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

U.S. Food and Drug Administration  (FDA)

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

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

Components of Participating Organizations

Center for Biologics Evaluation and Research (CBER)
Center for Drug Evaluation and Research (CDER)
Center for Devices and Radiological Health (CDRH)
Center for Tobacco Products (CTP)
Center for Veterinary Medicine (CVM)
Center for Food Safety and Applied Nutrition (CFSAN)
National Center for Toxicological Research (NCTR)
Office of the Commissioner (OC)
Office of Regulatory Affairs (ORA)

Funding Opportunity Title

FDA Scientific Conference Grant Program (R13)

Activity Code

R13 Support for Conferences and Scientific Meetings

Announcement Type

Reissue of PAR-14-237

Related Notices

None

Funding Opportunity Announcement (FOA) Number

PAR-16-378

Companion Funding Opportunity

Not Applicable

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

93.103 

Funding Opportunity Purpose

The purpose of the FDA (R13) Scientific Conference Grant Program is to facilitate the provision of federal financial assistance in support of small conferences and scientific meetings clearly aligned with the FDA mission. 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. Permission to submit a conference grant application does not assure funding or funding at the level requested. FDA will not issue a conference grant award unless it can be issued before the conference start date. 

Key Dates
Posted Date

July 27, 2016

Open Date (Earliest Submission Date)

August 1, 2016, 2017, 2018, 2019 for October 2016, 2017, 2018, 2019 application due dates.

February 1, 2017, 2018, 2019 for April 2017, 2018, 2019 application due dates.

Letter of Intent Due Date(s)

8 weeks prior to the selected application due date.

Prior approval (advance permission to apply) in the form of a Letter of Intent is required before submission of an application for conference support. Advance permission to submit an application must be requested early in the process and must be submitted no later than 8 weeks before the  selected application due date. Letter(s) of Intent received after 8 weeks prior to the application submission date will not be accepted. 

Application Due Date(s)

October 12, 2016 by 11:59 PM Eastern Time.

April 12, 2017 and October 12, 2017 by 11:59 PM Eastern Time.

April 12, 2018 and October 12, 2018 by 11:59 PM Eastern Time.

April 12, 2019 and October 11, 2019 by 11:59 PM Eastern Time.

Applicants are strongly encouraged to apply early and to pursue funding for their small scientific conference well in advance of (at least 6 months) the anticipated meeting 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 selected application due date. 

Late applications will not be accepted for this FOA.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

April deadline - June review

October deadline - December review

Generally objective review will occur two-three months after application receipt date. However, objective review date(s) depends on the availability of qualified reviewers and may not occur as listed above. Applicants are strongly encouraged to pursue funding for their small conferences and scientific meetings well in advance of the anticipated meeting date. 

Advisory Council Review

Not Applicable

Earliest Start Date

April deadline  - July

October deadline - January

Note: Earliest start date depends on objective review date(s) and may not occur as listed above. Applicants are strongly encouraged to pursue funding for their small scientific conference well in advance of (at least 6 months) the anticipated meeting date.

Expiration Date

October 12, 2019

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.



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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

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 an advance 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 of Intent 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 due date.

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

  • FOA Number and Title;
  • Selected application due date;
  • 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 Center/Office;
  • 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 Bryce.Jones@fda.hhs.gov.  Applicants are urged to initiate contact well in advance of the chosen application due date and no later than 8 weeks before that date. Advance permission to submit an application requests received after 8 weeks prior to the selected application due date will not be accepted. Please note that agreement to accept an application does not guarantee funding or funding at the level requested. 

See Section VIII. Other Information for award authorities and regulations.
Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Renewal

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

Funds Available and Anticipated Number of Awards

Funding availability and award volume are contingent upon FDA appropriations and the number of meritorious applications received.

Award Budget

Application budgets must reflect actual needs of the proposed project.  For more information related to budget preparation see Section IV.2.

Application budgets submitted to the following FDA Centers/Offices for review and funding consideration may not exceed the following in total cost per year:

OC: up to $50,000

CTP: up to $50,000

CVM: up to $25,000

ORA: up to $25,000

NCTR: up to $25,000

CDRH: Unlimited

CFSAN: Unlimited

CBER: Unlimited

CDER: Unlimited

**All funding consideration is based on the availability of funds**

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 (1) year. 

Applicants may propose a multi-year project period, up to five (5) years, for permanently sponsored conferences held annually or biennially on a recurring topic or theme. The availability of funding for subsequent years of multi-year project periods depends on annual appropriations and grantee performance. 

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

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the HHS Grants Policy Statement, are not allowed.

Required Registrations

Applicant Organizations

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

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • 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 6 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 with the following additional instructions:

Advance permission to submit an application is required for all FDA conference grant applications, including new and renewal applications.  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. Applications that do not include a permission-to-submit letter 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.

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.
  • Applications must state if registration fees will be charged, however such fees should not appear on the proposed budget.
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, with the following additional instructions: Research Strategy:  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), , 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 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: 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, and tentative agenda(s).  No other information or material should be submitted as appendices.
PHS Inclusion Enrollment Report

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

PHS Assignment Request Form

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

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, FDA's electronic system for grants administration. eRA Commons and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Late applications will not be accepted for this FOA.

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

Pre-award costs are allowable only as described in the HHS Grants Policy Statement.

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.

7. Other Submission Requirements and Information

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.  For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the assigned Grants Management Specialist and responsiveness by components of participating organizations, FDA. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

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

Section V. Application Review Information
1. Criteria

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

Scored Review Criteria

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

Significance (20 Points)

Does this conference 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 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?

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

       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 assigned

       Grants Management Specialist.

Vertebrate Animals

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

       Grants Management Specialist.

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.

 
Renewals

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

Revisions

Not Applicable.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

Not Applicable.

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by an Objective Review Committee using the stated review criteria.

As part of the objective review, all applications:

  • Will receive a written critique.

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

Applications will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by objective review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.
3. Anticipated Announcement and Award Dates

Successful applicants will be notified of additional information that may be required or other actions leading to an award. The decision not to award a grant, or to award a grant at a particular funding level, is discretionary and is not subject to appeal to any FDA or HHS official or board.

Section VI. Award Administration Information
1. Award Notices

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

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found in the HHS Grants Policy Statement.

2. Administrative and National Policy Requirements

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

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 Programmatic requirements may be part of the Notice of Award.

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: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

Objective Review Contact(s)

Kiara Fowler
U.S. Food and Drug Administration
Office of Acquisitions and Grants Services
Grants and Assistance Agreements Team
Telephone: 240-402-3099
Email: Kiara.Fowler@fda.hhs.gov

Financial/Grants Management Contact(s)

Kiara Fowler
U.S. Food and Drug Administration
Office of Acquisitions and Grants Services
Grants and Assistance Agreements Team
Telephone: 240-402-3099
Email: Kiara.Fowler@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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