Evaluating Quality Metrics for Risk-Based Surveillance of Drug Manufacturing Operations and Facilities (U01)

The summary for the Evaluating Quality Metrics for Risk-Based Surveillance of Drug Manufacturing Operations and Facilities (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 Drug Administration, which is the U.S. government agency offering this grant.
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.
Federal Grant Title: Evaluating Quality Metrics for Risk-Based Surveillance of Drug Manufacturing Operations and Facilities (U01)
Federal Agency Name: Food Drug Administration
Grant Categories: Consumer Protection Food and Nutrition Health
Type of Opportunity: Discretionary
Funding Opportunity Number: RFA-FD-16-004
Type of Funding: Cooperative Agreement
CFDA Numbers: 93.103
CFDA Descriptions: Food and Drug Administration_Research
Current Application Deadline: Oct 16, 2015
Original Application Deadline: Oct 16, 2015
Posted Date: Jul 31, 2015
Creation Date: Jul 31, 2015
Archive Date: Nov 15, 2015
Total Program Funding: $1,000,000
Maximum Federal Grant Award: $500,000
Minimum Federal Grant Award: none
Expected Number of Awards: 2
Cost Sharing or Matching: No
Applicants Eligible for this Grant
City or township governments
Independent school districts
For profit organizations other than small businesses
County governments
Public and State controlled institutions of higher education
Small businesses
Private institutions of higher education
State governments
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Native American tribal organizations (other than Federally recognized tribal governments)
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Native American tribal governments (Federally recognized)
Special district governments
Public housing authorities/Indian housing authorities
Additional Information on 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.
Link to Full Grant Announcement
Full Announcement of RFA-FD-16-004 on NIH Guide for Grants and Contracts
Grant Announcement Contact
Lisa Ko Grants Management Specialist
lisa.ko@fda.hhs.gov

Food & Drug Administration 301-443-5869
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