Development of an Integrated Mathematical Model for Comparative Characterization of Complex Molecules (U01)

The summary for the Development of an Integrated Mathematical Model for Comparative Characterization of Complex Molecules (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.

Development of an Integrated Mathematical Model for Comparative Characterization of Complex Molecules (U01): The goal of this project is to develop a mathematical algorithm or model to integrate in vitro chemical and biological characterization data to determine the degree of sufficiency of in vitro chemical and biological characterization assays, with respect to demonstrating similarity or sameness of the follow-on or generic version of macromolecules or complex drug substances to their reference products. The integrated mathematical and analytical approach developed in this project is expected to provide a "coherent picture" of molecular structure for complex macromolecules or drug substances, and thus may help to determine the extent to which the preclinical and/or clinical studies will be needed for generic or follow-on version of drug products containing these complex molecules.

Federal Grant Title:	Development of an Integrated Mathematical Model for Comparative Characterization of Complex Molecules (U01)
Federal Agency Name:	Food Drug Administration
Grant Categories:	Consumer Protection Food and Nutrition Health
Type of Opportunity:	Discretionary
Funding Opportunity Number:	RFA-FD-14-082
Type of Funding:	Cooperative Agreement
CFDA Numbers:	93.103
CFDA Descriptions:	Food and Drug Administration_Research
Current Application Deadline:	Jun 30, 2014
Original Application Deadline:	Jun 30, 2014
Posted Date:	May 19, 2014
Creation Date:	May 19, 2014
Archive Date:	Jul 30, 2014
Total Program Funding:	$600,000
Maximum Federal Grant Award:	$600,000
Minimum Federal Grant Award:	none
Expected Number of Awards:	1
Cost Sharing or Matching:	No

Applicants Eligible for this Grant: 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
Special district governments
Small businesses
County governments
City or township governments
Public housing authorities/Indian housing authorities
Native American tribal governments (Federally recognized)
Public and State controlled institutions of higher education
Independent school districts
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Private institutions of higher education
Native American tribal organizations (other than Federally recognized tribal governments)
For profit organizations other than small businesses
State governments
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 RFA-FD-14-082
Grant Announcement Contact: Lisa Ko Grants Management Specialist
[email protected]

Food & Drug Administration 301-443-5869
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