Post-market Surveillance of Generic Modified Release Products (U01)

The summary for the Post-market Surveillance of Generic Modified Release Products (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.

Post-market Surveillance of Generic Modified Release Products (U01): The purpose of this study is to analyze use, substitution patterns, safety and effectiveness of generic modified release products, and compare them with their respective brand name drug products and other generic drugs with different formulation design characteristics. The outcome(s) of this study will help determine if there are differences in the patterns of use, substitution, and safety and effectiveness associated with the studied generic modified release products, and to provide further evidence regarding their substitutability for brand name drugs.

Federal Grant Title:	Post-market Surveillance of Generic Modified Release Products (U01)
Federal Agency Name:	Food Drug Administration
Grant Categories:	Consumer Protection Food and Nutrition Health
Type of Opportunity:	Discretionary
Funding Opportunity Number:	RFA-FD-15-015
Type of Funding:	Cooperative Agreement
CFDA Numbers:	93.103
CFDA Descriptions:	Food and Drug Administration_Research
Current Application Deadline:	Jun 29, 2015
Original Application Deadline:	Jun 29, 2015
Posted Date:	Apr 20, 2015
Creation Date:	Apr 20, 2015
Archive Date:	Jul 29, 2015
Total Program Funding:	$500,000
Maximum Federal Grant Award:	$500,000
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
Native American tribal organizations (other than Federally recognized tribal governments)
Private institutions of higher education
State governments
For profit organizations other than small businesses
Native American tribal governments (Federally recognized)
County governments
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Public and State controlled institutions of higher education
Small businesses
City or township governments
Public housing authorities/Indian housing authorities
Special district governments
Independent school districts
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-15-015 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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