Notice Number: NOT-FD-12-004
Key Dates
Release Date: May 11, 2012
Issued by
U.S. Food and Drug Administration (FDA)
Purpose
The purpose of this Notice is to update Components of Participating Organizations, Funding Restrictions, and Agency Contacts originally issued in PA-11-310.
NOW READS:
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)
SHOULD READ:
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)
NOW READS:
Section IV. Application and Submission Information
5. 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.
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.
SHOULD READ:
Section IV. Application and Submission Information
5. 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 & UNALLOWABLE COSTS:
The following highlights allowable and unallowable costs under conference grants. No costs other than those specified in this subsection are allowable, including any qualifications on their allowability, are permitted under conference grants.
1. 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.
Proposed per diem 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 lodgings are furnished without charge or at a nominal cost (e.g., as part of the registration fee), the proposed per diem allowance must take this into consideration. Per diem may not include meals/food.
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.
2. 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.
Research Patient Care - Not allowable.
NOW READS:
Financial/Grants Management Contact(s)
Stephanie D. Bogan
Grants Management Specialist
Food and Drug Administration
Office of Acquisitions and Grants
Grants and Assistance Agreements Team
Email: [email protected]
Financial/Grants Management Contact(s)
Lisa Ko
U.S. Food and Drug Administration
Office of Acquisitions and Grants Services
Grants and Assistance Agreements Team
Ph: 301-827-5095
Email: [email protected]
SHOULD READ:
Financial/Grants Management Contact(s)
Lisa Ko
U.S. Food and Drug Administration
Office of Acquisitions and Grants Services
Grants and Assistance Agreements Team
Ph: 301-827-5095
Email: [email protected]
All other aspects of the FOA remain unchanged and applicants must meet all requirements of PA-11-310.
Inquiries
Please direct all inquiries to:
Lisa Ko
Grants Management Specialist
U.S. Food and Drug Administration
Office of Acquisition and Grants Services
5630 Fishers Lane Room 1096
Rockville, MD 20857
TEL: 301-827-5095
FAX: 301-827-1044
EMAIL: [email protected]
and Human Services (HHS)
