Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). 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. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

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

Background:
The National Antimicrobial Resistance Monitoring System (NARMS) is a U.S. public health surveillance system that tracks antibiotic resistance in enteric bacteria from humans, retail meats, and food animals. NARMS was established in 1996 through a Congressional mandate and is a collaboration of the U.S. Food and Drug Administration (FDA), the U.S. Centers for Disease Control and Prevention (CDC), the U.S. Department of Agriculture (USDA), and State and Local Public Health Departments. The primary bacteria under surveillance are Salmonella, Campylobacter, Escherichia coli, and Enterococcus. This FOA is limited to the retail food surveillance portion of the NARMS program.

Problem Statement:
Antimicrobial drugs have been widely used in human and veterinary medicine for more than 60 years, with tremendous benefits to both human and animal health. The development of resistance to these medicines poses a serious public health threat. Antimicrobial drug use creates selective evolutionary pressure that enables antimicrobial resistant bacteria to increase in numbers and thus increases the opportunity for individuals to become infected by resistant bacteria. When antimicrobial drugs are used in food-producing animals, they can enrich for populations of resistant strains that reach humans via the food supply.

Purpose:
FDA announces the availability of fiscal year (FY) 2016 funds to enhance and strengthen antibiotic resistance surveillance in retail food specimens within the National Antimicrobial Resistance Monitoring System (NARMS). This cooperative agreement with the NARMS retail food surveillance program will enable research and investigations for the collection of critical data that will inform FDApolicy and regulatory actions and benefit the public health by providing data and strategies for use by other public health stakeholders as well. Data from investigations conducted by applicants will assist in developing pre-approval safety evaluation of new animal antibiotics, determining parameters for the antimicrobial use in veterinary medicine, and the ability of public health actors to provide information to promote interventions to reduce resistance among foodborne bacteria. This cooperative agreement will address NARMS programmatic needs to implement effective surveillance and response for antibiotic resistance as recommended in the National Strategy for Combating Antibiotic-Resistant Bacteria (CARB). The chief goal of the NARMS food surveillance program is to improve the detection of and surveillance for antimicrobial resistance among enteric bacteria in raw retail meat commodities.

Goals and Objectives:
1. Applicant shall be able to collect and process samples within a relevant time frame, such as that described in the FDA protocol and guidelines
2. Applicant shall be able to perform microbiological tests, such as those described in the project protocol, of the total samples suggested by the FDA
3. Applicant shall be able to use microbiological results from the project to analyze quality assurance practices
4. Applicant shall be able to integrate and coordinate surveillance activities
5. Applicant shall be able to exchange relevant and complete surveillance data
6. Applicant shall be able to use data to inform program and policy development
7. Applicant shall be able to employ data for education on current and emerging hazards
8. Applicant shall be able to support awareness of antimicrobial resistance among the public
9. Applicant shall be able to identify foodborne illness outbreaks and coordinate outbreak investigations
10. Applicant shall be able to analyze antimicrobial resistance data for their jurisdiction over time
11. Applicant shall be able to defend their jurisdictions involvement in protecting and promoting the public's health

Areas of Interest:
FDA is requesting proposals that:
- enhance outbreak investigation response and reporting
- improve surveillance to drive public health action
- foster collaboration among city, county, state, and federal partners and other external partners
- sustain and enhance laboratory diagnostic capacity
- improve laboratory coordination and outreach/information flow in order to coordinate connections between epidemiology and laboratory functions, at state and local levels
- maintain and exchange integrated surveillance information system

Evaluation and Performance Measurement Strategy:
Required performance measures for the project period are listed below. Data will be reported on an annual basis, and are used to indicate progress made toward program outcomes. The purpose of evaluation and performance measurement is to help FDA and NARMS Cooperative Agreement awardees: 1) Monitor the extent to which activities planned were successfully completed (e.g., Were activities implemented correctly?); 2) Demonstrate how capacity building activities contribute towards program outcomes (e.g., Were outcomes of interest achieved?); and 3) Inform decisions about future programming that drive continuous program improvement for more efficient and effective program performance (e.g., What and how could things be improved?). Potential data sources will include awardee applications and progress reports (e.g., work plans, performance measures, and success stories).

Below are evaluation questions to be addressed by the FOA during this project period:
1. What are the major activities conducted by awardees that contributed towards achieving NARMS Retail Food Surveillance program outcomes?
2. What major goals or objectives were accomplished by awardees that contributed towards achieving NARMS Retail Food Surveillance program outcomes?
3. To what extent were awardees proposed activities implemented as planned?
4. To what extent were awardees able to collect and conduct microbiological tests on a relevant number number of retail meat samples per month?
5. To what extent were awardees able to conduct effective sampling?
7. To what extent were awardees able to submit isolates to FDA on a periodic basis?
8. To what extent did awardees correctly identify isolates submitted to FDA (including serotype for Salmonella isolates)?
9. To what extent did awardees attend and participate in NARMS Retail Food Surveillance quarterly calls?

HHS grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the HHS Grants Policy Statement, are not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.

System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

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

eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.

Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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

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

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The FDA will not accept duplicate or highly overlapping applications under review at the same time. This means that the FDA will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

Applicants must obtain the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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 FDA staff to estimate the potential review workload and plan the review.

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

• Descriptive title of proposed activity
• Name(s), email address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent via electronic mail as a PDF file with the FOA Number and the Institution's Name in the message subject heading to:

Bryce Jones via Bryce.Jones@fda.hhs.gov

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

• The Research Strategy must be submitted in the following format:

a) Maximum number of pages: 20 (excluding budget, budget narrative, appendices, and required forms). If your narrative exceeds the page limit, only the first pages within the page limit will be reviewed.

b) Font size: 12 point unreduced

c) Spacing: Single

d) Page Margins: 1 inch

e) Number all narrative pages

• The budget and budget narrative will be included as a separate attachment not to be counted in the Research Strategy page limit.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

• Project Summary/Abstract: A project abstract is a mandatory document within the Research and Related Other Project Information form. This project abstract should be a self-contained, brief summary of the proposed project including the purpose and expected outcomes. It is meant to serve as a succinct and accurate description of the proposed work when separated from the application. This summary must not include any proprietary or confidential information. Applicants must name this file "Project Summary".

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:

• Applications requesting multiple years of support must complete and submit a separate detailed budget breakdown and narrative justification for each year of financial support requested. The budget must be consistent with the stated program objectives and planned activities as outlined in Section I. Funding Opportunity Description.
• If an applicant is requesting indirect costs as part of their budget, a copy of the most recent Federal indirect cost rate or F&A agreement must be provided as part of the application submission. This agreement should be attached to the RESEARCH & RELATED Other Project Information Component as line #12 'Other Attachments'.
• If the applicant organization has never established an indirect cost rate and/or does not have a negotiated Federal indirect cost rate agreement, a de minimis indirect cost rate of 10 percent (10%) of modified total direct costs (MTDC) will be allowed. MTDC means all direct salaries and wages, applicable fringe benefits, materials and supplies, services, travel, and subaward and subcontracts up to the first $25,000 of each subaward or subcontract. MTDC excludes equipment, capital expenditures, charges for patient care, rental costs, tuition remission, scholarships and fellowships, participant support costs and the portion of each subaward and subcontract in excess of $25,000.
• When developing the budget narrative, applicants must consider whether the proposed budget is reasonable and consistent with the purpose, outcomes, and program strategy.
• Applicants should not request travel costs in excess of $1,500 and must be for NARMS specific activities. Only travel that is considered a required activity of this cooperative agreement will be funded by the FDA.
• Grant funds cannot be used for the following:

1. Molecular testing of isolates cultured from fresh retail meat/food for the NARMS program;
2. Collection and testing of meats and/or food products not specified in the sampling assignment;
3. Isolation of organisms other than those agreed to or specified in pilot study programs.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:

• Research Strategy: Applicants must submit a Research Strategy with the application forms. The Research Strategy must be written according to the following outline (see Research Strategy Outline below) using formatting guidelines in the Page Limitations Section. The application should contain a A) Background & Overview, B) Approach, C) Capacity of Applicants to Implement the Approach, and D) Evaluation and Performance Strategy. Applicants must name this file "Research Strategy".
• Research Strategy Outline:

A. Background & Overview: Applicants must provide a description of relevant background information that includes the context of the problem. Specifically:

i. List of the project component activities being addressed in the application.

ii. Provide information on population size, demographic characteristics, and types of fresh food retailers in your jurisdiction (i.e., traditional, non-traditional, modern retail).

iii. Describe organizational (especially as it relates to the integration of epidemiology and laboratory), fiscal, administrative, and/or programmatic challenges or limitations you expect to face, and measures to overcome them associated with the implementation of the activities you are proposing in this application. Describe plans to assure adequate planning and that activities (e.g., hiring, contracting, procurement, collaborations, etc.) are implemented quickly with rigorous tracking and oversight to avoid delays and reduce the potential for unobligated funds remaining at the end of the budget and project period.

iv. Provide any success stories to capture recent accomplishments that highlight the impact of the NARMS retail food surveillance program in your jurisdiction. These will be used to educate stakeholders, decision makers, and policymakers about the impact of the NARMS program.

B. Approach: Applicants must describe the core information relative to the project and how the applicant's response to the FOA will address the public health priority as described in the Funding Opportunity Description. Specifically:

i. Describe how the application will address the project's needs. Clearly identify the expected outcomes to be achieved by the end of the project period. In addition to the project period outcomes required by the Funding Opportunity Description, applicants should include any additional outcomes they anticipate. Outcomes are the results that the program intends to achieve. All outcomes must indicate the intended direction of change (i.e., increase, decrease, maintain, complete).

ii. Applicants should provide a clear and concise description of the strategies and activities they will use to achieve the project period outcomes. Briefly introduce the activity(ies) being proposed and describe what the expected outputs (e.g., milestones) and outcomes will be over the first 12-month budget period. Applicants may propose additional strategies and activities to achieve the outcomes and describe the rationale for selecting these. Also provide a brief discussion of what will be achieved (i.e., expected outputs and outcomes) over the entire five-year project period.

iii. If applicable, describe collaborations with programs and organizations either internal or external to FDA and describe the extent to which the strategies and activities will target specific population(s) in the collaborators jurisdiction.

C. Capacity of Applicants to Implement the Approach: Address your jurisdiction's current capacity to successfully implement the proposed strategies and activities (including describing staff and other infrastructure already in place that you will build upon).

• Progress Report: If your jurisdiction was funded in the previous funding period you must provide progress on those activities. The time period of progress reports covered should range from the beginning of your last funding period to the time of application. Progress Reports should:
• Describe major activities conducted, the progress of those activities, and significant milestones accomplished as a result of those activities.
• Address progress made for each performance measure written in the FY2017 proposal.
• If applicable, include the reasons that goals (e.g., targets for performance measures) were not met or activities (e.g., milestones) were incomplete, and a discussion of assistance needed to resolve the situation.
• If applicable, describe any barriers encountered, and how the barriers were addressed during implementation of these activities.

D. Evaluation and Performance Measurement Plan: Describe in a brief narrative (5 pages maximum) a plan to monitor activities, demonstrate progress towards program outcomes and inform future program decisions over the five-year project period. The plan should be consistent with the Evaluation and Performance Measurement Strategy listed in the Funding Opportunity Description. Reporting on this plan will occur on an annual basis and at the end of the project period. As needed and on request of the awardee, FDA will work with awardees during the first six months of the project period to finalize an evaluation and performance measurement plan to better monitor the progress of the activities implemented and outcomes achieved.

This plan, at a minimum, should address the following points:

i. Identify key program partners and describe how they will participate in the implementation of the evaluation plan as described within this FOA. These include persons involved in or affected by the program and primary users of the evaluation (e.g., staff from epidemiology, laboratory, and health information systems; program coordinators; partners (if applicable), PI's, etc.)

ii. Consider the evaluation questions outlined in the Evaluation and Performance Strategy. These questions will establish the scope and focus of the evaluation. Applicants may also choose to develop other evaluation questions, in addition to those defined by FDA.

iii. Describe the data (performance measures and associated data) and how you will use the data to answer evaluation questions.

iv. Describe how evaluating findings will be used at the applicant level. Discuss how data collected (i.e., performance measurement data) will be used and shared by the key program partners.

v. Discuss any barriers or challenges expected for implementing the plan, collecting data (i.e., responding to performance measures), and reporting on evaluation results. Describe how these potential barriers would be overcome. In addition, applicants may also describe other measures to be developed or additional data sources and data collection methods that applicants will use.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

All instructions in the SF424 (R&R) Application Guide must be followed.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, FDA's electronic system for grants administration. eRA Commons and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Late applications will not be accepted for this FOA.

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

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

Pre-award costs are allowable only as described in the HHS Grants Policy Statement.

Grant funds cannot be used for the following:

• Molecular testing of isolates cultured from fresh retail meat/food for the NARMS program;
• Collection and testing of meats and/or food products not specified in the sampling assignment;
• Isolation of organisms other than those agreed to or specified in pilot study programs.

Additional funding restrictions may be part of the Notice of Award.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to FDA. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the assigned Grants Management Specialist and responsiveness by components of participating organizations, FDA. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Only the review criteria described below will be considered in the review process.

Reviewers will consider each of the review criteria below in the determination of scientific merit.

Does the proposal demonstrate proficiency in food microbiology, and familiarity with best practices in laboratory microbiology protocols? Is the proposed work congruent with the public health priorities of the candidate institute so that testing will not be postponed by competing priorities and reporting of data will not be delayed or compromised?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Does the application challenge and seek to shift current research, surveillance, or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Is a refinement or improvement of approaches or methodologies, instrumentation, or interventions proposed?

Are the overall strategy, methodology, staffing and analyses appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Is the proposed work congruent with the public health priorities of the candidate institute so that testing will not be postponed by competing priorities and reporting of data will not be delayed or compromised? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

As applicable for the project proposed, reviewers will evaluate the following additional items, but will not give separate scores for these items and should not consider them in providing an overall score.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Not Applicable

Not Applicable

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by an Objective Review Committee using the stated review criteria.

As part of the objective review, all applications:

• Will receive a written critique.

Appeals of objective review will not be accepted for applications submitted in response to this FOA.

Applications will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by objective review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

Successful applicants will be notified of additional information that may be required or other actions leading to an award. The decision not to award a grant, or to award a grant at a particular funding level, is discretionary and is not subject to appeal to any FDA or HHS official or board.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found in the HHS Grants Policy Statement.

All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

FDA considers the sharing of research resources developed through FDA-sponsored research an important means to enhance the value and further the advancement of research. When research resources have been developed with FDA funds and the associated research findings published, those findings must be made readily available to the scientific community.

Upon acceptance for publication, scientific researchers must submit the author’s final manuscript of the peer-reviewed scientific publication resulting from research supported in whole or in part with FDA funds to the NIH National Library of Medicine's (NLM) PubMed Central (PMC). FDA defines the author's final manuscript as the final version accepted for journal publication, which includes all modifications from the publishing peer review process. The PMC archive is the designated repository for these manuscripts for use by the public, health care providers, educators, scientists, and FDA. Please see the FDA Public Access Policy.

Additional terms and conditions regarding FDA regulatory and Center for Veterinary Medicine programmatic requirements may be part of the Notice of Award.

The following special terms of award are in addition to, not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administrative regulations at 45 CFR 75, and other HHS, PHS, and FDA grant administrative policies.

Support will be in the form of a cooperative agreement. Substantive involvement by the awarding agency is inherent in the cooperative agreement award. Accordingly, FDA will have substantial involvement in the program activities of the project funded by the cooperative agreement.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the Notice of Award.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the HHS Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable FDA grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Email: support@grants.gov

Patrick McDermott
Director: NARMS
Food and Drug Administration
Center for Veterinary Medicine (CVM)
Telephone: 240-402-0891
Email: patrick.mcdermott@fda.hhs.gov

Rene Vasquez
Grants Management Specialist
Office of Acquisition & Grants Services (OAGS)
Food and Drug Administration
5630 Fishers Lane
Rockville, MD 20857
Telephone: 301-796-3546
Email: rene.vasquez@fda.hhs.gov

Rene Vasquez
Grants Management Specialist
Office of Acquisition & Grants Services (OAGS)
Food and Drug Administration
Telephone: 301-796-3546
Email: rene.vasquez@fda.hhs.gov

All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

Awards are made under the authorization of Sections 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.