05-11957. Support for Small Scientific Conference Grants; Availability of Grants; Request for Applications; Announcement Type: Modification of Notice; Funding Opportunity Number: HHS-GRANTS-110204-001; Catalog of Federal Domestic Assistance Number: ...

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

I. Funding Opportunity Description

The Food and Drug Administration (FDA) is revising the Request for Applications (RFA) published in the Federal Register of June 6, 2002 (67 FR 39013). This revised RFA supercedes the June 6, 2002, document in its entirety. FDA's authority to enter into grants and cooperative agreements is detailed under title XVII of the Public Health Service Act (42 U.S.C. 300u-1) or the Radiation Control for Health and Safety Act of 1968 (Pub. L. 90-602) (21 U.S.C. 360hh-ss, formerly 42 U.S.C. 263b-n).

1. Background

FDA recognizes the value of partially supporting scientific meetings and conferences designed to coordinate, exchange, and disseminate information when the objectives are clearly within the scope of the agency's mission. FDA's policy is to participate with other organizations to support meetings where practicable, rather than provide sole support. In view of the diversity of interests among the various FDA centers/offices, and in order to provide maximum flexibility, FDA will not set rigid requirements concerning the type of scientific meetings to be supported so long as they are within the agency's mission.

II. Award Information

FDA views the partial support of scientific conferences as an ongoing program and may award a limited number of grants each fiscal year. These awards are subject to availability of funds and range from $1,000 to $25,000 in direct costs only per conference. This announcement is intended to be a “Standing Program Announcement” and will be modified in the event of required changes to the program.

Support for this program will be in the form of a grant. These grants will be subject to all policies and requirements that govern the support for small scientific conference grant programs of FDA, including the provisions of 42 CFR part 52, and 45 CFR parts 74 and 92, as applicable. The length of support will last for up to 1 year from date of award.

III. Eligibility

1. Eligible Applicants

Conference grant support is available to any public or private nonprofit entity including State and local units of government, scientific and professional societies, faith-based organizations, and for-profit entities. For-profit entities must commit to excluding fees or profit from the conference in their request for support.

In the case of an international conference held in the United States or Canada, the U.S. component of an established international scientific or professional society is the eligible applicant. In exceptional cases, where there is no U.S. component, a grant to support a specific segment of an international conference may be awarded directly to a foreign institution provided that the following conditions are met: (1) Grants to foreign institutions or international organizations are not prohibited under the governing legislation and (2) approval of the Department of Health and Human Services (HHS) agency head or his or her designee is obtained in each case.

An individual is not eligible to receive grant funds in support of a conference. As provided in 2 U.S.C. 1611, organizations described in section 501(c)(4) of the Internal Revenue Code that engage in lobbying are not eligible to receive Federal funds constituting grant awards.

2. Cost Sharing or Matching

See section IV.2.B.11 of this document.

IV. Application and Submission

1. Addresses to Request Applications

FDA is accepting new applications for this program electronically via Grants.gov. Applicants are strongly encouraged to apply electronically by visiting the Web site http://www.grants.gov and following the instructions under “APPLY.” The applicant must register in the Central Contractor Registration (CCR) database in order to be able to submit the application. Information about CCR is available at http://www.grants.gov/​CCRRegister. (FDA has verified the Web site address, but FDA is not responsible for subsequent changes to the Web site after the document publishes in the Federal Register). The applicant must register with the Credential Provider for Grants.gov. Information about this requirement is available at http://www.grants.gov/​CredentialProvider. (FDA has verified the Web site address, but FDA is not responsible for subsequent changes to the Web site after the document publishes in the Federal Register). If applicants cannot submit applications through the electronic process, application forms are available from, and completed applications should be submitted to, Tya Marks, Division of Contracts and Grants Management (HFA-500), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7179, e-mail: [e-mail]. Applications hand-carried or commercially delivered should be addressed to 5630 Fishers Lane (HFA-500), rm. 2139, Rockville, MD 20857. Application instructions (PHS 5161-1 revised 7/00) and application forms (SF-424 revised 9/03) are available via the Internet at: http://www.hhs.gov/​forms.

2. Content and Form of Applications

A. Submission

If submission is electronic, the application package is posted under the “APPLY” section of this announcement under Grants.gov. The required application forms are listed under “Mandatory Documents.” They can be completed and submitted online.

If applicants are not submitting electronically, an original and two copies of the completed grant application form SF-424 (revised 9/03) should be delivered to the address listed in Addresses to Request Application in section IV of this document. The outside of the package should clearly state “Request for Conference Grant” and must be received by the appropriate submission date (see Submission Dates and Times in section IV of this document).

B. Content

Applications must include the following information:

1. Title that has the term scientific “conference,” “council,” “workshop,” or other similar description to assist in the identification of the request;

2. Location of the conference;

3. Expected number of registrants and type of audience expected, along with speaker credentials;

4. Dates of conference (inclusive). Each application must address only one specific conference;

5. Conference format and projected agenda, including list of principal areas or topics to be addressed;

6. Physical facilities required for the conduct of the meeting (e.g., simultaneous translation facilities);

7. Justification of the conference, including the problems it intends to clarify and any developments it may stimulate;

8. Brief biographical sketches of individuals responsible for planning the conference and indication of adequate support staff;

9. Information about all related conferences held by the applicant on this subject during the last 3 years (if known);

10. Details of proposed per diem/subsistence rates, transportation, printing, supplies, and facility rental costs;

11. The budget for the entire conference, budget items requested from FDA, budget items supported by other sources, and a list, including amounts, of all other anticipated support; and

12. The necessary checklist and assurance pages provided in each application package.

Some examples of allowable costs include the following items: (1) Salaries in proportion to the time or effort spent directly on the conference, (2) rental of necessary equipment, (3) travel and per diem, (4) supplies needed to conduct the meeting, (5) conference services, (6) publication costs, (7) registration fees, (8) working meals where business is transacted, and (9) speaker fees.

Some examples of nonallowable costs include the following items: (1) Purchase of equipment; (2) transportation costs exceeding coach class fares; (3) visas; (4) passports; (5) entertainment; (6) tips; (7) bar charges; (8) personal telephone calls; (9) laundry charges; (10) travel or expenses other than local mileage for local participants; (11) organization dues; (12) honoraria or other payments for the purpose of conferring distinction or communicating respect, esteem, or admiration; (13) patient care; (14) alterations or renovations; and (15) indirect costs.

Grant funds may not be used to provide general support for international scientific conferences held outside the United States or Canada. Grant funds may be awarded to a U.S. component of an international organization to provide limited support for specific segments of an international conference held outside the United States of Canada if the conference is compatible with FDA's mission. An example of such support would be a selected symposium, panel, or workshop within the conference, including the cost of planning and the cost of travel for U.S. participants for the specified segment of the scientific conference. Any Public Health Service (PHS) foreign travel restrictions that are in effect at the time of the award must be followed, including but not limited to, limitations or restrictions on countries to which travel will be supported, and budgetary or other limitations on availability of funds for foreign travel.

C. Letter of Intent

A letter of intent is not mandatory. However, applicants may submit a letter of intent to the contact (see Addressees to Request Applications in section IV of this document) at least 30 days prior to the application receipt date. Potential applicants are also encouraged to talk to the contact to determine if the proposed scientific conference is clearly consistent with FDA's interest, mission, and priorities. Potential applicants may fax letters of intent to: 301-827-7101 or e-mail: [e-mail].

3. Submission Dates and Times

Applications will be received and reviewed quarterly during each fiscal year. The receipt dates are in direct relation to the conference date and can be seen in table 1 of this document.

Table 1.—Key Receipt Dates

Earliest Beginning Conference Date	Receipt Date
December 15	October 15
March 15	January 15
June 15	April 15
September 15	July 15

If the receipt date falls on a weekend or holiday, it will be extended to the following workday. Responsive applications received after the quarterly deadline date will be held for the next review cycle if the conference date falls under the next cycle. Applications received after the quarterly deadline date for a conference within that review cycle will be returned to the applicant if not received in time for orderly processing.

Applications will be accepted during normal business hours, from 8 a.m. to 4:30 p.m., Monday through Friday, on or before the established receipt date. Applications will be considered on time if sent, mailed, or electronically submitted on or before the appropriate receipt date as evidenced by a legible U.S. Postal Service dated postmark or a legible date receipt from a commercial carrier. Private metered postmarks will not be acceptable as proof of timely mailing. Applicants should note that the U.S. Postal Service does not uniformly provide dated postmarks. Before relying on this method, applicants should check with their local post office.

4. Intergovernmental Review

The regulations issued under Executive Order 12372 may also apply to this program and are implemented through HHS regulations under 45 CFR part 100. Executive Order 12372 sets up a system for State and local government review of applications for Federal financial assistance. Applicants (other than federally recognized Indian tribal governments) should contact the State's Single Point of Contact (SPOC) as early as possible to alert them to the prospective application(s) and to receive any necessary instructions on the State's review processes. The names and addresses of SPOCs are listed on the Office of Management and Budget's (OMB's) Web site at http://www.whitehouse.gov/​omb/​grants/​spoc.html. (FDA has verified the Web site address, but FDA is not responsible for subsequent changes to the Web site after the document publishes in the Federal Register). The SPOC should send any State review process recommendations to FDA's administrative contact (see section IV of this document). The due date for the State process recommendation is no later than 60 days after the deadline date for the receipt of applications. FDA does not guarantee to accommodate or explain SPOC comments that are received after the 60-day cutoff.

5. Funding Restrictions

See section IV.2.B of this document.

6. Other Submission Requirements

See section IV.1 of this document.

V. Application Review Information

1. Criteria

Upon receipt, all applications submitted in response to this announcement will be evaluated for responsiveness to this RFA. Responsiveness is defined as submission of a complete application with original signatures within the required submission dates (see Submission Dates and Times in section IV of this document). Applications found to be nonresponsive will be returned to the applicant without further consideration.

An application will be considered nonresponsive if any of the following criteria are not met: (1) If the applicant organization is ineligible, (2) if it is received in the grants management office after the specified receipt date (see Submission Dates and Times in section IV of this document), (3) if it is incomplete or if it is missing any of the elements under Content and Form of Application in section IV of this document, (4) if it is illegible, (5) if the proposed conference is not within FDA's mission, (6) if the material presented is insufficient to determine an adequate review, and/or (7) if it exceeds the recommended threshold amount reflected in the RFA.

2. Review and Selection Process

Responsive applications will be reviewed and evaluated for their scientific and technical merit by an ad hoc review panel composed of experts in the field using the following criteria:

a. The content/subject matter and how current and appropriate it is for FDA's mission;

b. The conference plan and how thorough, reasonable, and appropriate it is for the intended audience;

c. The experience, training, and competence of the principal investigator/director and support staff;

d. The adequacy of the facilities;

e. The reasonableness of the proposed budget give the total conference plan, program, speakers, travel, and facilities; and

f. Previous experience of the organization/principal investigator.

VI. Award Administration Information

1. Award Notices

Successful applicants will be notified via Notice of Grant Award signed by the Chief Grants Management Officer, FDA.

2. Administrative and National Policy

Applications submitted under this program may be subject to the requirements of Executive Order 12372. FDA's conference grant program is described in the Catalog of Federal Domestic Assistance, No. 93.103. The applicable administrative regulations for this program are 45 CFR parts 74 and 92. The legislative authority is title XVII of the Public Health Service Act.

3. Reporting

A final Financial Status Report (SF-269) and a final progress report or conference proceedings are required. An original and two copies of these reports must be submitted to the Grants Management Office (see section VII of this document), within 90 days after the end of the budget period of the grant award. Copies of conference proceedings resulting from the meeting may be substituted for the final progress report. Failure to provide these reports in a timely manner may jeopardize future grant support or delay an award.

VII. Agency Contacts

For information regarding this program, please contact Tya Marks (see Addresses to Request Applications in section IV of this document).

VIII. Other Information

FDA strongly encourages all award recipients to provide a smoke-free workplace and to discourage the use of all tobacco products. This is consistent with FDA's mission to protect and advance the physical and mental health of the American people.

FDA is committed to achieving the health promotion and disease prevention objectives of “Healthy People 2010,” a national effort designed to reduce morbidity and mortality and to improve quality of life. Applicants may obtain a paper copy of the “Healthy People 2010” objectives, vols. I and II, for $70 ($87.50 foreign), S/N 017-000-00550-9, by writing to the Superintendent of Documents, U.S. Government Printing Office, P.O. Box 371954, Pittsburgh, PA 15250-7954. Telephone orders can be placed to 202-512-2250. The document is also available in CD-ROM format, S/N 017-001-00549-5, for $19 ($23.50 foreign), as well as on the Internet at http://www.healthypeople.gov under “Publications” (FDA has verified the Web site address, but FDA is not responsible for subsequent changes to the Web site after the document publishes in the Federal Register).

Information collection requirements requested on PHS Form SF-424 were approved and issued under OMB Circular A-102.

Data included in the application, if restricted with the legend specified in this section of the document, may be entitled to confidential treatment as trade secret or confidential commercial information within the meaning of the Freedom of Information Act (5 U.S.C. 552(b)(4)) and FDA's implementing regulations (21 CFR 20.61).

Unless disclosure is required under the Freedom of Information Act as amended (5 U.S.C. 552), as determined by the freedom of information officials of HHS or by a court, data contained in the portions of this application that have been specifically identified by page number, paragraph, etc., by the applicant as containing restricted information, shall not be used or disclosed except for evaluation purposes.

Dated: June 10, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.