Clinical Studies of Safety and Effectiveness of Orphan Products

The summary for the Clinical Studies of Safety and Effectiveness of Orphan Products Federal Grant is detailed below. It contains information such as the Catalog of Federal Domestic Assistance (CFDA) number, who is eligible for the grant, how much grant money will be awarded, important deadlines, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed in the Grant Announcement Contact section. If these sections are incomplete, please visit the website of the government agency that is offering this grant.


	Federal Grant Title:	Clinical Studies of Safety and Effectiveness of Orphan Products
	CFDA Number:	93.103
	CFDA Description:	Food and Drug Administration_Research
	Federal Agency Name:	Food and Drug Administration
	Category of Funding Activity:	Health
	Category Explanation:	Information not provided
	Opportunity Category:	Discretionary
	Funding Opportunity Number:	RFA-FDA-OPD-2006
	Document Type:	Modification to Previous Grants Notice
	Funding Instrument Type:	Grant
	Posted Date:	Feb 04, 2005
	Creation Date:	Feb 04, 2005
	Original Closing Date for Applications:	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.
	Current Closing Date for Applications:	Information not provided
	Archive Date:	Information not provided
	Expected Number of Awards:	10
	Estimated Total Program Funding:	$13,200,000
	Federal Grant Award Ceiling:	$350,000
	Federal Grant Award Floor:	Information not provided
	Cost Sharing or Matching Requirement:	No

Applicants Eligible for this Grant: State governments County governments City or township governments Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education For profit organizations other than small businesses Small businesses Others (see text field entitled "Additional Information on Eligibility" for clarification)
Additional Information on Eligibility: The grants are available to any foreign or domestic, public or private, for-profit or nonprofit entity (including State and local units of government). Federal agencies that are not part of the Department of Health and Human Services (HHS) may apply. Agencies that are part of HHS may not apply. For-profit entities must commit to excluding fees or profit in their request for support to receive grant awards. Organizations that engage in lobbying activities, as described in section 501(c)(4) of the Internal Revenue Code of 1968, are not eligible to receive grant awards. An application that has received two prior disapprovals is not eligible to apply.
Grant Description: 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.
Link to Full Grant Announcement: Clinical Studies of Safety and Effectiveness of Orphan Products
http://www.gpoaccess.gov/fr/index.html
Grant Announcement Contact: Polit, Cynthia, Senior Grants Management Specialist, Phone 301-827-7182, Fax 301-827-7101, Email cpolit@oc.fda.gov cpolit@oc.fda.gov Polit, Cynthia
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