Collaboration in Regulatory Science and Capacity to Advance Global Access to Safe Vaccines and Biological (U01)

The summary for the Collaboration in Regulatory Science and Capacity to Advance Global Access to Safe Vaccines and Biological (U01) 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:	Collaboration in Regulatory Science and Capacity to Advance Global Access to Safe Vaccines and Biological (U01)
	CFDA Number:	93.103
	CFDA Description:	Food and Drug Administration_Research
	Federal Agency Name:	Food and Drug Administration
	Category of Funding Activity:	Agriculture Business and Commerce Education Employment Labor and Training Environment Health Information and Statistics Natural Resources Regional Development Science and Technology
	Category Explanation:	Information not provided
	Opportunity Category:	Discretionary
	Funding Opportunity Number:	RFA-FD-11-011
	Document Type:	Modification to Previous Grants Notice
	Funding Instrument Type:	Cooperative Agreement
	Posted Date:	Jun 13, 2011
	Creation Date:	Jun 13, 2011
	Original Closing Date for Applications:	Jul 08, 2011
	Current Closing Date for Applications:	Jul 08, 2011
	Archive Date:	Aug 07, 2011
	Expected Number of Awards:	1
	Estimated Total Program Funding:	800,000
	Federal Grant Award Ceiling:	800,000
	Federal Grant Award Floor:	800,000
	Cost Sharing or Matching Requirement:	No

Applicants Eligible for this Grant: Others (see text field entitled "Additional Information on Eligibility" for clarification)
Additional Information on Eligibility: The Food and Drug Administration (FDA) announces its intention to accept and consider a single source application for award to the World Health Organization (WHO) in support of collaboration in regulatory science and capacity to advance global access to safe vaccines and biologicals that are of good quality and meet international standards.
Grant Description: The U.S. FDAs Center for Biologics Evaluation and Research (FDA/CBER) has been a leader and active participant in the global community to improve human health in the worlds populations over many years. Its international engagements have historically been, and continue to be, framed by a simple truth: protection of global public health against infectious disease threats translates into protection of U.S. public health. FDA, through CBER, has longstanding collaborations with the WHO in the area of vaccines and biologics. For example, the FDA/CBER has been a Pan American Health Organization (PAHO)/WHO Collaborating Center for Biological Standardization since 1998. The purpose, scope and areas of activity for each term are captured in a set of Terms of Reference (TOR) mutually agreed to by FDA/CBER and WHO and are reflective of their shared interest in supporting the quality, safety and standards work of both organizations. An important additional area is the FDA/CBER's engagement with the WHO Vaccine Prequalification Program. The WHO, through the QSS/IVB, provides advice to the United Nations Children's Fund (UNICEF) and other United Nations (UN) agencies on the acceptability, in principle, of vaccines considered for purchase by such agencies for vaccination programs they administer. An important part of the Vaccine Prequalification Program is WHO's reliance upon the national regulatory authority (NRA) of the country of manufacture of the vaccine if the NRA meets the WHO indicators that qualify it as a functional NRA. In 2009, FDA entered into a arrangement with WHO/QSS to enable FDA/CBER to serve as a reference NRA under this prequalification program, and the Center is currently a reference NRA for eight U.S. licensed vaccines including five influenza vaccines.
Link to Full Grant Announcement: http://www.fda.gov/biologicsbloodvaccines/scienceresearch/ucm251665.htm
Grant Announcement Contact: Vieda HUBBARD Grants Management Specialist Phone 301-827-7177

vieda.hubbard@fda.hhs.gov [vieda.hubbard@fda.hhs.gov]
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