Participating Organization(s)	U.S. Food and Drug Administration (FDA) NOTE: 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. Also note that AHRQ has different page limits than NIH for the application Research Strategy, which can be found within each individual FOA. The FDA does not follow the NIH Page Limitation Guidelines or the Enhanced Peer Review Scoring Criteria. Applicants are encouraged to consult with FDA Agency Contacts for additional information regarding page limits and the FDA Peer Review Process.
Components of Participating Organizations	Center for Food Safety and Applied Nutrition (CFSAN)/Office of Foods and Veterinary Medicine (OFVM)
Funding Opportunity Title	National Consumer Food Safety Education Conference (U13)
Activity Code	U13 Support for Conferences and Scientific Meetings
Announcement Type	New
Related Notices	None
Funding Opportunity Announcement (FOA) Number	RFA-FD-13-003
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.103
Funding Opportunity Purpose	The purpose of the National Consumer Food Safety Education Conference is to advance the knowledge, practice and effectiveness of health and food safety educators in support of two Healthy People 2020 goals: FS-1: To reduce infections caused by key pathogens transmitted commonly through food FS-5: To increase the proportion of consumers who follow key food safety practices The proposed conference follows on prior successful conferences (1997, 2002, 2006, and 2010) that were jointly sponsored by the US Department of Agriculture, Food Safety and Inspection Service, and the Food and Drug Administration for the purposes of enhancing public education and outreach to improve food handling practices, and for strengthening collaboration among internal and external stakeholders to prevent foodborne illness. There is great potential to engage health and food safety educators more directly as partners in support of the government’s efforts to prevent foodborne illness. A conference designed to activate field-based educators can be a powerful way to exponentially increase exposure of American consumers to critical evidence-based food safety practices that can reduce incidence of foodborne illness.

Posted Date	May 15, 2013
Open Date (Earliest Submission Date)	June 1, 2013
Letter of Intent Due Date(s)	Not Applicable
Application Due Date(s)	July 15, 2013 by 11:59 PM Eastern Time. Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) before 11:59 p.m. Eastern Time on the application due date. Applicants are encouraged to submit their applications to Grants.gov several days early to ensure enough time to correct any errors and to comply with the deadline. Late applications will not be accepted for this announcement.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	August 2013
Advisory Council Review	Not Applicable
Earliest Start Date	September 2013
Expiration Date	July 16, 2013
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that 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 agency’s specific interest is in maximizing partnerships in order to reach target populations, improve information transparency, and increase exposure to food safety messages and best practices.

Topics to be presented at the conference must include but are not limited to those listed below:

• Promoting proven strategies to increase attitudinal and behavioral modification of safe food handling behaviors in the general population;
• Techniques for using foodborne illness data to target strategies for educating consumers;
• Promoting effective marketing techniques for USDA/FDA’s Food Safe Families and other evidence-based food safety education platforms;
• Leadership and partnership development among private and public sector food safety educators/practitioners outreach and education to stakeholders on provisions of the new FDA Food Safety Modernization Act (FSMA) to vulnerable and underserved populations, and adoption of food safety best practices effective consumer tools and information to keep in-home food safe.

Nature and Need of project:

Educating consumers on important basic safe food handling and hand hygiene is an inherently decentralized activity. Individuals who are engaged in connecting with consumers on the importance of safe food handling and preparation to good health represent various public and private sector institutions, and include public health agencies, Cooperative Extension, consumer non-profits, food and beverage industry associations, food retailers, Science and health writers and journalists, health care providers, and medical communicators.

Some of the benefits of bringing health and food safety educators together around action on the HP2020 goals include:

• Allows field educators from public and private sectors to view themselves as true partners and participants in the work to achieve the HP 2020 goals.
• Allows for training of educators and tasking them with capturing and sharing data about their consumer education work in America’s communities.
• Ensure field educators are aware of, and utilizing food safety education platforms proven to be effective (Food Safe Families and others).
• Allows us to leverage the significant consumer outreach potential of voluntary private and public sector partners. We can capture specific commitments from partners to participate in nationwide, coordinated outreach activities. Participants share progress on prevention strategies and are inspired to continue to have an impact. We provide a forum for field educators to collaborate and problem solve with one another.

Previous National Food Safety Education Conferences 1997 (Washington, DC); 2002 (Orlando, FL); 2006 (Denver, CO); and 2010 (Atlanta, GA) have served as important platforms for field educator professional development; for setting government priorities; for nurturing public-private cooperation and information exchange; and for sharing progress with the public and the media on prevention strategies.

Here are brief descriptions of these events taken from conference proceedings and other document sources:

1997: Changing Strategies Changing Behavior: What food safety communicators need to know.

On June 12-13, 1997 the first national conference devoted exclusively to developing innovative education programs that can change consumers unsafe food handling behaviors was held in Washington, DC. The conference is one of many educational projects identified in President Clinton s food safety initiative to protect the public health. More than 550 educators attended the conference representing industry, trade and consumer organizations; state and local health and agriculture departments; corporations; universities; and the Cooperative Extension system.

2002: Thinking Globally- Working Locally

From September 18 through September 20, 2002, more than 600 food safety educators from around the United States and the world gathered in Orlando, Florida, to attend Thinking Globally- Working Locally, a conference on food safety education. It was sponsored by the US Department of Agriculture, Food Safety and Inspection Service and Cooperative State Research, Education and Extension Service, and the US Department of Health and Human Services, Centers for Disease Control and Prevention and Food and Drug Administration, in cooperation with the Partnership for Food Safety Education. Conference speakers covered the gamut of topics, addressing global issues, updating attendees on the status of food safety in the U.S., discussing food safety communications in a world confronting bioterrorism, summarizing the latest findings in consumer research, and highlighting educational initiatives from around the country and the world.

2006: Reaching At-Risk Audiences and Today’s Other Food Safety Challenges

A total of 612 people attended all or part of the 5-day event which included 10 pre-conference training workshops (September 25-26) and, from September 27-29, 9 plenary sessions, 77 oral presentations, 37 posters, and 39 exhibitors. The conference goals were to 1) share current surveillance and epidemiological data on food borne illness; 2) present strategies leading to enhanced food safety knowledge, skills, and abilities and in attitudinal and behavioral modification in general and at-risk populations; and 3) communicate the latest science-based safe food handling principles and practices.

2010: Advancements in Food Safety Education: Trends, Tools and Technologies

More than 700 people attended all or part of the 4-day event held March 23-26, 2010 in Atlanta, GA. The desired conference goals and themes were to identify causes and casualties using food borne illness surveillance, statistics and epidemiology; evaluate and improve the effectiveness of social marketing techniques and evaluation; explore the role of technology and social media in consumer education; extend partnerships and collaborations that improve public health; and engage medical professionals in food safety outreach.

Funding Instrument	Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, FDA scientific or program staff will assist, guide, coordinate, or participate in project activities.
Application Types Allowed	New The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon FDA appropriations and the submission of a sufficient number of meritorious applications. FDA/CFSAN/OFVM intends to commit up to $200,000 in FY 2013. It is anticipated that one (1) award will be made.
Award Budget	Application budgets are not limited, but need to reflect actual needs of the proposed project. The amount of financial assistance requested from FDA may not exceed $200,000.
Award Project Period	Awards in support of a single conference will be made for a project period commensurate with the time involved in planning and conducting the conference; including post-conference activities.  Typically, this will be one year.

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

Both domestic and international conferences may be supported; however, an international conference can be supported only through the U.S. representative organization of an international scientific or professional society. An individual is not eligible to receive a grant in support of a conference.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the HHS Grants Policy Statement, are not allowed.

Applicant Organizations

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

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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 NIH 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.

FDA will not accept any application in response to this FOA that is essentially the same as one currently pending objective review unless the applicant withdraws the pending application. FDA will not accept any application that is essentially the same as one already reviewed within the past twelve months, except for submission:

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

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, 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.

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 (otherwise referred to as the Project/Conference plan) is limited to 20 pages.

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

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:

• Applicants should submit a detailed budget breakdown for each budget category listed in the Budget Component form and provide a detailed narrative justification for all costs requested including any proposed per diem/subsistence rates, transportation, printing, supplies and facility rental costs.

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:

The Research Strategy (Project/Conference Plan) is where applicants should attach their narrative responses to the selection criteria and requirements published in this FOA.

The following information must be included in the Research Strategy (Project/Conference plan):

1. Title of conference.

2. Purpose of conference. Describe the objectives, specific program, and logistical arrangements for the meeting.

3. Explanation of how the conference directly supports the FDA/CFSAN/OFVM Mission.

4. Describe the format and agenda, including the principal topics to be covered, problems to be addressed, and developments or contributions the meeting might stimulate.

5. Location of conference. Include venue, city and state. Describe the logistical arrangements for the meeting.

6. State the expected size and composition of the audience, as well as the method of selection. Please include an estimated percentage breakdown of anticipated Non-Federal vs. Federal attendees.

7. Describe the composition and role of the organizing committee, and provide the names and credentials of key participants in the meeting, including the basis for their selection and documentation of their agreement to participate.

8. Describe plans for publicizing the meeting and publication of the proceedings. Identify related meetings held on the subject during the past three years. If this is one of a series of periodic meetings held by a permanent sponsoring organization, briefly describe and evaluate the last meeting in the series.

9. Letters of agreement from key speakers should be attached under Letters of Support (line item 14) in the PHS 398 Research Plan Component.

Applications must state if registration fees will be charged, however such fees should not appear on the proposed budget. 

Resource Sharing Plan:

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

• Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan) 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.

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

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

Organizations must submit applications via 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.

Applicants are responsible for viewing their application before the deadline 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.

Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) before 11:59 p.m. Eastern Time on the application due date. Applicants are encouraged to submit their applications to Grants.gov several days early to ensure enough time to correct any errors and to comply with the deadline. Late applications will not be accepted for this announcement.

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.

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.

UNALLOWABLE COSTS

Registration Fees: Not allowable.

Indirect Costs: 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.

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 NIH. 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 (SAM). 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 by the assigned Grants Management Specialist and responsiveness by a member of the Center for Food Safety and Applied Nutrition/Office of Foods and Veterinary Medicine's Program staff. Applications that are incomplete and/or nonresponsive will not be forwarded for review.

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

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

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).

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 this conference/scientific meeting address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these endeavors on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s) (20 points)

Is (are) the PD/PI(s) well suited for organizing and fulfilling the goals of this conference/scientific meeting? Are the qualifications and past performance of the PD/PI(s) appropriate, and are they well suited for their described roles in the conference/scientific meeting? Are the key personnel and selected speakers appropriate and well suited for their described roles in the conference/scientific meeting?

Innovation (20 points)

Does the conference/meeting employ novel approaches or methods to fulfill its purpose? Does the conference/scientific meeting draw together appropriate experts who may otherwise not have an opportunity to meet?

Approach (20 points)

Are the format and agenda for the conference/meeting appropriate for achieving the specified goals? Is the conference/meeting timely for the subject matter? For applications designating multiple PDs/PIs, is the Leadership Plan approach including the designated roles and responsibilities, governance and organizational structure consistent with and justified by the topics of the conference/meeting and the expertise of each of the PD/PIs?

Environment (20 points)

Is the conference/scientific meeting site appropriate? Does the applicant organization have the ability to contribute to the probability of success? Do the proposed meetings, exhibits, interactions, etc., take advantage of unique features of the environment or employ useful collaborative arrangements? Is institutional support evident?

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

Protections for Human Subjects

Generally not applicable. Reviewers should bring any concerns to the attention of the Objective Review Chairperson.

Inclusion of Women, Minorities, and Children 

Generally not applicable. Reviewers should bring any concerns to the attention of the Objective Review Chairperson.

Vertebrate Animals

Generally not applicable. Reviewers should bring any concerns to the attention of the Objective Review Chairperson.

Biohazards

Generally not applicable. Reviewers should bring any concerns to the attention of the Objective Review Chairperson.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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

Applications from Foreign Organizations

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

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Resource Sharing Plans

Not Applicable

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.

All applications determined to be complete and responsive will undergo an objective review process. An objective review panel will evaluate complete and responsive applications according to the criteria listed in the Review Criteria section above and will be scored using the pre-determined weighted criteria listed in the "Application Review Information."

As part of the objective review process, all applications:

• Will receive a written critique.

Applications will be ranked on the basis of their Impact Score and 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:

• Availability of funds.
• Relevance of the proposed project to Program priorities.
• Scientific and technical merit of the proposed project as determined by objective review.
• Proposed location of conference.
• Proposed duration of conference.

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

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

If the application is under consideration for funding, FDA may 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 as noted in the HHS Grants Policy Statement.

All FDA grant and cooperative agreement awards will be subject to all policies and requirements that govern the programs of FDA, including provisions of 42 CFR Part 52, 45 CFR Parts 74 and 92, and the DHHS Grants Policy Statement.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, DHHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other DHHS, PHS, and FDA grant administration policies.

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

The PD(s)/PI(s) will have the primary responsibility for:

• Planning, coordination and execution of the conference.
• All meeting logistics, including the development of materials for the meetings, travel and meeting management, and the distribution of follow-up materials and action items after the meetings.
• Identifying a list of topics for the conference and identifying a list of speakers appropriate to the topics.
• Maintaining the general oversight for ensuring compliance with the financial and administrative aspects of the award.
• Participating in a cooperative manner with FDA.
• Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and FDA policies.

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

An FDA Project Manager will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. Substantial involvement as a partner would include, for example, assisting in planning the agenda, selecting speakers, determining the content of the meeting, or determining the acceptability of submitted papers. Substantial involvement would not include serving as an invited speaker or providing limited advice

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

• An agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
• FDA will have prior approval of the appointment of all key administrative personnel proposed by the grantee.
• FDA will be directly involved in the guidance and development of the program, including reviewing and approving the agenda and speakers.

Areas of Joint Responsibility include:

• It is anticipated that decisions on all activities will be reached by consensus between the FDA and the PD(s)/PI(s).

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590) and financial statements as required in the HHS Grants Policy Statement.

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

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Phone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

Christi D. Sullenger
Office of Foods and Veterinary Medicine (OFVM)
Telephone: 301-796-7323
Email: christi.sullenger@fda.hhs.gov

Martin Bernard
Office of Acquisition & Grants Services (OAGS)
Telephone: 301-443-5869
Email: Martin.bernard@fda.hhs.gov

Martin Bernard
Office of Acquisition & Grants Services (OAGS)
Telephone: 301-443-5869
mail: Martin.bernard@fda.hhs.gov

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.