EXPIRED
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.
Office of Foods and Veterinary Medicine/Center for Food Safety and Applied Nutrition (CFSAN)
National Training, Education, Extension, Outreach, and Technical Assistance Competitive Grants Program: Regional Center Grants to Enhance Food Safety
R01 Research Project Grant
New
RFA-FD-15-034
None
93.103
FDA announces the availability of funding and requests applications for National Training, Education, Extension, Outreach, and Technical Assistance Competitive Grants Program: Regional Center Grants to Enhance Food Safety for fiscal year (FY) 2016. The intention of this program is to begin building an infrastructure that will support a national food safety training, education, extension, outreach, and technical assistance system and provide significant opportunities for funding through subcontracts and for partnerships with eligible stakeholder groups, including community-based and non-governmental organizations.
July 31, 2015
August 10, 2015
September 1, 2015
October 09, 2015 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.
Not Applicable
November 2015
Not Applicable
December 2, 2015
New Date August 27, 2015 per issuance of NOT-FD-15-013. (Original Expiration Date: October 10, 2015)
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.
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
The U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture’s National Institute of Food and Agriculture (NIFA) have joined in a collaborative partnership to administer and manage the National Training, Education, Extension, Outreach, and Technical Assistance Competitive Grants Program: Regional Center Grants to Enhance Food Safety. This program is designed to develop and implement a comprehensive food safety training, education and technical assistance program for those affected by the FDA Food Safety Modernization Act (FSMA). The intention is to begin building an infrastructure that will support a national food safety training, education, extension, outreach, and technical assistance system and provide significant opportunities for funding through subcontracts and for partnerships with eligible stakeholder groups, including community-based and non-governmental organizations. Specifically, this program will address the needs of owners and operators of small and medium-sized produce farms, beginning farmers, socially disadvantaged farmers, small processors, or small fresh fruit and vegetable merchant wholesalers. The joint program will award competitive grant funds that enable awardees to establish one National Coordination Center and four Regional Centers for Food Safety Training, Education, Extension, Outreach, and Technical Assistance. The National Coordination Center will coordinate the overall program, while the Regional Centers will reach out into local communities to work with FSMA audiences across the country. Regional Centers will also coordinate with one another through the National Coordination Center.
FDA is issuing this RFA to request applications for the establishment of two Regional Centers, one in the North Central Region and one in the Northeast Region as defined by Cooperative Extension System Regions (http://www.nifa.usda.gov/qlinks/partners/state_regions.html) for the Food Safety Training, Education, Extension, Outreach, and Technical Assistance Program. USDA NIFA will issue a separate Funding Opportunity Announcement to request applications for the establishment of two Regional Centers, one in the Western Region and one in the Southern Region for the Food Safety Training, Education, Extension, Outreach, and Technical Assistance Program. Although applications for the four Regional Centers will be submitted to separate agencies, FDA and NIFA will work jointly to manage and administer the overall program for the duration of the awards. The Regional Centers will lead, manage, and coordinate the regional development and implementation of food safety training, education, outreach and technical assistance programs for the intended audiences. Project Teams for the Regional Centers will be required to assemble training teams that include representatives from non-governmental organizations and community-based organizations. Training teams are also highly encouraged to include representatives from Extension, food hubs, local farm cooperatives, and others who can address specific needs of the communities they serve.
FDA has previously issued a separate Funding Opportunity Announcement for the National Coordination Center for Food Safety Training, Education, Extension, Outreach, and Technical Assistance (http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-15-003.html). Under the umbrella of the National Food Safety Training, Education, Extension, Outreach, and Technical Assistance Competitive Grant Program, jointly managed by FDA and NIFA, the National Coordination Center and the Regional Centers will work together to begin building an effective, seamless and sustainable program that will meet the needs of intended audiences affected by new FSMA guidelines.
The National Food Safety Training, Education, Extension, Outreach, and Technical Assistance Grant Program: Regional Centers Grants to Enhance Food Safety will award grants that increase the understanding and adoption of established food safety standards, guidance, and protocols. This program is designed to develop and implement a comprehensive food safety training, education and technical assistance program for those affected by the Food Safety Modernization Act (FSMA). Specifically, this program will address the needs of owners and operators of small and medium-sized produce farms, beginning farmers, socially disadvantaged farmers, small processors, or small fresh fruit and vegetable merchant wholesalers. Grants awarded through this program, to the extent possible, will be carried out in a manner that facilitates the integration of food safety standards and guidance with a variety of agricultural production and processing systems, including conventional, sustainable, organic, and conservation and environmental practices carried out by the eligible entities. The assistance provided by these programs shall be coordinated with and delivered in cooperation with similar services or assistance by other federal agencies or programs serving those eligible entities.
The FDA Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011. The law enabled the Food and Drug Administration (FDA), and its Federal food safety partners, to better protect public health, while strengthening the food safety system, by focusing increasingly on preventive food safety measures. FSMA requires the Secretary of Health and Human Services to establish preventive standards for produce safety and for the manufacturing/processing, packing and holding of human food. Successful implementation of new standards will require food safety training, education and technical assistance for small and mid-sized entities.
The Food Safety Modernization Act (FSMA) empowered the Food and Drug Administration (FDA), and its Federal food safety partners, to better protect public health, while strengthening the food safety system, by focusing increasingly on preventive food safety measures. FSMA provided FDA with new enforcement authorities not only to focus on prevention but to help contain problems as they occurred. The law also directed FDA to build an integrated national food safety system in partnership with state and local authorities.
To build an integrated national food safety system, new training related to FSMA will need to be available to all produce growers and vendors, to processors, and to merchant wholesalers. Owners and operators of small and medium-sized produce farms, beginning farmers, socially-disadvantaged farmers, small food processors, and small fruit and vegetable merchant wholesalers frequently have limited access to adequate and affordable food safety training, education, and outreach. Further, they have limited access to the technical assistance that will enable them to implement new food safety guidelines in their respective environments. NIFA, in close collaboration with FDA, will competitively award grants to organizations that develop and implement food safety training, education, extension, outreach and technical assistance to key target audiences, including owners and operators of small and medium-sized farms, small food processors, and small fruit and vegetable vendors affected by FSMA. The program will focus on helping those audiences understand and interpret new Federal food safety guidelines enacted under FSMA, thus enabling them to implement those guidelines in their respective environments and in each of their various agricultural production and processing systems. The intention of this program is to begin building an infrastructure that will support a national food safety training, education, extension, outreach, and technical assistance system and provide significant opportunities for funding through subcontracts and for partnerships with eligible stakeholder groups, including community-based and non-governmental organizations.
Program Area Priorities:
For FY 2015, the National Training, Education, Extension, Outreach, and Technical Assistance Competitive Grants Program: Regional Center Grants to Enhance Food Safety are expected to describe Regional Centers that have a leading role in coordinating the development and implementation of FSMA-related training, education, and outreach programs and resources for small and medium-sized farms, beginning farmers, socially disadvantaged farmers, small processors, and/or small fresh fruit and vegetable merchant wholesalers. An outreach plan for conducting education and training to a cadre of regional FSMA trainers must be developed, along with an implementation plan for extending both training and technical assistance to the targeted audiences of farmers, processors and vendors in the respective regions. The implementation plan must include details about how the project teams will assemble and prepare training teams that are required to include representatives from non-governmental organizations and community-based organizations. The National Training, Education, Extension, Outreach, and Technical Assistance Competitive Grants Program: Regional Center Grants to Enhance Food Safety program will fund projects that provide significant funding opportunities through subcontracts to or partnerships with eligible stakeholders, including community-based and non-governmental organizations and others who work directly with the target audiences, for the purpose of providing training and outreach to small and medium-sized farms, beginning farmers, socially-disadvantaged farmers, small food processors, and small fruit and vegetable vendors, and for the various production and processing systems. Project teams are also highly encouraged to include representatives from Extension, food hubs, local farm cooperatives, and others who can address specific needs of the communities they serve.
Applications for the Regional Centers must address all of the following:
Other Requirements
Post Award Program Management
In addition, this grant opportunity has common programmatic conditions in order to execute a seamlessly collaborative program between FDA and NIFA as one national unit. For fulfilling the purpose, the following common programmatic terms and conditions will be followed:
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
New
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
FDA/CFSAN intends to fund up to $633,333 total costs for fiscal year 2016 in support of this grant program.
It is anticipated that up to two (2) awards will be made, not to exceed $950,000 in total costs (direct plus indirect) for a three (3) year project period, per award.
FDA intends to make a second and third year of support available to the awardee that receives support in FY 2016. Funding beyond the first year will be noncompetitive and will depend on (1) satisfactory performance in meeting the FOA's stated goals and objectives during the first year and (2) the availability of Federal Fiscal Year funds.
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: $316,666
YR 02: $316,666
YR 03: $316,666
Funds should be requested for travel to the metropolitan Washington, D.C. area for annual meetings with program staff (the applicant should budget for one meeting per year for principal grantee staff).
National Training, Education, Extension, Outreach, and Technical Assistance Competitive Grants Program: Regional Center Grants to Enhance Food Safety
The maximum project period is 3 years
HHS grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Other
Award recipients may subcontract to organizations not eligible to apply directly for grant funds provided such organizations are necessary for the conduct of the project.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible
to apply.
Foreign components, as defined in the
HHS Grants Policy Statement, are not allowed.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission. Late applications will not be accepted for this FOA.
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.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for FDA support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the HHS Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The FDA will not accept duplicate or highly overlapping applications under review at the same time. This means that the FDA will not accept:
Applicants 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.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows FDA/CFSAN 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), 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 to:
Martin Bernard
Grants Management Specialist
Grants Management Branch
Food and Drug Administration
Office of Acquisition & Grants Services (OAGS)
Telephone: 240-402-7564
Email: [email protected]
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
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:
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. 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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Late applications will not be accepted for this FOA.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.
Pre-award costs are allowable only as described in the HHS Grants Policy Statement.
Additional funding restrictions may be part of the Notice of Award.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. PAPER APPLICATIONS WILL NOT BE ACCEPTED.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to FDA. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the assigned Grants Management Specialist and responsiveness by components of participating organizations, FDA. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.
Only the review criteria described below will be considered in the review process.
Reviewers will consider each of the review criteria below in the determination of scientific merit.
This criterion is used to assess the likelihood that this project will develop and implement a food safety training, education, extension, outreach, and technical assistance program with core competencies to address FSMA guidelines and protocols; mobilize a team of regional FSMA trainers and training teams that must include representatives from non-governmental organizations and community-based organizations. Teams are also highly encouraged to include representatives from Extension, food hubs, farm cooperatives and others skilled at working with key target audiences; and develop technical assistance plans for key target audiences, including owners and operators of small and medium-sized produce farms, beginning farmers, socially disadvantaged farmers, small processors, and small fresh fruit and vegetable merchant wholesalers. Elements considered include: a clear statement of the long-term goal(s) and supporting objectives of the proposed activities, identification of a problem or opportunity to be addressed; body of knowledge, preliminary data and other past activities used to substantiate the need for the proposed project; justification and criteria used to select the population groups to be served; innovation; and the degree to which the proposed project will be sustainable and will advance awareness, understanding, and implementation of new FSMA guidelines.
This criterion is used to assess the soundness of the proposed approach. Elements considered include: soundness/evidence-base of educational curricula to be used in the project; proposed activities and sequence of activities; participant and/or trainer recruitment; methodology and limitations of the proposed approach; project timeline; and expected new products and results (e.g., educational approaches including training curricula, workshops, meetings, conferences, exhibits, publications, electronic communication, fact sheets, newsletters, social media, and mass media)
This criterion is used to assess the adequacy of the proposed recruitment, training, and outreach plan and how the extension and outreach methodology will be evaluated. Elements considered include: stakeholder identification methods, data collection, analysis, and communication plans; and the strengths and limitations of the proposed evaluation approach.
Explicitly state the procedures or methodology you will apply to the proposed effort. This section should include but not necessarily be limited to, descriptions of:
(1) stakeholder involvement in
problem identification, planning, implementation and evaluation;
(2) proposed project activities, listed sequentially;
(3) techniques to be employed in this project, including their feasibility and
rationale;
(4) expected results;
(5) how extension and education activities will be evaluated;
(6) how data will be analyzed or interpreted;
(7) plans to communicate results to stakeholders and the public;
(8) pitfalls that might be encountered; and
(9) limitations to proposed procedures.
This criterion is used to assess adequacy of proposed project management, including key staff and their functions (to include their ability to serve key target audiences including owners and operators of small and medium-sized produce farms, beginning farmers, socially-disadvantaged farmers, small food processors, and small fruit and vegetable vendors), reporting, accounting procedures (for funds used by the parent organizations and local sites), and coordination of collaborative efforts with local and/or community partners involved in the project.
Project Timetable: The proposal should outline all important phases as a function of time, year by year, for the entire project, including periods beyond the grant funding period.
This criterion is used to assess the extent to which the total budget adequately supports the objectives, is appropriate to the project objectives being proposed, and is cost effective. Elements considered include: the necessity and reasonableness of costs to carry out project activities and achieve project objectives; the appropriateness of budget allocations between the applicant and any collaborating organization(s); and appropriateness of the budget relative to time committed to the project by key project personnel.
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 score.
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.
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.
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.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Wide Association Studies (GWAS) /Genomic Data Sharing Plan.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by an Objective Review Committee, using the stated review criteria.
As part of the objective review, all applications:
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:
Successful applicants will be notified of additional information that may be required or other actions leading to an award. The decision not to award a grant, or to award a grant at a particular funding level, is discretionary and is not subject to appeal to any FDA or HHS official or board.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found in the HHS Grants Policy Statement.
All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA.
Additional terms and conditions regarding FDA regulatory and CENTER FOR FOOD SAFETY AND APPLIED NUTRITION programmatic requirements may be part of the Notice of Award.
Cooperative Agreement Terms and Conditions of Award
Not Applicable
STANDARD TERMS AND CONDITIONS:
Reporting Requirements:
Periodic program monitoring will be conducted on an ongoing basis which may be in the form of telephone conversations between the Principal Investigator and the Project Officer/Grants Management Officer/Grants Management Specialist as well as the review of written reports.
1. Grants with Multiple Years: Grantees are required to submit the PHS Non-competing Grant Progress Report (PHS 2590) annually and is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-139.html.
The PHS 2590 Form must be submitted at least two (2) months prior to the next budget period start date, and should include a report of the previous meeting supported by the current grant as well as a full description of the next planned meeting to include the following:
A report of the previous meeting supported by the current grant as well as a full description of the next planned meeting to include the following: The grant number, the grant title, date and place of the meeting, the name the conference director, principal investigator, or program director as listed on the application, the name of the organization that conducted the meeting, listing of participants who participated as speakers (and their respective institutional affiliations ) in the formally planned sessions of the meeting.
In addition: Provide a summary capturing the overall
objectives of the meeting:
a. Explain about the overall objectives
b. Explain how successful the discussions on the agenda-topics
were
c. Explain what was accomplished from the discussions, etc.
d. Explain about any activities suggested for future
meetings
Please also include the plans for the next meeting to be
funded. Include:
a. Date(s) to be held (justify number of days)
b. Location of meeting (venue, city, state)
1. Agenda
d. Anticipated number of attendees
e. Breakdown of anticipated number of attendees, Federal vs.
non-Federal
2. A required annual Federal Financial Report (FFR) using
Form (SF-425) should be submitted within 90 days after the end date of the
budget period and is available at: http://grants.nih.gov/grants/forms.htm
3. NOTE on GRANT CLOSEOUT REQUIREMENT (when applicable):
A Final Program Progress Activity Report and Final Financial
Status Report must be submitted within 90 days after the expiration date of the
project period. Please make sure that your FFR matches with what is on your PMS
account for this award.
4. The recipient will conduct, when appropriate, an annual Single Audit as required by OMB Circular A-133. This audit must be submitted to the Federal Audit Clearinghouse at the Bureau of the Census within 9 months of the close of their fiscal year. If you need information on your organization’s obligations under the Single Audit Act, please visit the following website: http://harvester.census.gov/sac/. Valuable information is included under the Frequently Asked Questions section of that website.
5. ALL THE ABOVE REQUIREMENTS MUST BE SENT VIA E-MAIL OR
EXPRESS MAIL TO:
Martin Bernard
Grants Management Specialist
Food and Drug Administration, MSC HFA-500
5630 Fishers Lane, Rockville, MD 20857
[email protected]
6. PAYMENT MANAGEMENT SYSTEM (PMS):
Included are the following LINKS & Instructions for
drawing down funds, reporting expenditures, REQUIRED FORMS, and the help desk
info:
http://www.dpm.psc.gov/ - PMS Homepage
http://www.dpm.psc.gov/grant_recipient/guides_forms/ffr_user_form.aspx?-
LINK for PMS Contact/User Form
http://www.dpm.psc.gov/grant_recipient/new_grantee_information/hhs_1199a.aspx?
- Required FORM > SF 1199A
You can find these forms by clicking on PMS Homepage, then
clicking on Grant Recipient Info , then click on Forms
http://www.dpm.psc.gov/help/help.aspx?explorer.event=true -
LINK for PMS Help Desk Information
The phone number for the Help Desk is 877-614-5533, and the
email address is [email protected].
ALLOWABLE & UNALLOWABLE COSTS:
The following highlights allowable and unallowable costs under conference grants. No costs other than those specified in this subsection are allowable, including any qualifications on their allowability, are permitted under conference grants.
1. ALLOWABLE COSTS
Conference Services: Grant funds may be used for necessary recording of proceedings, simultaneous translation, and subsequent transcriptions.
Consultant Services: Grant funds may be used to pay consultant fees, including travel and supporting costs (per diem; subsistence is not allowable).
Equipment Rental: Grant funds may be used for the rental of necessary equipment.
Publication Costs: When grant funds are awarded to pay for either the entire or partial cost of publication of proceedings or a book or pamphlet, allowable costs include special plates, charts, diagrams, printing, distribution, mailing, postage, and general handling, unless otherwise specified at the time the grant is awarded.
Salaries: In accordance with the policy of the grantee organization, grant funds may be used for all or part of the salaries of professional personnel, clerical assistants, editorial assistants, and other non-professional staff in proportion to the time or effort directly related to the conference.
Speakers Fees: Speakers fees for services rendered are allowable.
Supplies: Grant funds may be used for the purchase of supplies for the conference if the supplies are received and used during the budget period.
Travel: Funds may be used for the travel of staff, speakers, participants, and attendees, if identified in the application and approved at the time of award. Travel expenses for employees of the grantee organization are governed by the grantee’s travel policies, consistently applied regardless of the source of funds.
Any U.S. foreign travel restrictions that are in effect at the time of the award will be followed, such as
A. Limitations or restrictions on countries to which
travel will be supported or
B. Budgetary or other limitations on availability of funds
for foreign travel.
Proposed per diem allowances must be reasonable and limited to the days of attendance at the conference plus the actual travel time to reach the conference location by the most direct route. Local mileage costs only may be paid for local participants. Where lodgings are furnished without charge or at a nominal cost (e.g., as part of the registration fee), the proposed per diem allowance must take this into consideration. Per Diem must not include any food and/or meals.
Transportation costs for attendees and participants at the conference may not exceed coach class fares. In all cases, U.S. flag carriers will be used where possible.
2. UNALLOWABLE COSTS
Registration Fees: Not allowable.
Alterations and Renovations (A&R): Not allowable.
Membership Dues: Not allowable.
Entertainment and Personal Expenses: Costs of amusement, diversion, social activities, ceremonials, and related incidental costs related thereto, such as meals, lodging, rentals, transportation gratuities, bar charges, tips, personal telephone calls, and laundry charges of participants or guests, are not allowable.
Food: All meals or light refreshments, regardless if certain meals are an integral and necessary part of a conference (i.e., a working meal where business is transacted), are not allowable and grant funds may not be used for such costs.
Equipment Purchase: Grant funds may not be used for the purchase of equipment.
Facilities and Administrative (F&A) Costs: Not allowable.
Federal Employees: Grant funds may not be used to pay for travel costs, or any payment to a Federal employee, except when the employee is on leave without pay status from his or her employing office.
Visas and Passports: Costs associated with obtaining visas and passports are not allowable.
Honoraria: Honoraria or other payments given for the purpose of conferring distinction or to symbolize respect, esteem, or admiration are not allowable.
Local Participants Expenses: With the exception of local mileage as indicated under allowable costs under Travel grant funds may not be used to pay per diem or expenses for local participants in the conference.
Research Patient Care: Not allowable.
For the Programmatic Contact of this project, please contact Mary Tijerina 301-402-7469, [email protected] or Scarlett Salem 240-402-2080 [email protected]
For Grants Management concerns related to the administrative and financial aspects of this project, please contact Martin Bernard at 240-402-7564 or [email protected].
When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the HHS Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable FDA grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system
problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: [email protected]
Grants.gov
Customer Support (Questions
regarding Grants.gov registration and submission, downloading forms and
application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]
Mary Tijerina
Consumer Safety Officer
Center for Food Safety and Applied Nutrition (CFSAN)
Telephone: 240-402-0405
Email: [email protected]
Scarlett Salem
Consumer Safety Officer
Center for Food Safety and Applied Nutrition (CFSAN)
Telephone: 240-402-2080
Email: [email protected]
Martin Bernard
Grants Management Specialist
Grants Management Branch
Food and Drug Administration
Office of Acquisition & Grants Services (OAGS)
Telephone: 240-402-7564
Email: [email protected]
Martin Bernard
Office of Acquisition & Grants Services (OAGS)
Food and Drug Administration
5630 Fishers Lane
Rockville, MD 20857
Telephone: 240-402-7564
Email: [email protected]
All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.
Awards are made under the authorization of Sections 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.