Participating Organization(s)	U.S. Food and Drug Administration (FDA) 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	Office of the Commissioner (OC) Office of Regulatory Affairs (ORA) Office of Orphan Products Development (OPD) Center for Biologics Evaluation and Research (CBER) Center for Drug Evaluation and Research (CDER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Tobacco Products (CTP) Center for Veterinary Medicine (CVM) National Center for Toxicological Research (NCTR)
Funding Opportunity Title	FDA Small Scientific Conference Grant Program (R13)
Activity Code	R13 Support for Conferences and Scientific Meetings
Announcement Type	New
Related Notices	May 29, 2014 - See Notice NOT-FD-14-009. May 23, 2014 - This PAR has been reissued as PAR-14-237. May 11, 2012 - See Notice NOT-FD-12-004. The purpose of this Notice is to update Components of Participating Organizations, Funding Restrictions, and Agency Contacts originally issued in this FOA.
Funding Opportunity Announcement (FOA) Number	PA-11-310
Companion FOA	Not Applicable
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.103
FOA Purpose	To facilitate the provision of federal financial assistance in support of scientific conferences clearly aligned with the FDA mission. Applicants must identify the FDA Office/Center best suited to support their proposed conference in the cover letter. Failure to identify the relevant Office/Center will disqualify an application. For more information about the FDA and its respective Offices/Centers, visit www.fda.gov.

Posted Date	August 19, 2011
Open Date (Earliest Submission Date)	September 15, 2011
Letter of Intent Due Date	Not Applicable
Application Due Date(s)	October 15; January 15; April 15; July 15, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	Deadline - Tentative Objective Review October 15 - November January 15 - February April 15 - May July 15 - August Note: Objective review date depends on the availability of qualified reviewers and may not occur as listed above. Applicants are strongly encouraged to pursue funding for their small scientific conference well in advance of the anticipated meeting date.
Advisory Council Review	Standard dates
Earliest Start Date(s)	Deadline - Earliest Start Date October 15 - December 1 January 15 - March 1 April 15 - June 1 July 15 - September 1 Note: Earliest start date depends on objective review date and may not occur as listed above. Applicants are strongly encouraged to pursue funding for their small scientific conference well in advance of the anticipated meeting date.
Expiration Date	May 24, 2014 per reissuance PAR-14-237 (Originally July 16, 2014)
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed in this FOA to do otherwise. 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 scientific conferences. A small scientific conference 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, each small scientific conference grant application must contain a cover letter. The cover letter must clearly state the primary objectives of the meeting, anticipated outcomes, and the FDA Office/Center that the application should be forwarded to for consideration. If the stated objectives and anticipated outcomes are not consistent with the mission and current program priorities of the targeted FDA Office/Center the application will not be forwarded for review. Failure to identify an Office/Center in the cover letter will disqualify an application. For more information about the FDA and its respective Offices and Centers, visit www.fda.gov.

Funding Instrument	Grant
Application Types Allowed	New
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 are not limited and must reflect actual needs of the proposed project. The amount of financial assistance requested from FDA may not exceed $50,000 For more information related to budget preparation see Section IV.2.
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. Applicants may propose a multi-year project period, up to 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.

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

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 - FDA Center/Offices are not eligible
• 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.

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) 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 SF 424 (R&R) Application Guide.

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

Provided that each application is scientifically distinct, applicant organizations may submit more than one application.

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.

The SF424 Research and Related forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. The following forms must be submitted in response to this FOA:

1. SF424 R&R Cover Component

2. R&R Project Performance Site Locations Component

3. R&R Other Project Information Component

4. R&R Senior/Key Person Profile (Expanded) Component

5. R&R Detailed Budget

6. PHS 398 Cover Page Supplement

7. PHS 398 Cover Letter

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

• For this specific FOA, the Research Strategy section is limited to 20 pages.

Applications in response to this FOA must include the SF 424 R&R Budget Component. Complete the form as instructed in the SF424 Application Guide. Please note, small scientific conference grant budgets must reflect the total cost of the conference, the costs for which support is requested (not to exceed $50,000), and a list of anticipated funders (federal and non-federal).

See section IV.5 for information about funding restrictions and allowable costs.

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

Submit one attachment, which may not exceed 20 pages, under the Research Strategy section (line item 3). Draft agenda and letters of agreement from key speakers should be attached at line item 14. Do not complete the Human Subjects Sections or Other Research Plan Sections unless applicable.

In the Conference Plan section of the application (uploaded as attachment #3), describe the objectives, specific program, and logistical arrangements for the meeting. Describe the format and agenda, including the principal topics to be covered, problems to be addressed, and developments or contributions the meeting might stimulate. Provide a detailed justification for the meeting, including the scientific need, timeliness, and usefulness of the meeting to the scientific community. 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.

State the expected size and composition of the audience, as well as the method of selection. 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.

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

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

A critical part of the application for FDA support of conferences is documentation of appropriate representation of women, racial/ethnic minorities, persons with disabilities, and other individuals who have been traditionally underrepresented in science. These individuals must be included in all aspects of planning, organization, and implementation of FDA sponsored and/or supported meetings. Appropriate representation means representation based on the availability of these scientists from these groups known to be working in a particular field of biomedical or behavioral research. If appropriate representation is not apparent, no award will be issued until program staff is assured of concerted recruitment efforts. Organizers of scientific meetings must document compliance with the Guidelines for Inclusion of Women, Minorities, and Persons with Disabilities in Scientific Meetings Supported by the NIH/FDA (http://grants.nih.gov/grants/funding/r13/index.htm). This Web site also includes addresses and information for offices at FDA that support conference activities.

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.

• Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan) are expected, but they are not applicable for this FOA.

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of 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.

Applicants are responsible for viewing their application in 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.

Only the following costs are allowable:

• Conference services: Necessary recording of proceedings, simultaneous translation, and subsequent transcriptions.
• Consultant Services: Consultant fees, including travel and supporting costs (per diem or subsistence).
• Equipment Rental: Rental of necessary equipment.
• Meals: Limited to meals that are an integral and necessary part of a conference (i.e., a working meal where business is transacted). See travel also.
• Publication costs: Publication of proceedings or a book or pamphlet, costs of special plates, charts, diagrams, printing, distribution, mailing, postage, and general handling.
• Salaries: In accordance with the policy of the recipient, 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.
• Supplies: Purchase of supplies for the conference if the supplies are received and used during the project period.
• Travel: 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 recipient are governed by the recipient’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 limitations or restrictions on countries to which travel will be supported or budgetary or other limitations on availability of funds for foreign travel.

Proposed per diem or subsistence 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 meals and/or lodgings are furnished without charge or at a nominal cost (e.g., as part of the registration fee), the proposed per diem or subsistence allowance must take this into consideration. 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.

Registration Fees are not allowable and should not be included in the budget.

Indirect Costs are not allowable and should not be included in the budget.

Applications must be submitted electronically via grants.gov following the instructions described in the SF 424 (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/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(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.

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 Central Contractor Registration (CCR). 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. Applications that are incomplete will not be forwarded for objective review.

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

In accordance with the FDA's objective review policy, each application submitted in response to this FOA will be assessed for scientific and technical merit as described below.

Reviewers will provide an overall impact/priority 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

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)

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

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

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

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/priority score, but will not give separate scores for these items.

Appropriate Representation

How well do the plans for inclusion of women, racial/ethnic minorities, persons with disabilities, and other individuals who traditionally have been underrepresented in science provide for their appropriate representation in the planning, organization, and execution of the proposed conference/scientific meeting?

Protections for Human Subjects

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

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

Biohazards

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

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/priority score.

Provision of Family Care Facilities

Are the plans to inform attendees about family care resources adequate?

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.

Applications will be evaluated for scientific and technical merit by (an) appropriate Objective Review Group(s), in accordance with FDA's Objective Review Policy and Procedures.

As part of the objective review process, all applications completed in compliance with this FOA and found to be aligned with the targeted FDA Office/Center's mission and program priorities will be forwarded for objective review and assigned an application score as described in Section V.1.

Applications will be ranked on the basis of their Impact/Priority Score. 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.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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, CCR Registration, and Transparency Act requirements.

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually 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.

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

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Stephanie D. Bogan
Grants Management Specialist
Food and Drug Administration
Office of Acquisitions and Grants
Grants and Assistance Agreements Team
Email: stephanie.bogan@fda.hhs.gov

Lisa Ko
U.S. Food and Drug Administration
Office of Acquisitions and Grants Services
Grants and Assistance Agreements Team
Ph: 301-827-5095
Email: Lisa.Ko@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.