Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

U.S. Food and Drug Administration  (FDA)

The FDA does not follow the NIH Page Limitation Guidelines or the 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/Office of the Commissioner (OC)/Office of International Programs

Funding Opportunity Title

Food Safety Preventive Controls and Produce Safety Standards:  Building Competency in Latin America in Support of the

U.S. Food Safety Modernization Act

Activity Code

U01 Research Project Cooperative Agreement

Announcement Type

New

Related Notices
  • August 17, 2017 - Extend Application Deadline- Food Safety Preventive Controls and Produce Safety Standards: Building Competency in Latin America in Support of the U.S. Food Safety Modernization Act. See Notice NOT-FD-17-012.
Funding Opportunity Announcement (FOA) Number

RFA-FD-17-011

Companion Funding Opportunity

None

Number of Applications

Section III. 3. Additional Information on Eligibility.

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

 93.103 

Funding Opportunity Purpose

Given the importance of the region in exporting human food to the United States, FDA proposes working with a multilateral institution in the region, specifically the Inter-American Institute for Cooperation on Agriculture (IICA), to develop an expert cadre to foster FSMA standards implementation.  IICA has been a strong U.S. government partner in Latin America and the Caribbean and can effectively play a pivotal role in FSMA training in the region.

The activities undertaken under this Cooperative Agreement would be targeted to training FDA’s regulatory counterparts who commit to doing further training in their respective countries, academia, and industry representatives.  By training regulators, IICA would be providing up-to-date information on FDA FSMA requirements, as well as good agricultural practice knowledge. If regulators or appropriate government institutions become trainers of the Alliance curriculum, they could possibly offer the training at lower costs, which can be a prohibitive factor for smaller business entities in understanding and implementing FSMA produce safety standards.

Key Dates

 

Posted Date

May 24, 2017

Open Date (Earliest Submission Date)

June 2, 2017

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

New Date August 11, 2017, 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

August, 2017

Advisory Council Review

Not Applicable

Earliest Start Date

September, 2017

Expiration Date

August 3, 2017

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.


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

Background:

The landmark bipartisan FDA Food Safety Modernization Act (FSMA), signed into law in January 2011, was one of the most significant steps in decades to prevent foodborne illness in people and animals.  FSMA will fundamentally change the U.S. food safety system from reactive to proactive. FSMA creates a risk-based regulatory framework (a system that weighs the risks through hazard analysis, preventive controls, oversight, and management of the controls) that holds food manufacturers accountable for having a food safety plan, verifying it is working, and taking corrective action when it is not.

FSMA also gives FDA unprecedented authority to better ensure that imported products meet U.S. standards and are safe for U.S. consumers. For the first time, importers have an explicit responsibility to verify that their foreign suppliers have adequate preventive controls in place to ensure that the food they produce is safe. Importers will be required to verify that food imported into the United States has been produced in a manner that provides the same level of public health protection as that required of U.S. food producers.

The Preventive Controls rule, finalized by the FDA in September 2015, mandates modern preventive practices in food processing and storage facilities. They carry out the comprehensive prevention vision of FSMA by extending standards and accountability for prevention to produce farms and importers. The Produce Safety rule builds on the Preventive Controls rule and establishes science-based standards for growing, harvesting, packing, and holding produce that are designed to work effectively for food safety across the wide diversity of produce farms.

FDA’s new import oversight tool kit will have a significant impact on food safety given that an estimated 15 percent of the U.S. food supply is imported, including 50 percent of fresh fruits, 20 percent of fresh vegetables and 80 percent of seafood, much of which comes from the Latin America region. Section 305 of FSMA directs FDA to develop a comprehensive plan to expand the capacity of foreign governments and their industries. One component of the plan is to address training of foreign governments and food producers on U.S. food safety requirements.

The FDA is committed to working with consumers and industry together to effectively implement the Preventive Controls rules and other FSMA rules in a timely way. FSMA builds a formal system of collaboration with other government agencies, both domestic and foreign. In doing so, FSMA explicitly recognizes that food safety stakeholders need to work together in an integrated way to achieve our public health goals.

With many countries in Latin America shipping fresh produce to the United States, building the   competency, knowledge and capacity of foreign regulators and industry are essential.  

Overview:

Given the importance of the region in exporting human food to the United States, FDA proposes working with a multilateral institution in the Latin America region, specifically the Inter-American Institute for Cooperation on Agriculture (IICA), to foster FSMA standards implementation by developing an expert cadre of relevant food safety stakeholders, including: regulators, industry, producers, universities, and trade associations, among others.

IICA has been a strong U.S. government partner in Latin America and the Caribbean and can effectively play a pivotal role in FSMA training in the region. IICA would provide training using the most up-to-date information on FDA FSMA requirements presented in the official curricula of the FDA alliances. By targeting regulators, appropriate government institutions, and non-governmental organizations, IICA may enhance the long-term impact and sustainability of these investments. As trainers of the official Alliance curricula, entities that are not profit seeking may be able to offer the training at lower costs, particularly to smaller businesses and producers who must implement FSMA standards when exporting to the United States, but for whom training costs by traditional providers may be cost prohibitive.

This effort will build upon and expand activities underway by CFSAN, the Produce Safety Alliance (PSA), the FSMA Preventive Controls Alliance (FSPCA), and other associated U.S. government programs by the U.S. Department of Agriculture (USDA) and the U.S. Agency for International Development (USAID).

CFSAN’s Office of Food Safety (OFS) is spearheading an effort to integrate various produce safety initiatives into a strategic framework for produce safety in the Americas, including, but not limited to:  the University of Maryland’s Joint Institute for Food Safety and Nutrition (JIFSAN), the Produce Safety Alliance (PSA), Food Safety and Agricultural Sustainability Training (FAST), and the US-Mexico Produce Safety Partnership. While each activity has discrete objectives, collectively, these activities should be synergistic in order to optimize the safety of imported foods into the United States. JIFSAN has been identified as the lead organization to coordinate international training, and JIFSAN should be a point of coordination with other regional organizations that have experience in food safety, for example: IICA, the Caribbean Community (CARICOM), and the International Regional Organization for Plant and Animal Health (Organismo Internacional Regional de Sanidad Agropecuaria, OIRSA).

Specific Areas of Research:

Training

This partnership would provide training to key food safety stakeholders in the region (e.g. government, industry, academia, nongovernmental organizations, etc.) to build a cadre of experts who can then provide additional training in their respective countries. The targeting for training programs should consider previous training (under FAST), volume of trade, and ability to “extend” the training.  IICA should research best practices in order to get a multiplier effect of the various international FSMA trainings in the region.  It is encouraged that IICA conduct research on the most effective methods for delivering training and the current needs in different countries.  Once countries are identified, research and needs assessments should be conducted in identified countries to guide the development of the training. 

IICA would use the standardized curricula and training materials developed by the official FDA Alliances to develop a cadre of participants trained by IICA, adding to those already trained by the Alliances in support of FSMA food safety standard implementation (i.e. FSPCA and PSA). IICA may choose to use regionally-specific case studies and variations in delivery modes which are most appropriate for the country/region.   

Strategic Workshops

IICA would host up to three (3) strategic workshops and seminars that offer the official Alliance training to regulatory authorities/government entities in the Americas. Countries should be identified and prioritized based on research to determine the most effective locations of the workshops, and in coordination with JIFSAN, and with consideration of other FSMA trainings that have been previously conducted by the FDA FSMA Alliances. IICA should develop a system to identify and prioritize the locations of these workshops, keeping in mind the previous and planned trainings by FSPCA and PSA.

Webinars

To enhance dissemination of FSMA principles by IICA and the Alliances, IICA would develop webinar(s) that can be downloaded from IICA’s website, based on the workshops/seminars provided in Item B (above) and be made available to foreign regulators, industry and other relevant stakeholders. The purposes would be to serve as references for those who received training to ensure knowledge retention, and to provide continuing education.  The proposed webinars should not be intended to replace the Alliance trainings, but may address additional regional and/or country-specific concerns.   

IICA should also develop a strategy to follow up with participants who received training including a strategy for following up with participants and with measures for knowledge transfer over time. 

Development of a Cadre of Food Safety Experts

IICA, in close collaboration with the official FSMA Alliances and their collaborators, commits to supporting FSMA’s preventive control and produce safety concepts. This cadre should be structured to have a sustainable multiplier effect to ensure an adequate knowledge base is maintained over time. This would include measures for outcomes and impact.

By targeting regulators, appropriate government institutions, and non-governmental organizations, IICA may enhance the long-term impact and sustainability of these investments. As trainers of the official Alliance curricula, entities that are not profit seeking may be able to offer the training at lower costs, particularly to smaller businesses and producers who must implement FSMA standards when exporting to the United States, but for whom training costs by traditional providers may be cost prohibitive. This cadre could include the development of a sub-group of government trainers. This would not only build the technical competencies of the FDA’s regulatory counterparts, but could facilitate low or no-cost trainings to growers who may not be able to afford training provided through the Alliances. Any such cadre or “hub” should feed into the larger FSMA international training frameworks. 

IICA might be one of the Collaborative Training Initiatives (CTIs) being developed by CFSAN/OFS’s strategic network of produce safety training in the Americas. Under this model, JIFSAN would be the main point of coordination for international produce training with other regional organizations (e.g., CARICOM, OIRSA). 

Measuring Success

The outcomes and impact of the activities conducted as part of this Cooperative Agreement should be measured and evaluated for impact.  IICA should conduct research after training activities are completed to determine effectiveness. It is encouraged that such efforts use the metrics frameworks that are in place and/or under development by FDA, JIFSAN, and the FSPCA to ensure efforts and results are aligned across FDA-supported FSMA international training activities.   

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

Funds Available and Anticipated Number of Awards

This award is contingent upon FDA appropriations and the submission of a meritorious applications. Award(s) will provide one (1) year of support and include future recommended support for two (2) additional year(s) contingent upon annual appropriations, availability of funding and satisfactory awardee performance.

FDA/Office of International Programs intends to fund up to $300,000, for fiscal year 2017 in support of this grant program. Funding in future years will be contingent on the availability of appropriations and successful performance in the award.

It is anticipated that one award will be made, not to exceed $1.1 million in total costs (direct plus indirect) over the possible 3-year course of the cooperative agreement

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: $300,000

YR 02: $400,000

YR 03: $400,000

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is three (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.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

The following organization is eligible to apply:

The Inter-American Institute for Cooperation on Agriculture (IICA)

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.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research Instructions for 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.

Page Limitations

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

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

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

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the HHS Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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.

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.

Overall Impact

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

 
Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance (20 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) (20 Points)

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

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 proposed?   

Approach (20 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 (20 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, subject populations, or collaborative arrangements?   

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

For Renewals, the committee will consider the progress made in the last funding period.

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

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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

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

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

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 the DUNS, SAM Registration, and Transparency Act requirements.2 Administrative and National Policy Requirements

All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement.

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.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), FDA awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgment about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all FDA grants and cooperative agreements.

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 FDA Office of International Programs programmatic requirements may be part of the Notice of Award.

Cooperative Agreement Terms and Conditions of Award

The administrative and funding mechanism used for this program is the cooperative agreement, an “assistance” 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 for the project resides with the awardees, although specific tasks and activities may be shared among the awardees and FDA. 

All awardees are required to participate in a cooperative manner with FDA.

An agency Program Official or Project Officer (PO) will be responsible for the normal technical and programmatic stewardship of the award and will be named in the Notice of Award (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.

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

Awardees have primary authorities and responsibilities to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their work.  FDA staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards.  Substantive involvement includes, but is not limited to on-site monitoring and participation in planning meetings and other conferences.

Roles and responsibilities are further delineated below.

Program Director/Principal Investigator Rights and Responsibilities

The Program Director (PD)/Principal Investigator (PI) will have the primary responsibility for the scientific, technical, and programmatic aspects of the grant and for day-to-day management of the project or program.  The PD/PI(s) will maintain general oversight for ensuring compliance with the financial and administrative aspects of the award.  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.

Throughout the term of the grant, the (PD)/ (PI) will have the primary responsibility for the following key areas:

1.  Overall management of the project

2. Agreement to work cooperatively

3.  Development and implementation of systems necessary for communications among the various project organizational components.

Further, the awardee is responsible for submitting interim progress reports (e.g., at specified intervals), when requested, to the FDA Project Officer (PO) and the Grants Management Specialist (listed as contacts on the Notice of Grant Award), including summary data on progress and expenses to date.

The awardee is encouraged to publish and publicly release and disseminate project results to the public and to FDA.  The awardee will work with the appropriate FDA staff to develop and implement all work products.

The awardee is responsible for obtaining approval for the development and design of FDA projects prior to execution.

All data, media and products will be shared freely by methods and within time periods to be specified by the Project Officer.

FDA Project Officer Responsibilities

An FDA Project Officer (PO) with professional/technical expertise and other members of the FDA staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The responsibilities of the PO include involvement during conduct of the activity, through technical assistance, advice, coordination, and/or other assistance activities.

As appropriate, the PO will participate in the definition of objectives and approaches, and in planning, conducting, analyzing, and producing campaign products developed under this cooperative agreement.  However, the dominant role and prime responsibility of the activity reside with the awardee(s) for the project.

The FDA through the PO will have access to work product generated under this Cooperative Agreement and may periodically review the work and progress reports.  The FDA PO may use information obtained from the project for the preparation of reports on the activities of the study/work. 

The PO will be directly involved in the guidance and development of the program and the collaborative structure of the program.

The PO will participate with the awardee in determining and carrying out the communications methodological approaches to be used. 

The PO will engage other FDA professional, scientific and administrative personnel to collaborate with the awardee, as necessary or required.

The PO will also serve as a member of any established Steering Committee.  [Paula Rausch will be PO and serve on the Steering Committee].  The Awardee(s) agrees to accept assistance from the designated PO.  This person will participate in the monitoring of issues relating to recruitment, follow-up, and adherence to project plans and will assist in the development and/or adjustment of project activity.

Additionally, an agency program official will be responsible for the normal administrative stewardship of the award and will be name in the award notice, in addition to the FDA PO.

Collaborative Responsibilities

As relevant, the PD/PI in collaboration with the PO will work collaboratively in evaluating the most appropriate methods relevant to the project, including program design and implementation, and evaluation of program results.  Campaign projects require FDA approval prior to implementation/initiation.

During performance of the award, the PO, with assistance of other professional/technical program staff designated based on their relevant expertise, may provide appropriate assistance, advice, and guidance.  The role of the PO will be to facilitate and not to direct the activities.  The decisions in all activities will be reached by consensus between the PD/PI and the PO, and FDA programmatic staff will be given the opportunity to offer input into this process.  The PO will facilitate liaison activity for partnerships and will provide assistance with access to FDA supported resources and services.

Steering Committee (Optional)

If a Steering Committee is determined to be necessary, it should be comprised of the PD(s)/PI(s) of the cooperative agreement, the leaders of additional performance sites, the FDA PO, and/’or the FDA agency program official.  The FDA PO will have primary responsibility for finalizing standard procedures and communication plans for all funded projects.  The steering committee will meet every three to six months, or as dictated by the needs of the project.  Each full member of the Steering Committee will have one vote, and all major decisions will be determined by majority vote of the Steering Committee.  Awardees will be required to accept and implement policies approved by the Steering Committee.

The primary governing body of the project will be the Steering Committee, which will have responsibility for the final details of project activity and policy decisions and will define the rules regarding access to media and distribution. [Note: FDA understands that the grantee has already established a Steering Committee for its campaign.  The FDA PO will become part of this existing committee.]

Dispute Resolution:

Any disagreements that may arise in technical or programmatic matters (within the scope of the award) between award recipients and the FDA may be brought to Dispute Resolution.  A Dispute Resolution Panel composed of three members will be convened.  The members shall include a designee of the Steering Committee chosen without FDA staff voting, one FDA designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardees’ right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

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. 

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

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: http://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 Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

Scientific/Research Contact(s)

Kristin Wedding
Office of International Programs (OIP)
Telephone: 301-796-1026
Email: kristin.wedding@fda.hhs.gov

Objective Review Contact(s)

Shashi Malhotra
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 240-402-7592
Email: Shashi.Malhotra@fda.hhs.gov

Financial/Grants Management Contact(s)

Shashi Malhotra
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 240-402-7592
Email: Shashi.Malhotra@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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