Apr 19, 2005
Applications will be accepted from 8 a.m. to 4:30 p.m., Monday through Friday until the established receipt date. Applications will be considered received on time if hand delivered to the address noted previously (see Addresses to Request Application in section IV.1 of this document) before the established receipt date, or sent or mailed by the receipt date as shown by a legible U.S. Postal Service dated postmark or a legible dated receipt from a commercial carrier. Private metered postmarks shall not be acceptable as proof of timely mailing. Applications not received on time will not be considered for review and will be returned to the applicant. (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). Please do not send applications to the CSR at NIH. Any application sent to NIH/CSR that is forwarded to the FDA Grants Management Office and not received in time for orderly processing will be judged nonresponsive and returned to the applicant. Applications must be submitted via U.S. mail or commercial carrier or hand delivered as stated previously. Currently, FDA is unable to receive applications electronically.
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The Food and Drug Administration (FDA) is announcing changes to its Office of Orphan Products Development (OPD) grant program for fiscal year (FY) 2006. This announcement supercedes the previous announcement of this program, which was published in the Federal Register of August 8, 2003 (68 FR 47340). Please note that there are new submission requests and requirements for this grant program. These include, but are not limited to, a requested letter of intent, a change in funding levels, a change in number of receipt dates, and changes in review criteria.
Please note when accessing the URL below to select "Federal Register, Volume 70 (2005)" search for "page 2642" and click submit.
Who can apply:
City Or Township Governments
Non-Government - General
Nonprofits Having A 501(C)(3) Status With The IRS, Other Than Institutions Of Higher Education
Nonprofits That Do Not Have A 501(C)(3) Status With The IRS, Other Than Institutions Of Higher Education
Other Private Institution/Organization
Private Institutions Of Higher Education
Private Nonprofit Institution/Organization (Includes Institutions Of Higher Education, Hospitals)
Public And State Controlled Institutions Of Higher Education
Small Business (Less Than 500 Employees
State (Includes District Of Columbia; Includes Institutions Of Higher Education And Hospitals)
U.S. Territories And Possessions (Includes Institutions Of Higher Education, Hospitals)
Eligible functional categories:
Food and Drug Administration_Research
Clinical Studies of Safety and Effectiveness of Orphan Products
If you have problems accessing the full announcement, please contact:
Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions & Grants Services