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Cooperative Agreement to Support the North Carolina State University, Prestage Department of Poultry Science and the Piedmont Research Station (U01)

Department of Health and Human Services

 

Part 1. Overview Information

 

Participating Organization(s)

U.S. Food and Drug Administration  (FDA)

The FDA does not follow the NIH Page Limitation Guidelines or the Enhanced Peer Review Scoring Criteria. The applicant is encouraged to consult with FDA Agency Contacts for additional information regarding page limits and the FDA Objective Review Process.

Components of Participating Organizations

Center for Food Safety and Applied Nutrition (CFSAN)

Funding Opportunity Title

Cooperative Agreement to Support the North Carolina State University, Prestage  Department of Poultry Science and the Piedmont Research Station (U01)

Activity Code

U01 Research Project – Cooperative Agreements
 

Announcement Type

New

Related Notices

None
 

Funding Opportunity Announcement (FOA) Number

RFA-FD-13-031
 

Companion Funding Opportunity

None

Number of Applications

Only one application per institution is allowed. Section III. 3. Additional Information on Eligibility.
 

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.103
 

Funding Opportunity Purpose

The Food and Drug Administration (FDA) is announcing its intention to receive and consider a single source application for the award of a cooperative agreement in fiscal year 2013 (FY13) to the North Carolina State University, Prestage Department of Poultry Science to support the Piedmont Research Station Poultry Unit, Salisbury, North Carolina.

In 2010, approximately 1,939 cases of Salmonellosis were reported in the U.S due to Salmonella Enteritidis contamination in shell eggs.  Consequently, the scientific investigation of the vertical and horizontal transmission of Salmonella in shell eggs has become a high research priority designated in the Center for Food Safety and Applied Nutrition's 2013 strategic science and research plan to address risk management of Salmonella transmission. FDA aims to implement preventative measures to reduce the vertical and horizontal transmission of Salmonella Enteritidis and potentially other Salmonella serovars to table eggs and poultry products.  Intensive genetic selection for enhanced egg production has altered the ability to resist microbial contamination within laying hen breeders.  Thus, it is imperative that interventional strategies be studied to ensure the safety and microbial integrity of egg and poultry products for consumption.

Therefore, the aim of FDA is to initiate a cooperative agreement with the North Carolina State University, Prestage Department of Poultry Science, in which collaborative research projects can be conducted at the Piedmont Research Station Poultry Unit, to parallel poultry and egg industry practices on a commercial scale to more accurately identify the primary routes of Salmonella transmission within the industry, and identify interventional strategies (dietary, environmental, disinfection) to reduce the risk of Salmonella transmission to table eggs. 

The purposes of this partnership are as follows:

1) To utilize a commercial research facility to parallel the transmission (vertical and horizontal) of Salmonella found within the egg production industry.

2) To determine how alterations in physical feed characteristics and housing may influence vertical and horizontal transmission. 

3) To examine how commercially utilized disinfection protocols affect horizontal transmission of Salmonella in alternative versus traditionally housed layer hens.

4) To examine the prevalence of differing Salmonella serovars in various environmental layer hen housing systems (conventional cage, enriched cage systems, and free-range).

 

Key Dates

 

Posted Date

 

Open Date (Earliest Submission Date)

June 1, 2013
 

Letter of Intent Due Date(s)

Not Applicable
 

Application Due
Date(s)

July 15, 2013 by 11:59 PM Eastern Time.  

Applicant should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) before 11:59 p.m. Eastern Time on the application due date. Applicant is encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due
Date(s)

Not Applicable
 

Scientific Merit Review

July 2013
 

Advisory Council Review

August 2013
 

Earliest Start Date

September 2013
 

Expiration Date

July 16, 2013

Due Dates for E.O. 12372

Not Applicable
 

 

Required Application Instructions

It is critical that applicant 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. Applicant 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. An application that does not comply with these instructions may be delayed or not accepted for review.

Table of Contents

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

Part 2. Full Text of Announcement

 

Section I. Funding Opportunity Description

FDA seeks to implement effective preventative measures to reduce the vertical and horizontal transmission of Salmonella Enteritidis and other Salmonella serovars to table eggs and poultry products. Intensive genetic selection for enhanced egg production has altered the ability to resist microbial contamination within laying hen breeders, a critical public health and food safety concern. Thus, it is imperative that interventional strategies are studied to develop preventive control measures and to ensure the safety of egg and poultry products for consumption.

This collaborative project aims to compare the type of Salmonella transmission (vertical or horizontal) in various production environments (conventional battery cages, enriched cage or free-range), a research priority designated in the Center for Food Safety and Applied Nutrition's 2013 strategic science and research plan to address risk management of Salmonella transmission.  Additionally, this study aims to examine the effect of environmental disinfecting and nutritional interventional strategies on the incidence and type of Salmonella transmission to eggs, egg products, and poultry products within a commercial-style research farm environment.  This study will utilize a commercial-style research model which parallels transmission found within an egg production facility, which is critical to understanding the means of Salmonella transmission in shell eggs within the commercial egg industry and may reveal other serovars of Salmonella present within the commercial egg industry which may pose a potential health risk to consumers.  In conjunction, FDA will conduct an in-house study, “In vivo and in vitro assessment of nutritional modulation on Salmonella Enteritidis (SE) and Salmonella Heidelberg (SH) challenge in pre- and post-molted layers”, to artificially infect by oral gavage layer hen breeders to more closely look at the effects of molting, various titers and serotype on transmission rates. 

While historically the concern over Salmonella has focused on Salmonella Enteritidis, there is a potential concern that other Salmonella serovars could be a source for egg-transmitted human salmonellosis.  Hence, this study aims to investigate the occurrence, transmission and virulence of varying Salmonella serovars. 
 

Section II. Award Information

Funding Instrument

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

Application Types Allowed

 

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

 

The Center for Food Safety and Applied Nutrition (CFSAN) at FDA intends to commit up to $50,000 in FY 2013.

It is anticipated that up to one (1) award will be made in FY 2013.
 

Award Budget

The estimated amount of support in FY 2013 will be up to $50,000 total costs (direct plus indirect costs) with the possibility of up to four additional years of support, subject to the availability of funds.  Future year amounts will depend on annual appropriations and successful performance.

Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs.

Year 01: $50,000
Year 02: $50,000
Year 03: $50,000
Year 04: $50,000
Year 05: $50,000 
 

Award Project Period

Scope of the proposed project should determine the project period.  The maximum project period is five (5) years.        
 

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Eligibility is limited to the North Carolina State University.

The North Carolina State University, Prestage Department of Poultry Science utilizes the Piedmont Research Station Poultry Unit (Salisbury, North Carolina) to conduct large scale research projects with commercial broilers, layers, broiler breeders and commercial-style egg incubation.  The Piedmont Research Station Poultry Unit is a unique facility that has housing for over 15,000 commercial layers, 8,000 broiler breeders, and incubation capacity to hatch more than 52,000 eggs at one time utilizing both multi-stage and single stage incubation.  The Layer Performance Management Test for North America is annually conducted at the Piedmont Research Station, with studies in applied production practices and nutrition management.  These facilities are able to evaluate the effects of a research project on a size and scale that mimics commercial poultry operations. 

The North Carolina State University, Prestage Department of Poultry Science utilizes their onsite feed mill, which is a research and educational feed mill that is designed and equipped to manufacture a variety of feed mix characteristics, formulations, and feed forms. It is currently used by FDA for training purposes associated with the safe feed-safe food program, and is among the few research feed mills in the country that is associated with animal research facilities. The mill has all of the typical process equipment found in commercial feed mills, including an 8 ton/hr CPM hammer mill, 8 ton/hr RMS roller mill, micro bin-batching system, a 500 lb horizontal ribbon mixer, a 2 ton double-shaft ribbon mixer, a 1 ton/hr CPM pellet mill with counter-flow cooler, a 10 ton/hr Bliss pellet mill with counter-flow cooler, pellet screener, bagger, bulk ingredient bins, finished feed bins, and an automated computer-controlled batch mixing and process operation.  This feed mill is able to manufacture feed of various feed ingredient grind size in mash or pellet forms. 

While other academic institutions also have outstanding poultry and egg research programs, they do not have commercial style research facilities such as the Piedmont Research Station Poultry Unit, feed mill and resources to conduct large scale commercial size research projects.  Moreover, the North Carolina State University, Prestage Department of Poultry Science and Piedmont Research Facility are within close geographic proximity for collaboration with the FDA Department of Immunobiology.  This will allow FDA's investigational scientists to travel by automobile on key experimental dates to initiate research experiments and collect tissue and environmental samples.  These samples will be transported within 24 hours back to the FDA Department of Immunobiology for microbiological testing and analysis.

Foreign Institutions

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

Required Registrations

Applicant Organization
The applicant organization 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 applicant 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 applicant be issued a DUNS number. After obtaining a DUNS number, applicant 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) – Applicant 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.
  • eRA Commons - Applicant must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. The organization can register with the eRA Commons as it is working through its SAM or Grants.gov registration. eRA Commons requires an organization 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 – Applicant must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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.

Eligible Individuals (Program Director/Principal Investigator)

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.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Only one application per institution (normally identified by having a unique TIN number) is allowed.

FDA will not accept any application that is essentially the same as one already reviewed within the past twelve months, except for submission:

  • To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
  • Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
  • Of an application with a changed grant activity code.

   

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicant must download 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.

2. Content and Form of Application Submission

It is critical that applicant follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. An application that is 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.

Page Limitations

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:

  • For this specific FOA, the Research Strategy section is limited to 30 pages.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

SF424(R&R) Cover (Required)

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

SF424(R&R) Project/Performance Site Locations (Required)

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

SF424(R&R) Other Project Information (Required)

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

SF424(R&R) Senior/Key Person Profile (Required)

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

R&R Budget (Required)

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

  • 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'.
  • An application requesting multiple years of support must complete and submit a separate detailed budget breakdown and narrative justification for each year of financial support requested.

PHS 398 Cover Letter (Optional)

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

PHS 398 Cover Page Supplement (Required)

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

PHS 398 Research Plan (Required)

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

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:

  • The application, 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.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicant is encouraged to submit its application before the due date to ensure that it has time to make any application corrections that might be necessary for successful submission.

The organization must submit its application to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicant 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.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. 

Applicant is responsible for viewing its 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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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.

6. Other Submission Requirements and Information

Application must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  

Applicant 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.

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 Managment. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, application will be evaluated for completeness by the assigned Grants Management Specialist and responsiveness by components of participating organizations, FDA. An application that is incomplete and/or nonresponsive will not be reviewed.  

Post Submission Materials

Applicant is required to follow the instructions for post-submission materials, as described in NOT-OD-10-115 .

Section V. Application Review Information

1. Criteria

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

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each.

Significance
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)    
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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?   
RFA/PAR only: Additional Questions may be added.

Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach
Are the overall strategy, methodology, and analyses well-reasoned and 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? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment
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? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects
For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 
When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards
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.

Resubmissions
Not Applicable

Renewals
Not Applicable

Revisions
Not Applicable

Additional Review Considerations

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

Applications from Foreign Organizations
Not Applicable

Select Agent Research
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).

Resource Sharing Plans
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) Genome Wide Association Studies (GWAS).

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

2. Review and Selection Process

An application determined to be complete and responsive will undergo an objective review process.  An objective review panel will evaluate a complete and responsive application according to the criteria listed in the Scored Review Criteria section above.

As part of the objective review, the application:

  • Will receive a written critique.

Appeals of initial objective review will not be accepted for applications submitted in response to this FOA.
Keep the appeals sentence for RFAs only; otherwise delete for all PA, PAR, PAS.

The application will receive a Composite Score and a funding recommendation from the Objective Review Panel.  Following the objective review, if recommended for funding, the application will receive a second level of review by the National Cancer Advisory Board.

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.

3. Anticipated Announcement and Award Dates

Information regarding the disposition of applications is available in the HHS Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, FDA will request "just-in-time" information from the applicant as described in the HHS Grants Policy Statement.

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.

Awardee 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 the DUNS, SAM Registration, and Transparency Act requirements as noted in the HHS Grants Policy Statement.
 

2. Administrative and National Policy Requirements

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

Additional terms and conditions regarding FDA regulatory and Programmatic requirements may be part of the Notice of Award.

Cooperative Agreement Terms and Conditions of Award
If this FOA is not a cooperative agreement, make no changes to this section.  If it IS a cooperative agreement, fill out the template “Cooperative Agreement Terms and Conditions of Award” as appropriate.  THEN, copy and paste all the text from that template into this section, replacing “Not Applicable” (below) with your text.

The following special terms of award are in addition to, and 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 administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and FDA grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an “acquisition" mechanism), in which substantial FDA programmatic involvement with the awardee is anticipated during the performance of the activities.  Under the cooperative agreement, the FDA purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role of activities.  Consistent with this concept, the dominant role and prime responsibility resides with the awardee for the project as a whole, although specific tasks and activities may be shared among the awardee and the FDA as defined below.

2. A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for and dominant role in planning, directing, and executing the proposed program, with the FDA staff being substantially involved as a partner with the PI.

The Principal Investigator will have primary responsibility for the financial management of program funds to adhere to the mission of the program as determined by the bilateral partnership.

Awardee will retain custody of and have primary rights to the data and software developed under this award, subject to Government rights of access consistent with current HHS, PHS, and FDA policies.

2. A.2. FDA Responsibilities

An FDA Project Officer will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The program project officer will monitor the grantee periodically. The monitoring may be in the form of telephone conversations, emails, or written correspondence between the project officer/grants management officer and the Principal Investigator.  Periodic site visits with officials of the grantee organization may also occur.  The results of these monitoring activities will be recorded in the official grant file and will be available to the grantee upon request, consistent with applicable disclosure statutes and with FDA disclosure regulations. Also, the grantee organization must comply with all special terms and conditions of the grant, including those that state that future funding will depend on recommendations from the project officer.  In addition,

a. FDA will have prior approval of the appointment of all key administrative and scientific personnel proposed by the grantee, as well as, any collaborative structure between NCSU and any other entities.

b. FDA will be directly involved in the guidance and development of the program and the collaborative structure for the program.

c. FDA scientists will participate, with the grantee, in determining and carrying out scientific and technical activities. Collaboration will also include data analysis, interpretation of findings and, where appropriate, co-authorship of publications.

Areas of Joint Responsibility include:

  • None; all responsibilities are divided between awardee and FDA staff as described above.

3. Reporting

When multiple years are involved, awardee will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the HHS Grants Policy Statement and the terms and conditions of 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 and the terms and conditions of the Notice of Award.

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.  See the HHS Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Phone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Ondulla Toomer, Ph.D.
Center for Food Safety and Applied Nutrition
Food and Drug Administration
8301 Muirkirk Road, MOD-1 (HFS-025)
Laurel, MD  20708
Telephone: 240-402-3430
Email: ondulla.toomer@fda.hhs.gov

Objective Review Contact(s)

Kimberly Pendleton Chew
Division of Acquisition Support and Grants
5630 Fishers Lane, Rm. 2105, HFA 500
Food and Drug Administration
Rockville, MD 20857
Telephone: 301-827-9363
Email:kimberly.pendleton@fda.hhs.gov

Financial/Grants Management Contact(s)

Kimberly Pendleton Chew
Division of Acquisition Support and Grants
5630 Fishers Lane, Rm. 2105, HFA 500
Food and Drug Administration
Rockville, MD 20857
Telephone: 301-827-9363
Email:kimberly.pendleton@fda.hhs.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Section 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74.