Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

U.S. Food and Drug Administration  (FDA)

The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.  Where this Funding Opportunity Announcement (FOA) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this FOA.

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

Components of Participating Organizations

FDA Center for Veterinary Medicine (CVM)

Funding Opportunity Title

Vet-LIRN Cooperative Agreement Program to Develop and Validate Testing Methods for Food Irradiation Specific Markers in Animal Feeds and Treats (U18)

Activity Code

U18 Research Demonstration – Cooperative Agreements

Announcement Type

New

Related Notices

  • NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015)
  • Funding Opportunity Announcement (FOA) Number

    PAR-16-132

    Companion Funding Opportunity

    None

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

    93.103 

    Funding Opportunity Purpose

    Food irradiation is a food preservation method which is used in many countries, both in human and animal food manufacturing. Treating food with irradiation results in large reduction in microbial contamination and insect pests. It is also useful in slowing ripening of fruit and for inhibiting sprouting of plant products.  In USA, the FDA regulates all aspects of irradiation, such as irradiation dose, product type, and labeling requirements.  The use of irradiation requires development of analytical methods capable to determine the irradiation status of wide variety of foods, in order to ensure that food is properly labeled, as well as to insure that products were properly handled during irradiation process.  Current FDA regulations allow a maximum absorbed dose of 50 kGy in animal feed, pet food, and treats that are irradiated to reduce microbial and insect pest contamination.  There are however, very few tests, with limited application, to quantify the actual dose used when irradiating animal food products. Depending on the type of food, various methods are available to detect food irradiation. For fatty foods, the major methods are based on chemical determination of compounds formed from the irradiation of lipids (hydrocarbons and 2-alkylcyclobutanones). It is believed that 2-alkylcyclobutanones (2-ACBs) are formed in food only by irradiation, and they are considered as markers for detecting the irradiation in food.  Electron spin resonance (ESP) spectroscopy detects irradiation induced paramagnetic centers (e.g. radicals). This method is applicable for detection of irradiated foods containing bone, cellulose or crystalline sugar. Thermoluminescence is a method applicable to those foods from which a sufficient amount of silicate minerals can be isolated. Photostimulated luminescence is a different method, which can be applied to detect irradiation of any food which contains mineral debris. DNA comet assay can be used to detect irradiation of any food containing DNA, with several limitations. Different microbiological methods are also available, but can only be used as a screening tool.

    The current funding opportunity is designed to develop analytical methods for detection and quantification of markers such as 2-ACB's in animal feeds and treats to help the FDA to determine and regulate the dose of irradiation that was used during production. Eligibility is limited to domestic (U.S) applicants.

    Key Dates
    Posted Date

    March 15, 2016

    Open Date (Earliest Submission Date)

    March 24, 2016 for May 25, 2016 application due date.
    March 1, 2017, 2018 for May 1, 2017, 2018 application due dates.  

    Letter of Intent Due Date(s)

    April 11, 2016 for May 25, 2016 application due date.

    For all subsequent application due dates, letter of intent will be due 60 days prior to the application due date.

    Application Due Date(s)

    May 25, 2016, by 11:59 PM Eastern Time.

    May 1, 2017, 2018, by 11:59 PM Eastern Time.

    Applicants are 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.

    Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) by 11:59 PM Eastern Time on the application due date. 

    Late applications will not be accepted for this FOA.

    AIDS Application Due Date(s)

    Not Applicable

    Scientific Merit Review

    June 2016

    June 2017, 2018

    Advisory Council Review

    Not Applicable

    Earliest Start Date

    September 2016

    August 2017, 2018

    Expiration Date

    May 2, 2018

    Due Dates for E.O. 12372

    Not Applicable

    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.


    A compatible version of Adobe Reader is required for download. For Assistance downloading this or any Grants.gov application package, please contact Grants.gov Customer Support at http://www.grants.gov/web/grants/support.html.
    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
    Purpose:

    The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM) Office of Research Veterinary Laboratory Investigation and Response Network (Vet-LIRN) is announcing the availability of fiscal year (FY) 2016 funds to develop analytical methods for detection and quantification of food irradiation specific markers such as 2 ACB’s in animal feeds and treats, primarily dehydrated meat or poultry products. This funding opportunity will support FDA’s ability to regulate irradiation of animal feed products.

    Food irradiation is an approved process, used on a broad variety of food products primarily in order to improve food safety and extend the shelf life of foods by reducing or eliminating microorganisms and insects. The FDA regulates all aspects of irradiation, such as irradiation dose, product type, and labeling requirements.

    The use of irradiation requires development of analytical methods capable to determine the irradiation status of wide variety of foods, in order to ensure that food is properly labeled and  handled during irradiation process.

    Specific areas of Interest:

    Current FDA regulations allow a maximum absorbed dose of 50 kGy in animal feed, pet food, and treats; however, limited tests are currently available for detection of irradiation, and measuring the absorbed dose in animal feed and treats.

    Irradiation, like other processing techniques, results in various types of changes in food products. The nature and extent of these changes depend on the kind of food subjected to irradiation and the irradiation dose. The methods used for detection of irradiated foods are based on physical, chemical, and biological changes in food products during irradiation.

    Several methods are currently available to detect food irradiation. Several of them are screening tests only, which require confirmation by validated method. We are not aware if applicability of these methods for animal feeds and treats has been evaluated, they are listed for informational purposes.

    Some of the most commonly used methods for detection of food irradiation are:

    • Detection of Irradiated food containing fat- GC analysis of hydrocarbons (EN 1784:2003)
      • This method has successfully being tested in interlaboratory tests on raw chicken, pork and beef, as well as camembert, avocado, papaya and mango.
      • As a limitation, saturated hydrocarbons are frequently present both as contaminants and as naturally occurring compounds in food.
      • However, some research suggests that some hydrocarbons were detected only in irradiated chicken meat samples regardless of cooking treatment which suggests that they could be used as irradiation markers.
    • Detection of Irradiated food containing fat – GC/MS analysis of 2-Alkylcyclobutanones (EN 1785:2003)
      • This method has successfully being tested in interlaboratory tests on raw chicken, pork and liquid whole egg
      • It is believed that 2-Alkylcyclobutanones (2-ACB’s) are formed in food only by irradiation, and they are considered as markers for detecting the irradiation in food
    • Detection of irradiated food containing bone - Method by ESR spectroscopy (EN 1786:1996)
      • This method is used for the detection of meat containing bone and fish containing bone which have been treated with ionizing radiation, by analysing the electron spin resonance (ESR) spectrum of the bones. ESR spectroscopy detects paramagnetic centres (e.g. radicals).
      • Interlaboratory studies have been successfully carried out with beef bones, trout bones and chicken bones. Since the radiation induced ESR signal is attributed to hydroxyapatite which is the principal component of bones, it is expected that the application of the method can be extended to all meat and fish species containing bones
      • The detection limit depends on the state of mineralization of the bones which is usually lower for small species.
    • Detection of irradiated food containing cellulose. Method by ESR spectroscopy (EN 1787:2000)
      • This method is used for the detection of foods containing cellulose which have been treated with ionizing radiation, by analysing the electron spin resonance (ESR) spectrum
      • Interlaboratory studies have been successfully carried out with pistachio nut shells, paprika powder, and fresh strawberries.
    • Thermoluminescence detection of irradiated food from which silicate minerals can be isolated (EN 1788:2001)
      • This method is used for the detection of irradiation treatment of food and/or food ingredients by thermoluminescence analysis of contaminating silicate minerals. This method is applicable to those foodstuffs from which a sufficient amount of silicate minerals can be isolated.
      • The method has been successfully tested in interlaboratory tests with herbs and spices as well as their mixtures, shellfish including shrimps and prawns, both fresh and dehydrated fruits and vegetables, and potatoes. Other studies demonstrate that the method is applicable to a large variety of foods
    • Detection of irradiated food containing crystalline sugar by ESR spectroscopy (EN13708:2001)
      • This method is used for the detection of foods containing crystalline sugars which have been treated with ionizing radiation, by analysing the electron spin resonance (ESR) spectrum of the food
      • Interlaboratory studies have been successfully carried out on dried figs, dried mangoes, dried papayas and raisins
    •  Detection of irradiated food using photostimulated luminescence (PSL) (EN 13751:2002)
      • The method has been successfully tested in interlaboratory trials using shellfish and herbs, spices and seasonings. From other studies it may be concluded that the method is applicable to a large variety of foods.
      • The PSL method may, in principle, be applied to detect irradiation of any food which contains mineral debris. PSL sensitivity of a sample depends on the quantities and types of minerals within the individual sample.
      • Optimum results are obtained from unblended products. The presence of salt in a product may dominate the PSL intensity to an extent which masks signals from any remaining irradiated ingredients.
    • Detection of irradiated food using Direct Epifluorescent Filter Technique/Aerobic Plate Count (DEFT/APC) — Screening method  (EN 13783:2001)
      • The method has been successfully tested in interlaboratory tests with herbs and spices.
      • One of the limitations of this method is that if fumigation or heat treatment has been used for decontamination, method is unreliable.
    • DNA Comet Assay for the detection of irradiated foodstuffs —Screening method (EN 13784:2001)
      • The DNA Comet Assay may, in principle, be applied to detect irradiation of any food containing DNA. However, major limitation for heat treated foods is that no cells will be available due to extensive heat damage.
    • Microbiological screening for irradiated food using LAL/GNB  procedures (EN 14569:2004)
      • This method uses Limulus amoebocyte lysate (LAL) test and the procedure of the enumeration of total Gram negative bacteria (GNB)
      • Method determines the number of viable Gram negative bacteria present in the test sample and the concentration of the bacterial endotoxin present on the surfaces of the Gram negative bacteria as lypopolysaccharides (LPS) serving as a measure for the estimation of total Gram negative bacteria, both viable and dead.
      • This method is not applicable to animal feeds or treats.

    Detection methods for irradiated foods have been developed continuously, since no single method could be applied to all types of food due to differences in chemical composition, physical and other characteristics.

    In addition to the methods listed above, a number of other methods have been evaluated for the testing of irradiated foods. For example, it has been demonstrated that furan was produced from carbohydrates and ascorbic acid after food irradiation. However, furan can also be formed in foods after thermal processing. Some researchers reported the use of o-tyrosine as a marker for irradiation process. O-tyrosine is an isomer of tyrosine (amino acid) which is not naturally present in foods. Some researches even showed linear relationship between irradiation dose and the amount of o-tyrosine. However, other research showed the presence of o-tyrosine in non-irradiated food samples in small amounts. Research is also being done on a development of ELISA kits for various chemical markers of irradiation, such as 2-ACB’s.

    FDA preliminary testing of animal treats indicates that some of the samples may show signs of irradiation even though they were not labeled as being irradiated. Preliminary testing was done according to European Standard EN 1785:2003, which is based on measurement of 2-ACB's produced by the irradiation of fatty acids and glycerides. This method is currently not validated for animal feeds or treats.

    FDA is requesting applications to develop analytical methods for detection and quantification of food irradiation specific markers such as2-ACB's in animal feeds and  treats.

    • Analytes of interest include, but are not limited to 2-ACB’s.
    • Methods must be validated for detection of irradiation doses from 0.5 kGy in products that contain at least 1% fat.

    Products of interest are animal feeds and treats, primarily dehydrated meat or poultry products.

    Applications should include:

    • A description of the preliminary method for each analyte (irradiation marker) and the matrix for testing validation (eg: 2-DCB in dog treats).
    • A timeline and milestones for method expansion for each analyte (eg: 2-DCB) and matrix (eg: dog treats).
    • Description of the work to be conducted in any collaborating or subcontracting laboratories/facilities if such facilities would be used.
    • Description of the chemical standard reagents and their sources.
    • Preliminary data on how the method performs
    • Plan for evaluation of a relationship between irradiation dose and  analyte (irradiation marker) production (minimum requested dose 0 kGy; maximum  requested dose 75 kGy)
    • Plan for evaluation of prolonged storage effects (12 months storage period, storage temperature +25 0 C) on a concentration of  analyte (irradiation marker) in tested matrix.
    • A description of the validation procedures and how they comply with accepted validation protocols (see FDA Office of Foods guidelines for the validation of chemical methods:http://www.fda.gov/downloads/ScienceResearch/FieldScience/UCM273418.pdf)
    • Timeline and milestones for the entire project.
    See Section VIII. Other Information for award authorities and regulations.
    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. See Section VI.2 for additional information about the substantial involvement for this FOA.

    Application Types Allowed

    New  
    Resubmission
    Revisions

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

    Funds Available and Anticipated Number of Awards

    The number of awards is contingent upon FDA appropriations and the submission of a sufficient number of meritorious applications. Future year amounts will depend on annual appropriations, availability of funding and awardee performance.

    FDA/CVM-Vet-LIRN intends to fund up to $99,000, for fiscal years 2016, 2017, 2018  in support of this grant program.

    It is anticipated that up to one (1) award will be made, not to exceed $99,000 in total costs (direct plus indirect) per award, per fiscal year.

    Award Budget

    Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs (direct and indirect):

    YR 01: $99,000
    YR 02: $99,000
    YR 03: $99,000
    YR 04: $99,000
    YR 05: $99,000

    Award Project Period

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

    The award will provide one (1) year support and include future recommended support for four (4) additional years, contingent upon satisfactory performance in the achievement of project and program objectives during the preceding year and the availability of federal fiscal year appropriations.

    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.

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    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)

    For-Profit Organizations

    • Small Businesses
    • For-Profit Organizations (Other than Small Businesses)

    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
    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 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.
    • 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.

    Program Directors/Principal Investigators (PD(s)/PI(s))

    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.

    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

    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.
    Section IV. Application and Submission Information
    1. Requesting an Application Package

    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.

    2. Content and Form of Application Submission

    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.

    Letter of Intent

    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
    Email: bryce.jones@fda.hhs.gov 

    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 15 pages.
    Instructions for Application Submission

    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.

    SF424(R&R) Cover

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

    SF424(R&R) Project/Performance Site Locations

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

    SF424(R&R) Other Project Information

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

    SF424(R&R) Senior/Key Person Profile

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

    R&R Budget

    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.
    • 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.
    • Employee salaries, wages and fringe benefits are allowable costs, however, salary costs are limited to 30% of the total direct cost.
    R&R Subaward Budget

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

    PHS 398 Cover Page Supplement

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

    PHS 398 Research Plan

    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 as provided in the SF424 (R&R) Application Guide, with the following modification:

    • Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

    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.

    PHS Inclusion Enrollment Report

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

    PHS Assignment Request Form

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

    3. Unique Entity Identifier and System for Award Management (SAM)

    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

    4. Submission Dates and Times

    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.

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. 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.

    Examples of Allowable costs:

    1. Employee salaries, wages and fringe benefits, however, salary costs are limited to 30% of the direct cost.

    2. Rental, purchasing, calibration, installation and maintenance of equipment (service plans).

    3. Registration fees.

    4. Purchase of IT equipment, software, support.

    5. Shipping and mailing of equipment, supplies and samples.

    6. Laboratory and office supplies.

    Examples of Non-allowable costs:

    1. Vehicle purchases.

    2. New building construction.

    3. Please also refer to the HHS Grants Policy Statement for additional information regarding costs.

    7. Other Submission Requirements and Information

    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.  

    Post Submission Materials

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

    Section V. Application Review Information
    1. Criteria

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

    Scored Review Criteria

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

    Significance (10 Points)

    Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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) (30 Points)

    Are the PD(s)/PI(s), 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 multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

    Innovation (20 Points)

    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?

    Approach (30 Points)

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

    If the project involves human subjects and/or FDA-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

    Environment (10 Points)

    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, or subject populations?

    Additional Review Criteria

    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.

    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 Guidelines for the Review of Human Subjects.

    Inclusion of Women, Minorities, and Children 

    When the proposed project involves human subjects and/or FDA-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

    Vertebrate Animals

    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.

    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

    For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous Objective Review Committee and changes made to the project.

    Renewals

    Not Applicable

    Revisions

    For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous Objective Review Committee are adequate and whether substantial changes are clearly evident.

    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)  Genomic Data Sharing Plan (GDS).

    Authentication of Key Biological and/or Chemical Resources:

    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.

    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

    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.
    3. Anticipated Announcement and Award Dates

    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.

    Section VI. Award Administration Information
    1. Award Notices

    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.

    2. Administrative and National Policy Requirements

    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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.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 http://www.hhs.gov/ocr/civilrights/understanding/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 http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.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 CVM programmatic requirements may be part of the Notice of Award.

    Cooperative Agreement Terms and Conditions of Award

    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 (HHS) grant administration regulations at 45 CFR Part 75, 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 awardees is anticipated during the performance of the activities.  Under the cooperative agreement, FDA's 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 in the activities.  Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and FDA as defined below.

    Substantive involvement includes, but is not limited to, the following:

    • FDA conducting on-site technical sessions with the grantee.
    • FDA hosting monthly (or at a frequency chosen by FDA) conference calls/webinar meetings with individual laboratories and all laboratories within the cooperative agreement.
    •  FDA concurrence with validation protocols developed by the awardees.
    • The assigned program director may also serve as an FDA Project Scientist.

    The following conditions of the award will apply to all funded applicants and must be maintained throughout the cooperative agreement.

    • The awardees will participate in conference calls with the Vet-LIRN Program office.
    • The awardees will cooperate with Vet-LIRN in the development and design of the validation criteria and protocols.
    • The awardees will define procedures for quality control, data analysis, and interpretation in conjunction with the Vet-LIRN program office.
    • The awardees will provide updates to the program office using uniform reporting forms.
    • Any publication or oral presentation of the results of this research project must undergo the usual FDA Office of Research and Center review and approval process. This process can take 30-90 days.

    A.1.Principal Investigator Rights and Responsibilities

    The PD(s)/PI(s) will have the primary responsibility for the scientific, technical, or programmatic aspects of the cooperative agreement and for day-to-day management of the project or program.  The PD(s)/PI(s) will maintain general oversight for ensuring compliance with the financial and administrative aspects of the award, as well as ensuring that all staff have sufficient clearance and/or background checks to work on this project or program.  This individual will work closely with designated officials within the recipient organization to create and maintain necessary documentation, including both technical and administrative reports; prepare justifications; appropriately acknowledge Federal support in publications, announcements, news programs, and other media; and ensure compliance with other Federal and organizational requirements.

    Participation in the Vet-LRN program will include access to non-public information from FDA.  Therefore, in order to participate, laboratory officials must sign a confidentiality agreement.

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

    A.2.FDA Responsibilities

    An FDA Project Officer (PO) will have substantial programmatic involvement as described below. The PO is the official responsible for the programmatic, scientific, and/or technical aspects of assigned applications and grants. The PO’s responsibilities include, but are not limited to, post-award monitoring of project/program performance, including review of progress reports and making site visits; and other activities complementary to those of the Grants Management Officer (GMO). The PO and the GMO work as a team in many of these activities.

    Additionally, an agency program official will be responsible for the scientific and programmatic stewardship of the award and will be named in the award notice.

    FDA will provide technical monitoring and/or direction of the work, including monitoring of data analysis, interpretation of analytical findings and their significance.

    FDA will assist and approve (as deemed appropriate) the substance of publications, co-authorship of publications and data release.

    A.3. Reporting

    An agency Program Official or Center Program Director/Project Officer will be responsible for the scientific and programmatic stewardship of the award and will be named in the NoA.

    Program monitoring of recipients will be conducted on an ongoing basis and written reports will be reviewed and evaluated at least semi-annually by the project officer. Project monitoring may also be in the form of telephone conversations between the project officer/grants management specialist and the project director/principal investigator.

    Mid-year and annual reports will be required. The Annual Progress Report will be due as part of the Research Performance Progress Report (RPPR).

    Grants with Multiple Years: When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR).

    Mid-year progress reports must contain, but are not limited to the following:

    A status report on the installation, training, and operational readiness of any equipment that is provided;

    A summary status of progress on development and validation of the method;

    A summary description of any collaborative efforts to evaluate the method

    Examples of Analyst working sheets and results of any blinded method tests.

    Monitoring Activities

    The program project officer will monitor grantees periodically. The monitoring may be in the form of telephone conversations, e-mails, or written correspondence between the project office/grants management office 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 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 cooperative agreement, including those which state that future funding of the study will depend on recommendations from the project officer.

    The scope of the recommendation will confirm that:

    (1) There has been acceptable progress on the project; (2) there is continued compliance with all FDA regulatory requirements; (3) if necessary, there is an indication that corrective action has taken place; and (4) assurance that any replacement of personnel will meet the testing requirements.

    3. Reporting

    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. 

    Section VII. Agency Contacts

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

    Application Submission Contacts

    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

    Scientific/Research Contact(s)

    Olgica Ceric
    Center for Veterinary Medicine (CVM)
    Telephone: 240-402-5419
    Email: olgica.ceric@fda.hhs.gov

    Objective Review Contact(s)

    Bryce Jones
    Office of Acquisition & Grants Services (OAGS)
    Food and Drug Administration (FDA)
    5630 Fishers Lane
    Rockville, MD 20857
    Telephone: 240-402-2111
    Email: bryce.jones@fda.hhs.gov

    Financial/Grants Management Contact(s)

    Bryce Jones
    Office of Acquisition & Grants Services (OAGS)
    Food and Drug Administration (FDA)
    5630 Fishers Lane
    Rockville, MD 20857
    Telephone: 240-402-2111
    Email: bryce.jones@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 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.

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