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SMG 2150.1

FDA STAFF MANUAL GUIDES, VOLUME III - GENERAL ADMINISTRATION

GRANTS ADMINISTRATION

FDA GUIDELINES FOR PARTIAL FUNDING OF SMALL SCIENTIFIC CONFERENCE GRANTS

Effective Date: 04/18/2002

[PDF Version]

 1. Purpose
 2. Definitions
 3. Policy
 4. Application Process
 5. Review Process
 6. Award of the Grant
 7. Procedures
 

Attachment A - FDA Program Contacts
Attachment B - Review Criteria

1. PURPOSE 

This guide states the policies and procedures of the Food and Drug Administration (FDA) for the application, review and award of small grants in support of scientific conferences. Such grants provide some, but not all, funding support for the direct costs associated with a conference which has objectives clearly within FDA's mission and its areas of program interest and priorities.

2. DEFINITIONS 

A. Scientific Conferences. These include symposia, seminars, workshops or other formal meetings held to:

1. Exchange scientific information, and

explore or clarify a scientific subject area.

2. The conference proceedings are usually published as a report or journal article.

B. Grantee. A grantee is a United States institution or an established scientific or professional society with a U.S. component eligible to receive grants. Faith-based organizations are eligible to apply for these conference grants. Individuals are not eligible to receive a grant for the support of a scientific conference. Organizations which engage in lobbying activities (IRS Code Section 501 {c} 4) are ineligible to receive grant funds.

C. Application. Form PHS-398, "Application for Public Health Service Grant," should be used to apply to FDA. State and local governments may use PHS 5161-1 (rev 7/00) Application forms and special instructions are available from:

Grants Management Office
Food and Drug Administration
5630 Fishers Lane
HFA-520
Rockville, Maryland 20857

Telephone: 301-827-7180

http://www.fda.gov/oc/ofacs/grants/

D. Center. As used in this Staff Manual Guide, the term includes the Office of Regulatory Affairs and all components of the Office of the Commissioner.

E. Allowable Costs. Special instruction for completing the application and determining what costs may be charged to a grant are available from the Office of Facilities, Acquisitions and Central Services (OFACS) at the telephone number listed above (2c).

F. Domestic and International Conferences.

1. Grant funds may be awarded to provide general support for those conferences, both domestic and international, that are held either in the United States or Canada.

2. For international conferences held outside the United States and Canada, grant funds may be awarded to the U.S. component of the international organization for support of specific aspects or segments of the conference (e.g., a panel which is part of the conference), but not for general support of the whole conference.

3. POLICY 

It is FDA policy to participate with other organizations in support of a scientific conference rather than provide the sole financial support. Partial funding will be predicated on the following criteria:

A. Conferences proposed for partial FDA funding support must be related to FDA's overall mission and must meet the objectives and the funding priorities of the FDA program area concerned;

B. Under these circumstances, FDA may provide partial support for a limited number of scientific conferences designed to coordinate, exchange and disseminate scientific information;

C. Such grants will ordinarily be awarded in amounts between $1,000 and $25,000 for direct cost expenditures associated with the conference. However, exceptions to those amounts may be made by the Director, OFACS, when appropriate.

D. Applicants are required to follow the Special Information and Instructions included in the application kit which address allowable costs and necessary budgetary information.

E. Applications received after the quarterly deadline date will be held for the next review cycle or returned to the applicant if time is not sufficient for FDA to conduct a review prior to the scheduled date of the proposed conference.

4. APPLICATION PROCESS 

A. Potential applicants should contact the Grants Management Office (see 2.c. above) to determine interest, current plans and program priorities before preparing and submitting a grant application to the Agency.

B. When an FDA employee in any program area is contacted by a potential applicant, that employee should inform their Center liaison (Attachment A).

C. Center liaisons should, in turn, advise the Grants Management Office (2.c. above).

D. When the institution or professional society decides to submit a conference grant application, their representative should request a package of material (PHS-398 and FDA Special Information and Instructions) from FDA (2.c. above).

E. The institution or professional society should plan to submit its conference grant application as far in advance of the conference as possible, but at a minimum of three months before the conference is scheduled to begin.

F. Applications should be submitted to the Grants Management Office (2.c. above).

G. Schedule. Complete applications that meet all the requirements for submission will be reviewed as follows:

Received byReviewed byAwarded by
January 15February 15March 15
April 15May 15June 15
July 15August 15September 15
October 15November 15December 15

5. REVIEW PROCESS  

After receipt and initial review for responsiveness by the Grants Management staff, the application will be sent to the appropriate Center(s) for a decision on mission relatedness, program interest and funding priority. If the Center(s) indicates an interest in potentially funding the application, an ad hoc review panel will be convened. The ad hoc review panels meet each month as needed, at the convenience of the reviewers.

A. Review Panel. A minimum of three senior FDA staff knowledgeable in the subject areas of the application will constitute the ad hoc review panel.

B. Conflict of Interest. The Department of Health and Human Services (DHHS) Standards of Conduct and the FDA Supplement to the DHHS Standards of Conduct apply. No FDA employee will participate in or be present during any review of an application from an organization in which the member, his or her spouse, parent, child or partner has a financial interest or is serving as an officer, director, trustee, presenter, partner, or employee, or is negotiating any arrangement concerning prospective employment.

C. Review Criteria. The committee will review the application and evaluate it based on criteria published as part of the Request for Applications in the Federal Register notice (see Attachment B).

D. Review Scoring. Each reviewer will score the application independently based solely on the review criteria. The range of scoring is 100-500 with 100 being the highest rating and 500 the lowest. The Summary Statement will reflect the average of all the reviewers' scores.

1. If the majority of the reviewers on the panel disapprove, the conference grant application it will be disapproved, with no score on the Summary Statement.

2. If a minority of the reviewers on the panel disapprove, a score of 500 will be used to indicate those reviewers' scores when calculating the average for the Summary Statement.

E. Executive Secretary. OFACS personnel will serve as the Executive Secretary to the review panel, document the review, average the scores given by the reviewers and write the Summary Statement.

F. Recommendation for Funding. The Summary Statement, with the recommendation for approval or disapproval, will be sent to the appropriate Center(s). Appropriate Center staff will make the final funding decision based on the Center's interests, mission and budgetary priorities.

6. AWARD OF THE GRANT 

If the Center(s) decides to fund the application based on the above criteria, Center Staff will notify the Grants Management Office by memo of their decision and will indicate the level of funding approved. Grants Management Staff will process the application as a new award according to criteria set forth in Staff Manual Guide FDA 2150.2, with the following exceptions:

A. The project period for the conference grant award will be for a period of up to one fiscal year only;

B. The award will be for direct costs only and will exclude travel for federal employees, honoraria, and any awards presented at the conference;

C. No grant award will be awarded after the start date of a conference. If the conference grant application is not recommended for approval by the Center(s), Center staff must notify OFACS of its decision. OFACS will notify the applicant in writing within thirty (30) days of Center notification.

7. PROCEDURES 

A. Applicants should submit a completed Form 398, " Public Health Service Grant Application," to FDA at the above address (2.c) State and local governments may use PHS 5161-1 (rev 7/00).

B. Applications should NOT be mailed or delivered to the National Institutes of Health.

C. Any FDA employee receiving a conference grant application should immediately refer it to OFACS, HFA 520, through their Center's liaison (see Attachment A).

D. Review procedures will follow those described above (see #5). Committee review will be based on criteria contained in the "Review Guidelines," (Attachment B) and will be documented accordingly by the Executive Secretary, OFACS.

E. Funding decisions will be made by the Center(s) based on its overall objectives and funding priorities.

F. Grant awards will be made by the Grants Management Officer, OFACS, with the approval of the Center(s) and the Office of Financial Management.

G. The earliest date for award of a conference grant is three months after the Agency receives a complete application that meets all the requirements for submission.

H. For any information regarding scientific conference grants, contact, OFACS, DCPM HFA-520, Phone: 301-827-7180.