reviewer will see. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons (http:// grants.nih. gov/grants /guide/url_redirect .htm? id=11123).

Information on the submission process is provided in the SF424 (R&R) Application Guide.

Note: HHS/CDC grant submission procedures do not provide a period of time beyond the grant application due date 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).

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