Building towards Statistically-Based Pharmaceutical Quality Standards (U01)

The summary for the Building towards Statistically-Based Pharmaceutical Quality Standards (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.

Building towards Statistically-Based Pharmaceutical Quality Standards (U01): The goal of this project is to generate data and develop a statistical sampling and analysis strategy to aid FDA/CDER policy in drafting data-based guidance in support of the use of appropriate statistical tools and standards. Specifically, the development of standards for statistical methods suitable for lot release which could be used to drive industry towards increased product and process understanding throughout the lifecycle of a product. The project will provide data, sampling and data analysis approaches to inform for the agency and the human pharmaceutical industry to advance the development of risk- and science-based standards. These projects could be split into subsets by product type, process type, manufacturing complexity and/or therapeutic index to facilitate understanding.

Federal Grant Title:	Building towards Statistically-Based Pharmaceutical Quality Standards (U01)
Federal Agency Name:	Food Drug Administration
Grant Categories:	Consumer Protection Food and Nutrition Health
Type of Opportunity:	Discretionary
Funding Opportunity Number:	RFA-FD-16-003
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:	$2,000,000
Maximum Federal Grant Award:	$1,000,000
Minimum Federal Grant Award:	none
Expected Number of Awards:	2
Cost Sharing or Matching:	No

Applicants Eligible for this Grant: County governments
City or township governments
Public housing authorities/Indian housing authorities
Native American tribal governments (Federally recognized)
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Independent school districts
Native American tribal organizations (other than Federally recognized tribal governments)
State governments
Special district governments
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Private institutions of higher education
Small businesses
For profit organizations other than small businesses
Public and State controlled institutions of higher education
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-16-003 on NIH Guide for Grants and Contracts
Grant Announcement Contact: Lisa Ko Grants Management Specialist
[email protected]

Food & Drug Administration 301-443-5869
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