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) grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, 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 as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Food and Drug Administration, which is the U.S. government agency offering this grant.
Collaboration in Regulatory Science and Capacity to Advance Global Access to Safe Vaccines and Biological (U01): 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.
Federal Grant Title: Collaboration in Regulatory Science and Capacity to Advance Global Access to Safe Vaccines and Biological (U01)
Federal Agency Name: Food and Drug Administration
Grant Categories: Agriculture Business and Commerce Education Employment Labor and Training Environment Health Information and Statistics Natural Resources Regional Development Science and Technology
Type of Opportunity: Discretionary
Funding Opportunity Number: RFA-FD-11-011
Type of Funding: Cooperative Agreement
CFDA Numbers: 93.103
CFDA Descriptions: Food and Drug Administration_Research
Current Application Deadline: Jul 08, 2011
Original Application Deadline: Jul 08, 2011
Posted Date: Jun 13, 2011
Creation Date: Jun 13, 2011
Archive Date: Aug 07, 2011
Total Program Funding: $800,000
Maximum Federal Grant Award: $800,000
Minimum Federal Grant Award: $800,000
Expected Number of Awards: 1
Cost Sharing or Matching: 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.
Link to Full Grant Announcement
Information not provided
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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