Evaluating Quality Metrics for Risk-Based Surveillance of Drug Manufacturing Operations and Facilities (U01)
The goal of this project is to evaluate a set of potential quality metrics for their utility in monitoring quality across the pharmaceutical manufacturing sector. This project aids to support FDA's efforts in transforming quality oversight from a qualitative to a quantitative and expertise-based assessment in order to assure that quality drugs are available to the American public. The outcomes of the project could also be used to assist in the development of a risk-based inspection approach for domestic and foreign drug establishments.
General information about this opportunity
Last Known Status
Deleted 11/15/2015 (Archived.)
Program Number
RFA-FD-16-004 Federal Agency/Office
Agency: Department of Health and Human ServicesOffice: Food and Drug Administration
Type(s) of Assistance Offered
Cooperative Agreement Number of Awards Available
2 Who is eligible to apply/benefit from this assistance?
Applicant Eligibility
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the HHS Grants Policy Statement, are allowed. What is the process for applying and being award this assistance?
Deadlines
10/16/2015 Other Assistance Considerations
Formula and Matching Requirements
This program does not have cost sharing or matching requirements. Who do I contact about this opportunity?
Headquarters Office
Lisa KoGrants Management Specialist
Website Address
http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-16-004.html
E-mail Address
lisa.ko@fda.hhs.gov
Financial Information
Obligations
$1,000,000.00 Range and Average of Financial Assistance
Awards up to $500,000.00
