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 FDA recognizes the value of supporting high quality, small conferences and scientific meetings relevant to its mission and to the public health. A small conference or scientific meeting is defined as a symposium, seminar, workshop, or any formal meeting, whether conducted face-to-face or virtually to exchange information and explore a defined subject, issue, or area of concern impacting the public's health within the scope of the FDA's mission. Support of such meetings is contingent upon the fiscal and programmatic interests and priorities of the FDA's respective Offices and Centers.

Therefore, a conference grant application is required to contain a permission-to-submit letter from one of the participating FDA Centers listed under Components of Participating Organizations.

Advance Permission to Submit an Application:

A letter requesting advance permission-to-submit a conference application is required and must be received via e-mail no later than eight (8) weeks prior to the selected application receipt date. The application receipt dates for conference grants are January 15 and June 15.

To request an advance permission to submit letter from one of the participating FDA Centers/Offices, applicants must submit the following information on applicant organizational letterhead:

• FOA Number and Title;
• FDA Center/Office that the application is seeking advance permission to apply to;
• Meeting/conference title;
• Location and date of proposed meeting/conference;
• Names, Address, Telephone number and email address of Institution(s) participating in the application;
• Name, Address, Telephone number and email address of the Principal Investigator/Project Director;
• Names of other key personnel (if any) and points of contact;
• Number of anticipated attendees;
• Purpose, benefit, objectives and/or justification of the meeting/conference and how it aligns with the mission and program priorities of the targeted FDA Office/Center;
• Estimated budget that will be requested for the meeting/conference and purpose; and
• List other sources of funding (secured and planned) if applicable.

All advance permission to submit an application requests must be submitted via email to [email protected]. Applicants are urged to initiate contact well in advance of the chosen application receipt date and no later than 8 weeks before that date. Please note that agreement to accept an application does not guarantee funding. Late applications will not be accepted.

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

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 HHS Grants Policy Statement explains, are not eligible to apply.

Applicant Organizations

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

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

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

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials either to 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 FDA support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

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.

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 is limited to 6 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.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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

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

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

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

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

• 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.
• Applications must state if registration fees will be charged, however such fees should not appear on the proposed budget.
• Recipients may not use program income as a source of matching or cost sharing unless explicitly authorized in the NoA.
• See section IV.5 for more information about funding restrictions and allowable costs.

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

Advance permission to submit an application is required for all FDA conference grant applications, including new and renewal applications. Advance permission to submit an application should be requested early in the process and no later than eight weeks before the receipt date. The letter from an FDA Center/Office documenting advance permission to submit an application (i.e., the permission-to-submit letter) must be submitted with the application and attached as a PDF document in the PHS398 Cover Letter Component. All applicants must include the permission-to-submit letter from the FDA staff member who has agreed to accept assignment of the application. If an application is received without an advance permission-to-submit letter, it will not be accepted for review. Note that advance permission to submit an application does not guarantee funding.

Only one advance permission-to-submit letter is required per application.

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

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

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

Note that this section will be called Conference Plan in the system-generated Table of Contents.

The Conference Plan section of the application (uploaded as the Research Strategy attachment, line item #3), is where applicants should attach their narrative responses to the selection criteria and requirements published in this FOA.

The following information must be included and addressed in the Conference Plan (Research Strategy):

• Title of the meeting/conference;
• Dates of conference(s);
• Location of the conference (venue, city, state);
• Expected number of registrants and type of audience expected with their credentials, as well the method of selection; if possible provide a percentage breakdown of Federal vs. Non-Federal attendees;
• Conference format and projected agenda(s), including list of principal areas or topics to be addressed and list of speakers;
• Physical facilities and logistical arrangements required for the conduct of the meeting;
• Justification of the conference(s), including the objectives, the problems it intends to clarify and any developments it may stimulate; the public health need, timeliness, and usefulness of the conference/meeting to the scientific community;
• Description of the composition and role of the organizing committee, and provide the names and credentials of key participants in the conference /meeting, including the basis for their selection and documentation of their agreement to participate (Letters of agreement to participate from key speakers and participants should be attached to line item #14 'Letters of Support') and;
• Information about all related conferences held on this subject during the last 3 years, (if available) and how the proposed conference/meeting is similar to, and/or different from these, and why it is still necessary and useful. If this is one of a series of periodic conferences/meetings held by a permanent sponsoring organization, briefly describe and evaluate the last conference/meeting in the series;
• Plans for publicizing the conference/meeting to all interested participants and for publishing the proceedings.
• If the conference will be a virtual conference, the applicant must address relevant details, such as the medium to be used, how invitations will be issued, and whether participation will be controlled in any manner.

Applications requesting multiple years of support must provide the following additional information for each future year requested, in as much detail as possible: Budget, meeting topics, tentative dates, locations, participants, and contingency plans for future meetings dependent upon, for example, the outcome of the first year’s conference/meeting or developments in the field.

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 modification:

• 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, with the following modification:

• The appendix is limited to announcements and reports of previous conferences under the same sponsorship.
• Tentative agenda(s).
• No other information or material should be submitted as appendices.

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. 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. FDA and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. Pre-award costs are allowable only as described in the HHS Grants Policy Statement.

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.

• Transportation costs for attendees and participants at the conference may not exceed coach class fares. In all cases, U.S. flag carriers must 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.

Conference awards should be issued before the actual start date of the conference.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to FDA. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the assigned Grants Management Specialist and responsiveness by the appropriate FDA Center/Office. Applications that are incomplete and/or nonresponsive will not be reviewed.

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

Only the review criteria described below will be considered in the review process. As part of the FDA mission, all applications submitted to the FDA in support of biomedical and behavioral research are evaluated for scientific and technical merit through the FDA objective review system.

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 assigned Grants Management Specialist.

Inclusion of Women, Minorities, and Children

Generally not applicable. Reviewers should bring any concerns to the attention of the assignedGrants Management Specialist.

Vertebrate Animals

Generally not applicable. Reviewers should bring any concerns to the attention of the assigned Grants Management Specialist.

Biohazards

Generally not applicable. Reviewers should bring any concerns to the attention of the assigned Grants Management Specialist.

Renewals

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

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

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 Scored Review Criteria section above. FDA will also consider current priorities when making funding decisions

As part of the objective review, all applications:

• Will receive a written critique.

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

Applications will be ranked on the basis of their Composite Score and will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

• Centers' current priorities.
• Technical merit of the proposed project as determined by objective review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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

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 as noted in the HHS Grants Policy Statement.

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

All conference material (promotional materials, agenda, publications and internet sites) related to this project must include an acknowledgement of FDA grant support and a disclaimer stating the following:

Funding for this conference was made possible [in part] by [insert grant number] from [insert FDA Center/Office name]. The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.

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

Cooperative Agreement Terms and Conditions of Award

The administrative and funding mechanism used for this program is 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 resides with the awardees for the project, although specific tasks and activities may be shared among the awardees and FDA as defined below.

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

b. 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 polices.

c. An agency program official or a Center program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. FDA staffs have substantial programmatic involvement that is above and beyond the normal stewardship role in awards as described below.

Principal Investigator(s) (PI)/Program Director (PD) responsibility

The Principal Investigator (PI)/Program Director (PD) will have 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, as well as ensuring that all staff has sufficient clearance and/or background checks to work on this project or program. This individual will work closely with designated officials within the recipient organization to prepare justifications; appropriately acknowledge Federal support in publications, announcements, news programs, and other media; and ensure compliance with other Federal and organizational requirements.

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 results, data and other products of the cooperative agreement, concordant with the governance and the approved plan for making data and materials available to the scientific community and FDA. Awardee will work with the appropriate FDA staff to develop and implement an appropriate rapid data release policy.

Manuscripts shall be submitted to FDA Project Officer within two weeks of submission for publication. Publications or oral presentations of work performed under this Cooperative Agreement will require appropriate acknowledgement of FDA support. Timely publication of major findings is encouraged

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

FDA Project Officer Responsibility

An FDA Project Officer (PO) with scientific/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, and publishing resulting work from activities under this cooperative agreement. However, the dominant role and prime responsibility for the activity reside with the awardees(s) for the project.

The PO will be responsible for the administration and general programmatic stewardship of the award and have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The FDA through the PO will have access to data generated under this Cooperative Agreement and may periodically review the data and progress reports. The FDA PO may use information obtained from the data for the preparation of internal reports on the activities of the cooperative agreement. However, awardees will retain custody of and have primary rights to all data developed under these awards or as stated in the terms and conditions of award.

Retain the right to have prior approval on the appointment of all key personnel substantially supported by the grant.

Be directly involved in the guidance and development of the program and the collaborative structure of for the program.

Participate with the grantee in determining and carrying out the approaches to be used. Collaboration will also include identifying topics, agendas, participants, and dissemination of findings and where appropriate, co-authorship of publications.

Arrange to have professional scientific and administrative/clerical personnel working in collaboration with the grantee as required.

Collaborative Responsibilities

As relevant, the PD/PIs in collaboration with PO will work collaboratively in evaluating the most appropriate methods, publication and dissemination of findings. Projects require FDA approval prior to implementation/initiation.

During performance of the award, the PO, with assistance from other 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. It is anticipated that decisions in all activities will be reached by consensus between the PD/PI and the PO and that the FDA programmatic staff will be given the opportunity to offer input into this process. The PO will facilitate liaison activity for partnerships, and provide assistance with access to FDA supported resources and services.

The FDA will work collaboratively to identify and coordinate training, professional development and training-related scientific exchange opportunities.

Dispute Resolution Process

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. It will have three members: a designee of the FDA staff, one recipient designee, and a third designee with expertise in the relevant area that 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.Disallowance of Cost.

Copyright

Except as provided in the conditions of the award, when a publication or similar copyrightable material is developed from work supported by HHS, the author is free to arrange for copyright without approval of the FDA. Such copyrighted materials are subject to a royalty-free, nonexclusive, and irrevocable license to the Federal government to reproduce them, translate them, publish them, and use and dispose of them, and to authorize others to do so for Federal government purposes.

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

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 Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
TTY: 301-451-5939
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726 Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

Martin Bernard
U.S. Food and Drug Administration
Office of Acquisitions and Grants Services
Grants and Assistance Agreements Team
Ph: 240-402-7564
Email: [email protected]

Martin Bernard
U.S. Food and Drug Administration
Office of Acquisitions and Grants Services
Grants and Assistance Agreements Team
Ph: 240-402-7564
Email: [email protected]

Recently issued trans-FDA policy notices may affect your application submission. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

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