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

Quick Facts

Due DateJune 30, 2014 (Monday)
Award AmountUp to $ 600,000
Category of Funding ActivityConsumer Protection
Food and Nutrition
Health
Eligible Applicants
  • State governments
  • County governments
  • City or township governments
  • Special district governments
  • Independent school districts
  • Public and State controlled institutions of higher education
  • Native American tribal governments (Federally recognized)
  • Public housing authorities/Indian housing authorities
  • Native American tribal organizations (other than Federally recognized tribal governments)
  • 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
  • Private institutions of higher education
  • For-profit organizations other than small businesses
  • Small businesses
  • Others - 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.

Program Description

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.

General Information

Funding Opportunity NumberRFA-FD-14-082
Funding Opportunity TitleDevelopment of an Integrated Mathematical Model for Comparative Characterization of Complex Molecules (U01)
Opportunity CategoryConsumer Protection
Food and Nutrition
Health
Funding Instrument TypeCooperative Agreement
Category ExplanationNot Available
Number of Awards1
Cost Sharing or Matching RequirementNo
Posted DateMay 19, 2014 (Monday)
Application Due DateJune 30, 2014 (Monday)
Application Archive DateJuly 30, 2014 (Wednesday)
Total Program Funding$ 600,000
Award AmountUp to $ 600,000
CFDA Number
  • 93.103 - Food and Drug Administration_Research

Eligible Applicants

  • State governments
  • County governments
  • City or township governments
  • Special district governments
  • Independent school districts
  • Public and State controlled institutions of higher education
  • Native American tribal governments (Federally recognized)
  • Public housing authorities/Indian housing authorities
  • Native American tribal organizations (other than Federally recognized tribal governments)
  • 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
  • Private institutions of higher education
  • For-profit organizations other than small businesses
  • Small businesses
  • Others - 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.

Contact Information

Agency NameDepartment of Health and Human Services
Program Information WebsiteFull Announcement RFA-FD-14-082
ContactOffice: Food & Drug Administration
Lisa Ko
Grants Management Specialist
lisa.ko@fda.hhs.gov

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